The World Trade Organization Ministerial Conference starting on Friday in Doha, Qatar, is due to make decisions on intellectual property that could reduce the power of biopharmaceutical companies to enforce patents and impinge on their ability to maintain regionally segmented pricing.

At issue is the wording of the already existing agreement on Trade-Related Aspects of Intellectual Property Rights, known as TRIPS, which many countries believe leaves too much room for interpretation (see "TRIPS Thumbnail", A5). While all of the more than 140 member countries of the WTO seem to agree that IP protection is crucial for the creation of new drugs and therapies, there is ambiguity about the flexibility of the treaty, especially with respect to compulsory licensing and parallel imports.

Thus the meeting will address two questions. Under what circumstances is a government allowed to override a patent and authorize another manufacturer to make a drug without the patent owner's approval? And when is a country allowed to import a product that is sold more cheaply elsewhere in the world without the patent holder's permission?

The members are divided about the answers. In preparing for the meeting, two draft positions on public health and access to medicines have been circulated. One draft (IP/C/W/312) is endorsed by a group of developing nations, led by Brazil and India. The other (IP/C/W/313) is supported by certain industrialized countries, namely the U.S., Canada, Japan, Switzerland and Australia. In September, the EU failed to adopt a common position on access to medicines for the Qatar meeting.

The chairman of the WTO General Council, Stuart Harbinson, has circulated his own draft, and the sponsors of W/312 and W/313 now are now focusing on their preferred options in the Harbinson draft rather than pressing forward with their original submissions.

To the developing countries and many non-governmental organizations (NGOs), the issue is cheap access to drugs against AIDS, malaria, tuberculosis, and other life-threatening epidemics. They insist that nothing in the TRIPS agreement prevents governments from prosecuting their public health policies at will and they do not want members to bring legal disputes about this subject to the WTO. These countries want no interference with their existing policies of compulsory licensing and parallel imports.

Their draft declaration states that each member "retains the right to establish its own policy and rules regarding the exhaustion of intellectual property rights" and has the "right to allow other use of the subject-matter of a patent without the authorization of the right holder." Specifically, "in the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use, members may grant compulsory licenses without prior efforts on the part of the user to obtain rights from the right holder."

As many of these countries lack manufacturing capabilities, they want to be allowed to issue compulsory licenses for production abroad. Other measures would include the right of abbreviated marketing approval for generics and the ability to use confidential data, such as test data, in the "public interest."

In addition, the developing nations want other countries to refrain from imposing or threatening to impose sanctions in response to compulsory licensing.