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Panel 2 jorque beloqui


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  • 1. AIDS: NGO initiatives for the access to treatment and intellectual property • Jorge A Beloqui • GIV (Grupo de Incentivo à Vida/ Group for Life Incentive) • 5511-5084-0255 • ABIA (Associação Brasileira Interdisciplinar de AIDS/ Brazilian Interdisciplinary AIDS Association) 5521-2223-1040 • RNP+ • IME-USP • GTPI (Rebrip) Jorge Beloqui, agosto 2010
  • 2. (preventive or therapeutic) against the HIV virus or Hepatitis C ? What are the current access issues experienced by the HPV vaccine? • Would they be available to everyone in the world who needs them? • Or would there be the same access problems that we experience with antiretrovirals? • In Brazil, should the Unified Health System SUS) import these drugs from developed nations paying the same price as them? • Would the manufacturing technology be transferred to Brazil or other developing nations? Jorge Beloqui, agosto 2010
  • 3. HPV Vaccine • Tested in Phase III in Brazilian women • Mass vaccination in Europe for young women • In Brazil it is available in private clinics, not through public services • Price: around 1000R$ (more than 500U$S) • Conclusion: Brazilian women participated in the risk of the trial but not in the benefit of the results Jorge Beloqui, agosto 2010
  • 4. Brazil and Patents (I) • There was no transferring of technology • Increased the amount of money spent in foreign markets for the purchase of products patented in Brazil • There are few Brazilian patents in demand. The greater part comes from developed nations. • This caused the closure of several factories and prevented the investment of new ones in Brazil Jorge Beloqui, agosto 2010
  • 5. PARALYZED AND UNIMPLEMENTED UNITS INDUSTRIAL COMPLEX OF FINE CHEMISTRY   PERÍOD 89-99 (D. Barbosa) Pharmaceutical Pharmo- Agro- Additives, Type Intermediaries chemicals chemicals Aromatic TOTAL and Dyes Paralyzed 241 407 73 375 1.096 Not Implemented 208 110 10 27 355 TOTAL 449 517 83 402 1.451 Jorge Beloqui, agosto 2010
  • 6. How can patents create a barrier to access? • Because they establish a (temporary) monopoly, which is often widened over time • This monopoly presents an opportunity to skyrocket prices to unreasonable amounts • And thus diminishes access to treatment • This is the concern of NGOs working in the HIV/AIDS sector, as well as that of the people living with the virus • It is key to highlight that this access issue affects everyone using a new, patented drug: psychopharmaceuticals; chemotherapy; antihypertensive, asthma, and cholesterol medications; antibiotics; contraceptives; vaccines; etc. • Paid by the Public System agosto our own pockets Jorge Beloqui, or from 2010
  • 7. Effects of the distribution policy of antiretroviral drugs Brazil üReduction in mortality rates  40 - 70% ü Reduction in morbidity rates  60 - 80% ü Decrease of new HIV/AIDS cases 58.000 (until 2002) ü Decrease of HIV/AIDS-related deaths  90.000 ü Reduction of hospitalizations: 7x decreas Jorge Beloqui, agosto 2010
  • 8. In Brazil Universal access policy. The Ministry of Health is the only buyer. Budget 2008 = US$ 640 million December 2008 - 190.000 persons using ARVs Jorge Beloqui, agosto 2010
  • 9. ARVs distributed in Brazil - 2008 I P ITRN and ITRNt § RITONAVIR (1996)* § ZIDOVUDINA (1993)* § SAQUINAVIR (1996)* § ESTAVUDINA (1997)* § INDINAVIR (1997)* § DIDANOSINA (1998)* § NELFINAVIR (1998)** § LAMIVUDINA (1999)* § AMPRENAVIR (2001) § ABACAVIR (2001) § LOPINAVIR/r (2002) § TENOFOVIR (2003) § ATAZANAVIR (2004) § DIDANOSINA EC (2005) § FOSAMPRENAVIR (2007) ITRNN § DARUNAVIR (2008) Fusion Inhibitors § NEVIRAPINA (2001)* § EFAVIRENZ (1999) § ENFUVIRTIDE * national manufacturing– not protected by patents (2005) Jorge Beloqui, agosto **excluded in 2007 2010
  • 10. • 2009 Raltegravir • 2009 Maraviroc • 2010 Etravirine Jorge Beloqui, agosto 2010
  • 11. Getting close to Universal Access ü 94,8% coverage of ARVs – universal access ü Average Cost ü First line (AZT – 3TC – D4T – DDI – TDF – EFZ – NVP) – US$ 667 per patient/per year ü Second line (LPV/r – SQV – IDV – ATV – FOS – RTV) US$ 2,114 per patient/per year– 25% of all patients * Excluding costs from Darunavir and T20 Jorge Beloqui, agosto 2010
  • 12. Compulsory Licensing 2007 - Efavirenz End of 2006: Thailand implements compulsory licensing for EFV, Lopinavi/r and Plavix. Beginning of 2007: another 3 compulsory licenses are issued (Glivec among them) Brazil: EFV becomes the most widely used, imported ARV – 75.000 patients Long negotiation process – stable price since 2003 - US$ 1,59/pill – Thailand – 1.2% prevalence, 17.000 patients – US$ 0,67/pill – Dominican Republic – 1.1% prevalence • Jorge Beloqui, agosto 1,500 patients- US$ 0,67/pill 2010
  • 13. Compulsory Licensing 2007 - Efavirenz Annual Cost – from US$ 580.00 to US$166.36 per patient/per year – US$ 0,46 (including royalties and freightage) “Savings” estimated up to 2012 - US$ 237 millions In 2007 – from US$ 42 millions to US$ 12 millions Current National Manufacturing Jorge Beloqui, agosto 2010
  • 14. ANVISA Report 2010 n ANVISA is the Brazilian National Sanitary Agency n Selected Prices of selected Medicines during 2009 n in R$ n 1 US dollar ~ 1.8 R$
  • 15. ARVs ARV Br US Sp It Gr Ca Au Fr amp 536 693 546 742 mar 681 871 942 1221 1093 ral 1011 1879 2451 1540 1787 2505 kal 1029 1158 1234 794 1154 1184 947 1392
  • 16. GLIVEC (Imatinib, in R$) BR US Sp It Gr Ca Au Fr 3978 3040 3660 2329 3359 2919 2988 3562
  • 17. NGO (HIV/AIDS) Initiatives Jorge Beloqui, agosto 2010
  • 18. NGO (HIV/AIDS) Initiatives (II) • The Latin American and Caribbean Forum on HIV/AIDS (Río de Janeiro- November 5th and 6th, 2000) • 2001: demonstrations staged outside the US Consulates in SP, Recife, Rio de Janeiro , due to the handing over of a letter about ‘a contentious Brazil’ by the US in the WTO • 2001 June: lobby in the US Congress • The Brazilian Ministry of Health threatens to grant compulsory licensing to two antiretrovirals (Nelfinavir y Efavirenz); and Glivec (for leukemia) • A group of 39 pharmaceutical companies take action against the South African government to prevent the parallel importing of ARVs; • Doha Declaration (WTO) • The United Nations Commission on Human Rights: access to essential medicines as a human right; • UN GA: launches the Global Fund to Fight AIDS, Tuberculosis, and Malaria; Jorge Beloqui, agosto 2010
  • 19. NGO (HIV/AIDS) Initiatives (III) • State Health Conference (SP, 2001) • Letter to the US Treasury Secretary (August 2002) • XII ENONG (SP, 2003) • Government Transition Team (Nov. 2003) • National Conference of Science, Technology and Innovation in Health (CNCTIS) • National Conference on Pharmaceutical Assistance (2004) Jorge Beloqui, agosto 2010
  • 20. Key action: December 1st, 2004 • On the World AIDS day, the State of São Paulo AIDS/NGO Forum requested President Lula to implement a compulsory licensing (called ‘patent-breaking’) of AIDS drugs that formed a large part of the budget for ARVs. • The AIDS/NGO Forums of the States of Goiás and Ceará did the same Jorge Beloqui, agosto 2010
  • 21. Future Prospects: Access to Antiretrovirals • Second-line treatments are becoming more and more important • Current second-line treatments may become first-line treatments in the future •The prices of third-line drugs can skyrocket (i.e. T-20) • According to 2005 and 2008 surveys, there are approximately 700,000 persons living with HIV in Brazil Jorge Beloqui, agosto 2010
  • 22. Demo in São Paulo Jorge Beloqui, agosto 2010
  • 23. February 2005 crisis (I) • In this month there was a lack of diverse ARVs in Brazil • This crisis presented itself from the beginning of Lula’s term of government (2003), with localized and each time more frequent ARVs scarcity • There was a lack of nationally produced drugs, as well as imported ones • The first case was due to low quality and a scarcity of raw materials Jorge Beloqui, agosto 2010
  • 24. The crisis of February, 2005 (II) • Exhibited the great dependency that Brazil has on drugs • The crisis has not been completely overcome, but it has significantly improved • Some people think that Brazil will never return to its previous stock rates and stability Jorge Beloqui, agosto 2010
  • 25. Bill 22/2003 • Several letters were sent by NGOs (AIDS) supporting Bill 22/2003 by Congressman R Gouveia, that declared that HIV treatments should not be patentable • Bill was approved by several Commission in the House of Representatives. But it needs to be voted in plenary due to a requirement. Jorge Beloqui, agosto 2010
  • 26. 2005: Approved motions on compulsory licensing and Bill 22 (PL22) • RNP+ SE (Cedral (SP), march) • ERONG SE (Guarapari (ES), august) • ERONG Sul (SC, august) • RNP+ (Florianópolis (SC), august) • XIII ENONG (Curitiba, september) Jorge Beloqui, agosto 2010
  • 27. Resolutions • 2005 : The NHC approved a resolution for the issuing of compulsory licenses for tenofovir, efavirenz and lopinavir/rtv • The Ministry refused to sanction the resolution • Regional Council of Medicine of the State of Sao Paulo’s (CREMESP) Jorge Beloqui, agosto 2010
  • 28. May 2007 Jorge Beloqui, agosto 2010
  • 29. The Working Group on Intellectual Property (WGIP) visits the Civil House (I) • In February of 2005, a meeting of advisors from the Presidency of the Republic Civil House (similar to the head of the Cabinet Ministers) took place to discuss the regulations of the previous resolution by Anvisa (National Health Surveillance Agency) (law 10196) Jorge Beloqui, agosto 2010
  • 30. The Working Group on Intellectual Property (GTPI) visits the Civil House (II) • This law establishes that patent applications for medicines submitted to INPI (National Industrial Property Institute) must have the previous approval of Anvisa • Anvisa would not grant its approval for second use or for new formulations • Thus, we supported this law’s regulations Jorge Beloqui, agosto 2010
  • 31. What is the WGIP? Jorge Beloqui, agosto 2010
  • 32. Brazilian Network for the Integration of Peoples (REBRIP) – 2001 Network formed by non-governmental organizations and social movements. Divided into Work Groups- Agriculture, Commerce, Environment, Services, Intellectual Property, Gender, and Parliament. Monitoring of free trade agreements, encouragement of public debate, NGO training and awareness-raising about topics related to multilateral organizations. Jorge Beloqui, agosto 2010
  • 33. Working Group on Intellectual Property - 2001/2002 Membership – Brazilian Interdisciplinary AIDS Association (coordinators), HIV/AIDS NGOs and Brazilian human rights groups (GIV, GAPA-RS & SP, Conectas, RNP+), Intellectual Property researchers, Oxfam, Doctors without Borders, and other NGOs Jorge Beloqui, agosto 2010
  • 34. The WGIP and Rebrip aim to minimize the negative impact of the patent system for the access to medicines in Brazil Jorge Beloqui, agosto 2010
  • 35. Action in the different spheres of government TRIPS Context Mobilização da opinião pública e capacitação Pressure against Legislativ projects derived from e TRIPS-plus Opposition to laws the undue Public Demand for granting of Compulsory patents Licensing Executiv Judicial e Jorge Beloqui, agosto 2010
  • 36. Publication: Brazil is a “Tiger without Teeth” Jorge Beloqui, agosto 2010
  • 37. Public Civil Action (ACP) - 2005 Actors 5 NGOs (AIDS) 1 Human rights group 1 Consumer Protection group Federal Public Prosecutor’s Office A demand to the National Attorney to oblige the Executive branch of government to issue a compulsory license for Lopinavir/ritonavir (Kaletra®) Jorge Beloqui, agosto 2010
  • 38. Technical Consultancy by the WGIP and MSF Verification of the national capacity to manufacture AIDS medicines (public and private laboratories) Jorge Beloqui, agosto 2010
  • 39. Booklet on Patents and Access to Medicines Spanish Version: a_patentes_es.pdf es.pdf Jorge Beloqui, agosto 2010
  • 40. WGIP: prevent the undue granting of patents (2006) • Presented technical arguments to subsidize the exam applied to patent applications by the National Industrial Property Institute (INPI) n Aimed to prevent the issuing of patents that do not meet the requirements for patentability n And to avert the widening of the drug monopoly, through the acquirement of patents for old (and widely used) medicines Jorge Beloqui, agosto 2010
  • 41. WGIP: prevent the undue granting of patents (2006) • Tenofovir (TDF) – does not meet the inventive step criterion • 2nd patent for Lopinavir/ritonavir – illegal request, as it already possesses the first pipeline patent (includes arguments about the unconstitutional nature of the pipeline patent system) Jorge Beloqui, agosto 2010
  • 42. Tenofovir – 2008/09 first-line ARV – quick increase – 33.000 patients. Patent was issued in Brazil in 1995. The Ministry of Health declared TDF as part of the ‘public interest’ in April, 2008. TDF patent was denied in July, 2009. – Brazil – US$ 3,25/pill = US$ 1.186/year – Thailand – US$ 1,24/pill = US$ 454/year – Gilead Access Price - US$ 0,567/pill = US$ 207/year Jorge Beloqui, agosto 2010
  • 43. TRIPS flexibilities and their use (2007) • Great importance of the compulsory licenses issued by Thailand (efv, lop/r, plavix, imatinib and others) for the access to these drugs by developing countries and for the effective use of TRIPS flexibilities • Open letter of solidarity to Thailand (on compulsory licenses) was signed by 80 Latin American organizations and social movements • Letter denouncing Novartis’ actions in India Jorge Beloqui, agosto 2010
  • 44. Questions and answers about the compulsory licensing of Efavirenz in Brazil f Jorge Beloqui, agosto 2010
  • 45. Other Activities (I) • Workshop on Pipeline patents and access to medicines in São Paulo (2007): provided widespread coverage and criticism of the topic in conjunction with politicians, the media, activists, and specialists. Jorge Beloqui, agosto 2010
  • 46. Other Activities (II) • In May 2009, the Federal General Attorney filed a legal action claiming the unconstitutionality of pipeline patents (ADI) 4234 • Diverse Amicus Curiae (among them: ABIFINA, WGIP, Pró-Genéricos, Abrasem, etc) Jorge Beloqui, agosto 2010
  • 47. Other Activities (III) • Cooperation with India, Thailand, China, Colombia and South Africa was launched to undertake a study on access to medicines, and joint actions to oppose patents (India) and lend solidarity (compulsory licensing in Thailand and Colombia) since 2008 • Satellite Events at the IAS and AIDS Conferences Jorge Beloqui, agosto 2010
  • 48. The case of Truvada (I) • Truvada (Gilead, tenofovir + emtricitabine) is a combination of ARVs, widely used as first line regime for HIV • Licensed by FDA and EMEA in 2005 • Though used in clinical trials in Brazil Gilead did not apply for a license in Brazil till September 25th, 2009. This in part due to a solicitation by GTPI, and SP AIDS/NGOs FOrum Jorge Beloqui, agosto 2010
  • 49. The case of Truvada (II) • Tenofovir was also licensed for Hep B treatment by FDA in August 2008 • And also by EMEA • Due to an agreement with Glaxo, which produces Hepsera (for Hep B), they did not ask for a license in Brazil for this use. • It was a kind of Tordesilhas Treaty! Jorge Beloqui, agosto 2010
  • 50. Jorge Beloqui, agosto 2010
  • 51. Jorge Beloqui, agosto 2010
  • 52. The case of Truvada (III) n So the M o H asked for an “ex officio” license to ANVISA for the use of Tenofovir for Hep B. n Of course in developed countries both drugs are licensed for Hep B! 52
  • 53. Freedom and Necessity • The issue of access to medicines does not only encompass health needs (sensu stricto), but is also a matter of individual and collective freedom; • There needs to be a wide choice range (freedom) for patients; • The fight for universal access to ARVs and other pharmaceutical products (vaccines) is also an opportunity to publicly participate and be socially included; • The implementation of TRIPS flexibilities is fundamental to sustain the universal access policy for AIDS drugs and to promote the transfer of technology in the pharmaceutical sector; freedom to R&D, production and commerce • The real challenge is to create new mechanisms for the protection of intellectual property that do not interfere with the necessities of the population, specially the low-income portion Jorge Beloqui, agosto 2010
  • 54. University, patents and access (I) • Universities should stress the importance of REAL INNOVATION instead of helping pharma to obtain evergreening patents • This is one of the natural effects of the current patent system: try to extend the monopoly! • Here we have a clear conflict between MARKET and PUBLIC INTERESTS Jorge Beloqui, agosto 2010
  • 55. University, patents and access (II) • Universities should stress the importance of performing only clinical trials in Brazil whose results will be useful for Brazilians: this was not the case with HPV vaccine, for example. • It is not acceptable that Brazilians participate in the risks but not in the benefits • Universities should stress the importance of divulgating and presenting alternatives to the existing monopolies system as a way to reward innovation Jorge Beloqui, agosto 2010
  • 56. University, patents and access (III) • Universities should become aware that there are persons with many health needs in the Universities, among students, employees and professors • Universities should stress the importance of access for all citizens as a right superior to intellectual property and monopolies. Especially in case of health Jorge Beloqui, agosto 2010
  • 57. Patenting the Sun • A journalist asked Jonas Salk: "Who has the right to patent the anti-polio vaccine?" • Salk responded: "The people. Patenting the vaccine would be like patenting the sun" Jorge Beloqui, agosto 2010
  • 58. Thank You! • Phone #: 011-5084-0255 • Fax: 011-3814-4135 • Jorge Beloqui, agosto 2010