Counterfeit drug debate heats up at World Health Assembly

As expected, member states including Brazil, India and Thailand urged the World Health Organization to step back from its role as secretariat of the IMPACT initiative against counterfeit medicines at the World Health Assembly this week.

As reported last week, the countries disagree with the WHO's working definition of the term 'counterfeit', which they maintain is being confused with intellectual property rights (IPR) issues, preferring instead terms such as 'falsely labelled', 'spurious' and 'substandard'.

They also say there is a conflict of interest with WHO's involvement in IMPACT as the group also includes representation from the research-based pharmaceutical industry in addition to regulators, customs and other national and transnational bodies such as Interpol.

The controversy has been fuelled by several cases in which generic medicines en route from India to markets in Latin America were detained by customs whilst in transit through the EU - allegedly at the request of pharmaceutical brand owners - on the grounds that they were suspected counterfeits and/or violated IPR. Last week, India and Brazil filed complaints to the WTO over the issue.

India, Brazil and Thailand are claiming that there is a hidden agenda at IMPACT to safeguard the rights of brandname drug manufacturers and inhibit the trade in generic medicines, even in parts of the world where there is no effective IP protection. As a result people in the developing world are at risk of losing access to essential drugs, they maintain.

What is clear is that the debate over IMPACT and the WHO's role within it is becoming polarised, with developed world countries largely in favour and a block of developing nations taking the opposing view.

A joint draft resolution proposed at the WHA by India and Thailand urges the WHO to abandon IMPACT and set up a separate programme to tackle the quality, safety and efficacy of medicines without any element of IP protection.

They ask WHO Director General Dr. Margaret Chan to set up an intergovernmental effort on fake medicines which is "evidence-based, transparent and member-driven," and to provide support to member states in strengthening their national drug regulatory authorities with a focus on "capacity, technical knowledge, infrastructure, facilities, and ... robust systems."

That in itself is no small task. WHO estimates that one third of all its member states have no regulatory agency for medicines in place at all, while in another third the regulatory function is understaffed, underfunded and unable to carry out its role effectively.

The also ask for support on the development of techniques for testing fake medicines, something which is currently handled by IMPACT's Working Group on Technology.

The WG is currently working on a diverse set of topics, including updating a WHO guide to anti-counterfeiting technologies to include tamper-evident closures, drawing up a checklist for enforcement agencies on fast-tracking authentication of suspect counterfeit pharmaceuticals, and undertaking a comparative analysis of different field testing techniques.

The topic remains on the agenda for today's WHA session.


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