AEGiS-BAR: BMS allows off-patent d4T production Bay Area ReporterImportant note: Information in this article was accurate in 2001. The state of the art may have changed since the publication date.
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BMS allows off-patent d4T production

Bay Area Reporter - March 23, 2001
Liz Highleyman


Last Wednesday, March 14, Bristol-Myers Squibb (BMS) announced that it would allow other companies to produce cheaper generic versions of its nucleoside analog drug d4T (stavudine, marketed as Zerit) for sale to South Africa.

The announcement came amid worldwide controversy over intellectual property laws limiting drug access in poor countries, which has been spotlighted by an ongoing lawsuit by the Pharmaceutical Manufacturers' Association against the South African government. BMS is one of 39 drug companies taking part in the suit, which went to trial on March 5 but was delayed until mid-April.

According to BMS Executive Vice President John McGoldrick, "This is not about profits and patents; it's about poverty and a devastating disease. We seek no profits on AIDS drugs in Africa, and we will not let our patents be an obstacle." It remains unclear whether BMS will offer licenses to other companies that wish to produce anti-HIV drugs, or instead will decline to enforce its patent.

BMS also announced in a press release that it would reduce the combined price of d4T and ddI (didanosine, or Videx) to about $1 per day for all African countries participating in the ACCESS program, a joint initiative sponsored by the United Nations and five drug companies. The combined U.S. price for d4T and ddI is about $10,000 annually. The recommended standard triple therapy for HIV requires that the two nucleoside analog drugs be used with a protease inhibitor. So far, four countries (the Ivory Coast, Rwanda, Senegal, and Uganda) have agreed to take part in the program; other countries remain concerned about keeping open their option to produce or import cheaper drugs. BMS also said it plans to donate $15 million to help African countries promote "local solutions" to deal with AIDS.

The drug company made its announcement in the wake of protests against Yale University, which initially developed d4T. Yale holds the patent on the drug, but maintains a licensing contract with BMS. The humanitarian group Medecins Sans Frontieres/Doctors Without Borders and Yale law students pressured the university to allow South Africa to import generic d4T. Yale indicated that it had "removed all barriers" that would prevent BMS from allowing the manufacture of generic versions of the drug.

According to press releases issued last week, the university was "gratified that Yale's efforts paved the way for the significant action announced by Bristol-Myers," and that it would "continue to encourage all pharmaceutical companies to make their AIDS drugs affordable and widely available in Africa."

South Africa's Treatment Action Campaign called the BMS move "a major victory" for AIDS treatment activists. Kate Krauss of ACT UP/Philadelphia, which has spearheaded protests against patent restrictions on AIDS drugs, said that the BMS initiative is "groundbreaking," in that it is the "the first time that a U.S. drug company has acknowledged that generic drugs are the key to saving lives." TAC and ACT UP are both part of the Health GAP Coalition, which has been working for the past two years to increase access to drugs in poor countries.

Last Friday, the Health GAP Coalition sent a letter to BMS asking the company to issue "non-exclusive, voluntary, royalty-free licenses to any bona fide manufacturer or distributor - whether government, NGO, or private company - to use their intellectual property for HIV/AIDS drugs," and to extend such licenses to all non-OECD (less developed) countries and Mexico. According to the letter, the lives of people with AIDS in these countries "are no less important than those in Africa." Health GAP also asked BMS to open its books, establish a research fund, and "agree not to sue or pressure countries that are undertaking measures to make essential medicines available to their people."

Activists continue to demand that BMS withdraw from the South African lawsuit, a move the company has resisted because the suit is "aimed at protecting their rights to all prescription drugs, not just AIDS drugs."

In San Francisco, as the Bay Area Reporter went to press, a demonstration outside a BMS-sponsored gala reception at the National AIDS Update Conference on March 21 was scheduled to go forward.

Activists, including members of ACT UP/East Bay, Global Exchange, and Survive AIDS, planned to ask attendees to boycott the BMS reception and to "question their relationships to the pharmaceutical companies which are involved in the lawsuit against the government of South Africa."
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