India has told the World Health Organisation (WHO) to confine itself to pronouncing on public health issues and not get involved in official attempts to define “counterfeit” drugs.
The definition of “counterfeit” being proposed by the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) – a global coalition established by WHO in 2006 – is opposed by India and a number of Latin American and Southeast Asian nations because, they say, it confuses quality and intellectual property rights (IPR) issues and could therefore harm the legitimate generics trade between major producers such as India and developing nations.
However, WHO is attempting to get its members’ approval of the IMPACT definition at the upcoming World Health Assembly in Geneva, Switzerland, May 17-22.
At a meeting in Geneva last week, India’s Permanent Mission to the World Trade Organisation (WTO) told WHO to confine itself to its “mandate on public health and [its] role in strengthening national health surveillance systems…and not associate itself with IMPACT.”
The Mission added that IMPACT should be working with the WTO, the World Intellectual Property Organisation (WIPO) or the Anti-Counterfeiting Trade Agreement rather than with WHO, and that the latter organisation should stick to dealing with quality issues.
India – which is currently undertaking major initiatives to raise awareness among African nations of the quality of Indian-made generics and counter what it calls “propaganda” against its export trade – said last week that it is ready to file a complaint against seizures of Indian-made generics bound for developing nations while they are in transit in the European Union (EU), just as soon as Brazil receives the necessary approval to jointly submit the complaint.
Last year’s assurances by EU Trade Commissioner Katherine Ashton that the disputes would be resolved without the need for WTO involvement have not been met, a government official told the Economic Times of India.
“We are very clear that customs officials in the EU countries bent WTO rules when they seized good-quality off-patent medicines being shipped from India. We won’t have a problem proving our case,” the official said.
Other pro-generic initiatives include a Special Bulletin on the Indian Pharma Industry produced by Pharmexcil, the Indian government’s pharmaceutical exports promotion council, which will be included with the May issue of the journal Africa Health and also distributed widely throughout Africa for free.
The government is also setting up trade delegations and conferences to promote Indian generics; one such meeting in Kenya last week heard India’s Deputy High Commissioner Dr Ketan Shukla describe plans to connect wireless networks across Kenya to expand India’s generic drugs business there.
Also in Kenya, HIV/AIDS patients have asked the Constitutional Court to overturn the controversial Anti-Counterfeit Act because they say it fails to acknowledge and exempt generic drugs from the definition of counterfeits, in accordance with WTO requirements, and this is denying them access to affordable essential drugs.
Moreover, they say, the Act gives the Kenya Revenue Authority “excessive powers that may be abused,” because officials lack the expertise to distinguish genuine generics from counterfeit drugs, and it could also allow them to seize parallel imports, which were made legal in Kenya in 2001.
The Court is due to give its decision on April 23.
