A/HRC/11/12 page 14 3. Compulsory licensing and government use 36. Compulsory licensing derives from article 31 of TRIPS. It enables member States to license the use of a patented invention for itself or a third party “without authorization” of the patentee. Although TRIPS places some restrictions on compulsory licences, member States are free to determine the grounds upon which to issue a compulsory licence, which can include: (a) refusal to license; (b) public interest; (c) public health and nutrition; (d) national emergency or situation of extreme urgency; (e) anti-competitive practices; (f) dependent patents; and (g) failure to exploit or insufficiency of working.40 Member States also have the freedom to establish new grounds as they deem appropriate. 37. Paragraph 5 (b) of the Doha Declaration specifically reaffirmed the right of member States to determine the grounds for issuing compulsory licences. Countries are free to provide grounds to protect public health and promote access to medicines for all. TRIPS does not restrict the use of compulsory licences to situations of national emergency or other circumstances of extreme urgency, or to cases of HIV, tuberculosis and malaria. As such, the issuance of compulsory licences by Thailand on heart disease, cancer and HIV medicines is in compliance with TRIPS.41 38. Government use is a species of compulsory licence, which allows the use of a patented invention by or for a government for a public non-commercial use. Countries can issue such licences to third parties to make patented medicines for governments in order to make the medicines available to the public. The expression “public non-commercial purpose” is not defined and countries have the freedom to define and implement such use. The United States of America and the United Kingdom of Great Britain and Northern Ireland patent laws provide useful examples of how patents can be broadly used for almost any public non-commercial purpose.42 The restriction under article 31 of prior negotiations with the patentee does not apply to government use. This allows for a speedy process that assists governments in meeting their obligations to provide access to medicines. 39. While many countries have adopted mechanisms to issue compulsory licences, the grounds for use have varied43 and procedures in national laws are at times cumbersome and need to be streamlined and simplified to facilitate issuance of such licences. 40 See footnote 37, pages 28-30. 41 F. M. Abbott and J. H. Reichman, “The Doha Round’s public health legacy: strategies for the production and diffusion of patented medicines under the amended TRIPS provisions”, Journal of International Economic Law, vol. 10, No. 4, (2007), p. 921. 42 C. Oh, “Compulsory licences: recent experiences in developing countries” International Journal of Intellectual Property Management, vol. 1, No. 1/2 (2006), p. 22. 43 See footnote 18 above, p. 61, Table 6.

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