Rwanda's New Intellectual Property Law and Compulsory Licensing for Export Under the WTO: Not Quite a Panacea
| Published date | 01 June 2013 |
| Date | 01 June 2013 |
| DOI | 10.3366/ajicl.2013.0062 |
| Pages | 279-294 |
In September 2008, Rwanda imported 26,000 packs of TriAvir from Canada.
TriAvir is a fixed dose combination (FDC) product of the patented anti-retroviral drugs, zidovudine, lamivudine and nevirapine developed by the Canadian generics manufacturer, Apotex.
In doing so, the East African state became the first importing country to make use of and benefit from the World Trade Organization (WTO) procedure painstakingly negotiated to resolve the conflict between intellectual property rights (IPRs) standards under the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) and access to medicines.The WTO procedure referred to is the Implementation of para. 6 of the Doha Declaration on the TRIPS Agreement and Public Health, WT/L/540 (Decision of the General Council of 30 August 2003) (hereinafter 30 August Decision). For background on the problem of IPRs and access to medicines as well as the negotiations, see F. Abbott, ‘The Doha Declaration on the TRIPS Agreement and Public Health: Lighting a Dark Corner at the WTO’, 5
Before the importation could occur, Apotex, a Canadian producer of generic medicines, had to successfully navigate a difficult and time-consuming process under Canadian patent laws. This was necessary in order to legally attain a compulsory licence to manufacture and export a generic fixed-dosed combination of three patented medicines used in the treatment of HIV/AIDS.
The Apotex–Rwanda case is to date the only example of countries successfully using the 30 August Decision. The legal and administrative rigours in Canada's compulsory licence for export regime have been cited by scholars and industry as key factors explaining the paucity in utilisation of the system which came into force in Canada more than seven years ago.
For example, A. Webber and L. Mills, ‘A One Time Only Combination: Emergency Medicine Exports under Canada's Access to Medicines Regime’, 12(1)
Given the difficulties that Apotex had to contend with in Canada, it was fortuitous that the firm did not face similar obstacles in Rwanda. This was in large part because at the time of the importation, Rwanda's intellectual property (IP) law had not yet come into effect, substantially minimising delays on the import side.
While existing literature tends to focus on Canada's implementation of legislation, this paper is novel in that it engages with pertinent legislation in Rwanda. This analysis will take into account recent changes to Rwanda's IP regime, studying the relevant provisions of the East African country's law. The purpose of this exercise is to determine whether importation under the 30 August Decision and implementing legislation can provide a viable means of fulfilling demand for essential medicines in Rwanda given the African country's new law.
Part II outlines key aspects of the 30 August Decision, part III provides a background on Rwanda and the country's IP regime, while part IV identifies and analyses three major barriers to the effective utilisation of the WTO compulsory licence for export regime. The analysis draws upon relevant legal provisions and empirical knowledge garnered from the Apotex–Rwanda case study, shedding light on how Rwanda's new law is likely to impact the country's future use of the 30 August Decision. The paper concludes with an assessment of whether the 30 August Decision in fact solves the problem of countries like Rwanda that lack manufacturing capacity in the pharmaceutical sector or whether alternative means should be explored.
The 30 August Decision is a Decision of the WTO's General Council which contains eleven paragraphs and an Annex including three substantive waivers. Here it is pertinent to note that a waiver does not imply any change of substantive treaty obligations; it only temporarily suspends their operation for each member until a permanent amendment of the relevant TRIPS provisions becomes effective for that member.
See 30 August Decision,
Two of the waivers pertain to article 31(f) while the other relates to article 31(h).
Article 31(f) of the TRIPS Agreement is the provision that made it illegal to issue a compulsory licence to produce patented products for the specific purpose of exporting to another jurisdiction. Article 31(h) created the obligation to provide adequate remuneration to a patent holder when a compulsory licence has been issued.
The waivers are subject to certain conditions which mainly attempt to minimise the possibility of trade diversion and the use of the mechanism for commercial purposesParagraph 1 contains three important definitions which apply for the purposes of the 30 August Decision: pharmaceutical products, eligible importing members and eligible exporting members.
T. Kongolo,
In order to be eligible for the said waiver, the member should be a party to a Regional Trade Agreement (RTA) within the meaning of article XXIV of the General Agreement on Tariffs and Trade (GATT) 1994 and the Decision of 28 November 1979 on Differential and More Favourable Treatment Reciprocity and Fuller Participation of Developing Countries (Enabling Clause), membership of which at least 50 per cent is comprised of LDCs. SADC, EAC and COMESA are the only institutions that fulfil these criteria.
M. Nkomo,
The 30 August Decision is accompanied by a statement that was read out by the chairperson of the General Council, which had been prepared and forwarded to him by the chairperson of the TRIPS Council (Chairperson's Statement).
General Council Chairperson's Statement, 30 August 2003, available at
While the legal status of the Chairperson's Statement is uncertain, some commentators are of the view that it cannot create any obligations or conditions on its own.
P. Vandoren, and J. Eeckhaute, ‘The WTO Decision on Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health’, 6(6)
Abbott,
Pursuant to paragraph 11 of the 30 August Decision, on 6 December 2005, WTO members decided to make the Decision and the waivers provided therein permanent by amending article 31 of TRIPS through the Decision on the Amendment of the TRIPS Agreement (Amendment Decision).
Amendment of the TRIPS Agreement, WT/L/641 (Decision of the General Council of 6 December 2005).
This amendment will become effective only when two-thirds of the WTO membership adopt it; this is yet to occur.For a detailed analysis of the Amendment Decision, see D. Matthews, ‘From the August 30, 2003 WTO Decision to the December 6, 2005 Agreement on an Amendment to TRIPS: Improving Access to Medicines in Developing Countries?’, 10
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