The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement and most national patent laws allow for the granting of compulsory licences for a variety of reasons. Compulsory licenses may be an important tool enabling a country to get access to drugs at affordable prices. While any country may use compulsory licences for this purpose, however, many — especially the least developed countries (LDCs) — lack or have insufficient pharmaceutical manufacturing capacities to make effective use of the system. Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health instructed the Council for TRIPS to find an expeditious solution to this problem. This paper1 reviews the solution reached, as contained in the World Trade Organization (WTO) Decision adopted on 30th August, 2003, and the steps that should be taken in order to make it operative. It argues that a permanent solution to this problem should be based on a more straightforward and simpler approach.
This paper is partially based on the study prepared by the author for the World Health Organization, ‘Implications of the Doha Declaration on the TRIPS Agreement and Public Health’, WHO, Geneva, 2002.
2.
WT/MIN(01)/DEC/W/2, 14th November, 2001, hereafter referred to as ‘the Doha Declaration’.
See, eg BallanceR.PogányJ.ForstnerH. (1992) ‘The World's Pharmaceutical Industry. An International Perspective on Innovation, Competition and Policy’, UNIDO, Vienna.
5.
See, eg OXFAM (2002) ‘TRIPS and Public Health. The Next Battle’, OXFAM, London.
For other options, see CorreaC. (2002) ‘Implications of the Doha Declaration on the TRIPS Agreement and public health’, WHO, Geneva.
9.
In the absence of consensus, an amendment to a WTO Multilateral Trade Agreement must be approved by a two-thirds majority, but it only becomes binding on members that accepted it. An amendment may also be adopted by a three-fourths majority as binding on all members, but any member which has not accepted it shall be free to withdraw from the WTO or to remain as a member with the consent of the Ministerial Conference (Art. X.1 and 2 of the Agreement Establishing the WTO).
10.
See WT/DS114/R, 17th March, 2000, available at www.wto.org.
This review shall be deemed to fulfil the review requirements of Art. IX:4 of the WTO Agreement.
14.
Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Japan, Luxembourg, the Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, Switzerland, the UK and the USA.
15.
It is understood that this notification does not need to be approved by a WTO body in order for a country to use the system set out in the Decision.
16.
The legal value of the Chair's statement, which is not part of the Decision itself, is not discussed here.
17.
Some developed countries' patent laws, however, provide for compulsory licences or governmental use for export without the limitation imposed by Art. 31 (f). Such is the case with Art. 168 of the Australian Patent Act and Art. 55 (2) of the Patent Act of New Zealand, which permit exports under an agreement with a foreign country to supply products required for the defence of that country. Article 48B (d)(i) of the UK Patent Act provides for a compulsory licence in respect of a patent whose proprietor is not a WTO proprietor when the owner's failure to license the patent on reasonable grounds means that a market for the export of a patented product made in the UK is not being supplied.
18.
The Canadian government has indicated its willingness to amend patent law in order to supply pharmaceutical products under the Decision. The International Federation of Pharmaceutical Manufacturers' Associations (IFPMA) criticised this move, suggesting that ‘the changes contemplated in Canada will erode patent protection and scare off future research spending by biotech investors wary of changes to intellectual property right guarantees’ (ChaseS.FaganD. (2003) ‘Drug companies balk at Ottawa's AIDS plan’, Globe and Mail, Saturday, 27th September; available at http://www.globeandmail.com/servlet/story/RTGAM.20030927.waids0927/BNStory/).
For example, the patent owner may frustrate the rapid implementation of a compulsory licence by an appeal against the government's decision, or through judicial injunctions. For example, in the Philippines, 51 compulsory licence petitions were granted before the adoption of the 1998 patent law, but no licence was actually executed. In some cases, the requesting company was ultimately unable to market the products due to appellate proceedings that delayed the execution of the decision. The delay in the proceedings led to the dismissal of 23 applications due to the petitioners ‘withdrawal of the petition or due to the petitioners’ lack of interest or failure to prosecute the petition. Eight petitions were dismissed because the patent expired while the petitions were still pending. The only compulsory licence petition granted after the new Philippine Intellectual Property Code, took effect on 1st January, 1998 was filed on 8th December, 1991, when the old Patent Law was in effect. This petition was finally granted on 19th December, 2001, that is, after a period often years. The remaining petitions filed under the old Philippine Patent Law are still pending. Communication by Susan Villanueva, 26th September, 2003 (on file with the author).
21.
Within the meaning of Art. XXIV of the GATT 1994 and the Decision of 28th November, 1979, on Differential and More Favourable Treatment Reciprocity and Fuller Participation of Developing Countries (L/4903).
22.
See CorreaC. (2002) ‘Protection of Data Submitted for the Regulation of Pharmaceuticals. Implementing the Standards of the TRIPS Agreement’, Geneva, South Centre; Indian Institute of Foreign Trade (2003) ‘Article 39.3 of the TRIPs Agreement: Its genesis and the present context’, New Delhi.
