The World Health Organization-led working group of member states on “substandard/spurious/falsely-labelled/falsified/counterfeit” (SSFFC) medical products has reached consensus on a new mechanism to prevent and control SSFFC medical products and associated activities. The creation of the new mechanism comes as the future of WHO involvement in an interagency anti-counterfeiting taskforce is in question.

The SSFFC working group met behind closed doors from 25-28 October at the WHO, reaching a late-night agreement on the last day of the meeting.

Chaired by Zambian Ambassador Darlington Mwape, the working group agreed upon a draft resolution with an annex including mechanism goals, objectives and terms of reference. The working group also produced a report on its work.

Advanced, unedited versions of the SSFFC documents are available here: SSFFC Draft Resolution [pdf], SSFFC Draft Resolution Annex (goals, objectives, TORs) [pdf], and Working Group Report [pdf]

These will be presented at the next regular World Health Assembly Executive Board meeting on 16-23 January [note: this week’s WHO Executive Board meeting is an exceptional gathering on WHO reform]. The proposal would then go to the annual World Health Assembly in May for final approval (IPW, WHO, 24 May 2011).

According to the draft resolution, the new member state mechanism on SSFFC will be open to all member states and “should include expertise in national health and medical products regulatory matters.” In general, the draft mechanism documents show an effort to broaden participation of governments in WHO activities related to this problem, with increased transparency and reporting.

The mechanism is intended to focus on public health, “excluding intellectual property and trade considerations,” according to the resolution.

Saving Definitions for Later

Not only is SSFFC difficult to say, it is also difficult to define. This is another point that the group agreed upon in their deliberations. In fact, one of the new mechanism’s objectives is “to further develop definitions of SSFFC medical products.” For now, the mechanism is directed to use the term SSFFC until the governing bodies have agreed upon a definition.

For the sake of key working definitions, the WHO defines substandard medicines as “products whose composition and ingredients do not meet the correct scientific specifications” while counterfeit medicines are “deliberately and fraudulently mislabelled with respect to identity and/or source.”

Irrespective of the terminology, SSFFC medical products are a problem that the WHO has made a priority of addressing. At the working group’s first meeting on 28 February 2011, WHO Director General Margaret Chan said in her opening remarks: “The first priority for public health, and priority for the WHO, is to protect populations from the harm caused by poor-quality, unsafe medicines. The objective is to keep these harmful products off the market everywhere, but especially in the developing world.”

A Concerted Compromise

Governments from both developing and developed countries stress that this mechanism should promote the quality, safety and efficacy of medicines rather than focus on fakes. A developed country delegate outside of the meeting said, “This is not about counterfeits, copies or fakes. This is about intentionally harmful fakes that are inefficacious, that can build virus resistance or that can be deadly.”

Although there was a clear consensus on the mission of keeping harmful medical products off the market, questions were raised on how best to address the problem. According to sources, one of the main questions was how and to what extent the new mechanism should address issues related to access and availability of medicines.

A delegate from a least developed country said, “It is important to look at the whole picture and not just part of it. The problem of access and affordability of medicines in countries leaves a vacuum. And it’s because of this vacuum that we have the problem of SSFFC.”

The debate did not fall along clear developing/developed country lines. During the last day of the meeting, the African Group submitted a proposal [pdf] of six objectives that did not include issues related to medicine access or availability. One delegate explained that there are other avenues available to improving access to medicines and that this mechanism is meant to assure quality, safe and efficacious medicines and to protect people from the risks of SSFFC.

In the end, both access and availability were included in the working group’s draft resolution. The mechanism’s goal is in part “to protect public health and promote access to affordable, safe, efficacious and quality medical products.” One of the objectives calls for strong collaboration between the new mechanism and “the work of other areas of WHO that address access to quality, safe, efficacious and affordable medical products.”

IMPACT’s Uncertain Future

Outlined in the agenda, the SSFFC working group also addressed the WHO’s relationship with the International Medical Products Anti-Counterfeiting Taskforce (IMPACT). The WHO launched the taskforce in February 2006 in response to the increasing public health problem of counterfeit medicines. According to IMPACT’s website, IMPACT is a partnership of all of the “major anti-counterfeiting players” tasked to “halt the production, trading and selling of fake medicines around the globe.” IMPACT includes the international police agency Interpol, among other organisations.

The taskforce has incurred criticism from a number of stakeholders including the non-governmental Third World Network, Affordable Medicines for Africa, and OXFAM. At the outset of the meeting, over 50 NGOs issued an open letter [pdf] to the SSFFC chair, calling for the WHO to disassociate itself from IMPACT. The letter raised a number of concerns including “the role played by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) in IMPACT’s activities, the lack of transparency surrounding IMPACT’s activities, and lack of accountability as IMPACT has operated outside the purview of WHO member states.” It also took issue with the taskforce’s role in matters related to anti-counterfeiting and IP enforcement.

Although the SSFFC reviewed the WHO’s current and future relationship with IMPACT, no decisions were made. According to the meeting report, “There were divergent views expressed with regard to WHO’s involvement in the Taskforce” and that “a way forward on this specific issue could emerge when the new mechanism is considered.”