REGIONAL COMMITTEE
Provisional Agenda item 5.5.1
Sixty-fifth Session Yogyakarta, Indonesia 5–7 September 2012
SEA/RC65/10 20 July 2012
Reports of WHO global working/advisory groups: Substandard/spurious/falsely-labelled/falsified/counterfeit medical products and stengthening drug regulatory authorities The issue of substandard/spurious/falsely-labelled/falsified/counterfeit medical products (SSFFC) has been discussed at the World Health Assembly since 2010 following the seizure in 2008 of generic medicines in transit through the Netherlands on the basis of infringement of intellectual property. Since then the lack of a uniform definition of “counterfeit” medical products and certain activities of International Medical Products Anti-counterfeiting Task Force (IMPACT) set up to combat counterfeit medical products in 2006, have engaged the attention of Member States. IMPACT and WHO’s involvement was discussed at the Sixty-third World Health Assembly in 2010. The World Health Assembly decided “to establish a time-limited and results-oriented working group on substandard/spurious/falsely-labelled/falsified/counterfeit medical products comprised of and open to all Member States” to examine inter alia WHO’s role in ensuring availability of quality, safe, efficacious and affordable medical products and WHO’s relationship with IMPACT. The Inter-Governmental Working Group (IGWG) presented its report to the Sixty-fifth World Health Assembly in 2012. Indonesia was Vice-Chair in both the IGWG meetings of 2011. There is unanimous support for WHO’s role in measures to ensure the availability of good quality, safe, efficacious and affordable medical products and concern was also expressed at the lack of sufficient financing for WHO’s work in this area. The IGWG recommendations are incorporated into Resolution WHA65.19 which urges Member States to: (1) (2) voluntarily participate and collaborate with the proposed Member State Mechanism; provide sufficient financial resources (US$ 2 370 000–3 230 000 in 2012–2013) to strengthen the work of the Secretariat in this area;
and requests the Director-General to:
support the proposed Member State Mechanism; assist Member States in building capacity to prevent and control SSFFC, which will necessarily involve strengthening drug regulatory authorities.
At the Sixty-fifth World Health Assembly, 33 delegations made statements on SSFFC. A number of delegations emphasized the importance of WHO’s involvement in combating SSFFC and expressed their concern about the funding gap. It is important that all Member States participate, and Member States of SEA Region adequately engage in this proposed new Member State Mechanism. Member States may like to consider their support to improving access to safe, efficacious and affordable medicines of good quality by strengthening drug regulatory authorities, incorporating public health safeguards and not decreasing access through intellectual property policies. The High-Level Preparatory (HLP) Meeting held in the Regional Office in New Delhi from 3 to 5 July 2012, reviewed the working paper and made the following recommendations: Actions by Member States (1) (2) (3) To participate in the proposed Member State Mechanism. To undertake in-depth assessments of the capacity of the national drug regulatory authorities (NDRAs) in combating SSFFC. To provide sufficient human and financial resources to strengthen the capacity of NDRAs in combating SSFFC.
Actions by WHO-SEARO (1) (2) (3) To provide technical support to Member States to undertake in-depth assessments of the capacity of the NDRAs in combating SSFFC. To develop, based on evidence from the assessment in Member States, a regional medium-term strategic plan to combat SSFFC. To explore the possibility of establishing a mechanism for bulk purchase of drugs and vaccines of assured quality particularly for Member States who depend on importation of drugs and vaccines. To report the progress and outcome of the implementation of the regional mediumterm strategic plan to the Sixty-eighth meeting of the Regional Committee.
(4)
The working paper has been revised to include discussions from the HLP Meeting and is submitted with the HLP Meeting recommendations to the Sixty-fifth Session of the Regional Committee for its consideration.
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Introduction 1. The issue of SSFFC has been discussed at the World Health Assembly since 2010 following the seizure in 2008 of generic medicines in transit through the Netherlands on the basis of infringement of intellectual property. Some of the blame for this seizure was put onto the International Medical Products Anti-counterfeiting Task Force (IMPACT) which had been set up to combat counterfeits in 2006 at the request of the 11th International Conference on Drug Regulatory Authorities in 2004. Prior to 2008, the WHO definition of counterfeit medicines was generally used internationally, but since then there has been no agreement on definitions or on the role of WHO in IMPACT.
WHO’s involvement in combating counterfeit medicines 2. WHO’s involvement in addressing the issue of counterfeit medical products is described in document A63/23, discussed at the Sixty-third World Health Assembly and with contents as summarized below:
The definition, “A counterfeit medicine is one which is deliberately and fraudulently mislabelled with respect to identify and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredient or with fake packaging” was documented in 1992. This definition has been used subsequently in World Health Assembly resolutions WHA47.13 in 1994, WHA52.19 in 1999 and in many WHO Expert Committee reports during 1996-2006. WHO has been working since 1988 to combat counterfeit medicines. During the period 2008–2009, some disagreement over this definition occurred during discussions in WHO Governing Body meetings following the wrongful seizure in the Netherlands of medical products in transit that were not counterfeit according to the definition above, did not infringe the intellectual property of the country of final destination but which did infringe the intellectual property laws of the Netherlands (should the products have been destined for the Netherlands – which they were not). Following this disagreement of definition, WHO headquarters made an inquiry on the terminology used in national laws with its Member States through a circular letter and subsequently presented the preliminary outcome during an Open Forum in March 2010. Responses were received from 60 Member States and most countries indicated that they used the word “counterfeit” in their national legislation and that they used it in a medicines regulatory (quality-and-safety-related) context. The draft report is currently posted on the WHO web site for feedback from Member States.
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International Medical Products Anti-Counterfeiting Taskforce (IMPACT) 3. A description of IMPACT and WHO’s involvement in it is described in document A63/INF.DOC./3, discussed at the Sixty-third World Health Assembly and with contents as summarized below:
IMPACT was formed in 2006 under WHO leadership on the recommendation of the 11th International Conference of Drug Regulatory Authorities in 2004 where it was recognized that a coordinated approach by many different partners is needed to combat counterfeit medicines. WHO invited all Member States to join IMPACT and currently membership includes: 30–40 Member States, INTERPOL, the World Customs Organization, the World Intellectual Property Organization (WIPO), the World Trade Organization (WTO), the Organization for Economic Co-operation and Development (OECD), the European Commission (EC), the Council of Europe, the Commonwealth Secretariat, the Association of Southeast Asian Nations (ASEAN) Secretariat and numerous nongovernmental organizations competent in combating counterfeit medicines. Within IMPACT, five working groups were formed to make recommendations and develop tools for use in the areas of: (1) regulatory implementation; (2) enforcement; (3) technology,;(4) communications; and (5) legislative and regulatory infrastructure. The partners of IMPACT reached consensus on the following issues: (1) “Counterfeit” medicines should not be confused with issues relating to medicines that are not authorized for marketing in a given country nor with patents violations or disputes. The word “counterfeit” is also commonly used in relation to goods that infringe trademarks. Falsified or counterfeit medical products may infringe intellectual property rights, but whether a good is considered counterfeit from a public health perspective is independent of whether the product infringes intellectual property rights. According to its mandate, WHO is working on the issue of counterfeit medical products from a public health perspective. The other aspects, including the enforcement of intellectual property rights, come under the mandate of other bodies or international organizations. The activities of WHO’s Secretariat and IMPACT are clearly different with two different web sites established and a new WHO factsheet issued.
(2)
(3)
Sixty-third World Health Assembly 4. The two reports, A63/23 and A63/INF.DOC./3, prepared by the Secretariat were debated at the Sixty-third World Health Assembly in May 2010. All together five draft resolutions and decisions were tabled for discussion by Member States, including three draft resolutions, two
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draft decisions and 26 interventions. Decision WHA63(10) Substandard/spurious/falsely labelled/counterfeit medical products was finally adopted by consensus. This decision reaffirmed the fundamental role of WHO in ensuring the safety, efficacy, quality and efficacy of medical products and:
Decided “to establish a time-limited and results-oriented working group on substandard/spurious/falsely labelled/falsified/counterfeit medical products comprised of and open to all Member States”. Requested the WHO Director-General “to convene and facilitate the work of the working group”. Decided that “the working group would examine the following matters from a public health perspective, excluding trade and intellectual property considerations”: (a) (b) (c) WHO’s role in ensuring availability of quality, safe, efficacious and affordable medical products; WHO’s relationship with IMPACT; WHO’s role in the prevention and control of medical products of compromised quality, safety and efficacy, such as substandard/spurious/falsely labelled/falsified/ counterfeit medical products (SSFFC) from a public health perspective, excluding trade and intellectual property considerations; Any issues raised in the proposal contained in documents A63/A/Conf.Paper no.4 rev.1, A63/A/Conf.Paper no.5 and A63/Conf.Paper no.7.
(d)
Decided that the working groups shall report on progress to the 128th session of the Executive Board and make recommendations to Sixty-fourth World Health Assembly.
Sixty-fourth World Health Assembly 5. the time of the Sixty-fourth World Health Assembly in May 2011, only the first IGWG meeting had taken place – during 28 February to 3 March and attended by 93 Member States. The documents discussed at the World Health Assembly were based on the deliberations of the first IGWG meeting. 6. Documents A64/16 and A/SSFFC/IGWG/5 were debated and, as recorded in document WHA64(10), Member States decided to accept the “next steps” contained in document A64/16:
the inter-governmental working group to have more time to complete its work and to make specific recommendations to the Sixty-fifth World Health Assembly;
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WHO to continue its programmatic work related to the World Health Assembly mandates contained in resolutions WHA41.16, WHA47.13, WHA61.21, which are not related to IMPACT; mechanisms adopted by WHO to fulfil its mandate should ensure transparency and inclusiveness in their conception and composition, avoiding conflicts of interest in the actors involved and guaranteeing oversight of activities and accountability.
Sixty-fifth World Health Assembly 7. By the time of the 130th session of the Executive Board in January 2012, the second IGWG had taken place, during 25–28 October 2011, and had been attended by 90 Member States. The documents discussed at the Sixty-fifth World Health Assembly are based on the deliberations of the IGWG meetings (which can be found at http://apps.who.int/gb/ssffc).
Substandard/spurious/falsely-labelled/falsified/counterfeit medical products: report of the Working Group of Member States 8. Document A65/23 describes the report of the IGWG on SSFFC. Deliberations and recommendations were made in three areas: (1) WHO’s role in measures to ensure the availability of good quality, safe, efficacious and affordable medical products where unanimous support was expressed for WHO’s role in such measures and where concern was also expressed at the lack of sufficient financing for WHO’s work in this area. The IGWG agreed to the continuation and importance of strengthening WHO’s activities in this area. WHO’s role in the prevention and control of medical products of compromised quality, safety and efficacy such as substandard/spurious /falselylabelled/falsified/counterfeit medical products from a public health perspective, excluding trade and intellectual property considerations where two main options were discussed: (1) establishing a subcommittee of the WHO Expert Committee for Pharmaceutical Preparations to give technical advice on SSFFC; and (2) establishing a new Member State Mechanism to address SSFFCC, which would draw on expert advice and collaborate with the International Conference of Drug Regulatory Authorities (ICDRA) and other stakeholders, as appropriate. The IGWG agreed to recommend that the World Health Assembly set up a new Member State Mechanism, which would make use of existing WHO structures, would meet annually and would report to the World Health Assembly after three years. The IGWG further agreed to recommendations as proposed in EB130/R13. WHO’s relationship with IMPACT where various options as contained in document A/SSDDC/WG/2/4 were discussed (disengagement from IMPACT; continued relationship with IMPACT but with a reformed format and procedures; or an alternative mechanism). The IGWG could not agree and it was felt that a way forward
(2)
(3)
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could emerge when the new Member State Mechanism is considered at the Sixty-fifth World Health Assembly. It was agreed that the new mechanism should promote effective collaboration among Member States and the Secretariat and would draw on expert advice and collaborate with the ICDRA. The IGWG further agreed to recommendations as proposed in EB130/R13.
Resolution WHA65.19: Substandard/spurious/falsely-labelled/ falsified/counterfeit medical products 9. Resolution EB130 was debated at the Sixty-fifth World Health Assembly and unanimously adopted Resolution WHA65.19, which: (a) Reaffirms the fundamental role of WHO in ensuring the quality, safety and efficacy of medical products; in promoting access to affordable, quality, safe and efficacious medicines; and in supporting national drug regulatory authorities in this area, in particular in developing and least developed countries. Decides to establish a new Member State Mechanism for international collaboration among Member States, from a public health perspective, excluding trade and intellectual property considerations, regarding SSFFCs in accordance with the goals, objectives and terms of reference annexed in the resolution and to review the Mechanism after 3 years of operation. urges Member States (1) (2) (d) to voluntarily participate and collaborate with the proposed Member State Mechanism; provide sufficient financial resources (US$ 2 370 000–3 230 000 in 2012–2013) to strengthen the work of the Secretariat in this area. to support the Member States Mechanism proposed; to assist Member States in building capacity to prevent and control SSFFCC.
(b)
(c)
requests the Director-General (1) (2)
Strengthening drug regulatory authorities 10. WHO defines effective medicines regulation1 as promoting and protecting public health by ensuring that:
medicines are of the required quality, safety and efficacy; medicines are appropriately manufactured, stored, distributed and dispensed; illegal manufacturing and trade are detected and adequately sanctioned;
1
http://www.who.int/medicines/areas/quality_safety/regulation_legislation/en/index.html
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health professionals and patients have the necessary information to enable them to use medicines rationally; promotion and adverting is fair, balanced and aimed at rational drug use; access to medicines is not hindered by unjustified regulatory work.
11. Thus strong/effective national drug regulatory authorities are required with a clear mission, legal basis, objectives, appropriate organizational structure, sufficient qualified staff, adequate financing, access to up-to-date evidence-based technical literature, equipment and information, capacity to exert effective market control and transparent decision-making. Unfortunately, in many countries, NDRAs are under-resourced and thus weak. Furthermore, it is difficult for many countries, particularly small ones, to undertake all the technical functions. 12. WHO’s role in supporting medicines regulation is twofold. Firstly, WHO develops internationally recognized norms, standards and guidelines. Secondly, WHO provides guidance, technical assistance and training so that countries can implement global guidelines to meet their regulatory requirements. Regulatory support to countries includes assessing national medicines regulatory systems and providing information and training. In addition, WHO runs the ICDRA two yearly and facilitates international cooperation and harmonization. SEAR countries have regularly participated in ICDRA and also benefited from training in regulation. Harmonization of regulation means that every country does not have to undertake all technical functions itself but can benefit from sharing of information. Three SEA Region countries are members of ASEAN where efforts at harmonization have been ongoing for some years. Other SEAR countries are now actively exploring setting up a similar process in the South Asian Association for Regional Cooperation (SAARC).
South-East Asia Region perspective 13. Since the seizure in the Netherlands in 2008 of medical products incorrectly labelled as counterfeit, as a result of possible infringement of intellectual property rights, some Member States have had different views on the definition of “counterfeit” and the activities of IMPACT. As a result, they adopted Regional Committee resolution SEA/RC62/R6 in September 2009. This resolution focuses on improving access to safe, efficacious, affordable medicines of good quality by strengthening drug regulatory authorities, incorporating public health safeguards and not decreasing access through intellectual property policies. The definition of counterfeit medicines agreed with WHO’s 1992 definition. SEAR countries participated in the Sixty-third World Health Assembly in May 2010, in both IGWGs in 2011 and in the Sixty-fifth World Health Assembly in May 2012. Indonesia was a Vice-Chair in both the IGWG meetings of 2011. In addition, there was a previous resolution SEA/RC55/R4 on accessibility to essential medicines which urged Member States to strengthen drug regulatory authorities and urged the Regional Director to provide technical assistance. 14. At the High Level Preparatory Meeting for the Sixty-fifth Regional Committee, there was discussion about the need to strengthen national drug regulatory authorities (NDRAs) in order to better combat SSFFC. The Secretariat mentioned that they had undertaken some review of
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NDRAs while conducting situational analyses of the pharmaceutical sector in 9 out of 11 countries during the past 2 years. In addition, an in-depth assessment of the NDRA may be conducted at country request and such assessments had been conducted in five countries during the past 10 years. It was felt that much technical support had been piecemeal and that a Regional Committee resolution was needed on strengthening NDRAs to better combat SSFFC and to develop a regional medium-term strategic plan to combat SSFFC. In addition, some Member States mentioned that it was difficult for small countries to procure medicines of good quality and requested WHO to explore the possibility of a mechanism for bulk purchase of drugs and vaccines of assured quality for those countries depending on importation.
Conclusions 15. At the Sixty-fifth World Health Assembly, 33 delegations made statements on SSFFC and a number of delegations emphasized the importance of WHO being involved in combating SSFFC and expressed their concern about the funding gap. Resolution WHA65.19 was unanimously passed, proposing a new Member State Mechanism to combat SSFFCs and reaffirming WHO’s role in strengthening NDRAs. It is important that all Member States participate in the new Member State Mechanism. The principles behind the resolution adopted by the Sixty-fifth World Health Assembly are the same as those articulated in resolution SEA/RC62/R6. Both resolutions focus on improving access to safe, efficacious and affordable medicines of good quality by strengthening drug regulatory authorities, incorporating public health safeguards and not decreasing access through intellectual property policies. In addition, Member States are now considering whether a resolution on strengthening NDRAs in order to better combat SSFFC is needed at the Sixty-fifth Regional Committee.