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
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:
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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