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Pharmasud: Local knowledge, building markets, and globalization: two modes of pharmaceutical innovation in the South

ANR contract 2009-2011
Coordinator: Maurice Cassier (Cermes3)

This project aimed to explore new methods for the constitution, mobilization, and transfer of knowledge related to the invention of drugs in the emerging countries. For this, we conducted a comparative study of two modes of production and regulation of pharmaceutical knowledge: “copy regime” and “reformulation regime.” These modes use distinct forms of knowledge, schemes, and institutional arrangements. Our working hypothesis was that the copy mode today characterizes the research on generic drugs being conducted in Brazil whereas the reformulation regime dominates the industrialization of the preparations of medicinal plants as implemented by the Indian firms. The research focused on these two configurations, and in particular on the history of their appearance, the schemes that characterize them, and the social dynamics and circulation – North-South and South-South – that support them today.

The choice of two national configurations (Brazil and India) did not mean, however, performing a detailed comparison of the same processes in order to reveal what the effects of the national context might be. What we aimed to compare was of a different order: we explored two different methods of innovation, two contrasted strategies of response to common stakes reflecting the current characteristics of the globalization of drugs. It was therefore not a term-to-term comparison. The two innovation models were studied around four themes: knowledge-production dynamics, intellectual property and international law, production practices, certification and standardization, and the relationship between pharmaceutical innovation and public health.

Over the past two years, we focused our analysis of the two selected innovation models, copy in Brazil and reformulation in India, on the stakes involved in the innovation and appropriation of pharmaceutical knowledge. The seminar that we held in early March 2012 in Rio testifies to the narrowing of our work on these two major issues.

While the innovation processes studied in Brazil and in India are profoundly different, one consisting in reverse engineering of new patented medical technologies and innovating by combining existing chemical molecules, and the other consisting in reformulating and industrializing traditional drugs containing plants, the two knowledge-production models question an international system of pharmaceutical innovation based on patents by asserting the right to health in Brazil and in India, by opposing to it the coding of traditional knowledge. Our work of the past two years also made it possible to reveal a plurality of innovation schemes, in Brazil as well as in India, and to describe original schemes for the protection and regulation of intellectual property in the two countries. The firms studied in the two countries are still likely to claim drugs patents that recently came into effect in the two countries, in Brazil in 1997 and in India in 2005, for uses that it will be up to us to follow and to document. To summarize, the two models studied here appear as models of pharmaceutical innovation that are alternatives to the standard model of innovation, mainly in Brazil because innovation in the field of HIV/AIDS, and neglected and chronic diseases is part of the “right to health” written into the Constitution, and the country’s public-health policy is based on universal access to treatment, and in India mainly because the reformulation and the industrialization of traditional medicines are based on knowledge and medical thinking that do not belong to the molecular paradigm of the pharmaceutical research that dominated therapeutic innovation in the twentieth century.

Even though the modes of innovation studied here are not comparable term-to-term, we were able to point out new drug patent-filing practices by Indian firms working in the field of formulation as well as by Brazilian firms and public laboratories. The policies to manage these patents—for control, defense, technology negotiations and transfer, and market building—were followed. We thus observed a twofold policy with respect to patents, in India as well as in Brazil, of opposition and raising the patentability criteria in order to defend the pharmaceutical public domain, and of local firms’ taking out patents, in particular to defend their knowledge in the national market in India. We also studied in the two models of innovation of the particular regulation procedures of industrial property known as “oppositions” to a patent, which are used as much by Brazilian laboratories and activists to make patented molecules fall into the public domain as by the government and Native Indian activists to defend before the European Patent Office the traditional substances that have been built into international patents by US or European firms.

Pharmaceutical innovation processes in Brazil are set in the country’s health policy. The strong tensions that appeared between the new drug-patentability scheme promoted by the WHO, which Brazil had joined since 1997, and the policy of universal access to treatment for HIV/AIDS patients announced in 1996 led to “nationalization” processes of two patented antiretroviral drugs, Efavirenz and Tenofovir. These ended in favor of a mandatory license for the Merck drug (Efavirenz) in 2007, and in a victorious opposition procedure for Tenofovir, which made the drug fall under the public domain in 2008 and the production of generic drugs, certified by Brazil’s National Health Surveillance Agency. These legal disputes engaged by the Ministry of Health authorized a process to acquire the technology through reverse engineering under partnerships between public pharmaceutical laboratories and private laboratories producing the active ingredients. The consortia and partnerships set up to produce these two drugs were used as a test in the implementation of a neo-developmental policy combining the acquisition of new pharmaceutical technologies, the production of certified generic drugs distributed through the public health system, and financial incentives to encourage the constitution of so-called “strategic” Product Development Partnerships.

This innovation system uses several knowledge-learning and -production mechanisms: first, reverse engineering or unwrapping the technology, as the economist Celso Furtado called it, which consists in duplicating technology by partially reinventing it when the patented technology is never the one contained in the original patent. The imitating laboratories can then develop innovations derived from the copied molecules by producing modified molecules, polymorphic ones, or hybrid molecules, which they can then patent. The public laboratories specialize in innovation by combining existing molecules, which supposes the availability, in terms of intellectual property rights, of the molecules to be combined. We engaged in specific studies of the formulation work undertaken by the public laboratories to invent fixed-dose combinations against HIV/AIDS or malaria. We also explored in-depth the dynamics, which are diversified, of collective invention within consortia or PDPs when they partnered competitor or complementary laboratories. Lastly, in these technology-acquisition processes, knowledge and raw materials are exchanged between the Brazilian laboratories and their Indian counterparts during the reverse engineering process and the industrialization of the active ingredients and the drugs.

Our work also studied several public and citizen regulation schemes for drug patents when these latter contradict the universal-access policy and the production of generic drugs. There is in particular a remarkable procedure for the examination and attribution of drug patents giving veto power to the national drug agency, a completely unorthodox procedure at the international scale. There are also opposition procedures that can be initiated by NGOs, patient associations and the Ministry of Health, and the mandatory licensing procedure used in 2007. This regulation has led to a noteworthy politization of the patent issue in Brazil, due as much to state actions as to what is called “civil society.”

To end with, we undertook to explore and to analyze the innovation schemes addressing so-called neglected diseases (malaria, leishmaniasis, Chagas disease, tuberculosis) and we are starting to analyze an economy of innovation and the biopolitics of neglected diseases, which are very different from those associated HIV/AIDS as conflicts on intellectual property and confrontations with proprietary laboratories have yielded to public-private arrangements involving new actors such as the DNDI laboratory, an offshoot of Doctors without Borders.

Regarding the work done in India, the innovation processes of the traditional-medicine industry have revealed a form of “alternative modernity,” distinguished from development models focused on transfers of knowledge and techniques from the countries of the North and calling upon other types of knowledge than that which has dominated the molecular paradigm of pharmaceutical research since the second half of the twentieth century. The strategies of reformulation of traditional preparations promoted by Indian firms and researchers are essentially foreign to the chemical-screening model. Like bioprospecting, which has been reinstated by the rise of biotechnology, they privilege using medicinal plants, but contrary to these latter, the idea is less to purify active ingredients than to exploit the properties of mixtures. The Ayurvedic industry is reinventing its remedies and to do so, borrows from various orders of medical thought, with various techniques hailing from modern galenics, biomedicine, and traditional medicine as they were formalized within the framework of professionalization and the integration policies that have been implemented since the country’s independence.

This model involves, however, a major transformation in traditional medicine since it supposes not only industrialization and the move to mass production but also the emergence of a world of Ayurvedic pharmacy focused on the collection and manipulation of medicinal plants in a world that had thus far been medical and clinical, asserting a “holistic” and individual approach to the diseases. The “reformulation regime” that we studied here is based on knowledge-production schemes that link the local and the global in an original way because it is about creating new “traditional” drugs for the biomedical disorders of a cosmopolitan clientele.Rather than transforming India’s drugs into one or more marginal forms of biomedicine, the reformulation scheme indicates a pharmaceuticalization process. Our work endeavored to study and categorize this process.

The reformulation scheme is penetrated by essential tensions related not only to the epistemic status of the products, their problematic relationship with the texts and Ayurvedic practices, but also to the conditions for exploiting them. These tensions are particularly visible in the field of standardization, toxicity tests, and above all property rights, due to the association between systematic documentation practices in the name of protecting traditional knowledge against “biopiracy” and appropriation strategies by the brand and national patents. A “looping effect” linking reformulation practices with patent filing in connection with so-called proprietary Ayurvedic drugs is one of the noteworthy results of our analyses. We now wish to study this looping effect and the distinctive features of the relations between appropriations and innovations on which it reports.