Bill C-9, An Act to Amend the Patent Act and the Food and Drugs Act (the Jean Chrétien Pledge to Africa Act) and its accompanying regulations came into force on May 13, 2005. Bill C-9 seeks to implement the Decision of the World Trade Organization (WTO) General Council of August 30, 2003 ("Decision"). The Decision implements paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, and allows any member country to export pharmaceutical products made under compulsory licences within the terms set out in the Decision. A detailed overview of Bill C-9 was reported in our June 2004 issue of Rx IP Update.
Industry Canada News Release
Regulations Amending the Food and Drug Regulations (1402 – Drugs for Developing Countries)
Regulations Amending the Medical Devices Regulations (Developing Countries)
Use of Patented Products for International Humanitarian Purposes Regulations
Schedule 1 of the amended Patent Act lists the eligible patented pharmaceutical products. On May 14, 2005, the Government published a proposed amendment to Schedule 1 to list lamivudine + nevarapine + zidovudine 150mg/200mg/300mg fixed-dose combination tablets. Interested parties may make representations on this proposal by June 13, 2005.