Intellectual Property and Access to Medicines. (MDS-3: Managing Access to Medicines and Health Technologies, Chapter 3) (2012; 21 pages)
Abstract
In an era of increasingly globalized trade, pharmaceutical
patents play a key role in the availability and affordability
of medicines, as shown by the conflict over access to antiretroviral
medicines for people living with HIV/AIDS in
resource-limited countries. Patent protection can also be
a contentious issue in high-income countries, when high
medicine prices impede access to effective treatment.
Governments grant intellectual property rights as an
incentive to produce inventions that will benefit society
as a whole. The varied extent of protection and enforcement
of these around the world became a source of
tension in international economic relations, leading
to international negotiations within the World Trade
Organization (WTO). These negotiations resulted in
the Agreement on Trade-Related Aspects of Intellectual
Property Rights (TRIPS), which is a set of trade rules
meant to introduce a global system to monitor and
enforce the protection of intellectual property rights
among WTO members.
TRIPS covers five essential issues—
• How to apply basic principles of the trading system
and other international intellectual property agreements
• How to give adequate protection to intellectual
property rights
• How to enforce such rights adequately in a country’s
own territories
• How to settle disputes on intellectual property
among members of the WTO
• What special transitional arrangements to apply
during the period when the new system is being
introduced
Developing countries expressed concerns regarding the
possible effect of TRIPS, including the following—
• TRIPS treats medicines like any other commodity,
but medicines are not ordinary consumer products.
• Prices will likely be higher for new medicines in
countries with no previous patent protection.
• Generic competition will be delayed in countries
with a previous patent term less than twenty years.
• The local pharmaceutical industry could be weakened,
and dependence on developed countries may
increase.
• TRIPS may not improve research and development
(R&D) decisions regarding treatments for the diseases
common in poor countries.
The minimum standards required by TRIPS resulted in
developing countries losing some capacity to regulate
pharmaceutical patents and control the cost of medicines;
however, the agreement left some flexibility for
them to take measures to protect public health. Because
the provisions relating to patents and pharmaceutical
regulation are confusing and contentious, regulators
must acquire the relevant technical expertise to use
these flexibilities within TRIPS to improve access to
medicines.
The international rules regarding intellectual property
are evolving quickly. Developing countries must actively
participate in discussions of the future of the intellectual
property system to ensure its appropriateness for
countries at very different levels of development. As the
rules evolve, their impact must be properly understood
if policies are to be based on relevant evidence.
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