New Accord

January 1, 2002
Kevin Gopal
Pharmaceutical Executive

For once, health activists and the pharma industry both welcomed a World Trade Organization declaration on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and public health, but there is little doubt that it opens the way to further compulsory licensing and parallel imports.

For once, health activists and the pharma industry both welcomed a World Trade Organization declaration on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and public health, but there is little doubt that it opens the way to further compulsory licensing and parallel imports.

The declaration, issued by WTO's ministerial conference in Doha, Qatar in November, draws on two draft statements: one from developed nations and the other from 60 developing countries. The first recognizes that intellectual property protection is important for the development of new medicines. The second addresses the TRIPS agreement's effect on drug prices, saying, "It does not and should not prevent members from taking measures to protect public health."

The carefully worded document is political and therefore open to challenges, but activists and developing nations agree that it clarifies their interpretations of the ambivalent agreement. One passage is particularly relevant: "While re-iterating our commitment to the TRIPS agreement, we affirm that it can and should be interpreted and implemented in a manner supportive of WTO members' right to protect public health and to promote access to medicines for all. In this connection, we reaffirm the right of WTO members to use to the full, the provisions in the TRIPS agreement, which provide flexibility for this purpose."

Generics manufacturers that stand to gain from making AIDS drugs are not so happy. Commenting on the declaration's lack of provision for countries without manufacturing capacity to import medicines produced elsewhere under compulsory license, Amar Lulla, joint managing director of Cipla, told the Indian Times: "There is no gain. Not allowing exports is a major deterrent" to getting medications to those who need them.

But Ellen 't Hoen of Medecins Sans Frontieres believes that the declaration, "unthinkable six months, six weeks, even six days ago," is a major step forward in acknowledging the serious conflicts between TRIPS' obligations and the need to protect public health. "Countries can ensure access to medicines without fear of being dragged into a legal battle," she said. "Now it's up to governments to use that power to bring down the cost of medicines and increase access to life-saving treatments."

The declaration also revises the time-table for developing countries to implement TRIPS' provisions for medicines to 2016-a ten-year extension on the previous agreement-and says compulsory licensing need not be restricted to pandemics, as the US-led draft argued. Furthermore, WTO members have the freedom to determine the grounds on which they might grant compulsory licenses, such as national public health crises, including those relating to HIV/AIDS, tuberculosis, malaria, and other epidemics.

Ministers did oppose one proposal put forward by the developing nations: that countries without manufacturing capacity be allowed to import medicines made under compulsory license in another country. They called on the TRIPS Council to find an "expeditious solution" to the problem and report to the WTO General Council before the end of 2002. Says 't Hoen, "We are confident that this issue will be resolved next year."

Dr. Harvey Bale, director-general of the International Federation of Pharmaceutical Manufacturers Associations, welcomes the outcome of what were difficult talks, saying they reflect a balanced view that encourages both innovation and improved access to medicines. Yet, noting that some opponents sought to overturn it, he says the declaration recognizes that TRIPS is only one aspect of a much wider solution for increasing access to medicines and "underscores the global need for continued research and development into HIV/AIDS and other life-threatening diseases."

Brian Ager, director-general of the European Federation of Pharmaceutical Industries and Associations (EFPIA), agrees that TRIPS is only one part of a bigger question. He says, "It is time to focus on the real barriers, such as the lack of healthcare infrastructure, financing, and education in developing countries, and to find sustainable solutions to the lack of access to healthcare in developing countries."