On 2 October, Health Canada released for public comment regulations that would enable the export of low-cost generic versions of patented drugs to developing countries. The regulations seek to implement Bill C-9, "An Act to amend the Patent Act and the Food and Drugs Act (the Jean Chrétien Pledge to Africa)" that was passed on 14 May 2004 by the Canadian legislature after vigorous debate between the government, non-governmental organisations, and pharmaceutical companies (see BRIDGES Weekly, 10 March 2004).

The Canadian regulation is the first attempt internationally to implement a WTO General Council Decision of 30 August 2003 to waive patent rights to permit developing countries to import less expensive versions of high-priority medicines from other countries (see BRIDGES Weekly, 15 October 2003). This decision was the result of over a year of deliberations on the implementation of the November 2001 Doha Declaration on the TRIPS Agreement and Public Health. The Declaration urged the WTO General Council to look into ways to ensure that countries without any domestic production capacity could take advantage of compulsory licensing provisions in TRIPS to import essential medicines from other countries.

Key provisions in the new Canadian regulations include a requirement that drugs produced in Canada under this programme be packaged in a "distinctly different" manner from domestic drugs, including a marking of "XCL" on solid dosage forms. Drugs permitted under the program are listed in the Act itself and the list is derived principally from the World Health Organisation (WHO) Model List of Essential Medicines; any new proposals to add drugs to the list must be approved by the federal cabinet. Civil society groups such as the Canadian HIV/AIDS Legal Network had urged a more flexible approach to the permitted drug list, such as using the WHO list as the de facto Canadian list, but this approach was rejected owing to the need to ensure that all exported drugs under the new program meet the Canadian Food and Drugs Act and its regulations.

At the same time, civil society groups celebrated the fact that there is no so-called "right of first refusal" clause in the new regulations that would have allowed patent-holders to anticipate and take over contracts negotiated between generic pharmaceutical manufacturers and developing country purchasers. They noted, however, that generic drug-makers must seek a voluntary license from the patent holder before applying for a compulsory license. Generic manufacturers must also pay "adequate" remuneration to the patent holder, with the royalty amount to be determined on a case-by-case basis depending on the level of development of the importing country and the economic value of the drug that has been authorised. The legislation is not limited to dealing with HIV/AIDS, TB, and malaria, other "emergencies", or just drugs on the WHO list; rather, it is expressly humanitarian and aims to enable the provision of essential medicines by adding them to the list should the need arise.

The new regulations are open for public comment for 75 days and can be accessed in the 2 October issue of the Canadian Gazette: http://canadagazette.gc.ca/partI/2004/20041002/pdf/g1-13840.pdf.

The Canadian HIV/AIDS Legal Network has produced a short analysis of Bill C-9 which is available on-line at http://www.aidslaw.ca/Maincontent/issues/cts/patent-amend/billC-9flyer300604.pdf.

ICTSD reporting; "Canadian Government Issues Regulations On Patented Drug Exports to Third World," WTO REPORTER, 5 October 2004.