|Image from here|
Around two years ago, I had written a post on the need to balance the data exclusivity debate in India (Shamnad has responded to that post over here). I wanted to expand that post into a full length academic essay and I finally got the time to do so, after a lot of procrastination. The article is available for download over here from SSRN.
I’m yet to submit it for publication to any journal and was hoping to do so after receiving some comments from our readers.
The structure of the essay is as follows:
(i) Part I seeks to introduce the concept of data exclusivity followed by a discussion of the regulatory regime for Indian pharmaceuticals;
(ii) Part II seeks to examine the Indian policy debates on data exclusivity and the contradictions therein, with specific reference to reports on the subject commissioned by the GoI or the Parliament.
(iii) Part III seeks to question the assumption that it is okay for India to free-ride off foreign clinical trial data instead of conducting its own clinical trials on the Indian population in order to validate drugs on the Indian people who often are of a different genetic disposition from the population in the more developed countries and who also live in a different socio-economic context from people in the more developed countries. This part of the essay seeks to establish a direct link between the regulatory requirement for local clinical trials in India and a data exclusivity regime to incentivize such clinical trials in India. If it can be argued that India should conduct more rigorous clinical trials on Indians, it necessarily follows that India can no longer free-ride off clinical trial data in foreign countries to grant its regulatory approvals. Once it is established that India cannot free-ride off foreign clinical trial data, it follows that India will have to put in place measures to incentivize clinical trials on Indians, especially since the threshold for patent protection in India has been placed so high. In the circumstances, data exclusivity could effectively prove to be just the incentive required to encourage more companies to conduct local clinical trials.
(iv) Part IV, seeks to examine the possibility of spurring innovation in the pharmaceutical industry, especially in the areas of Fixed-Drug-Combination (FDC) and traditional knowledge (TK) medicine. Incentives for innovation in both of these areas are poorly served by Indian patent law and a data exclusivity regime may serve as a better incentive.