May 13, 1998
Dr. Stuart Nightingale
United States Food and Drug Administration
Rockville, Maryland
via Internet: SNIGHTIN@BANGATE.FDA.GOV
Dr. Nightingale:
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 themselves.
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 them?"
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 objectives.
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.
Sincerely,
James Packard Love
Consumer Project on Technology
P.O. Box 19367, Washington, DC 20036
http://www.cptech.org
love@cptech.org
Subject: Firm attempts to patent meningitis bacteria
The Guardian Thursday May 7, 1998
An American company has applied to patent one of the bacteria that causes meningitis. It could lead to royalties being paid on every treatment if a new vaccine against the illness is found.
The application is one of three filed with the European Patent Office by Human Genome Sciences (HGS), who are seeking to be the first to own the whole genetic sequence of bacteria. If the application is granted, as seems likely, it will open the door for commercial companies to patent any lifeform from which they think they can make money - including human gene sequences.
The prospect has appalled scientists in the field, who believe discoveries should be shared for the common good and that the scramble for patents for commercial gain will damage research.
There were 2,660 cases in England and Wales last year of the most dangerous meningococcal form of meningitis, of which 243 were fatal. Many of the victims of the largest outbreak for 50 years were young children. The illness strikes quickly and is difficult to diagnose.
Julia Warren of the Meningitis Research Foundation said: "The idea that someone should try to patent bacteria and then claim a royalty on our research if we find a vaccine had never occurred to me. I am stunned. It could make treating children prohibitively expensive. All our money goes on research: we cannot afford royalties as well. Will these companies accept responsibility if people die because we could not afford to vaccinate them?"
The Wellcome Trust, which encourages the sharing of gene research, also fears the consequences. Celia Caulcott said: "There is evidence that commercial companies are doing research and then not publishing it while they look for ways to exploit the knowledge they have gained. Patenting the knowledge and so having the power to stop people developing vaccines and other preventive medicines for killer diseases would be an appalling result."
Until the American applications, scientists had restricted themselves to patenting individual genes or microbiological processes for which they had already isolated a commercial use. This new blanket patenting of an entire gene sequence covers any future possible use of the data for medical purposes.
Two of the three applications are for troublesome bacteria where active research is under way to find treatments. The first is Haemphilus inflenzae, which causes meningitis and is one of the few strains for which an effective vaccine exists. However, most research is directed towards finding a vaccine for meningococcal meningitis, for which as yet no patent has been applied but is certain to follow if this application succeeds.
Another patent has been applied for Mycoplasma genitalium which is usually sexually transmitted and causes urethritus, a painful inflammation. The Department of Health is investigating a screening programme for this illness. The third bacteria causes no human disease, but if a gene is extracted for any medical application royalties would be due.
The applications, each the thickness of a telephone directory, have been filed at the British Library in advance of a debate on patenting in the European parliament on Tuesday. This is expected to agree a new EU directive which backs the idea that all lifeforms can be patented for profit.
Until now the idea that living organisms can be patented has not been thought to be acceptable on legal grounds because a patent implies both an invention and an industrial application. A gene sequence is merely a discovery and was not previously thought possible to patent one.
The applications are based on the work of Dr Craig Venter, who pioneered large-scale gene sequencing. He originally tried to claim patents on small fragments of genes but has since said he is opposed to the idea.
However, his erstwhile partner, William Haseltine, who runs HGS, has applied for 200 patents on individual human genes, and says it is legitimate business. "We were the first to discover these genome sequences and to describe practical medical benefits. We have broken no new ground and acted within established patent rules."
He accepted that scientists had never before attempted to patent a living organism.
Wendy Watson, of the Hereditary Breast Cancer Helpline, said: "Genes are becoming a global currency and patents mean that currency will end up in the hands of a select few. We may end up with monopolies we cannot overrule. This will harm patients."