MSF | 29 May 2017
MSF response on the India-EFTA free trade agreement negotiations in Liechtenstein this week
Background
On 30 May 2017 (Tuesday), trade talks will resume for the India-EFTA (European Free Trade Association) free trade agreement (FTA) in Liechtenstein, between India and the EFTA countries of Switzerland, Norway, Iceland and Liechtenstein. Through this deal, Swiss pharmaceutical corporations are working to erode India’s ability to produce and supply generic medicines for people across the developing world. The proposed provisions in the FTA would promote a strategy that pharmaceutical corporations use to prolong their monopolies, called ‘evergreening.’ 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 a medicine is not patented or no longer patented.
Pharmaceutical corporations have long been seeking a more extensive granting of patent protection on medicines than that offered by India’s pro-public-health law. In 2006, 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 – see below). In India’s Patents Act, Section 3(d) discourages the granting of patents on new forms of known medicines, effectively preventing evergreening. Abusive evergreening practices and safeguards to prevent them were central to this case, and to the future of India’s role as ‘pharmacy of the developing world. ‘Novartis lost in India’s Supreme Court in 2013.
MSF relies heavily on affordable generic medicines from India to do its medical work around the world. Two thirds of the medicines MSF uses to treat people with HIV, tuberculosis and malaria are generics made in India. Fierce market competition among generic manufacturers in India resulted in the price of HIV medicines coming down by nearly 99%, from $10,000 per person per year in 2000 to around $150. Ten years later – today, treatment is available for less than $100. This has allowed HIV treatment to be dramatically scaled up, with more than 18 million people receiving antiretroviral therapy today.
MSF quote:
“India’s patent law puts people’s lives over pharmaceutical corporations’ profits, and millions of people across the developing world are alive today because of affordable generic medicines made in India. Swiss pharmaceutical corporations have long been trying to stamp out the competition from India, and now through the EFTA-India trade deal have enlisted the Swiss government to their bidding. By pushing for so-called ‘data exclusivity,’ pharmaceutical corporations are trying to get a backdoor route to a monopoly, even when a drug doesn’t merit a patent under India’s law.
We urge the Indian negotiators to stand strong and reject any provisions that will be harmful for people’s access to the medicines they need to stay alive and healthy.”
Leena Menghaney, South Asia Head, MSF Access Campaign
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 who 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.