Important note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.

Reuters NewMedia - Sunday, April 11, 1999

Organisations from the United States and abroad, including the humanitarian group Doctors Without Borders, say U.S. officials have threatened trade sanctions against countries that could benefit from a little-known practice called compulsory licensing. Supporters say such licenses could help poor countries gain access to cheaper AIDS drugs.

Pharmaceutical companies in the United States oppose compulsory licensing and have lobbied U.S. trade officials to discourage it in order to protect companies' patents on AIDS drugs.

The drug companies say they need a certain level of profit to finance further research, but one of the drugs sought was developed by U.S. government research and the patent is still held by the Clinton administration.

AIDS is rampaging through Africa and some Asian nations. Health experts say 12 million people have died from the disease in sub-Saharan Africa, with infection rates running as high as 25 percent in some countries.

AIDS activists, consumer groups and physicians say compulsory licenses may be one means of helping narrow the gap between those who can afford AIDS treatments and those who cannot.

"It wouldn't solve all the problems," said James Love, director of the Consumer Project on Technology, a U.S.-based consumer group. "But it might keep a lot of people alive until a new generation of drugs appears."

Under world trade rules governing intellectual property, compulsory licenses allow companies to make cheaper, generic versions of AIDS drug, even while the drugs' makers hold exclusive patent rights to the medications.

Countries must prove a license would serve a public need, such as health care, and the patent holder must receive "adequate" payment. Disputes have been settled by respective countries' courts.

The licenses were first adopted by many countries in the 1883 Paris Convention as a check on the patent holder, who was viewed as holding a monopoly on a particular product. They are now included in World Trade Organisation rules. The United States has issued compulsory licenses for satellite technology, television programming, music and other goods.

Now, health groups around the world have seized on compulsory licenses as a way to provide lower cost treatments to millions of AIDS sufferers in countries such as South Africa and Thailand.

About 60 nongovernmental organisations that gathered in Geneva last month criticised U.S. policy on the licenses, and U.S.-based health and labour groups are joining AIDS groups such as ACT-UP for a rally and march in downtown Washington, D.C., later this month.

They also have support on Capitol Hill. Representative Jesse Jackson Jr., an Illinois Democrat, has introduced legislation that would forbid the Clinton administration from retaliating against any African countries that seek compulsory licenses.

In Thailand, health advocates urged the government to seek a license for ddI, or didanosine. The U.S. government holds the patent on the drug, which is sold by Bristol Myers Squibb for slightly more per day than the average daily wage in Thailand, said Dr. Bernard Pecoul, director of Doctors Without Borders.

"One of the solutions to this problem would be for the Thai government to use compulsory licenses," Pecoul said in a phone interview. "But the Thai government was under strong pressure from the U.S. Embassy to not use compulsory licenses."

A spokeswoman for Health Secretary Donna Shalala, who technically holds the ddI patent, said the agency was reviewing the situation. The U.S. Trade Representative's office said it could not confirm whether U.S. officials had pressured foreign countries to forego compulsory licenses.

But U.S. Patent and Trademark Office officials said the United States has made its opposition clear in bilateral negotiations with other countries.

"We do not think compulsory licensing is necessary," patent official Lois Boland said. "We do not support them in general."

Drug makers say losing some patent protection could discourage new drug development by pharmaceutical companies, who have spent up to $1 billion developing a single AIDS drug.

"The period of market exclusivity is something promised to the inventor," said Tom Bombelles, assistant vice president for the Pharmaceutical Research and Manufacturers of America. "A compulsory license is a form of breaking that promise."

Pharmaceutical companies are working with the United Nations to find ways to make AIDS drugs available in poor countries, Bombelles added.

Even with compulsory licenses, foreign countries may find manufacturing AIDS drugs too complex. And just making inexpensive drugs available in poorer countries does not guarantee results. Many developing countries do not have the tools to make sure people get the drugs and take them, according to U.S. patent officials and drug makers.

"One of the fallacies of the compulsory licensing approach is that all you have to do is give people some pills," Bombelles said. "That's just wrong."

Compulsory licensing advocates acknowledge they would not be a magic bullet for stemming the worldwide AIDS crisis. But they say they could be a start.

"Once that hurdle is eliminated, the remaining complexities are more easily addressed," AIDS activist Eric Sawyer said.

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