TWN Info Service on Intellectual Property Issues (May11/08)
26 May 2011
Third World Network

Work to continue to clarify “counterfeit” medicines, WHO’s role 

[An earlier version of this article was published in the South-North Development Monitor (SUNS) #7158 dated 26 May 2011]

Geneva, 25 May (K. M. Gopakumar): Health officials who met on 16 to 24 May agreed that work will continue on clarifying WHO’s role in the prevention and control of medical products with compromised quality, safety and efficacy from a public health perspective.  

The World Health Assembly (WHA) agreed to extend the mandate of the open-ended intergovernmental Working Group on sub-standard/spurious/falsely-labelled/falsified/counterfeit (SSFFC) medical products to enable it to complete its work and report to the WHA in 2012. 

The Working Group was established at last year’s WHA session (Decision 63.10) following stormy divisive discussions on the continued use of the term “counterfeit” by WHO to refer to medical products with compromised quality, safety and efficacy, WHO’s role in addressing compromised (“counterfeit”) medicines as well as its relationship to the International Medical Product Anti-Counterfeit Taskforce (IMPACT). The title of the Working Group itself reflects the deep divisions among Member States.

[IMPACT is an initiative led by the multinational pharmaceutical industry and the International Criminal Police Organisation (Interpol) and funded by the Organization for Economic Cooperation and Development (OECD) member countries that are engaged in IP enforcement and anti-counterfeiting activities.]

The Working Group was unable to resolve the deep divisions during a three-day meeting that took place on 28 February to 2 March 2011 at the WHO headquarters in Geneva. 

[The holding of that first meeting of the Working Group was delayed for months, as WHO member states could not agree on the Chair of the Working Group. According to sources, some developed countries insisted that Germany should either Chair or co-chair the Working Group. However this was unacceptable to several others as Germany also chairs the Legislative and Regulatory Infrastructure Working Group of IMPACT.]

The WHA considered the report of the Working Group (A 64/16) that contains the outcome of the first meeting of the Working Group (see SUNS #7103 dated 8 March 2011). It agreed to accept the “next steps” contained in the report that requested that the WHA consider extending the mandate of the Working Group to allow the Working Group to complete its work as soon as possible, building on the work thus far achieved.

The decision calls for resuming the work of the Working Group as soon as possible following the just concluded WHA and to report to the 65th session of the WHA next year. 

It also states that WHO should continue its programmatic work related to the WHA mandates contained in resolutions WHA41.16, WHA47.13, and WHA61.21 while noting these resolutions are not related to IMPACT. (The three decisions give a mandate to WHO to work on issues of counterfeit, substandard, spurious and falsely labeled medical products.)

It further notes that mechanisms adopted by WHO to fulfill its mandate should ensure transparency and inclusiveness in their conception and composition, avoiding the emergence of conflicts of interest in the actors involved and should guarantee oversight of its activities and accountability.

The Working Group was established by the 2010 WHA Decision 63.10 following contentious discussions on how to approach compromised (“counterfeit”) medicines. Many developing countries expressed misgivings over WHO's role in "counterfeits", as its use in a dual context (i.e. in the context of intellectual property as well as health) results in the undermining of affordable generic medicines. 

At the 2010 WHA session Brazil, India, Kenya and many other developing countries also called for WHO to disassociate itself from IMPACT. 

Other countries fought to retain the status quo.

To resolve the differences, the Working Group was mandated to examine, from a public health perspective, excluding trade and intellectual property considerations, the following: WHO's role in measures to ensure 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-labeled/falsified/counterfeit medical products from a public health perspective. 

The Working Group was expected to make specific recommendations on these issues and to report to the 64th WHA through the Executive Board meeting in January 2011. As the Working Group was unable to complete its mandate, the Working Group requested the WHA to consider extending its mandate. 

Extension of the Working Group mandate last week would have been a rather quick and straightforward matter, had it not been for resistance from certain member states particularly the EU, sources said. As a result consideration of the issue by the WHA was repeatedly adjourned, until differences on the extension were resolved by informal discussions. 

SUNS also learned that Nigeria had proposed for the consideration of the African region a draft resolution allowing WHO to continue “business as usual” on the issue of substandard/spurious/falsely labelled/falsified/counterfeit, bypassing the Working Group. It also proposed that WHO could bring together partners for sharing best practices, as an attempt to legitimise IMPACT.  Such a draft failed to garner support of the region, SUNS learned.  

[Nigeria holds the position of vice-chair in IMPACT.]

Although finally agreement was reached on extension of the Working Group mandate, interventions by member states revealed divergences on expectations of the Working Group. 

India, speaking on behalf of countries linked to the WHO South East Asia Region Office (SEARO) reiterated the importance SEARO countries attach to access to quality, safe, efficacious (QSE) and affordable medical products. 

It added that some quarters wished to promote deliberate confusion between intellectual property considerations and quality related issues using the problems regarding access and affordability posed by high prices, weak drug regulatory infrastructure and other capacity constraints. 

On WHO’s relationship with IMPACT, India noted that IMPACT “has shifted its office out of the WHO and relocated to Italy.  We continue to hold the view that IMPACT has a predominant IPR agenda and has no mandate to be associated with the WHO in any way.  The WHO should therefore, terminate any remaining links with IMPACT if it has to pursue its global public health mandate with undivided attention. We understand that such an action should not be procedurally difficult since IMPACT’s creation or bringing it into the WHO was not based on the decision of WHO governing bodies but was taken by the WHO Secretariat”. 

India also explicitly called on the WHO Secretariat “to terminate all WHO relations with IMPACT till the outcome of Working Group is finalised and its recommendations are endorsed by the 65th World Health Assembly”. Such measures should include, inter alia, removal of the WHO’s logo from IMPACT communications and their website, it added. 

India also cautioned WHO that IPR enforcement should be kept outside the scope of WHO’s work on QSE of medicines.  

It also expressed serious concerns on “TRIPS-plus” intellectual property enforcement initiatives in multilateral fora, plurilateral agreements such as the Anti-Counterfeiting Trade Agreement (ACTA) as well as negotiation of IPR Chapters in RTAs because these initiatives create impediments to access to affordable medicines. 

It also added that SEARO countries did not wish to embark on another arduous exercise to replace ‘counterfeits’ with another contentious term which may not be understood uniformly by all Member States since Member States use different terminologies to identify medical products of compromised QSE.  

Thus India and others need to leave to national authorities the task of interpreting what QSE means in the context of their national standards and determining appropriate terminology rather than the WHO prescribing a terminology.

It further said that SEARO countries were convinced that the only way to deal with medical products of compromised QSE is to strengthen drug regulatory authorities (DRAs). 

It also urged the Working Group to draw up a clear schedule for meetings so as to conclude its work and report to the 65th WHA through the 130th session of the Executive Board, while strongly recommending that the next meeting take place in June 2011.  

India also urged Member States to deliberate in the Working Group the possible establishment of a Member State driven mechanism within the WHO to deal with QSE issues, including, strengthening national drug regulatory authorities.  “Such a mechanism (i) should be drawn up in a transparent manner, (ii) should avoid conflicts of interests, (iii) should be Member State driven, and (iv) should have a clear mandate from the WHO governing bodies”, it added. 

Uruguay speaking on behalf of the UNASUR (Union of South American Nations) countries said that while combating counterfeit medicines was a priority, (member states need) to ensure that such initiatives to combat counterfeits do not undermine the universal access to needed medicines. 

Tanzania speaking on behalf the 46 Member states of the African Region noted that SSFFC medical products constitute a major public health concern for the WHO and its Member states. It further said that “the illegitimate manufacture, distribution, widespread availability and indiscriminate use of these products is detrimental to health and may lead to therapeutic failure, exacerbation of diseases, disability and injury, waste of scarce resources, loss of confidence in health care systems and death”.

Tanzania agreed that while the magnitude of the problem is not exactly known, the existence of even one case of these medical products was unacceptable.

Further Tanzania said that the problem occurs predominantly in the context of poor legislation together with inadequate enforcement of existing legislation and absent or weak national medicines regulatory authorities. It also cited the high cost of medical products as one of the reasons for the circulation of SSFFC.

Thailand said that WHO’s role on the SSFFC medical products should be solely concentrated on its primary mandates on public health; and WHO should not get involved in the  issues of IPR related to counterfeit medical products.

It added that collaboration between WHO and IMPACT results in lack of confidence and trust in the organization by some Member States and stressed that collaboration with outside entities should be handled with care, transparency and avoidance of conflict of interest.

Thailand went on to recommend that, “WHO suspends all its relations with IMPACT until the outcome of the Working Group is finalized and its recommendations are endorsed by the (65th WHA session". 

Kenya also demanded the disassociation of WHO from IMPACT. 

Hungary on behalf of the EU, said that QSE of medical products should be a priority in global health policy adding that the market of falsified medicines is a global one, involving both generic and branded medicines. 

On IMPACT Hungary, while acknowledging concerns raised by some member states regarding the governance of IMPACT, said that IMPACT has proved to be efficient. It added that the issue of definitions, and the relationship between WHO and IMPACT needs further reflections. 

Hungary further acknowledged that the problem of SSFFC is multi-layer and extends from essential policy questions around availability and affordability of quality medicines to criminal activities by people who deliberately produce falsified medicines with the aim of making money, regardless of the public health consequences. It further stated that EU did recognise that strengthening national regulatory capacity to monitor the quality of medicines in circulation within a country is necessary. 

Hungary also pointed out that questions around high quality and affordable medicines are crucial and are being addressed appropriately at several other places within WHO and it complements the Working Group’s discussion on SSFFC. It also said that the Working Group’s focus should be on efforts against falsified medical products and their production from a public health perspective detached from issues related to infringement of intellectual property. Further it said that “WHO and Member States should also concentrate on improving the QSE of medicines from producers who have the aim of producing legitimate products but do not have the skills or means to succeed in doing so.”

Brazil expressed its regret for the delayed beginning of the Working Group’s deliberations by almost nine months. It also reiterated its “belief that an intergovernmental group, operating in full transparency, is the only possible way to restore mutual trust and to set the basis for a strong WHO response to fake medicines”.

Kenya stated that the term counterfeit is related to intellectual property and goes beyond public health. It also expressed fear that generic medicines might be equated with counterfeit medicines and called for strengthening of the regulatory framework. 

Sri Lanka said that “WHO needs to be cautious not to allow any intellectual property rights enforcement agencies, such as IMPACT, to affiliate their work with the WHO, including the use of the WHO logo in communication materials”. It also noted that “the focus of the working group should also be to capture as to how to enhance the developing country capacities to enhance the production of quality generic drugs through technology transfer and financing”.

The US expressed its support for IMPACT. Further it also said that the extension of the duration of the Working Group does not alter the original nature of the working group as stated in WHA 63.10 i.e. a time limited and result oriented working group 

France said that combating counterfeit does not affect trade in generic products, further adding that falsified medicines are not generic medicines. It also supported the work of IMPACT adding that the multi-disciplinary approach of IMPACT should be preserved.+