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:: Comission on Intellectual __Property Regulation, __Innovation & Public
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:: Escuela Nacional de
__ Salud Pública
__ (ENSP/ FIOCRUZ)
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PAHO/WHO Collaborating Center in Pharmaceutical Policy

:: Report of the PAHO __Working Group on IPR_
__ and Access to _Medicines, April 2004
:: __
 
 
 
 

 

Intellectual Property Regulation

The protection of intellectual property rights (IPR) is promulgated through a complex and dynamic system involving the establishment of Trade Agreements at the global, regional and/or national levels. The global reference for IPR has been established through the World Trade Organization (WTO) Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), a multilateral agreement binding on all WTO members requiring member states to incorporate new IP standards into national legislation within a certain time frame. The majority of Latin America and Caribbean countries should comply with the provisions of TRIPS by 2005.

At the same time, countries in the region are moving to establish regional or sub-regional trade agreements that include provisions on IPR. Trade negotiations involving countries in the Americas are thus ongoing at three distinct levels: at the global level through the WTO, at the regional or sub-regional level e.g. Free Trade Areas of the Americas (FTAA), Central American Free Trade Area (CAFTA) negotiation, and in the Andean region, and bilaterally between countries.

The impact of trade agreements and IP provisions contained within on access to medicines is one of considerable debate . Stakeholders in favor of application of standards favoring a high degree of IP protection consider that access to medicines will be facilitated through: increased levels of research and development in pharmaceuticals as monies earned from the sale of patented products are re-invested by the R & D industry to fund new and innovative medicines; technology transfer and foreign direct investment stimulating economic growth and the development of local industry: reduced flows in human resource capital to the industrialized world.

Others however consider that IPR regulation will adversely affect access to medicines in that it will increase the level of divestment from the developing country, increase imports of medicines into the developing country, reduce local production, economic growth and employment, and increase the dependence of smaller economies on large economies. In addition, generic competition will be reduced through the implementation of restrictive IPR, rendering medicines less available, less affordable and less accessible.

As an organization specialized in public health, the position of PAHO and WHO vis a vis global agreements such as TRIPS, regional, sub-regional or bilateral trade agreements in the Americas is based on the fundamental principles of equitable access to medicines for all.
• Access to medicines is part of the basic right of health for all
• Essential medicines must not be considered as any other marketable product
• Patent systems can represent an effective incentive for R & D, but
• Patents must be administered in an impartial manner, protecting the interests of the holder of the patent while at the same time safeguarding public health

Therefore, PAHO advocates that countries make full use of the flexibilities and safeguards presented within TRIPS and confirmed by the DOHA Declaration on Public Health, to promote access to medicines.

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1 Globalization, Patents and Drugs, An Annotated Bibliography: 2nd Edition, Health Economics and Drugs, EDM Series, WHO, EDM/PAR/2001.1