Donít swallow this pill

Troubling news reports indicate that a newly-minted Free Trade Agreement between the European Union and India would permit companies to circumvent visionary safeguards built into India's 2005 Patents Act, widely seen as one of the most progressive patent laws in the world. Over the past decade, India fought hard to bring its laws into full compliance with international standards, while simultaneously protecting public health and safeguarding India's pharmaceutical industry. Now, the EU's trade negotiators are trying to take away those gains.

The EU campaign may be summarised in four parts.

First, paying lip service to public health: the EU frequently does so, but in a leaked draft agreement it has been gunning for restrictions on drug-safety data ó known as "data exclusivity" ó that would harm India's flourishing drug industry, and impede production of low-cost drugs for India's own citizens and other developing countries. Data exclusivity opens a backdoor channel for companies to "evergreen" their drugs, by adding anywhere from five-to-10 years of market

exclusivity before a generic producer can access clinical data necessary to secure government authorisation for generic manufacturing.

Medecins Sans Frontieres notes that data exclusivity will jeopardise production, as 80 per cent of the HIV drugs it is using to treat AIDS in developing countries are produced in India.

The World Trade Organisation's trade agreement ó which India must comply with ó does not require data exclusivity. The EU wants India to add this optional restriction on drug-safety data for the benefit of European-based drug companies, not for the benefit of India. That's why, until now, India's commerce and health ministries have strongly opposed it. So has Brazil, India's closest economic cousin.

Second, gutting India's own laws. Astonishingly, even if India's own patent office determines that a product does not warrant patent protection, data exclusivity could be used to subvert India's Patent Act. The act's framers strived very hard to limit patents to truly inventive products. That's why India's law does not permit patents on a new drug that offers only modest revisions to an existing drug compound (for example, by altering dosage), which does nothing to enhance therapeutic benefits.

Earlier this month, for example, India rejected Abbott Laboratories' request for a patent on its HIV drug Kaletra, because it did not consider it inventive. Kaletra is a combination of two earlier HIV medications, lopinavir and ritonavir. Now, as a result, Indian firms can proceed with production of cheaper, generic versions of this critical drug, which attacks HIV-virus mutations that have become resistant to older drugs.

Tragically, if the EU-India agreement is signed, legal decisions like this one will be meaningless. Data exclusivity will impede production of generic drugs for TB, cancer, and other chronic diseases. Unlike patents, however, data exclusivity cannot be challenged under Indian law.

Third, by pushing the myth of "compulsory licensing". The EU wants India to think that a compulsory licence, which allows waiver of patent protection in exceptional circumstances, is sufficient to protect India's interests. In a January 6, 2011, letter, EU Commissioner Karel De Gucht wrote that "nothing in the [EU-India free trade] agreement will prevent India from using compulsory licensing for manufacture and export of medicines to other developing countries in need." This statement is misleading. First, compulsory licensing is a long and nearly impossible process. Second, Thailand and other countries have been subjected to harsh retaliatory trade sanctions after such licensing. Third, de Gucht hides the fact that a compulsory licence can only override a patent, not data exclusivity.

Finally, by limiting transparency. The EU has kept Indian citizens in the dark by failing to make a complete draft agreement available for public review. Indian authorities, too, have failed to solicit input from civil society groups and experts, even though prior national debates over intellectual property have produced special commissions with substantial citizen input.

This FTA should be seen for what it is: a Trojan Horse that the EU has rolled into New Delhi, under the cover of darkness, to subvert India's visionary Patents Act. A final decision on this agreement is scheduled for March, so there is no time to waste.

First, India must recognise it is not required to implement data exclusivity under international law; it should reject EU pressure to do so. Second, it is imperative that all future debate around this EU-India agreement involve genuine transparency and public consultation. Every Indian citizen has a stake in this debate: if this agreement passes, it will harm Indian industries, gut India's public health system through higher drug prices, and jeopardise global public health.

The writer is a lawyer who works on treatment access and intellectual property. This piece was co-written by Tahir Amin, also an intellectual property lawyer

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