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LATEST NEWS UPDATES | Strong medicine for poor countries-Nayanima Basu

Strong medicine for poor countries-Nayanima Basu

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published Published on Apr 30, 2013   modified Modified on Apr 30, 2013
-The Business Standard


The Novartis verdict by the Supreme Court emphasised the importance of flexibilities in drug patent laws, in contrast to Western countries which are seeking TRIPS-plus hardening through free-trade agreements

As curtains on the six-year-long legal tussle with Swiss drug giant Novartis AG finally came down earlier this month, the Indian government did not waste a second in hailing the Indian patent law which it said was in "full conformity" with intellectual property rules under the World Trade Organization (WTO), which is referred to as the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement. However, ironically, it was India that had severe objections to the agreement and had accused it of being tilted towards the developed world when it became a signatory to the deal in 1995. Later, in 2005, India amended its patent law to act in accordance with the TRIPS agreement and moved to a regime of product patents. Till then, the country recognised only process patents. In other words, Indian pharmaceutical companies were free to make any medicine in the world so long as they used an unpatented process to do that - even that provision was loosely monitored.

The recent judgment by India's Supreme Court to not grant patent for Novartis' blockbuster cancer medicine Glivec was not only seen as the victory of India's patent law, specifically section 3 (d) which mandates the need for a substantive innovation while deciding on a case for grant of a fresh patent, but it also firmly asserted India's adherence to global IPR norms under the TRIPS deal. Section 3(d) of the Indian Patents Act, the constitutionality of which was challenged in the Glivec case, provides a patenting standard which is fully within the standards laid down in TRIPS. On its part, Novartis had alleged that section 3(d) violated TRIPS in the Madras High Court but did not appeal against the rejection of this argument by the High Court.


* * *

The TRIPS agreement is a "minimum standards agreement" which is designed to provide flexibility for national regulatory systems for intellectual property. The Doha Declaration has further emphasised that public health objectives of members cannot be compromised for intellectual property protection. Thus, it is time that India and other developing countries analyse whether the TRIPS agreement is indeed a powerful tool that guarantees few, if not large scale, safeguards to ward off pressure tactics by the G8 countries, especially the US. These countries are pushing for TRIPS-plus provisions, meaning addition of tougher intellectual property standards that will narrow the flexibilities offered under the existing pact, which further proves the point that the existing agreement is not that bad for developing countries.

"The TRIPS agreement does have flexibilities, but developed countries are trying to erode these flexibilities. Recent trends suggest that developed countries are seeking to raise the bar for intellectual property protection even higher. Instead of maximising public welfare, we are increasingly moving towards a maximalist protection rights culture which almost totally ignores public interest. There appears to be an attempt to curtail, if not totally erode, the flexibilities in the TRIPS agreement," says Abhijit Das, head of Centre for WTO Studies in the Indian Institute of Foreign Trade.

TRIPS flexibilities (like compulsory licenses) are an integral part of the intellectual property architecture and do not face any serious challenge within the WTO at present. The real battleground for circumscribing these flexibilities is the 'Free Trade Agreement' (FTA) negotiations which usually take place among partners with unequal strength - a case in point being the bilateral trade pact that is currently being negotiated between India and the European Union. Under the talks, EU has apparently demanded for certain tightening of intellectual property protection norms, especially in the pharmaceutical sector, which, if acceded to, might turn out to be destructive for India's thriving generic drugs industry.

Similar demands for narrowing some of the flexibilities have been made by the US under the Doha rounds of global trade talks. These pertain to scope of patentability, patent challenges, intellectual property enforcement, data exclusivity, patent terms extensions, patent linkage, compulsory licensing and parallel importation of cheaper medicines. Some of the FTA negotiations aim to expand the scope of patentability to include new forms even if there is no efficacy, evergreening of old drug patents and patenting of plants and animals, diagnostic, therapeutic and surgical methods. Besides, another safeguard offered by TRIPS deal that the regional and bilateral trade deals seek to diminish is on intellectual property enforcement by imposing new mechanisms of enforcement.

"There is no reason for the Indian government to feel defensive or to negotiate any tightening of intellectual property provisions in FTAs like the India-EU agreement. On the contrary, it would be suicidal," says a senior WTO official based in Geneva. The issue really is that the Indian patent law could soon be a model for other countries that are keen to control the spiralling healthcare costs. After the Novartis' verdict by the Supreme Court, several developing countries are thinking of introducing provisions similar to 3(d) in their legislation. "Politically, the Supreme Court decision has given a fillip for greater emphasis on access to medicines worldwide. I feel there will be greater pressure for tightening patentability criteria and intellectual property protection rules for medicines around the world," the official adds.

According to DG Shah, secretary general of Indian Pharmaceutical Alliance (IPA), any TRIPs-plus provision will raise the bar for generic entry and will delay competition. It will adversely affect access to medicine in India as well as other developing countries. "The developed countries will now try to block the access to cheaper medicines by forcing the government to amend section 3(d) of the patent law," Shah adds. Agrees Nagesh Kumar of UN Economic and Social Commission for Asia and the Pacific (UNESCAP), who believes any TRIPS-plus provision will affect the affordability of drugs by encouraging the evergreening of patents and by making provisions of compulsory licensing difficult to implement.


* * *

Clandestinely, the developed countries are now trying to bring in tougher intellectual property norms through large-scale deals like the proposed Trans Pacific Partnership which is being negotiated amongst the US, Japan, Canada, Mexico, Peru, Chile, Vietnam, Malaysia, Singapore, Brunei, Australia and New Zealand. Negotiations like this one will provide a good indication of how the narrowing of the flexibilities in the TRIPS agreement is taking place. The proponents of the deal hope that they can convert the provisions of this partnership into global rules by mainstreaming them into WTO at some point in time.

"It is clear that TRIPS-plus agreements in the case of healthcare are purely protectionist and should be rejected in FTAs in particular. India, with a large and successful generic industry which is doing extremely well in the world markets, must specially resist all TRIPS-plus agreements relating to healthcare in FTAs. The WTO-plus route is an immediate concern particularly in the context of pharmaceutical products," avers Manoj Pant, professor at the Centre for International Trade and Development (School of International Studies), Jawaharlal Nehru University.

The introduction of IPRs as an issue with binding rules within the multilateral trading system was very controversial during the Uruguay Round of GATT (General Agreement on Tariffs and Trade). It continues to remain so, after the TRIPS agreement was incorporated within the WTO.

The Business Standard, 27 April, 2013, http://www.business-standard.com/article/economy-policy/strong-medicine-for-poor-countries-113042700502_1.html


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