(2002; 56 pages) [French] [Spanish]
1. The adoption of the Doha Ministerial Declaration on TRIPS and Public Health was the outcome of carefully elaborated strategy by developing countries and a significant achievement for those nations.
2. The Doha Declaration recognizes the “gravity” of the public health problems afflicting many developing and LDCs, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics. But the Declaration reflects the concerns of developing countries and LDCs about the implications of the TRIPS Agreement with regard to public health in general, without limitation to certain diseases.
3. While acknowledging the role of intellectual property protection “for the development of new medicines”, the Declaration specifically recognizes concerns about its effects on prices.
4. The Declaration affirms that “the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health”, and that it should be interpreted accordingly.
5. In establishing that Public Health is a clearly stated purpose of the Agreement, the Doha Declaration establishes a specific rule of interpretation that gives content to the general interpretive provisions of the Vienna Convention on the Law of the Treaties on which GATT/WTO jurisprudence has been built up. Therefore, in cases of ambiguity, panels and the Appellate Body should opt for interpretations that are effectively “supportive of WTO Members’ right to protect Public Health”.
6. The confirmation that the TRIPS Agreement has left room for flexibility at the national level has important political and legal implications. It indicates that the pressures to impede the use of available flexibilities run counter to the spirit and purpose of the TRIPS Agreement. In legal terms, it means that panels and the Appellate Body must interpret the Agreement and the laws and regulations adopted to implement it in light of the public health needs of individual Members.
7. The Declaration clarifies that “public health crises” can represent “a national emergency or other circumstances of extreme urgency”, and that an “emergency” may be either a short-term problem, or a long-lasting situation. The Declaration also places the burden on a complaining Member to prove that an emergency or urgency does not exist.
8. The Doha Declaration clarifies Members’ right to adopt an international principle of exhaustion of rights (determining the rules by which parallel imports may be accepted). The Declaration states that “the effect of the provisions in the TRIPS Agreement ... is to leave each Member free to establish its own regime for such exhaustion without challenge”.
9. The Declaration recognizes an unresolved problem relating to TRIPS and Public Health - the use of compulsory licensing in countries with little or no manufacturing capacity or insufficient market demand - and commits the governing body of the TRIPS, the TRIPS Council, to reach a solution in 2002.
10. In considering various approaches to the problem of compulsory licensing in countries with little or no manufacturing capacity or insufficient market demand, Members must be mindful of choosing an approach that provides adequate incentives for the production and export of the medicines in need.
11. Desirable features of any possible solution to the problem of compulsory licensing in countries with little or no manufacturing capacity or insufficient market demand would include: a stable international legal framework; transparency and predictability of the applicable rules in the exporting and importing countries; simple and speedy legal procedures in the exporting and importing countries; equality of opportunities for countries in need of medicines, even for products not patented in the importing country; facilitation of a multiplicity of potential suppliers of the required medicines, both from developed and developing countries; and broad coverage in terms of health problems and the range of medicines.
12. The Doha Declaration permits LDCs to opt for an extension of the transitional period provided for under Article 66.1 of the TRIPS Agreement in relation to pharmaceutical patents. However, because all but a few LDCs already grant patent protection to pharmaceuticals, this apparent concession to LDCs may have little practical effect.
13. It is implicit within the Doha Declaration that differentiation in patent rules may be necessary to protect public health. The singling out of public health, and in particular pharmaceuticals, as an issue needing special attention in TRIPS implementation constitutes recognition that public health-related patents may be treated differently from other patents.
14. The Doha Declaration is a strong political statement that can make it easier for developing countries to adopt measures necessary to ensure access to health care without the fear of being dragged into a legal battle. The Declaration is also a Ministerial decision with legal effects on the Members and on the WTO bodies, particularly the Dispute Settlement Body and the Council for TRIPS.