Canada's Access to Medicines Regime is intended
to address public health problems afflicting many developing and least-developed
countries, especially those resulting from HIV/AIDS, tuberculosis, malaria
and other diseases. The Regime can only be successful with the participation
of Canadian generic pharmaceutical companies. Under the Regime, the Canadian Commissioner
of Patents can issue a compulsory licence to a pharmaceutical company allowing the manufacture and export of an
eligible drug or medical device to an eligible
Pharmaceutical companies and medical device manufacturers
can reap certain benefits by participating in
- Companies can benefit from the public relations associated with being
actively involved in providing humanitarian relief to developing countries
that are trying to deal with public health problems.
- Companies have the opportunity to build ongoing relationships with developing
countries, which could lead to further joint initiatives in the future.
- Health Canada will review products intended for export according
to the same process and standards as products for the Canadian market.
A separate review stream has been created for these products.
- Manufacturers can apply to have the fees associated with the review process
remitted to them once a compulsory licence is issued for the product.
- Drugs authorized for export under the Regime will, upon meeting the
requirements of the Patented Medicines (Notice of Compliance) Regulations and the Food and Drug Regulations, be granted an authorization
by Health Canada for marketing in Canada.
- Pharmaceutical companies can cover their development and production expenses
through the sale of their pharmaceutical products to importing countries
and are allowed a marginal rate of return.
To participate in the Regime,
a company must meet the requirements prescribed by the Patent
Act, the Use
of Patented Products for International Humanitarian Purposes Regulations,
and Drugs Act and the Food and Drug Regulations. Once
a company is granted a compulsory licence, it must meet the Conditions
of Compulsory Licences throughout the validity period of the licence.