March 28, 2001 Letter to US Secretary of Health and Human Services Tommy Thompson regarding access to NIH funded patents

March 28, 2001

Secretary Tommy Thompson
Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20201

Dear Mr. Thompson:

We are writing to request that the Department of Health and Human Services (DHHS) enter into an agreement that would enable the World Health Organization, UNICEF and other public health organizations to use US government rights in patents on medicines and other health care inventions. We made a similar request to the Clinton Administration, in a September 3, 1999 letter to NIH Director Dr. Harold Varmus. Dr. Varmus responded on October 19, 1999, indicating the matter was still under review, but also expressing opposition to our request. I am attaching our correspondence, which includes this statement by Dr. Varmus:

On balance, I am not convinced of the benefit of the standardized transfer of manufacturing and distribution rights to the WHO or any other nonprofit organization.

Subsequently Congresswoman Jan Schakowsky wrote to Secretary Shalala making a similar request, and received a nearly identical response.

What is at stake is an important moral and economic issue. The US taxpayers are now asked to fund more than $20 billion in R&D for health care annually. These expenditures lead to a plethora of patents and other intellectual property rights, not only for HIV drugs such as the patents on products such as ddI, d4T, ddC, Ziagen, Norvir or Kaletra, but also for many other medicines, diagnostic devices and tests and other inventions. It is morally repugnant for the US government to permit private parties to obtain exclusive rights to market these inventions in South Africa, the Philippines, Brazil, Kenya, Romania and their countries, without provisions to help make these products available to save the lives of poor and middle class people.

The recent announcement by Bristol-Myers Squibb that it will reduce the price for d4T, an HIV drug invented at Yale on a government grant, from ten dollars per day to fifteen cents per day, for some patients in some Africa countries, is a positive step, but it came only after student pressure at Yale, a request by CIPLA, an Indian generic drug company, for a compulsory license for the d4T patent in South Africa, and years of criticism from many quarters of the d4T price. The fact that it took so long, and required pressure from so many, in a period when there are 20,000 persons per month dying from AIDS in South Africa alone, shows that our current public policy is broken. Not only should the d4T price gouging in South Africa have ended years ago, but policymakers have to be more responsive and pro-active to public health concerns. In particular, there needs to be a more systematic and comprehensive solution, rather than a few isolated corporate PR damage control responses under only the most extreme forms of pressure.

Under the federal Bayh-Dole Act and regulations enacted thereunder (18 USC 200 et seq.) the government can enter into an agreement with the World Health Organization or other international public health and development groups, such as UNICEF or UNAIDS, giving the organizations the right to use foreign rights in patents that benefited from federal funding. Your department can write any safeguards that it feels are appropriate for such authorizations, and could for example, simply create a procedure whereby the WHO or another organization could request use, subject to whatever restrictions and conditions were deemed appropriate to protect the public interest for a particular license.

The fact that this has not happened, after years of requests, shows a disregard for the public health in poor countries. It is also short-sighted, because with increasing globalization, diseases in other countries intensify dangers for our citizens. This is not a proud chapter in our government’s history, and we ask that the Bush Administration correct this longstanding failure, and do what is best for the public health.

We ask to meet with you and your staff to discuss these matters further.


Ralph Nader
P.O. Box 19312
Washington, DC 20036

James Love
Consumer Project on Technology
P.O. Box 19367
Washington, DC 20036

Robert Weissman
Essential Action
P.O. Box 19405
Washington, DC 20036