Implications of the Doha Declaration on the Trips Agreement and Public Health - Health Economics and Drugs Series No. 012
(2002; 56 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentForeword
View the documentAcknowledgements
View the documentAbbreviations and acronyms
View the documentExecutive summary
View the documentIntroduction
View the documentScope
View the documentThe role of TRIPS and IPRs
Open this folder and view contentsPublic health measures
Close this folderFlexibility in TRIPS
View the documentInterpretation
View the documentCompulsory licences
View the documentEmergency
View the documentExhaustion
Open this folder and view contentsMembers with insufficient or no manufacturing capacities
View the documentTransfer of technology to LDCs
View the documentExtension of transitional period for LDCs
View the documentSpecial treatment under TRIPS
View the documentLegal status of the Doha Declaration
View the documentIssues not covered in the Declaration
View the documentConclusions
View the documentAnnex 1 - Doha Declaration on the TRIPS Agreement and Public Health
View the documentAnnex 2 - Levels of development of pharmaceutical industry, by country
View the documentReferences

Flexibility in TRIPS

The second part of paragraph 4 of the Doha Declaration reflects one of the main concerns of developing countries in the process leading to the Doha Ministerial.

The concept of “flexibility”41 as applied to the obligations imposed by the TRIPS Agreement, has been central to several analyses of the TRIPS Agreement42 and to the position of developing countries at the Council for TRIPS in the special sessions on TRIPS and health43. Spelling out some of the available flexibility was the main objective of the Declaration.

41 “Flexible” means “easily led, manageable, adaptable, versatile, supple, complacent” (Concise Oxford Dictionary, p. 373).

42 See, e.g., Correa (2000a); Reichman (1997).

43 The European Commission also held, in its submission of 12 June 2001, that “In the view of the EC and their Member States, the Agreement’s objectives, principles and purpose (set out in Articles 7 and 8), special transitional arrangements and other provisions give these countries a sufficiently wide margin of discretion in implementing it. This margin enables them to set up an intellectual property regime that meets their policy needs and is capable of responding to public health concerns” (IP/C/W/280).

The Declaration stresses the flexibility “for this purpose”, that is, for the purpose of adopting measures to protect public health. As indicated by the coverage of paragraph 5, Members, only specified, in a non-exhaustive manner, some of the aspects of the Agreement that provide for such a flexibility (“...we recognize that these flexibilities include...”)44.

44 Note that both the developing countries’ and the EC submissions to the special session of 20 June 2001, mentioned other aspects where members enjoy flexibility, such as the “Bolar provision” and the protection of data submitted for the marketing approval of pharmaceuticals (Article 39.3 of the Agreement). See IP/C/W/296 and IP/C/W/280.

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, especially in the light of the recognized “gravity of the problems” faced in the area of public health by developing countries and LDCs. In legal terms, such confirmation 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 States.

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