The WHO’s Complex Path On Counterfeiting, R&D Financing, Pandemics

The World Health Organization is following a complicated timeline for new mandates on combating fake medicines, creating alternative financing mechanisms for research and development on neglected diseases, and improving pandemic influenza preparedness.

WHO members at the annual World Health Assembly in May increased their involvement in several critical processes at the UN agency, creating a new landscape for addressing the issues, resulting in a multidimensional roadmap ahead. The Assembly outcome placed health topics deemed too political for the secretariat into the hands of several newly-created working groups including member states. Secretariat support is required to run these groups.

The timeframe for these groups is outlined below.

 
Recommendations on Fake Medicines in 10 Months

The dispute regarding the term ‘counterfeit’ arose from the fear that its use, in relation to medicines, would create confusion and risk prioritising intellectual property enforcement over health. This fear was reinforced by seizures of generic medicines in transit by the European Union, which eventually resulted in dispute settlement cases before the World Trade Organization. The final decision was called substandard/spurious/falsely-labelled/falsified/counterfeit medical products WHA 63(10).

The International Medical Products Anti-Counterfeiting Taskforce (IMPACT), a WHO initiative in conjunction with Interpol, has been working on a strategy to combat ‘counterfeit medical products’. IMPACT has been criticised by developing countries and civil society for having strong ties to those advocating higher levels of IP enforcement, beginning with a report submitted in January 2009 to the WHO advisory Executive Board. These concerns eventually led to an intense debate at the WHA, however, an agreement was reached on a way forward.

Governments agreed to the establishment of a time-limited working group of member states and instructed the director general to convene and facilitate the work of this working group.

The path adopted by governments is primarily focussed on procedure. This may be a result of the great number of divergent views expressed in the different proposals and by governments during the WHA. This divergence can be seen in a statement made by Brazil and the response of the European Union. Some countries seem to be “trying to disguise trade and commercial interests under public health,” the Brazilian ambassador told a committee on the counterfeit issue at the WHA (IPW, WHO, 20 May 2010).

The Brazilian government also questioned the close relationship between WHO and IMPACT, a concern held by a number of developing countries. Spain, on behalf of the EU, defended the work of IMPACT as essential to protect the public from dangerous products.

The focus of the working group will include the following topics, according to a copy of the decision available here [pdf]:

• WHO’s role in measures to ensure the availability of quality, safe, efficacious and affordable medicines;
• WHO’s relationship with International Medical Products Anti-Counterfeiting Taskforce;
• WHO’s role in prevention and control of medical products of compromised quality, safety and efficacy such as counterfeit medicines from public health;
• Addressing the issues raised by the proposals submitted by the Union of South American Nations, the African Group, and India and Thailand.

Reconciling these four proposals will be one of the challenges facing governments after the procedural steps of this resolution have been carried out. For example, the African Group proposal says that counterfeit medicines create a massive problem, needs immediate addressing, whereas UNASUR focuses more on the fact that counterfeit terminology, according to them, fails to address real public health concerns and is in fact detrimental.

A WHO source told Intellectual Property Watch last week that governments are “currently discussing what they want to do amongst themselves,” including deciding whether or not to be involved.

Timeframe for Working Group

128th Executive Board Meeting: 17-25 January 2011	Progress report on establishment of working group
64th WHA 16-25: May 2011	Report containing specific recommendations

 

New Experts to Find Financing Solutions for R&D

A critical outcome of a 2008 WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property was the creation of an expert working group to find innovative ways to fund research and development to treat diseases disproportionately affecting the poor.

However, almost from the outset this group was plagued with suspicion, as governments and civil society groups questioned the transparency of its processes and its influences from pharmaceutical stakeholders. Many governments could not accept its final report, and at the WHA decided to establish a second working group – with more member state control – to take the issue forward. The agreement to establish this new Consultative Expert Working Group (CEWG) is contained in resolution WHA 63.28, available here [pdf].

Following the resolution on the establishment of the CEWG on research and development, the WHO has made available online information regarding the working of the previous expert working group (EWG), including: all proposals it considered including their source and their authors; criteria used to assess the proposals; the stakeholders that were interviewed and the sources of the statistics used.

The DG must establish a CEWG to take the work of the EWG forward. The CEWG is tasked with conducting a deeper analysis of all proposals of the EWG as well as any new proposals submitted. During this analysis, the CEWG must examine the appropriateness of different R&D financing approaches and the feasibility of their implementation. A notable addition was 2(e) which requires the CEWG to observe scientific integrity and to be free from conflicts of interest in its work.

Governments are tasked with nominating experts with which to establish a roster that should be submitted by the regional directors. After the Executive Board in May 2011 has approved the composition of the group of experts, the director general must establish the group and facilitate its work. During the CEWG’s work, the director general is required to provide governments with regular updates on the implementation of its work plan and make available all documents used at the conclusion of the process.

Timeframe for CEWG

End of June 2010	Director General to provide materials used by EWG
129th Executive Board Meeting: 12-13 May 2011	Work plan and inception report submitted
130th Executive Board Meeting	Progress report
65th WHA in 2012	Final report submitted

 

Another Try on Pandemic Influenza Preparedness

After the outbreak of avian flu in 2005, the WHO created an intergovernmental working group in order to develop systems to be prepared for further outbreaks of pandemic influenza. However, the working group failed to complete its work due to disagreements over a number of areas, including how to deal with the intellectual property aspects of the agreement and the text of a Standard Material Transfer Agreement for the exchange of pandemic related materials. Thereafter, the director general attempted to finish this work but was also unsuccessful. Governments then proposed another open-ended working group meeting before the May 2010 WHA in an attempt to finish; unable to do so, they suggested continued meetings of the working group for another year (IPW, WHO, 14 May 2010).

At the recent WHA, governments requested the director general to support the work of the Open-Ended Working Group, and decided the Working Group will report through the Executive Board, at its 128th session, to the 64th WHA. The resolution is available here [pdf].

Timeframe for Open-Ended Working Group

128th Executive Board: 17-25 January 2011	Progress report on completing the framework for preparedness
64th WHA 16-25: May 2011	Report submitted

 

Kaitlin Mara contributed to this article.
Emma Broster is an intern with Intellectual Property Watch.