Subject Open Letter to FDA
E-DRUG Open letter to Stuart Nightingale FDA Associate Commissioner
May 13, 1998
Dr. Stuart Nightingale
United States Food and Drug Administration
via Internet: SNIGHTIN@BANGTE.FDA.GOV
I am writing to you, a key member of the U.S. Delegation to the 1998
World Health Assembly in Geneva, to discuss two points.
First, I understand that the U.S. Delegation has proposed a substantial
modification of the World Health Assembly resolution on the Revised Drug
Strategy. The U.S. seeks to eliminate a provision that now says that
"public-health interests rather than commercial interests have 'primacy'
in pharmaceutical and health polices." Furthermore, the U.S. wants to
change the provision that member countries "review options under the
Agreement on Trade Related Aspects of Intellectual Property Rights
(TRIPS) to safeguard access to essential drugs," to a much different
provision that says that countries should seek to provide access to
essential drugs only after 20 year patents have expired.
These and other changes the U.S. is seeking in the resolution would
stand the proposed WHA Revised Drug Strategy on its head. You are
asking the WHA to endorse the notion that commercial interests are on a
par with public health interests. In addition, in asking that countries
eschew policies that protect the public health until 20 year patents
expire, you want the WHA to endorse positions even more favorable to the
commercial interests of the pharmaceutical industry than those endorsed
by the GATT negotiators.
As a U.S. Citizen, I am appalled that the Clinton Administration seeks
to establish that in matters concerning trade and health care, public
health considerations are not the primary concern. I am attaching a
copy of a letter which was sent on May 12, 1998 to James McGlinchey of
the Office of Intellectual Property and Competition of the U.S. State
Department concerning this resolution. As the letter indicates, there
are many trade disputes involving health care where the World Trade
Organization (WTO) and other trade organizations will be confronted with
issues that raise issues that could be viewed as commercial or public
health matters. It is essential that public health officials stand up
and say that public health is number one, and comes first, before
commercial interests, and that intellectual property rights (IPRs) be
viewed as means to achieve public health ends, rather than ends
No one is proposing that the WHA endorse the elimination of IPRs, but
rather that countries implement the TRIPS and other trade agreements in
ways that promote access to essential drugs. For example, under the
TRIPS, countries can use compulsory licensing of essential medical
technologies to broaden access to medicines. Even the International
Federation of Pharmaceutical Manufacturers (IFPMA) would admit that the
TRIPS already provides many safeguards for commercial interests which
must be followed in the compulsory licensing process. You are proposing
that countries not even consider the use of compulsory licensing during
the 20 year term of a patent.
The use of compulsory licensing will be particularly important in areas
of biotechnology, where companies are staking out very broad patent
claims. I am attaching a copy of a May 7, 1998 article in the Guardian
which describes new patent applications by Human Genome Sciences (HGS)
on "the whole genetic sequence" of bacteria that causes meningitis.
Apparently these [and similar] patents are so broad they will dominate
inventions by other researchers to treat meningitis [and other
diseases]. The Wellcome Trust refers to the prospect of HGS having "the
power to stop people developing vaccines and other preventive medicines
for killer diseases" as "an appalling result." An official of The
Meningitis Research Foundation says the new patents will give HGS the
right to demand royalties for a vaccine the Meningitis Research
Foundation is developing, and asks "will these companies accept
responsibility if people die because we could not afford to vaccinate
Suppose, for example, that a company obtained patents that would
control access to vaccines for AIDS, or for treatments of malaria, a
disease which kills 5 percent of African children. Suppose, further,
that this company is guided by the same ethical considerations as a
company like Genzyme, Inc., which set prices for Ceredase, a government
funded invention, at more than $500,000 for a year of treatment, or
Bristol-Myers Squibb, which sets prices for the cancer drug Taxol,
another NIH funded invention, at 20 times its production costs.
Is it truly the position of the Clinton Administration that the world
should wait 20 years before taking steps to ensure that companies do not
abuse patent rights and create unnecessary barriers for access to an
essential drug? This is an extreme position, and not one that should
be adopted by the World Health Assembly.
Moreover, we are increasingly seeing strategies where firms use the
initial 20-year patent period to build patent portfolios that block
entry by competitors, long after the initial patent expires. In
traditional pharmaceuticals, firms first patent compounds, then the
indications for use and manufacturing methods, and next the doses and
treatment regimes. In biotechnology, there are new areas to establish
broad patents, like those for gene sequences, that may permit firms to
control entire areas of medical research.
Second, I would like to comment on reports that you personally have
opposed the publication and distribution of the World Health
Organization's November 1997 report "Globalization and Access to Drugs,
Implications of the WTO/TRIPS Agreement." The only factual mistake I am
aware of in this report is a regrettable but relatively unimportant one,
the definition of a counterfeit drug. I am sure that you would agree
that the controversy over this publication concerns its policy
recommendations and not factual matters.
At the May 7-8 Washington, DC, Workshop on Intellectual Property,
Health Care and International Trade Agreements, which you did not
attend, it was quite clear that public officials in developing countries
are bewildered by the many changes in patent and pharmaceutical
regulation laws which they are required to enact to comply with TRIPS.
The amount of misinformation that they receive from pharmaceutical
company lawyers and lobbyists, U.S. embassy officials and others is
appalling, and it is predictably biased in favor of the commercial
interests of pharmaceutical companies. For example, South Africa was
told that parallel imports of pharmaceuticals violated TRIPS and
international law, Cyprus was given a copy of the Hatch/Waxman Act that
was missing the "Bolar" provision regarding patent exceptions for
medical research, Guatemala was told that it would be in violation of
the TRIPS trademark provisions if it adopted the World Health
Organization (WHO) rules on marketing of breast milk substitutes, and
there has been much misinformation given to many countries regarding
TRIPSs and policies to promote generic drugs.
Most public health officials are not experts on intellectual property
rules. They should not have to rely upon self-interested information
from pharmaceutical companies. The WHO's publications on the TRIPS and
the health care sector provide a small measure of balance to debates in
countries rewriting patent and regulatory laws in response to trade
pressures from the United States and the European Union. It is a simple
matter of fairness that these countries, many of them very poor, should
have access to basic information about the trade agreements. The U.S.
has many compelling arguments to make regarding the benefits of
intellectual property protection for health care research. We should
not rely upon ignorance and intimidation to achieve foreign policy
Finally, you should consider the possibility that your own isolation
from public health and consumer groups and your close working
relationship with the IFPMA and its members has distorted your own
understanding of these issues. I encourage you to meet with public
health and consumer groups to broaden dialogue on these issues, and to
create internal controls which ensure that U.S. policy makers receive
balanced input on these matters.
James Packard Love
Consumer Project on Technology
P.O. Box 19367, Washington, DC 20036
Consumer Project on Technology
P.O. Box 19367, Washington, DC 20036
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