Modernizing regulatory practices will ensure Canada provides Canadians with the best of what health discovery and research offers.
ACCESS TO NEXT GENERATION BIOTECHNOLOGY THERAPIES
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 Health Canada, Federal Provincial and Territorial governments and Health Technology Assessment Agencies to create a better environment for the adoption of breakthrough therapies and greater recognition of the value of innovation.
BIOTECanada AND VACCINE INDUSTRY COMMITTEE PROVIDE FEEDBACK TO the patented medicine prices review boarD (PMPRB) draft guidelines consultations
On August 4, 2020 BIOTECanada and the Vaccine Industry Committee submitted industry responses to the PMPRB June 2020 revised draft Guidelines draft consultation. This follows the publication of new regulations on August 21, 2019 amending the patented medicines regulations and first set of draft Guidelines published November 2019. The industry provided detailed comments to PMPRB on the June 2020 revised draft guidelines and urged the regulator to hold off on implementation of the new Guidelines until technical working groups are established to address and work through the significant implantation challenges identified in the draft Guidelines.
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 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. The June 2020 revised draft Guidelines do not encourage this approach and raise serious complexities as it relates to access of vaccines.
BIOTECanada and the Vaccine Industry Committee submitted responses to Health Canada’s, Canada Gazette Part I consultation on the proposed Amendments to the Patented Medicines Regulations February 14, 2018.
Past BIOTECanada and Vaccine Industry Committee submissions to Health Canada’s pre- consultation on the proposed amendments to the Patented Medicines regulations can be found 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.