Bill C-9 Draft Patent Regulations Open for Public Comment

The draft Regulations for Bill C-9, stemming from what is often referred to as the "Jean Chrétien Pledge to Africa", are open for public comments and questions. Submissions will be accepted until December 17, 2004. Passed by Parliament on May 14, 2004, Bill C-9 amends both the Patent Act and the Food and Drugs Act. The legislation was designed to implement the WTO decision of August 30, 2003 to waive certain trade obligations under the TRIPS Agreement which are thought to prevent effective responses to public health emergencies in developing countries, such as those caused by outbreaks of HIV/AIDS, malaria and tuberculosis. The Patent Act will be amended to permit the Commissioner of Patents to grant export-only compulsory licences to Canadian pharmaceutical manufacturers wishing to supply a lower-cost version of an eligible patented product to an eligible impoverished country. The Food and Drugs Act will be amended so that exported products will be required to meet the same safety and quality standards as those available to Canadian consumers. Although Bill C-9 has received Royal Assent, it will not come into force until its Regulations have been adopted. The Regulations were developed jointly by Industry Canada and Health Canada in consultation with brand name pharmaceutical manufacturers, generic manufacturers and interested NGOs. They were pre-published in the Canada Gazette (October 2, 2004) and will be open for examination and comment during a 75-day consultation period. The patent-related Regulations set out the information to be disclosed and the forms to be filled out to obtain, maintain and renew an export licence. The health-related Regulations are intended to ensure that products exported under the Access to Medicines Program meet the same standards as those products coming to the Canadian market. Proposed Regulations also require drugs and devices destined for export under licence to be marked to distinguish them from the products to be sold in Canada. For the proposed Regulations and background, visit: http://canadagazette.gc.ca/partI/2004/20041002/pdf/g1-13840.pdf. For the news release from Industry Canada, see: http://makeashorterlink.com/?D22824E99. Summary by: Clare McCurley