The United States government appeared to have performed a u-turn on Monday by opening the way for American approval and purchase of cheap ”pirated” copies of Aids drugs to save the lives of the poor in the regions of the world hardest hit by the pandemic.
George Bush has promised $15-billion for the fight against HIV in developing countries over five years. But the former drug company boss who runs the president’s emergency plan, the ex-Eli Lilly chief executive Randall Tobias, has often said the money would be spent only on high-quality patented drugs from the giant pharmaceutical companies that have a huge presence and substantial political influence in the US.
Aids campaigners protested that fewer lives would be saved, because the drugs made by the giant companies are significantly more expensive than the copies made by generics companies in countries such as India, where the patents do not yet apply.
Although the World Health Organisation has approved the quality of the generic medicines, which combine three different drugs in one tablet, Tobias had insisted it could not be certain that they would meet US standards.
On Sunday the US government appeared to back down. The health and human services secretary, Tommy Thompson, announced an ”expedited review process” to would allow generic companies — as well as the multinationals — to seek approval for their combination pills from the US food and drug administration.
Under the new guidance ”the US will be able to provide life-saving drugs at lower prices to millions of people in Africa and the Caribbean”, a statement from Thompson’s office said. It signalled an end to the battle over Aids drug patents, in which the US government had sided with the big companies.
”Secretary Thompson and Ambassador Tobias said drug patent issues that apply in developed nations should not impede purchase of these drugs for developing countries,” the statement went on.
Peter Piot, the executive director of UNAids, called it ”a real change in policy”, while Stephen Lewis, the UN special envoy on HIV/Aids in Africa, said it was ”an unexpected and excellent move”.
Thompson said the food and drug administration’s approval would take two to six weeks, and the usual $500 000 fee could be waived.
The announcement will also stir the multinational drug giants into unprecedented collaboration — they hold patents on individual drugs that could be produced as more cost-effective combined pills if they work together.
Bristol Myers Squibb, Gilead and Merck immediately announced they were in talks on producing a fixed-dose combination pill. – Guardian Unlimited Â