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India-UK FTA lands in row over patent evergreening

Live Mint - 18 November 2022

India-UK FTA lands in row over patent evergreening
By Priyanka Sharma, Ravi Dutta Mishra

A clause allowing patent evergreening in the India-UK free trade agreement will harm India’s generics industry and the UK’s healthcare service that is dependent on Indian drugs, The Lancet warned, prompting the UK to declare the future of its health service is “not on the table".

Controversy ballooned after a leaked draft intellectual property chapter of the FTA was said to include a clause that would allow British pharma companies to ‘evergreen’ their drug patents. Evergreening is the practice of companies filing for patent extensions by making minor changes to their drugs just before the patent expires at 20 years.

The Lancet, a British medical journal, said such a clause would hurt Indian generic drug manufacturers and create problems for the UK’s National Health Service (NHS).

The journal said the leaked chapter contains 12 Articles that go beyond the requirements of the World Trade Organization’s (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement).

After the Lancet article, a British spokesperson made comments that appeared to go well beyond the routine denials the UK has issued thus far.

“We will never agree any provisions that would increase the cost of medicines for our National Health Service. The National Health Service, its services and the cost of medicines are not on the table. Protecting the National Health Service is a fundamental principle of our trade policy, and our commitment to this will not change during our negotiations with India," a British High Commission spokesperson said in response to a query from Mint.

“We do not comment on the details of live negotiations and will only sign a deal that is fair, reciprocal and ultimately in the best interests of both countries."

The Indian bulk drug industry accounts for a quarter of the price-controlled medicines in the UK and is a lifeline for some of the world’s poorest nations.

Médecins Sans Frontières (MSF), which campaigns on health issues, said the so-called “TRIPS-plus" provisions could undermine India’s public health safeguards by requiring the country to change its national intellectual property and drug approval laws to introduce more monopolies on medicines, The Lancet reported.

“Article E.2.2 of the leaked chapter stipulates that each party “shall" allow a new medical use of a known medicine to be patentable and shall not require a patent applicant to prove enhanced efficacy for a new medical use or a new form of a known substance or the composition as the precondition for patenting," MSF added.

“We have to live with the TRIPS agreement, that is not the issue —the issue is TRIPS-plus demand," said Pradeep S. Mehta, secretary general, CUTS International, a global trade-focussed non-governmental organization.

“In over 100 bilateral investment treaties that the US signed, all of them have TRIPS-plus provisions which has caused problems across the globe. Such provisions are not in the interest of an exporting country like India or of other developing countries."

Médecins Sans Frontières called for the UK to withdraw the chapter completely and for India to make sure that barriers to affordable medicines are not written into the trade pact.

Notably, the Indian commerce and industry ministry has termed the draft intellectual property chapter “distorted and mischievous".

“Branded medicines that are still under patent are relatively expensive. However, generic medicines are cheaper and considered equally effective, as long as quality standards are maintained," said Dr Rajeev Jayadevan, former president of the Indian Medical Association in Cochin.

 source: Live Mint