The WTO TRIPS Agreement and Public Health: The WTO TRIPS Agreement and Public Health Atty. Tanya Lat Presentation for the 3rd Regional Seminar for Young Progressives Southeast Asia (YPSEA) 25 October 2005, Discovery Suites Pasig City, Metro Manila


What are intellectual property rights (IPRs)?: What are intellectual property rights (IPRs)? IPRs are the legal rights given to persons over the creations of their minds. They usually give the creator an exclusive right over the use of his/her creation for a certain period of time.


The WTO TRIPS Agreement: The WTO TRIPS Agreement Trade-Related Aspects of Intellectual Property Rights Negotiated from September 1986 to the end of 1993 Text adopted at Marrakech (Morocco) in April 1994 and came into effect with the establishment of the WTO on 1 Jan. 1995 Most comprehensive international agreement on intellectual property to date


IPRs under the TRIPS Agreement: IPRs under the TRIPS Agreement COPYRIGHT Artistic works Literary works Computer software and data bases Related (neighboring) rights Performers Phonogram producers Broadcasters


IPRs under the TRIPS Agreement: IPRs under the TRIPS Agreement (2) INDUSTRIAL PROPERTY Patents Trademarks Geographical indications Industrial designs Plant varieties protection Topographies of integrated circuits Undisclosed information


TRIPS and Public Health: TRIPS and Public Health The issue of patents vis-à-vis access to medicines


TRIPS and Public Health: TRIPS and Public Health The TRIPS Agreement introduced the most drastic harmonizing effect with respect to pharmaceutical patents.


How does a patent work?: How does a patent work? A patent grants the inventor the right to prevent others from making, selling, importing, or using the protected invention without authorization for a fixed period of time within a country.


Why give inventors patent protection?: Why give inventors patent protection? To enable them to recover the costs of research and development To give them incentives to keep on inventing


Patents and access to medicine : Patents and access to medicine Patented medicines are generally more expensive than their generic counterparts. High prices for medicines in developing countries have seriously compromised the ability of governments, communities, and other players in the health sector to effectively manage infectious diseases. High drug prices leave governments with little money left over to spend on other related health needs like infrastructure and training.


The TRIPS flexibilities-access to medicines debate: The TRIPS flexibilities-access to medicines debate South Africa’s Medicines and Related Substances Amendment Act (Act No. 90 of 1997) - Permitted the health minister to revoke pharma patent rights if the associated medicines were too expensive - Empowered the health minister to order compulsory licensing - Permitted parallel importation - Required pharmacists to employ generic substitution


What is a compulsory license? : What is a compulsory license? It is a license granted by the government to a third party to use a patent or exploit an invention without the authorization of the patent holder. It is an essential government instrument to intervene in the market: it can limit patent rights to prevent abuses and correct market failures.


What is parallel importation?: What is parallel importation? Parallel importation is the bringing in of goods into a country without the authorization of the patent holder after those goods were placed legitimately in circulation elsewhere.


The TRIPS flexibilities-access to medicines debate: The TRIPS flexibilities-access to medicines debate Brazil’s Industrial Property Law (Law 9279, 1997) - Permitted the issuance of compulsory licenses in cases where patent holders choose to supply the market through imports rather than through local production This was aimed primarily at transferring production of AIDS drugs to domestic firms and government agencies in order to reduce their prices below those on the U.S. and E.U. markets. This active intervention dramatically reduced treatment costs in Brazil.


Reaction of pharmaceutical companies to the South African and Brazilian laws:: Reaction of pharmaceutical companies to the South African and Brazilian laws: VIGOROUS OPPOSITION The pharmaceutical industry argues that the issue of access to medicines is not a patents issue but one of social welfare policies.


Objectives of TRIPS (Preamble) : Objectives of TRIPS (Preamble) To reduce distortions and impediments to trade To promote effective and adequate IPR protection To ensure that enforcement measures do not lead to barriers to trade To cater to the special needs of developing and least-developed countries


Objectives of TRIPS (Article 7) : Objectives of TRIPS (Article 7) The protection & enforcement of IPRs should contribute to: The promotion of technological innovation, The transfer and dissemination of technology To the mutual advantage of producers & users In a manner conducive to social and economic welfare To balance rights and obligations


TRIPS and Public Health: TRIPS and Public Health Members may, in formulating or amending their laws and regulations, adopt measures to: Protect public health and nutrition Promote the public interest in sectors of vital importance to their socio-economic and technological development Prevent the abuse of IPRs or practices which (1) unreasonably restrain trade, or (2) adversely affect international transfer of technology (Article 8)


Doha Ministerial Declaration on TRIPS and Public Health: Doha Ministerial Declaration on TRIPS and Public Health “We agree that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all. In this connection, we reaffirm the right of WTO Members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose.” (Par. 4)


TRIPS Flexibilities: TRIPS Flexibilities The Doha Declaration affirmed that flexible interpretation & implementation of TRIPS includes: The right to grant compulsory licenses (But recognized that Members with insufficient or no manufacturing capacities in pharma sector could face difficulties in using compulsory licensing.) The right to determine what constitutes “national emergency or other circumstances of extreme urgency”. (Public health crises include HIV/AIDS, tuberculosis, malaria and other epidemics.) Each Member is free to establish its own regime for exhaustion of IPRs. (This is relevant to the option of parallel importation.)


Challenges to the application of TRIPS flexibilities: Challenges to the application of TRIPS flexibilities Engagement at the domestic/local level - Domestic legislation & policies Opposition/lobbying by the pharmaceutical industry Tools used by the pharmaceutical industry (e.g., ever-greening patents) Lack of capacity to avail of TRIPS flexibility (e.g., lack of drug manufacturing capacity to use compulsory licensing) Pressure by developed countries to enact TRIPS-plus legislation


The problem of TRIPS Plus+: The problem of TRIPS Plus+ Developed countries are seeking higher levels of IPR protection than those provided in the TRIPS Agreement. This is being done through bilateral or multilateral agreements.


The Challenge: The Challenge To actively participate in the debate on TRIPS, public health and access to medicines, and To push for reforms at both the local and international level


Slide24: Maraming salamat po.


TRIPS provisions relevant to public health, esp. access to medicines: TRIPS provisions relevant to public health, esp. access to medicines Patent availability and exceptions (Art. 27) Patent rights and exceptions (Art. 28, 30, 6) Compulsory licenses and government use (Art. 31, 40) Parallel importation Protection of undisclosed information, including test data (Art. 39)


Basic Principles of TRIPS: Basic Principles of TRIPS National Treatment (Article 3) Most-Favored-Nation Treatment (Article 4)