WHO can't shake off counterfeit drug controversy

Globe with capsulesThe World Health Organization (WHO) has come under fire for allegedly blocking the attendance of non-governmental organisations at its latest meeting on counterfeit and otherwise illegal medicines in Buenos Aires.

The complaint has been raised by a group of academics led by Professor Amir Attaran from University of Ottawa, Canada, who have called for an international treaty to tackle the trade in what the WHO currently refers to as substandard/spurious/falsely-labelled/falsified/counterfeit medical products.

The latest development comes against a backdrop in which efforts to coordinate an international, regulatory or legislative response to medicines counterfeiting have been routinely undermined by political and commercial in-fighting.

Attaran claims that NGOs are being kept away from the WHO meeting at the request of India, although India's Health Ministry has denied the accusations. Another NGO - the World Federation of Public Health Associations - also says it has been excluded from the meeting.

The WHO's executive board adopted a resolution earlier this year to set up a member state 'mechanism' to tackle the trade in counterfeit medicines from a public health perspective and without any consideration of intellectual property (IP) issues.

Last year, the WHO agreed to set up the intergovernmental working group to look into its handling of SSFFCs amid claims that counterfeits and legitimate generics were being conflated by those pursuing an IP rights agenda.

The Buenos Aires meeting is the first to be held since the mechanism was proposed, and has been convened to make decisions on the structure and governance of the platform. The agenda and documents from the ongoing meeting are available here.

Meanwhile, Attaran et al make the plea for an international treaty in the British Medical Journal (BMJ), in which they write that "the twin challenges of safeguarding the quality of genuine medicine and criminalising falsified ones has been held back by controversy over intellectual property rights and confusion over terms".

The international treaty should follow similar lines to those already in place to help fight counterfeiting of banknotes since the 1920s, and the recently-agreed Framework Convention on Tobacco Control (FCTC) that will "legally mandate global tracking and tracing for tobacco products and internationally criminalise illicit trade".

Among the measures proposed are a clear definition for the different types of illegitimate medicines - an attempt to tackle the oft-repeated claim that in some cases legislation confuses the term counterfeit with legitimate generic medicines - and the drawing up of specific crimes in international public health law on the manufacture, trafficking or sale of falsified medicines.

The academics also call for intergovernmental cooperation on the reporting, investigation and prosecution of falsification cases, including seizure of criminals' assets, and the drawing up of standards to assist in the creation of a track-and-trace system for medicines.

"WHO's member states should ask WHO staff to embark on a similar process to that which created the FCTC," write the authors of the article.

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