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Compulsory licensing of essential medical technologies
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Info-Policy-Notes | News from Consumer Project on Technology
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March 25, 1999
The following statement will be distributed today
at a meeting with the press at the Palais des Nations
in Geneva, Switzerland, for a meeting to begins
tomorrow. Information about the event is on web
at http://www.cptech.org/march99-cl
Jamie Love
Statement of James Love, Director
Consumer Projection Technology
http://www.cptech.org
Regarding
March 26 meeting on compulsory licensing of essential
medical technologies
Tomorrow's meeting will be the first significant effort
to address an important and timely issue. Under what terms
will developing countries obtain access to new essential
medical technologies? That said, it is important to also
say that the issue of compulsory licensing is not only for
the poorer countries. Indeed, compulsory licensing is a
fact of life in developing countries, including the United
States of America. New high tech medical treatments based
upon biotechnology and gene therapies present a number of
problems that will be addressed by compulsory licensing. So
while compulsory licensing of patents on medical
technologies is extremely important to developing countries,
it will also be important for the most developed countries,
and for consumers and patients everywhere.
The second point I would like to make is that
compulsory licensing of patents is consistent with
international law, consistent with the agreements
administered by the World Trade Organization (WTO), and
consistent with well established practices in the patent
field. The major trade and intellectual property agreements
do not prohibit compulsory licensing of patents, and indeed
they provide for specific mechanisms and conditions under
which compulsory licensing can be done. That is to say that
there is already a framework and system of safeguards for
compulsory licensing to ensure that the interests of patent
owners and national governments are respected. The most
important such agreement is Article 31 of the TRIPS
agreement.
Why then is this meeting even needed, or why is this
meeting so controversial? The answer is in part that the
large pharmaceutical companies oppose the use of compulsory
licensing of medicines, and they have lobbied developed
countries like the United States, England and Italy, and the
European Union, to particularly oppose compulsory licensing
of medicines in the poor countries. This has already
resulted in trade pressures against the practice of
compulsory licensing of drugs for HIV/AIDS and other
essential medicines, and it may result in a future dispute
before the WTO.
The pharmaceutical companies may believe the poor
countries will abuse the compulsory licensing system, that
this will lower returns from research and development (R&D),
or that it will undermine their ability to charge high
prices in the more developed countries. These companies are
businesses, and they will be lobbying all around the world
to protect their business interests. Their concerns about
R&D incentives are legitimate concerns for those concerned
about the public health, because we are concerned both about
access to medicines and the mechanisms to fund the R&D that
creates new and better medicines.
The best public policies about compulsory licensing of
essential medical technologies are those that will best
serve public health goals, and which explicitly address the
obvious ethical dilemmas. Patents are used to restrict
access to inventions. This is considered a necessary
practice in order to create economic incentives to fund R&D.
But we cannot be blind to the impact of these mechanisms, if
left unchecked, particularly when the consequences of
exclusion are illness or death. The restrictions on access
must be reasonable, and they must not create situations
where entire populations are denied access to known
therapies.
It is also the case that there are many abuses in the
patent system itself. Indeed the United States Federal
Trade Commission and the US National Institutes of Health
have both recently issued reports that highlight specific
problems patents cause for medical research and follow-on or
related research in new high technology medical fields.
There are also problems of excessive prices for drugs,
including drugs developed by the government. It is worth
mentioning that several important HIV/AIDS drugs that are
targets for compulsory licensing were developed mostly or
entirely by the government. For example, ddI, an important
HIV drug for low-end multidrug therapies, and a drug that is
a subject of a compulsory licensing dispute in Thailand, is
a US government invention, that is licensed on an exclusive
basis to Bristol-Myers Squibb. There is no economic reason
to give Bristol-Myers Squibb the right to charge a monopoly
price for this drug, and there is certainly no ethical case
to oppose compulsory licensing of ddI. There are many
similar cases.
Trade policies on intellectual property and health care
should be designed to accomplish public health goals. Many
of the persons here today will be involved in discussions
before the World Health Assembly in May on a resolution that
will formally declare that public health concerns should be
primary over all other issues.
It is our opinion that the existing WTO agreement on
intellectual property, the so called TRIPS agreement, does
provide the safeguards, exceptions and mechanisms, like
compulsory licensing of patents, to protect essential public
health interests, including concerns over access to
medicines.
We also believe it is appropriate to begin a dialogue
on a new framework for trade discussions that addresses the
most important issue, which is the mechanisms to ensure
adequate and fair sharing of the costs of funding essential
medical research. We have proposed a new focus on essential
medical research, to shape policies by national governments
and international trade regimes. Our initial proposal for a
framework for a program in essential health care research is
on the Internet at http://www.cptech.org/ip/health
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