India–EFTA trade talks may make medicines more expensive

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MSF | 22 March 2017

India–EFTA trade talks may make medicines more expensive

Geneva/New Delhi, 22 March 2017 - As intellectual property (IP) negotiators from India and the four countries from EFTA (European Free Trade Association) meet in New Delhi this week to resume talks, Médecins Sans Frontières (MSF), International Treatment Preparedness Coalition, and Public Eye warn that Swiss negotiators are demanding the inclusion of harmful intellectual property measures that could adversely impact access to medicines. EFTA is a trade bloc of four European countries outside of the European Union, made up of Switzerland, Iceland, Norway and Liechtenstein.

India has a pro-public-health patent law that has enabled low-priced, generic versions of life-saving medicines to be produced, upon which millions of people around the world rely. Indian generic manufacturers have also innovated to adapt medicines to the specific needs of resource-poor settings, such as three-in-one fixed-dose combination treatments, or special formulations needed to treat children. Competition among generic manufacturers in India has brought the price of HIV treatment down by more than 99%. These factors have revolutionised HIV treatment, allowing it to be expanded to more than 17 million people across the developing world.

“India’s law has long annoyed Swiss pharmaceutical corporations, with Novartis and Roche even having tried to overturn safeguards in India’s patent law and block registration of more affordable versions of medicines in the Indian courts,” said Loon Gangte of the International Treatment Preparedness Coalition. “Swiss pharmaceutical corporations have so far failed to further their strategies to create new monopolies on medicines, but they have now convinced the Swiss government to take up their fight for pharmaceutical profiteering in the India–EFTA trade agreement.”

The proposed provisions – revealed in a leaked intellectual property (IP) chapter of the negotiations – would protect and lengthen ‘evergreening’ monopoly strategies of Swiss and other pharmaceutical corporations, eroding India’s ability to produce and supply generic medicines. The provisions proposed by Swiss negotiators include data exclusivity, a form of monopoly via the regulatory system that prevents the marketing of generic formulations, even when patents no longer apply or exist on the medicine. Corporations could employ this technique to block generic competition from India and thus keep medicine prices high and out of reach of people in developing countries for longer periods of time.

“We are worried that the harmful provisions the Swiss government is pushing for, which go beyond what’s required under internationally-agreed law, will further create exclusive rights for profiteering and serve to undermine what remains of generic competition in India”, said Leena Menghaney, South Asia Head of MSF’s Access Campaign.“We hope that Commerce Minister Nirmala Sitharaman’s commitment to not engage in these excessive provisions, known as ‘TRIPS-Plus’ measures, will remain firm in the EFTA negotiations.”

Generic manufacturing from India has been under constant assault from powerful pharmaceutical corporations, who receive support from countries like the United States, Japan and Switzerland. These governments in turn pressure the Indian government in bilateral trade negotiations to raise the bar of IP provisions, in a bid for an increased number and forms of monopolies.

“We are outraged to see that the Swiss government leading the EFTA trade negotiations attack the pharmacy of the developing world with its actions,” said Patrick Durisch, Public Eye, a Swiss-based organisation focusing on global justice. “Switzerland must respect the right to health and stop exerting pressure on the Indian government to adopt increased levels of intellectual property – over and above what World Trade Organization trade rules mandate.”

Swiss corporations vs. the Union of India

In 2005, in compliance with international trade rules, India began granting patents on medicines but designed its law with safeguards–including a clause known as Section 3(d) that prevents companies from abusing the patent system. India’s strict patentability criteria prevents pharmaceutical corporations from perpetually extending monopolies by gaining patents on modifications to existing drugs.

Seeking a more extensive granting of patent protection for its products than that offered by Indian law, the Swiss pharmaceutical corporation Novartis took the Indian government to court in a long-drawn out legal battle over its 2005 Patents Act (Novartis vs Union of India).

On 1 April 2013, India’s Supreme Court sent a clear signal that the patentability criteria should be strictly applied by patent offices and frivolous patent applications should be rejected. The Court upheld the clause known as Section 3(d) that prevents pharmaceutical companies from abusing the patent system and rejected Novartis’s patent claims on imatinib mesylate (Glivec).

More recently, the Swiss corporation Roche, in an effort to prevent the marketing of potentially affordable versions of a breast cancer drug, claimed it had data exclusivity and copyright on the clinical studies published in its package insert accompanying the pharmaceutical product. The courts dismissed the Swiss firm’s claims and upheld the Indian drug regulator’s approval to competitors to market the cancer drug.

EFTA negotiating text

Leaked document : March 15, 2017 Note by Switzerland on India EFTA TEPA IP Chapter, Knowledge Ecology International available here.

EFTA-India FTA negotiations began in October 2008 and 15 rounds of negotiations have been held to date. Leaked Text : Draft Chapter of IP of India-EFTA FTA is available here.

source: MSF