Consultations

BIOMANUfacturing strategy Submission

In March 2021, BIOTECanada submitted targeted recommendations to the federal government in the context of the government’s biomanufacturing consultation. The entire life sciences ecosystem must be the foundation for determining the success of this public policy commitment. From academic research to small start-up companies to multinational commercial interests, a continuum of capacity building is the essence of how success for this initiative will be realized. The challenge for Canada is to build a sustainable system to respond to current and future health emergencies. Read the full submission here.

Submission to federal budget consultations

In August 2020, BIOTECanada submitted a recommendation to the Federal government to invest $500 million to establish the Life Sciences Capital Catalyst Initiative (LS-VCCI)a life sciences venture envelope with the critical capital necessary and incentives to attract private capital (from Canadian institutional investors Canadian Pension Plan (CPP), OMERS etc. as well as international sources) in order to grow the availability of capital to domestic life science venture funds, top performing later stage companies, as well as key seed stage initiatives.

To maximize the return to government on its investment, the proposed “Life Sciences VCCI” would have three (3) major functions, namely:

  • Finance seed and early stage funding vehicles:  These vehicles will support company creation and early stage growth of innovations/companies emerging from Canada’s leading academic institutions;
  • Grow Canadian venture capital fund capacity: Strengthen and grow the Canadian venture capital investment pool by facilitating the collaboration of Canadian venture capital firms and attract investment from larger domestic investors and investors from outside Canada; and,
  • Create Canadian-based anchor companies: Provide later stage companies (private or public) access to investment capital to support their ability to grow in Canada and ultimately mature into domestic anchor companies.

Read BIOTECanada’s full submission here.

feedback to PMPRB draft guidelines

In August, 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.

Read the BIOTECanada PMPRB Submission to the Draft Guidelines here – August 2020

Read the VIC PMPRB Submission to the Draft Guidelines here – August 2020