Medicines and Health Products Division

Access to medicines –WHO perspective

SDG 3. Goal 3: Ensure healthy lives and promote well-being for all at all ages

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Access to essential medicines - proportion of health facilities that have a core set of

relevant essential medicines available and affordable on a sustainable basis

SDG Indicator 3.b.3.

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• available → medicine is available in a facility when it is found in this facility by the interviewer

on the day of data collection

• affordable → medicine is affordable when no extra daily wages are needed for the lowest paid

unskilled government sector worker to purchase a monthly dose treatment of this medicine after

fulfilling basic needs represented by the national poverty line

No access =

available + not affordable

not available + affordable

not available + not affordable

𝑆𝐷𝐺3.𝑏.3 =𝐹𝑎𝑐𝑖𝑙𝑖𝑡𝑖𝑒𝑠 𝑤𝑖𝑡ℎ 𝑎𝑣𝑎𝑖𝑙𝑎𝑏𝑙𝑒 𝑎𝑛𝑑 𝑎𝑓𝑓𝑜𝑟𝑑𝑎𝑏𝑙𝑒 𝑏𝑎𝑠𝑘𝑒𝑡 𝑜𝑓 𝑚𝑒𝑑𝑖𝑐𝑖𝑛𝑒𝑠 (𝑛)

𝑆𝑢𝑟𝑣𝑒𝑦𝑒𝑑 𝐹𝑎𝑐𝑖𝑙𝑖𝑡𝑖𝑒𝑠 (𝑛)

GPW13

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72nd World Health Assembly: some highlights

• Approval of “Access Roadmap for Access to Medicines, Vaccines and other Health Technologies, 2019-2023”

http://apps.who.int/gb/ebwha/pdf_files/WHA72/A72_17-en.pdf

• Resolution on Transparency “Improving the transparency of markets for

medicines, vaccines, and other health products”http://apps.who.int/gb/ebwha/pdf_files/WHA72/A72_R8-en.pdf

• Launch of Interagency statement on “Promoting Local production of

Medicines and other Health Technologies”https://www.unaids.org/en/resources/presscentre/pressreleaseandst

atementarchive/2019/may/20190524_local-production-medicines

• Launch of a “Strategy for prevention and control” of snakebite envenominghttps://www.who.int/snakebites/resources/9789241515641/en/

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72nd WHA: Resolution on Transparency Adopted

• Improving the transparency of markets for medicines, vaccines and other

health products in an effort to expand access

• The resolution urges Member States to enhance public sharing of

information on actual prices paid by governments and other buyers for

health products, and greater transparency on pharmaceutical patents,

clinical trial results and other determinants of pricing along the value chain

from laboratory to patient

• It requests the WHO secretariat to support efforts towards transparency

and monitor the impact of transparency on affordability and availability of

health products, including the effect of differential pricing

http://apps.who.int/gb/ebwha/pdf_files/WHA72/A72_R8-en.pdf

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Fair Pricing Forum: April 2019 Johannesburg

Working definition:

A fair price is one that is affordable for health systems and patients and that at the same time provides sufficient market incentive for industry to invest in innovation and the production of medicines.

• More than 200 participants

• Key topics:

o pricing transparency

o Incentives for innovation, private public partnerships

www.who.int/sdg/global-action-plan

A Joint Initiative of:

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ACCELERATE: 7 cross-cutting areas

1.Sustainable financing

Global Fund, World Bank,

Gavi

Improve the generation,

allocation, and use of

funds for health.

2. Primary Health Care (PHC)

UNICEF & WHO

Support and reform the

PHC system

4.Determinants of health

UNDP & UN Women

Collectively advocate for a

new multisectoral

paradigm to address the

determinants of health

5.R&D, innovation & access

WHO (supported by Wellcome Trust)

Invest and support new

innovations to reach those

most in need at country

level

6.Data and digital health

UNFPA and WHO

Better harness technology

to gather, store and

analyze data to improve

health decision making

3.Community & civil society

engagement

UNAIDS and WHO

Establish mechanisms to

improve CSO engagement

in global health

7.Innovative programming in

fragile settings/outbreaks WFP and WHO

Strengthen the

humanitarian-development

nexus

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72nd WHA: Access Roadmap

• Aims to assist in achieving the Sustainable Development Goals by ensuring “availability, accessibility, acceptability and affordability” of health products of assured quality

• Based on existing WHO mandates in key Health Assembly resolutions of the last 10 years related to access to safe, effective and quality medicines, vaccines and health products

• Outlines the programming of WHO’s work on access to medicines and vaccines for the period 2019–2023, including activities, actions and deliverables

Improving equitable access

• R&D that meets public health needs and improves access to health products• Application & management of IP to contribute to innovation & promote public health• Evidence-based selection and fair and affordable pricing• Procurement and supply chain management• Appropriate prescribing, dispensing and rational use

Ensuring quality, safety and efficacy of health products

• Regulatory systems strengthening• Assessment of the quality, safety and efficacy of health products through

prequalification• Market surveillance of quality, safety and performance

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http://apps.who.int/gb/ebwha/pdf_files/WHA72/A72_17-en.pdf

Access Roadmap - Activities and Actions

• Development and implementation of WHO technical guidelines, norms and standards for quality assurance and safety of health products

• Support improvement of regulatory systems, promoting reliance and collaboration

• Strengthen preparedness for entry of medicines, vaccines and other health products into countries experiencing a public health emergency or crisis

• Maintain and expand the prequalification service

• Support strengthening national capacity to ensure the quality, safety and efficacy of health products

Ensuring quality, safety and efficacy of health products

• Regulatory systems strengthening• Assessment of the quality, safety and efficacy of health products through

prequalification• Market surveillance of quality, safety and performance

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Access Roadmap - Activities and Actions

• Continue to set priorities for health research and development in areas of compelling health need

• Coordinated actions on health research and development

• Support improved capacity for research and development and clinical trials in countries

• Foster innovation and access to health products by appropriate intellectual property rules and management

• Provide technical support and capacity building

• Support processes for evidence-based selection, including health technology assessment and their implementation

• Encourage more transparent and better policies and actions to ensure fairer pricing and reduction of out-of-pocket payments

Improving equitable access

• R&D that meets public health needs and improves access to health products• Application & management of IP to contribute to innovation & promote public health• Evidence-based selection and fair and affordable pricing

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Access Roadmap – Activities and Actions

• Support collaborative approaches to strategic procurement of health products

• Support countries in efficient procurement and supply chain management of health products

• Improve capability and capacity for detecting, preventing and responding to shortages of medicines and vaccines

• Support for adequate supply management and appropriate use of health products in emergencies and crisis situations

• Interventions that improve use of health products

• Support capacity for monitoring

Improving equitable access

• Procurement and supply chain management• Appropriate prescribing, dispensing and rational use

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Access Roadmap - Actions

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Strategic area

Improving equitable access to health products

Activity

Appropriate prescribing, dispensing and rational use of medicines and health products

Action

Interventions that improve use of health products

Action

Support capacity for monitoring

Access Roadmap - Deliverables

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Action

Interventions that improve use of health products

• Support for strengthening national structures and capacity for the regular development and revision of national treatment guidelines that are aligned with both the national essential medicines list selection process and prescribing practices.

• In collaboration with partners, support for regional/national capacity development of the pharmacy and allied workforce to strengthen the medication-use process, ranging from improving adherence to regulations and guidelines to ensuring patient safety.

Access Roadmap - Deliverables

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Action

Interventions that improve use of health products

• Support for implementing stewardship programmes, with a focus on antimicrobials; guidance on alignment of standard treatment guidance, with resistance pattern and national action plans for antimicrobial resistance; and support for using the Access, Watch and Reserve (AWARE) and the AWARE Index for quality improvement and stewardship interventions.

• Support for the development of national policies and regulations to ensure access, appropriate prescribing, dispensing and use of controlled medicines, including guidance on optimizing relevant legislation and support for strengthening the capacity of prescribers and dispensers to ensure access and quality of service and minimize the risk of diversion.

Level of engagement depends on local context and maturity of health system

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Service delivery • Provide guidance and information on maintenance of medical devices and assistive products

Technical

Assistance

• Provide guidance and information on the pricing of health products, supporting countries in monitoring

prices of these products, and working with countries to put in place national strategies and policies on

prices of medicines, including the use of generic medicines.

Strategic

support

• Support the strengthening of regulatory systems of medicines, vaccines and other health products that

contributes significantly to i.) the availability of efficacious, good quality, and safe medical products,

and ii.) the prevention and detection of SF medicines.

• Implement the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual

Property, including policies on local production of health products, and stimulating a public-health

driven research and development agenda.

Policy dialogue • Provide policy guidance and support to countries to develop, implement, monitor and evaluate

national policies and strategies on medicines and health products that aim to expand access within the

wider framework of UHC.

• Promote networking, coordination of partners in the field and collaboration with a number of WHO

collaborating centres.

To enhance access to generic medicines WHO develops - with the help of labs - a list of

medicines for which clinical studies can be waived:

• WHO guidelines on Multisource (generic) pharmaceutical products: guidelines on

registration requirements to establish interchangeability (revision)

Annex 6, WHO Technical Report Series 1003, 2017 – includes chapter on “biowaiver”,

i.e. criteria how clinical studies can be waived

• Proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential

Medicines immediate-release, solid oral dosage forms

Annex 8, WHO Technical Report Series 937, 2006:

Please see Annex 6, WHO TRS 1003, 2017 for the current policy regarding biowaivers.

The table with BCS classifications is currently being revised

Example 1

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• to facilitate deliveries in the supply chain, update of the WHO GOOD STORAGE AND

DISTRIBUTION PRACTICES FOR MEDICAL PRODUCTS

• Setting out steps to assist in fulfilling the responsibilities involved in the different stages

within the supply chain and to avoid the introduction of substandard and falsified

products into the market.

• The relevant sections should be considered as particular roles that entities play in the

storage and distribution of medical products.

Example 2

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Following discussions relating to establishing policy for remaining shelf life (RSL) of medical

products upon delivery, and considering the discussion between the IPC group

representatives, it was decided to initiate a project to establish a policy on remaining shelf

life for procurement and supply of medical products.

The aims of this policy document are to:

• ensure that there is a balance between enforcing the remaining shelf life policy and

ensuring availability of medical products

• facilitate the national authorization of importation of medical products where

applicable

• promote and support the efficient processing of medical products in the supply chain at

all levels and thus prevent wastage because of delays

Example 3

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• assist in ensuring that there is sufficient stock of medical products, with acceptable

remaining shelf life, in-country

• prevent dumping of medical products

• ensure that barriers to access and supply of medical products are addressed;

• prevent stock-outs

• prevent receiving donations of medical products that are not in accordance with this

guideline

• prevent having expired stock of medical products

Example 3 (cont.)

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A world where every child, man and woman has access to

the quality essential medicines, vaccines and other health

products they need to lead a healthy and productive life.

Thank you

Sabin Kopp

Group Lead

Medicines Quality Assurance