New intellectual property rights policy a mix baggage for Indian pharma
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New Delhi: Any discussion on intellectual property (IP) in India has implications on its health sector due to numerous legal and regulatory battles between the Indian generic industry and branded drugs produced by multinational companies (MNCs).
Developed countries, especially the US, have been pushing for a tighter patents regime in India in favour of their own MNCs. This context has determined the way the National Intellectual Property Rights Policy, approved by the cabinet last Thursday, has been framed.
Experts believe that the policy shows that the government has not succumbed to demands from the US, but that it should have made the policy more radical to protect India’s generic industry.
“This policy has something for everyone, be it industry, or public, or the US negotiators,” said Biswajit Dhar, professor of economics at Jawaharlal Nehru University, Delhi. He said the policy does not tilt towards any one stakeholder, which is not good news for the Indian generic industry.
“That is an issue which different stakeholders have to be very cautious about. The government is under tremendous pressure to yield to the multinationals. The language of the policy shows that Americans are putting a lot of pressure on the government,” he said
He added that the policy does not say anything about the generic industry. “There has to be a very clear articulation in the interest of the generic industry, which we do not see here,” said Dhar. He added that the best outcome of the policy is that Doha Declaration (of the World Trade Organization, or WTO) is the standard for framing IPR rules in India under an agreement known as the Trade Related Aspects of Intellectual Property Rights or TRIPS.
The policy says, “India shall remain committed to the Doha Declaration on TRIPS Agreement and Public Health.” The Doha Declaration is a 2001 WTO text which recognised that IP and patent regimes have to be weighed against the context of burning health issues like HIV/AIDS, tuberculosis, malaria and other epidemics that primarily affect the developing nations. Through bilateral agreements, developed countries have been trying to extract more than the promises of TRIPs, the agreement on trade-related aspects of intellectual property rights.
“If you combine the finance minister’s speech and the text of the policy, then it is clear that the government is not going to do anything more than TRIPs and that is really good,” said Leena Menghaney, head of south Asia, Access Campaign, Médecins Sans Frontières, an international non-profit.
She said that it means India has successfully resisted demands of TRIPs plus—bilateral agreements that provide for stronger protection for patents—with regard to international pharmaceuticals, i.e. data exclusivity, patent linkage and patent-term extension. She also said that it is laudable that the policy also does not open debate on Section 3(d) of Indian Patent Act, 1970, which is the primary contentious issue between India and MNCs like Novartis and GlaxoSmithKline.
Section 3(d) says that inventions that are discoveries of a new form of a known substance and do not result in increased efficacy are not patentable. Novartis’s cancer drug Glivec and GSK’s breast cancer drug Tykerb were denied patents by Indian courts on this grounds. Had a patent come in place, the medicines would be sold at a price many times higher than what their generic versions by Indian companies cost.
India’s generic industry is also concerned.
Finance minister Arun Jaitley said in a press conference on Friday, “We believe that our existing laws, they are all WTO compliant, and as and when global trends move forward, a continuous evolution of these laws will always be required.”
Commenting on Jaitley’s remarks, D.G. Shah, secretary general, Indian Pharmaceutical Alliance, said, “The word ‘evolution’ is a matter of concern because it has moved in one direction only, pressured by the developed countries. Hence, unless the government is ready with funding and programmes to ensure access to medicine for all, any change in the legislative framework would hurt not only the generic industry, but the people of India.”
A major issue of concern is IP enforcement and linking IP with innovation.
“The policy sees IP as an end in itself. But most of the research in India is conducted in universities which are publicly funded. We cannot give patent for such knowledge to individuals,” said Shamnad Basheer, a legal scholar who runs blog Spicy IP.
Meghaneyl agrees with Basheer.
“There is an overemphasis on IP enforcement. But it does not address the gaps which innovators face in the bio-medical field. The developed countries are not developing medicines for diseases of the third world like malaria. The policy does not help create an atmosphere where Indian companies can develop such medicines. Putting innovation within the framework of IP will not help,” said Menghaney.