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Friday, February 16, 2007

A2K! Big Pharma Wants Clinical Trial Data To Be Its Big Secret

In the name of "harmonizing" global standards for intellectual property rights, patents, and so on, the TRIPS Agreement (Agreement on Trade-Related Aspects of Intellectual Property Rights) has in fact radically extended patent terms (20 years is the TRIPS mandated minimum term) or introduced patent regimes for the first time in many countries, especially in many countries currently euphemized as "underdeveloped" ("overexploited" would be a more accurate designation). The cheaper generic medicines on which many neglected people depend in the overexploited regions of the "developing world" are developed and distributed only in places where such patent regimes do not exist (or, otherwise, only after patents expire), and so it is well understood by now that the ongoing implementation of TRIPS in such countries is most likely, on balance, to restrict access to life-saving medicines in places where people are already most vulnerable, all in order to preserve and increase the fortunes of the already fortunate elites who hold these patents.

This connection between global patent extensions and the correlated restriction of access to medicines is by now widely discussed and pretty well understood, but Karin Timmermans proposes in a short and very accessible essay available from the Public Library of Science (PLoS Medicine), entitled "Monopolizing Clinical Trial Data: Implications and Trends," that "largely outside the limelight" of these discussions of patents and access, a separate and less well-understood "notion of data exclusivity has quietly been introduced and promoted" as part of the same discourse of intellectual property "harmonization," and which has implications for access that are just as worrying. Data exclusivity grants exclusive rights over the data, and this crucially includes both clinical and preclinical trial data, that is required for the registration of pharmaceuticals in the first place. "Data exclusivity, too," Timmermans points out, "can jeopardize access to medicines and negatively affect public health."

1 comment:

Anonymous said...

The already-bloated IP legislative trend is perhaps the most unapologetically elitist trend in late high capitalism. It is the logical theoretical and practical advancement of the system and is clearly a danger to the underpriveleged in just about every way possible. It hits hardest in places where exploitation has already done maximum damage. This is just growing evidence of the hostility and lack of regard of the sweeping IP stage, in perhaps its most disgustingly overt life-denying occurrence.