Cleaning up after Mashelkar

Published : Mar 23, 2007 00:00 IST

THE ETHICS OF granting patents for medicines is extremely dubious given the life-and-death issues involved. Here, a protest in New Delhi, in 2006, against the legal ban on the copying of patented drugs.-V.V. KRISHNAN

THE ETHICS OF granting patents for medicines is extremely dubious given the life-and-death issues involved. Here, a protest in New Delhi, in 2006, against the legal ban on the copying of patented drugs.-V.V. KRISHNAN

A JPC to look into the patents law and a strong initiative to promote innovation in pharmaceuticals through the non-patent route are needed.

FORMER Director-General of Council of Scientific and Industrial Research R.A. Mashelkar has brought disgrace upon India's scientific establishment by producing a tawdry, poorly argued, unbalanced and pro-big business report on India's patents law, at the core of which lies rank plagiarism. Mashelkar has withdrawn the discredited report of the "Technical Expert Group on Patent Law Issues", which he headed. He says he did this to uphold "scientific ethics". But he continues to say: "I stand by the report and its findings, 100 per cent... ."

He claims that there was no "plagiarism" and that "it would be wrong to attach motives" to the fact that a critical part of his committee's report was bodily lifted from a previously published paper. He minimises and trivialises this thoroughly deplorable and indefensible practice as consisting of mere "technical inaccuracies" or a "copying error by the sub-committee" that wrote the draft.

It is disingenuous to argue that only "eight to ten lines" were extracted verbatim from the paper in question (by Shamnad Basheer), which was commissioned and published by the United Kingdom-based pro-pharmaceutical industry Intellectual Property Institute. The paper's commissioning clearly points to a conflict of interest.

What is crucial is that the plagiarised portion forms the heart of the Mashelkar Committee's recommendation that India should not limit the "granting of patents for pharmaceutical substances to new chemical entities only" as that would be incompatible with India's obligations under the TRIPS (Trade-Related Intellectual Property Rights) Agreement of the World Trade Organisation (WTO). The recommendation is backed by very little analysis. It cites Basheer, who wrote the paper as a doctoral student, as an authority.

Yet, Mashelkar has the gall to offer to "re-examine" the old report and "resubmit" it.

This is not the only instance of plagiarism that Mashelkar stands accused of. In 2004, he co-authored with Shahid Alikhan a book entitled Intellectual Property and Competitive Strategies in the 21st Century (Kluwer Law International, 2004). The bulk of its section on traditional resource rights is lifted from a paper by Graham Dutfield carried in the Bulletin of the Working Group of Traditional Resource Rights (TRR) Spring 1996, No. 2 (The Times of India, February 28). There are as many as five paragraphs in the Mashelkar-Alikhan book that merely paraphrase, or repeat verbatim, sentences from Dutfield's paper, without attribution or acknowledgment.

This is not the place to discuss Mashelkar or any of the other members of his committee, at least two of whom (Govardhan Mehta and N.R. Madhava Menon) are distinguished and highly regarded individuals. What is material here is not just the ethics of plagiarism but the policy bias of the Expert Group towards Big Pharma and its view that "incremental innovation", and not just new chemical molecules/entities, should be patentable.

This is a prescription for "evergreening", or the virtually limitless patenting of minor or marginal modifications to drugs in order to retain a monopoly over producing them for indefinite periods. As the "Glivec/Gleevec" case by Novartis now being heard by the Madras High Court demonstrates, this can mean a 1,200 per cent difference in the price of medicines for leukaemia and effective denial of patient access to cheaper drugs.

Big Pharma vigorously promotes and justifies "evergreening" because it is the surest guarantee of monopoly-based superprofits. But "evergreening" is demonstrably harmful to the goal of promoting public access to essential drugs at reasonable or affordable prices.

Mashelkar has often unambiguously expressed his pro-industry bias by rooting for monopolistic patents and by urging Indian scientists to file patent applications "before publishing their research". Mashelkar is all praise for a highly questionable legislation being drafted by the Science and Technology Ministry, which is modelled on the lines of the controversial Bayh-Dole Act passed in the United States in 1980, which lifted a long-standing ban on the patenting of federally funded research and facilitated an unhealthy nexus between universities, laboratories and corporate interests.

The issue of granting stiff intellectual property rights (IPR) protection such as patents for innovation in pharmaceuticals is deeply fraught. As this Column has argued earlier, the very concept of "intellectual property" is problematic: all individual innovations are based and built on the past achievements of others and the common pool of human knowledge. It is even harder to argue that innovations in respect of health-related products should be privileged for pecuniary reward. The ethics of granting patents for medicines is extremely dubious given the life-and-death issues involved.

Philosophically, it makes little sense to "reward" any innovation through a negative right - in reality, a monopolistic privilege to produce a particular product (or rather, to prevent others from making it). There are other, perfectly viable, forms of recognising and appreciating innovation - for instance, through peer-group acknowledgement. In any case, most patents are held not by individual innovators but by corporations.

India capitulated to Western pressure to negotiate TRIPS in the Uruguay Round and then found itself left with no choice but to sign the agreement in 1994 and allow the patenting of pharmaceutical products - as distinct from patenting the processes of making them, which is what the Patents Act, 1970, did.

But this was seen and acknowledged as a compromise driven by compulsions - not the ideal state of affairs as India would like them to be, nor one to be desired. Thus, India amended its Patents Act in 2005 only under explicit pressure from the WTO, which demanded that a mere notification in respect of product patenting would not be enough.

However, the Mashelkar Committee report and the new Bill on "rewarding" scientists all point to a major shift in thinking among some of our policymakers. Product patenting - and in general, a stiff, highly monopolistic IPR regime strongly biased in industry's favour - is now seen as acceptable, desirable and worthy in and of itself.

This is a dangerous sign. It also tells us that policy on important issues such as IPR in respect of medicines or computer software cannot be left in the hands of "eminent" scientists and "experts", many of whom have fallen prey to corporate ways of looking at the world - in which private greed becomes the motive force of innovation, growth and development.

We need to take remedial measures - urgently and without hesitation. To start with, the Mashelkar Committee has completely lost its credibility. It would be pointless to replace it with yet another "expert" committee. As the unhappy experience with the Knowledge Commission shows, what we need is less technical expertise and more political clarity and a vision rooted in the public interest.

It would be best to set up a Joint Parliamentary Committee (JPC), which can summon experts whenever necessary but which will be guided by the spirit of the debate on the patents issue in Parliament in April 2005. The JPC should subject experts' views to the scrutiny of the public interest.

We need to do much more. There is no reason why we should not explore the limits of TRIPS to the fullest extent (including its public interest-related Articles 7 and 8) and do whatever is possible within its framework, as elaborated by the Doha Declaration on Public Health.

Equally, we must draw a clear line of distinction between the interests of the pharmaceuticals industry, including its wholly indigenous sector, and the larger social good. The two were closely related (yet conceptually separate) during the TRIPS debate but have become increasingly divergent. Many Indian drug manufacturers support patents for incremental innovations but with a raised bar.

At least three important initiatives are in order (the last two of which I am indebted to my scientist friend Satyajit Rath of the National Institute of Immunology). First, we must make the granting of patents an adversarial process. Put simply, this means that as in criminal law, which treats an accused as innocent unless proved guilty beyond reasonable doubt, access to knowledge or innovation must be treated as unrestricted unless proved patentable on the strict criteria of novelty, original invention, utility, industrial application, and so on.

A patent applicant would have to submit extensive data to back his/her claim and allow it to be scrutinised in an adversarial fashion (akin to cross-examination in a criminal trial). This will hopefully limit the number of patents and toughen the criteria for granting them so that the larger public interest of establishing access to affordable medicines prevails over parochial considerations of profit.

Equally important in such an amended law would be an emphasis on compulsory licensing, or the grant of a licence to a non-patent holder to manufacture a product considered essential in the larger national interest or in a medical emergency (a situation that is near-perennial in Indian society where half the population lacks access to modern medicines).

Second, we must use public instruments to establish access to essential medicines and to make them affordable. We have a number of pharmaceuticals public sector undertakings (PSUs) that, despite official neglect, lack of support for innovations, and the depredations of the private sector, possess a fair amount of research and development (R&D) capability, good-quality special materials such as yeasts for fermentation, and a proven capacity to make low-cost products.

The PSUs must be revitalised. They deserve strong R&D support. They should be mandated to produce "social good"-related drugs for national health programmes in large quantities. The government should procure drugs directly from them rather than buy them from the open market.

In any compulsory licensing regime, PSUs will have a special, probably irreplaceable, role. Many Indian private manufacturers might hesitate to work with compulsory licences for fear of an adverse reaction from the original patent-holder. PSUs would have fewer constraints.

Equally important is a policy declaration by the government that the fruits of publicly funded research cannot be and will not be patented. Instead, they would be placed in protected commons and made accessible to all institutions and companies that agree not to patent them even though they may use them to generate profits.

No less significant, we must institute "patent-busting" - just the way many multinational corporations do. This is a perfectly legal operation to break into the patent "thicket" or "hedge" that companies build around a single innovation so that it can be shielded and its patent monopoly preserved. This is perfectly compatible with TRIPS, indeed even with restrictive patents laws in Western Europe and the U.S. It must be put to full use.

This is the only way India can still fulfil the worthy objective of medicines and health for all while remaining TRIPS-compatible and yet not caving in to market fundamentalism.


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