Canada’s regulatory regime needs to adapt to these vast changes to healthcare. Modernizing regulatory practices will ensure Canada provides Canadians with the best of what health discovery and research offers.

Access To Innovative Therapies

Innovative biotechnology companies developing advanced therapies face challenges in getting their products to Canadian patients. Restricted market access and slow adoption of new technologies has serious implications for Canadians. BIOTECanada is working with Federal Provincial and Territorial review bodies such as the Common Drug Review (CDR) to create a better environment for the adoption of breakthrough therapies and greater recognition of the value of innovation.


On February 14, 2018
BIOTECanada and the Vaccine Industry Committee submitted industry responses to the Canada Gazette Part I Consultation – Regulations Amending the Patented Medicines Regulations. The industry provide detailed comments to Health Canada on the Regulatory Impact Analysis Statement and the proposed regulatory text.

The BIOTECanada submission highlights Canada’s vibrant biotechnology ecosystem, a national network with world leading research and development bringing solutions to improve healthcare. The submission notes changes to the regulatory framework should be made in a fair and balanced approach to avoid unintended consequences and ensure innovation and access of biologics medicines for Canadians.

Vaccines are a prime example of a class of patented products for which there is low risk, and therefore should be managed with limited regulatory burden including adoption of a “complaint” based approach similar to over the counter products. The Vaccine Industry Committee submission stated that strict regulatory oversight is not necessary for vaccines given the competitive bid process that establishes a fair market price and represents the vast majority of doses dispensed in the Canadian market.

Read full BIOTECanada Canada Gazette Part I submission here.

Read full Vaccine Industry Committee’s Canada Gazette Part I submission here. 

BIOTECanada and the Vaccine Industry Committee also submitted responses to Health Canada’s pre- consultation on the proposed amendments to the Patented Medicines regulations in June 2017.

Read the full BIOTECanada pre-consultation submission – click here.

Read the full Vaccine Industry Committee pre-consultation submission – click here.

Establishing a Canadian Orphan Product Policy

Canadians who live with orphan diseases deserve the same access to life-saving interventions as in other countries. BIOTECanada is working with all levels of government and key partners to establish a forward-looking Orphan Product Policy with the necessary legislative and regulatory parameters to ensure Canadians can get the therapies they need, and that companies have an incentive to develop and introduce products for orphan diseases. Read more.

Subsequent Entry BiologicS (SEBS)

The term Subsequent Entry Biologic (SEB) is used by Health Canada to describe “a biologic product that is similar to and would enter the market subsequent to an approved innovator biologic product.” The agency is currently considering the regulatory process by which such products would be granted a marketing licence in Canada.

BIOTECanada supports the creation of a regulatory pathway for the regulation of SEBs that incorporates processes and requirements that protect the safety of patients.

BIOTECanada members have developed a set of principles that the biotechnology industry believes should guide the introduction and regulation of SEBs in the Canadian marketplace.