MÉDECINS SANS FRONTIÈRES ACCESS CAMPAIGN WHY BRAZIL SHOULD REFORM ITS LAW AND BOOST MEDICAL ISSUE ISSUE BRIEF INNOVATION TO PROMOTE ACCESS TO MEDICINES

Governments have a responsibility to act to protect and improve the health of people.

Brazil is one of many governments working to strike a balance between public and private interests in determining how medical innovation is conducted and incentivised – and how medical products and technologies can be made accessible for the benefit of public health.

One key area where governments can intervene is ensuring medicines aren’t priced out of reach. Multiple strategies can be adopted to reach this goal: one is determining with precision what type of pharmaceutical products deserve a patent, with the aim of eliminating the granting of their contribution to medical research Commission on Social Security and unnecessary or frivolous that and by ensuring drug development Family approved the Report from keep drug prices higher for longer; is done in a way that doesn’t the “Special Sub-Commission on the another is using the mechanisms that automatically lead to high prices. Development of the Health Industrial are authorised by international trade Complex, Production of Drugs, The Brazilian Congress is already rules to overcome patent barriers, once Equipment and Other Inputs”2. Both patents have been granted. The most compiling evidence on the need documents encourage changes in critical aspect is having a patent law for reform of the patent law and the patent law and with the medical that is well-designed and provides an the need to explore alternative innovation framework, based on adequate framework for public health mechanisms to promote medical concrete proposals. goals to be met. research that responds to priority health needs. In October 2013, after At this point, several bills and One other key area is that of medical broad consultations with multiple recommendations have been innovation. The current paradigm tabled in the Brazilian Congress. for research and development (R&D) stakeholders from Brazilian society, is one where medical innovation is the Center of Studies and Strategic Approval of these would both incentivised through the promise of Debates (CEDES), a technical- ensure the patent law is better high drug prices, backed by patent consultative body comprised of 11 suited to answer public health monopolies. This model leaves many parliamentarians1 published “Brazil’s needs, and enable Brazil to play a pressing health needs unaddressed. Patent Reform: innovation towards leading global role in addressing Governments need to intervene to national competitiveness”. One the fundamental flaws in medical address this market failure by boosting year later, in October 2014, the research. The time to act is now.

MSF Access Campaign Médecins Sans Frontières, Rue de Lausanne 78, CP 116, CH-1211 Geneva 21, Switzerland Tel: + 41 (0) 22 849 84 05 Fax: + 41 (0) 22 849 84 04 Email: [email protected]

www.msfaccess.org facebook.com/MSFaccess twitter.com/MSF_access ISSUE BRIEF Médecins Sans Frontières Access Campaign | Why Brazil should reform its patent law and boost medical innovation to promote access to medicines

I - THE CONTEXT: INTERNATIONAL OBLIGATIONS, NATIONAL PREROGATIVES

The impact of this rapid implementation sustainability of the Brazilian response was felt strongly in public health to HIV was put at risk. programmes in Brazil. The universal Committed to universal access access to HIV/AIDS treatment to treatment, yet faced with an programme, which was initiated in ever-increasing demand for patented and 1996, had as one of its main pillars expensive drugs, Brazil prioritised efforts ensuring the accessibility of medicines by relying on affordable, locally to reform the international intellectual produced generic drugs. Following the property system. Brazil’s push to change 1996 law, however, generic production international norms so that they would was only possible for medicines ensure access to essential medicines introduced in Brazil prior to 1997. As culminated in the approval of the Doha newer, more effective but patented Declaration on TRIPS and Public Health © Andre Francois Andre © drugs started to be introduced into in 2001. ‘Doha’ was a landmark political HIV treatment guidelines, the financial moment, which confirmed that countries In 1995, members of the World burden of the treatment programme have the prerogative to use flexibilities in Trade Organization (WTO) adopted increased exponentially, and the order to protect public health. the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, under which countries agreed to set minimum standards The TRIPS Agreement, for all its provisions on for patent protection, including on pharmaceutical products. the protection of scientific knowledge, contains measures allowing for the promotion of public Brazil did not grant pharmaceutical patents at the time, but was obliged health. We are pleased that this Special Session to introduce such measures upon has acknowledged the efforts of countries to inception of the WTO. Following intense develop domestic industries in order to increase pressure from the US government and multinational pharmaceutical access to medicines and protect the health of companies, an Industrial Property their populations. Law was adopted in 1996, despite the availability of a ‘transition period’ which JOSÉ SERRA, MINISTER OF HEALTH OF BRAZIL, SPECIAL SESSION OF would have allowed Brazil to wait until THE GENERAL ASSEMBLY OF THE UNITED NATIONS ON HIV/AIDS, 2005 to introduce patent laws. JUNE 2001

Brazilian civil society played a key role in securing the constitutional recognition that “healthcare is the right of all citizens and the duty of the State”, in pushing government to make AIDS treatment a high priority and introduce health-oriented IP reforms. GTPI, a coalition of NGOs created in 2003, advocates for the rights of people living with HIV (PLHIV) and pushes for the use of flexibilities allowed within the framework of international trade rules.

2 Médecins Sans Frontières Access Campaign | Why Brazil should reform its patent law and boost medical innovation to promote access to medicines ISSUE BRIEF

II - MECHANISMS TO ENSURE ACCESS TO MEDICINES: WHAT BRAZIL HAS ACCOMPLISHED

Brazil has already put in place a number of policies and taken steps to ensure access to We are determined to use all TRIPS flexibilities, medicines for its population. including the issuing of compulsory licences, if this is the only way to guarantee the continuity ANVISA’s Prior Consent of our HIV/AIDS programme. In Brazil, officials from the Agência DR. HUMBERTO COSTA, MINISTER OF HEALTH OF BRAZIL, Nacional de Vigilância Sanitária WORLD HEALTH ASSEMBLY, MAY 2005 (ANVISA, the body responsible for regulation and approval of medicines in the country) participate in the process of analysing patent applications on pharmaceutical products, instead of Innovation and Public Health in • National impact: In 2006, when the leaving this task exclusively to patent 2006, for example, identifies the first generic versions of tenofovir, office examiners. This provision, known participation of public health a critical drug for the treatment as ‘prior consent,’ was adopted in 2001 authorities in the analysis of of HIV, reached the international in order to “ensure the best technical pharmaceutical patent applications market, the price charged in Brazil standards in the process of decisions as a positive measure that protects by the company Gilead, who had over pharmaceutical patents”3. It allows public health, since it helps to prevent filed a , was ANVISA to work in partnership with the granting of frivolous patents. 10 times higher than the most National Institute of Industrial Property affordable generic option available. (INPI). ANVISA’s prior consent is In order to encourage competition Patent oppositions that would bring the price down, critical to ensure the patent law is patent oppositions were filed by the implemented in a way that balances the Out of the huge number of patent Grupo de Trabalho em Propriedade private rights of patent applicants with applications made by pharmaceutical Intelectual (GTPI), a civil society the public interest. companies, only a few refer to genuine inventions, and most are organisation, and by Farmanguinhos, • National impact: Of the 1,346 for minor variants of already known Brazil’s largest government-owned patent applications analysed by pharmaceutical substances. Such laboratory. In August 2008, INPI ANVISA between 2001 and 2009, ‘low-quality’ patents can be avoided rejected the patent application for 209 did not receive prior consent. tenofovir on the grounds that it if countries provide strict standards in 90 of these had been approved by lacked inventiveness, as claimed in their patent-granting process, but even INPI, but were subsequently rejected the patent oppositions. Thanks to then there is no guarantee that patent following ANVISA’s review. ANVISA’s the rejection, the government was offices will enforce them. prior review also contributed to the able to explore options to supply the quality of patent applications: of Patent opposition procedures can apply drug at lower prices. the 988 applications that received pressure for more rigorous standards • International impact: The patent ANVISA’s prior consent, about 40% during the patent examination process, opposition presented in Brazil helped were required to reduce the scope of reinforcing the need to reject non- show that Gilead’s monopoly over claims or to enhance disclosure of the qualifying patents. They can also tenofovir was sustained by a patent invention. present new arguments which were that could be successfully challenged. • International impact: ANVISA’s not previously considered by the patent The opposition also helped to prior consent is seen as a model to office, thus improving patent quality. emphasise the importance of ensuring be reproduced in other countries. Brazil’s law adopted the model of the patent law and patent examination The final Report of the World “support to examination”, which allows process enables the rejection of patent Health Organization’s Commission interested parties to present arguments applications when these on Intellectual Property Rights, and documents to the patent examiner. are undeserved. Continued overleaf

3 ISSUE BRIEF Médecins Sans Frontières Access Campaign | Why Brazil should reform its patent law and boost medical innovation to promote access to medicines

Continued

Compulsory licences A compulsory licence is a government Health Ministry US$1.2 billion in pharmaceutical ingredients, in order order that allows a company other than treatment costs in recent years.4 When to be able to produce generics the patent-holder to manufacture a a compulsory licence was issued for locally, created economies of scale patented product without the consent efavirenz in 2007, the price dropped and contributed to transforming the of the patent owner (although the from $580 for one year’s treatment market for HIV medicines in to a low- patent owner is still paid for use of the to $158. Over five years, the savings margin, high-volume model.6 Other patent), or to enable the import of such generated by the compulsory licence countries have also issued compulsory a product from a generic manufacturer were approximately $103 million and licences, including Thailand in 2006 in another country. Compulsory the number of patients treated with and 2007, Ecuador in 2009 and 2012, licensing has been incorporated into the drug increased around 30%5. Indonesia in 2012, and India in 2012. Brazilian legislation and can be issued • International impact: The threats for a number of reasons, including to issue compulsory licences were Between our trade and economic abuses by the patent owner, backed up by a strategy involving or in the case of a national emergency our health, we have government-owned laboratories, or a public interest declared by the chosen to look after which were able to calculate the federal authorities. cost of manufacturing specific our health. • National impact: In Brazil, the threat drugs. Brazil thereby helped to LUIZ INACIO LULA DA SILVA, of issuing a compulsory licence increase transparency of global PRESIDENT OF BRAZIL, SPEAKING has been used to pressure drug drug prices, and prompted a global companies during price negotiations policy dialogue on affordable ON BRAZIL’S DECISION TO ISSUE for medicines to treat HIV/AIDS. access to treatment. In addition, a A COMPULSORY LICENCE ON THE This strategy has saved the Brazilian strong market demand for active HIV DRUG EFAVIRENZ, 2007

MEDICAL INNOVATION Brazil has played an important role in the development impact on access to medicines when they are used of WHO’s Global Strategy and Plan of Action on Public to prevent competition; and 3) there is insufficient Health, Innovation and Intellectual Property (GSPOA), R&D for diseases that prevail in developing countries. which was a significant milestone in addressing issues Increasingly, Brazil has been supporting the view that of sustainable research and development, innovation cooperation on health R&D must rely on mechanisms and access to medicines. In seeking a meaningful that promote open knowledge innovation, data sharing implementation of GSPOA, Brazilian representatives and coordinated R&D efforts.1,7 have made several political statements in different multilateral fora recognising that: 1) intellectual property does not necessarily have a positive effect on economic development; 2) patents can have a dramatic

The granting of frivolous patents may do enormous harm to R&D activities and disrupt the necessary flows across innovation chains.

BRAZILIAN DELEGATION AT THE TRIPS COUNCIL - WORLD TRADE ORGANIZATION, 2012 © Jorge Dirkx

4 Médecins Sans Frontières Access Campaign | Why Brazil should reform its patent law and boost medical innovation to promote access to medicines ISSUE BRIEF

III – NEXT STEPS: WHY BRAZIL SHOULD REVIVE ITS LEADERSHIP ON ACCESS TO MEDICINES AND MEDICAL INNOVATION

Increasing access to new therapies and technologies is also important. Brazil respects its intellectual property commitments. Yet we are convinced that the flexibilities contained in the WTO’s TRIPS Agreement, in the Doha Declaration on the TRIPS Agreement and Public Health, and in the World Health Organization’s Global Strategy on Public Health, Innovation and Intellectual Property, are indispensable for policies that guarantee the right to health.

DILMA ROUSSEFF, PRESIDENT OF BRAZIL, AT THE UN HIGH-LEVEL MEETING OF THE GENERAL ASSEMBLY ON THE PREVENTION AND CONTROL OF NON-COMMUNICABLE DISEASES, SEPTEMBER 2011

Despite these important initiatives to Access to medicines is intrinsically linked real costs of drug development, but it secure access to medicines, challenges to the way we pay for medical research also steers innovation away from areas and threats remain. Brazil, with one of and drug development. The current of greatest health need and towards the oldest cohorts of people on HIV R&D model not only leads to higher areas of greatest profitability, skewing treatment in the world, will face increasing prices, as it gives patent-holders a free priorities and leaving many pressing pressure as more and more people hand in determining prices without health needs unaddressed. develop resistance to their medicines and providing any transparency on the will need to be switched to second-line or third-line regimens – which typically cost double and at least 15 times more than a first-line combination, respectively. ANTIRETROVIRAL PRICES IN US$, 2013 Source: Brazilian Ministry of Health, reply to access to information request 2013 The challenges caused by high prices are not limited to HIV; the prices announced for many new drugs, Lowest price available Price in Brazil including bedaquiline for tuberculosis, sofosbuvir for hepatitis C and many 16000 cancer medicines, are astronomically 14000 high, particularly in middle-income countries such as Brazil which represent 12000 growing market opportunities for the 10000 pharmaceutical industry. 8000

6000 Cost in US$

4000

2000

0 /MSF 1st line therapy 2nd line therapy 3rd line therapy (TDF + 3TC + EFV) (TDF + 3TC + lpv/r) (RAL + DRV/r + ETV)

Continued overleaf © Andrea Bussotti

5 ISSUE BRIEF Médecins Sans Frontières Access Campaign | Why Brazil should reform its patent law and boost medical innovation to promote access to medicines

Continued (1) REDUCE FLAWS IN THE PATENT SYSTEM IN ORDER TO BETTER SERVE THE PUBLIC INTEREST The report Brazil’s Patent Reform: A summary of the positive changes being proposed can be found in the following table: Innovation Towards National Competitiveness (2013) reinforces the What improvements can the reforms tabled in Brazilian congress bring? point that using patents to reward Flaws in the Improvements innovation is a flawed model, leading Bill nº Outcome to a growing innovation crisis, and current law proposed Improved public characterised by a constant lack of access Patent examiners are Pre-grant patent participation in the to the fruits of innovation. The result obliged to recognise oppositions may not patent examination arguments presented 5402/2013 is increased technological asymmetry be considered by process; stronger through pre-grant between countries, and a huge imbalance patent examiners rejection of patent oppositions between costs and benefits from the undeserved patents Clarify that ANVISA public health perspective. By its turn, the Secure the participation Uncertainty over is entitled to analyse report from the “Special Sub-Commission of the health sector in the role performed the fulfilment of all 5402/2013 the review of patents, on the Development of the Health by ANVISA on the 3943/2012 to avoid the granting of Industrial Complex, Production of Drugs, examining patents requirements established underserved patents Equipment and Other Inputs” (2014) by the patent law List a number of defends the use of TRIPS flexibilities, the Patentability criteria common pharmaceutical Reinforce the rejection need for increased generic competition, does not detail which 5402/2013 claims that cannot be of frivolous patents, for kind of pharmaceutical 3995/2008 the urgent need to reform Brazilian considered innovative example patents on new claims are considered 2511/2007 patent law, and the search for new R&D enough to deserve forms of known medicines innovative or not and innovation models, especially those a patent Remove barriers to the Better grounds to that de-link R&D costs from the final Limitations on the use 8090/2014 issuance of compulsory address abuses in price of products. of compulsory licences 5402/2013 licences and strengthen monopolies, protect and governmental-use 2846/2011 the mechanism allowing public health policies and Both reports suggest that the Brazilian licences to promote 303/2003 governmental supply countries without price reductions 139/1999 government should work on two fronts use of patents manufacturing capacity to fix the innovation and access crisis: Open channels to Ensure that generic Remove provisions that (1) Reduce flaws in the patent system in extend the monopoly competition starts can lead to monopoly 5402/2013 term beyond the as soon as a patent order to better serve the public interest extensions (see table). standard 20 years monopoly ends (2) Increase public investment and Allow parallel Limitation on the use Change the regimen to importing of lower cost implement alternative R&D incentives that of parallel importation international exhaustion 8091/2014 patented or generic promote innovation, but also allow for mechanism of rights products put onto the access to affordable medicines (see page 8). international market

6 Médecins Sans Frontières Access Campaign | Why Brazil should reform its patent law and boost medical innovation to promote access to medicines ISSUE BRIEF

Analysis of provisions under discussion at Brazilian congress

Measures to protect public health criteria already established by law, and amendment would change the regimen to ensure that patent applications not international exhaustion of rights, which Patentability criteria: Whereas the 1996 approved by ANVISA are in fact rejected. allows for importation of both patented law is insufficiently precise in terms of and generic products on the market in defining what deserves a patent in Brazil, Compulsory licences and government use of any other country. The majority of WTO some new bills specifically identify types of patents: Brazil currently lacks an explicit countries have international exhaustion pharmaceutical patent claims that may not mechanism for governmental use of of rights, and parallel importing has be considered inventive. These provisions patents, although it does already allow been widely practised by some Western directly tackle the industry strategy known compulsory licences. Authorising the countries. By improving and using this as ‘’, when multinational public, non-commercial use of a patent flexibility, Brazil can achieve greater price pharmaceutical companies apply for by government agencies will allow public reductions for a variety of drugs. secondary patents for trivial changes interests to be prioritised more quickly. to existing compounds, so that patents This provision is fully in line with TRIPS Measures harmful to public health and monopolies can be ever extended, obligations, and is common practice in Patent term extensions: Currently, under blocking generic competition and limiting many countries, serving as an important Article 40 of the 1996 law, the duration supply options for government treatment tool to balance the private rights of of a patent is limited to 20 years from programmes. By introducing stricter patent holders with the public interest. the date of filing the patent application. patentability criteria, Brazil will improve In addition, it is important that Brazil Nevertheless, the law also allows for its ability to reject and revoke undeserved maintains a wide variety of grounds compensation for the time spent for patents. Experience from countries such as in patent law for issuing compulsory examination of the patent application, India show that reducing patent barriers licences, including those concerning so that the period of patent protection enables the local development and use ‘refuse to deal’, anti-competitive practices is longer than 20 years. This is a typical of fixed-dose combinations, which for and other situations, particularly while ‘TRIPS-plus’ provision (in that it goes diseases such as HIV and TB are critical the balance between patent monopoly above and beyond what Brazil is obliged to provide patients with effective, easy- and knowledge diffusion is considered to do under the TRIPS Agreement), and to-take combinations. Strict patentability broken. One of the bills would also one that should be revoked. Indeed, the criteria is also a way to encourage include in Brazilian law the possibility time needed to complete a thorough companies to focus on developing new of using a compulsory licence for substantive examination may be lengthy, medicines, instead of seeking patents on exportation of patented products (also but this is a common practice across minor modifications to existing products. known as the Paragraph 6 mechanism), countries and is not specific to Brazil. Pre-grant oppositions: A proposed namely products manufactured through Granting patent term extensions not amendment would make it mandatory for a patented process, for the purpose of only unnecessarily extends the term of patent examiners to respond to oppositions supplying countries with insufficient or patent protection, but it places undue that are filed, thereby formalising the no manufacturing capacity. This is an pressure on patent examiners that have pre-grant opposition proceeding. Such a important step towards making full use of to review thousands of frivolous patent change would enable Brazil to capitalise all flexibilities available under international applications filed by multinational on the experience gained from cases trade rules, and would enable Brazilian pharmaceutical companies. such as the tenofovir opposition, and to manufacturers to strengthen access to Data exclusivity: Through data exclusivity, strengthen the opposition mechanism so medicines in other developing countries. multinational pharmaceutical companies that it is a more effective tool serving the Parallel importation: This flexibility, allowed can delay generic competition by public interest. This is in line with Brazil’s under TRIPS, enables countries to obtain preventing a national drug regulatory position at WTO calling for strengthening the best price on the global market for authority from relying on original test of opposition systems. medicines, as it allows imports of a lower data to establish the bioequivalence of ANVISA prior consent: Involving the cost medicine without the patent owners’ a generic medicine. This is not required Ministry of Health in the examination consent, if that product has been put on under the TRIPS Agreement, which only of pharmaceutical patent applications the market in another country. Parallel requires protection of undisclosed data in has been recognised as an innovative importation provisions, however, can the context of unfair competition. Some and effective mechanism under Brazil’s be drafted in different ways. In Brazil bills propose that no data exclusivity is patent system from the perspective it was incorporated under a national allowed during the drug registration of safeguarding public health needs exhaustion of rights regimen. This model procedures. By rejecting data exclusivity, of the country. By clarifying the provides greater protection to patent Brazil’s patent law could ensure the patent law, Congress can secure owners than required under international monopoly position of originator ANVISA’s involvement in the analysis of trade rules and in practice allows them companies is not unfairly prolonged patentability requirements and other to block parallel importing. A proposed through regulatory procedures.

7 ISSUE BRIEF Médecins Sans Frontières Access Campaign | Why Brazil should reform its patent law and boost medical innovation to promote access to medicines

(2) INCREASE PUBLIC INVESTMENT AND IMPLEMENT ALTERNATIVE R&D INCENTIVES THAT PROMOTE INNOVATION AND ACCESS TO AFFORDABLE MEDICINES Since at least 2001, Brazil has been than conferring monopoly rights as an a position to lead discussions globally on actively pushing for resolutions and incentive, prizes pay out in full as soon how these incentives can be refined and decisions that highlight the problems as the milestone is reached, allowing brought to scale. in the patent system, and calling for for immediate dissemination of the Much of the R&D behind successful solutions. The Global strategy and plan new technology at fair, competitive new drugs is heavily subsidised by the of action on public health, innovation prices. The aim of such a prize would taxpayer. Globally, at least 40% of all and intellectual property, which was be to demonstrate how alternative R&D is paid for from the public purse approved at the World Health Assembly incentives to monopoly rights can work and by philanthropic organisations. in 2008 under a strong leadership from in practice. It would be a ‘test case’ in Despite the use of public funding for Brazil and other UNASUR countries, has order to learn from the experience and new treatments, governments and paved the way for the current debate at pioneer new models. individuals are often then faced with WHO on new innovation models. MSF perspectives on the National Fund: high prices for medicines, secured by In order to continue this leadership In line with the Brazil’s patent reform the patent regime. In effect, people at the global level, Brazil should take report’s recommendations, the research are paying twice for new drugs. And action at the national level to implement results stemming from any increased in many cases, this investment results the recommendations in Brazil’s Patent public financial contribution should be in the neglect of non-lucrative heath Reform: innovation towards national placed in the public domain or made needs and exclusion of patients who competitiveness (2013) and the “Special available through a mandatory open cannot afford the increasingly expensive Sub-Comission on the Development access platform. The report further treatments that industry chooses to of the Health Industrial Complex, recommends that research priorities be develop. The medical innovation system Production of Drugs, Equipment and coordinated and defined by the Ministries is broken – it’s time we fixed it for the Other Inputs” report (2014), which are: of Health, and Science, Technology and benefit of everyone. We urgently need a) Creation of a national health innovation Innovation. MSF would add to this the an alternative system, one where R&D prize, to stimulate research under a non- importance of coordinating with WHO investments result in needs-driven exclusivity regimen, placing results in an to ensure global coherence. Moreover, innovation and access. Leadership from open access platform; and MSF would like to stress that attention countries like Brazil will be critical in reconciling medical innovation with b) Create a fund for priority health needs should be paid to the whole innovation its original purpose: to achieve better that accounts for at least 0.01% of GDP. cycle, so that R&D efforts support the eventual delivery of affordable and medical outcomes and ensure the fruits MSF perspectives on the National Prize: accessible health tools on the market, of science are equally shared. The report from the “Special Sub- rather than focusing exclusively on Commission” recommends that the funding to ‘de-risk’ R&D efforts by Ministry of Health establish a health supporting early stage R&D. innovation prize in Brazil. MSF suggests that efforts could begin with the In demonstrating a strong commitment IINNOVATION ACCESS definition of a clear prize target in to the R&D needs of developing countries terms of a priority health technology. through increased financing, and As ‘pull’ incentives, prizes pay for R&D demonstrating how alternative incentives efforts on the delivery of results; rather work at the national level, Brazil will be in

REFERENCES 1 Câmara dos deputados: Center for Studies and Strategic Discussions. Brazil’s patent reform: innovation towards national competitiveness [Online]. 2013 Oct 23 [cited 2014 Dec 04]. Available from: http://www2.camara.leg.br/a-camara/altosestudos 2 Commission on Social Security and Family. Special sub-commission on the development of the health industrial complex, production of drugs, equipment and other inputs [Online]. 2014 Oct [cited 2014 Dec 04]. Available from: http://www.camara.gov.br/proposicoesWeb/prop_mostrarintegra?codteor=1263052&filename=REL+1/2014+CSSF 3 Diário do Congresso Nacional: Exposição de motivos n.º 92,de 13 de dezembro de 1999, publicada de 28 de janeiro de 2000 (p. 2656 a 2663), referente à MP 2006/1999 4 Nunn A, Fonseca E, Bastos F, Gruskin S, Salomon J. Evolution of Antiretroviral Drug costs in Brazil in the context of free and universal access to AIDS treatment [Online]. 2007 Nov 13 [cited 2014 Dec 04]. Available from: http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.0040305 5 Neves da Silva FV, Hallal R, Guimarães. Compulsory license and access to medicines: economics savings of efavirenz in Brazil. Presented at: The 19th International AIDS Conference; 2012 Jul; Washington. Powerpoint presentation available from: http://pag.aids2012.org/PAGMaterial/PPT/940_3379/cl%20efv%20final.pptx 6 Nunn A, Fonseca E, Bastos F, Gruskin S. AIDS treatment in Brazil: impacts and challenges. Health Aff [Online]. 2009 Jul-Aug [cited 2014 Dec 04]; 28(4):1103-1113. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2782963/ 7 Brazil TRIPS Council. Statement on “intellectual property and innovation.” [Online]. 2012 Nov [cited 2014 Dec 04]. Available from: http://www.ip-watch.org/weblog/ wp-content/uploads/2012/11/Brazil-Statement-TRIPS-Council-Nov-2012.pdf

MSF Access Campaign Médecins Sans Frontières, Rue de Lausanne 78, CP 116, CH-1211 Geneva 21, Switzerland Tel: + 41 (0) 22 849 84 05 Fax: + 41 (0) 22 849 84 04 Email: [email protected]

www.msfaccess.org facebook.com/MSFaccess twitter.com/MSF_access