THE MASHELKAR COMMITTEE REPORT AND “INDUSTRY” CAPTURE ALLEGATIONS

I was greeted this morning by a TOI editorial written by a colleague of mine from Oxford, Sudhir Krishnaswamy, who now teaches at the National Law School, Bangalore. I’ve always respected Sudhir as someone who exuded academic rigour—and was therefore surprised at reading an editorial that rested on superficial analysis and touted fancy terms. Even more surprising was the fact that this came after we had exchanged some communications on this theme in the past. Sudhir had emailed asking for a copy of my paper that I submitted to the Mashelkar Committee. I sent this and received a reply from him stating that he disagreed with the conclusions. When I wrote back asking him as to what he specifically disagreed with and why, he didn’t bother to respond. I was disappointed as I hoped to engage him in a discussion on the substantive issues. And then I see this editorial in the press, where, in relation to my paper, he states:

“In either circumstance, we must conclude that research done under these conditions is ‘consultancy’ research which represents the concerns of a particular interest group.”

Had Sudhir patiently read my paper, dug a little deeper and assessed the overall situation with more objective eyes, he might not have jumped to this perverse conclusion that my paper represented “concerns of a particular interest group”.

1. Firstly, it was not commissioned by Interpat but by the IPI (Intellectual Property Institute). I had nothing to do with Interpat or where the funding came from—it was the IPI that was commissioning this and my dealings were with the IPI.

2. IPI has a number of members, including Interpat, and being a non profit body, isn’t it reasonable that it’s funding come from its member/members? IPI has on its board my supervisor at Oxford, Professor David Vaver, as also Sir Hugh Laddie, two very well known and respected academics/judges in the UK. Sir Laddie was also, till recently, a patent judge and a very respected one at that. The IPI’s council members include academic stalwarts such as Professor John Adams, Professor Lionel Bently, Professor Michael Blakeney, Professor Gerald Dworkin, Professor James Lahore and Professor Hector MacQueen. It also includes reputed judges such as the The Rt Hon Lord Justice Jacob (President), The Hon Mr Justice Kitchin and The Hon Mr Justice Pumfrey. These are very well reputed academics and judges, who are certainly not in the “pay” of industry. All of this information is available on the IPI website. To therefore call the IPI an industry mouthpiece (or an “industry” that is capable of “capturing”) is perverse and smacks of ignorance and sheer laziness in investigating the matter deeper and assessing the situation with more open and objective eyes.

I don’t blame public health activists for jumping to these sort of conclusions, since they have had a very difficult fight and it is only more recently that their voices are beginning to be heard in India. One is more likely to pardon their resort to rhetoric in accord to accomplish their goals in a setting that has thus far, not been very favourable to their cause. However, it is not becoming of an academic to be prone to such a tendency. Perhaps for an academic who feels left out of the whole debate, this stems out of a desperate need to make his/her voice felt in some way. Except that he/she would have gained far more credibility and made more sense, had he/she taken the pains to probe a little deeper.

3. The IPI was interested in going international with their research activities and in particular, on focussing on India and China. Professor David Vaver referred them to me, when they queried him on an “Indian” expert that could objectively analyse the questions posed to the Committee. I was more than happy to do this, particularly since there were no strings attached and no “gag” clauses–that would prevent all my hard work from being submitted to the Committee, if they weren’t happy with the results. It was also understood that I would be the author of this paper, completely independent and free to come to the conclusions that I thought were right. Our agreement was that they (the IPI) would only endorse my paper, if Professor David Vaver, who was the head of the Oxford IP Research Center, thought that the paper was sound in its reasoning/analysis/conclusions. He did so, and the IPI was happy to endorse my findings and send the paper to the Committee.

4. They were also very transparent in their dealings with me and informed me about the Interpat funding and we agreed that this had to be mentioned in the paper.

5. Incidentally, I did another paper for the IPI on the tricky issue of Article 39.3 and regulatory data protection, where again, they wanted an independent Indian expert to assess the standard for protection under Art 39.3 and to assess whether Indian law was complaint with such a standard. I found that Article 39.3 did not require “data exclusivity”–rather, its minimum standard was one of “compensatory liability”–where the data would be “compulsory licensed” and could be relied upon by an Indian generic, provided a reasonable royalty was paid. Those following the Thai compulsory licensing controversy will appreciate that if there is one term that makes big pharma squirm, it is “compulsory licensing”.

Guess what—-this report, again funded by Interpat and advocating that horrible term “compulsory licensing” was submitted to a government committee by the IPI (despite the fact that funding came to IPI from Interpat). Certainly not the kind of reaction one would expect from a body “captured” by industry interests.

Interestingly, over dinner at a New Delhi restaurant last year, I had appraised Sudhir of this second report on Article 39.3 and how this was neither favourable to big pharma (who didn’t like the term “compulsory licensing”) nor the generics or public health activists (who wanted to continue with the status quo and not have to pay royalties for reliance on this data). And that strangely enough, I was in a no-man’s land—some might say, precisely the spot for academics who aren’t exactly “captured” by interests.

Even apart from all of this, lets look at this whole controversy logically. Friends of mine say that I’m stupid to keep insisting on “logic” when what sells today is “rhetoric”. I will credit the Indian public with more intelligence than swaying blindly to rhetoric. Were I an academic “captured” by “industry”:

i) I wouldn’t have insisted on an Interpat attribution in my paper. No one would have had a clue and this entire controversy would never have erupted. After all the IPI is funded by all/most of its members and who would know? I think the IPI would have strongly objected to this non-attribution, but then IPI is also supposedly an “industry” captured body, right?

ii) I wouldn’t have been foolish enough to put that stuff out on my blog, stating that the Committee lifted its conclusions from my report. I, and more importantly, the IPI and Interpat would have rejoiced secretly at having achieved this coup, without anyone knowing any better.

iii) I wouldn’t have gone around critiquing a committee that I thought was favourable to the industry interests that I represent. See my first blog post on the Committee Report, where I note:

“What worried me, however, is that while it took me about 35 pages to come to the conclusion that keeping non NCEs or incremental pharmaceutical inventions outside the scope of patentability would contravene Article 27 of TRIPS, the Committee disposed of this issue in a couple of paragraphs.
….I’m not entirely sure that the issue is a simple one. Would non NCE substances or incremental pharmaceutical advances amount to “inventions” under Article 27, which mandates that “patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application”.

A recent article by Mr Dinesh Abrol, a public health advocate and a co-convenor of the National Working Group on Patent Laws makes the same point:

Interestingly, Shamnad Basheer himself states: “The key failing of the Committee is not engaging with the tough policy issues. The conclusions may be correct, but there is much to be said for the manner in which they were arrived at.”

Were I captured by “industry”, why would I question the fact that the Committee didn’t reason out its conclusions? Shouldn’t I be happy that my so called consultancy “client” got what it wanted i.e. a finding that the proposed amendments were not TRIPS compatible.

And this brings me to the larger issue of how the debates around this controversy (and the larger public health vs patent controversy) are getting increasingly polarised and are slowly forcing us towards a George Bush kind of view:

“EITHER YOU’RE WITH US OR YOU’RE AGAINST US”

Very famous words in the context of Iraq. But not a very sophisticated approach to life, particularly for an academic. Do academics have to take sides in these debates that are getting increasingly polarised? Particularly so, when they are from India, the land of the Buddha, an evolved spiritual leader, who advocated the “middle path”–an approach that entails being “neutral, upright, and centered. It means to investigate and penetrate the core of life and all things with an upright, unbiased attitude. In order to solve a problem, we should position ourselves on neutral, upright and unbiased ground. We investigate the problem from various angles, analyze the findings, understand the truth thoroughly, and find a reasonable conclusion”.

I would only ask that skeptics take a look at Popping Patented Pills: Europe and a Decade’s Dose of TRIPS. This article co-authored with my supervisor, Professor David Vaver, Director, Oxford IP Research Center, takes a very critical look at big pharma. If that’s not enough, take a look at Taming of the Flu: Working Through the Tamiflu Patents in India. This article takes a critical look at Roche’s stand in not licensing its patents over Tamiflu, despite fears of an acute shortage. It is co-authored with a public health activist, Tahir Amin….someone I find to be very balanced and willing to listen to hard facts/data and reason.

If this is again not enough, take a look at my blog which has posts on the Tamiflu dispute (critiquing Roche’s tough stand on patents) and on the Novartis case (opining that contrary to what Novartis claims, section 3(d) is perfectly compatible with TRIPS). Surely an Interpat paid “captured” academic would never write anything that prejudices the case of one its key members i.e. Novartis.

I read Manoj Mitta’s piece in The Times of India, where he quotes one of the Mashelkar Committee members, Dr Madhav Menon, who also happens to the founder Director of the National Law School of India (where Sudhir now teaches), as stating:

“As an academic, I believe that the committee should be willing to revisit its conclusions in the light of any fresh empirical evidence”

Spoken like a true academic. And this is exactly what we need–a move away from rhetoric and a move towards evidence based research and empirical analysis. And I am glad that at least some sensible academics are now making a call for this. As opposed to others, who may feel left out of the whole debate and resort to fancy terms like “industry capture” to make themselves heard. If there is anything that deserves “moral censure” (again a term used in Sudhir’s article), it is precisely this sort of a publicity stunt that lacks rigorous analysis and is informed less by logic and more by shoddy investigation.