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Intellectual Property and Access to Medicines: A General overview of the TRIPS Agreement Intellectual Property Rights and Access to Essential Medicines: Challenges and Opportunities in Free Trade Agreement Negotiations, Multilateral Instruments and National Laws 21-22 June 2010, Kyiv, Ukraine Tenu Avafia HIV/AIDS Practice, UNDP HIV prevalence (%) in adults (15–49) in Eastern Europe and Central Asia, 2007 2.16 Comparison of 2005 and 2007 percentage coverage of antiretroviral therapy for people with advanced HIV and percentage coverage of antiretroviral drugs for HIV positive pregnant women by region Antiretroviral Therapy 100 2005 2007 Prevention of Mother to Child Transmission 2005 2007 Percent (%) 80 60 40 20 0 Sub-Saharan Africa Source: UNAIDS/UNICEF/W HO Latin America East, South EasternEurope and the and and Caribbean South-East Asia Central Asia North Africa and the Middle East GLOBAL Patent applications per country Source: Worldmapper.org 15-49 Age Group living with HIV Number of people receiving antiretroviral therapy in low- and middle-income countries, by region, 2002–2008 4.5 North Africa and the Middle East 4.0 Europe and Central Asia 3.5 East, South and South-East Asia Latin America and the Caribbean 3.0 Millions Sub-Saharan Africa 2.5 2.0 1.5 1.0 0.5 0.0 End 2002 End 2003 End 2004 End 2005 End 2006 End 2007 End 2008 Why do TRIPS flexibilities continue to be important? • • • • • • • Only 17% of People needing ART in region are receiving treatment Treatment programs expected to be strained by Global economic crisis Anticipated scale-down of funding for GFATM treatment Programmes in region by 10% from next year Most commonly used 1st line of AZT 3TC, EFV cost $ 357 in middle income countries Less than 5% of patients currently on ARVs are receiving 2nd line treatment Most commonly used 2nd line ARV (didanosine, abacavir and ritonavirboosted lopinavir) cost U$ 3306 in middle income countries Cost of treatment will increase with the introduction of 2nd line treatment and different medicine combinations Why do TRIPS flexibilities continue to be important? • • • • • • • • MSF reported that treating 58 patients on 2nd line ARVs cost the same as treating 550 patients on 1st line Possible scale-down of funding for GFATM treatment Programmes? Impact of new Indian Patents Amendments Act replacing 1970 Act not yet felt India provides large supply of generic 2nd line ARVs Indian Patent offices starting to grant more patents post 2005 Patenting of new medicines in India will impact availability of 2nd and 3rd line medicines in CIS Sustainability enhanced by using TRIPS flexibilities to reduce costs and to sustain/increase treatment August 30 2003 Mechanism is an important flexibility for developing countries The treatment time-bomb http://www.aidsportal.org/repos/APPGTi mebomb091.pdf Policy space available to countries before TRIPS • Since formal recognition of IP, there have always been exceptions • England’s 1st IP law of 1623 motivated by incentive to attract French and Dutch craftsmen who were more technologically advanced • German Reichspatentgesetz of 1877 did not allow granting of patents against public order or morality • Most comprehensive international agreement for patents was 1883 Paris Convention • Paris Convention still provided significant policy space to shape IP policy, with major exception being national treatment principle • India e.g. changed its law in 1970 to exclude pharmaceutical patents, allowed local companies to reverse engineer, produce cheaper generics • Most developed countries only granted pharmaceutical patents after their industries developed e.g. Switzerland 1977, Italy 1978 (5th largest pharmaceutical producer), Spain in 1986 (entry into force in 1992) A push towards the TRIPS Agreement • According to UNCTAD Report of 1974, 84% of patents in low income countries belonged to 5 countries: US, France, Germany, Switzerland and UK • High income countries attempted to revise Paris Convention in 1980, 1981, 1982 & 1984 to include more enforcement and dispute settlement provisions without success • From early 1980s, Industry groups in US e.g. Association of American Publishers, Anti-counterfeiting Coalition, Agricultural chemicals producers Pharma began pressing for new IP multilateral agreement • US asserted in Uruguay trading round that IP needed to be addressed to prevent its use as a non tariff barrier • US enacted Omnibus Trade and Tariff Act of 1988, Section 301 allowed for bilateral sanctions to be imposed for IP violations • Agreement on intellectual property included in Uruguay Round Minimum standards imposed by TRIPS • WTO established 1 January 1995, TRIPS one of 3 primary instruments • TRIPS prescribes minimum standards for IP protection including enforcement • TRIPS Agreement regulates copyrights and related rights, trademarks, geographical indications, industrial designs, patents, layout-designs (topographies) of integrated circuits and protection of undisclosed information • Article 33 provides for 20 year minimum patent protection • TRIPS contains exceptions to patent rights and flexibilities for use by countries to reduce medicine prices e.g. compulsory licensing • Attempts by lower income countries to use flexibilities challenged by high income countries at WTO and pharmaceutical companies in domestic courts E.g. - compulsory licensing dispute involving Brazil & US at WTO - Parallel importation case involving PMA and SA government Doha Declaration on TRIPS & Public Health (2001) • We agree that the TRIPS Agreement does not and should not prevent members from taking measures to protect public health • Each member has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted • However, in terms of Article 31(f): 51% must be for supply of the domestic market. 49% can be exported (nonpredominant portion) Two problems arose: • What if 49% of what a country exports is not enough to meet global demand? • What if a country has insufficient or no manufacturing capacity? Paragraph 6 Doha Declaration “We recognize that WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement” “We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002” 30 August 2003 Agreement • Mechanism allows exporting countries to issue CL and to export entire amount to countries in need • Several requirements must be met before the medicines can be exported under the mechanism: (i) notification of WTO Secretariat by importing country of medicine names and quantities; (ii) exporting company must give notice on quantity of medicines being shipped, distinguishing features to prevent anti-diversion; (iii) negotiations for VL must occur and fail before CL granted; (iv) exporting country has to provide info on the quantities and countries being supplied • Canada became the first country to pass legislation to implement August 30 Agreement • Other countries that have amended laws to export under CL include China, EU, India, Korea, Netherlands and Norway Reflections on 30 August Agreement • To date, only use of 30 August Mechanism in 6 and a half years has been the Rwanda/Canada case • Process of obtaining medicines through Decision slow • Would this solution work for public health emergency? • If decision ratified by 2/3rds of WTO membership, it becomes permanent (102 countries) • 27 ratifications at present (depending on how you count the EU) • Should this be re-visited by WTO Member States? • TRIPS Council meeting in June 2010 proposing a Workshop later in 2010 to determine effectiveness UNDP service offerings: Technical & policy support • Providing technical and policy support to countries in the process of amending IP legislation • Policy support on utilizing TRIPS flexibilities (e.g. Thailand compulsory licensing mission in partnership with WHO, UNAIDS, WTO & UNCTAD) and Ecuador meeting before compulsory license issued • Capacity development of patent examiners from 7 African, 9 LAC and 6 countries from RBAS on examination of pharmaceutical patents from public health perspective • Developing capacity of government officials in Asia, Africa, Latin America , Caribbean, Eastern Europe ( with WHO, PAHO, OSI) • Training parliamentarians (gatekeepers)