Benefits for companies participating in Canada's Access to Medicines Regime
The pharmaceutical company must complete and submit to the Commissioner of Patents a Solemn or Statutory Declaration Under Paragraph 21.04(3)(c) of the Patent Act. The form sets out the information that must appear in the declaration, including that the company
- unsuccessfully sought a voluntary licence from the patent holder or holders at least 30 days prior to the date of the application; and
- provided the patent holder or holders with information that is substantially the same as in its application.
An attempt to negotiate a voluntary licence is required to comply with Article 31(b) of the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).
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 importing country.
Pharmaceutical companies and medical device manufacturers can reap certain benefits by participating in the Regime:
- 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, the Food 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.
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