Letter to Tommy Thompson, urging the U.S. Dept of Health and Human Services provide the World Health Organization with access to U.S. government-funded medical inventions

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.
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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

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 other 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.

Sincerely,

Ralph Nader

James Love

Robert Weissman

Letter to Bristol-Myers-Squibb, Re: Discount Deals for South Africa

Dear Charles A. Heimbold, Jr.
We are writing to follow up on Bristol-Myers Squibb’s announcement earlier this week of concessionary terms for the provision of d4T and ddI in Africa.
We support the issuance by patent holders of voluntary, royalty-free, non-exclusive licenses of essential life-saving medicines to all potential bona fide manufacturers and suppliers, for all non-OECD countries plus Mexico.
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March 16, 2001

Charles A. Heimbold, Jr.
Chief Executive Officer,
Bristol-Myers Squibb
345 Park Avenue
New York, NY 10154

Dear Charles A. Heimbold, Jr.

We are writing to follow up on Bristol-Myers Squibb’s announcement earlier this week of concessionary terms for the provision of d4T and ddI in Africa.

We support the issuance by patent holders of voluntary, royalty-free, non-exclusive licenses of essential life-saving medicines to all potential bona fide manufacturers and suppliers, for all non-OECD countries plus Mexico.

Your recent announcement seems to represent a near-first step to achieving this aim.

The BMS press release and statements attributed to BMS spokespeople suggest that you are willing to forgo enforcement of patent rights in South Africa, and that you do not claim intellectual property rights on these products anywhere else in sub-Saharan Africa. [Footnote: “The particular mechanism could be just non-enforcement of the patent by us,” he [John McGoldrick, BMS executive vice president] said. “It could be some kind of technical mechanism. . . . It doesn’t really matter to us. . . . Our key decision is: Take that patent off as any factor in availability of Zerit in South Africa.” (“Another Firm Cuts HIV Drug Prices,” by Karen DeYoung and Bill Brubaker, Washington Post, March 15, 2001); ” Bristol-Myers Squibb has made an agreement with Yale University to grant a free license under the patent for Zerit (rights to which are owned by Yale and Bristol-Myers Squibb) to treat AIDS in sub-Saharan Africa.” BMS News Release, March 14, 2001.] BMS seems to have been ambiguous as to whether this purported release on patent right claims extends to both ddI and d4T, or just to d4T.

If you are sincere in your claim to forego patent rights in sub-Saharan Africa, there is no conceivable reason for you to refuse to issue formal, voluntary, royalty-free, non-exclusive licenses for both ddI and d4T to all potential bona fide manufacturers and suppliers. Indeed, you should prefer such an approach to encouraging other manufacturers and suppliers to violate your intellectual property claims in Africa.

From our point of view, which is focused on achieving access to life-saving medicines, the issuance of a license is vital. First, companies may reasonably be reluctant to forge ahead with production in South Africa or export to South Africa on the basis of an informal and imprecise statement from Bristol-Myers Squibb. Indeed, many may reasonably take the position that they respect intellectual property claims, and will refuse to sell in a market without a formal license. Second, it is possible that companies may confront registration difficulties if they do not have a valid, formal license for a product patented by another.

To effectively enable others to produce and market the drugs, we ask that you also issue a similar license to the registration data (marketing approval information showing safety and efficacy) connected to the drugs. If protections on such data still exist, they could effectively bar introduction of generic competition for years.

It is also vital that BMS provide to the public the fullest knowledge it has on other intellectual property claims related to ddI and d4T, held by entities other than BMS, in South Africa and elsewhere in Africa. These entities will also need to issue licenses for generic makers and suppliers to produce and supply the drug for South Africa.

As you know from experience, there is little technical difficulty in issuing such licenses. We urge you in the strongest terms to issue such licenses today, on both ddI and d4T. Doing so will represent a genuine first step in the effort to deliver medicines needed to save the lives of the millions in the developing world now living with an HIV/AIDS death sentence hanging over their heads.

You must also extend the voluntary licenses to all non-OECD countries. For the vast majority in these countries with HIV/AIDS, lifesaving pharmaceuticals are out of reach. Their lives are no less important than those in Africa.

Issuance of voluntary licenses is not a cure-all, nor does it represent the full extent of what the pharmaceutical companies must do. Certainly, if BMS is acting in good faith, it must immediately withdraw from the lawsuit challenging South Africa’s Medicines Act. Attached, you will find a set of criteria that we believe should apply to all drug companies making life-saving medicines, including criteria for assessing concessionary offers and outlining the moral imperatives resting with the companies to enable poor countries to achieve sustainable access to life-saving medicines.

We look forward to your immediate response to these requests.

Sincerely,

Robert Weissman
Co-Director
Essential Action
P.O. Box 19405
Washington, D.C. 20036