Rich countries backsliding on WTO commitments on drug patent rules says Oxfam International
24 June 2002
Rich countries are backsliding on their commitment to agree to new WTO measures to help people in poor countries gain access to affordable medicines, says Oxfam International, leading up to a crucial WTO meeting in Geneva on June 25-27. Failure to agree to effective measures for the provision of life-saving medicines under the TRIPS agreement will put the lives of millions of people at risk.
At the WTO Ministerial Conference in Doha last November, WTO members promised to not let WTO patent rules block access to affordable medicines, affirming the right of governments to use the existing public health safeguards set forth in the TRIPS agreement. The compulsory licensing safeguard allows governments to override patents and authorize the production and import of cheap generic versions of newly patented medicines.
In Doha, WTO members also recognized the problems faced by poor countries, most of which lack the technical and economic capacity to manufacture their own cheap medicines and therefore must make use of TRIPS safeguards to import them. After 2005, these countries will no longer be able to import these medicines unless a flexible interpretation of TRIPS to provide for the export of medicines and health related products to countries in need is agreed upon by WTO members. Member States committed to finding a solution to this problem by the end of 2002.
“The whole point of the Doha Declaration on TRIPS and Public Health was to shift the balance in TRIPS away from purely commercial considerations in favor of public health,” says Ruth Mayne of Oxfam International. “Unfortunately, parts of the pharmaceutical industry are trying to persuade rich countries to weaken and restrict proposed new measures, which would effectively roll back the public health gains made at Doha”.
A simple, speedy, and effective solution to this problem that would allow poor drug-importing countries to gain access to affordable new medicines has been proposed by NGOs such as Oxfam International, Doctors without Borders, Third World Network, and Consumer Project on Technology, along with various developing countries. They propose that WTO members simply agree that countries can use the existing exceptions to patent rights contained in the TRIPS Agreement (under Article 30) to export pharmaceuticals and health related products to other countries.
But the US Administration and much of the pharmaceutical industry, including the Association of the British Pharmaceutical Industry which represents the major pharmaceutical companies such as Pfizer, GSK, Bayer, Aventis, Astra Zeneca and others, have argued instead for the weakest possible solution: a waiver on disputes related to compulsory licensing for export. Others, such as the International Pharmaceutical Manufacturing Association, have refused to publicly take a position on this crucial issue.
“The industry and the US say they are committed to a solution but a waiver would only be a temporary measure. Also, it would have to be reviewed annually, which would deter governments and companies from using it. This would waste a unique political opportunity to achieve a permanent solution”, argues Oxfam.
Some companies are seeking to restrict solutions to only the poorest countries, to just three diseases (HIV/AIDS, Tuberculosis, and Malaria) or to “emergency” health situations only. “Such restrictions are unacceptable, as they would leave many developing countries unable to use the safeguards or obtain vital new medicines to treat other killer diseases in the future. These types of restrictions run counter to the intent of the Doha Declaration”, argues Oxfam. “The Doha Declaration affirmed that the Agreement can and should be interpreted and implemented in a manner supportive of WTO members’ right to protect public health and, in particular, to promote access to medicines for all patients,” says the organization.
The European Community recently expressed its preference for a complex solution applicable to only the least developed and low-income countries and containing other restrictive conditions. This approach would involve amending the compulsory licencing provisions in TRIPS to allow generic-producing countries to issue a compulsory license for the export of pharmaceutical and health products; the generics could then be sent to third party countries in need of the medicines but which lack the necessary manufacturing capacity to produce them. The problem with this option is that both the importing and exporting countries would have to issue a compulsory license, which is a burdensome process. And because the solution contains no guarantee protecting the licensing countries from legal challenges, the compulsory licenses could be challenged by pharmaceutical companies.
“That the EC is even considering an amendment of this sort to TRIPS is a big step forward, but in the ruthless and byzantine world of trade rules and disputes, their option has little chance of guaranteeing poor people access to the vital new medicines they need,” says Oxfam. “The EC has played a positive role, but is now letting itself be blown off course by the industry lobby, one-sided legal arguments, and opposition by some EC member states”.
“Governments must keep their eye on the ball. The main criteria should be whether the solution will be lasting and whether poor drug-importing countries will be able to use it quickly and effectively in practice. Legal arguments can be concocted to support any option. The real issue is one of political leadership,” states the organization.
More generally, governments and companies need to integrate the Doha Declaration into all their patent policies and practices. Governments should refrain from using bilateral agreements, such as the recently signed US-Chile trade agreement, to ratchet up intellectual property standards beyond those set forth in TRIPS. And the pharmaceutical industry should respect the rights of governments to use the TRIPS safeguards in full.
Oxfam comments: “The Doha Declaration was an important and welcome step, but the danger is that we will end up with a follow-up measure for poor drug-importing countries that looks good on paper but has little impact in the real world. Fortunately, there is still time to get it right.”
NOTES TO EDITORS
14, 000 people die every day from preventable infectious diseases, yet much of the premature death and illness could be avoided if poor people had access to affordable medicines. Most poor people in low and middle-income countries pay out of their own pockets for medicines. In Oxfam’s experience very poor people frequently attempt to buy medicines, especially if the disease is life threatening; they will take children out of school, go into debt, sell oxen, and even land in order to do so.
The problems posed by WTO patent rules will extend beyond the high prices of patented HIV/AIDS medicines to future new and improved medicines needed to treat not just tuberculosis and malaria, but also drug-resistant variants of serious diseases that pose public health threats such as pneumonia, meningitis, diarrhea, and sexually transmitted diseases. It is also sometimes forgotten that developing countries are increasingly facing non-communicable diseases such as diabetes, hypertension, cancer, heart disease – diseases previously associated primarily with rich countries. And the WHO has pointed to mental illnesses and neurological diseases as growing threats to health worldwide.
Since the pattern of diseases that threaten public health changes over time for a range of reasons, including resistance, it is essential that the issue of access to necessary medicines be resolved now so that diseases yet to emerge as major concerns can be treated effectively in the future.
At the moment, poor importing countries can issue a compulsory license to import cheap generic versions of patented medicines from a handful of other developing countries which still have thriving generic industries. But once these latter countries comply with TRIPS, by 2005 at the latest, they will no longer be able to produce and sell generic versions of newly patented medicines. Importing countries will therefore lose this source of affordable medicines. Even if the producing country wants to issue a compulsory license to export medicines, its ability to do could be limited as TRIPS says that compulsory licenses must be issued predominantly for domestic use.
