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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
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