Doha Declaration on TRIPS and Public Health: Sub-paragraph 5 (b)
5. Accordingly and in the light of paragraph 4 above, while maintaining our commitments in the TRIPS Agreement, we recognize that these flexibilities include: ...
b. Each Member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted.
Developing countries have identified compulsory licensing as one of the key instruments that may limit the exclusive rights of the patent owner when needed to fulfill certain objectives of public policy, particularly in order to ensure the availability of alternative sources for the supply of medicines at lower prices48.
48 See, e.g., Velasquez and Boulet, 1999; Correa (2000a).
Sub-paragraph 5 (b) of the Doha Declaration deals with an issue central to the interests of developing countries. It simply states what is apparent: Article 31 sets forth a number of conditions for the granting of compulsory licences (case-by-case determination; prior negotiation, in certain cases, with the patent owner; remuneration, etc.), but it does not limit the grounds on which such licences can be granted. Though Article 31 refers to some of the possible grounds (such as emergency and anti-competitive practices) for issuing compulsory licences, it leaves Members full freedom to stipulate other grounds, such as non-working, public health or public interest.
Though sub-paragraph 5 (b) does not add anything substantively to the understanding of TRIPS, the Doha Declaration specifically employs the expression “compulsory licence”, which is not found in the TRIPS Agreement itself49. The use of this terminology may help to create awareness, particularly among health ministries in developing countries and LDCs, about the possible utilization of compulsory licences to meet public health and other objectives50.
49 TRIPS Article 31 is entitled “[O]ther use without authorization of the right holder”.
50 Despite the fact that the governmental use for a non-commercial purpose of a patent is not mentioned in the commented paragraph, such mechanism can also be important to attain public health objectives.