Is compulsory licensing a potential strategy to confront the growing problem of access to essential medicines in developing countries? On 26 March 1999 more than 1 20 delegates from 30 countries met in Geneva to discuss this question, at a meeting organized by Médecins Sans Frontières, Health Action International and the Consumer Project on Technology, with support from the Rockefeller Foundation.
Delegates from NGOs, national governments, international organizations and industry heard that the HIV/AIDS pandemic illustrates the magnitude of the problem. Twenty-six of the estimated 33 million people infected with HIV globally live in Sub-Saharan Africa. Yet they have virtually no access to antiretrovirals because their cost puts them out of reach for all but a tiny minority. The situation is similar in South-East Asia. Medicines for other life-threatening diseases, such as tuberculosis, malaria and meningitis, are equally unaffordable for millions of people. Doctors know that their patients are dying unnecessarily.
Conference delegates looked at the practical considerations of using compulsory licensing (by which governments can oblige patent holders to license their product to others), as a means of making drugs available in poor countries. Compulsory licensing is a provision of the new TRIPS Agreement (Trade-Related Aspects of Intellectual Property, part of the World Trade Organization agreements). It has historically been used by developed and developing countries for the benefit of society, by restricting the monopoly rights of patent holders. James Love, of the Consumer Project on Technology, asserted that this is neither in conflict with TRIPS nor any other multilateral agreement on trade or intellectual property.
Many speakers argued that lower drug prices in developing countries would not be a serious threat to research and development funding because they account for a small percentage of pharmaceutical sales, just 1.3% in Africa, for example. Participants were told that the legal basis for compulsory licensing is in Article 31 of the TRIPS Agreement. This says that Member States may “use the subject of a patent without the authorisation of a right holder, including use by the government or third parties authorised by the government” when justified by the public interest. Article 31 also states that “the right holder shall be paid adequate remuneration... taking into account the economic value of the authorisation.”
However, other participants asserted that losing some patent protection could well discourage new drug development by companies, arguing that compulsory licensing breaks the promise of market exclusivity that is given to an inventor. US patent official Lois Boland said that her country viewed the TRIPS Agreement as offering “a minimum standard of protection”.
A Tanzanian woman, the third of three wives, buries her husband, who along with the previous wives died of AIDS. Now she is responsible for 11 children. The difference in treatment available for AIDS patients in rich and poor countries is an increasingly emotive issue (Photo: WHO/L. Gubb)
Dr Michael Scholtz, Executive Director of the Health Technology and Pharmaceuticals Cluster at WHO, pledged the Organization’s support to developing countries, saying “WHO respects the importance of patents and understands their role in both the developed and developing countries. However, we now have a mandate to consider the public health implications of implementing the TRIPS Agreement”*.
* Perspectives on the public health aspects of the WTO and TRIPS Agreements can be found in the WHO document Globalization and Access to Drugs, Health Economics and Drugs DAP Series No. 7. WHO/DAP/98.9.
The Conference organizers agreed that WHO should take a leading role in assisting countries to analyse the pharmaceutical and public health implications of WTO agreements,
Lobbying for change
Conference presenters advised developing country delegates to check the status of their domestic law provisions for compulsory licences and parallel imports. and to lobby for change if they are more restrictive than the TRIPS Agreement demands. They also pointed out that technical assistance to become TRIPS compliant is available from the World Intellectual Property Organization, if domestic governments request it.
Delegates resolved to demand that their national governments use existing legal means to increase the supply of affordable essential drugs. If price is a criterion for inclusion in the national essential drugs lists, then participants urged the international community to find a way to bring down the cost of vital drugs in developing countries.