India seeks new WHO policy for fake drugs

Written by Soma Das | New Delhi | Updated: May 21 2010, 03:39am hrs
The government has urged the World Health Organisation (WHO) to address the issue of spurious, substandard drugs through an effective alternative instead of confusing it with the 'counterfeit medical products'.

Basically the government has proposed to the WHO that the term counterfeit shouldnt be used as an equivalent of fake or spurious drugs. The term 'counterfeit' instead relates to IP infringement. The existing forum within WHO to deal with issues related to anti-counterfeit medical product is called International Medical Products Anti Counterfeiting Taskforce (IMPACT). Neither the anti-counterfeiting taskforce, nor its terms of reference have been approved by any governing body of WHO, the government argues in the proposal it is tabling at Geneva where the World Health Assembly is being held.

Additionally the proposal has also raised the question of the conflict of interest in the task forces composition. The civil society has been raising this issue in last few years, raising their decibel in the run upto the meet.

Days before the meet started, a letter signed by over 40 civil society groups urged the WHO to distance itself from the IMPACT, citing the task forces links to pharma industry bodies from the regulated markets and other groups raising issue of conflict of interest. Among the requests India has made to Director General of WHO, it has asked the proposed new programme to deal with the spurious and substandard drugs that, avoids conflicts of interests, is evidence-based, transparent and member driven.

A similar proposal is being pushed by a group of Latin American countries, which has floated the idea of an intergovernmental working group with participation of member states and secretariat to prevent and control falsified medical products (spurious drugs) from a public health perspective, excluding commercial and intellectual property considerations.

Definition of counterfeit trademark goods in the TRIPS agreement includes trademark violation. IP related violations in case of drugs are currently being confused with spurious or substandard drugs, at times bringing perfectly legitimate generic drugs under the counterfeit umbrella, labeling them illegal. Such actions hamper access to affordable medicines, says the government citing the examples of in transit drug seizures that Indian companies had to face in select European countries, primarily Netherlands.

India, along with Brazil have recently moved to WTO to settle the issue. The discussion on counterfeit medical products which figures in the agenda of World Health Assembly and is likely to come up for discussion either on Wednesday evening or Thursday.

In a related development the union health minister Ghulam Nabi Azad, who is representing India in the meet stated that the Indian vaccines industry is producing h igh quality vaccines at affordable prices for the domestic and the global market. He added that it is important for the WHO prequalification process to be expedited to further facilitate Indian vaccine manufacturers in playing a vital role in assuring global security of vaccines.

He further emphasised that the WHO needs to steer clear from commercially motivated debates over 'counterfeit' drugs that have only hampered public health by preventing access to good quality low cost generic drugs. "We also need to urgently resolve the deadlock over sharing virus, vaccines and other benefits. We firmly believe that virus sharing and benefit sharing must be on an equal footing," the minister stated.