AIDS TREATMENT NEWS Issue #314, March 5, 1999
John S. James

Thai AIDS and health organizations learned that under Thailand's patent laws, and consistent with international laws and treaty obligations, fluconazole could be sold in Thailand on a nonprofit basis for about 4% of its current cost, which would mean that everybody who needed this drug could receive it. Many lives would be saved, and at no cost to the patent holder, which would receive a small royalty as opposed to receiving nothing when patients cannot buy the drug at all. But the proprietary pharmaceutical industry strongly opposes any such relief, fearing precedents which could lead to weakening of intellectual-property protection in more important markets--regardless of the specifics of each case, and regardless of the human costs of this abuse of U.S. state power. Until now, because so few people have understood the issue, only this industry has had significant input into the U.S. trade policies which make medicines many times more expensive in poor countries than they would otherwise be.

James Love of the Consumer Project on Technology--an organization started by Ralph Nader and based in Washington, D.C.--has proposed using "compulsory licensing" to help make modern pharmaceuticals available in poor countries. Compulsory licensing--already widely used in the United States itself and in most other countries, and allowed under certain conditions by GATT and other international trade agreements--means that a nation's government, for an important public purpose, can allow the domestic use of a patent or other intellectual property, under terms and conditions which that government sets. For example, Thailand could use compulsory licensing to allow Thai companies to buy bulk fluconazole, ddI, or other essential medications from generic pharmaceutical manufacturers, sell the drug for use in Thailand, and pay a royalty to the patent holder (usually between 1% and 10% of sales); to protect the patent holder, the specific arrangements would be subject to review by the World Trade Organization (WTO) in Geneva, if challenged by a member country. But instead of letting such a case go to the WTO--which could set precedents, and almost certainly would bring more visibility to this way of bridging the treatment gap in poor countries--the U.S. pressured Thailand to change its patent laws in ways that will outlaw this possibility for that country. (For technical background on compulsory licensing, see http://www.cptech.org/ip/health/cl.)

This issue is critically important because even a small group of citizens, focused on bringing balance to U.S. trade policy concerning intellectual-property protection of pharmaceuticals, could have enormous human impact throughout the world. A balanced policy would still protect intellectual property, in order to preserve incentives for corporate drug development. But it would ask that people in poor countries be required to contribute to profits only according to their ability to pay--instead of being written off and left to die without treatment (while contributing nothing at all to financing drug development, because they are asked to pay an impossible price which prohibits any sale). The alternative to policy reform is to make the great majority of the world's people wait up to 20 years (for patents to expire) for access to new treatments for AIDS, cancer, tuberculosis, and other diseases--a wait which is becoming increasingly serious due to the greatly accelerating pace of developments in biology and medicine.

This issue is new in that until only a few years ago, GATT and other international trade agreements did not cover pharmaceutical patents at all (see GATT and the Gap: How to Save Lives," AIDS TREATMENT NEWS #307, November 20, 1998-- available at http://www.aids.org/atn). Until recently, no one much cared if poor countries made their own AZT or other drugs without permission of the patent holder. Today's GATT agreement does cover pharmaceutical patents, while allowing some flexibility that could be used to protect human health. But pharmaceutical-industry players now have a new focus available for their energies--protecting their intellectual- property rights as much as possible, in every situation, regardless of the human impact in developing countries--and so far they have been the only voice heard in U.S. policy. Lack of access to medication has long been a deadly problem, but only recently--triggered by the new GATT coverage of pharmaceutical patents--has the U.S. government imposed itself as a major, active obstacle to a workable solution.

Those who believe nothing can be done to change U.S. trade policy if pharmaceutical companies object should consider tobacco, also a powerful industry. A decade ago the U.S. used its economic might to force small countries like Thailand to allow U.S. tobacco companies to promote widespread smoking there. After protest from cancer organizations and others, U.S. trade policy on tobacco was significantly improved.

A movement to reform U.S. trade policy regarding pharmaceutical patents in developing countries would have several strategic advantages:

* The moral issue is clear--corporate profits vs. human life, with people denied lifesaving medicines just so that precedents can be set or maintained;

* Individuals affected can easily be found--allowing publicity to be much more effective;

* Life-and-death impact on up to 90% of the world's population creates billions of potential allies, who can substantially contribute to the global effort by raising the visibility of what is happening in their communities;

* The movement seeks an achievable goal of changing policies to enable people to improve their own conditions--instead of trying to provide drugs to most of the world through charity;

* The manufacturing facilities, distribution channels, and laws and treaties required, are already in place;

* Policy reform would not necessarily cost anything to U.S. government or industry;

* Besides saving many lives, intellectual-property reform on pharmaceuticals could also end needless bad will and diplomatic disputes between the U.S. and India, South Africa, and many other countries--opening doors to alliances with persons and organizations interested primarily in foreign policy. Is it rational that a single industry totally dominate U.S. policy in this area, creating trade disputes with dozens of nations in its narrow pursuit of self- interest?

* The problem will not go away; the system in place today will not correct itself in any foreseeable future. For the U.S. government, the choice will remain whether to cooperate with millions of people who are trying to save their lives, or continue fighting against them.

A strategic challenge is that, unlike with tobacco, the leadership of the U.S. medical community is heavily funded by the industry strongly opposed to reform. But the main reason a large movement did not develop earlier, we believe, is that few have understood this issue, which has medical, legal, economic, political, and diplomatic aspects. Until recently, almost no one working in AIDS knew what compulsory licensing is, let alone knew that laws and treaties allowing it are already in place. But several organizations and projects have recently begun working in this area, starting independently, often without even knowing about the others--a sign that the time is right for this issue to become more prominent.

A coalition of AIDS and health-care advocacy organizations is now forming to press for compulsory licensing and other approaches to broadening global access to AIDS treatments. For more information on this as-yet-unnamed effort, you can contact ACT UP/Philadelphia at 215-731-1844, or P.O. Box 22439 Land Title Station, Philadelphia PA 19110, or email Asia Russell, asia@critpath.org.

Here is a way of "bridging the gap" in treatment access that can actually work--not just for a few people but for millions throughout the world, for AIDS and other diseases alike.

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