for Action on Essential Medicines in Africa 2002-2008 ...for Action on Essential Medicines in Africa...

WHO-HAI Africa Regional Collaboration for Action on Essential Medicines in Africa 2002-2008 Evaluation January - April 2009 Final Report to DFID August 2009 Nel Druce, Pascale Brudon and Dieneba Kone Bamba DFID Health Resource Centre 5-23 Old Street London EC1V 9HL Tel: +44 (0) 207 251 9555 Fax: +44 (0) 207 251 9552

The DFID Health Resource Centre (HRC) provides technical assistance and information to the British Government’s Department for International Development (DFID) and its partners in support of pro-poor health policies, financing and services. The HRC is based at HLSP's London office and consists of an international consortium of three organisations: HLSP Ltd, UK; Ifakara Health Research and Development Centre, Tanzania (IHRDC) and ICDDR,B - Centre for Health and Population Research, Bangladesh. This report was produced by the Health Resource Centre on behalf of the Department for International Development, and does not necessarily represent the views or the policy of DFID. Title: WHO-HAI Africa Regional Collaboration for Action on Essential Medicines in Africa 2002-2008 Evaluation January to April 2009 Final report Author: Nel Druce, Pascale Brudon and Dieneba Kone Bamba Date: August 2009 DFID Health Resource Centre 5-23 Old Street London EC1V 9HL Tel: +44 (0) 20 7251 9555 Fax: +44 (0) 20 7251 9552

WHO-HAI Africa Regional Collaboration for Action on Essential Medicines in Africa 2002-2008 Evaluation report to DFID, August 2009

DFID HRC ref: 254835 3

ACKNOWLEDGEMENTS The evaluation team would like to sincerely thank staff at WHO, HAI Africa and all stakeholders interviewed at global, regional and country levels for their time and insights into the Programme, and all those responding to the evaluation questionnaires in the 15 countries participating in the Programme. We would also like to thank the NPOs and colleagues in Country Offices and the DFID Health Resource Centre for their assistance with logistics. However, the team takes full responsibility for the content of the report and for the conclusions and recommendations made. ACRONYMS AFRO WHO Regional Office for Africa AIDS Acquired Immune Deficiency Syndrome ARV Anti-retroviral ATM Access to medicines CEMAC Communauté Économique et Monétaire de l'Afrique Centrale

(Economic and Monetary Community of Central Africa) CO WHO Country Office CSO Civil Society Organisation EAC East African Community EC European Commission ECOWAS Economic Community of West African States EDM Essential Drugs and Medicines Policy GLP Good Laboratory Practices HIV Human Immuno-deficiency Virus Geneva HQ WHO Headquarters ICT Inter Country Support Team INRUD International Network for the Rational Use of Drugs IP Intellectual Property IPR Intellectual Property Rights MOH Ministry of Health MRA Medicines Regulatory Authority MSH Management Sciences for Health MTR Mid-Term Review NGO Non-Government Organization NMP National Medicines Policy NMR National Medicines Regulation NPO National Professional Officer REC Regional Economic Community SADC Southern Africa Development Community STG Standard Treatment Guidelines TA Technical assistance TB Tuberculosis TCM Technical Cooperation for Essential Drugs and Traditional Medicines,

WHO HQ TFDA Tanzania Food and Drug Authority TOR Terms of Reference TRIPS Trade-Related Aspects of Intellectual Property Rights UEMOA Union Economique et Monétaire Ouest Africaine (Economic and

Monetary Union of West Africa) WHO World Health Organization WMS WHO Medicines Strategy 2004-2007 WR WHO Representative WTO World Trade Organization



TABLE OF CONTENTS

1 EXECUTIVE SUMMARY......................................................................................... 6

1.1 Introduction and evaluation approach.............................................................................. 6

1.2 Programme description and context ................................................................................ 6

1.3 Programme achievements............................................................................................... 7

1.4 Programme challenges and limitations ............................................................................ 9

1.5 Added value of the Programme ......................................................................................10

1.6 Programme lessons learnt..............................................................................................11

1.7 Conclusions and recommendations................................................................................12

2 INTRODUCTION ................................................................................................... 16

2.1 The scope of the evaluation............................................................................................16

2.2 Programme description ..................................................................................................16

2.3 Evaluation approach and method ...................................................................................18

2.4 Global and national context ............................................................................................19

3 PROGRAMME ACHIEVEMENTS AGAINST GOAL AND PURPOSE.................. 23

3.1 Contribution to achieving the Programme goal ...............................................................23

3.2 Achievement of Programme purpose..............................................................................25

4 PROGRAMME ACHIEVEMENTS AGAINST OUTPUTS...................................... 31

4.1 Progress in WHO WMS country outcomes .....................................................................31

4.2 Progress in HAI Africa outputs........................................................................................39

5 MANAGEMENT, FINANCING AND OPERATIONAL ISSUES............................. 45

5.1 WHO at national, regional and global levels ...................................................................45

5.2 HAI Africa .......................................................................................................................47

5.3 Programme financing .....................................................................................................47

5.4 Role of DFID...................................................................................................................48

6 CHALLENGES, LIMITATIONS AND RISK MANAGEMENT................................ 49

6.1 Contextual challenges ....................................................................................................49



6.2 Organisational factors.....................................................................................................50

6.3 Programme risks and limitations.....................................................................................51

7 ADDED VALUE..................................................................................................... 53

7.1 Added value of the WHO NPO programme ....................................................................53

7.2 Added value of collaboration with HAI Africa ..................................................................54

8 LESSONS LEARNT AND OPPORTUNITIES ....................................................... 55

8.1 WHO has significant comparative advantage in essential medicines, put into practice by the NPO network ..................................................................................................................55

8.2 Focused support is needed for civil society engagement................................................55

8.3 Balancing national priorities with promoting other critical concerns.................................55

8.4 Complementary strategic and technical roles for WHO at country level ..........................55

8.5 Flexible and innovative funding arrangements by DFID have benefited the programme.56

8.6 Resources are needed at regional and global as well as national levels to deliver country outcomes..............................................................................................................................56

9 CONCLUSIONS AND RECOMMENDATIONS ..................................................... 57

ANNEX 1: EVALUATION TERMS OF REFERENCE .............................................. 63

ANNEX 2: PERSONS INTERVIEWED..................................................................... 67

ANNEX 3: DOCUMENTS CONSULTED.................................................................. 71



1 EXECUTIVE SUMMARY

1.1 Introduction and evaluation approach DFID has been financing the Programme for WHO-HAI Africa Regional Collaboration for Action on Essential Medicines in Africa 2002 – 2008 through a contribution of £6 million. This report provides an evaluation of the Programme, and draws out lessons learned for WHO’s health systems and medicines strategy, for the role and participation of civil society, and for initiatives such as the multi-stakeholder Medicines Transparency Alliance (MeTA), and WHO’s project on Good Governance for Medicines. The evaluation covers the three components supported by DFID:

• WHO Medicines National Professional Officer (EDM/NPO) salaries and activity costs in 15 countries (Cameroon, Central African Republic, Chad, Congo Republic, Democratic Republic of Congo, Ethiopia, Ghana, Kenya, Mali, Nigeria, Rwanda, Senegal, Tanzania, Uganda, and Zambia), together with technical support, training and supervision provided by WHO Geneva and AFRO, and external consultants.

• Separate funding to HAI Africa, a civil society network based in Kenya, to support advocacy, research, network development and capacity building.

• Funding earmarked within each organisation’s budget for additional collaborative activities undertaken with civil society and government in three selected countries with NPOs (Ghana, Kenya and Uganda).

The evaluation methodology included a review of programme documentation, data from WHO’s periodic surveys (Level 1 surveys in 2003 and 2007), surveys carried out by WHO and HAI Africa on availability and affordability in 14 countries, and other national studies. Team members visited four countries with NPOs (Congo Republic, Ethiopia, Senegal, Tanzania), and one without (Malawi), as well as WHO regional and headquarter offices, interviewing over 160 stakeholders. Analysis draws on responses to questionnaires sent to all NPOs, WHO Representatives (WRs) and national counterparts (n = 45). The evaluation also refers to the DFID review of the Collaboration in 2004 and the participatory review commissioned by WHO and HAI Africa in 2007/8 visits to Kenya, Uganda and Ghana.

1.2 Programme description and context The Programme provided WHO and HAI Africa with finance to increase levels of technical support at country level, for the common purpose of strengthening collaboration and capacity in government and in civil society for improving policy and practice on access to affordable, quality medicines and rational use. Two important and innovative features of the Programme model were: a) creation by WHO of new positions for NPOs or medicines advisers, based in Country Offices; and b) channelling funds to WHO and civil society for separate and joint actions, on the premise that both have key roles to play in improving access, and that ‘when diverse stakeholders such as governments, CSOs and WHO work collaboratively to improve access to medicines, they are able to achieve greater impact toward common goals’. DFID and WHO agreed that the WHO Medicines Strategy (WMS): Countries at the Core 2004-2007 should provide the framework for planning and monitoring country expected outcomes under its four objectives of policy, access, quality and safety and rational use. HAI Africa’s logframe has separate outputs concerned with building network capacity, convening civil society stakeholders and providing information and support to national and regional research and policy-advocacy. WHO and HAI Africa developed an additional logframe to jointly manage their Collaborative outputs in Kenya, Ghana and Uganda. Programme funding comprised approximately £1million pa over six years, 75% to WHO and 25% to HAI Africa. One year no cost extensions were agreed in 2008 for both organisations. The Programme has developed in a changing national and global context, which has brought challenges and opportunities. Commitments and funding from the international community to



the health sector have increased dramatically, especially for TB, AIDS, malaria and immunisation, through the GFATM, GAVI, PEPFAR, UNITAID and other initiatives. Following early focus on targeted programmes, there is now growing emphasis on addressing essential medicines supplies as a core health systems component, and funders such as GFATM, GAVI and PEPFAR now fund health system strengthening activities. WHO maintains a critical and unique role in medicines – in developing global norms and standards, and in support to government and other stakeholders for safe, effective and affordable health products and technologies. This role has gained prominence as one of WHO’s 13 new medium term strategic plan objectives, 2008-2013. WHO is a key global partner in aid effectiveness efforts, and a player in country efforts to improve harmonisation and alignment, through the IHP+, and good governance initiatives. Equally important, WHO continues to implement its strategy for intensifying country support and decentralisation, to which this Programme contributes. Recognition by global and regional initiatives (such as IHP+ and the Global Fund) of civil society’s contribution to governance, policy, and monitoring, in addition to service delivery, is providing a more favourable environment for better inclusion of civil society, and also for WHO to facilitate partnership and collaboration. The role for civil society in contributing to service delivery, especially in the field of HIV and AIDS has been elevated with involvement in many treatment programmes. In sub Saharan Africa, the emergency of faith based initiatives as a critical source of service delivery is well documented. However, capacity for and inclusion by government of civil society in governance initiatives (such as independent monitoring) and policy dialogue remains weak and fragmented at national, regional and international levels.

1.3 Programme achievements The medicines NPO programme has been a relevant and successful approach to enabling improvements in WMS country outcome indicators especially in areas of policy, access, and quality and safety. The programme has prioritised capacity building and technical inputs to policy, regulation, procurement and supply management, pharmaceutical situation assessment and research to improve the evidence base for access (availability, affordability and price surveys). NPOs have enabled counterparts to achieve more, more rapidly to deliver national plan activities – on average, national activity budgets and implementation rates are significantly higher in NPO countries. Data collection and the evidence base for the sector have been strengthened: for the first time there have been methodologically sound assessments conducted of the pharmaceutical situation, of procurement and supply systems, and of medicine availability and affordability (with comprehensive WHO HAI Africa surveys undertaken in 14 and published in 11 of the 15 countries). In four countries, where the Programme has supported joint work with HAI Africa and network members (Kenya, Uganda, Ghana and also, not originally planned, in Tanzania), regular monitoring of availability and prices has taken place, providing a rich source of evidence for advocacy on improving access. The NPO in Nigeria has initiated monitoring activities, with limited involvement of HAI Africa. NPOs have supported a range of policy outputs, including new national medicines policies, updated essential medicines lists and standard treatment guidelines. These have been drawing fully on WHO tools and guidance, and are based on thorough national situation assessments. There are many examples of effective WHO support for building national institutions and systems. In Tanzania, for example, capacity and performance in the major agencies responsible for procurement and supply management (Medical Stores Department), and for product quality and safety (Tanzanian Food and Drugs Authority) have greatly improved over



the programme period. The TFDA is now recognised as most developed among regulatory agencies in the region. Improving co-ordination among other government agencies, disease programmes and with other stakeholders has been a programme priority. National medicines policies have been developed in consultation with cross sectoral working groups (often including stakeholders such as the private sector, NGOs and development partners). In several countries, including Tanzania and Uganda, the NPO supported setting up pharmaceutical technical working groups under the sector wide approach. In Congo Republic, the NPO spearheaded the organisation of a high level round table in 2008 on the problems related to medicines, and in Senegal, the NPO helped convene several high level workshops for the national policy, rational use and pharmacovigilance. In the three Collaboration countries, and in Tanzania, WHO has supported country working groups with the national pharmacy department and HAI Africa, and convened multi-stakeholder groups to review the medicines price and availability monitoring data. NPOs have also successfully promoted collaborative work across disease programmes, especially for introducing new anti-malarial medicines and ARVs (market assessment, surveillance and monitoring, procurement and treatment policies). They have used programme needs for new product introduction as an entry point for wider procurement and regulatory system strengthening. In Kenya, the counterpart cites research and policy work with the malaria programme and the regulatory agency that has facilitated their working together in a more coherent way. In Tanzania, Senegal and Congo Republic, NPOs have provided technical advice on ACT policy, including free access in Congo. NPOs have also improved the design and implementation for medicines procurement and supply management in funding proposals. For example, in Congo Republic and Tanzania, NPOs have led in developing pharmaceutical components for Global Fund proposals. With respect to WHO, the Programme’s approach and ways of working have been effective ones. The Programme has both drawn on and helped strengthen WHO’s value and profile as a strategic as well as technical partner in the area of pharmaceuticals, especially in the public sector. The effectiveness of the overall Programme approach has been assisted by the WHO Medicines Strategy, which is based on national priorities and is in part implemented through the NPO programme. The Programme has had a strong country focus, with plans and activities owned by the government. The Programme approach has taken the form of intensive engagement and facilitation of actions by the WHO NPO among key stakeholders, enabled by limited funding for nationally planned and prioritised activities, and support for government leadership. As a respected national expert in pharmacy, NPOs have drawn effectively upon their local knowledge and contacts, and on regional and global technical resources. NPOs are scored highly by those national counterparts responding to the questionnaire (11 of 16 including Zanzibar), in terms of their knowledge, access to resources, networks and ability to accelerate a wide range of national processes. The Programme has built a cadre of skilled regional professionals. HAI Africa’s achievements include a strong and well justified regional reputation (albeit mainly in anglophone countries) for providing professional expertise and convening a rights-based consumer voice on medicines issues. It has a unique niche, repeatedly cited as the only NGO in Africa that takes a system wide approach to essential medicines. HAI Africa is also credited with drawing together issue based NGOs (e.g. ARV and malaria treatment access groups) and raising the medicines profile in wider health rights networks such as EQUINET. Contributions to regional and global policy fora, such as the East Africa Community and promoting an African consensus on the need to protect public health safeguards in trade negotiations, and the World Health Assembly Resolution on rational use of medicines, are widely recognised. HAI Africa has worked with several organizations in the region to spearhead civil society input to the policy discussions of WHO’s intergovernmental Working Group on Innovation, Public Health and Intellectual Property (IGWG). Efforts in building capacity of member groups are also acknowledged, especially with HEPS Uganda,



and engaging national health networks and coalitions in new national activities for access to medicines in countries including Malawi, Zambia and Zimbabwe (notably the new Stop Stockouts campaign). HAI Africa and WHO have together successfully improved collaboration among MOHs, WHO and HAI Africa’s network of CSOs to produce research and policy-related outputs, in Kenya, Ghana and Uganda. The project has created the stimulus and provided resources for joint research and policy development, drawing on the existing effective partnership work by WHO and HAI on the pricing survey, and their regional and global reputations. There is now tripartite ownership over substantial areas of work, and the involvement of civil society has helped build confidence in the value of robust and independent research. The Collaboration has provided a concrete and funded mechanism for building a positive attitude to dialogue and joint working between partners, especially in opening a new (and previously closed) door for civil society, for involving academia, and for seizing opportunities such as links with disease control programmes in Kenya and Uganda, and the national insurance scheme in Ghana.

1.4 Programme challenges and limitations While achievements in capacity for policy and regulatory frameworks are substantial, progress in their implementation – and contributing to the goal of improved access, quality and safety and rational use by consumers and providers - is less encouraging. Comparative data on access, quality, safety and rational use across the six years is limited, although the Programme itself has generated robust baseline data and follow up surveys in some countries. Where trend data exists (in the four countries where monitoring on availability and affordability is taking place), the picture for improved availability across public, private and faith based sectors is mixed. For example, in Uganda, availability has improved in public and mission sectors, while in Kenya, internal conflict in early 2008 interrupted the positive trend. The effectiveness of the programme is limited by external factors: the weak capacity of national administrations, limited vision for public health and the pharmaceutical sector, the need for better governance, and still weak strategies for policy implementation and coordination among stakeholders, especially civil society and the non state sector. Indeed, the most difficult part of the work is likely to be over the next five years - to translate the many policies, plans and guidelines into practices which will make access to quality essential medicines a reality for the people. The Programme has done best in WHO core areas of expertise: in its evidence based approach to medicines policy, selection of medicines and the essential medicines list, supply management, and in normative work to improve rational use, quality and safety. WHO has less experience in medicine financing and affordability issues, and in collaborating with others on rational use. These issues are widely acknowledged by all stakeholders, including at the global level, as major challenges. Defining and assessing the impact of policy interventions on consumer prices continues to be technically and politically challenging. Partners also recognise the need to do much more regarding provider and consumer education, for better health outcomes and value for money. The World Health Assembly’s Resolution on Rational Use of Medicines in 2007, following robust leadership from Kenya, with NPO support, should facilitate greater efforts. Internal constraints and challenges are also important to note. Despite of its central importance to WHO’s strategy, continued finance for country support through NPOs is a major concern. Recently introduced ceilings on budgets linked to WHO’s strategic objectives may be preventing allocations to staff salaries and government tends to prefer activity funds. However, it is encouraging that five WHO country offices (Central Africa, Democratic Republic of Congo, Ghana, Nigeria, and Uganda) have included 100% NPO salary costs in the regular budget, and Tanzania is contributing 50%. New donors such as UNITAID and



philanthropic foundations tend to be willing to spend only a small percentage of funds on NPOs and country based activities. There are good working relationships between the WHO Geneva staff managing the Programme and the AFRO Regional Advisers, and mutual understanding of the reporting, financing and accountability lines (NPO – Country Office WHO Representative – AFRO). However, co-ordination of country support by WHO is sometimes challenging, given AFRO’s lead role in technical support and Geneva’s responsibility for developing norms and standards. A continual balancing act between country priorities and new work for norms and standards, which requires country input, is needed, together with robust mechanisms for co-ordinating demand on countries and supporting requests for technical assistance by AFRO and Geneva. Geneva remains overall accountable for programme finances and responsible for its delivery, although the lead on staff management lies with the WR, and with AFRO. This means that Geneva is accountable to donors without always being able to influence major decisions in relation to NPOs. The choice and performance of the NPO are the most important factors for success in the programme. To be effective, they also need support from the WHO Representative, from the Regional Office and HQ and from their colleagues in the NPO network. Their mainly technical role is not always complemented by a strong strategic one. This may be limiting WHO’s ability to provide effective support at country level in some areas, such as health system strengthening. Integration of the Geneva medicines department into the Health Systems cluster is beginning, which presents tremendous opportunities as well as challenges. As yet, there seems to be limited knowledge within the Health Systems cluster of the NPO programme, and limited links with important initiatives such as the IHP+ agenda. For example, in Ethiopia the NPO and counterpart had planned but did not implement the procurement mapping process, although procurement is one of six issues in the 2009 ministerial communiqué. For HAI Africa, its new regional campaign, such as Stop Stockouts, demonstrate its growing competence, credibility and confidence in using its ‘flagship’ evidence base to influence policy and implementation. However, overall advocacy and communication activities need further expertise and expansion, in terms of building both civil society’s challenge function and consumer awareness strategies to improve access. Similarly, although some effort has taken place on rational use, consumer organisations have an as yet unfilled role to play. Last, the Secretariat is small and likely to remain so, which means that HAI Africa and its board must continue to be highly strategic in selecting a limited number of activities, focusing on those that will have the most impact. While new joint funding with WHO might not be an appropriate funding strategy, both organisations need to consider how best to continue their effective collaboration.

1.5 Added value of the Programme The Programme’s achievements have had added value (enabling or accelerating change that would have otherwise been less likely to take place), demonstrated in the following examples. Increased profile for essential medicines concept and evidence based medicines policy: Tools, data and the evidence base for assessing the pharmaceutical sector now exist. This has supported collection of robust, high quality baseline information, much better knowledge of national medicines situations, which support evidence-based policy, drawing on WHO standards, strategies and methods. Increased capacity and recognition for the regulatory, procurement and supply system: There are many examples of effective WHO support, with partners, for building institutional sustainability and systems. The introduction of new medicines has been used strategically as



a platform or entry point for strengthening wider systems. Weak governance and limited transparency is recognized as a major issue more than before. Funding leveraged: NPOs have secured more attention and funding for both essential drugs and for development of the pharmaceutical system and services, and helped make the best use of those resources through strategic investments and promoting co-ordination. Additional finance has been leveraged from the EC, donors such as the Gates Foundation, national development partners and through support to Global Fund proposals. Improved co-ordination among government programmes, development partners, civil society and others: The approach has enabled significant progress in collaboration on pharmaceuticals in the health sector, across disease programmes and between public, private and not for profit sectors. A leading development partner in Tanzania commented: ‘I do want to commend your leadership – just what we need for technical staff in WHO.’ Support for and inclusion of a credible civil society voice: The Collaboration activities and results have also delivered significant added value for HAI Africa, enhancing credibility, respect and inclusion in the three focus countries. At national level, this also helps fulfil government commitments to support great civil society involvement in policy processes and sector wide approaches that emphasize the need for partnership with the NGOs in health policy dialogue and delivery. Enhanced regional linkages and initiatives: while not envisaged as a major focus of the programme, the Programme’s network approach, where NPOs work together across regional economic communities has promoted new regional initiatives. This is particularly the case for the East Africa Community, where NPOs are supporting working groups for pooled procurement, pricing policy development and harmonisation of regulatory processes.

1.6 Programme lessons learnt WHO has significant comparative advantage in essential medicines, which NPOs have been able to put into practice at country level: WHO’s independence, its trusted relationship with the ministry of health and its global expertise and normative role has enabled the medicines NPOs to influence counterparts to develop the evidence base, to try innovative approaches, such as promoting collaboration with civil society and the private sector, and to promote investment in pharmaceutical system capacity. The model well illustrates WHO’s vision that the NPOs provide ‘an open window on WHO for national counterparts’. Findings show that, to be successful, support is needed from the WR, from the RO and HQ and from colleagues in the network. The active NPO network and annual regional meetings are an integral part of the programme’s success. Focused and formal models of support are needed for civil society engagement: The Programme component to fund and promote collaboration with civil society has encouraged very new ways of working by WHO – working actively to involve civil society as a partner in policy dialogue and a challenge function with government. WHO has been able to broker effective and productive relationships with civil society and others, where Collaborative activities were specifically sponsored by Programme funding for formal working arrangements for WHO and HAI Africa. However, in the others, engagement tends to be weaker and poorly institutionalised. Specific resources and focused effort from AFRO and HQ are needed to stimulate this. Balancing national priorities with promoting other critical concerns: It has been critical to focus effort on priorities of the country, in order to have strong country ownership. However, this has meant less dialogue on, and technical support to, appropriate strategies for promoting rational drug use. This is a missed opportunity, given the significant investments in introducing new and costly medicines. It is positive that HAI Africa is working with several AIDS treatment action campaigns, for whom adherence is of major importance.



Complementary strategic and technical roles for WHO at country level: The most effective approach lies in WHO Country Office capability to complement technical inputs (provided by NPOs) with strategic ones (provided to some extent by the NPO but mainly by the WR and RO/HQ teams). In the best performing countries, the WR is using their position to play a complementary high level strategic and advisory role – recognised by government and valued by other development partners. In countries where this strategic role is weaker, the profile of medicines as a systems issue is less obvious, and support for disease programme efforts is less likely to be linked to wider investment in the health system. Flexible and innovative funding arrangements by DFID have benefited the programme: DFID’s willingness to provide flexible support to WHO’s own strategy, the WMS, is in line with principles for aid effectiveness and reduces transaction costs. Other donors are keen to support global work but reluctant to fund country support. However, the DFID example has encouraged other donors such as the EC to adopt a similar approach. In addition, DFID was a strong promoter of the collaborative component of the programme, and funding for HAI Africa. Without this spur, strong engagement between WHO and HAI Africa as partners would have been unlikely. Resources are needed at regional and global as well as national levels to deliver country outcomes: Programme success lies in effective global and regional support to national efforts. Geneva and AFRO medicines teams have worked together in securing NPO funding, developing and supporting country-led workplans and providing appropriate technical assistance. For civil society partnerships, the normative, technical and institutional support from WHO’s advisors at all three levels, have helped to open the door wider for civil society to engage in policy level discussions with government officials. The role of HAI Africa as a regional secretariat (including links to HAI Global and partnership with WHO), has been equally critical. Both ministry officials and HAI Africa members refer to the role that HAI Africa Secretariat plays in providing credibility and confidence for country level activities with CSOs linked to HAI Africa. These are important lessons for initiatives such as MeTA.

1.7 Conclusions and recommendations WHO Medicines Strategy indicators demonstrate significant and overarching improvements in the policy and regulatory environment in the selected countries from 2003 to 2007. NPOs have enabled a robust evidence base for the sector, secured more attention and funding for both essential drugs and for development of the pharmaceutical system and services, and helped make the best use of those resources through strategic investments and promoting co-ordination. However, limited progress on access, quality and other indicators (where data exists) highlights the gap between a sound policy framework and the challenges in implementing it. These lie both in the wider context (especially with regard to the complexity of the medicines supply chain and limited capacity and hierarchical position of national counterparts) and in aspects of WHO’s own strategy and human resources capacity. Much of this will require more strategic engagement and advocacy on pharmaceutical issues by WHO at sector policy level as part of wider advocacy for health system strengthening and the re-vitalisation of primary health care as well as technical inputs. WHO is an important player and is expected to be a strong voice and support in relation to medicines. There is great potential in harnessing the Health System Cluster’s expertise at HQ and AFRO for ensuring that medicines are a key component of core system issues such as health financing and human resources. A stronger WHO ‘position’ is needed for a balanced approach to systems and disease programme support. This implies both more emphasis on WHO’s upstream role with sector donors and ministry senior management and a more co-ordinated and strategic role for WHO’s Health Systems teams in country offices. The success of the Programme approach depends on complementary roles for the WR, in strategic leadership, and for the NPO, as



technical expert. This works well in some countries, but could be more effective in others. Some WHO initiatives are appreciated by government but are not yet well known to other stakeholders, for example the Good Governance for Medicines, medicine monitoring and the procurement and supply chain mapping exercise. WHO’s recognised primary partner is government, but the emphasis of both WHO and government still tends to be the public sector. The agency has an important but as yet under-developed role to play in facilitating the government’s stewardship role for the pharmaceutical sub sector as a whole – supporting affordable access across private and public providers, similar indeed to its accepted role in quality and safety. First steps have been taken in multi-stakeholder working with civil society, especially through the collaborative work with HAI Africa and its members. Working with civil society is challenging, given weak capacity and legitimacy. WHO has demonstrated that it can play an effective broker role, with specific funds and resources, and that this approach delivers results, contributing for example to improved accountability. However, although engagement with civil society is part of WHO’s Medium Term Strategic Plan, strategies for inclusion in good governance initiatives and policy dialogue do not appear to be systematically supported at country or regional level. Recommendations for WHO’s broader strategy 1 Medicines must be an integral component of WHO’s vision for health policy and systems, and for revitalising primary health care. The inclusion of medicines in the Health Systems cluster in both HQ and in AFRO provides a significant opportunity to develop and promote this vision at all levels. WHO is recommended to develop a clearer position on its comparative advantage in pharmaceuticals and to bring this to bear at global and regional levels, as well in countries, with its development partners. 2 Decentralisation and intensifying country support is a priority for WHO. This Programme demonstrates the importance of well selected and supported NPOs, with small but adequate activity budgets, in accelerating country progress. WHO is recommended to ensure that the emerging vision and strategy for the Health Systems Cluster (and the medicines component) includes a substantive component for country support that builds on lessons learnt (and which may also assist in prioritising activities under the new WMS). 3 Country offices play both technical and strategic roles at country level in the health system strengthening agenda (including good governance, rational use, financing and affordability, integrated procurement and supply management, and adequate human resources). WHO is recommended to ensure that COs are strategically addressing (and promoting harmonisation and alignment with other partners) the medicines agenda at high level donor and government fora as part of action plans for new primary health care and health system strengthening. 4 Weak governance is a major barrier to improving medicines access. WHO’s role in promoting a common message on good governance is critical and the Good Governance for Medicines project is appreciated by government. WHO is in a unique position to promote dialogue and engagement by government with other sectors including civil society and the private sector, and promote increased participation in fora for policy development and dialogue. WHO is advised to strengthen its effort across the organisation for working with other partners and to promote the inclusion of, as a priority, stakeholders such as civil society in accountability and transparency efforts, such as MeTA.



Recommendations for WHO Medicines NPO Programme 5 This review has highlighted the importance of national context in influencing Programme progress, and the need for appropriate staffing. In many countries, an NPO with good support and well integrated into the WHO country team may be the best strategy. Where a multiplicity of international partners is working, it may be necessary to have an international staff. This could include recruiting a wider range of expertise in the NPO network or drawing upon new expertise in the AFRO and Geneva health systems teams. Short rotation of HQ or AFRO staff to countries may be considered when dealing with a specific problem. WHO is recommended to assess the specific national situations and priorities, develop tailored country support strategies and objectives, and staff the country office accordingly. 6 The NPO’s effective role is critical to country support, but the cadre is a whole is not systematically supported by WHO across the organisation in terms of career development and performance management. WHO may need to consider the career development structure for this (and indeed other) NPO cadres and to review the mechanisms in place for WHO HQ and RO to evaluate and improve their performance in close collaboration with the WR. 7 Programme financing is not secured, and it is likely that a template approach is no longer appropriate, but that different sub-regions and country contexts will require different models. WHO needs to work together with its external partners at national and global levels to find ways to finance the NPO within WHO but with a mandate supported by all of them. WHO Geneva and AFRO should develop the Programme and financing strategies together – and much will depend on donor preferences and trends. 8 With the emphasis on implementation for improved access, quality and safety, and rational use, the Programme is recommended to promote and strengthen access to technical expertise in:

• better use of research data, especially medicines monitoring information, to support a) advocacy and communication activities with a wider group of policy makers, civil society organisations, consumers and the public at large (as proposed by MeTA) and b) the development, implementation and monitoring of policy objectives (e.g. components of a pricing policy) and sector level monitoring indicators;

• financing and affordability issues, including pricing policies and their implementation, drawing on WHO Health System Cluster expertise; and

• working with HAI Africa and others, developing an evidence based approach for improving rational use among consumers as well as providers.

9 WHO is recommended to strengthen inclusive strategies for involving civil society and the non-state sector in for example, mechanisms such as MeTA for increased national and local accountability for drug availability and pricing, stakeholder based strategies for consumer and provider education for rational use, and development of public private partnerships for pharmaceuticals (such as the ADDO scheme in Tanzania). 10 WHO is recommended to consider further how to maximise potential for impact at regional level, given that only limited progress has been possible in the absence of capacity at the health desks of the regional economic community organisations, and continue working with others to fund and recruit regional posts. Recommendations for HAI Africa 11 Progress has been made in developing the HAI Africa Network, but it needs further effort to define the Network model and involve members more actively in regionally supported campaigns that have national objectives. The Collaboration project of HAI Africa, carrying out the availability and pricing surveys with WHO, produces much excellent information, but publicity for the various activities on medicines policy and research is still lacking. The high degree of labour and resource investment in conducting the pricing surveys makes it even



more imperative to undertake the incremental additional effort needed to ensure policy impact. It will also be important for WHO and HAI Africa to continue to work together even in the absence of joint Programme funding. HAI Africa is recommended to:

• deepen Africa-wide campaigns in furtherance of HAI Africa's objectives, such as the recently launched Stop Stockouts campaign to eliminate pharmaceutical stockouts (drawing on the evidence base collected by country members).

• further develop resources and ensure it has capacity to build skills in advocacy and communications with its network members who are conducting county level campaigns.

• continue its role in convening civil society, facilitating an expert civil society voice and consensus positions, and communicating this in regional and global policy fora, including the African Union.

• consider the case for all the publications it now leads on, in terms of whether their impact justifies the significant investment in time.

Recommendations for DFID 12 DFID’s flexible funding has been a success factor for the Programme, in particular its support for the WMS and to joint work with civil society. DFID finance is now channelled through UK regular contributions to WHO, and to regional (eg the Southern African Regional Programme for Access to Medicines) and (more rarely, given DFID’s commitment to budget support) support to WHO (eg Burundi). DFID is recommended to continue advocating at all levels for WHO’s vision for health policy and systems, with the pharmaceuticals sub sector as a key component, including for IHP+, and for intensifying country support. DFID is further recommended to take programme lessons learnt into account with regards to initiatives such as MeTA and SARPAM. These include WHO’s brokering role and regional capacity in both WHO and civil society to support national efforts. .



2 INTRODUCTION

2.1 The scope of the evaluation WHO and HAI Africa are committed to increasing access to and appropriate use of safe and effective essential medicines in order to help improve health, in particular of the most disadvantaged in countries in Africa. In 2002, recognising the extent of the challenge of ensuring access to and appropriate use of essential medicines, the Programme for WHO-HAI Africa Regional Collaboration for Action on Essential Medicines in Africa was established with DFID funding (hereafter called the Programme). Since then other donors such as the EC have started supporting the Programme in Africa, and in other regions. This report responds to Terms of Reference (Annex 1) for an evaluation of DFID’s contribution of £6million to the Programme for WHO and to HAI Africa during the six year period 2002-2008. This in depth review for DFID will inform wider DFID, WHO and HAI Africa thinking about the future of the Programme and partnerships with civil society, and the development of other initiatives such as the multi-stakeholder Medicines Transparency Alliance (MeTA), and WHO’s project on Good Governance for Medicines. The evaluation covers the three components supported by DFID:

• WHO Medicines National Professional Officer (NPO) salaries and selected country activity costs in 15 countries in Africa, together with a contribution to technical support, training and supervision provided by WHO Geneva and AFRO regional advisers and to inputs by external consultants;

• separate funding to HAI Africa, a civil society network based in Kenya, to support advocacy, research, network development and capacity building for civil society working on medicines in Africa; and

• funding earmarked within each organisation’s budget for additional collaborative activities undertaken with civil society and government in three selected countries with NPOs in Africa (Ghana, Kenya and Uganda).

The report first describes the context for the Programme’s three components, provides an overview of the Programme’s achievements at goal, purpose and output levels, comments on its impact, relevance, sustainability and effectiveness, and on management and operational issues. This is followed by a discussion of constraints and challenges, value added and lessons learned, and conclusions and recommendations. Note that the evaluation does not provide details of all the activities carried out through the Programme at global, regional and national levels. Annual reports prepared for DFID by WHO and HAI Africa provide this information.

2.2 Programme description The Programme provided WHO and HAI Africa with finance to increase levels of technical support at country level, for strengthening government action and wider research and policy-advocacy activities on access to medicines. Two important and innovative features of the Programme model were: a) creation by WHO of new positions for national professional officers (NPOs) or medicines advisers, based in Country Offices, to provide technical advice and channel technical resources for government counterparts and other partners; and b) channelling funds to WHO and civil society, on the premise that both have key roles to play in improving access to medicines, and that ‘when diverse stakeholders such as governments, CSOs and WHO work collaboratively to improve access to medicines, they are able to achieve greater impact toward common goals’. WHO and HAI Africa components share the same logframe goal and purpose, following revisions to the logframe in 2003.



Goal: Improved equitable and sustainable access to and appropriate use of essential medicines in the 15 selected countries Purpose: Increased collaboration and capacity of stakeholders (ministries of health, health workers, civil society, consumers) to develop, implement and monitor policy and programmes for access, quality and use of medicines Logframe outputs/objectives differ. With respect to WHO, the Programme was designed to contribute to the achievement of the 2000-2003 and 2004-2007 WHO Medicines Strategy: Countries at the Core (WMS)1. The WMS comprises the overall goal (as above), four objectives (Policy, Access, Quality and Safety, and Rational Use, which include seven components), and a number of expected outcomes relevant to regional and country levels. DFID’s support has mainly been used to support five of the seven components, excluding norms and standards (mainly global level) and traditional medicine. With respect to HAI Africa, a separate logframe was developed for its outputs, which included the collaborative work with WHO. Although improved collaboration between MOH, WHO and HAI Africa in selected countries, was an important shared Programme objective for both organisations, it is not explicitly included in the WMS framework. Instead, WHO and HAI Africa developed a joint logframe and workplans for the Collaboration component in the three selected countries (Ghana, Uganda and Kenya). Programme objectives (WHO’s Medicines Strategy 2004-2007)2 Goal: Improved equitable and sustainable access to and appropriate use of essential medicines in the 15 selected countries Purpose: Increased collaboration and capacity of stakeholders (ministries of health, health workers, civil society, consumers) to develop, implement and monitor policy and programmes for access, quality and use of medicines Objective 1 Policy Commitment among all stakeholders to medicines policies based on the essential medicines concept; and to coordinated implementation, monitoring and evaluation of policies Component 1: Implementation and monitoring of policies (including trade related) Objective 2 Access Equitable financing, affordability and delivery of essential medicines in line with the Millennium Development Goals Target 17 Component 3: Fair financing mechanisms and affordability of essential medicines Component 4: Medicines supply systems Objective 3 Quality and safety The quality, safety and efficacy of all medicines assured by strengthening and putting into practice regulatory and quality assurance standards Component 6: Medicines regulation and quality assurance systems Objective 5 Rational use Therapeutically sound and cost-effective use of medicines by health professionals and consumers Component 7: Rational use by health professionals and consumers

1 Early in the Programme (2003), and in light of DFID’s commitment to supporting WHO’s wider strategic priorities and results-based performance management, it was agreed that a separate WHO logframe was not appropriate, and that WHO’s progress would be measured against the WMS outcomes. 2 All WMS components included, except no 2 TM/CAM and no 5 Norms and standards for pharmaceuticals (global level)



WHO recruited NPOs or Essential Medicines Advisers in the 15 selected African countries to advise governments on essential medicines (including Cameroon, Central African Republic, Chad, Congo Republic, Democratic Republic of Congo, Ethiopia, Ghana, Kenya, Mali, Nigeria, Rwanda, Senegal, Tanzania, Uganda, and Zambia). The NPOs provide support to their respective ministries of health to improve access to medicines through monitoring the country pharmaceutical situations to identify interventions, implement them and assess their impact. An important part of their work is building country-level partnerships with civil society organizations, donor agencies and other stakeholders. Programme support includes a component for strengthening the regional office and WHO headquarters to support the NPOs and manage the project. Since 2004, other donors such as the EC have supported the Programme (for WHO) and enabled its expansion to further countries and scaling up technical inputs to the medicine related activities in countries and regional economic and development organisations in Africa (e.g. EAC, SADC). The overall network of country medicines advisers now covers 15 countries in Africa and about 15 more in other WHO Regions. HAI Africa is funded to develop regional advocacy and technical support, and to build an effective civil society network for access to medicines (ATM) in Africa. HAI Global and HAI’s regional networks also have a long standing partnership with WHO on the national availability, price and affordability surveys (now completed in over 50 countries) and are developing approaches to undertake regular price, availability and affordability monitoring. The Collaborative component supports WHO and HAI Africa to work directly with ministries of health together in three countries, Kenya, Ghana and Uganda, to collaboratively develop medicines policies and programmes as well as plan and implement associated activities, including building capacity for the substantive participation of stakeholders. In addition, collaborative work has taken place with civil society in Tanzania.

2.3 Evaluation approach and method The evaluation focuses on the three components (support to the WMS through NPOs in 15 countries, to HAI Africa and collaborative activities in three countries) funded by DFID. In addition to documenting results, it also explores process issues – what has worked well and less well in terms of the approach taken by WHO and HAI Africa to building country and regional capacity and partnership working in government and civil society. Programme achievements are reviewed against the goal, purpose and objectives and using OECD DAC indicators (impact, relevance, effectiveness and sustainability). Some comments are made on value for money, but analysis is limited owing to the extent to which overall financing for the WMS can be disaggregated by activity or results. The evaluation methodology included review of programme documentation, data from WHO’s periodic surveys in all countries (the pharmaceutical assessments known as Level 1 surveys in 2003 and 2007), surveys carried out by WHO and HAI Africa on availability and affordability in 14 countries, and other national studies and surveys. Team members visited four countries with NPOs (Congo Republic, Ethiopia, Senegal, Tanzania), and one without (Malawi), as well as WHO regional and headquarter offices. They interviewed over 160 stakeholders in WHO, ministries of health (pharmaceuticals department and other programmes), regulatory and procurement agencies, development partners and civil society (including CSOs, faith based sector and professional associations). Information was obtained from semi-structured interviews based on a questionnaire including open-ended questions. Analysis also draws on responses to questionnaires sent to all NPOs, WHO Representatives (WRs) and national counterparts the 15 countries (n = 45). Responses were received from 14 NPOs, 13 national counterparts in 10 countries (mainly chief pharmacists and national disease programme managers) and 8 WRs. The response rate from NPOs and national counterparts was encouraging, but it was disappointing to receive responses from only half the WRs.



With respect to HAI Africa and the collaborative activities with WHO, the evaluation draws on the OPR (output to purpose review) of the Collaboration in 2004, the participatory and qualitative review commissioned by WHO and HAI Africa in 2007/8 (visits to Kenya, Uganda and Ghana) as well as HAI Africa activities in the countries visited and information provided during a short visit to HAI Africa’s Secretariat in Kenya. The three-person evaluation team also drew on its collective expertise in pharmacy, health policy and public health, and its extensive experience in working with national governments, WHO and NGOs3. The evaluation does not attempt to systematically compare the progress made in NPO versus non NPO countries, although it draws on stakeholder views in Malawi (a non NPO country). Systematic comparison between NPO and non NPO countries has limited value, given the great variation between countries in both categories, the criteria used for selecting the NPO countries and the staggered starting times for NPOs. Attribution of results to the Programme is complex, given the environment and WHO’s role in assisting government-led efforts. There has been a significant increase in technical assistance and funding for medicines from PEPFAR, UNITAID, GFATM, and the President’s Malaria Initiative during the period. However, a distinguishing feature of the Programme lies in its support to medicines policy, supply and regulatory systems as a whole, and not to specific disease programmes. The evaluation therefore assessed progress and demonstration of added value in this area, in particular.

2.4 Global and national context 2.4.1 Global and regional levels The programme with WHO and HAI Africa has developed since 2001 in a changing national and global context, which has brought challenges and opportunities. After somewhat reduced emphasis in the 1990s, medicines policy and access have become more prominent as, for example, countries comply with World Trade Organisation (WTO) requirements for trade legislation, the Doha Declaration and its implications for intellectual property rights and public health. Commitments and funding from the international community to the health sector have increased dramatically, especially for essential medicines and other supplies for TB, AIDS, malaria and immunisation, through the GFATM, GAVI, PEPFAR, UNITAID and other initiatives. Despite the successes of these targeted programmes in increasing access to medicines, they have contributed to fragmentation and creation of parallel procurement and supply systems in the health sector. There is now growing emphasis on addressing essential medicines supplies as a priority for wider systems strengthening, financed through health system strengthening components of the GFATM, GAVI and PEPFAR. WHO maintains a critical and unique role in the field of medicines. The importance of WHO’s role in norms and standards and country support for safe, effective and affordable health products and technologies is emphasised in WHO’s Engaging for Health: A Global Health Agenda, 11th General Programme of Work, WHO 2006-2015 and specifically addressed through Strategic Objective 11 in the new Medium Term Strategic Plan, WHO 2008-2013. In recent years, WHO has placed increasing emphasis on decentralisation of resources and technical support by Geneva and regional offices to countries. Organisationally, several changes have affected this programme and the way in which support to countries is managed and co-ordinated with AFRO4. 3 One member of the team is a Board member of HAI Global. This did not provoke conflict of interest as HAI Africa has independent management and governance arrangements, and, furthermore, other team members reviewed HAI Africa’s performance. 4 In 2001, the programme was managed by DAP (Drug Action Programme) which was part of the EDM department (Essential Drugs and Medicines Policy) in the Health Technologies and Pharmaceuticals cluster. In 2004, it was decided to create two departments: TCM (Technical Cooperation on Medicines) and PSM (Policy and Standards); this Programme became part of TCM and continued to be handled by the same coordinator. In



More broadly, WHO is committed to wider aid effectiveness efforts. The 2005 Paris Declaration for Aid Effectiveness committed signatory donors and governments to greater harmonisation and alignment, which the International Health Partnership and related initiatives (IHP+), set up in 2007, seeks to foster in the health sector in countries (including several countries with Medicines NPOs). There is also growing commitment to the involvement of civil society in poverty reduction and health and in improving governance, expressed in, for example, the Ouagadougou Declaration on primary health care and health systems, facilitated by WHO in April 2008, by several declarations in support of Universal Access, and by the IHP+ compact signatories. Greater involvement and representation of civil society in governance mechanisms at the global level is also now mandated, in for example the global fund, UNITAID, UNAIDS and other initiatives. WHO itself has a pilot Good Governance for Medicines project for strengthening accountability at country level. DFID and its multilateral, civil society and private sector partners launched the Medicines Transparency Alliance (MeTA) in 2008, which supports increased transparency and accountability in the medicines supply chain, to be achieved through multistakeholder working. Pilot activities are taking place in seven countries including Ghana, Uganda, and Zambia where partners’ experience through this Programme is already contributing to planning for MeTA as a country led initiative. 2.4.2 National level The 15 countries selected for the DFID funded NPO posts were: Cameroon, Central Africa Republic, Chad, Congo Republic, Democratic Republic of Congo, Ethiopia, Ghana, Kenya, Mali, Nigeria, Rwanda, Senegal, Tanzania, Uganda, and Zambia. Some countries were staffed in 2002, but others not until 2007. The selection process has been an informal one, based on consultation by AFRO with potential countries, and applying four major criteria:

• interest and commitment from the ministry of health and chief pharmacist; • sufficient national capacity, coupled with identified need for increased technical

support; • interest and commitment of the WHO Country Office (the WHO Representative at the

time); and • representation across major economic regional blocs in sub-Saharan Africa.

The 15 countries vary – the majority are low income countries, while two have middle income status (Congo Republic and Cameroon). They include countries with strengthening democratic government and improving aid effectiveness (Ghana, Malawi, Uganda, Senegal), post conflict countries (Rwanda), fragile states (DRC), and two federal states (Nigeria, Ethiopia). However, overall poverty levels are high and access by the majority of the population to health services is poor in all of them. Equally, the health sector also illustrates a range of forms, although reforms towards stronger sector policy, planning and management have taken place in most of the countries. In the majority, overall policy direction is provided by a governmental pharmaceuticals unit or department, led by a senior pharmacist, but they are rarely members of senior management, often working to the chief medical officer or sited within the medical services division. Ethiopia is the exception, where the pharmaceutical sector is in process of reform and reorganization. There is no pharmacy department in the MOH, and the Drug Administration

2007, there was the creation of one department: EMP (Essential Medicines and Pharmaceuticals Policies) and the move of EMP under the HSS cluster (Health Systems and Services). The new EMP department (around 100 staff) is constituted of five units: three technical ones (access and rational use; quality and safety of medicines; and traditional medicine) and two others: Information and evidence for policy (MIE) and Medicine programme coordination (MPC). This last unit is composed of three professional staff (of whom two are also working with other units), who manage this Programme and other country focused activities such as WHO support to MeTA.



and Control Authority (DACA) is a semi autonomous agency, responsible for the overall policy implementation and administration of the sector. In the francophone countries, the governmental pharmaceutical departments are named ‘Directorate of Pharmacy and Medicines: DPM’ and they are responsible for pharmaceutical policy implementation, drugs and professionals regulation. In some, (Mali, Senegal and Congo Republic), the DPM is in charge of a drugs quality control laboratory. Procurement and supply management are organised as semi-autonomous entities in most of francophone countries. Only in Côte d’Ivoire and Gabon are they part of the MOH. For anglophone countries, procurement, supply management and regulatory functions for products and professionals are also established as semi-autonomous bodies (such as Malawi’s Central Medical Stores, Malawi Pharmacy and Poisons board, Tanzania’s Medical Stores Department, Food and Drugs Authority and Pharmacy Council or the newly established Pharmaceuticals Fund and Supply Agency (PFSA) in Ethiopia responsible for the procurement, supply, distribution and use of medical equipment and drugs in health institutions). The extent to which supplies are delivered through vertical programmes or an integrated system also varies, but in most countries there are now efforts being made to bring systems together and reduce duplication. In some countries the procurement is done both at national and district levels for the public sector. In the countries (about half) where a health sector wide management approach is in place, a technical working group is often mandated to co-ordinate effort for pharmaceutical policy and services delivery. There is a national pharmaceutical sector strategic plan which guides all the activities within the sub sector. In SWAp countries, there is often an explicit emphasis on partnership with the community based organizations and CSOs in policy and health care delivery and efforts have been made for representation of CSOs on health and medicines policy committees within the MOHs. In other countries, the pharmaceutical sub-sector may not be well integrated into wider planning processes. Mainly, the emphasis is on the public sector and key donor and public sector players are members of any working groups. In most of the countries, several donors are active in the health and pharmaceutical sectors. Bilateral donors include DFID, USAID, France, the Netherlands, Norway and Germany. Multilaterals such as the World Bank and EC are active in health and the pharmaceutical sub sector in some. Substantial disease programme funding is in place from GFATM, PEPFAR, GAVI Alliance and the U.S. President’s Malaria Initiative. In several – Tanzania, Uganda, Ghana – the pharmaceutical sub sector with the establishment of essential medicines programmes was the focus of intensive support until sector reform and shifts in donor trends in the late 90s. Since then, with the establishment of the sector wide approach, earmarked funding has been reduced and major donors such as DFID and the Netherlands have shifted to funding the general budget or the health basket fund, although the sub sector may remain a significant policy focus for them. DANIDA maintains technical support and earmarked funding to the pharmaceutical sub-sector in Kenya, Uganda and Tanzania, USAID in Tanzania and Ethiopia, and the EC in Congo Republic. In most countries, the faith-based sector is a major supplier of services and of medicines, sometimes procuring these through the public sector (Senegal, Congo Republic, and Côte D’Ivoire) or faith-based procurement agencies, as in Kenya. The private sector is growing, and pharmacies are often a major source of medicines for consumers in both rural and urban areas. In a few countries, such as Ghana and Tanzania, efforts are being made with technical support (usually from US funded technical agencies), to improve quality and availability in the private sector. Schemes include the ADDO programme with private drug shops in Tanzania, and SHEF in Kenya. The global and regional initiatives mentioned above provide a more favourable environment for stronger MOH and civil society partnerships and collaborations, and also for WHO to facilitate them. The role for civil society in contributing to service delivery, especially in the



field of HIV and AIDS is now well accepted. Some government policy statements recommend the engagement of communities and CSOs mainly in healthcare delivery. In some cases CSOs are represented on some technical working groups under sector wide approaches. Overall, capacity and recognition by government for engagement in policy dialogue and monitoring remains weak, despite international commitments. Civil society capacity on ATM is also weak. Rarely, consumer organisations in countries with a more active and recognised civil society, such as Senegal, are engaged in monitoring medicines and health care pricing. In addition to HAI Africa, a few other networks are involved in medicines activities, such as INRUD, Ecumenical Pharmaceutical Network and EQUINET, as well as organisations and coalitions working on health or disease specific issues such as HIV (eg the Christian Relief and Development Association (CRDA) in Ethiopia, a highly functional network of more than 300 NGOs/CSOs). Civil society’s potential contribution to good governance (eg transparency and accountability), and to policy dialogue processes remains challenging and lacking in legitimacy. At national level some CSOs are organized in form of coalitions which target particular activities within the access to essential medicines. NGOs face many challenges in terms of capacity, resources and in gaining recognition as strategic partners with government in policy dialogue.



3 PROGRAMME ACHIEVEMENTS AGAINST GOAL AND PURPOSE

3.1 Contribution to achieving the Programme goal The Programme was designed to contribute to the overall goal of WHO’s Medicines Strategy, which is: ‘to ensure the quality, efficacy, safety and rational use of medicines, including traditional medicines, and promote equitable and sustainable access to essential medicines, particularly for the poor and disadvantaged’. Assessment of achievements at goal level is hampered by the fact that progress data for the indicators exists for only a few of the countries. This is commonly recognised. Access to affordable medicines is an MDG 8 target, and the recent 2008 progress report (from the MDG Gap Task Force) also remarks on the complexity of measuring progress and the limited data available. Standard methods for assessing access were developed by WHO and HAI Africa only in 2004. Fourteen of the 15 countries now have baseline data on access in public, private and not for profit sectors. This in itself is a significant achievement, collected through availability and pricing surveys in carried out with technical and financial support from WHO and HAI Africa, as one of the Programme’s major activities. However, for several countries, the baseline dates from 2006 or later (e.g. Congo Republic), too short a time in which to demonstrate progress. Also, just a few countries have been able to carry out monitoring of progress against this baseline and hence data on change in goal level access indicators is not available for all countries. WHO is carrying out a second round of Level 2 household surveys in some countries, but analysis is not expected until late 2009. Monitoring availability and pricing has been carried out in some countries, including Senegal and Nigeria, and the countries where HAI Africa and its partners have been working together, Kenya, Ghana, Uganda and Tanzania. Trend data on availability and affordability is derived from the base line survey and monitoring carried out by a multistakeholder team (funded by HAI Africa or WHO, from the Programme budget). In these countries, the picture is mixed. Overall, availability in Tanzania, for example, is poor at 50% or less in all three sectors (Figure 1). There is a slight improvement in availability of the surveyed medicines in the public sector between 2007 and 2008, but still less than in 2006. Availability in the mission sector has improved slightly. Figure 1: Comparison of overall availability of medicines in the public, private and mission sectors for November 2006, June 2007 and July 2008, Tanzania

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In Senegal medicines availability has improved, but is falling in the current economic downturn. An assessment was done in Senegal in 2003 by the MOH with the support of the EDM/NPO. Regarding medicines availability the national median rate was 88% in regional medical stores, 78% in health centres and 85% in private pharmacies. The latest assessment was done in 2005 by an independent consultant using HAI/WHO methodology, based on 50



essential medicines. The median availability of medicines had risen to 98% in all sectors. However, because of the economic crisis the medicine overall availability is now estimated to have fallen to 80%. The critical issue is affordability. The 2005 survey showed that medicines prices are high compared to MSH international reference prices. In Uganda (Figure 2a), data generated by the Programme (HAI Africa/HEPS Uganda, MOH and WHO medicines baseline and monitoring surveys) shows an encouraging trend in the availability of a basket of key medicines in public and mission sectors increasing in parallel over the period 2004-8, but with decreasing availability in the private sector. Medicines are free at point of use in the public sector, but availability (under 60%) still remains lower than in both mission and private sectors. In Kenya (Figure 2b), public sector availability at health centre level is gradually improving until internal conflict disrupts the supply chain in early 2008. Figure 2a: Median availability in basket of key medicines in Uganda 2004-08 (public, private and mission sectors)

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Figure 3 shows that in Kenya the new first line combination therapy for malaria had become widely available in the public sector in two years since its introduction in 2006. Figure 3: Availability of new anti-malarials in Kenya (reproduced from MDG Gap Task Force Report, MDG 8)

Similarly, some data in some countries is available on progress in indicators of quality, safety and rational use. For example, in Tanzania, the Tanzania Food and Drugs Authority (TFDA) reports that non-registered medicines comprised just 2% of the market in 2005, a substantial fall from 26% in 2002. The number of products registered with the TFDA has grown from 20 in 1999 to over 3,000. The 2007 Drug Tracking Survey highlighted problems with Medical Stores Department capacity to manage contracts and maintain adequate stock levels at national and regional levels. However, since then, improved contract management, quantification and forecasting systems are beginning to take effect, with improved availability at central level. There is survey data on rational use (knowledge, attitudes, practices etc) from countries such as Senegal, Tanzania and Ghana (commissioned through this Programme), but no trend information.

3.2 Achievement of Programme purpose This sub section describes achievements at purpose level for the WHO NPO programme, and HAI Africa. The shared purpose is: increased collaboration and capacity of stakeholders (government, civil society, consumers) to develop, implement and monitor policy and programmes for access, quality and use of medicines. In addition, the section also documents purpose level progress on Collaborative activities between WHO and HAI Africa in Ghana, Kenya and Uganda. 3.2.1 Achievement of purpose for WHO NPO programme WHO has made substantial achievements towards the programme’s purpose, particularly in developing capacity for more robust policy and regulatory frameworks. Table 1 summarises progress made across the four objectives in WMS using selected indicators from the 2003 and 2007 pharmaceutical situation (Level 1) surveys, provided by NPOs. These indicators have been used as proxies by WHO for improved policy and practices across countries5. This section provides an overview of progress (with more detail in the next section).

5 WHO’s EDM TCM department commissioned an informal review of the WMS indicators and results in 2007. While overall progress was positive, the review also critiqued the indicators and data sources, which mainly are drawn from WHO and counterpart reports, and do not assess WHO results directly.



An important caveat to the value of using Level 1 indicators for this evaluation (and indeed the WMS) is that significant progress or lack of it cannot be attributed to WHO, which is a key partner and technical agency working to support government-led activities. On the other hand, interviews with stakeholders, and questionnaire responses from NPO counterparts, indicate that the WHO country office has made a critical and unique contribution. Few other agencies, with the exception of DANIDA, DFID and US technical partners (in selected countries), are making technical and financial investments in strengthening overall pharmaceutical policy, and the regulatory and supply systems, as opposed to focusing solely on disease programme requirements for products. In terms of a counterfactual, if WHO were not providing this support, it is unlikely that any other agency would have the technical capacity or substantive links with government to do so. This has been a highly relevant and successful approach, enabling improvements in the WMS country outcome indicators and significant progress in communicating and implementing the concept and vision for essential medicines. All the countries report increased visibility of the pharmaceutical sector and of the essential medicines concept, better understanding and willingness to invest in medicines supply from a system perspective and better collaboration for pharmaceuticals in the health sector, across disease programmes and between public, private and not for profit sectors. The programme has prioritised capacity building and technical inputs to policy, regulation, procurement and supply management, pharmaceutical situation assessment and research to improve the evidence base for access (availability, affordability and price surveys). The NPOs have been initiating, facilitating and contributing to a very large number of capacity building activities over the last two to six years (depending on the country), in accordance with national priorities. The emphasis has been on WMS objectives for policy and access, followed by quality and safety, then rational use. The overall framework for medicines policy, regulation and procurement has been strengthened in all countries during the period, which is greatly attributable to NPO and other WHO contributions. Data collection and the evidence base for the sector have been strengthened: for the first time there have been methodologically sound assessments conducted of the pharmaceutical situation, of procurement systems, and of medicine availability and affordability (with WHO HAI Africa surveys in 14 of the 15 countries). National policies for essential medicines, essential medicines lists and standard treatment guidelines have been drawing heavily on WHO strategy and tools. There are many good examples of effective WHO support for building institutional sustainability for national institutions and systems. In Tanzania, for example, capacity for implementation and performance in the major agencies responsible for procurement and supply management (Medical Stores Department), and for product quality and safety (TFDA) have improved over the programme period (See box 2, next section). Congo Republic’s experience illustrates aspects of programmatic sustainability and capacity building common to most NPO countries. There was a strong need for WHO to offer competent managerial and technical support to the MOH, given the pharmacy unit’s limited capacity to take full advantage of the WHO country budget and technical support. The NPO, because of his knowledge of the country and of the MOH, has been able to make full use of the various competencies available in WHO (technical expertise, policy advice, tools, funds, etc.) to the benefit of the country.



Table 1: Progress on selected indicators from WHO’s Medicines Strategy 2004-20076 WMS OVIs (selected for DFID) 2003 data 2007 data Goal: Improved equitable and sustainable access to and appropriate use of essential medicines in the 15 selected countries

No cross country data set for indicators; overall poor

Continued mixed picture; increase in data available on access but limited improvements for countries where data available; limited data for quality, safety, rational use

Purpose: Increased collaboration and capacity of stakeholders (ministries of health, health workers, civil society, consumers) to develop, implement and monitor policy and programmes for access, quality and use of medicines. (Although not included in the WMS, a separate logframe was developed with the purpose of ‘Improved collaboration between MOH, WHO and HAI Africa in selected countries’.)

As per 2003 baseline (below)

- Overall improvement in policy and monitoring framework; challenges in implementation - Improved co-ordination taking place in public health sector; increased links with civil society and private sector - WHO-HAI Africa collaboration in 4 NPO countries (3 planned, one additional) [Under Objectives below: Progress = green No change or data not comparable = yellow No progress = red}

Objective 1 Policy OVI 1.1.1 Countries with an official national medicines policy document – new or updated within the last 10 years

8 of 13

Drafted in 11 of 14, approved in 7

OVI 1.1.2 Countries with a national medicines policy implementation plan – new or updated within the last 5 years

7 of 14

7 of 10

OVI 1.2 Countries having conducted a national assessment of their pharmaceutical situation in the last 4 years

8 of 12

10 of 11 (incl. access)

OVI 1.3 Countries integrating TRIPS Agreement flexibilities to protect public health into national legislation.

5 of 13

7 of 12 (plus 2 in process)

OVI 1.4 Countries that provide basic and continuing ed. progs for pharmacists

3 of 13 8 of 14

Objective 2 Access OVI 3.1 Countries where less than 50% of the population have access to essential medicines

- 12 of 13 (free HIV/AIDS medicines at public health facilities: new indicator 2007)

OVI 3.5 Countries with a pricing policy for maximum retail mark up in the private sector

2 of 8

5 of 11

OVI 4.1 Countries with public sector procurement limited to national essential medicines list

12 of 14

9 of 13

OVI 4.3 Countries with local production capability

2 of 13 2 of 13 (R&D only assessed in 2007)

Objective 3 Quality and safety OVI 6.1 Countries implementing basic medicines regulatory functions (2003); legal provision for marketing authorisation (2007)

10 of 13

13 of 14

OVI 6.2 Countries with a computerized medicines registration system

10 of 14

9 of 13

OVI 6.3 Countries with basic quality assurance procedures

11 of 12

10 of 14

OVI 6.4 Countries monitoring adverse drug reactions

5 of 11

8 of 14

OVI 6.5 Countries with <10% tested 6 of 10 3 of 8

6 Five of seven WMS components are included, excepting 2) Traditional and alternative medicines and 5) Norms and standards for pharmaceuticals (global level). Focus on the country level outcomes specified under each component. Data is based on 14 countries, excluding CAR which is a very recent entrant to the programme. Denominator varies according to number of countries responding to the survey.



medicines failing quality tests Objective 4 Rational use OVI 7.2.1. Countries with national list of essential medicines updated within the last 5 years

11 of 13

13 of 14

OVI 7.2.2. Countries with treatment guidelines updated within the last 5 years

7 of 13

11 of 14

OVI 7.3 Countries with a national medicines information centre able to provide independent information on medicines to prescribers and/or dispensers

3 of 14

5 of 14

OVI 7.6 Countries with DTCs in the majority of regions/provinces

2 of 8

2 of 12

OVI 7.7 Countries that include the concept of essential medicines in basic medicine and/or pharmacy curricula.

9 of 11

9 of 14

Improved co-ordination among other government agencies, disease programmes and with other stakeholders has been a programme priority. These include convening national medicines policy working groups (often including stakeholders such as the private sector and NGOs), new sector technical working groups, multi-stakeholder groups for medicines monitoring and availability, and joint work with disease programmes. WHO is widely credited for advocating for and supporting better co-ordination between government programmes and other public sector bodies. In Tanzania, the NPO supported the MOHSW the Pharmaceutical TWG in 2006, and the NPO continues to act as its Secretariat. A leading development partner in Tanzania commented: ‘I do want to commend your leadership – just what we need for technical staff in WHO.’ The WHO biennial planning process involves MOHSW departments and programmes, and key bodies such as the Tanzania Food and Drugs Authority, which has enabled intra-government debate and funding of activities linked to overall strengthening of policy, regulation and procurement systems. Tanzania is also a One UN pilot country, and the NPO’s workplan includes activities funded through the One UN Fund (eg Post Marketing Surveillance and monitoring Adverse Drug Reactions for ARVs). However, the extent to which UN agencies are working jointly on procurement, for example, is not clear. Several continue to finance and procure products for specific programmes. There are strong links and collaborative work across disease programmes, especially on the malarial ACT policy and market surveillance, and for ARVs. In Kenya, the counterpart cites research and policy work with the malaria programme and the regulatory agency on new anti-malarials that has facilitated their working together in a more coherent way. NPOs have also improved the design and implementation of the components for medicines procurement and supply management of global initiatives and disease oriented programmes. They are working in close collaboration with other NPOs of the WHO country offices (health services, malaria, HIV/AIDS; TB, etc.) and with national staff on issues related to medicines in their respective programmes. In for example, Congo Republic and Tanzania, NPOs have led PMS components of proposals for the Global Fund (HIV, TB, Malaria). As one counterpart commented: ‘It would have been difficult without the Medicines NPO’. In Senegal, the NPO is the ‘undisputed co-ordinator’ of discussions on rational use with HIV, malaria, vaccines and TB. WHO has taken some steps towards promoting the involvement of non public sector stakeholders (NMP consultation processes, medicines monitoring). Consultation with stakeholders beyond government has increased. In Congo Republic, the NPO spearheaded the organisation of a high level round table in 2008 on the problems related to medicines,



and in Senegal, the NPO helped convene several high level workshops for the national policy, rational use and pharmacovigilance. The programme’s approach can be summarised as intensive engagement, dialogue and facilitation of actions by the WHO NPO among key stakeholders, enabled by funding for nationally planned and prioritised activities, and clearly led by the government. As respected national experts in pharmacy, the NPOs have drawn upon their local knowledge and contacts, as well as regional and global resources. The participatory planning approaches adopted by the NPOs, the quality of the expertise, and the seed money provided on the basis of the annual plans and budgets, have contributed to the results. The NPO ability to ‘put pressure’ on and convene technical stakeholders is well appreciated by counterparts: policy development processes have involved new multi-stakeholder working groups in nearly all countries. Although all these policy products have required extremely lengthy processes, the NPOs are widely credited with ensuring that they are based on WHO normative guidance and standards. These activities were funded by WHO through the EC and DFID projects, by government and by other donors. NPOs have enabled counterparts to achieve more, more rapidly: both national activity budgets and implementation rates are higher in NPO countries. In the words of one WR, the presence of a NPO has made a real difference in implementing activities, indeed: ‘Without an NPO, it would be useless to provide funds’. 3.2.2 Achievement of purpose for HAI Africa HAI Africa adopted two approaches for achieving the Programme’s purpose: a) building capacity of HAI Africa both as a regional Secretariat and as a Network to strengthen national and regional efforts, working with WHO and ministries of health where appropriate and possible and b) specific collaborative activities with WHO and MOHs in three countries (Ghana, Kenya and Uganda, using approximately 25% of HAI Africa programme funds). The funding has resulted in building measurable Secretariat and Network capacity for action, including the birth and strengthening of HAI Africa as an effective regional organisation. When HAI Africa was constituted in 1997 it was as a department within HAI Europe in Amsterdam, relocating to Africa in 1998. Following expiry of its first grant from DFID in 2000, an opportunity for the collaboration with WHO on ATM was conceptualised by DFID and developed with the two organizations after separate applications for funding. In 2001 HAI Africa’s Collaboration Project, providing support to the three countries, was the main activity, and the organisation was not constituted as an independent NGO. By 2004, HAI Africa had a committed and effective regional board and was legally set up in Kenya. It is working to its strategic plan 2006-10, which includes the Collaboration programme and two other areas, the Network programme (capacity building, research and advocacy), and the International Voice programme. The Collaboration programme supports the joint activities in Ghana, Uganda and Kenya. HAI Africa members in other countries, such as Tanzania, Malawi and Zambia, are developing the model in their contexts. HAI Africa has members in 20 countries and has continued to grow its membership since its inception. HAI Africa has established a strong regional reputation (albeit mainly in anglophone countries) for providing professional expertise and a rights-based consumer voice on medicines issues. It has secured and maintained a unique niche, repeatedly cited as the only NGO in Africa that takes a system wide approach to essential medicines, and is also credited with drawing together issue based NGOs (e.g. ARV and malaria access groups) and raising the medicines profile in wider health rights initiatives such as EQUINET. Contributions to regional and global policy fora, such as the World Health Assembly, the East Africa Community and promoting an African consensus on public health safeguards in trade negotiations are widely recognised. Efforts in building capacity of member groups are also acknowledged, especially with HEPS Uganda, and engaging national coalitions for health in Malawi, Zambia and Zimbabwe.



NGOs in countries visited report confidence in HAI Africa’s ability to represent their interests in access to medicines in relevant fora, and to provide high quality technical back-up and information resources for their work. On a regional and international level, HAI Africa has increased the voice and influence of civil society on consensus positions taken by the Africa Union ministers of health, the EAC and the World Health Assembly the rational use of medicines resolution and intellectual property rights (see box on the Africa Civil Society Coalition on the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG). 3.2.3 HAI Africa and WHO Collaboration purpose (three countries) HAI Africa and WHO developed a separate logframe for the Collaboration, with the purpose: improved collaboration among MOHs, WHO and HAI Africa’s network of CSOs to increase availability and affordability of medicines in selected countries. This has been fully achieved in the three selected countries, Ghana, Kenya and Uganda, with Collaboration partners at global, regional and country levels making significant progress in both joint working processes and in research and policy-related outputs. The Collaboration’s global and regional project management group has met regularly, to guide project strategy and implementation. Collaboration Country Working Groups - set up in 2005, with terms of reference - have helped define roles, responsibilities and expectations. Partners continue to communicate through meetings and activities, despite the fact that HAI Africa’s funding contribution ended in mid 2008. Joint working between partners has greatly strengthened through the project and resulted in a range of research and policy outputs. The partnership has provided a new and unique space for dialogue and collaborative activities to help meet national priorities in improving access to quality medicines, and to produce robust and independent data. The project has created the stimulus and provided resources for joint work, drawing on the existing effective partnership work by WHO and HAI on the pricing survey, and their regional and global reputations. There is now tripartite ownership over substantial areas of work. The Collaboration activities and results have delivered significant added value for HAI Africa, with joint working and products with WHO and MOHs ensuring credibility and respect in other countries. One of the most significant effects has been the contribution of the project to a change of attitude to working with civil society by the MOHs. The Collaboration has provided a concrete and funded mechanism for building a positive attitude to dialogue and joint working between partners, especially in opening a new (and previously closed) door for civil society, for involving academia, and for seizing opportunities such as links with disease control programmes in Kenya and Uganda, and the national insurance scheme in Ghana. Additionally, in Tanzania, HAI Africa partnership with an academic department and the Christian Social Services Commission (co-ordinating the faith based sector) has improved multi-stakeholder working with MOH, with full support from WHO, although it has not been possible to identify other CS partners. In Malawi (a non NPO country), HAI Africa has a well developed partnership with Malawi Health Equity Network on medicines research and advocacy, although WHO’s Country Office is not yet playing a facilitatory role.



4 PROGRAMME ACHIEVEMENTS AGAINST OUTPUTS As mentioned above, WHO’s NPO programme has targeted the expected country outcomes in the WHO Medicines Strategy for its outputs, while HAI Africa has a separate set of logframe outputs.

4.1 Progress in WHO WMS country outcomes In terms of effectiveness, the Programme approach has been successful in supporting delivery of the WMS objectives and expected outcomes (see summary in Table 1). The following section provides examples under each WMS objective, drawing on experience in the countries visited in 2008 and 2009, and on data provided by WHO and from the questionnaires. 4.1.1 Objective 1: Policy (Components 1and 2 of the WMS) Component 1 (national policy development and implementation, protecting public health in trade agreements and building capacity) has been a major programme focus, given the outdated and/or weak frameworks previously in use. NPOs have been supporting the development of the overall policy and implementation framework (plus a new medicines act in Zanzibar, and legislation for promotion of medicines and responsibilities of medical professionals, in Mali, for example). As shown in Figure 4, during the last five years new or revised national medicine policies (NMPs) have been drafted in 12 of 15 countries, and they have been approved together in about half of them (publication is subject to sometimes slow ministerial and parliamentary processes). One key outlier is Uganda, where other priorities have been deemed more important by the MOH. Countries are at different stages in revising their NMPs.Technical assistance has been provided through AFRO Regional Advisers, WHO Geneva and independent experts recruited through WHO and other partners, drawing on WHO normative frameworks, and intensive ongoing dialogue and stakeholder consultation. In addition to the national medicines policies, other policy achievements include making essential medicines free of charge for vulnerable groups such as children, the elderly, pregnant women, and the poor, and also notable success in policies for access to anti-retroviral and malaria treatments. This latter is linked to increased advocacy and public funding through initiatives such as the GFATM for disease programmes, while also reflecting the engagement of medicines NPOs with programme policy processes. In Republic of Congo, the NPO supported drafting the policy for the free distribution of anti-malarial pharmaceuticals to children and pregnant women, which increases access to certain essential medicines to the poor. In Senegal, the NPO supported negotiation with stakeholders to ensure access to anti malarial medicines at low prices in 2006 in collaboration with the malaria NPOs, MOH and private sector. Figure 4: Progress in developing national medicines policies

Sub-sector assess-ment

NMP c'ttee formed

Draft document produced

S'holders consulted and consensus reached

NMP approved printed and disseminated

Supportive legislation enacted/implementation plan is approved

Cameroon 2008 2008 2008

CAR 2008 2009

Chad 2001, 2007 2008 2008

Congo 2006 2004

2006 Implementation plan

DRC 2006 2005

2006 implementation plan



Ethiopia 2003 2006 2006 2007

2007 Implementation plan

Ghana 2002 2004

2006 implementation plan

Kenya 2003 2007 2007

Mali 2008 2009

New medicines legislation

Nigeria

2002 2004 2004 2005

Implementation plan (2006); Traditional Medicines Policy (2005)

Rwanda 2004

Senegal 2003 2004

2004-2005 2006

Tanzania (Mainland) 2008 2008

Tanzania (Zanzibar)

2002

2008

Traditional Medicines Policy (2008); Food, Drugs and Cosmetics Act (2006)

Uganda 2002

Zambia 2008 2008

A marked change is the acceptance in ministries of the value of wider consultation among stakeholders across public and non-profit stakeholders, which results in more robust and broadly owned policy, and hence implementation is more likely. In Tanzania, the working group was chaired by a private sector representative. In Cameroon and Central Africa, the NPO counterpart cited the NPO’s effective role in support to the working group in charge of revising the national policy. Kenya’s process – enhanced through full collaboration with HAI Africa and civil society - is described in Box 1. Research and assessment sponsored by WHO (and HAI Africa, in the case of the pricing surveys) is consistently disseminated through multistakeholder workshops. For example, in Republic of Congo, the assessment of the pharmaceutical sector in 2006 and again in 2008 was followed by a round table, gathering all the stakeholders (public and private sectors, NGOs and development partners) to review the problems and design solutions. Box 1: Kenya: Consultation for the new national medicines policy Kenya’s revised national medicines policy represents a substantial development from the first policy, published in 1994, and reflects wider trends in the pharmaceutical sub-sector and linkages with other health and development policies. Importantly, it emphasises enhancing collaboration with other sectors and with partners, including civil society. It also includes a full role for consumers, both in representation and ensuring accountability in the system, and as purchasers and users of medicines. One of its overarching objectives is improving the appropriate use of medicines. The new draft policy was developed through a highly participatory and consultative process. A technical working group of the MoH undertook the first stages, with representatives of various MOH departments, health institutions, as well as the private sector, training institutions, professional associations, and civil society. WHO has been closely involved in this process through the WHO Country Office. In addition, specific technical expertise on medicines policies issues was provided from HQ. The Collaboration process – which involved detailed discussion and review with civil society - helped ensure that civil society was fully engaged and that consumer interests were well represented. As a MOH official commented, ‘The chances of implementing the new policy are much greater now with stakeholder consensus.’



The evidence base for policy in the sub-sector has been greatly improved, with baseline situation assessments in 2002, at least two Level I surveys in all countries (and Level 2 surveys underway in a few countries). Some progress has been made on incorporating TRIPS flexibilities, especially in East Africa/EAC. It should be noted that, at the beginning of the programme, knowledge and expertise on this subject in the MOHs (and indeed in WHO country offices) was limited. Through NPO professional development, and with WHO AFRO and Geneva support, the NPO has been able to accelerate the process in countries such as Tanzania – helping the MOH to access appropriate legal expertise and to better represent the interests of public health with ministries of justice and for industry and trade. In Tanzania and Uganda, a consultation group was established and amendments have been drafted by external consultants recruited by WHO, working with HAI Africa in Uganda. In Kenya, the new Industrial Property Act is in place and HAI Africa, and the MOH, with WHO’s support, continue to prevent several proposed amendments that would limit use of public health flexibilities. Workshops on TRIPS have been conducted by the NPO in Ethiopia. Although Component 2 (traditional medicine) is not DFID’s focus, the NPOs in most countries have been requested to develop the national approach to licensing and training traditional practitioners, code of ethics and product regulation. These aspects of the policy framework are often being developed for the first time and WHO’s contribution is regarded as essential and invaluable in all responding countries. For instance, the collaboration with the programme and the NPO has allowed Ethiopia to make real progress in relation to the evaluation of traditional medicines. This is important as 85% of the population continue to use traditional medicines. 4.1.2 Objective 2: Access (Components 3 and 4) With respect to Component 3 (improving financing and affordability), one of the programme’s major achievements has been strengthening the evidence base in the countries on access (availability, pricing and affordability surveys). NPO countries were among the first to carry out the surveys, usually with expert technical support from HAI Africa as well as WHO, and 14 of the countries now have a baseline analysis for medicines availability and affordability (published in 11), and monitoring is taking place in five, including Nigeria (Figure 5). For the first time, the government and others have reliable data with which to compare prices and availability across the public, faith based and private sectors. Kenya’s monitoring newsletter explores availability of key programme medicines (reproductive health, paediatric drugs, as well as for HIV and malaria), which is valued by the programme managers and raises the profile of less prominent programmes. Equally important, comparable data is now available across the region. In most countries, the surveys were overseen by a multi-stakeholder advisory group, including WHO, which supported ownership and independence of findings, as well as data quality and credibility through involvement of WHO and HAI Africa. WHO’s role in supporting multi-stakeholder advisory groups and brokering representation with government has been critical. However, in Malawi, where there is no NPO but where HAI Africa works on medicines related advocacy with MHEN, the main health civil society network, WHO was not proactively involved in the recent survey. This may have had implications for (as yet) limited government acceptance of the method and findings, although the chief pharmacist was a nominal member of the advisory group. Where HAI Africa WHO Collaboration activities were funded with civil society (Uganda, Ghana and Kenya), monitoring of pricing and availability began in 2006. Tanzania is the only NPO country without specific funding for civil society collaboration to have started medicines price and availability monitoring activities with HAI Africa, a project delivered by the pharmacy dept at Muhimbili University and the faith based sector’s co-ordinating body and supported by HAI Africa and WHO. The monitoring process has been strongly supported by



WHO and HAI Africa and has become institutionalised to some extent, through ministry membership of the advisory group. Nigeria has developed a country specific approach to monitoring, without tailored HAI support. There is some evidence of a stronger culture for using data in planning and decision making processes. For example, recommendations were used in Congo for increasing the drug budget. Procurement agency staff cite the surveys as a source of evidence for procurement prices achieved. In Ghana, the method was adapted to serve the needs of the new national insurance agency for a price reference system, and in Tanzania, the pharmaceutical technical working group is planning to further institutionalise and develop monitoring as a routine exercise. In Kenya there has been budgetary submissions by CSOs to demand for increment of funding for essential medicines. At a global and regional level, data collected through monitoring activities contributed to WHO’s contribution to the global MDG 8 monitoring report published in 2008 (see Figure 3). The data is also likely to be of value in monitoring worsening affordability as the financial crisis affects households in Africa. Figure 5: Increased data available on medicines prices and availability

Medicines prices/avail. survey

Report published and disseminated

Advocacy work

Further studies carried out

Medicines price monitoring

Cameroon 2002

CAR

Chad 2004

Congo 2007 2007 2007 onwards

DRC 2009 2009 onwards

Ethiopia 2004 2005 2005 onwards

Financing of medicines in 2007

Ghana 2004 2004 onwards

health insurance in 2008; household survey in 2008; perceptions on generics 2007

Since 2007

Kenya 2004 2004 2004 onwards

household survey in 2008; health insurance in 2008

Since 2006

Mali 2004 2005 2005 onwards

Nigeria 2004 2006 2006 onwards

health insurance in 2008; household survey in 2007

Since 2007

Rwanda 2008

Senegal 2005 2005 2005 onwards

Tanzania 2004 2004 onwards

health insurance in 2008

Since 2006



Uganda 2004 2004 2004 onwards

Price components 2008- Household survey 2008

Since 2006

Zambia 2008

However, this important project has some weaknesses in strategies to institutionalise activities, to communicate the findings and follow up on recommendations. Only Kenya has budgeted for monitoring activities and included them in routine ministry activities. Monitoring was intended to be three or six monthly, but has experienced both funding challenges and procedural delays, so that in all four countries, data from the previous year had not been published. Overall, wider advocacy and communication of the information, especially in forms suitable for consumers, has not been extensive. Nor has the activity been consistently presented to sector technical working groups or incorporated into annual sector monitoring activities, despite the fact that most sector performance frameworks include measures of medicine availability. The policy implications of the findings, including recommendations for pricing policies, have not been fully reviewed nor pros and cons debated across sectors, since the initial dissemination workshops. Some key stakeholders at country level have limited awareness and have not been not engaged in government led discussions (e.g. pharmacy professionals and the private sector). At the same time, with recent increases in prices and media coverage, there is growing public demand and ministerial interest for medicines pricing policies such as retail price controls for the private sector. Overall, WHO has been able to provide rather limited support on developing pricing policy. With respect to medicines financing, in the seven countries for which data is available from the two Level 1 surveys in 2003 and 2007, per capita spending on essential drugs has increased over the Programme period. This is due to many reasons, such as local procurement of more costly drugs, and also cannot be attributed to WHO. However, WHO’s advocacy and profile raising activities have certainly contributed to an increased profile for medicines as a systems issue, and also to support for procurement and supply of commodities for HIV, malaria and TB programmes, including through WHO inputs to GFATM proposals. The number of countries with policies for coverage by at least part of the population by national insurance, and for essential medicines, has also increased. The pricing data and method were used in Ghana to develop the drug reimbursement policy for all providers registered with the new national health insurance scheme – as the data provided a neutral and independent price reference table for providers across public, private and faith based sectors. NPOs have strongly promoted policies to ensure that key essential medicines for public health are free of charge at facility level, and also free to defined target groups. WHO and HAI Africa access surveys show that public sector procurement, where competitive and transparent, tends to deliver a procurement price comparable to international reference prices, which contributes to value for money. More countries are now centrally procuring medicines through the MOH or semi-autonomous agencies and hence benefiting from economies of scale and improving the quality and safety of the products, purchasing them from approved sources. In the Congo Republic, for example, the NPO has been actively involved in the launching and functioning of the central procurement agency since 2006, and it has an increased role in supplying health facilities with essential medicines. Progress has also been made on Component 4 (efficient and secure systems for medicine supply). National activities for procurement and supply management supported by the NPOs included developing plans to strengthen the supply system, mapping and assessment of the supply systems for essential medicines in 11 countries (Figure 6), annual quantification of



medicines needs and procurement plans, manuals for managing medicines in heath facilities and training in drug management, and policy for medicines donations. WHO country offices have contributed significantly to supporting public sector procurement and supply management capacity, including providing normative guidance. This also leveraged other donor funding for long term TA on forecasting, stock control/inventory management systems, and contract management with suppliers. NPOs are sometimes members of procurement agency boards and of committees for preparing and evaluating tenders (eg in Congo). WHO has also supported training for health workers at all levels, including staff at central, zonal/regional levels and some districts for medicines management. Figure 6: Progress in capacity and co-ordination for procurement and supply management (PMS)

Training/ support to strengthen PMS

Supply system assessed/partners mapped

Partners engaged

Tools/instruments for supply management produced

Procurement plan developed/support to coordinate partners

Cameroon ��

CAR ��

Chad ��

Congo ��

DRC ��

Ethiopia ��

Ghana ��

Kenya ��

Mali ��

Nigeria ��

Rwanda ��

Senegal ��

Tanzania ��

Uganda ��

Zambia ��

The Country Offices and NPOs play an important technical and co-ordinating role in Global Fund applications. The NPOs often manage the process to develop the section on procurement with national partners – a role that they have effectively delivered, and which has also brought additional resources to the sub-sector. The NPOs have sponsored discussions within the EAC on pooled procurement of medicines and WHO has conducted a regional assessment of procurement practices (to support regional efforts for pooled procurement) and provided technical support to mapping national supply chains. In several countries (including Republic of Congo, Senegal, Tanzania) the mapping process has enabled WHO to better promote coordination of donor, government



and other stakeholders. Here, government counterparts are well engaged and value the preliminary findings, which point to weaknesses in the system with regard to the vertical programmes, and there has been a dissemination workshop. Several recommendations have been included in Tanzania’s new health sector support plan. In Senegal, this supported advocacy for procurement of all public sector medicines through the national agency. However, awareness among other stakeholders is not high as yet, and next steps with regard to agreeing and implementing the recommendations have been developed in four countries. With respect to advising on local production, WHO has made efforts, for example in Tanzania, to engage with local pharmaceutical industry, and supported a pre-qualification workshop to take place. In Ethiopia, the NPO supported a new technical committee, under the Ministry of Trade and Industry, to develop a strategy for the pharmaceutical industry. However, local production remains a highly politicised issue where national capacity building is not necessarily a cost effective strategy. In Tanzania, the local ARV supplier remains un-qualified, but is registered with TFDA and supplies ARV products (purchased through the domestic budget only). 4.1.3 Objective 3: Quality and safety (Component 6) Significant efforts have been made to improve regulatory capacity and systems all NPO countries (Component 6, Figure 7). Substantial impact has been achieved, working with other partners, including DFID, DANIDA and USAID sponsored agencies such as MSH. WHO has sourced required TA and provided seed funding, which has then catalysed funding from other donors. Activities have included assessment of the drug regulatory system, strengthening of the national quality assurance laboratory, supply of minilabs, support to pharmaco-vigilance planning, post marketing surveillance, and testing samples of medicines for quality, preparation of guidelines for clinical screening, training of health personnel in post marketing and safety of medicines, and access to regional training opportunities and to inspecting standards for GMP. Support to training of staff and improvement of quality assurance systems from registration to inspection and laboratory control has been an important contribution of the NPO in Ethiopia. The Nigerian regulatory agency (NAFDAC) is widely recognised for its increased capacity, achieved in part through NPO inputs. The counterpart particularly valued support for NAFDAC’s appraisal, which helped in developing and obtaining funding for the strategic plan (with DFID bilateral finance, through the Health Commodities Project). Figure 7: Progress in national medicines regulatory authority capacity

Training for MRA

MRA assessed and plans developed

Further training/support is provided in eg ph'vigilance and counterfeit medicines

Computerized registration system (SIAMED) installed

Legislation/ guidelines for regulating pharmaceuticals enacted

Cameroon ��

CAR ��

Chad ��

Congo ��

DRC ��

Ethiopia ��

Ghana ��

Kenya ��

Mali ��



Nigeria ��

Rwanda ��

Senegal ��

Tanzania ��

Uganda ��

Zambia ��

WHO medicines and other programme NPOs have worked together with national counterparts to ensure that the introduction of quality testing and post marketing surveillance for new medicines for malaria and ART have supported strengthening the regulatory agency and its quality and safety systems, rather than remaining as one-off programme efforts. However, in most countries, capacity for quality assurance and inspection remains weak at sub national levels. Box 2: Improved performance of the TFDA, Tanzania In Tanzania, WHO has contributed to successful reform of the regulatory bodies, with the separation of the Pharmacy Board into the Pharmacy Council and the Tanzanian Food and Drug Authority (TFDA). The regulatory agency, TFDA, demonstrates much improved performance and transparency, through for example its new quality management system and website. The aim is to get ISO 9001 in 2009. Medicines are now routinely tested at borders and importation sites, and facilities inspected for GMP. Industry clients (e.g. represented by the Tanzanian Association of Pharmaceutical Industries) report improved services, in terms of both quality and efficiency, of the registration process. WHO and others such as MSH through its SEAM programme have contributed to developing capacity with the TFDA, which is now regarded as one of the strongest in the EAC. Processes are supported with WHO’s normative guidance on the regulatory function, training and technical assistance. Tanzanian inspectors are now participating in WHO Geneva’s team, in the Prequalification programme. Training has included effective drug registration (focus on bioequivalence), guidance on drug donations and safe disposal of medicines, quality assurance for drug inspectors. Quality assurance monitoring systems have been introduced for ARVs and anti-malarials and a new quality management system for product registration, clinical trials and procurement. Commercial clients report better satisfaction with the process, although some delays still occur. 4.1.4 Objective 4: Rational use (Component 7) With respect to providing guidance on rational use of medicines (RUM), NPOs have supported national activities such as revision of essential medicines lists (EMLs), national formularies and standard treatment guidelines (STGs), support to research about the use of medicines by providers and consumers (e.g. Congo Republic, Ethiopia, Kenya, Ghana, Senegal Tanzania, Uganda), professional training and campaigns for consumer education (Figure 8). Figure 8: Progress in promoting and building capacity for rational use of medicines (RUM)

Training in RUM

EML developed/ updated

STGs developed/ updated

Further work (eg establishment of DTCs, rational use campaigns, studies)

Cameroon ��

CAR ��

Chad �� Congo

��

DRC ��

Ethiopia ��



Ghana ��

Kenya ��

Mali ��

Nigeria ��

Rwanda ��

Senegal ��

Tanzania ��

Uganda ��

Zambia ��

Counterparts are especially positive about work on rational use in Chad and Senegal. WHO has also helped promote best practices. For example, in Tanzania the NPO helped influence the reduction of a long list of over 700 essential products to a more manageable 300 - the process was much complicated by intensive lobbying by professionals and industry for product inclusion. In Ethiopia, the NPO supported the creation of Drug Information Centres (DICs) and Drug Therapeutics Committees (DTCs); these initiatives were scaled up nation wide in 56 facilities. In Kenya national guidelines for rational use of medicines have been formulated with support from WHO and HAI Africa. At regional and international levels, WHO worked with national authorities in advocating for increased attention to the rational use of medicines (RUM). Indeed, Kenya led the move with fellow EAC members, and with assistance from HAI Africa and WHO, to introduce the successful RUM resolution to the 2007 World Health Assembly. However, there has been less progress on, and less WHO support for, developing and implementing rational use strategies with provider and consumer organisations. Most of the national policies promote (but do not mandate) generic substitution but many professionals remain sceptical. In a few countries, such as Uganda, civil society has been involved, through the Collaboration project, in developing consumer education campaign materials. But in general, implementation of rational use strategies is weak. National therapeutics committees and hospital based DTCs are rarely well institutionalised. As yet there is limited consensus on the most effective strategies and approaches to education and behaviour change. Technical resources are also limited, in comparison to other areas, and this may not be a field of comparative advantage for most NPOs.

4.2 Progress in HAI Africa outputs HAI Africa has made good progress against its outputs (summarised in Table 2). Table 2 HAI Africa revised logframe 2004 – 2008 (narrative summary) Purpose: Increased collaboration and capacity of stakeholders (ministries of health, health workers, civil society, consumers) to develop, implement and monitor policy and programmes for access, quality and use of medicines Output 1: Increased capacity of Africa NGOs to work for increased equitable access and increased appropriate use of medicines Output 2: Increased capacity of range of stakeholders to engage in design, implementation, M&E or medicines policies and programmes at national, regional and international levels Output 3: Increased dissemination of information on essential medicines, issues and policies Output 4: Expanded participation in and strengthened coordination of HAI Africa Network Output 5: WHO-HAI Africa Collaboration implemented in selected African countries through the operational collaboration logframe



In summary, during the timeframe of this programme, HAI Africa has become established as a credible, effective and well organised regional NGO, with key partnerships with other civil society stakeholders, governments and the EAC, and WHO AFRO and Geneva. It is recognised by stakeholders as a leading voice for essential medicines in the region and consequently, it has been invited to join regional committees and regional meetings (eg WHO AFRO working group on traditional medicine, EAC working groups/meetings for regional harmonisation, pricing and procurement). HAI Africa’s key results are achieved through three main strategies:

• convening regional capacity building and networking events, such as the 2007 regional meeting on access to medicines, attended by over 70 participants;

• facilitating regional advocacy and policy engagement in fora such as the East African Community’s technical working group on pricing policy and pooled procurement and the Inter-Governmental Working Group on IP; and

• supporting selected organisations at national level as ‘active partners’ or hubs for taking national activities forward with national NGOs and research groups, and contributing to regional activities.

HAI Africa has mobilised and empowered existing health CSOs and coalitions to address medicines as a human rights and systems issue (Zambia, Zimbabwe, Malawi) and has strengthened their capacity and legitimacy to contribute to policy dialogue (see Table 3 below). HAI Africa has facilitated the establishment of new NGOs/professional networks for medicines in Uganda, Ghana and Tanzania and new coalitions with AIDS, TB and malaria advocates in Kenya, Uganda, Zambia. HAI Africa has worked jointly with other regional networks such as Ecumenical Pharmaceuticals Network (EPN), Equinet, and the Third World Network., including a pan-Africa experts meeting with the EPN in 2007 and a seminar on stockouts and essential medicines with OSI and the Southern African Treatment Access Movement in 2008. HAI Africa has generated evidence for decision making, translated that evidence into easily digestible formats and has facilitated dissemination and policy change. Examples of evidence generation include building the regional evidence base on pricing and availability jointly with CS partners; a malaria medicines market assessment and monitoring in Tanzania, Malawi, Kenya, and Uganda, jointly with national NGOs, MOHs, Medicines for Malaria Venture and more recently with the Affordable Medicines Facility for Malaria; and new regional projects on medicines promotion, anti-counterfeit legislation, and impact of intellectual property legislation on medicines regulatory agencies in five countries. HAI Africa is developing capacity to translate complex data and information into educational and campaigning materials, for example, the 2008 Stop Stockouts Campaign underway in 11 countries and materials produced for the African Civil Society Coalition on IGWG. At the regional and global levels, HAI Africa’s efforts have also significantly contributed to policy change via:

• Africa-wide positions supporting World Health Assembly resolutions on rational use of medicines, intellectual property and public health, and R&D

• Africa consensus for the Global Strategy and Plan of Action of the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property

• Contribution to the civil society voice in the WHO Commission on Social Determinants of Health (through negotiating a contract with WHO)

• Support to improving globally relevant research methods and evidence base on pricing and affordability, including feasible monitoring methodology and data used in the 2008 MDG 8 Report

• Support to formulation and lessons learned for multi-stakeholder participation and MeTA, the Medicines Transparency Alliance

• Representation on the UN Millennium Project Taskforce on access to essential medicines



4.2.1 Outputs 1 and 4: Increased capacity of NGOs to work for access and RUM, and expanded participation in and strengthened coordination of HAI Africa Network As a small, regional network, HAI Africa’s Secretariat has developed its membership and capacity building strategy in light of both the limits on its own capacity and its regional focus. HAI Africa’s main active partners in nine focus countries, are listed in Table 3. They have been selected based on their interest in medicines issues, and capacity and credibility at the national level. HAI Africa has been able to provide them with limited funds for capacity building, research and advocacy activities. Most of the active partner organisations are involved in consumer awareness and communication activities, lobbying and advocacy, research and data collection, policy dialogue processes and training/capacity. It is appropriate that fostering a network of interested individuals has not been a focus, although about 50 individuals in 20 countries are registered Network members, and involved in national and regional activities. Table 3: HAI Africa’s ‘active partners’ at national level Country Name of group Scope Examples of outputs with HAI Africa Ghana Health Access

Network (HAN) Health NGO, focus medicines

Coalition partner in IGWG Africa coalition. Key CS organization in baseline survey and level 2 household survey, and pricing surveys. Collaboration member in Ghana with WHO.

Kenya Consumer Information Network (CIN)

Consumer issues

Key national partner in Stockout campaign. Coalition partner in IGWG Africa coalition. Key CSO stakeholder in campaigns to prevent IP amendments and anti-counterfeit bill.

Malawi Malawi Health Equity Network (MHEN)

Health and equity network, new work medicines

Country coordinator for Stockout campaign in Malawi. Manager, medicine prices and availability survey Coalition partner in IGWG Africa coalition

Mauritius Institute for Consumer Protection

Consumer issues

Regional host for training on advocacy for essential medicines

Rwanda Bureau des Formations Medicales Agréées du Rwanda (BUFMAR)

Health, new work on medicines

Pricing survey contributions. Participated in medicine monitoring workshop in Mauritius

Tanzania Muhimbili University- Faculty of Pharmacy (MUHAS)

Medicines, academic organisation

Medicine survey and monitoring manager. Coalition partner in IGWG Africa coalition.

Uganda HEPS Coalition for Health Promotion and Social Development

Health rights, medicines emphasis

Collaboration partner with WHO and MOH; medicines survey and monitoring manager Lead organization for Stockout campaign Coalition partner in IGWG CS Africa group

Action Group for Health, Human Rights and HIV/AIDS (AGHA)

Health, HIV/AIDS focus

Key partner in the Stock out campaign group. Training on advocacy for essential medicines (AEM Seminar-Nairobi)

Zambia CHESSORE Centre for Health, Science and Social Research

Health research, new work medicines

Coalition partner in IGWG Africa coalition. Conducted the medicine price survey in Zambia.

Treatment Advocacy and Literacy Campaign (TALC)

HIV/AIDS Training on advocacy for essential medicines (AEM Seminar- Nairobi) Regional stock out campaign

Zimb’we Community Working Group on Health

Health and equity network, new work medicines

Focal point for regional stockout campaign and country coordinator for Zimbabwe. Participated in medicine monitoring workshop Coalition partner of IGWG Africa CS group.



Civil society work on access to medicines, in terms of promoting essential medicines as a concept and as a system strengthening and rights issue, has been and is still very limited in Africa. HAI Africa has done well in terms of mobilising and supporting organisations with both wider objectives (health and equity) or more specific ones (e.g. ARV treatment access) to put more emphasis on access to essential medicines as both a right and a community health issue. In the nine focus countries, other organisations are also working with HAI Africa and its national active partner, such as Christian Health Association of Malawi (CHAM) on the medicine price survey in Malawi, the Tanzanian Association of NGOs (TANGO), and the Catholic Pharmaceutical Service and Africa Health Research Organisation, Ghana. Additionally, activities have involved organisations in other countries, such as Parliamentarians for Women’s Health, Namibia; the Global Advancement Initiative, Nigeria; and the Alliance for Consumers and the Environment, Togo. Supply agencies are also members, such as CHAN Medi-Pharm Ltd in Nigeria, and the Joint Medical Store in Uganda. Regional partners include Equinet, EPN, Third World Network, and the South and East Africa Health Civil Society Network. HAI Africa also convened an NGO network for the WHO Commission on the Social Determinants of Health. Capacity building events at national and regional levels include joint regional and national trainings with WHO and HAI Global on medicines price surveys and monitoring, regional consultations for IGWG, pricing workshops with the EAC and WHO AFRO, and advocacy workshops at regional levels, with OSI technical assistance. HAI Africa is achieving a balance between its role in Kenya with its regional function and support to other countries. HAI Africa works with several national NGOs and networks, such as the Consumer Information Network, the Hospices and Palliative Care Association (KEHPCA) and the United Civil Society Coalition on AIDS, TB and Malaria, which brings together several large issue specific networks in Kenya. Despite HAI Africa’s efforts to identify and build capacity with a Kenyan NGO to take the lead on medicines issues in Kenya, this has not proved possible. Kenyan NGOs report great confidence in HAI Africa’s ability to represent their medicines interests in relevant fora, and to provide high quality technical back-up and information resources for their work. HAI Africa also provided newly formed NGOs in Uganda and Ghana with some organisational support at the beginning of the project. However, this is an exception and is not regarded as a sustainable option by HAI Africa. 4.2.2 Output 2: Increased capacity of range of stakeholders to engage in policy development and dialogue HAI Africa’s support has resulted in improved engagement by civil society in national, regional and global participation in policy and advocacy processes. Examples include:

• invited membership of government and regional technical committees (e.g. pharmaceuticals technical working groups in Uganda and Ghana, and the EAC technical group for Harmonisation of Pharmaceutical Policies and Regulations)

• participation in national consultations for national medicines policies, implementation plans, rational use guidelines, new malaria treatment polices (Kenya, Uganda, Malawi, Tanzania, Zambia

• leading roles in multi-stakeholder medicines surveys and monitoring committees in four countries

• Coalition of African Civil Society on IGWG (11 countries) has established a CSO position for IGWG and influences regional and global reports, and continues work on GSPA monitoring plan by civil society



HAI Africa has also supported advocacy campaigns to prevent amendments and new work to influence anti-counterfeit bills (which could result in preventing generic importation) in Kenya and Uganda. In both countries civil society action has enabled the rapid mobilisation of many organisations to take part in lobbying and demonstrations when needed, for example to publicise IP issues with parliamentarians. It has been possible to complement this approach with support to governmental dialogue between ministries of health, justice and trade and industry. In Kenya this approach has prevented the passing of several amendments to limit use of TRIPs public health flexibilities. Box 3: Increasing civil society impact through collective voice: the African Civil Society Coalition on IGWG7 In 2007 and 2008, HAI Africa led a Coalition of health, trade and human-rights civil society organizations from various African countries to develop a common position on the issues pertaining to, and the negotiations surrounding, the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG). The Coalition came together twice, and maintained good communications through a dedicated email list, where documents were shared, progress was noted, and further plans were made. HAI Africa drafted briefing papers for circulation to the group for input and adaptation in their countries. The Coalition was represented at the various IGWG negotiations in Geneva. Members of the Coalition were invited to attend regional WHO AFRO meetings of Member States as the Africa Group worked on developing their position. The Coalition’s biggest impact was felt following its second meeting in Arusha, in April 2008. Additions, deletions, and suggestions were incorporated into the draft, which became known as “the Arusha text.” After further meetings of delegates and the Africa Group, the original “Arusha text” was adopted as the official African Group position and, as such, was used throughout the official negotiations in Geneva. A significant part of the Coalition’s “Arusha text” was adopted into the final Global Strategy and Plan of Action (GSPA). The efforts of the Coalition were acknowledged and appreciated by the official delegations and the Africa Group as a whole. The IGWG process presented an important opportunity to the Coalition to become competent in the issues and to make African civil society’s voice heard on the need for a new system for R&D and access to essential medicines. Work continues for the Coalition in supporting the implementation and monitoring of the GSPA. It is notable that participation has been most effective in the Collaboration countries, where WHO’s facilitatory role has supported inclusion of civil society in governmental policy processes in the pharmaceuticals sub-sector (see next section). HAI Africa is also supporting a regional learning approach to gain experience in complex access issues such as addressing stockouts, and intellectual property rights and anti-counterfeit legislation. Research and policy advocacy initiatives are first developed with Kenyan organisations, which help to demonstrate feasibility and support a strategic approach to taking first steps for other national and regional policy advocacy and campaigns. The new MeTA initiative in Ghana, Uganda and Zambia is also building on HAI Africa experiences. 4.2.3 Output 3: Increased dissemination of information on essential medicines, issues and policies The Secretariat has responded to direct enquiries and provided technical assistance to strengthen the work of the national partners described above in both research and advocacy. HAI Africa also maintains a data quality assurance role for medicines monitoring activities

7 The African CS Coalition on IGWG includes HAI Africa, EPN, DNDi Africa Liaison Office, HERAF Kenya, CIN Kenya, SEATINI, CWGH Zimbabwe, MWENGO Zimbabwe, CHESSORE Zambia, HEPS Uganda, WLAC Tz, SAfAIDS, ICP Mauritius, APPiA Cameroon, Oxfam GB RSA



carried out in four countries (Uganda, Kenya, Ghana and Tanzania). In addition to the Collaboration countries, HAI Africa has supported research efforts in Tanzania and Malawi. For example, MHEN in Malawi reported that HAI Africa’s technical back-up gives it credibility with the government and others in the complex area of medicines, has deepened understanding of the issues, and enabled it to lead the pricing research. However, MHEN would like more support on advocacy strategies as part of follow up to the 2008 pricing survey. Numerous products have been developed and disseminated, notably the first fact sheet on Global Fund requirements and procedures for procurement of medicines (2003), together with a position on donated products; pricing survey reports and monitoring newsletters; briefings on intellectual property and anti-counterfeit issues; briefings for various campaigns. HAI Africa produces two newsletters, NANASI and Practical Pharmacy. However, a recent review by an independent consultant with OSI recommended HAI Africa to reconsider the level of effort required for these products, given relevance to its mission and staffing constraints. 4.2.4 Output 5: Collaboration outputs in Ghana, Kenya and Uganda Prior to the Collaboration project, there was little history of joint working between government and civil society on medicines in Kenya and Uganda. In Ghana the high level multi-stakeholder Access to Medicines Advisory Group included civil society, but partners had not worked jointly before. Co-ordinated by the MOH in each country, HAI Africa members and the WHO national medicines advisers have worked with senior MOH programme staff to plan and manage activities for research, and for policy development and implementation, in line with each country’s strategic plan for the pharmaceutical sub-sector. Building on the established working relationship between MOHs and WHO, the partners have selected the issues where HAI Africa’s expertise and mandate can add value, with regard to contributing to policy development, and monitoring its implementation, consumer rights and representation, and information and communications. Priorities have included national medicines policies, medicine pricing and availability, rational medicine use and promoting the protection of public health safeguards in trade legislation. There is now a substantial evidence base on the availability, affordability and pricing of medicines, across public, private and not-for-profit providers. The results - robust, timely and independent datasets produced through multi stakeholder processes - have direct relevance to policy makers. Equally important, partners are effectively managing a co-ordinated approach to achieve shared policy goals – through civil society advocacy and campaigning, intra-government representations by the MOH and parliamentary lobbying - to protect public health safeguards in new trade laws in Kenya and Uganda, and to remove taxes and tariffs on selected essential medicines and raw materials in Ghana. The partners are working with other stakeholders to generate timely and policy-relevant research. In Kenya, the national regulatory agency and the malaria programme have been able to survey the anti-malarial market, which will inform efforts to remove unregistered and poor quality products. In Uganda, the WHO/HAI research methods have been adapted to provide a baseline for the pilot of the new global anti-malarial subsidy. In Ghana, the partners have worked with the National Health Insurance Authority to support research to set the reimbursement prices for medicines for all accredited providers in the new insurance system.



5 MANAGEMENT, FINANCING AND OPERATIONAL ISSUES

5.1 WHO at national, regional and global levels 5.1.1 WHO Programme staffing The majority of the 15 NPOs have been in post since 2002, although some were appointed later (Republic of Congo, 2005; Zambia, 2005; Mali, 2007). NPO counterparts are the Chief Pharmacist and their team, the regulatory, procurement and supply management staff, and those responsible for medicines issues in other MOH programmes and departments. The NPOs are all senior national professional pharmacists, mainly recruited from the national ministry of health. Some also have experience in regulatory and/or procurement agencies. While their pharmacy qualifications and experience are critical to their credibility, few have extensive training in public health, health economics or health policy, or have experience outside the public sector in the not for profit or private sectors. Notable exceptions are Kenya, where the NPO worked with the faith based sector. The NPOs work to terms of reference developed in 2001, which have not been updated but remain relevant. One NPO cited her priorities as to: identify problems in the system, source and secure quality TA, ensure WHO messages bought to country, translate WHO and AFRO strategies into country reality; provide seed money and attract funds for needed activities. This list well summarises the NPO scope of work. Within COs, the WHO Representatives have been generally supportive of the activities of the NPO. The NPO is fully part of the WHO team and is considered as a very good professional by the WRs (rated highly by the 8 respondents to the questionnaire). NPOs are universally scored very highly by those counterparts responding (11 of 16 including Zanzibar), in terms of their ability to contribute effectively to a wide range of national processes. Counterparts especially value the synergies generated by NPO knowledge of the national system and people, and their ability to access relevant WHO technical and financial resources. As one MOH official said: ‘He knows where to go for solving a problem’. Others remarked on NPO and WHO’s ability to:

• pull together resources for needed activities (Chad), • contribute to development of a framework for teamwork for all involved in the

pharmaceutical field (Rwanda), and involve wide range of stakeholders (Uganda); • contribute to capacity building and integration of disease programmes e.g. treatment

protocols (Zanzibar, Senegal; • advocate for integration into the central supply system avoiding parallelism, Uganda,

Senegal; increase use of WHO norms and standards at country level , Uganda; • contribute to improving the management and quality of drugs in health facilities

through training, manuals and guidelines and more rational use of drugs through training, manuals and development of Drugs and Therapeutic Centres (Ethiopia);

• contribute to improved implementation of the medicines component of various global initiatives and disease oriented programmes as the NPOs work in close collaboration with other NPOs of the WHO country offices (health services, malaria, HIV/AIDS; TB, etc.) and with national staff (Congo).

Counterparts appreciate opportunities for information on experiences in other countries and sharing with colleagues during the annual meetings. NPOs tend to take a highly facilitatory and consensus building approach – bringing together major stakeholders such as private pharmacists in surveys/research, discussions, and round tables. Where their skills in team work and facilitation are weaker, they tend to be less effective. It is also important to note that NPOs roles are primarily technical ones, and only the minority are playing high level strategic



roles. This has implications for WHO in terms of its ability to bring to bear complementary technical support and strategic influence, which is discussed in later sections. WHO Geneva and AFRO have promoted a model of peer support and networking for the NPOs (similar to that for malaria and HIV NPOs). Annual global and regional planning meetings are held, sometimes with counterparts. The NPO network is an active one, where they exchange information, documents and help each other. However, there is limited use or promotion of new information and communication technologies, such as the community e-net platform, set up by WHO Geneva and moderated by AFRO. NPOs are provided with opportunities for developing their skills, through for example regional roles, such as convening a working group for pooled procurement for the EAC, and for human resource issues in pharmaceutical services. Selected NPOs are developing specific expertise and act as a technical resource for the RO in other countries. For example, the Republic of Congo NPO has provided TA in Angola, Cameroon, Central Africa, Madagascar and RDC. His missions have been appreciated, this was not planned at the beginning and it is an important aspect of the programme: it contributes to retain the NPO and gives him credibility vis à vis his counterparts and the other stakeholders in Congo. Other professional development opportunities have included attendance at annual meetings, international professional conferences, other regional meetings and trainings e.g. price monitoring. Individuals have been encouraged to develop expertise and lead roles within the network to some extent e.g. in human resources (contributing a chapter to the World Medicines Situation Report), pricing research, pooled procurement and supply chain mapping. However, overall, a career development pathway for the cadre is lacking, which will have implications for both recruitment and retention in the longer term. 5.1.2 WHO management and planning processes Processes and mechanisms for Programme management and financing are mainly working well, both within WHO and with the MOH. As one interviewee said, ‘Fingers are on the right buttons’ in terms of WHO’s ability to match and meet MOH priorities. A major strength of the programme’s approach is its robust country led planning exercises carried out jointly by the MOH and the WHO country office, and involving other public sector stakeholders. The resulting plans of action take into account the wider objectives of the WMS and the national strategic plans. However, these plans are not always well known by and shared with other partners. Also in some cases, the MOH sees this budget as its own budget and is reluctant to share it with other development partners or NGOs. Some NPOs are addressing this situation. The COs have an annual budget of about US$100,000 for activities related to medicines, allocated under WHO SO11, based on the action plan agreed with government. Implementation and monitoring are the responsibility of the NPO. Three monthly reports and follow up through the annual regional meetings for planning and evaluation are regarded as effective tools. They strengthen links between the NPO and counterparts, push counterparts to be more involved and active, and give them an opportunity to exchange with others. This, especially the latter, is appreciated by both WHO colleagues and counterparts. Other WHO staff are reportedly not able to report progress against plans and budget so promptly. NPOs are able to increase capacity of countries to carry out their planned activities and to deliver their pharmaceutical strategy. Compared with non NPO countries, the 15 NPO countries have utilised $87,000 versus $16,000 per annum on national medicines plan activities. Actual versus planned expenditure is also higher compared with non NPO countries (at 79% versus 64% budget implementation). However in spite of the NPO, absorption capacity in some countries remains a real problem, mentioned in nearly all questionnaire responses. This problem is reported to be sometimes aggravated by the fact the funds tended to arrive late for COs in the reporting year (February/March), but needed to be obligated by end of September of the same year. This issue was raised in monitoring EC programme funds, and the situation has been improved



recently, with funds arriving in January 2009. Some Regional Office decisions are made in cutting country plans according to budgets, while trying to accommodate country priorities, and these are not always well understood by Geneva. There are good working relationships between the WHO Geneva staff managing the Programme and the AFRO Regional Advisers, and mutual understanding of the reporting, financing and accountability lines (NPO – WR – AFRO). Geneva remains overall accountable for programme finances and responsible for its delivery, although the lead on staff management lies with the WR, and with AFRO. This means that Geneva is accountable to donors without always being able to influence major decisions in relation to NPOs. For example, strategic discussions about certain NPOs with lower performance than others or about reallocation of NPOs do not seem to take place within AFRO or between AFRO and HQ. The same applies for the future of the programme where AFRO seems to rely heavily on Geneva. 5.1.3 WHO technical assistance Technical support requested of and provided by WHO’s Regional Office is perceived to be of good quality, timely and flexible by those interviewed at country level, although there are some dissatisfied with the slowness of response. There is no systematic assessment by COs or RO in place for client feedback. TA is sourced from both HQ and AFRO – NPOs often call or e-mail for advice. Providing TA through its three regional advisers, is especially appreciated as it is not perceived a country cost – hence RAs are extremely busy and need to include RA time in the country plan.

5.2 HAI Africa HAI Africa has developed effective governance and management procedures for its small staff in Nairobi, a finding verified by a review in 2008 by the OSI, another funder. It has established a regional Board comprised of well regarded professionals in medicines, network development and financial management, a small but effective team of professionals (3 people) and support staff. The organization has a sound organizational infrastructure, is well run, appropriate management and financial systems are in place, staff understand their responsibilities, and there is good team rapport. The current co-ordinator has tendered his resignation after five years of service, but has committed himself to securing succession. While this will undoubtedly affect the team and the Network, the leadership handover is being done in a responsible way and does not appear to be affecting morale.

5.3 Programme financing Overall Programme funding of £6million was agreed for six years (2002 – 2008), at GBP£1million/US1.5 - 2million per year, with a 75% share to WHO (£750,000 pa, approx $1million) and 25% to HAI Africa. The original agreement with DFID committed WHO to providing an annual audited statement of income and expenditure. Over the Programme period 2002 – end 2008, transfers made to WHO amounted to £4,417,100. Over the period there was an underspend of 14%, which is providing a no cost extension agreed with DFID to cover Programme salaries and activities in 2009. Implementation rates at country level have been mainly good (at 80-90%) and the underspend was mainly due to unanticipated delays in recruiting NPOs and getting the Programme started at country level. Over 75% of Programme funds are channelled to regional and national levels, well in line with WHO commitments to decentralise resources. The split between staff and activities over the Programme period averages at 40:60. This is complemented by the EC allocation, at 30:70. Financial monitoring of country plans and expenditure is well executed by AFRO, with support from Geneva, but it was difficult to obtain an aggregate breakdown of Programme expenditure from AFRO. HAI Africa has managed its annual budget of about £250,000 well, with sound reports from its independent auditor. With an overall spend of £1,514,837, there was some underspend



before the project gained momentum in 2004, and HAI Africa was granted a six month no cost extension in 2008 by DFID, for use of remaining funds. HAI Africa, as it has expanded its portfolio and donors beyond this programme, has reduced its dependence on this DFID project from 95% in 2001 to 60% of total income in 2007. This is linked to a doubling in total income with new funding from the HAI Global Programme (which raises funds for its regional networks), Oxfam, Open Society Institute, the Ford Foundation and other WHO funds. Both organisations allocated a proportion of their annual funding to the Collaboration in Ghana, Uganda and Kenya, for management, technical support, regional and country activities. HAI Africa has transferred to members in Ghana and Uganda/spends in Kenya a total of $50,000 per year for country activities, such as medicines monitoring. The WHO NPO workplan allocated between $20-40,000 pa in each country for Collaborative work. The total available in each country is therefore no more than $50,000, which has been used effectively for a wide array of research, workshops and dissemination activities. Some Collaboration activities continue as part of the NPO programme with WHO’s no cost extension until end 2009.

5.4 Role of DFID DFID has been willing to be highly flexible in terms of its original willingness to commit to an innovative project with some level of risk, and in arranging no cost extensions, for example. The flexible approach of the funder, DFID UK, in providing complementary but separate funding streams to WHO’s WMS strategy and HAI Africa, has enabled the partners to develop new and productive ways of working together. In addition to funds, DFID has also contributed to the Programme mainly through the well regarded inputs of an independent consultant, who has represented DFID on the Collaboration’s management group (three countries). Sustained linkages with health advisers in DFID’s regional and global policy teams, and at country level, have been limited, because DFID’s regional directorates have limited resources to advise on any regional health initiatives, and country offices tend to focus on overall health sector development. Despite this, DFID has been supportive of the project and recognises its value as a model for multi-stakeholder working, especially with regard to supporting civil society engagement at policy level with government. Indeed it has clearly informed DFID’s approach to MeTA, although MeTA would perhaps have benefited from an earlier review of the Programme’s experience.



6 CHALLENGES, LIMITATIONS AND RISK MANAGEMENT

6.1 Contextual challenges All the countries have experienced an increasingly complex environment for drug policy, given changes in intellectual property arising from TRIPS, which are mainly handled by the ministries of trade and justice at national level, and in procurement and supply management, given additional funding for vertical disease programmes through the GFATM, PEPFAR and others. Until recently, the trend has been for significant investments in product procurement and supply management for particular programmes, which has also reportedly adversely affecting the overall supply of essential drugs in systems with integrated supply. WHO, among others has undoubtedly contributed to recent emphasis on the need to support the wider regulatory, procurement and supply management systems to deliver the products, in part through contributing to GFATM proposals, and also by contributing to introduction of new products as a way to promote wider system efficiencies. Indeed, the original programme proposal hypothesised that NPOs would be able to contribute to ensuring that new products were made available in a timely fashion to patients. This has clearly been the case. Now, there are great opportunities for steering policy and finance to support balanced integrated systems. As one bilateral aid official said: ‘We want to support the system to support the programmes’. Workforce constraints severely affect the pharmacy sector, as with all human resources for health in sub-Saharan Africa. This has implications both for capacity building efforts by WHO and explains in part the policy-implementation gap. While some of the challenges have been tackled for overarching policy and in building capacity of central agencies, by WHO and others, the management and supply of pharmaceuticals to health facilities continues to be affected by severe institutional constraints. The pharmacy unit is low in the hierarchy of the ministries’ policy structures and is often a weak player in strategic planning for the health sector, mainly due to lack of staff and resources. Several chief pharmacists have been replaced, which affects continuity. Regional and district posts are understaffed. Capacity for quantification is limited and demand-led systems for drug ordering are not yet functioning optimally. These constraints have serious impact on the ability of the NPO to take forward some activities. The government is in the driving seat. Without political commitment, things will not change. It is important to make a careful analysis of the obstacles when developing a programme such as this, and include strategies tailored to address them. Civil society, even in the three countries where WHO and HAI Africa have worked together to build approaches to capacity building and inclusion, remains weak and lacks a presence in medicines issues. Though in most countries there are explicit statements in policy instruments for CSO involvement, the practice at the MOH has not yet reached these policy aspirations. The activities with civil society (protection of consumers or/and patients) are very limited in most of the NPO countries, and the roles civil society can play in relation to monitoring the poor behaviours of health personnel, prices of services and drugs are often under-valued by WHO and government. Additionally, there is the challenge of funding for CSOs involved in policy advocacy as opposed to service delivery. Governance challenges are frequently raised as a further barrier to policy implementation, and need to be addressed more proactively by WHO. The potential role for civil society in governance, accountability and transparency does not always seem to be recognized by WHO and other stakeholders. Involvement of civil society is important in good governance accountability and transparency initiatives. MeTA has been launched in Ghana, Uganda and Zambia, with full involvement of civil society, and building on the Collaborative ways of working and relationships – this is an important opportunity for WHO, whose ability to build



and broker trust between stakeholders is an important comparative advantage not always maximised. In Malawi for example (not an NPO country), the Focal Point for Medicines in the WHO country office is supporting WHO’s Good Governance for Medicines project, with input from a Regional Adviser. This has resulted in a well appreciated assessment by national stakeholders (e.g. Pharmaceuticals Dept, Pharmacy Board). The assessment covers: registration; selection; procurement; inspection; promotion; Government stakeholders found the assessment helpful – highlighting risks e.g. role of private pharmacists as GMP inspectors. However, it is little known outside the public sector, and several key donors and civil society groups, including HAI Africa’s partner, were not aware of it. It will be important for WHO to bring in stakeholders in developing policy recommendations, and a monitoring and implementation plan.

6.2 Organisational factors There has been limited discussion about next steps for the programme and future funding possibilities within WHO, between AFRO, WRs and Geneva. It seems difficult for the country office to put NPOs on the country budget (given constraints on, and stagnation of, the regular budget). In the past, WRs may have avoided including the medicines NPO in the budget, given the existence of quite substantial voluntary funds through DFID and the EC programmes. However, five COs (Central Africa, Democratic Congo, Ghana, Nigeria, and Uganda) have included NPOs in their regular budgets, and in Tanzania, 50% of the salary has been allocated for 2010-11 biennium. The commitment of WHO COs appears variable: it may be significant that only just over half (8) returned the questionnaire. Ceilings on both regular and voluntary budgets are now set by AFRO and HQ on all strategic objectives including SO11. As DFID’s contribution comes to an end, these are perceived as too low in countries to enable a post to be funded from the regular budget as well as activities (desired by the MOH). Cost sharing with other WHO programmes may be feasible although there are already NPOs for HIV/AIDS, malaria and health systems. Cost sharing with other agencies seems complicated to organize, but should be considered as an option given WHO’s contribution to improving the effectiveness of disease programme funding. Co-ordination of country support is sometimes challenging, given AFRO’s lead role in country support and Geneva responsibility for developing norms and standards. With over 100 staff in EMP, coupled with demands from staff in the other divisions in Health Systems and other clusters, the demands on the NPOs can be great. However WRs have been supportive in managing the workload. WHO Geneva’s recent re-organisation of the two medicines departments (for technical co-operation and normative work and policy) into one should in principle foster both better coordination and increase the technical inputs to regions and countries, as strongly requested by them. Some decentralization has taken place, and capacity for medicines support in AFRO has been strengthened, with three regional advisers in place (and two posts planned, based in the three Inter Country Teams). A continual balancing act between country priorities and new work for norms and standards, which requires country input, is needed. However, the role of the Medicines Programmes Co-ordination unit as a ‘mandatory’ focal point when dealing with regions and countries is not strong enough and activities requested by the technical teams are not always well integrated in national plans, and create a burden on national staff. In addition, the technical units are not always available for answering country needs. Integration into the Health Systems cluster is beginning, but it may be challenging to develop a joint vision and strategy. Essential medicines are different from other health systems issues; there is more need for normative guidance where WHO has clear comparative advantage. In health systems, there are many more players with little consensus, and



Geneva has a less clear role at country level. As yet, there seems to be limited knowledge within HS cluster of the NPO programme, and limited links with important initiatives such as the IHP+ agenda. For example, Ethiopia had planned but did not implement the procurement mapping process, although procurement is one of six issues in the 2009 ministerial communiqué. At country level WHO is fully involved at the strategic level, and a contributor to the MDG Performance Fund. However, technical staff, including the NPO, were less aware of these wider processes. It is also the case that procurement matters are led by Ethiopia’s new procurement agency and the World Bank. For HAI Africa, its new campaigns, such as Stop Stockouts, demonstrate its growing competence, credibility and confidence in using its ‘flagship’ evidence base to influence policy. However, overall advocacy and communication activities need further expertise and expansion, in terms of building both civil society’s challenge function and consumer awareness strategies to improve access. Similarly, although some effort has taken place on rational use, consumer organisations have an as yet unfilled role to play. HAI Africa and its active partners are establishing themselves as expert researchers. However, this role (as for example, research service providers with MMV and AMFM) must be balanced with maintaining an independent voice for civil society. Last, the Secretariat is small and likely to remain so, which means that HAI Africa and its board must continue to be highly strategic in selecting a limited number of activities, focusing on those that will have the most impact. While new joint funding with WHO might not be an appropriate funding strategy, both organisations need to consider how best to continue their effective collaboration.

6.3 Programme risks and limitations The Programme has proactively addressed many of the risks identified in the project appraisal, such as health systems failure to implement the essential drugs concept, as well as managing to continue in spite of national crises and conflict (eg in Kenya). It is notable that only the NPO questionnaire response was received (and very late in the evaluation process) from the DRC, which continues to experience conflict. However, it is important to highlight a number of limitations, which are also linked to the risks identified. With respect to engagement with consumers and civil society, the groundwork done by WHO as a broker with HAI Africa and civil society in the Collaboration countries (Kenya, Uganda and Ghana) has laid strong foundations for future partnership and demonstrated that civil society can be credible with government. However, there has been limited engagement with NGOs and consumer unions in non-Collaboration countries, such as the Republic of Congo and Ethiopia. Even in Senegal, where civil society is more developed and its legitimacy better recognised by government, links with both the government and WHO are weak. The main consumer organisation has undertaken its own health and medicines price surveys.� While some in WHO see clear need for civil society engagement and would like to see funding for groups to be involved in activities such as consumer education, others in the organisation are less supportive. The involvement of the pharmaceutical associations has been more actively sought by the NPOs, probably because of a common pharmacy background. Several interviewees commented that WHO’s upstream role in facilitating strengthening and co-ordination of the sub sector as a component of the wider health system could be more robust, in some countries. As one national counterpart put it: ‘WHO could do even better if it more aggressively drove integration, the health systems approach, and less vertical programming’. In some countries, WHO has not developed a CO approach to health system strengthening, and not yet received significant support to do so. Collaboration with other stakeholders on pharmaceutical issues has not always been strong, for instance with



international partners and their technical advisers. The role of the NPO and the mandate of WHO in relation to medicines could also be better promoted within the broader development community, in some countries. While there has been progress in developing the evidence base, in policy formulation, and in strengthening regulatory frameworks, less has been achieved in implementing policy for better access, making quality medicines more available and affordable. There are a number of reasons for this. The Programme has done best in WHO core areas of expertise: in its evidence based approach to medicines policy, selection of medicines and the essential medicines list, supply management, and in normative work to improve rational use, quality and safety. WHO has less experience in medicine financing and affordability issues, and in collaborating with others on implementing strategies for rational use. The WHO and HAI Africa access surveys all include a recommendation to develop appropriate pricing policies, but there has been little or no development of pricing policies in any country. Two WHO supported official meetings have reviewed policy implications of the survey findings. One was held for several African countries in 2006 and one for the East African Community members in 2007. Civil society partners were invited for the first time to both workshops, and shared their experiences in addressing pricing issues in their countries. This issue is widely acknowledged by all stakeholders, including at the global level, as a major challenge – the complex process of developing medicine pricing and policies to ensure affordable prices and effective competition in a well-regulated market place. With regard to rational use, for example, the programme has supported significant collection of data and research, and development of policy and guidelines for rational use, the essential medicines list and standard treatment guidelines. However, there has been less progress especially with consumers, in part due to its being given lower prioritisation with government and in part because of the complexity of changing provider and consumer behaviour. Both these issues represent major challenges and opportunities for WHO. Ultimately the effectiveness of the approach is limited by two factors: the sphere of influence and skills of the NPO and, even more importantly, the capacity and willingness of the government to implement. As discussed above, implementation is seriously constrained by limited national absorptive capacity, the human resources crisis and governance challenges – issues that WHO is making efforts to address through the Health Systems Cluster’s work programme (which now includes the medicines team), Good Governance for Medicines and engagement with MeTA. The success of the NPO programme is highly dependent on appropriate human resources – ‘having the right person in place’, as one WHO publication puts it. This approach can entail significant risk and management challenges. In a small minority of countries, the Programme has been less able to develop intensive dialogue with stakeholders and to greatly influence the pharmaceutical sector. Dialogue and technical support is often confined to the technical institutions, and limited strategic discussion takes place. Personality and background prevent working as part of a team and actively participating in the many multistakeholder groups dealing with access to medicines. The size and type of donor presence and structure of the subsector are important factors that should shape WHO’s comparative advantage and should direct both its strategic and technical functions and its staffing decisions. For example, in some settings, an international adviser may have more impact, especially where the environment is complex.



7 ADDED VALUE The programme’s added value is defined in two ways: a) the additional contribution made by WHO to the achievement of national (and WMS) outcomes in the NPO countries; and b) the benefits enabled by the participation of HAI Africa as a civil society network.

7.1 Added value of the WHO NPO programme 7.1.1 Increased profile for essential medicines and evidence based medicines policy More attention is paid to essential medicines supply, and availability of medicines is becoming an increased concern of senior MOH management in all the countries visited. As one senior official said: ‘The NPO has been an ambassador and educator for essential medicines’. Prior to NPO appointments, the WHO CO had limited dedicated staff time and funds for medicines activities. In countries without NPOs, this still applies: for example in Malawi, the malaria NPO (trained in public health) is the Focal Person, with about 20% allocated to medicines activities. Although his inputs are appreciated, the limits on both his time and expertise are recognised by stakeholders, particularly among pharmacists. The NPOs have also shown the important roles to be played by pharmacists in the system. In Senegal, each national disease programme has recruited one or two pharmacists within the programme management team. 7.1.2 Increased importance of the regulatory, procurement and supply system WHO’s advocacy on the need to support the ‘horizontal’ supply system as well as the products delivered through targeted programmes has contributed to more awareness of the importance of robust policy and regulatory framework for pharmaceuticals and other essential supplies. In Tanzania, data and recommendations from the Procurement and Supply chain mapping exercise are well represented in the new strategic plan for the health sector. The introduction of new medicines has been used strategically as a platform or entry point for strengthening wider procurement and regulatory system as much as possible. The NPOs have contributed to improving the efficiency and effectiveness of medicines supply for the disease specific programmes. Weak governance and limited transparency is recognized as a major issue more than before, in countries such as Congo. 7.1.3 Increased funding Several countries have seen increased resources for medicines in the national budget. NPOs have also increased ability of countries to attract more funding from other donors (e.g. GFATM) and from WHO’s budget itself, as ability to disburse funds has been high. Work on essential medicines ‘took off’ following the NPO appointment. Until then WHO had been providing only limited support. NPOs have provided a highly cost effective approach to helping to accelerate activities. Seed funding provided by WHO for specific activities and TA has attracted other donors and got the ball rolling. 7.1.4 Improved co-ordination among government, civil society and development partners WHO is well positioned to support multi-stakeholder working, with its close links to government and role as a technical partner. The NPO has been instrumental in setting up new sector working groups for pharmaceuticals, especially among the various public sector agencies and programmes, and donors. There are strong linkages with other national programmes – NPOs have worked together with other WHO and government staff on anti-malarials and ARVs policy, regulation, and market surveillance in all the countries. The Programme has stimulated new relationships with other stakeholders in some countries (e.g. manufacturers, civil society). 7.1.5 Regional linkages and initiatives While not envisaged as a major or strategic focus of the programme, the network approach taken by the WHO NPO programme has promoted regional initiatives by ministries of health as members of the regional economic community bodies. This is particularly the case for agencies in the EAC, where NPOs are supporting working groups for pooled procurement,



pricing policy development and harmonisation of regulatory processes. This is slow given that some countries are much less developed in capacity. The Africa wide position for IGWG was developed as a rolling process through collaborative work between HAI Africa and Kenyan government, together with other EAC and then AU members.

7.2 Added value of collaboration with HAI Africa There are three areas of added value: 1) a space to generate synergies, among stakeholders with diverse interests and expertise for fulfilling national medicines policy needs; 2) an enabling mechanism for the MOH and civil society to increase mutual trust and respect and to engage as strategic partners in policy processes; and 3) a process for consultative, policy-relevant research that directly involves decision makers, meets country needs and increases the likelihood of policy implementation. In each country, the CWG is viewed by partners as providing a unique and important mechanism that provides a space for dialogue and collaborative activities. This space has helped change attitudes and working approaches for both civil society and government in the pharmaceutical sub sector. This has also been enhanced by the need for ministries of health to respond to government directives that promote strategic partnerships with CSOs in health policy and service delivery. The review found that the Collaboration has added value by providing the MOH with a means of constructively working with CSOs, for helping to put policy for partnerships into practice, and for consultative processes that will increase the likelihood of effective policy implementation. It has enabled civil society to contribute more effectively to policy dialogue with government officials in the pharmaceutical sub sector. Competent contributions to a relevant, credible and independent evidence base are proving essential ingredients for recognition by government of civil society’s value as a strategic partner.



8 LESSONS LEARNT AND OPPORTUNITIES

8.1 WHO has significant comparative advantage in essential medicines, put into practice by the NPO network WHO’s independence, its trusted relationship with the ministry of health and its global expertise and normative role has enabled the NPOs to influence counterparts to adopt proven good practices, to carry out research, to try innovative approaches, such as promoting collaboration with civil society and the private sector, and to promote investment in pharmaceutical system capacity. NPOs have secured more attention and funding for both essential drugs and for development of the pharmaceutical system and services, and helped make the best use of those resources through strategic investments and promoting co-ordination. As a senior MOHSW official put it: ‘We cannot work in isolation – the NPO helps us know what is working in other countries and the latest best practice’. At the same time, NPO familiarity with the national context means that they are ‘a very active actor in the system’. The model well illustrates WHO’s vision that the NPOs provide ‘an open window on WHO for national counterparts’. Findings show that, to be successful, support is needed from the WR, from the RO and HQ and from colleagues in the network. The network and annual regional meetings are an integral part of the programme’s success.

8.2 Focused support is needed for civil society engagement The Programme component to fund and promote collaboration with civil society has encouraged very new ways of working by WHO – working actively to involve civil society as a partner in policy dialogue and a challenge function with government (versus more traditional roles in service delivery and monitoring). In the countries where Collaborative activities were sponsored through WHO and HAI Africa, WHO has proved able to broker effective and productive relationships with civil society and others. However, in the others, engagement tends to be weaker and not institutionalised. WHO is well placed to build further linkages with stakeholders beyond the public and faith based sectors, which is not happening yet in most countries. Earmarked resources and focused effort from AFRO and HQ are needed to stimulate this.

8.3 Balancing national priorities with promoting other critical concerns It has been critical to focus effort on priorities of the country, in order to have strong country ownership. In most countries, ministries have prioritised policy, regulation and access. However, this has meant less dialogue on, and technical support to, appropriate strategies for promoting rational drug use, and for its importance in terms of both health outcomes and value for money for consumers and the public sector. RUM is a complex area which needs to involve the medical profession and consumers and not only the pharmacy department, and it may be more difficult for a NPO who is a pharmacist to be very pro active in this area. This is a missed opportunity, given the significant investments in introducing new and costly medicines. It is positive that HAI Africa is working with several treatment action campaigns, for whom adherence is of major importance.

8.4 Complementary strategic and technical roles for WHO at country level Findings demonstrate that the most effective approach lies in WHO’s capability to complement technical inputs (provided by NPOs) with strategic ones (provided to some extent by the NPO but mainly by the WR and RO/HQ teams). The NPOs - as pharmacists - are more familiar with people and organizations dealing with drugs and with specific technical issues and their sphere of influence is inevitably limited among external development partners and senior management in the ministry, especially in complex aid environments. For the WR to push for the medicines agenda he/she needs to be supported by a strong NPO; WHO’s impact is limited if technical inputs are weak. Likewise, in the best performing countries, the WR is using their position to play a complementary high level strategic and



advisory role – recognised by government and valued by other development partners. Examples include the WR’s strong emphasis on medicines as a major priority in high level donor-government working groups and sector wide policy groups, and advocacy for investment in pharmaceutical systems. In countries where this strategic role is weaker, the profile of medicines as a systems issue is less obvious, and support for disease programme efforts is less likely to be linked to wider investment in the health system.

8.5 Flexible and innovative funding arrangements by DFID have benefited the programme DFID’s funding for six years gave time for start-up over 18 months (NPO recruitment etc). WHO has since built in start up phases into new programmes. DFID’s willingness to provide flexible support to WHO’s own strategy, the WMS, is in line with principles for aid effectiveness and reduces transaction costs. DFID understands that medicines needs specific support as key component of health sector; providing support for horizontal approach to EM across disease programmes and to the new primary health care agenda. Programme support is over 80% channelled to country level. Other donors are keen to support global work but reluctant to fund country needs linked to it, or to fund broader EM country support. However, the DFID example has encouraged other donors such as the EC to adopt a similar approach. In addition, DFID was a strong promoter of the collaborative component of the programme, and funding for HAI Africa. Without this spur, engagement between WHO and HAI Africa as partners would have been unlikely.

8.6 Resources are needed at regional and global as well as national levels to deliver country outcomes In recent years, WHO has been shifting its strategic focus and budget to country level support. The Geneva medicines department is viewed as a good performer in terms of working with country offices and with AFRO, for example in securing NPO funding, developing and supporting country-led workplans and providing appropriate technical assistance. The role of AFRO and WHO Geneva have provided valued TA and guidance to the NPOs. For civil society partnerships, the normative, technical and institutional support from WHO’s technical advisors at all three levels, have helped to open the door wider for civil society to engage in policy level discussions with government officials. For WHO Geneva and WHO AFRO, the approach is providing a useful model for supporting country-led approaches, and for strengthening government-MOH-civil society partnerships. HAI Africa (including links to HAI Global), has been equally critical to the model’s credibility, with the network’s growing regional reputation for professional expertise and its commitment to health and consumer rights. The Collaboration has contributed to the strengthening of HAI Africa as an increasingly effective regional network, one of the very few working on a broad medicines agenda, as opposed to HIV and other disease programmes. Both ministry officials and HAI Africa members refer to the role that HAI Africa Secretariat plays in providing credibility and confidence for country level activities with CSOs linked to HAI Africa.



9 CONCLUSIONS AND RECOMMENDATIONS 9.1 Conclusions WHO Medicines Strategy indicators demonstrate significant and broad improvements in the policy and regulatory environment in the selected countries from 2003 to 2007. NPOs have enabled the production of a robust evidence base for the sector, accelerated the development of policy and regulatory frameworks and capacity, secured more attention and funding for both essential drugs and for development of the pharmaceutical system and services, and helped make the best use of those resources through strategic investments and promoting co-ordination. HAI Africa and the NPO network have helped refine the global approach to pricing surveys and to develop monitoring; building on and improving research methods, and, in selected countries, successfully facilitated the inclusion of civil society in efforts with government to improve the evidence base and policy environment. The programme has had a strong country focus, with plans and activities owned and led by the government. The programme has contributed to raising WHO’s perceived value and profile as a strategic partner in the area of pharmaceuticals, especially in the public sector. The presence of an NPO had drawn support to the pharmaceutical sub sector, and increased government’s absorptive capacity to carry out activities. The Programme strategy, across the 15 countries, comprises a respected, experienced NPO, working within a well supported Africa-wide network, with access to activity funding and high quality TA, and using a structured approach to national planning, implementing and reporting with counterparts. The great majority of NPOs are regarded by as both competent individuals and contributing to an effective network. The Programme has built a cadre of skilled regional professionals. The effectiveness of the overall Programme approach has been assisted by the WHO medicines department’s clear and practical strategy and objectives, based on national priorities and set out in the WMS, which has supported regional and national implementation through the NPO programme. Implementation rates in NPO countries have been higher, and progress on core activities slower, in countries without NPOs. WHO’s country programmes are reported to underperform, and have lower activity rates, if they do not have dedicated staff. However, while achievement of progress purpose and outputs has been very positive, progress towards the WMS goal - improving access, quality and safety and rational use by consumers and providers - is less encouraging. Comparative data on access, quality, safety and rational use across the six years is limited, although the Programme has generated robust baseline data and follow up surveys in some countries. Where data exists, progress is limited. This highlights the gap between a sound policy framework and the challenges in implementing it, which lie both in the wider context (especially with regard to the complexity of the medicines supply chain and limited capacity and hierarchical position of national counterparts) and in aspects of WHO’s own strategy and human resources. The effectiveness of the programme remains limited by the weak capacity of national administrations, the limited vision for public health and the pharmaceutical sector, and the need for better governance, and strategies for policy implementation and coordination among various stakeholders. Indeed, the most difficult part of the work is likely to be over the next five years - to translate the many policies, plans and guidelines into practices which will make access to essential medicines a reality for the people. Now that updated policy, regulatory and procurement frameworks are in place and supported by a robust evidence base, it will be important for WHO to provide further support to three main areas: improving governance; policy implementation; and communication and co-



ordination with a wider group of stakeholders, drawing on the lessons learned and comparative advantage described in the previous section. With respect to specific technical areas, limited progress has been made in developing pricing policies globally and in any of the countries. Defining and assessing the impact of policy interventions on consumer prices continues to be technically and politically challenging, and is also being addressed through expert meetings at the global level. With increased popular and political attention on medicine prices across the public and non-state sectors, WHO’s support for multi-stakeholder consultation and debating policy options for medicines pricing will be critical within the overall framework of health financing. There has been some activity to develop policy and guidelines on rational use of medicines, but partners also recognise the need to do more regarding consumer education. Kenya’s effective support to the World Health Assembly’s Resolution on Rational Use of Medicines in 2007 now provides the enabling policy environment for national decision makers to prioritise rational use with a wider group of stakeholders representing consumer and provider needs. Some WHO initiatives are appreciated by government but are not yet are not well known or routinely used by other stakeholders, for example the Good Governance for Medicines pilots, medicine price monitoring and the procurement and supply chain mapping exercise. Research on prices across sectors has not yet been communicated in appropriate forms to consumers, to increase transparency. Some resources have supported developing specific advocacy messages for identified target audiences, and HAI Africa and WHO have organised a workshop and provided resources for developing national advocacy strategies on medicine pricing, but more needs to be done. The NPOs are greatly appreciated and have influence with a range of national counterparts. NPO local knowledge of the health, governance and financing system is invaluable. All the NPOs are pharmacists, which is critical to their credibility and effectiveness. However, expectations are high that WHO can contribute to a very wide range of issues in the sub sector, including medicines as a systems issue, public health, public private partnerships and medicines financing. The current cadre of NPOs (and regional advisers) lacks this wider expertise and this may be limiting WHO’s ability to provide effective support at country level, and also explain lack of progress in some areas (e.g. pricing policies and rational use). A greater range among the NPOs may enrich their learning and contribution as an NPO cadre. Professional development opportunities have included attendance at annual meetings, international professional conferences, other regional meetings and trainings e.g. price monitoring. Individuals have been encouraged to develop expertise and lead roles within the network to some extent e.g. in human resources (contributing a chapter to the World Medicines Situation Report), pricing research, pooled procurement and supply chain mapping. However, overall, a career development pathway is lacking, which will have implications for both recruitment and retention in the longer term. More broadly, country implementation of the WMS will require more strategic engagement and advocacy on pharmaceutical issues by WHO at sector policy level as part of wider advocacy for health system strengthening and the re-vitalisation of primary health care as well as technical inputs. There is great potential in harnessing the Health System Cluster’s expertise at HQ and AFRO for ensuring that medicines are a key component of core system issues such as health financing and human resources, and that the focus of the cluster as a whole is on country support. WHO is an important player and is expected to be a strong voice and support in relation to medicines. All the persons interviewed expected a highly visible engagement of WHO. They expected WHO to support coordination, to provide high level policy and technical support, to share experiences from other countries, to disseminate information, guidelines, best practice



and innovation, to work with all the parties including civil society, to act as a broker, and to advise on effective strategies for drug financing and for improving use of medicines. A stronger WHO ‘position’ is needed for a balanced approach to systems and disease programme support. A stronger WHO voice is needed for increased funding for procurement and supply management and rational use strategies by the programmes. This implies both more emphasis on WHO’s upstream role with sector donors and ministry senior management and a more co-ordinated and strategic role for WHO’s Health Systems teams in country offices, of which the medicines NPO is a member. The NPOs work closely with HIV, malaria and other programme NPOs, but the case for strengthening medicines as a systems issue has not been fully articulated by WHO. The success of the Programme approach depends on complementary roles for the WR, in strategic leadership, and for the NPO, as technical expert. This works well in some countries, but could be more effective in others. WHO continues to have – and is perceived to have by other partners – a public sector emphasis, and to prioritise its relationship with government. But, while government must remain WHO’s primary partner, as one interviewee put it – it is ‘high time for WHO to come out of its public sector box’. As a key policy and technical adviser to government, WHO has an important but as yet under-developed role to play in facilitating the government’s stewardship role for the pharmaceutical sub sector as a whole, and its support to strategies not only in the public sector. For example, in Tanzania, the pharmaceutical sector working group has a public sector focus, and WHO has not engaged until recently with the ADDO scheme (to improve quality and availability in private pharmacies). Stakeholders perceive that the time is ripe for WHO to promote a vision of government stewardship of the pharmaceutical sector as a whole – where government takes an oversight or role for ensuring access (affordability, availability) across all sectors, similar indeed to its accepted role in quality and safety. This includes more proactive engagement with the private sector. For WHO’s medicines work at country level, first steps have been taken in multi-stakeholder working with civil society, especially through the collaborative work with HAI Africa and its members. Working with civil society is a special challenge, given weak capacity. WHO has demonstrated that it can play an effective broker role, with specific funds and resources, and that this approach delivers results, contributing for example to improved accountability. Support by HAI Africa, as a respected regional group, also assists the process of recognition and inclusion by government. However, although engagement with civil society is part of WHO’s Medium Term Strategic Plan, strategies for inclusion in good governance initiatives and policy dialogue do not appear to be systematically supported at country or regional level. While the Programme is contributing to sustainable capacity building, its own financial sustainability is a major concern. The countries will continue to need technical and policy support for delivering national priorities and WMS components for many more years. Development assistance is increasingly channelled through general and sector budget support, and WHO’s technical capacity to support MOHs becomes ever more important at country level. However, this strategy can work only if WHO has the appropriate policies and finance in place to recruit and retain keep the best NPOs. WHO needs to work together with its external partners at national and global levels (EC, GF, UNICEF, WHO, WB) to find ways to finance the NPO within WHO but with a mandate supported by all of them. Financing country level staff and activities for WHO has been a major challenge since key bilaterals shifted to SWAps (DANIDA, Dutch etc). WHO’s regular budget has not increased in real terms, and the organisation is highly reliant on voluntary funds. Recently introduced ceilings on budgets linked to WHO’s strategic objectives may be preventing allocations to staff salaries and government tends to prefer activity funds. Equally, the existence of project funds may have acted as a disincentive to WRs to include the salary in the regular budget during the life of the project. However, five COs have included 100% NPO salary costs in the regular budget, and one a 50% contribution. New donors such as UNITAID and philanthropic foundations tend to be willing to spend only a small percentage of funds on NPOs and



country based activities. This is a difficult situation for WHO, given that the NPO system is a proven model for developing effective country capacity in WHO priority areas. HAI Africa has made good progress through the Programme. Since its establishment as a legal and independent entity as a regional Secretariat in Kenya in 2004, DFID funding, including for Collaboration activities with WHO, has contributed greatly to establishing the basis for a robust and effective (albeit small) organisation and a platform for furthering its unique research and policy-advocacy activities on essential medicines. Some progress has been made in developing the HAI Africa Network, but it needs further effort to define the Network model and involve members more actively in regionally supported campaigns that have national objectives. The Collaboration project of HAI Africa with WHO, in carrying out the availability and pricing surveys, for example, produces much excellent and independent information, but publicity for the various activities on medicines policy and research is still lacking. But the information is not adequately communicated to the media, or used as the basis of policy advocacy. The high degree of labour and resource investment in conducting the pricing surveys makes it even more imperative to undertake the incremental additional effort needed to ensure policy impact. It will also be important for WHO and HAI Africa to continue to work together even in the absence of joint Programme funding. The following recommendations fall into four categories: those with implications for WHO’s broader strategy, for WHO’s Medicines NPO Programme, for HAI Africa and for DFID. 9.2 Recommendations for WHO’s broader strategy 1 Medicines must be an integral component of WHO’s vision for health policy and systems, and for revitalising primary health care. The inclusion of medicines in the Health Systems cluster in both HQ and in AFRO provides a significant opportunity to develop and promote this vision at all levels. WHO is recommended to develop a clearer position on its comparative advantage in pharmaceuticals and to bring this to bear at global and regional levels, as well in countries, with its development partners. 2 Decentralisation and intensifying country support is a priority for WHO. This Programme demonstrates the importance of well selected and supported NPOs, with small activity budgets, in accelerating country progress. The emerging vision and strategy for the Health Systems Cluster (and the medicines component) is recommended to include a substantive component for country support that builds on lessons learnt (and which may also assist in prioritising activities under the new WMS). 3 Country offices play both technical and strategic roles at country level. WHO is recommended to ensure that COs are strategically addressing (and promoting harmonisation and alignment with other partners) the medicines agenda at high level donor and government fora as part of the new primary health care and health system strengthening (emphasising issues such as good governance, rational use, financing and affordability, integrated procurement and supply management, and adequate human resources). 4 Weak governance is a major barrier to improving medicines access. WHO’s role in promoting a common message on good governance is critical. WHO is in a unique position to promote dialogue and engagement by government with other sectors including civil society and the private sector, and to promote increased participation in fora for policy development and dialogue. Although WHO’s Good Governance for Medicines project is appreciated by government, more effort across WHO is needed for working with other partners and to include stakeholders such as civil society in accountability and transparency efforts, for example in MeTA.



9.3 Recommendations for the Medicines NPO Programme 5 This review has highlighted the importance of national context in influencing Programme progress. WHO is recommended to assess the specific national situations and priorities, develop tailored country support strategies and objectives, and staff the country office accordingly. In many countries, an NPO with good support and well integrated into the WHO country team may be the best strategy. Where a multiplicity of international partners is working, it may be necessary to have an international staff. This could include recruiting a wider range of expertise in the NPO network or drawing upon new expertise in the AFRO and Geneva health systems teams. Short rotation of HQ or AFRO staff to countries may be considered when dealing with a specific problem. 6 The choice of the NPO is the most important factor for success in such a programme. And, to be successful, not only do they need the support from the WR, from the RO and HQ and from their colleagues in the network but they also need to be proactive and able to grasp the broad issues and the politics when dealing with medicines. Stronger mechanisms are required for WHO HQ and RO to evaluate their performance in close collaboration with the WR and map their competencies in order to develop specific support plans. These plans can include training in certain technical issues but also in team work, communication skills, and strategic relationship building. More broadly, NPOs lack a career development structure within WHO. This issue is likely to be a wider one for other WHO NPO cadres as well. 7 WHO Geneva and AFRO should develop the Programme and financing strategies together – and much will depend on donor preferences and trends. Expansion (multiple NPOs each dealing with a different programme) is not feasible. There is also broad acceptance that developing an all Africa network of NPOs is not a sustainable option. WHO needs to work together with its external partners at national and global levels to find ways to finance the NPO within WHO but with a mandate supported by all of them. It is likely that a template approach is no longer appropriate, but that different contexts will require different models. There are several suggested proposals but no shared view as yet.

• NPOs could be based in a country, but provide support to a small group of countries. • The regional Inter Country Teams could be expanded further to provide regional

support (and reduce number of NPOs at country level) • Some countries may require NPOs dealing specifically with medicines, working

closely with a health system expert. Countries will be selected because of the very severe or special needs in relation to pharmaceutical.

• Others may need a stronger health systems group, with access to pharmaceuticals expertise when needed.

• Consideration should be given to a more competitive approach, where MOHs bid for NPOs for specific tasks over a limited time period.

The selected approaches need to complement current, and necessary, moves to strengthen WHO and other donor support to the health desks of the regional economic community organisations for medicines harmonisation (pricing, regulation, procurement etc) 8 The Programme is recommended to promote and strengthen access to technical expertise in:

• better use of research data, especially medicines monitoring information, to support a) advocacy and communication activities with a wider group of policy makers, civil society organisations, consumers and the public at large (as proposed by MeTA) and b) the development, implementation and monitoring of policy objectives (e.g. components of a pricing policy) and sector level monitoring indicators;

• financing and affordability issues, including pricing policies and their implementation, drawing on WHO Health System Cluster expertise; and

• working with HAI Africa and others, developing an evidence based approach for improving rational use among consumers as well as providers.



9 WHO is recommended to strengthen inclusive strategies for involving civil society and the non-state sector in for example, mechanisms such as MeTA for increased national and local accountability for drug availability and pricing, stakeholder based strategies for consumer and provider education for rational use, and development of public private partnerships for pharmaceuticals (such as the ADDO scheme in Tanzania). 10 WHO is recommended to consider further how to maximise potential for impact at regional level, given that only limited progress has been possible in the absence of capacity at the health desks of the regional economic community organisations, and continue working with others to fund and recruit regional posts. 9.4 Recommendations for HAI Africa 11 HAI Africa is recommended to:

• deepen Africa-wide campaigns in furtherance of HAI Africa's objectives, such as the recently launched Stop Stockouts campaign to eliminate pharmaceutical stockouts (drawing on the evidence base collected by country members).

• further develop resources and ensure it has capacity to build skills in advocacy and communications with its network members who are conducting county level campaigns.

• continue its role in convening civil society, facilitating an expert civil society voice and consensus positions, and communicating this in regional and global policy fora, including the African Union.

• consider the case for all the publications it now leads on, in terms of whether their impact justifies the significant investment in time.

9.5 Recommendations for DFID 12 DFID’s flexible funding has been a success factor for the Programme, in particular its support for the WMS and to joint work with civil society. DFID finance is now channelled through UK regular contributions to WHO, and to regional (eg the Southern African Regional Programme for Access to Medicines) and (more rarely, given DFID’s commitment to budget support) support to WHO (eg Burundi). Given WHO’s technical strengths in medicines issues, DFID is recommended to continue advocating at all levels for WHO’s vision for health policy and systems, with the pharmaceuticals sub sector as a key component, including for IHP+, and for intensifying country support. DFID is further recommended to take programme lessons learnt into account with regards to initiatives such as MeTA and SARPAM. These include WHO’s brokering role and regional capacity in both WHO and civil society to support national efforts.



ANNEX 1: EVALUATION TERMS OF REFERENCE Evaluation of the WHO - HAI Africa Regional Collaboration on Action for Essential Medicines in Africa 2002 - 2008 January to April 2009 1. Background WHO and HAI Africa are committed to increasing access to and appropriate use of safe and effective essential medicines in order to help improve health, in particular of the most disadvantaged in countries in Africa. In 2001, in recognising the extent of the challenge of ensuring access to and appropriate use of essential medicines, the WHO-HAI Africa Regional Collaboration for Action on Essential Medicines in Africa was formed with DFID funding. The Programme, due to end in 20088, provided WHO & HAI Africa with finance to increase levels of technical support at country level, for strengthening government action and wider advocacy on access to medicines. A new position in WHO country offices for Medicines National Professional Officers (EDM/NPOs) or WHO Essential Medicines Advisers has been created in selected African countries to advise governments on issues around essential medicines policy and access. Programme support includes a component for strengthening civil society’s role, through the network HAI Africa, based in Kenya. Since 2004, other donors such as the EC have supported the programme and enabled its expansion to further countries and scaling up of provision of technical inputs to the medicine related activities in countries and regional economic and development organisations in Africa (e.g. EAC, SADC). The overall network of country medicines advisers now covers 15 countries in Africa and about 15 more in other WHO Regions. 2. Purpose and scope of the evaluation These Terms of Reference are for an evaluation of DFID’s contribution to the WHO Regional programme and to HAI Africa. WHO and HAI Africa have requested this in depth review, where lessons learned will inform both wider WHO and HAI Africa thinking about the future of this WHO programme and partnerships with civil society, and the development of the multi-stakeholder Medicines Transparency Initiative (MeTA). DFID funding has supported three main components of this work:

• Contribution to NPO salary and activity costs in countries in Africa including the 15 NPO countries, together with a contribution to technical support and supervision provided by HQ Geneva and AFRO staff teams.

• Support for additional collaborative activities undertaken with civil society and government in three countries with NPOs in Africa (Ghana, Kenya and Uganda)

• Separate funding to HAI Africa to enable collaborative work with WHO and ministries of health in the above three selected countries and to support wider network development and capacity building in other countries.

The evaluation will focus on these three components, while taking into account the contributions of other donors. In particular, it will explore the results of the programme in the countries receiving DFID support (see Annex 1). With respect to the collaborative activities with HAI Africa, it will draw on the internal review carried out in three countries 2008, as well as HAI Africa activities in other countries. DFID programme support was designed to contribute to the achievement of 2004 -2007 WHO’s overall Medicines Strategy (Countries at the Core), which includes outputs and targets relevant to regional and country levels. In light of DFID’s commitment to supporting WHO’s own results-based performance frameworks, it was agreed that a separate logframe

8 A no cost extension has been granted by DFID until end 2009



was not appropriate. However, a logframe was developed for the Collaborative work with civil society, and for the HAI Africa support (nested within its wider organisational performance framework). The evaluation will therefore assess progress against targets in WHO’s own strategic framework as well as national strategic plans for the health sector and national medicines programme. In addition to documenting results, it will also explore process issues – what has worked well and less well in terms of the approach taken by WHO and HAI Africa to building country and regional capacity and partnership working in government and civil society. Progress will also be measured based on the OPR (output to purpose review) of the Collaboration that took place in 2004. The evaluation will explore the following questions, based on the OECD DAC general evaluation criteria: a) Impact What overall impact has the Programme had on policy and practice at national level? What evidence is there of concrete change in people’s access to affordable quality medicines? What has the programme contributed to achievement of a) national strategy outputs and b) WHO’s Medicines Strategy targets? What has been the impact on capacity of stakeholders including WHO, MOH, HAI Africa, key professional cadres, and civil society in the selected countries? Were there benefits to the wider health sector (e.g. priority disease programmes, regulatory capacity) and other stakeholders (e.g. faith based sector?). It is noted that attributing impact to this Programme will not be easy, given the range of influences. However, process results will be important to document and easier to link to Programme outputs. b) Effectiveness What has the Programme achieved – both planned and unplanned outputs? To what extent have the programme’s strategies and ways of working contributed to its successes? How/why were the approaches successful/less successful? What are the strengths and limitations of the Programme as a whole – its approach, types of technical and financial support, roles of WHO and HAI Africa at global, regional and country levels, the NPO network, selected priorities at national, regional and international levels? What could have been done better or differently? Why? Any missed opportunities? What factors in the wider environment have helped progress to be made? What has hindered progress, and what have been the main challenges? For example, in the national medicines sub-sector, in the health sector, in WHO, in the wider institutional and funding environment. c) Relevance To what extent is the programme relevant to the needs of its beneficiaries – especially at country level ? Have the approach and activities been tailored to the national strategy and needs? d) Sustainability To what extent are programme benefits likely to be sustained after the end of the funding? For example, in terms of technical capacity in government, effective partnership (e.g. involving civil society), institutionally (e.g. raised profile of essential medicines supply as a systems issue) and financially (e.g. partner willing to invest in WHO work in countries and in the NPO network). e) Efficiency Has the programme provided value for money – could the funds have been used differently and more effectively? What is the evidence for this?



f) Added value What positive difference has the programme made at various levels? What would have happened in the absence of the programme? What could not have been achieved without it? How has the approach been innovative and contributed to wider lesson learning and innovation by WHO, HAI Africa and others? Additionally, the review will include consideration of the issues of coherence, complementarity and co-ordination. For example, how did WHO and HAI Africa co-ordinate working with key partners at country, regional and global levels? 3. Methodology and approach The methodology will include:

• Desk top review of background documents, progress reports and work plans for selected countries and relevant national, regional and international meeting reports.

• Review of relevant data from Levels I and II surveys (where available) and the 2007 evaluation of the medicines strategy both to provide the context at country level and to examine any trends over time. WHO Geneva will provide support to analyse the data (e.g. three level 1 surveys over 1999 – 2007).

• Synthesis of achievements of the programme based on annual monitoring reports • Survey for NPOs, WRs and national counterparts - this will be prepared and sent out

by end Dec, for returning by end Jan, 2009. • Interviews of major stakeholders involved in medicines policy and programming in five

selected countries. Interviewees will include the Ministry of Health (counterparts and representatives of other relevant divisions/units), relevant agencies in regulation and supply, WHO staff, international and national partners, civil society organizations.

• Interviews with staff and other stakeholders at regional and global levels (WHO AFRO, WHO Geneva, DFID, HAI Africa, officials in regional organisations)

• With reference to the collaborative work with HAI Africa, the evaluation will draw extensively upon a participatory and qualitative review commissioned by WHO and HAI Africa in 2007/8, drawing on documentation and information gathered from over 70 structured interviews with partners and stakeholders at country, regional and global level.

Country visits Five countries have been selected on the basis of the following criteria: a range of regional economic groups and languages; one NPO country per WHO sub region; one UN reform country; Level 1 survey data; range of civil society activity. The NPO countries are: Ethiopia, Congo Republic, Senegal and United Republic of Tanzania. One non-NPO country is included, Malawi, which has received DFID funds and where HAI Africa has active members. The evaluation will draw on data from the 2008 country visits to Uganda, Kenya and Ghana. Additionally, a brief visit will be made to Nairobi, to meet with HAI Africa Secretariat. 4. Outputs The review will result in two products: a) A completed Project Completion Report (PCR) in DFID format, for DFID’s internal purposes. The logframe for this will be agreed with DFID and WHO, given that the programme support was provided against the WHO Medicine’s Strategy (and not a standard DFID log frame). b) An external report, for wide dissemination to stakeholders, which will:

• Summarise progress against intended aims and outputs, at national, regional and



international levels • Record key achievements and analyse how these came about, drawing on the

questions above • Identify any missed opportunities, if appropriate • Document any key challenges and suggest how these might be overcome • Document key lessons learned • Make appropriate recommendations for next steps

Final reports will be presented to WHO and DFID by mid May 2009. 5. Experience and qualifications The review will be led by a suitably qualified consultant team, providing skills and experience in medicines policy and programming at national and regional levels in Africa, institutional knowledge of issues WHO, MOHs and civil society. The consultant shall have:

� Knowledge and understanding of global level medicines policies, related agencies, and funding flows

� Understanding of health and pharmaceutical systems in Africa � Familiarity with ministries of health and pharmaceutical sectors in Africa � Familiarity with civil society networks in the area of medicines and their functioning in

Africa � Familiarity with WHO � Experience of qualitative reviews and report writing � Interpersonal and writing skills

In addition to consultant team, three additional days are included in the budget for a consultant familiar with the programme to help with synthesizing the five year annual reports. 6. Project reporting and management The contract will be financed by DFID and managed by DFID’s Health Resource Centre. Travel arrangements, hotel bookings and other preparations will be the responsibility of the Resource Centre working with WHO HQ, AFRO and country offices and with HAI Africa. The team will report to Saul Walker, DFID’s ATM adviser.



ANNEX 2: PERSONS INTERVIEWED Congo (Republic) M Raoul Alfred Emilienne, Minister of Health M Florent Niama, General Director of Social Action and Family (MOH) Dr Ettienne Mokondjimobe Pharm D- PhD Director of Pharmacies, Laboratories and Medicine Dr Jean Serge Assemenkoum Pharm, Directorate of Pharmacies Laboratories and medicine, Head of registration and consumption of medicine services Dr Ondzé Jacques Armand, Directorate of Pharmacies Laboratories and medicine: Head of medicine quality control Service Dr Mssessabeka Jean Pierre Pharm, Directorate of Pharmacies, Laboratories and medicine: Head of pharmaceutical information and documentation service Dr Elisabeth Dibantsa Pharm Directorate of Pharmacies Laboratories and medicine: Head of pharmaceutical and professional regulation Service Dr Emeka, Head of social action coordination service (SCAS) Dr Jean de Dieu Obouaka Pharm. Director of « la Congolaise des Médicaments Essentiels et generiques » (COMEG), Dr Crepin Akenandé Pharm., la Congolaise des Médicaments Essentiels et Génériques » (COMEG) Procurement and quality assurance manager Dr Destin Mossimbi Pharm., la Congolaise des Médicaments Essentiels et Génériques »(COMEG) specific programs stock manager Dr Mamadou D. Ball, WR /WHO/CO Brazzaville Dr Bidounga Norbert, NPO Malaria/HIV/TB WHO/CO Dr Mooyokani Jeremie, NPO Health System/ WHO/CO Dr Ray Mankele (pharmacist) NPO/EDM/WHO/CO M François Ngakosso, Congolese association for consumers’ right (ACDDC) President of Ouenzé-Talangaï subcommittee M Dominique Assolo Bongui Congolese association for consumers’ right (ACDDC) President of Mongali subcommittee, M Gabriel Massenngo Congolese association for consumers’ right (ACDDC) member of subcommittee M Jean Charles Claude Ongoly President of Pharmacists Central Council A Jean Paul Binimbi President of Pharmacists Central council B, Malonga André, General Secretary of National Pharmacists’ Council M Appolinaire Fila, President of Pharmacists Central council D M Jacques Poaty, Membre of Pharmacists Central Council D M Atta Alphonsine Ekomba, President of Pharmacists Departmental Council A, Brazzaville M Gaston Edgar Elenga member National Pharmacists’ Council, of M Celestin Bongui, Member of National Pharmacists’ Council Dr Koen Vanormelingen, UNICEF /REP M Salvator Nibipanga, UNICEF M Godefroy Malondah, UNICEF Dr Alfred Ibouanga, Heath System support Project for Congo Brazzaville (PASCOB) National Manager Ethiopia Dr Fatoumata Nafo-Traore, WHO Representative Mr Bekele Tefera, EDM NPO Mrs Doris Odera, Administrative Officer, WHO CO Dr Daniel Argaw, Programme Officer for Disease prevention and control (DPC), WHO CO Dr Worku Bekele, NPO Malaria, WHO CO Dr Thierry Comolet, TB expert, WHO CO Dr Gebrekidan Mestin, NPO Health Systems and Services Strengthening, WHO CO Dr Nehemie Mbakuliyemo, Team leader EPI, WHO CO Dr Ato Berhanu Feyissa, Former Head of PSLD MOH



Mr. Wondwossen Ayele Haile, Deputy Director General, PFSA Mr Yehulu Denekew, Director General DACA Mr Dawit Dikasso, Deputy DG DACA Mr Mengisteab W.Aregay, Deputy DG DACA Mr. Kelbessa Ugra, EHNRI Mr. Bikila Bayissa, Head of the National Quality Control Laboratory Mrs Ali Forder, Health and HIV/AIDS advisor, DFID Ethiopia Ms Elise Nalbandian, Social Sector Expert, European Union, Delegation of the EC in Dr. Luwei Pearson, Chief, Health Section, UNICEF Hendro Supaat, Procurement Services Officer, UNICEF Mr. Daniel Ayele, Private Sector Development, Pharmaceuticals, Senior Program Officer, GTZ Dr Negussu Mekonnen, Country Representative, MSH Ethiopia Mr Dessalegn Tesfaye, Commodity security advisor, SCMS Mr Haymanot Assefa, President EPA Mr Bruck Messele, Vice President EPA Dr. Meshesha Shewarega, Executive Director, CRDA Mr Tafese Refera, Head communication and Information, CRDA Mr Kiflemariam Gebrewold, Special adviser, CRDA Mr Tadesse Gessese, Member of the Board, Ethiopian Consumer Protection Association Mr Ashenafi Abate, Public Relations Officer, Ethiopian Consumer Protection Association Malawi Mr Chafulumira, Chief Pharmacist, MOH Mrs Ivy M Zingano, Director CMS Mr Aaron Sosola, Deputy Registrar, PMPB Mr Wilford Mathiya, Drug Insecptor, Pharmacy Medicines and Poisons Board Dr Felicitas Zawaira, WR Malawi Mr Wilfred Dodoli, Malarai NPO and Medicines Focal Person, WHO Mrs Chanza, Reproductive Health NPO Dr Limbambala, HIV Focal Point Mr Ndongo, Procurement, UNICEF Ms Martha Kwataine, National Co-ordinator, Malawi Health Equity Network Ms Rose Kumwenda Ng’oma, Deputy Exec Director, CHAM Mr Langton Mukura, Pharmacist, CHAM Ms Nettie Dzabala, Pharmacology, College of Medicine and Managing Director Kabula Pharmacy Mr Sanjay Awasthi, Country Director, Oxfam UK Mr Benson Phiri, Advocacy Manager, National Organisation of Nurses and Midwives Dr Jason Lane, Team Leader Health and HIV/AIDS, DFID Malawi Ms Alisa M Cameron, Health Team Leader, USAID Malawi Mr Blessing Botha, Programme Manager, CIDA Ms Cynthia Kamtengeni, Seniro Programme Assoc, MSH Malawi Senegal Mr Moussa Mbaye, Permanent secretary MSPM Pr Mounirou CISS, Pharmacist in charge of National Laboratory of medicines quality control Pr Papa Amadou Diop (Pharmacist) Director of Pharmacy and laboratories, Dr Papa Birama NDIAYE, General Manager of National Procurement Pharmacy (PNA) Dr Dr Daouda Diop, Head of technical department of National Procurement Pharmacy (PNA) Dr Mame Bocar LÖ, Coordinator of the National Tuberculosis program Dr Talla DIOP Pharmacist, Head of procurement office of the National Tuberculosis program Dr Mame Birame DIOUF Deputy coordinator of National Malaria program Dr Mamadou Lamine DIOUF Pharm., in Charge of procurements of the National Malaria program Dr Oulymata Diop, AIDS/IST Division



Papa Menoumbé Ndiaye, AIDS/IST Division Dr Henriette Cécile Diop, Head of private medicine and traditional medicine Division Alioune AW, Traditional medicine Bureau Dr Coly Malang, Acting WR and NPO in charge of DPC program Dr Bacary Sambou, NPO in charge of Malaria program Dr Ndella DIAKHATE, NPO in charge of VIH/SIDA & TB program Dr Ngom mamadou Pharm, NPO in charge of EDM Dr Cheikou Oumar Dis Pharm., President of Senegal National Pharmaceutical Council Mr Ahmadou Sall, Consumers association (SOS) Mr Abdoulaye Ndaw, President of Senegal Association of traditional medicine practitioners Dr Bruno Floury, French Cooperation, Health Minister Technical Advisor Dr Flavia Guidetti, UNICEF Health program manager Dr Serigne Abdou Diagne (pharmacist), MSH Management Sciences for Health Senior Technical Advisor Senegal Ms Aissatou Diack, WB Senior Health specialist Tanzania Dr Deo Mtasiwa, Chief Medical Officer, MOHSW Dr Z Berege, Director of Hospital Services, MOHSW Mr Joseph Muhume, Chief Pharmacist, Pharmaceutical Services Unit, MOHSW Ms Mercy Kimaro, Deputy Chief Pharmacist, MOHSW Mr Shonga, Malaria Programme Ms Mildred Kinyawa, Registrar, Pharmacy Council Mr Jumanne Mkumbo, Head Registration Dept, Pharmacy Council Ms Margaret Ndomondo-Sigonda, Director General, TFDA Mr Didas Mutabingwa, Manager Quality Management, TFDA Mr Hiiti Sillo, Acting Director Medicines and Cosmetics, TFDA Dr S S Ngendabanka, Director Business Support, TFDA Mr Joseph Mgaya, Director General, MSD Ms Lucy Nderimo, Director Pharmaceutical and Technical Services Dr Laminethiam, Acting WR and HIV team leader Dr E Nangawe, NPO MPN Ms Rose Shija, NPO EDM Prof Mary Justin-Temu, Head Dept of Pharmaceuticals, Muhimbili University of Health and Allied Sciences Ms Marsha Macatta-Yambi, Director Malaria Communities Programme, Christian Social Services Commission Dr Sam Nyaywa, Adviser, Health Sector Programme Support, DANIDA Dr R Mbwasi, Senior Technical Adviser, MSH Tanzania Mr Michael Gabra, Regional Technical Adviser, MSH Dr Edmund Rutta, MSH Mr Tim Rochet, USAID DELIVER Mr Harish, Tanzanian Association of Pharmaceutical Industry WHO AFRO Dr Lusanba Dikasa Director program management WHO/RO/Africa (DPM) Dr Chris N. MWIKISA, Head of Division of Health System & Services Development Dr Ossy M.J.Kasilo Regional Advisor Traditional Medicine; Acting Program Manager for EDM WHO/AFRO/RO, Dr Jean-Marie Trapsida, EDM Co-ordinator Dr Jackson Sillah MC Manager/ MALARIA/AFRO/WHO/RO, Dr KI- Zerbo Georges A. Malaria Program Manager WHO/AFRO/RO Dr Abayneh Tamer Desta (Pharmacist, Technical Officer Essential Medicine program Dr Moses Chisale (Pharmacist) Regional Advisor Essential Medicines Program (EDM) Dr Habib Somanje, Medical Officer/HPS/DSD Dr Moeti M. Assistant Regional Director WHO/AFRO/RO,



Dr Assimawe Pana, Medical Officer Strategic Planning Regional Program on AIDS WHO/AFRO/RO WHO Geneva Dr Carissa Etienne, ADG Health Systems and Services Dr Hans Hogerzeil, Director, EMP Dr Richard Laing, Medical Officer, Dr Gilles Forte, Technical Co-ordinator Ms Helen Tata, Technical Officer, Medicines Policy and Supply Management Dr Clive Ondari, Co-ordinator, Policy, Access and Rational Use Dr Magali Babaley, PSM Mr Samvel Azatyan, Regulatory Support QSM Ms Shanthi Pal, Pharmacovigilance, QSM Ms Mary Cooper?? QSM Ms Sabina Kopf?? QSM Ms Pamela Drameh, Ext Rels Officer, Health Systems and Services Mr Bob Fryatt, HSS, IHP Dr Varatharajan Durairaj, health economist, health systems financing Mr Jorg Uwe Hetzke, IT HSS Dr Vincent Habiyambere, Medical Officer, Systems Strengthening for HIV, Dept for HIV Mr Boniface Dongmo Nguimfack, Technical Officer Ms Precious Matsoso, former Director TCM, current Director IPH Dr Shambhu Acharya, Co-ordinator, Dept Country Focus



ANNEX 3: DOCUMENTS CONSULTED Global and regional

•••• AFRO Essential Medicines Price Indicator, WHO AFRO Sept 2007 •••• Attawell Kathy and Trap Birna, for DFID and WHO/EDM-HAI Africa Output to purpose

review, Regional Collaboration for Action on Essential Drugs in Africa, 2004 •••• DFID MeTA background documents, various, DFID 2007/08 •••• DFID Project Memorandum, Regional Collaboration for Action on Essential Drugs in

Africa, 2001 •••• Grey A, Assessment of implementation, impact and process of the WHO Medicines

Strategy 2004-2007, Final Report November 2007 •••• HAI Africa/SATAMo/OSI, Report of Seminar on Stockouts of Essential Medicines in

Africa, October 2008 •••• HAI Africa and EPN, Pan-Africa Experts Meeting on Access to and Rational Use of

Medicines, November 2007 •••• Health Action International Africa: strategy 2006-2010, HAI Africa Nairobi •••• HAI Africa Annual Reports 2004-2007 •••• HAI Africa logframe and progress reports 2002-2007 •••• HAI Africa Collaboration quantitative M&E reports, 2005-2007 (various PMG, CWG

and activity reports, press cuttings etc) •••• WHO and HAI Africa, Medicine prices surveys and proposed interventions to improve

sustainable access to affordable medicines in 11 sub-Saharan African countries, 2007

•••• HAI Africa and WHO, Regional Collaboration for Action on Essential Medicines in Africa, Activity reports 2005 – 2007,

•••• MDG Gap Task Force Report, MDG 8: Delivering the Global Partnership for Achieving the MDGs, 2008

•••• Weissman R, for OSI, Perspectives on HAIAfrica’s activities and opportunities, September 2008

•••• WHO Putting the Right People in Place: Who National Medicines Advisers in Africa, 2006

•••• WHO TCM and HAI Africa, Terms of reference, Country Working Groups and Programme Management Group, 2005

•••• WHO TCM and HAI Africa, Collaboration Programme MOU, October 2004 •••• WHO Terms of Reference for Medicines NPOs in the African Region, 2001 •••• WHO, Programme reports to DFID and EC, 2005 – 2008 •••• WHO CD Rom and List of published documents from NPO countries (over 70 policy

documents and studies by WMS objective) 2009 •••• WHO Medicines Policy Documents from Selected African Countries, CDRom 2005 •••• WHO Engaging for Health: A Global Health Agenda, 11th General Programme of

Work, WHO 2006-2015 •••• WHO Medium Term Strategic Plan, WHO 2008-2013 •••• WHO Scaling up for Better Health: Workplan for the International Health Partnership

and related initiatives (IHP+), 2007-2009 •••• WHO IHP+ Progress Report, May 2008 •••• WHO Country Co-operation Strategies, 2006 •••• WHO Country Focus, Annual Report 2006 •••• WHO Country Focus Policy, Roadmap 2006- 2013 •••• WHO Medicines Strategy: Countries at the Core, 2004-2007 •••• WHO Nairobi Report: Strengthening WHO support to countries for better health

outcomes in the African region, 2004 •••• WHO Maputo Report: WHO support to countries for scaling up essential interventions

towards universal coverage in Africa, 2002



Congo •••• Stratégie pharmaceutique de l’OMS 2004- 2007 les pays en première ligne

OMS/EDM2004.2 •••• Politique Nationale pharmaceutique Mai 2004 •••• Liste nationale des Médicaments essentiels 4ème Ed. MSASP/OMS Octobre 2006 •••• Manuel du technicien de laboratoire périphérique MSASP/LNSP/OMS •••• Politique Nationale de Médecine Traditionnelle Avril 2006 •••• Code de Déontologie des tradipraticiens du Congo •••• Les bonnes pratiques transfusionnelles OMS/CNTS/CONGO Juillet 2008 •••• Enquête sur les prix des médicaments –Congo MSASF/OMS Juillet 2007 •••• Charte des dons des produits pharmaceutiques MSASF/OMS Septembre 2007 •••• Plan National des Approvisionnements en médicaments essentiels Décembre 2006 •••• Plan National d’Approvisionnement et de Distribution des médicaments -2009

MSASF/OMS •••• Harmonisation des politiques Pharmaceutiques Nationales dans la zone CEMAC

OMS Congo/AFRO •••• Enquête sur les médicaments pédiatriques du Congo Mai 2007 •••• Manuel de gestion des médicaments dans les centres de santé intégrés et hôpitaux

de référence MSASF/OMS •••• Evaluation des besoins en médicaments des circonscriptions socio-sanitaires et des

hôpitaux généraux du Congo MSASF Septembre 2008 •••• Mission d’appui à l’évaluation du secteur pharmaceutique de la république d’Angola

R.MANKELE Mai - Juillet 2008 •••• Evaluation du secteur pharmaceutique de l’Angola : accès, qualité et usage rationnel

Août 2007 •••• Evaluation du secteur pharmaceutique du Congo OMS/MSASF Juillet 2006 •••• Cartographie du système d’approvisionnement en médicaments essentiels de la

république du Congo •••• Plan Directeur Pharmaceutique National Novembre 2005 •••• Rapport trimestriel de suivi et d’évaluation du POA •••• Rapport de mission du NPO (CSS de GAMBOMA, Formation des gestionnaires de

médicaments des CSS DE GAMBOMA, DJAMBALA et GOMA TSE TSE) •••• Réunion de concertation OMSAFRO/OMS Congo sur la mise en œuvre de la

décision de gratuité du traitement antipaludique pour les enfants de zéro à 15 ans et les femmes enceintes ainsi que les tests biologiques en vue du dépistage du VIH/SIDA 2008

•••• Elaboration de la table d’équivalence des médicaments essentiels •••• Plan stratégique pour le renforcement du secteur pharmaceutique de l’Angola •••• Rapport de la revue de la Direction des Pharmacies, des Laboratoires et du

médicament au Congo, J.M.Trapsida ; Ray Mankélé Juin 2008 •••• Etude de faisabilité pour la mise en place du laboratoire de contrôle qualité des

médicaments •••• Liste Nationale des Médicaments Essentiels 2008

Ethiopia

•••• Ethiopia Country Pharmaceutical profile and NPO, 2008 •••• Health Sector Strategic plan, (HSDP III), 2005/6-2009/10, Federal Ministry of Health,

Ethiopia, 2005 •••• Ethiopia Health Sector Development Programme, HSDP III, Mid Term Review, Addis

Ababa, July 2008 •••• Assessment of the pharmaceutical sector in Ethiopia, October 2003 •••• Survey on prices of medicines in Ethiopia, October 2005 •••• Drug Financing study in Ethiopia, June-August 2007 •••• Training module on drug supply management for primary health care workers

(PELD/FMOH and WHO)



•••• Operational guidelines for monitoring adverse reactions of traditional drugs, February 2007

•••• National Drug Policy of the Federal Democratic Republic of Ethiopia (final draft), September 2007

•••• Essential Drugs List for Ethiopia, September 2004 and List of drugs for Ethiopia, 5th edition, September 2007

•••• Strategic plan for the development of the Ethiopian pharmaceuticals and medical supplies manufacturing industry subsector, December 2007, Ministry of Trade and Industry.

•••• Report on Workshop and training on Drug and Therapeutic Committees (DTCs), Pan Afrique hotel, Palace hotel, Nazareth, 13-18 December 2004

•••• Proceedings of drug supply management training for health center staff (in two rounds), 22-27 November 2004 and from 29 November to 04 December 2004, Pan Afrique hotel, Nazareth

•••• Training course on assessment of application for marketing authorization of multi source (generic) products (conducted in collaboration with QSM/HQ), Addis Ababa, 20-24 September 2004

•••• Report on workshop on process mapping and supply chain integration as well as quantification exercise, 27-30 March 2007. Pyramid paradise hotel, Debrezeit

•••• Report on training of trainers on drug supply management at health center level, from 27 August to 05 September 2003, Rift valley hotel, Nazareth

•••• Report on assessment of Procurement and Supply management (PSM) of Ethiopia, October 12, 2006, Adama Mekonnen hotel, Nazareth

•••• Report on sensitization workshop on TRIPS and access to medicines, 18-19 September 2006, Palace hotel, Nazareth

•••• Report on the training of Pharmacy personnel on supply management and rational use of Antiretroviral drugs (in two rounds), 13-17 October and 12-14 November 2005

•••• Report on consultative work shop on the draft guidelines for safety monitoring of herbal medicines 30-31 October 2006, Palace hotel, Nazareth

Malawi

•••• Government of Malawi, National Medicine Policy, July 2008 •••• Government of Malawi, National Pharmaceutical Strategic Plan 2009- 2013,

September 2008 •••• O&M IT/S and Management Services Ltd, Assessment of Drug and Medical Supplies

Leakages from Medical Stores and Public Health Facilities, Malawi August 2006 •••• MOH, MHEN (with HAI Africa), Medicines Prices, Availability and Affordability in

Malawi, September 2008 (draft) Tanzania

•••• Euro Health Group, Drug Tracking Study, Final Report August 2007 •••• MOHSW Mapping of Procurement and supply Management System of Essential

Medcines and Medical Supplies, Stakeholder Meeting presentation June 2008 •••• MOHSW Health Sector Strategic Plan III 2009-15, Draft August 2008 •••• MOHSW and WHO, Survey of Medicines Prices in Tanzania 2004 •••• MOHSW Guidelines on drug donation and disposal of medicines, 2005 •••• MOHSW United Republic of Tanzania, National Medicines Policy, draft March 2009 •••• MOHSW, United Republic of Tanzania, NMP Implementation Plan, draft March 2009 •••• MOHSW, Medicines Prices Monitor, June-July 2008 •••• MOHSW Health Sector Strategic Plan II 2003-2008, April 2003 •••• MOH Zanzibar Standard Treatment Guidelines and National Formulary 2005 •••• MOH Zanzibar, Medicines Act, 2006 •••• MOH Zanzibar National Medicines Policy and Implementation Plans, 2008 •••• MSH SEAM Improving Access to Essential Medicines: the ADDO initiative, Tanzania •••• WHO Report of Baseline Pharmaceutical Situation 2002



•••• WHO Level 1 survey reports 2003 and 2007 •••• WHO, EC and DFID POAs and reports 2005-2008

Senegal

•••• Rapport : Atelier d’Analyse de la situation du secteur pharmaceutique : Dakar du 11 au 12 août 2004

•••• Rapport Atelier de finalisation du document de politique nationale pharmaceutique, Somone 258 26 Novembre 2005

•••• Politique Nationale pharmaceutique MSPM/DPL/ octobre 2006 •••• Liste nationale des Médicaments essentiels •••• Plan Directeur Pharmaceutique National MSPM/DPL/OMS Octobre 2008 •••• Atelier sur l’avant projet du plan directeur pharmaceutique national (PDPN) •••• Rapport de l’Atelier de validation du plan directeur pharmaceutique national 23-24

Octobre 2008 •••• Guide de bonnes pratiques pour la réalisation des essais cliniques au Sénégal

MSPM/OMS Janvier 2009 Draft 2 •••• Plan d’Action du système National de Pharmacovigilance 2008-2010

MSPM/DPL/OMS Août 2008 •••• Guide des bonnes pratiques de distribution en gros des médicaments MSPM/DPL •••• Cartographie et évaluation approfondie du système pharmaceutique au Sénégal :

Rapport final, MSPM/DPL/OMS Novembre 2007 •••• Système d’approvisionnement des produits pharmaceutiques au Sénégal Avril 2008 •••• Evaluation du Secteur Pharmaceutique au Sénégal MSPM/DPL/OMS Octobre 2003 •••• Guide de formation de gérants de dépôts des formations sanitaires MSPM/DPL/OMS

Juillet 2005 •••• Enquête sur les prix des médicaments au Sénégal MSPM/DPL/OMS Décembre 2005 •••• Liste des tradi-particiens du Sénégal •••• Projet de loi relative à l’exercice de la Médecine traditionnelle MSPM •••• Projet de décret portant application de la loi relative à l’exercice de la médecine

traditionnelle et créant le conseil national des tradipraticiens MSPM •••• Projet de décret portant code de déontologie des tradipraticiens •••• Plan stratégique pour la promotion de la médecine traditionnelle 2007- 2010

Septembre 2006

for Action on Essential Medicines in Africa 2002-2008 ...for Action on Essential Medicines in Africa...

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