Making the medicine go down

To help protect against allegations that clinical trials come to India simply because it is easy to cut corners here, the CRO industry has driven the establishment of a stringent ethical regime which includes institutional review, collection of informed consent from trial subjects, and rigorous monitoring of trials.

But the end-game should be about making healthcare accessible to the vast majority of India8217;s population. Over the past three decades, the Indian pharmaceutical industry, through its expertise in reverse engineering generic drugs, has already succeeded in making some of the most affordable drugs in the world. India has emerged as 8220;the pharmacy of the developing world8221;, making vital contributions especially in the global treatment of HIV-AIDS. This success was enabled by a patent regime that allowed process patents on drugs, which has however been replaced by a WTO-compliant product patent regime in 2005. The new patent regime mandates a more stringent protection of intellectual property that favours Western pharmaceutical companies developing novel drugs 8212; thereby curtailing generic companies8217; ability to reverse engineer drugs for the twenty year period of the product patent.

India8217;s 2005 Patent Act does attempt, within constraints, to balance the protection of intellectual property with public health. But how much freedom we can actually exercise to interpret the law in ways that benefit public health is the crucial question. The magnitude of this challenge was evidenced in the judicial challenge by the Swiss multinational Novartis to the denial of a patent to its anti-cancer drug, Gleevec in the Madras High Court. Although Novartis lost its case, the fact that the interpretation of our own patent laws could be thus contested is a cause for concern.

The stakes are high in terms of drug access, and this has already been evidenced in the case of Gleevec. Gleevec is a revolutionary drug in the treatment of chronic myelogenous leukemia. Generic versions of the drug were already being made in India before Novartis applied for its patent. These generics were selling at an average of Rs. 8000 8211; 10000 per patient per month. Before the patent application, Novartis applied for and received exclusive marketing rights in India for Gleevec, forcing generic manufacturers to stop making the drug. Novartis8217; price for Gleevec was Rs. 120000 per patient per month, a 12- to 15-fold increase. If the court had ruled in favor of Novartis, access to an essential cancer drug would have become difficult or impossible for many patients who already had access to that drug. Such effects have already been seen in South Korea, one of the first countries outside the US to approve Gleevec and conduct clinical trials for the drug. In spite of that, negotiating with Novartis to sell the drug at a price affordable to Korean patients turned out to be a major battle.

Debates around clinical trials tend to be limited to matters of procedural ethics, but they must be extended to include the global political economy of drug development as well. Ethically conducted clinical trials will not in themselves suffice to benefit India8217;s population unless this is coupled with considerations about how to make experimental drugs accessible to those who need it. Equally, innovative drug development capacity has to be fostered in India. The Indian generic industry is best positioned to realize the former goal; and high-level basic and translational research is essential to realize the latter. CROs will contribute to neither goal, which is why any debate on clinical trials, pro or con, has to look beyond just their interests.

The writer is associate professor of anthropology at the University of California, Irvine