Healthcare & Life Sciences updates

Canada

Contributed by Smart & Biggar
PMPRB news
  • Canada
  • 13 November 2019

The Patented Medicine Prices Review Board has released its CompassRx 2017/18 Annual Public Drug Plan Expenditure Report and related news release reporting various statistics regarding prescription drug expenditures by Canadian public drug plans. The report indicates that prescription drug expenditure by public plans increased by 7.4% to C$11.4 billion in 2017-18.

Competition Bureau concludes investigation into alleged restrictions of off-label use of vaccines
  • Canada
  • 13 November 2019

The Competition Bureau has conducted a preliminary investigation into allegations that a vaccine manufacturer tried to contractually restrict a provincial public immunisation programme's off-label use of a vaccine product. The alleged conduct could have resulted in higher costs for the province by preventing public health authorities from using competing products in their immunisation programmes.

Health Canada updates Guidance Document: The Management of Drug Submissions and Applications
  • Canada
  • 06 November 2019

Health Canada recently released an updated version of Guidance Document: The Management of Drug Submissions and Applications. The updates follow on from an earlier consultation and reflect the updated processes and procedures relating to filing a submission or application with Health Canada.

Court dismisses judicial review application of minister of health's interchangeability designation
  • Canada
  • 06 November 2019

The Court of Queen's Bench of Alberta recently dismissed Allergan's application for judicial review of the Alberta minister of health's decision to designate Allergan's glaucoma treatment product Lumigan RC 0.01% and Sandoz's generic bimatoprost ophthalmic solution Vistitan 0.03% as interchangeable. While the criteria for interchangeability decisions and resubmissions may differ, the questions as framed by Allergan were "opposite sides of the same coin".

Certificate of supplementary protection regime: second anniversary update
  • Canada
  • 23 October 2019

The certificate of supplementary protection (CSP) regime recently celebrated its second anniversary. This article looks back on the previous year and provides an updated summary of approvals, rejections and pending applications, as well as further reminders and tips, including (among others) that it is important to consider the possibility of a CSP early in the drug development and approval lifecycle.


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