Opinion A bitter pill

At issue is a key provision in India’s 2005 Patent (Amendment) Act — section 3(d). Introduced by Parliament as a health safeguard,this provision disallows product patents on modifications of existing drugs (a practice known as “evergreening”),unless those modifications demonstrate significantly enhanced therapeutic efficacy. Novartis is arguing in court to weaken the interpretation of this provision to such an extent that it would end up being a dead letter. Its claim is that by curtailing the scope of product patents,section 3(d) reduces incentives to invest in the research and development of new drugs.

This suggests a simple correlation between stronger patents and more innovation. But the recent history of pharmaceutical development presents a more complicated picture. In spite of stringent intellectual property protections,the multinational pharmaceutical industry is not particularly innovative. While this industry presents itself as an innovator in global policy debates around intellectual property,the “innovation deficit” is acknowledged within industry circles. For instance,a 2008 survey of 360 senior pharmaceutical industry executives,conducted by Deloitte,predicted that over the next decade,most research and development would not be conducted within large pharmaceutical companies. Indeed,the trend has been towards in-licensing promising molecules from smaller companies,or acquiring a smaller company altogether. Mergers and acquisitions,rather than research and development,increasingly constitute the cornerstone of the industry’s business model.

Furthermore,most recent product innovation in the Western pharmaceutical industry has been enabled by research universities,and underwritten in significant measure by public and philanthropic money. Take the case of Glivec itself. Novartis insists that a product patent on the drug is just acknowledgement of its role in “inventing” the drug. Undoubtedly,Novartis played an essential role in Glivec’s development. But one also has to consider the role of academic medical centres where clinical trials were conducted — the important research of Brian Druker at the Oregon Health and Science University,which showed this was a molecule that could be effective in the treatment of chronic myeloid leukemia,and the fundamental research on chromosomal translocation conducted by Janet Rowley at the University of Chicago in the early 1970s,which was not done with drug development in mind but which provided the mechanistic understanding without which Glivec would have been inconceivable.

Nevertheless,Novartis’s arguments get traction in the context of the prevalent structure of pharmaceutical development. This is because the pharmaceutical industry tends to be the only entity with the capital resources and infrastructure to take drugs through clinical trials and bring them to the market. In the US,for instance,there has been tremendous public investment in academic research that enables drug discovery; but drug development itself has been left almost entirely to the private sector.

As long as we are dependent on highly capitalised,privatised structures of pharmaceutical development,we will be trapped in the Faustian bargain that Novartis presents,where innovation by definition requires corporate monopoly. In such a situation,access to essential medicines depends purely on the will,privilege and generosity of pharmaceutical companies. What is needed in India is an innovation policy that can provide more open models of pharmaceutical development. Such alternatives must involve serious public investment in research as well as creative mechanisms through which such investments can lead to non-proprietary modes of drug development. This is inconceivable unless there is public funding of clinical trials,and an active attempt to build and sustain a public-sector pharmaceutical industry.

Far from attending to the public infrastructure needed for pharmaceutical innovation,the Indian state has progressively abdicated its responsibilities towards public health. It has let public-sector drug manufacturing capacity wither. It does not have a functional system of price controls on essential medicines. It provides no nationalised health insurance schemes,leaving drug pricing and access entirely to market mechanisms. It has liberalised regulation for clinical trials in a manner driven by the interests of private entities. And while there has been investment in building centres of research excellence in the life sciences,there has been little strategic conceptualisation on how these institutions can function to facilitate public interest or public health.

While the judicial thrust of Novartis’s arguments about innovation is on a particular provision of the Patent Act,there are broader implications for policy. An adequate policy response to Novartis cannot happen as long as pharmaceutical research and development is beholden to corporate interests. Innovation in the public interest can only happen if we are willing to consider mechanisms by which therapeutic development,manufacture and access can be socialised.

The writer is associate professor of anthropology,University of Chicago

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