World Health Organization member states have decided to establish a new mechanism for international collaboration to prevent and control “substandard, spurious, falsely-labelled, falsified and counterfeit medical products” (SSFFC). Excluding trade and intellectual property considerations, this mechanism is called to approach the problem strictly from a public health perspective.

In a committee meeting on the SSFFC resolution on 25 May during the World Health Assembly (WHA), member states showed wide support for the mechanism proposal, adopting it without amendment.

The SSFFC resolution will be submitted to the plenary for approval on the last day of the 65th WHA on 26 May.

The approved resolution was number EB130.R13, available here, which was published in document EB130/2012/REC/1, from the January Executive Board meeting.

A Welcomed New Mechanism

The goal of the mechanism is to “protect public health and promote access to affordable, safe, efficacious and quality medical products, promote, through effective collaboration among member states and the secretariat, the prevention and control of SSFFC medical products and associated activities.”

At least 20 member states and several official World Health Organization (WHO) observers delivered statements on the resolution, widely showing support for this general goal. The European Union, in its statement, said, “It is high time that WHO is active again on this important public health issue.”

Additionally, the EU said it would consider shifting their SSFFC activities to the new mechanism if it is successful in providing “a good, result-oriented platform for coordinated, multi-sectorial cooperation to help prevent falsified medicines from undermining the credibility of our health systems.”

Mario Ottiglio, associate director of Public Affairs and Global Health Policy at the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), expressed his support of the new mechanism. He said, “Fake medicines at best cheat people, at worst kill. It’s a crime against patients and it is only right that we should expect the global health community to tackle it with the same vigour of any other health threat.”

“Patients worldwide are counting on WHO’s leadership to meet their expectations about an agenda that puts their lives and safety at the front through a multi-stakeholder and multi-disciplinary effort,” said Ottiglio.

Developing countries also welcomed the new mechanism and supported its establishment. But several presented concerns in their statements, making note of the areas of contention that remain, and likely foreshadowing some challenges to come.

Foreseeable Challenges

One area of concern mentioned by several members is the current and future relationship between the WHO and the International Medical Products Anti-Counterfeiting Taskforce (IMPACT), which ties WHO to enforcement groups like Interpol.

During its intervention, the delegation of Thailand said, “Good collaboration based on trust and free from conflict of interest among stakeholders at country, regional and global level are required to combat SSFFC. We register our serious concern on the COI [conflict on interest] of R&D pharma membership in IMPACT.”

The statement made by the CMC Churches Action for Health, on behalf of Third World Network and People’s Health Movement, said succinctly, “With the establishment of this mechanism, it is time to dissociate WHO from IMPACT.”

The delegate from Brazil also raised concerns regarding the taskforce. The official said, “The activities carried out by IMPACT and the attempts to redefine the term “counterfeit” – already defined in the TRIPS Agreement – were examples of the lack of clarity between intellectual property aspects and public health collective interests within WHO.”

“These concerns were highlighted by the emergence of numerous anti-counterfeiting measures linked to TRIPS-plus standards and IP enforcement, such as the Anti-Counterfeiting Trade Agreement (ACTA) and the 19 detentions by customs authorities of medicines in transit through the EU,” said the Brazilian delegate. TRIPS refers to the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights.

But Brazil emphasised that the mechanism would operate in a “transparent” manner and would focus on these issues from a “public health perspective.” Additionally, the delegate said that the WHO needs to address the “root problem” that leads to the spread of poor quality medications: “namely the unequal access of the world population to essential medicines.”

Another big issue already facing the new mechanism is the development of definitions related to SSFFC, a point that India raised during its intervention.

The issues raised during the assembly meeting closely reflected the debate that occurred during the SSFFC working group’s meeting, which was held in Geneva last October (IPW, Public Health, 1 November 2012).

The group’s recommendations were transmitted, considered and adopted by the Executive Board at its 130th session in January 2012.

The first formal meeting of the mechanism is set to be held in Buenos Aires, Argentina on 19 November with a preparatory meeting in Geneva. However, the delegation from Nigeria, took issue with the South American location, raising concern over the associated expenses.

In response, Argentina said that it would ensure that no country would be excluded from participation due to financial limitations. The delegate also mentioned looking at specialised fundraising to address the issue.

The working group report is available here.