Posted by: davidjolson | 05/22/2010

Counterfeit medications: Who should police them?

This is a guest blog of Rachel Irwin, PhD candidate of the London School of Hygiene and Tropical Medicine, a research assistant at the London School of Economics and a member of the Global Health Council delegation to the 2010 World Health Assembly.

FRIDAY UPDATE TO BLOG POST BELOW: After several round of negotiations and draft proposals Friday, Committee A concluded that the best way forward was to create an open-ended working group to discuss public health issues relating to counterfeit medications (but not intellectual property or trade ones) and to report back to the 64th World Health Assembly in May 2011.

GENEVA, Switzerland – Questions of global (health) governance and the World Health Organization are not new and were exemplified by Wednesday’s passionate discussion on counterfeit medication, which proved how exciting the process of global health diplomacy can be here at the 63rd World Health Assembly.

India started off the debate, calling for the WHO to differentiate between the notions of “counterfeit” on one hand and “quality, safety and efficacy” (QSE) on the other. General consensus amongst developing countries is that the former is an intellectual property (IP) issue outside the public health remit of the WHO and best left to institutions as the World Trade Organization and WIPO (World Intellectual Property Organization). The WHO should instead focus, they say, on QSE. The overall concern is that the WHO will be the WTO’s handmaiden and that IP concerns will negatively impact upon access to medication.

The thing is, if framed and negotiated properly, this could be one in which trade and health interests actually work together. No one wants counterfeit medications and, as the representative from the International Federation of Pharmaceutical Manufacturers and Associations noted, counterfeiters target both branded and generic medications.

India and all delegates are  definitely correct in that we need a standard definition of “counterfeit.” And WHO Director-General Margaret Chan made it clear that the WHO’s competency and mandate is a public health one, not a trade one.

However, I argue that we cannot separate out these issues of public health, IP and the policing of counterfeit medications. They are just too inter-related.  The Spanish delegate, speaking on behalf of the European Union, said that the WHO should continue to serve as an umbrella under which these issues are discussed (as in IMPACT, an anti-counterfeiting task force that brings the key international stakeholders together).  Yes – IMPACT may or may not be the best way to do this (and there were calls in the debate for WHO to “divorce” IMPACT) but  – although the WHO is not an IP or trade organisation, if it steps out completely of the non-public health aspects of counterfeiting, it risks allowing WTO, WIPO and others to overstep their bounds into health territory.

At the moment, countries are in considerable disagreement on how to proceed and the matter is suspended while a small working group is meeting on the issue. However, reporting live from Committee A at 19:32 Geneva time – many countries and the WHA president are confused on what this small group is actually discussing and we’re waiting to to hear back from this group (or apparently several

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