The Regulations Amending the Food and Drug Regulations (Serious Adverse Drug Reaction Reporting – Hospitals) and Regulations Amending the Medical Devices Regulations (Medical Device Incident Reporting — Hospitals) were recently published. The amendments were enacted further to Vanessa's Law and will require all hospitals to provide specific information relating to serious adverse drug reactions and medical device incidents within 30 days of first documenting the reaction or incident in the hospital.
Most interlocutory decisions under the Patented Medicines (Notice of Compliance) (PMNOC) Regulations are made by prothonotaries of the Federal Court. The first Federal Court of Appeal decision in an appeal of an interlocutory order under the amended PMNOC Regulations was recently issued. The court found that the prothonotary had been entitled to arrive at a view of what was best for the particular proceeding and saw no reviewable error that would justify its intervention.
The Federal Court of Appeal recently granted the Patented Medicine Prices Review Board's (PMPRB's) appeal and returned to the board the matter of whether the invention of the patent at hand pertained to Galderma's Differin. The court addressed several issues, including whether the PMPRB had acted unreasonably in limiting its review of the patent to selected portions.
The Federal Court recently struck Novo Nordisk's judicial review application challenging the minster of health's decision to accept for review an abbreviated new drug submission filed by Teva Canada. In striking the application, the court concluded that Novo Nordisk had neither direct nor public interest standing in the matter.
The first half of 2019 has seen a number of changes to life sciences IP and regulatory law, including the proposed amendments to the Food and Drugs Act. In addition, the Advisory Council on the Implementation of National Pharmacare released its final report, which recommends that Canada implement a universal, single-payer, public pharmacare programme by enacting new legislation and proceeding in a stepwise approach to implementation.