Data Protection: Early Days

Canada amended its Data Protection Regulations in 2006, aiming to provide protection for "innovative drugs." This was Canada's second attempt to implement its 1994 NAFTA and TRIPS treaty obligations that require signatory member countries to protect data that is originated from considerable effort and required to be submitted for government approval. The current term of protection is eight years counting from the innovative drug's date of approval (notice of compliance) preventing others from making a direct or indirect comparison from receiving approval until expiry of that term. In addition, a pediatric six-month extension is available if certain criteria are met.

Under the Canadian system, a register of innovative drugs is maintained, listing all drugs that have been found by Health Canada to be eligible for protection. Protection is typically requested by the innovator during the regulatory submission process. Once found to be eligible, a product may lose protection if it is not marketed in Canada.

The Regulations have now survived a challenge to their validity. In December, 2010, a Federal Court of Appeal judgment upheld their validity (2010 FCA 334) with leave to appeal to the...