Canada Notifies Compulsory Licence to Export

Last week, Canada became the first country to notify the TRIPS Council of the World Trade Organization (WTO) under Paragraph 2(c) of the Decision of 30 August 2003 on the Implementation of Paragraph 6 of the Doha Declaration of the TRIPS Agreement and Public Health.

The notification follows the earlier notification to import made by Rwanda, 17 July, under paragraph 2(a). This earlier notification informed the WTO of the intention to import 260 000 packs of the fixed-dosed combination treatment for HIV-AIDS, TriAvir. Canada's notification to export the medicine to Rwanda is required under the Decision of 30 August 2003 and, according to the WTO news item, "completes the circle" of the first export to occur under the paragraph system.

According to the notification published Friday, Canada has authorised Apotex to export TriAvir to Rwanda. Apotex, the largest Canadian-owned pharmaceutical company, announced in a press release last month the decision by the Federal Commission of Patents to issue the compulsory licence under Canada's Access to Medicines Regime Program (CAMR). The CAMR was established as a mechanism by which to facilitate the access of developing countries to necessary medicines for HIV-AIDS, malaria, tuberculosis and other serious diseases. Nevertheless, Apotex criticises the process as "unnecessarily complex" and "controlled by the multinational pharmaceutical companies who hold patents for drugs like Apo-Triavir."

Canada's notification under paragraph 2(c) fulfils the requirements under that provision to provide to the TRIPS Council relevant infromation on the compulsory licence. As such, the notification announces the authorisation for the medicine to be produced and exported to Rwanda, the conditions governing the compulsory licence and the medicine covered by the licence. Also required is the website of the company licensed to produce the generic version where posts on quantities and other relevant information are to be published before export occurs. Future notifications of exports will be published on the WTO's dedicated page.

As seen previously on IPKat, the UK Intellectual Property Office (IPO) has launched its informal consultation on the proposed changes to the UK Patents Act 1977 to give effect to the Communities' implementation of the Decision on Paragraph 6 on compulsory licences and supplementary protection certificates - Regulation (EC) No 816/2006 of the European Parliament and of the Council of 17 May 2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems (Compulsory Licences Regulation). The deadline for responses is 31 October.

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