E-drug: Increase in Global Access to Essential Drugs Sought
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[distributed as fair use. HH]
JAMA Vol. 283 No. 3, January 19, 2000
Increase in Global Access to Essential Drugs Sought
David Banta, MD, MPH
Amsterdam-Globalization-the issue that elicited the December
demonstrations in Seattle-is a force that now affects every person,
every patient, every physician in the world. For physicians in the
United States, perhaps the most relevant aspects of globalization
concern current access to and prices of pharmaceuticals.
Driven by economics and a trade orientation, the thrust for
globalization comes from large corporations with strong support from
some governments, notably that of the United States. The main
instrument of globalization is the World Trade Organization (WTO), a
body that resulted from the Final Act of the General Agreement on
Tariffs and Trade (GATT) Uruguay Round, which was signed on April
15, 1994. The WTO has 135 country members, and 30 more wish to
join. The GATT agreement ratified the worldwide implementation of a
free-trade economy.
In the new century, globalization has focused attention on the effects
of international rules regarding intellectual property rights. (Credit:
Map Art)
Shortly before the ill-fated WTO Ministerial Conference convened in
Seattle, and in preparation for it, a group met here to consider the
effect of the WTO and of international rules on intellectual property
rights (that is, patents) on access to pharmaceuticals, particularly new
drugs. M�decins Sans Fronti�res (the international medical aid
organization that won the 1999 Nobel Peace Prize), Health Action
International (an international network of consumer groups concerned
with health and development working for rational drug use), and the
Consumer Project on Technology (a Washington, DC-based part of the
Ralph Nader organization), cosponsored a conference called
"Increasing Access to Essential Drugs in a Globalised Economy." More
than 350 people from over 50 countries, including policymakers,
clinicians, and representatives of industry, nongovermental
organizations, and consumer-oriented organizations, participated in the
meeting on November 25-26.
RELEVANT PROVISIONS
Two types of provisions in the WTO agreement are particularly
relevant for pharmaceutical policy: (1) those whose purpose is to put
an end to protectionist measures (these provisions are probably
particularly aimed at developing countries and seek to open all
members of the WTO to the global economy); and (2) those that
define as mandatory the protection through patents of new drugs and
their respective manufacturing processes. This particularly applies to
the Trade Related Aspects of Intellectual Property Rights (TRIPS)
agreement. Implementation of the TRIPS agreement in national patent
law is compulsory for all WTO members by 2006 at the latest.
The implementation of the TRIPS agreement will have consequences
for access to medicines, especially in developing countries. Increased
patent protection will lead to higher drug prices, while the number of
patented drugs of public health importance will almost surely increase
in the coming years. These higher prices, along with other factors, will
affect access to drugs. Enforcement of WTO regulations will have an
impact on local manufacturing capacity and will remove a source of
generic drugs, which are important everywhere but are especially so in
developing countries.
Furthermore, research and development by multinational
pharmaceutical firms tends to neglect tropical diseases such as
malaria. There is no reason to believe that the WTO provisions would
lead to more industry investment in such diseases, so local innovation
is of great importance.
Austin Davis, MD, general director of M�decins Sans Fronti�res in
the Netherlands, discussed these issues in his opening presentation.
Davis acknowledged the industry position that protection for
intellectual property is necessary to ensure continued innovation in the
development of pharmaceuticals. However, he pointed to the results
of a free-trade market that leads to technology being treated as a
commodity rather than a means to serve people. Hakan Bjorkman of
the United Nations Development Programme underscored the same
point, emphasizing that the market is good for efficiency but not for
equity, and proposing a focus on human rights as a framework for
global governance.
Others pointed to provisions of TRIPS that could be used to
strengthen public health inputs. For example, Article 8 states that
members may "adopt measures necessary to protect public health and
nutrition, and to promote the public interest in sectors of vital
importance to their socio-economic and technological development,
provided that such measures are consistent with the provisions of this
agreement."
Evelien Herfkens, minister of development cooperation of the
Netherlands, enumerated steps that must be taken to ensure a balance
between the interests of industry and those of consumers. There are
two specific ways to attenuate the possible harmful consequences of
the intellectual property clauses of TRIPS that are allowed in the
agreement, she said. These are the introduction of parallel imports,
which means the holder of a patent cannot prevent a country from
importing a drug from a subsidiary of the patent holder in another
country in which the drug is cheaper, and compulsory licensing, which
means that WTO members may, in certain circumstances, use the
subject matter of a patent without authorization of the patent holder.
One such circumstance is when the expense of a drug makes it
impossible for poor countries where it is needed to purchase it. The
most publicized example recently has been HIV infection, in which
drugs to counter the virus and opportunistic infections are produced in
some developing countries for a fraction of their cost on the
international market. For example, zidovudine is produced in Thailand
and India and fluconazole is produced in India. Thailand is currently
seeking a compulsory license for didanosine.
These provisions are not "loopholes," as some dissenters have said,
but are integral parts of the negotiated agreement that should be
actively used, many believe. Minister Herfkens stated that "We cannot
accept the kind of bilateral dealing in which one country puts
pressures on another," especially to prevent compulsory licensing. She
was particularly critical of the United States for pressuring developing
countries such as South Africa, Albania, and Sri Lanka by such means
as meetings, letters, and the threat of trade sanctions.
The South African case has been much reported since AIDS activists
have demonstrated against Vice President Al Gore for putting pressure
on that country not to include compulsory licensing and parallel import
provisions in its proposed pharmaceutical law. Despite this stance of
the US government, Carlos Correo, PhD, professor of law at the
University of Buenos Aires in Argentina, pointed out that the United
States has used compulsory licensing more than 100 times when
patents were felt not to be favorable to the public good. In fact, the
US Federal Trade Commission has sought compulsory licenses on a
number of pharmaceutical products as recently as 1997 (further
information is available on the Consumer Project on Technology Web
site at http://www.cptech.org).
Gro Harlem Brundtland, MD, director-general of the World Health
Organization (WHO), in a video presentation to the meeting,
emphasized that access to essential drugs is a key priority for the
WHO. Last May, the World Health Assembly adopted Resolution
WHA52.19 on the Revised Drug Strategy. This resolution gives the
WHO the go-ahead to expand its work on a range of issues, including
the effects of international trade agreements, that affect access,
quality, and rational use of drugs. Brundtland said the WHO is working
with the WTO to ensure pharmaceutical innovation coupled with
reasonable prices of pharmaceuticals. She strongly endorsed
compulsory licensing and parallel imports. However, Michael Scholtz,
WHO executive director for health technology and pharmaceuticals,
responding for WHO to questions, would not specify what actions the
WHO intends to take with regard to the WTO. Some participants in
the meeting criticized the lack of specificity in his remarks. Others,
especially those from African countries, said they look to the WHO for
leadership and expressed hope that the organization would take a
strong position on these issues.
A US CONSUMER ISSUE ALSO
The issues are also of importance to US consumers, who make up
about 25% of the world market for pharmaceuticals. New drugs are
already very expensive and are likely to become more so. People in
the United States who lack comprehensive health insurance are
especially at risk of not having access to new innovative drugs.
There seemed to be a consensus among participants at the meeting
that the WTO is here to stay, but that there is a need for more health
and public health concerns. At the end of the conference, James
Orbinski, MD, president of the International Council of M�decins Sans
Fronti�res, read a statement from the conference organizers in which
they asked the WTO to set up a working group on access to
medicines that would include a strong role for the WHO. He said that
his organization's Access to Essential Medicines campaign has three
main objectives: negotiating exceptions from trade agreements for
health purposes, overcoming barriers to access, and stimulating
research and development on neglected diseases. M�decins Sans
Fronti�res wants to see governments put on public record their active
political support for the principle that health takes priority and that
WTO rules must not be allowed to override public health needs.
Acknowledging the concern about access to essential pharmaceutical
products, President Bill Clinton told the WTO in Seattle last month that
the US Department of Health and Human Services will work with the
US Trade Representative "to make sure that our intellectual property
policy is flexible enough to respond to legitimate public health crises."
Simultaneously, the US Trade Representative announced that South
Africa had been removed from the Special 301 "Watch List" for
possible trade sanctions.
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