Use of Patents for International Humanitarian Purposes to Address Public Health Problems (Canada's Access to Medicines Regime)
On May 14, 2004, the Jean Chrétien Pledge to Africa Act (formerly Bill C-9) received Royal Assent. This legislation amended the Patent Act and the Food and Drugs Act to provide the framework enabling Canada to respond to an August 30, 2003, decision of the General Council of the World Trade Organization (WTO).
By that decision, WTO Members, such as Canada, agreed to waive certain obligations in the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which were thought to be a potential barrier to effective responses to health emergencies.
With the implementation of the Use of Patented Products for International Humanitarian Purposes Regulations, Canada became one of the first countries to permit the grant of authorizations to Canadian pharmaceutical manufacturers who wish to supply lower-cost versions of patented pharmaceutical products to countries with inadequate or no pharmaceutical manufacturing capabilities.
- Eligible importing countries
- WTO Member Country
- Non-WTO Country
Eligible importing countries
The agreement of August 30, 2003 is only between Member countries of the WTO.
In spite of this, Canada has chosen to implement the decision in a way that allows both developing and least developed non-WTO Member countries to import eligible patented pharmaceutical products.
The Canadian Parliament felt that the moral imperative of assisting the world’s least developed countries would outweigh the risk of any trade challenge that may arise as a result. These countries have been listed as eligible importers in the Act.
As for the less vulnerable non-WTO Member developing countries, they are not automatically eligible to import but can be individually added to the list following a case-by-case assessment by the Governor in Council.
WTO Member Country
A WTO Member Country must notify the WTO of the name and the quantity of the required product and, if a domestic patent protects the product, indicate the Member's intention to grant authorization to use the invention pertaining to the product in question. This notification will be posted on a dedicated area of the WTO Web site.
Unless the importing Member is a least developed country, the notice must also contain a declaration by that Member that it has no or insufficient capacity to manufacture the required product.
Consideration by Canada for any non-WTO country seeking to import pharmaceutical products under the regime requireswritten notice to the Government of Canada through diplomatic channels and is conditional upon agreement to specific criteria:
- Least developed country (LDC) : The government would be required to formally state that it will not import licenced products for commercial purposes, and that it will adopt measures consistent with the August 30th decision to prevent re-exportation of pharmaceutical products to other countries.
- Developing country : In addition to the above LDC requirements, developing countries must also qualify for official development assistance according to the Organisation for Economic Co-operation and Development (OECD). The country must also formally state that it is experiencing substantially the same conditions under which developing country WTO Members on Schedule 4 may import licenced pharmaceutical products (e.g., urgent circumstances and insufficient manufacturing capacity).