British Columbia and Canada Achieve Data Protection

British Columbia has successfully achieved internationally competitive data protection standards for innovation of biological products in Canada. Data protection ensures that competitors cannot use information for a certain, limited time period for the purpose of coming to market with a competing product.

On October 5^th, Industry Canada’s Regulations Amending the Patented Medicines (Notice of Compliance) Regulations and Health Canada’s Regulation Amending the Food and Drug Regulations (Data Protection) were approved by the Governor in Council and registered.

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 30(3)a of the Food and Drugs Act, hereby makes the annexed Regulations Amending the Food and Drug Regulations (Data Protection).

Section C.08.004.1 of the Food and Drug Regulations¹ is replaced by the following:

(8) Paragraph (3)b does not apply to a subsequent manufacturer if the innovator consents to the issuance of a notice of compliance to the subsequent manufacturer before the end of the period of eight years specified in that paragraph or of eight years and six months specified in subsection (4).

Unofficial electronic copies of these documents are available at http://www.ic.gc.ca and the revised regulations will be published in the Canada Gazette, Part II, on October 18^th.

This level of data protection under the Food and Drug Regulations Act makes Canada and British Columbia competitive internationally and positions us to become a world leader in life sciences.