New Delhi: Three of the key government departments involved in free trade agreement (FTA) negotiations with European countries appear to be not on the same page on provisions under discussion that directly relate to pharmaceutical products, ThePrint has learnt.
India and the four countries that form the European Free Trade Association (EFTA) — Iceland, Liechtenstein, Norway, and Switzerland — are negotiating a Trade and Economic Partnership Agreement (TEPA), with an aim to boost economic ties.
India has also been holding trade negotiations with the US, the UK and the European Union (EU) over the last several months, but the agreement with the EFTA is likely to be finalised this month.
Last month, at least two meetings — as part of the negotiations with the EFTA — were held where representatives of the Department of Industry and Internal Trade Promotion (DPIIT) under the Union Ministry of Commerce and Trade, the Ministry of Health and Family Welfare, and the Department of Pharmaceuticals (DoP) were present.
Representatives of the Organisation of Pharmaceutical Producers of India (OPPI), which represents multinational drugmakers, and the Indian Pharmaceutical Alliance (IPA), a network of research-based Indian pharma companies, were also invited for the meetings.
The differences, it is learnt, are primarily regarding demands from pharma companies in Switzerland and Norway.
“Following the meeting, the DPIIT has supported several provisions of TRIPS-plus that the foreign pharma companies are pushing for; but the health ministry and the DoP are opposing them,” said a senior government source who was present in the meetings.
TRIPS-plus is an informal term for protection of intellectual property (IP) rights that goes beyond the requirements of the trade-related aspects of IP rights (TRIPs) agreement. These are norms for higher levels of protection, advocated by the developed countries but not prescribed by the World Trade Organisation (WTO)’s TRIPs regime.
India is WTO-TRIPs-compliant and, as of now, the provisions under the country’s Patents Act, 1970, are aligned with the regime.
A second official present in the meetings told ThePrint that the reservations expressed by some government departments on the proposed clauses are on the grounds that they will hamper patients’ access to life-saving drugs, and also hurt the local pharmaceutical industry.
“While the foreign drugmakers stand to gain from the proposed provisions, there seems no benefit to India from the suggested clauses,” the second official said.
Among the provisions being pushed by foreign pharma companies is introduction of the regulatory data protection (RDP) system, also known as “data exclusivity” for new drugs.
This protection ensures that a drug regulator cannot rely on the originator company’s data for approval of a second and subsequent manufacturer’s application for a specified period from the date of marketing approval to the innovator.
Explaining its implications, a health ministry official said the Central Drugs Standard Control Organisation (CDSCO) “at present does not recognise the Patents Act, and approves bridging studies and market authorisation even for drugs under patent to non-innovative companies based on the scientific evidence”.
“Once the regulatory data protection system is introduced in India, this could change,” the official added.
The official said this will delay the launch of generic drugs in the market even after a patent on a drug by a foreign company expires.
The sources cited above also said that the DPIIT is in favour of extending data exclusivity for biologics — a relatively newer class of medicines that are made using living cells that require complex manufacturing and special handling processes.
If India agrees to the provisions such as RDS, it will need to align its patent norms accordingly.
ThePrint reached DPIIT secretary Rajesh Kumar Singh, health secretary Apurva Chandra and DoP secretary Arunish Chawala over email, text messages and calls, but got no response. This report will be updated if and when a response is received.
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Split views
When contacted, the OPPI told ThePrint that the association and its member companies were given an opportunity to submit their perspective, on behalf of innovative pharma companies, on the EFTA TEPA text on the protection of undisclosed information.
“OPPI expressed its support for creation of an innovative ecosystem in the country and sought to clarify that RDP is not just for MNC pharma companies but it will particularly help in spurring innovation in AYUSH, phyto-products that are not permitted patent protection under the Patents Act, 1970, as investments in development of products that do not otherwise qualify for patents, can also benefit from market exclusivity for a certain period,” said OPPI director general Anil Matai.
It goes without saying, he added, that the innovative biopharmaceutical industry uses its scientific and technical expertise to research, develop, manufacture and distribute safe and effective treatments and vaccines to patients around the world.
“This applies not just to MNC pharma companies alone, but also to Indian pharma innovators — and quite a few Indian companies have supported India agreeing to provide RDP to encourage innovation in the country,” he added.
Matai also said that OPPI member companies believe that it is the right time to extend RDP to biologics, as understanding of genetics and molecular biology has grown exponentially in the last couple of decades.
But IPA secretary general Sudarshan Jain countered the claims, stressing that the RDP-related provisions, once introduced in the country’s patent norms, will prove detrimental to India’s drug industry and patients.
“India continues to be the pharmacy of the world, and we want patent norms to exist the way they are currently because any change will not only impact the way crucial drugs are accessed in India but across the world,” he said.
His opinions were echoed by K.M. Gopakumar, legal adviser and senior researcher at Third World Network, a group of organisations that works for promoting the causes of developing countries. Gopakumar said the patients will be the biggest sufferers.
“A number of life-saving drugs, when under patent, remain unaffordable to Indian patients. Once the patent norms get tougher, the patients will suffer even more,” he added.
Indian drugmakers, last year, wrote to the government, asking it to decline the terms suggested by foreign pharma firms.
(Edited by Sunanda Ranjan)
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