Overview on Medicines Regulation: regulatory cooperation and harmonization in focus Dr Samvel Azatyan Manager, Medicines Regulatory Support Programme Quality Assurance and Safety: Medicines Essential Medicines and Pharmaceutical Policies World Health Organization E-mail: azatyans@who.int 1 Forecasting Global ARV demand 2010-2012 and improving access to adult
What is medicines regulation? 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 doctors and pharmacists have difficulties, unless specially trained.. Medicines regulation is the totality of all measures - legal, administrative and technical - which governments undertake to ensure the safety, efficacy and quality of medicines, as well as the relevance and accuracy of product information. 2 Forecasting Global ARV demand 2010-2012 and improving access to adult
Why regulating medicines? Consequences of under-regulation (weak regulatory capacity) irrational consumption and prescription; substandard, counterfeit, harmful, useless medicines on the market. Consequences of over- or improper regulation shortage of needed medicines or delayed access; increased costs of medicines due to the cost of regulatory system. 3 Forecasting Global ARV demand 2010-2012 and improving access to adult
What are the issues? Can all national regulators assess and inspect all the new innovative products that come to their markets? Can and should all the regulators assess and inspect all the generic medicines? Does repetitive assessment and inspections give added value? How to build confidence in scientific assessments/ inspections carried out by other parties? How regulators can best contribute to the public health with the (limited) resources they have? 4 Forecasting Global ARV demand 2010-2012 and improving access to adult
Can all national regulators assess and inspect all products that come to their markets? In theory, and only in theory, YES But who can pay the bill? Thus, in practice, NO 5 Forecasting Global ARV demand 2010-2012 and improving access to adult
Differences in regulatory capacity Due to chronic shortages of human and technical resources, many regulatory authorities do not have the full capacity to perform all regulatory functions; Weak regulatory frameworks and lack of enforcement lead to various bottlenecks, limiting access to essential medicines. 193 WHO Member States: 20% 50% 30% Developed Varying Limited 6 Forecasting Global ARV demand 2010-2012 and improving access to adult
Does repetitive assessment and inspections give added value? YES, provided the previous assessment has been based on different (lower) set of standards, or missed important issues (due to different qualifications, views); Usually NO, if the same standards are used; Usually NO, if the capacity for assessment is not present, or does not equal to the one of the first assessment; Duplicate efforts, or trust colleagues? That is the question! 7 Forecasting Global ARV demand 2010-2012 and improving access to adult
How regulators can best contribute to the public health with the resources they have? Avoid doing things that do not give added value, concentrate on things that do give added value; Concentrate on high risk areas/products; Be pragmatic: Nice to know forget it, need to know get it! And learn making difference between the two; Cooperate with partners in order to increase regulatory capacity by elimination of duplicated activities Facilitated by comparable standards and administrative requirements. 8 Forecasting Global ARV demand 2010-2012 and improving access to adult
Sharing of expertise vs. recognition of decision 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. 9 Forecasting Global ARV demand 2010-2012 and improving access to adult
New regulatory pathways Smaller or less resourced regulatory authorities often 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; Canada's Access to Medicines Regime assessment of products according to WHO Model List of Essential Medicines; Other orphan medicines, paediatric medicines. 10 Forecasting Global ARV demand 2010-2012 and improving access to adult
WHO approaches for regulatory support 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. 11 Forecasting Global ARV demand 2010-2012 and improving access to adult
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? 12 Forecasting Global ARV demand 2010-2012 and improving access to adult
What we do mean under Harmonization? True harmonization goes further than just 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. 13 Forecasting Global ARV demand 2010-2012 and improving access to adult
What we do not mean under Harmonization? Harmonization does not 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 14 Forecasting Global ARV demand 2010-2012 and improving access to adult
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: MEASURABLE PUBLIC HEALTH GAINS There may be other gains, but these should be in the centre. 15 Forecasting Global ARV demand 2010-2012 and improving access to adult
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 dubious safety and efficacy medicines; Increasing trust in generic medicines (also better value for money). 16 Forecasting Global ARV demand 2010-2012 and improving access to adult
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 also its price); Domestic manufacture may not always win; Wholesale and retail businesses may loose many of the products that were bestsellers for them. 17 Forecasting Global ARV demand 2010-2012 and improving access to adult
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). 18 Forecasting Global ARV demand 2010-2012 and improving access to adult
Regulatory harmonization in Africa Africa a continent of huge diversity and complex unity, with numerous Regional Economic Communities (REC); overlaps and politically complicated environment. 19 Forecasting Global ARV demand 2010-2012 and improving access to adult
African Medicines Registration Harmonization 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 20 Forecasting Global ARV demand 2010-2012 and improving access to adult
African Medicines Registration Harmonization 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. 21 Forecasting Global ARV demand 2010-2012 and improving access to adult
African Medicines Registration Harmonization 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 from committed RECs and seek financial and technical support for the most sound and promising proposals among them. 22 Forecasting Global ARV demand 2010-2012 and improving access to adult
African Medicines Registration Harmonization Initiative (AMRHI) next steps for further implementation of the project: By 31st May 2009 RECs are invited to submit to WHO and NEPAD a summary project proposal in support of regional medicine registration harmonization. A draft format and a suggested scope and outline are available. NEPAD and WHO are willing to give limited technical support to the development of such regional proposals. April-May 2009: Submission of summary project proposals; June 2009: Review of proposals and feedback to RECs; July-October 2009: Selected RECs to submit their full project proposals to NEPAD & WHO; November-December 2009: Review of full project proposals by Project consortium and submission to interested Donors; January-June 2010: Implementation of first approved projects. 23 Forecasting Global ARV demand 2010-2012 and improving access to adult
Conclusions Sharing of information, collaboration and harmonization can help reduce workload and improve 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; Harmonization could contribute in building regulatory capacity and trust, which is an important achievement in its own right. 24 Forecasting Global ARV demand 2010-2012 and improving access to adult
Thank you! www.who.int/medicines mrsmail@who.int Photo by: www.buildmyaudience.com 25 Forecasting Global ARV demand 2010-2012 and improving access to adult