Public health, innovation and intellectual property 1 |1 | Dr Germán Velásquez Director WHO Secretariat Public Health, Innovation and Intellectual Property The evolution of the access to medicines debate internationally Access to Essential Medicines, HIV and Intellectual Property Rights Regional Meeting Sponsored by UNDP/OSI September 2009 Kiev, Ukraine

Public health, innovation and intellectual property 2 |2 | Plan of the presentation 1.Access to medicines: global overview 2.IP policy situation before 1995 from GATT to WTO 3.Changes with the WTO/TRIPS Agreement in WHO perspectives and technical assistance

Public health, innovation and intellectual property 3 |3 | Access to ARVs According to WHO/UNAIDS/UNICEF 2008 report, the number of people who need ARV treatment is estimated at 9 million The report also says that only 3 million out of the 9 million people are receiving ARV treatment … 97% of the 3 million on ARVs are treated with the "first line" treatment, available in generic form at a cost of between US$ 150 and US$ 300 per person per year… During the following years, many of the patients have to pass to the "second line" treatment ( in some countries in Latin America, 30% of the patients are already on "second line" ) and the cost increases to US$ or US$ per patient per year…

Public health, innovation and intellectual property 4 |4 | People are dying because of lack of access to essential drugs 10.3 million children under 5 years of age die in developing countries each year. About 8.6 million of these deaths are due to communicable, perinatal and nutritional conditions. A large proportion of these deaths could be prevented if those at risk had access to essential drugs.

Public health, innovation and intellectual property 5 |5 | Plan of the presentation 1.Access to medicines: global overview 2.IP policy situation before 1995 from GATT to WTO 3.Changes with the WTO/TRIPS Agreement in WHO perspectives and technical assistance

Public health, innovation and intellectual property 6 |6 | GATT GATT: General Agreement on Tariffs and Trade, signed in 1947 by 23 countries Purpose: to reduce barriers to international trade and to lower customs tariffs Method: the “Rounds” periodic negotiating cycles the Kennedy Round, the Tokyo Round, the Uruguay Round, In 1994 the World Trade Organization replaces GATT

Public health, innovation and intellectual property 7 |7 | WTO Entered into force in countries participating in the Uruguay Round negotiations Today, 153 Members and 30 observer governments

Public health, innovation and intellectual property 8 |8 | From Uruguay Round ( ) to WTO The new World Trade Organization (WTO) replaces the previous GATT New trade agreements are annexed to the WTO Agreement, including the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) WTO members are automatically bound by all WTO multilateral trade agreements

Public health, innovation and intellectual property 9 |9 | Plan of the presentation 1.Access to medicines: global overview 2.IP policy situation before 1995 from GATT to WTO 3.Changes with the WTO/TRIPS Agreement in WHO perspectives and technical assistance

Public health, innovation and intellectual property 10 | Differences GATT / WTO GATT only a treaty (no institutional basis) trade of goods free adherence to agreements annexed dispute settlement system inefficient WTO a real and permanent international organization trade of goods, services, intellectual property rights multilateral trade agreements binding all members an integrated and efficient dispute settlement system

Public health, innovation and intellectual property 11 | The TRIPS Agreement: “Trade-Related Aspects of Intellectual Property Rights” (1994) Some characteristics: Minimum standards for intellectual property Obligatory for all members of the WTO New: patents for pharmaceuticals: products and processes Patents for a minimum period of 20 years A certain amount of freedom for Member States

Public health, innovation and intellectual property 12 | Before TRIPS: diversity Patents granted either for pharmaceutical products, or for pharmaceutical processes, or both, or no patents available for drugs Patent term protection varied from 5 to 20 years Exceptions to patent exclusive rights and compulsory licences unlimited

Public health, innovation and intellectual property 13 | After TRIPS: uniformity Patents must be available in all WTO Member States for pharmaceutical products and processes Minimum duration of 20 years from the filing date Exceptions are limited Compulsory licences are conditional

Public health, innovation and intellectual property 14 | Patents Title granted by the public authorities conferring a temporary monopoly in a specific country on an invention, in exchange for divulging this invention to the public Regulated by national law only (conditions of granting, duration, exceptions, compulsory licences) No international patent exists: current international conventions only facilitate patent protection in different countries

Public health, innovation and intellectual property 15 | Application of TRIPS 1996 in developed countries 2000 in developing countries in general 2005 in developing countries using the transitional period like India 2006 in least developed countries (LDC) 2016 extension given by Doha for LDC

Public health, innovation and intellectual property 16 | Plan of the presentation 1.Access to medicines: global overview 2.IP policy situation before 1995 from GATT to WTO 3.Changes with the WTO/TRIPS Agreement in WHO perspectives and technical assistance

Public health, innovation and intellectual property 17 | Concerns expressed by several countries on the impact of TRIPS High prices for new drugs in countries with no previous patent protection system Generic competition delayed in countries with previous patent term less than 20 years Weakening of local pharmaceutical industry - concentration of drug production … increasing dependence of developing countries

Public health, innovation and intellectual property 18 | TRIPS and public health tensions Introduction of IP regimes of developed countries in developing countries HIV epidemic – price of ARVs Bilateral trade agreements/IP restrictions WTO – TRIPS – Doha debate Litigation from the pharmaceutical industry against developing country governments (South Africa, India…) According to a EU report, pharmaceutical originator companies are delaying or blocking market entry of competing medicines (July 2009)

Public health, innovation and intellectual property 19 | May Revised Drug Strategy The Fifty-second World Health Assembly, … Requests the Director-General: "...to cooperate with Member States, at their request …in monitoring and analysing the pharmaceutical and public health implications of relevant international agreements, including trade agreements, so that Member States … are able to maximize the positive and mitigate the negative impact of those agreements …" (resolution WHA52.19)

Public health, innovation and intellectual property 20 | WHO mandate on public health, innovation and intellectual property 1996 (WHA 49.14): requesting WHO to study and inform on the impact of WTO on medicines 1999 (WHA52.19): Revised drug strategy 2000 (WHA53.14): HIV/AIDS: confronting the epidemic 2001 (WHA54.10): Scaling up the response to HIV/AIDS 2001 (WHA54.11): WHO medicines strategy 2002 (WHA55.14): Ensuring accessibility of essential medicines 2003 (WHA56.27): Intellectual property rights, innovation and public health 2003 (WHA56.30): Global health sector strategy for HIV/AIDS 2004 (WHA57.14): Scaling up treatment for HIV/AIDS 2006 (WHA59.24): Public health, innovation, essential health research and IPR: towards a global strategy and plan of action 2006 (WHA59.26): International trade and health 2007 (WHA60.18): Malaria 2007 (WHA60.30): Public health, innovation and intellectual property 2008 (WHA61.21): the WHA adopts the global strategy and agreed parts of the plan of action on public health, innovation and intellectual property

Public health, innovation and intellectual property 21 | Background 1996–2009 Since 1999, four WHA resolutions have given WHO the mandate to: Assist Members States to develop medicines and health policies related to international trade agreements Monitor, analyse, study and report on health implications of international trade agreements Provide technical and policy support to countries that intend to make use of TRIPS flexibilities Promote new thinking on innovation and access to medicines Promote education and training in the application and management of Intellectual Property from the public health perspective

Public health, innovation and intellectual property 22 | WHO programme of work on pharmaceuticals and IPR Guidance on cost-containment mechanisms and policies for essential medicines Training and briefings on TRIPS flexibilities Advice on the revision of national laws related to health and pharmaceuticals Organization of inter-ministerial meetings (health, trade and patent offices) Monitoring and evaluation of the impact of TRIPS

Public health, innovation and intellectual property 23 | WHO policy perspectives on access to essential medicines in the context of globalization WHO supports any measure which will improve access to all essential medicines, including mechanisms to promote competition, such as: –price information –generic policies –reduced duties, taxes, mark ups –parallel imports –application of WTO/TRIPS flexibilities

Public health, innovation and intellectual property 24 | Conclusions: points for policy makers Introduction of a public health perspective into the intellectual property protection regime Incorporation and use of the flexibilities permitted by the TRIPS Agreement in the revision of national laws and regulations (e.g. Bolar provision, compulsory licensing, exceptions to exclusive rights, introduction of public health perspective in the criteria of patentability, extension of the transitional period…) Implementation of the Doha Declaration Caution with «TRIPS-plus» provisions Monitoring of the public health impact of new trade agreements

Public health, innovation and intellectual property 25 | Summary Table: Examples of compulsory licences by/for developing countries Date Country Type Product April 2003Zimbabwe CL all HIV/AIDS-related medicines Oct. 2003Malaysia GU didanosine zidovudine FDC didanosine+zidovudine Sept. 2004Zambia CL FDC of lamivudine+ stavudine+nevirapine Oct. 2004Indonesia GU lamivudine nevirapine Nov. 2006Thailand GU efavirenz Jan. 2007Thailand GU lopinavir/ritonavir Jan. 2007Thailand GU clopidogrel March 2007Indonesia GU efavirenz May 2007Brazil GU efavirenz Sept. 2007Canada for export to Rwanda CL FDC of lamivudine+ zidovudine+nevirapine Jan. 2008Thailand GU several cancer drugs CL = compulsory license; GU = government use (CL for public non-commercial use).