Dr Samvel Azatyan Manager, Medicines Regulatory Support Programme
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Transcript of Dr Samvel Azatyan Manager, Medicines Regulatory Support Programme
1 |WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, 31 October - 4 November 2011, WHO Headquarters, Geneva
Dr Samvel AzatyanManager, Medicines Regulatory Support ProgrammeQuality Assurance and Safety: MedicinesEssential Medicines and Pharmaceutical PoliciesWorld Health OrganizationE-mail: [email protected]
Overview on Medicines Regulation: regulatory cooperation andharmonization in the focus
2 |WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, 31 October - 4 November 2011, WHO Headquarters, Geneva
Why regulation of medicines is needed?
What is special with medicines, compared to other goods / commodities?
As a rule, patients are not able to make independent judgement about of the QUALITY, SAFETY and EFFICACY;─ Even health professionals have difficulties, unless they are
specially trained;
Medicines regulation is the totality of all measures - legal, administrative and technical - which governments undertake to ensure the quality, efficacy and safety of medicines, as well as the relevance and accuracy of the product information.
3 |WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, 31 October - 4 November 2011, WHO Headquarters, Geneva
irrational consumption and prescription; quality of medicines is not assured - substandard,
counterfeit, harmful, useless medicines on the market.
Consequences of under-regulation dueto the weak regulatory capacity
Consequences of over- or improper regulation shortage of needed medicines or delayed access; increased costs of medicines due to the cost of
regulatory system.
Why regulation of medicines is needed?
4 |WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, 31 October - 4 November 2011, WHO Headquarters, Geneva
Rationale for Government's role
Governments are obliged to intervene in the activities of the pharmaceutical sector due to public health and safety concerns;
In this context, medicines regulation is a public policy that restricts private sector activities in order to attain social goals identified by the State;
Medicines regulation in the countries is performed through National Medicines Regulatory Authorities
(NMRAs)
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Medicines regulatory authority
In a broad sense medicines regulatory authority means a network (institution) that administers the full spectrum of drug regulatory activities, including at least the following functions:
Marketing authorization for new products and variation of existing authorizations;
GMP, GCP, GLP inspections; Licensing and post-license control of manufacturers,
wholesalers and other distribution channels; Quality control laboratory testing; Adverse drug reaction monitoring; Provision of drug information and promotion of
rational drug use; Enforcement operations; Monitoring of Drug Utilization, etc.
6 |WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, 31 October - 4 November 2011, WHO Headquarters, Geneva
Medicines regulation should: Have patient in the focus; Be evidence and science based; Be risk based; Bring added value; Respect interests of stakeholders and real possibilities; Be transparent but respect confidentiality; Be effective and flexible; Be part of broader overall pharmaceutical policy of the
country.
Main principles of medicines regulation – although, not always observed..
7 |WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, 31 October - 4 November 2011, WHO Headquarters, Geneva
Main principles of medicines regulation – although, not always observed..
…But also keep in mind, that:
Regulations must be attuned not to the wishes, but to available resources (technical, human, financial, etc.);
Due to the complexity and resource constrains, the requirements developed and successfully implemented in one country may not be equally successful in another country;
… Attempts to apply more sophisticated requirements may have (at least, in short term) serious public health implications.
8 |WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, 31 October - 4 November 2011, WHO Headquarters, Geneva
Differences in regulatory capacity globally
193 WHO Member States:
20% 50%
30% DevelopedVariableLimited
The reality is that many regulatory authorities don't have the full capacity to perform all regulatory functions, due to chronic shortages of human, technical, financial and other resources
9 |WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, 31 October - 4 November 2011, WHO Headquarters, Geneva
Differences in regulatory capacity in African Region
46 WHO Member States:
4%
33%
24%
39% DevelopedModerateBasicLimited
Source: WHO/AFRO/EDP/04.5: Availability of Drug Regulatory and Quality Assurance Elements in Member States of the WHO African Region, 2004, Brazzaville.
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WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, 31 October - 4 November 2011, WHO Headquarters, Geneva
Assessments of medicines regulatory systems in 26 sub-Saharan African countries
Guidelines and assessment procedures are not up to international standards and are often of an administrative rather than technical nature;
Wide-ranging exemption clauses not justified by a risk assessment, for example for public sector imports or donations;
Scarce resources severely limited technical assessment of dossiers;
In spite of resource constraints few countries relied on decisions made by other regulators (such as stringent NMRAs or by the WHO Prequalification Programme);
Regulatory decisions by other competent authorities were not widely recognized.
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WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, 31 October - 4 November 2011, WHO Headquarters, Geneva
Chronic shortages of resources; Different institutional arrangements existing
for the regulation of medicines in different settings;
Expertise and capacity existing in different NMRAs are different too..
Even well-resourced regulatory authorities are not anymore able and willing to carry the burden alone..
There is a clear need for a new approaches in the medicines regulation.
Critical issues in regulation of medicines
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WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, 31 October - 4 November 2011, WHO Headquarters, Geneva
Increasing difficulty for regulators to make fare balance between potential risks involved with new medicines and increasing public expectations for the safety of medicines;
Greater access to information and demand for quality information;
Increasing number of borderline products with health claims;
The gaps among regulatory systems of WHO Member States are rather increasing than decreasing.
Main challenges in regulation
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WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, 31 October - 4 November 2011, WHO Headquarters, Geneva
"Innovative" approaches to cope with increasing demands and limited resources
Avoid doing things that do not give added value; Concentrate on things that do give added value; Pragmatically and focus on priority issues, which are
most relevant for public health (risk-benefit approach); Increase effectiveness of internal operations; Co-operate with partners in order to eliminate
duplicated activities; Share your work with others – do what you can do
better and let others to do what they can do better
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WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, 31 October - 4 November 2011, WHO Headquarters, Geneva
Prioritization of the regulatory activities
Many NMRAs with limited resources may limit their scope of activities to performance of those "core" regulatory functions, which could potentially bring maximum added value to the public health;
Other regulatory functions could be more and more shared with the colleagues in other NMRAs (especially in the frameworks of existing RECs) and relying on the opinions made and decisions taken by other regulators;
This will allow WHO and other partners to prioritize the support efforts and to introduce a system for accreditation (or prequalification) of NMRAs for performance of specific regulatory functions, in accordance with specific international standards.
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WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, 31 October - 4 November 2011, WHO Headquarters, Geneva
More specific "innovative" (or heretic..) approach
Introduction of the concept of "levelling" for the pharmaceutical products (essential medicines), according to the "quality-related risk", into:─ Low risk products─ Medium risk products─ High risk products
This will create incentives and motivation for the development, in case if NMRA wishes to "jump" a level up, e.g., from regulation of low risk products to medium risk products.
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WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, 31 October - 4 November 2011, WHO Headquarters, Geneva
Developing evidence - assessments of regulatory systems worldwide (around 50 NMRAs assessed in all 6 regions);
Providing direct technical support (capacity building, tools and guidance) to regions and countries (with PQ and IVB);
Stimulating / initiating collaboration between regulators from various countries on various regulatory activities (from "North → South" to "South ↔ South");
Facilitating the establishment of "Centres of excellence" for regulatory affairs;
Promoting harmonization.
What MRS is doing to support regulators
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WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, 31 October - 4 November 2011, WHO Headquarters, Geneva
Collaboration with other Programmes and Units within EMP and outside
HSS/EMPQSM (PQ, Safety)QSM (Quality Assurance)QSM (Blood products)MAR (GGM)
Medicines Regulatory Support
Disease-oriented programmes
HTM/GMP(Global Malaria Programme)Other Programmes
FCH/IVBQSS(Regulatory pathways)
National Medicines Regulatory Authorities
WHO Regional Offices WHO Country Offices
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WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, 31 October - 4 November 2011, WHO Headquarters, Geneva
Faster access to medicines throughsharing of regulatory information
MRS is working with regulators to find out how best to build confidence in regulatory decisions taken by other regulators, including:
─ how to facilitate exchange of consolidated information about assessments and inspections;
─ without challenging their sovereignty.
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WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, 31 October - 4 November 2011, WHO Headquarters, Geneva
Acceptance of expertise is not equal to acceptance of decision:
Acceptance of expertise– is sovereign and complex regulatory decision of NRA based on
scientific arguments and confidence; – may be applied case to case;– is followed by formal independent decision according to national
legislation and mandate of national MRA; Acceptance of decision
– is a formal legal act, frequently requiring international treaties;– may modify liabilities of involved parties and requires legal
specification of acceptance and non-acceptance.
Sharing of expertise vs. recognition of decision
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WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, 31 October - 4 November 2011, WHO Headquarters, Geneva
New regulatory approaches
Smaller or less resourced regulatory authorities more and more starting to rely on the approvals or opinions issued by the well-resourced regulatory authorities
Examples of this type of initiatives include, but are not limited to:
WHO PQP - HIV/AIDS, TB, malaria, RH, paediatric therapy; US PEPFAR - HIV/AIDS; EU Article 58 – assessment of products for use outside the
European Union territory; Canada's Access to Medicines Regime – assessment of
products according to WHO Model List of Essential Medicines; Other – orphan medicines, paediatric medicines.
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WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, 31 October - 4 November 2011, WHO Headquarters, Geneva
Regulatory harmonization
In a broad sense harmonization means harmonization of technical requirements for medicines regulation, i.e., legislations, guidelines, procedures, etc.
These requirements relate to the quality, safety and efficacy of the medicinal products;
These requirements differ in complexity, from one type of marketing authorization application to another;
To start with innovators or with generics? Or both?
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WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, 31 October - 4 November 2011, WHO Headquarters, Geneva
What we What we dodo mean under Harmonization? mean under Harmonization?
True harmonization goes further than just development of common documentation;
It requires effective communication and collaboration aimed at building capacity and trust (e.g., information sharing, recognition and joint working);
In combination, these activities can lead to similar or collaborative approaches to drug registration;
Paving the way for mutual recognition and/or centralized registration (if desired) in the longer-term future.
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WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, 31 October - 4 November 2011, WHO Headquarters, Geneva
What we What we do not do not mean under Harmonization?mean under Harmonization?
Harmonization doesn't mean a loss of national sovereignty / autonomy (and certainly not in the early stages)
Common documentation stipulates the requirements for registration;
Better communication enables countries to chose which information they will use;
Collaborative mechanisms, such as joint assessments or inspections, does not imply collaborative decision-making!
In all cases the registration decision itself stays firmly in the hands of sovereign nations
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WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, 31 October - 4 November 2011, WHO Headquarters, Geneva
Scope and objectives for harmonization
Objective of drug regulation: TO IMPROVE AND PROMOTE PUBLIC HEALTH
In case harmonization is supported by International Community – main objective should be:
►
There may be other gains, but these should be in the centre.
MEASURABLE PUBLIC HEALTH GAINS
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WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, 31 October - 4 November 2011, WHO Headquarters, Geneva
Potential public health gains from harmonization
Less risk of being harmed by medicines (safety risks combined with no treatment effect risks) as gradual improvement of quality, safety and efficacy of products on the markets is expected;
More rapid access to needed medicines (high priority essential medicines, new medicines…);
Better value for money (both for out of pocket and public funds), as no waste on substandard and of poor-quality medicines;
Increasing trust in generic medicines (also better value for money).
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WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, 31 October - 4 November 2011, WHO Headquarters, Geneva
Potential gains have to be balanced with… potential losses
Increased price level of medicines (quality has its price);
Reduced access – not all medicines on the market may meet new harmonized standards;
Increasing price for medicines regulation (harmonization has its price too);
Local industry may not always win;
Wholesale and retail businesses may loose many of the products that were bestsellers for them.
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WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, 31 October - 4 November 2011, WHO Headquarters, Geneva
Potential scope for harmonization in Africa
Harmonization of technical requirements– Generic drugs vs NCEs – move from generics to NCEs– Priorities (CTD, modules for generics, GMP), timeframes and
working methods for creation of guidelines to be determined;
Implementation of harmonized technical requirements;
Establishing for priority products a special pathway – one set of assessments/inspections – access to all markets
– Either via "centralized procedure" (one application, one process and one result for all) or "mutual recognition" (same application for all or some, one MRA does the job and others recognize without duplication).
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WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, 31 October - 4 November 2011, WHO Headquarters, Geneva
Regulatory harmonization in Africa
Africa – a continent of huge diversity and complex unity, with numerous Regional Economic Communities (REC);
… overlaps and politically complicated environment.
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WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, 31 October - 4 November 2011, WHO Headquarters, Geneva
African Medicines RegistrationHarmonization Initiative (AMRHI)
Process started with the informal consultations in ICDRA Meeting, September 2008, Bern, Switzerland;
In response to the growing recognition of the potential benefits of harmonizing medicines registration in Africa, a WHO concept paper was developed to describe a proposed approach to supporting drug registration harmonization within and across African regional groupings.
WHO Drug Information, Volume 22, Number 3, 2008
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WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, 31 October - 4 November 2011, WHO Headquarters, Geneva
African Medicines RegistrationHarmonization Initiative (AMRHI)
Further discussions and orientation in the meeting in Johannesburg, South Africa, 24-26 February 2009, organized jointly by BMGF, NEPAD, William J. Clinton Foundation and the WHO.
The purpose of the meeting was: to explore the possibilities of supporting medicine registration
harmonization, as an initial first step to broader regulatory harmonization within African Regional Economic Communities (RECs) and organizations, and
to initiate a strategic approach to develop project proposals for mobilizing the necessary financial and technical resources to support RECs undertaking medicine registration harmonization.
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WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, 31 October - 4 November 2011, WHO Headquarters, Geneva
African Medicines RegistrationHarmonization Initiative (AMRHI)
Donor partners, NEPAD and WHO confirmed their interest in supporting the RECs, including necessary actions to support national implementation, strengthen national regulatory agencies and promote inter-REC and continental exchange of information, coordination and technical consistency.
Their strategic approach was to invite summary project proposals (SPPs) from committed RECs and seek financial and technical support for the most sound and promising proposals among them.
Several RECs have submitted their SPPs and at this stage one of them has been approverd – East African Community
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WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, 31 October - 4 November 2011, WHO Headquarters, Geneva
Conclusions
Medicines regulation is not anymore a "single-player" activity;
Prioritization of regulatory activities, work sharing and collaboration can help reduce workload and improve public health by improving overall regulatory performance.
It can help to direct the expert knowledge and resources to performance of the functions that can improve public health and facilitate access to essential medicines;
Formation of effective networks between regulatory authorities nationally and internationally may facilitate sharing of scarce resources and eliminate duplicating of activities.
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WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, 31 October - 4 November 2011, WHO Headquarters, Geneva
Thank you!
www.who.int/medicines
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