Drug safety data: mine, all mine!

India gets a lecture on how it's not alright to share

Published July 15, 2006 12:31AM (EDT)

An "Inter-Ministerial Committee" is meeting this week in India to discuss whether India should bend to foreign pressure and provide "data exclusivity" for pharmaceutical products.

When a drug company applies for permission to market a product in a country, it is usually required to provide test data showing the drug is safe and effective. That data, in turn, can be very useful to producers of generic versions of those drugs, who would rather avoid the expense of repeating all the clinical trials for a chemical compound that is identical to the original product.

The U.S., European Union, and international pharmaceutical industry believe that using test data in such a manner amounts to unfair competition. So they are using every tool at their disposal to lobby for data exclusivity -- meaning that no one else be allowed access to the information. Health activists say this is just another way to keep drug prices high, with consequent negative public health implications. Generic manufacturers argue that it is a technique that can also be employed to extend the effective length of patent protection.

For our purposes here, the critical thing to note is that Article 39.3, the relevant clause of the WTO Agreement on Trade Related Aspects of Intellectual Property, is by no means clear on exactly what nations are required to do with such data. For a definitive investigation of the ambiguities in TRIPS, read Carlos Correa's extraordinarily informative analysis.

To be sure, the pharmaceutical industry would and does dispute Correa's conclusion -- which is that Article 39.3 does not mandate exclusive protection of such data. But it's clearly a debatable issue. Certainly India, even as it was amending its patent laws to bring them into harmony with TRIPS over the past decade, took the position all along that data exclusivity was not part of the bargain.

Now India appears to be changing its stance, possibly because of unrelenting pressure from the U.S. So here's yet another example of how the U.S. exerts bilateral pressure to get concessions greater than what has been agreed to via multilateral negotiations. TRIPS may have been a bad deal for developing nations to start with, but it keeps getting worse.

By Andrew Leonard

Andrew Leonard is a staff writer at Salon. On Twitter, @koxinga21.

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