Pharmaceutical patent issues: A taste of our own medicine

New Crisis, The, May/Jun 2002 by Thurman, Sandra L

The Color Line

Patient disputed have become increasingly common as trade between nations flows easier, but perhaps nowhere does the controversy have more dire consequences than in the pharmaceutical industry. The war on terrorism has brought new fears into the minds of Americans, not least of which is anthrax.

To address those concerns, the Bush Administration has reversed an earlier stance and decided to negotiate firmly and directly with Bayer to acquire the company's drug Cipro, which is prescribed to treat patients exposed to anthrax.

The Bush administration threatened to override the German company's patent rights. In response to the administration's threat, Bayer agreed to supply up to 300 million Cipro tablets at the drastically reduced price of 95 cents per tablet and donate 2 million more tablets for emergency workers. To meet what was fortunately an overestimated demand, Bayer tripled production and committed to strict manufacturing deadlines.

The United States found itself in a situation similar to one that mostly African countries have faced for years. But the outcome was very different. The United States, better financially equipped than any other country to afford the market rate for medicine to treat a public health crisis, sought and received a discount few are willing to extend to those countries most in need.

Throughout recent history, the United States has been the main force in protecting patent rights worldwide. The new stance taken during the anthrax scare was a clear divergence from this path. The question remains how supportive the administration will be when the need extends to public health crises beyond U.S. borders, including a response to what is perhaps the most deadly global health crisis of our time - AIDS.

While it is difficult to compare the AIDS pandemic with the anthrax crisis, there are similarities. Both involve a public health issue, both require responses that fall under the guidelines of the TradeRelated Intellectual Property Rights (TRIPS) agreement and both have brought to the spotlight the way pharmaceutical companies respond to nations in times of crisis. There are also stark differences.

While the effects of terrorism post-- Sept. 11 - including the tragic consequences of the anthrax crisis - have gone unparalleled in the United States, the same argument can be made for the consequences of AIDS worldwide. While the effects of the anthrax crisis was felt across the nation, only about a dozen people here reported symptoms from direct exposure; around the world, more than 16,000 people become HIV-positive every day. While five deaths were attributed to anthrax, every day AIDS buries more than 8,000 men, women and children worldwide. And while the anthrax crisis was felt most here in the United States, the epicenter of the AIDS crisis is beyond our borders, sweeping across Africa, the Caribbean, Asia and the former Soviet Union.

Perhaps the most striking difference is that while a terrorist act is hard to predict and to prevent, the response to anthrax was immediate and successfully targeted because resources were made available. The gravity of the AIDS situation is known, but the resources have not been made available.

Calls for help to the pharmaceutical industry by those fighting AIDS have so far gone largely unheeded, and affordable drugs remain out of reach of the majority of those most in need. According to Doctors Without Borders, only 25,000 to 30,000 of the 2.5 million to 3 million people who would most benefit from treatment actually receive it. Drug patent disputes continue to mean the difference between life and death for many in African nations. Although TRIPS gives all nations the right to override patents and a mechanism for compensating the patent-holders, most developing nations have been reluctant to invoke it for fear of lengthy disputes before World Trade Organization (WTO) settlement panels. While governments are allowed to bypass patents in addressing national health emergencies, the United States has strongly argued that drug companies need to be assured of the money from patents to afford new research.

To strengthen their ability to respond appropriately to the AIDS crisis, representatives of developing nations gathered at the WTO meeting late last year to negotiate a process for importing and exporting generic drugs in the face of public health emergencies.

Today, more than 65 million people worldwide have been infected with HIV, and 25 million have lost their lives to AIDS. Africa is home to more than twothirds of the 40 million HIV-positive people worldwide, and the disease is spreading quickly in other regions of the developing world. Experts predict that by 2005, more than 100 million people will have been infected, and 40 million children will have been orphaned.

In the wake of Sept. 11, the global AIDS crisis has all but disappeared for too many Americans and policymakers. And as the global community continues to search for an adequate response to the AIDS pandemic, more than 1 million men, women and children have died of AIDS since that dreadful day, and more than 2 million have become HIV infected.