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.
The Canadian Agency for Drugs and Technologies in Health recently reported changes to transition Cancer Drug Implementation Advisory Committee functions to the CADTH pan-Canadian Oncology Drug Review process. Among other things, the changes aim to enhance the transparency of the pan-Canadian cancer drug review process and allow for greater stakeholder input into the development of a provisional algorithm for each new cancer drug or indication.
The Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Post-market Surveillance of Medical Devices) were recently pre-published. These proposed changes were made in accordance with Vanessa's Law. The proposed regulations would implement changes to the Food and Drug Regulations and Medical Devices Regulations and (among other things) establish a regulatory framework to require assessments, tests and studies of medical devices.
The Patented Medicine Prices Review Board (PMPRB) recently published the 2018 edition of the Meds Pipeline Monitor – a horizon-scanning report which provides a snapshot of the new drug landscape. The PMPRB report considered the 733 medicines that are currently in Phase III clinical trials or pre-registration and identified 30 that have the potential to address an unmet need, offer an improvement over existing therapies and treat serious conditions.
The minister of health recently published the final report from the Advisory Council on the Implementation of National Pharmacare. The council has recommended that Canada implement universal, single-payer, public pharmacare by enacting new legislation and proceeding in a stepwise approach to implementation.
The Federal Court recently dismissed Alexion's application for judicial review of a Patented Medicines Price Review Board (PMPRB) panel's decision that Soliris (eculizumab) had been sold at an excessive price and its order fixing the amount of the payment to offset excess revenues (C$4.2 million). The application was dismissed on the grounds that, among other things, the PMPRB had not been unreasonable in ordering payment of excess revenues based on the highest international price comparison.
Health Canada has published its Overview of the Reporting Adverse Reactions to Marketed Health Products – Guidance Document for Industry. The guidance document provides market authorisation holders with assistance on how to report adverse reactions to pharmaceutical drugs, biologics, radiopharmaceutical drugs and natural health products.
The Supreme Court of Canada has denied Apotex leave to appeal in two recent cases. In the first case, Apotex sought leave to appeal a decision of the Ontario Court of Appeal permitting Sanofi and Schering to amend their defences to claims relating to ramipril. In the second case, Apotex sought leave to appeal a decision of the Federal Court of Appeal relating to damages awarded to Eli Lilly in respect of Apotex's infringement of process patents relating to cefaclor.
Two sets of proposed amendments to the Food and Drug Regulations were recently published and contain provisions which would streamline the process for providing access to unauthorised drugs for medical emergencies. Access to the drugs will continue to be facilitated through the Special Access Programme for human drugs and the Emergency Drug Release Programme for veterinary products.
Health Canada recently released the new Guidance Document: Regulatory Requirements for Drug Identification Numbers. The document assists in interpreting the regulatory requirements associated with drug identification numbers and offers guidance to manufacturers on their obligation to accurately report notifications for a change of drug status to Health Canada.
The Federal Court has granted in part Pharmascience's motion to strike out portions of Teva's statement of claim under Subsection 6(1) of the Patented Medicines (Notice of Compliance) (PMNOC) Regulations relating to glatiramer acetate (Teva's Copaxone and Pharmascience's Glatect). The court found that it is plain and obvious that Section 6.02 of the PMNOC Regulations prohibits the joinder of a regular infringement action under the Patent Act with an action pursuant to Subsection 6(1).
The Patented Medicine Prices Review Board (PMPRB) previously announced that the steering committee on guidelines modernisation would hold its final meeting on 13 May 2019 to discuss both a draft report of its deliberations and the working group's final report. Once the steering committee's report has been finalised and the regulatory amendments have been published in Part II of the Canada Gazette, the PMPRB will release its draft guidelines for public consultation.
The Federal Court of Appeal recently affirmed the Federal Court's dismissal of Apotex's application for judicial review of a minister of health decision relating to its Apo-Omeprazole (omeprazole magnesium) delayed-release tablets. The minister had issued a Notice of Non-Compliance – Withdrawal letter in respect of Apotex's abbreviated new drug submission on the basis that the tablets were not bioequivalent to the relevant Canadian reference product.
The Federal Court recently dismissed Servier's application for a prohibition order under the pre-amended Patented Medicines (Notice of Compliance) Regulations for Canadian Patent 2,423,825 regarding a perindopril arginine/amlodipine product (Servier's Viacoram). Apotex had alleged that the patent was invalid for obviousness, overbreadth, inutility and insufficiency.
The Ontario Court of Appeal has overturned the Ontario Superior Court of Justice's finding that online sales of prescription eyewear by Essilor Group Canada Inc to Ontario residents violated the Regulated Health Professions Act. The court found that the mere act of delivery did not, in itself, establish a sufficient connection to Ontario so as to bring Essilor's online transactions within the ambit of the act.
In two recent cases, the Federal Court considered procedural decisions in actions under the Patented Medicines (Notice of Compliance) Regulations. In one case, the court ordered that common validity issues in actions relating to Bayer's Xarelto against Apotex and Teva will be heard concurrently. In another case, the court refused to allow the plaintiffs to name additional Teva parties as further defendants in three actions relating to Celltrion's Herzuma, a trastuzumab biosimilar of Roche's Herceptin.