Walking the fine line between IP and public health


The rise of a protectionist US under President Donald Trump, may have long-term implications on India’s public health objectives

The year ahead in 2017 is going to be challenging for India’s intellectual property (IP) policy. Since 1994, when the country became a member of the World Trade Organisation (WTO), it has been trying to walk a fine line, balancing its treaty obligations to protect the IP of its trading partners with a national public health objective of ensuring reasonably priced medicines. The coming year is going to make it more difficult to maintain that balance.

The key factor to look out for, is the rise of a protectionist USA under President Donald Trump. A protectionist US usually takes aggressive steps to protect the IP of its companies, especially since IP is regarded as its most valuable export. Its protectionism manifests itself in a set of carefully calibrated policy tools such as the annual Special 301 reports of the United States Trade Representatives (USTR) which review IP policies of all trading partners. In the pre-WTO era, these Special 301 reports were usually accompanied with threats of trade sanctions against errant partners, with the objective of forcing countries to upgrade IP laws to serve US interests. The approach paid rich dividends at the time.

After the signing of the WTO Agreement, the USTR continued to release its Special 301 reports. But the unilateral trade sanctions that the US indulged in earlier is now tempered by an international adjudicatory body functioning under the aegis of the WTO with a mandate to judge violations of the Agreement on Trade Related Intellectual Property (TRIPS).

Crucial challenge

The crucial challenge for the Indian government is to prepare a strategy to deal with the possibility that President Trump will no longer respect multilateralism . Rather than work within the confines of the WTO Agreement, the US may resort to bullying tactics by threatening and imposing unilateral sanctions against trading partners like India who refuse to align with US interests on IP. Toeing the US line may have long-term implications on public health in India, particularly because the Americans are likely to demand more expansive patent protection for their pharmaceutical inventions. A related issue is that of India’s stance in trade talks on the issue of data exclusivity. A data exclusivity regime would forbid manufacturers of generic drugs from relying on clinical data submitted by innovator pharmaceutical companies (for a certain period of time) while applying for regulatory approval. Therefore, if a generic manufacturer wants regulatory approval for a drug during the data exclusivity period, it would have to replicate the clinical trials (and spend that much time and money) for the drug in question.

Trade treaties

India is currently in the process of negotiating two important trade treaties. The first is a free trade agreement (FTA) with the European Union (EU). The FTA has been under negotiation since 2007 and has made little progress for many reasons, one of which is, reportedly, India’s refusal to agree to a data exclusivity regime for pharmaceuticals (domestically, though, the Indian government has agreed to a data exclusivity regime for agro-chemicals). The second treaty is the Regional Comprehensive Economic Partnership (RCEP) which India is negotiating with ASEAN, Australia, China, Japan, New Zealand and Korea. According to reports, the RCEP seeks to bring in wide ranging data exclusivity provisions for both pharmaceuticals and biologics.

The proceedings of these trade negotiations remain shrouded in secrecy, and generally lack transparency.

It is therefore difficult to confirm the reports of leaked drafts of treaty texts being negotiated in the media. India certainly needs to increase its share of world trade, but will the government make concessions on those provisions of Indian IP law which protect public health?

(The writers are authors of Create, Copy, Disrupt: India’s Intellectual Property Dilemmas which was published by Oxford University Press in December, 2016. Views expressed are personal)

Published on January 20, 2017

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