1 Introduction
Brazil has entered a period of acute crisis characterized by a slump in industrial production, including pharmaceutical production in 2015, as well as a crisis in the Unified Health System (SUS) which faces cost cutting in the face of rising unemployment. In addition, a decline in the use of private insurance is increasing the demand for care in the public sector.1 Yet the systems introduced from the mid-1990s to encourage the nationalization of foreign technologies, local pharmaceutical production and access to treatment remain active. This is evidenced in the following developments: in December 2016, the Brazilian government and leading firms agreed on a new programme consisting of Product Development Partnerships (PDP ) to acquire new health technologies and produce âstrategicâ medications for the SUS; in January 2017, Brazilâs National Institute of Industrial Property (NIIP) dismissed Gileadâs application for a patent on Truvada, a therapeutic combination for the prophylactic treatment of HIV/AIDS, and in so doing authorized the production of a Brazilian generic; and the consortium formed in May 2016 by three private-sector laboratories and Fiocruz is still investing in the production of a generic sofosbuvir to supply the governmentâs hepatitis C programme.
The past two decades have been characterized by the revival and growth of Brazilian health industries under the combined effects of: the local medication production policy to treat the Aids epidemic from the early 1990s, initiated by private- and public-sector laboratories; the enactment of the law on generic medicines and the creation of the National Health Surveillance Agency in 1999;2 and the policy and funding of the National Social and Economic Development Bank (BNDES) to develop the âhealth industrial complexâ, from 2003. In January 2001, the New York Times lauded Brazilian policy in this area.3
The research team that has authored this book has studied and, in some cases, participated directly in the progressive invention of what now resembles a full-blown innovation system, consisting of: (1) numerous technological and industrial partnerships between science, government and industry; (2) regulatory and industrial property institutions, including the National Institute of Industrial Property, the National Health Surveillance Agency, interministerial groups, and civil society organizations, notably patient and citizen associations; and (3) mechanisms for the evaluation and certification of medicines, with the Health Surveillance Agency and a network of bio-equivalence centres in universities and in Contract Research Organizations (CROs).
While our first research papers published in 2003 concerned the reverse engineering work of chemists in public- and private-sector laboratories (Cassier and Correa 2003), who were seeking to develop techniques for the analysis, synthesis and formulation of antiretroviral drugs for HIV/Aids, this volume focuses on a subsequent phase characterized by the proliferation of collective invention structures and industrial partnerships during the 2000s and 2010s, in the form of national and international consortiums, Productive Development Partnerships (PDPs),4 and contracts and alliances between university laboratories, pharmaceutical firms and start-ups created around scientific institutions. These industrial partnerships and technological consortiums continue to spread, despite the unfavourable economic and industrial climate especially since 2014. The number of PDPs grew from 11 in 2009 to 104 in 2013. In 2014 and 2015, 20 new PDPs were set up. They are either between national public- and private-sector laboratories, to duplicate technologies, or between Brazilian laboratories and international firms that own or have licences for transferred technologies. Their scope extends beyond antiretrovirals for HIV/Aids, to recombinant insulin provided by an Indian firm and a Ukrainian laboratory, and a vaccine transferred by Glaxo, for example. We note that Brazilâs PDP policy is now being a target of strong opposition by the US pharmaceutical industry syndicate, which is concerned about the emergence of an autonomous industrial policy in the field of medicinal drugs, and about the preference given in these partnerships to firms that produce in Brazil: âBrazil: Productive Development Partnerships (PDPs ) and government purchasing: ⊠It remains unclear how the current PDP model might limit competition or how Brazil will apply the government purchasing program that offers preferences to locally manufactured products and services in public biddings. For these reasons, PhRMA requests that Brazil be placed on the Priority Watch List for the 2016 Special 301 Reportâ (The Pharmaceutical Research and Manufacturers of America (PhRMA), special 301 submission 2016).
The current economic and budgetary crisis could lead to reduced funding for these operations, but could also be an incentive to maintain or strengthen them, as a means both to boost investments (cf. the announcement of BNDES funding in 2015 and 2016 to finance the health industry complex) and to reduce the health product trade deficit that worsened in the 2000s and is weighing on Brazilâs health economy. We need to remember that the financial crisis that hit Brazil in the early 1980s was a driver of the policy to support local production of active principles through a reverse engineering programme undertaken by Codetec , the R&D firm of Campinas University, with funds from CEME , the Medicines Centre (Central de Medicamentos ). In October 2015 the Ministry of Health announced nine new PDPs, highlighting their economic advantages for the government.5 At the beginning of that year the Brazilian development bank (BNDES ) had announced an investment programme for the health industry complex, justified by the related reduction of the health trade deficit.6 The acquisition of new technologies and the growth of the health industries were thus seen as strategic answers to the economic crisis. For example, in September 2015, in the field of interest to us here, the BNDES granted an essentially non-refundable loan for the development of new therapeutic and diagnostic technologies to treat some of the so-called âneglectedâ diseases (Chagas , leishmaniasis, tuberculosis) by the Oswaldo Cruz Foundation, in partnership with Drugs for Neglected Diseases (DNDI ), a foundation created by MSF (MĂ©decins Sans FrontiĂšres) to coordinate R&D projects. At the same time, strong tension was running throughout the public health system, evidenced by demonstrations in June 2013 and 2014 demanding âhospitals rather than stadiumsâ.7
2 Copying and Social Medicine
A crucial characteristic of this Brazilian experience of rebuilding the countryâs health industries from the early 1990s is that it took place in direct relation to the constitutional right to health, which was enshrined in the new Constitution of 1988.8 The demands of HIV/Aids patients and the first initiatives to distribute Azidothymidine or Zidovudine (AZT) played a major role in mobilizing both this legal instrument and the pharmaceutical laboratories that could duplicate the only molecule available at the time. The Director of Microbiologica, the first firm to copy AZT, saw the firmâs engagement as the outcome of a technological opportunity: the laboratoryâs expertise in small molecule chemistry. It was a response to the Aids movementsâ demands for access to treatment: âMany people died at the time. But these people started these ONGs, non-governmental organizations, and these started to make, to organize pressure immediately. So when it appeared, we decided we'd produce AZT in Brazil ⊠And AZT is a nucleoside and the experience and competence of this company is in nucleic acid chemistry. So for us it's like manna from heaven.â9 In 1996, the Ministry of Health decided to set up a national copying programme, while the president of Brazil issued a decree that organized the universal and free distribution of medicines to treat the Aids epidemic. The ministry summoned the director of the federal pharmaceutical laboratory, Eloan Pinheiro, and gave her the list of antiretrovirals that it was purchasing at a high price from multinational firms: âAnd then they called me and said: you need to develop drugs for Aids. And I said letâs goâ.10 Pinheiro compared this list to the list of medicines not under patent in Brazil and decided: âweâll try to reproduce these medicines here in Brazilâ. This programme was launched in a context of epidemic urgency and the fear of being swamped by the number of treatments to distribute: âthe evaluation of the WHO was so bad they supposed that by 2000 Brazil would have one million people [with HIV/Aids], and the prices of the international companies were very highâ (Eloan Pinheiro).
While the Farmanguinhos federal laboratory started to supply the Health Ministry for the distribution of free generic ARVs to Brazilian patients, Eloan Pinheiro was also involved in an international movement, initiated by MĂ©decins Sans FrontiĂšres, to revive therapeutic innovation for a set of pathologies known as âneglected diseasesâ that barely benefited from new molecules put on the market (PĂ©coul and Trouiller 1999). In 1999, MSF created the DND Working Group, consisting of experts who had been working for a long time on tropical diseases at the WHO, the Walter Reed Army Institute of Research, the Harvard School of Public Health, as well as several experts at scientific or pharmaceutical institutions in developing countries, including Mahidol University in Malaya and the Oswaldo Cruz Foundation . Pinheiro, who had just launched several generic ARVs, was invited by MSF to participate in this working group: âAt the time, we had huge visibility because we had produced all the generics for HIV (the antiretrovirals). It was t...