17 May 2005

PC 2005-859 Regulations Amending the Food and Drug Regulations (1402 – Drugs for Developing Countries)

In the November 2001 Doha Declaration, WTO members recognized the gravity of the public health problems afflicting many developing and least-developed countries, especially those resulting from HIV, AIDS, tuberculosis, malaria and other epidemics.

On 30 August 2003 the WTO General Council waived certain provisions of the Agreement on Trade-Related Intellectual Property Rights (TRIPS), which were thought to be a barrier to effective responses to such public health problems. The waived TRIPS obligations relate to the terms and conditions under which member states can authorize the use of a patented invention without the consent of the patent holder. Prior to the waiver of TRIPS obligations, such use could only be authorized predominantly for the supply of the domestic market. This had the effect of preventing developed WTO members, such as Canada, from authorizing the production of low-cost versions of the patented medicine solely for export to least-developed and developing countries unable to manufacture their own….

Bill C-9, An Act to amend the Patent Act and Food and Drugs Act, sets out the legislative framework which will allow manufacturers to obtain an authorization (compulsory licence) allowing them to make, construct and use a patented invention solely for the purpose of exporting a pharmaceutical product to eligible importing countries, provided that manufactures meet certain conditions….

As the WTO’s definition of “pharmaceutical products” includes products that Canada regulates as drugs or medical devices, regulatory changes have been made to both the Food and Drug Regulations as well as the Medical Devices Regulations…. These regulatory amendments create a new Division 7 to the Food and Drug Regulations….

Manufacturers must, in writing, notify the Minister of Health no less than 15 days prior to the start of manufacturing of the first lot, and no less than 15 days prior to the exportation of each subsequent lot. … This provision provides the Health Products and Food Branch Inspectorate with adequate notice to facilitate the scheduling of inspections….