The Doha Declaration includes preambular provisions (paragraphs 1 to 4), a provision aimed at confirming the interpretation of certain rules of the TRIPS Agreement (paragraph 5), and two operative provisions requiring action by the Council for TRIPS in relation to countries with no or insufficient manufacturing capacity in pharmaceuticals (paragraph 6), and for the extension of the transitional period for LDCs in relation to the protection of pharmaceutical products (paragraph 7).
The problems addressed by the Doha Declaration are defined in paragraph 1 in broad terms. Members recognize the “gravity” of the public health problems afflicting many developing and LDCs, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics.
Doha Declaration on TRIPS and Public Health: Paragraph 1
1. We recognize the gravity of the public health problems afflicting many developing and least-developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics.
While some developed countries attempted to limit the scope of the Declaration22 to the HIV/AIDS crisis, the adopted text 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. The reference to some specific “epidemics”23 does not imply that the Declaration is limited to them. It covers any “public health problem”, including those that may be derived from diseases that affect the population in developing as well as developed countries, such as asthma or cancer.
22 The disagreement on the scope of the declaration was reflected in the partly bracketed title of the draft declaration (“access to medicines”) (“public health”). Throughout the negotiations, the USA, supported by Switzerland, proposed a text that referred to “health crisis”, “pandemics” and “infectious disease” only. See ‘t Hoen, 2001, p.13.
23 “Epidemic” is a disease prevalent among a community at a special time; one of the draft texts of the Declaration alluded instead to “pandemics”, that is, a disease prevalent over the whole of the country or over the whole world (The Concise Oxford Dictionary, p. 324 and 738).
Further, though access to medicines was the main preoccupation that led to the Doha Declaration, the Declaration covers not only medicines, but any product, method or technology for health care. Thus, the Declaration applies to pharmaceutical products, processes and uses, surgical, therapeutic and diagnostic methods24, diagnostic kits as well as medical equipment.
24 It should be noted that WTO Members can exclude these methods from patentability (see Article 27.3 (a) of the TRIPS Agreement).
Finally, while patents have been the focus of the debate on this issue, the Declaration applies to all areas of intellectual property covered by the TRIPS Agreement, including protection of test data submitted for the marketing approval of pharmaceuticals25.
25 See para. 7 of the Declaration.