On the 13th of last month, a timely day-long panel discussion was conducted by NLU Delhi on the Novartis decision of the Supreme Court. Among the participants, the ones whose presentations I found particularly insightful were that of Adarsh Ramanujan of Lakshmikumaran and Sridharan, Dr.K.M.Gopakumar of Third World Network, Mr.Mark Heywood, Founder of Treatment Action Campaign (South Africa), Dr.Gopakumar G.Nair of Gopakumar Nair and Associates, and Mr.P.H.Kurian, former Controller General of Patents, Designs and Trademarks.
In the post-lunch session chaired by Mr.C.H.Unni, Deputy Chief of Bureau, Mint, I had the opportunity to present some of my views which went beyond the decision. This post captures some of those views.
With pharma patent litigation having taken centre stage, the one thing that we need to be wary of is the temptation to expect the patent system to solve all our healthcare challenges, including that of affordable access to medicines. This temptation becomes a necessity all the more in the absence of a clear-cut healthcare strategy, since the Government would want to be seen as doing something, and patent busting is probably the most public way that the government can probably think of to achieve that object, given the (un)popular perception of patents and innovator drug companies.
Patents are without a doubt relevant to the debate, and patents which add no value must definitely be weeded out. But the question is, apart from pitting innovator drug companies against generics and deriving a vicarious pleasure out of this slugfest, have we truly explored all plausible and available options under and outside the Patents Act, 1970?
For instance, if the Government is truly keen on weeding out frivolous patent applications or patents, it ought to have actively explored the pre and post-grant opposition mechanisms, besides revocation by filing oppositions and revocations. After all, the definition of “person” under the Act includes the government, so what has stopped the Ministry of Health from filing oppositions to frivolous patent applications?
Also, what has the stopped the Government from stocking adequate quantities of patented drugs in hospitals and dispensaries owned by the Government, thereby giving effect to Section 47(4) of the Act? Wouldn’t this help increase affordable access to drugs?
Apart from patent-related issues, one of the issues central to the discourse is elevating the quality of research undertaken by Indian pharma companies and providing impetus to the growth of home-grown entities in related areas such as clinical trials. Instead of investing efforts in this direction, the Government has in fact contributed to the potential decline of Indian clinical trial industry by implementing feckless provisions such as the new Rule 122DAB of the Drugs and Cosmetics Rules, 1945, which states that failure of an investigational product to provide the intended therapeutic effect shall be considered as having caused a clinical trial-related injury or death!
As argued in an earlier post, if the very purpose of the trial is to evaluate the drug, what sense does it make to hold the sponsor of a trial or the Clinical Trial Organization responsible for failure of the drug to provide the intended therapeutic effect?
Unfortunately, instead of addressing issues like these, the discourse seems to be focussing entirely on the system of patents. It would help to first formulate our healthcare goals in specific terms, and then explore options under multiple legislations, instead of putting all our eggs in the patent basket.