Healthcare & Life Sciences, Canada updates

Ontario Court of Appeal overturns ban on online sales of prescription eyewear to Ontario residents
Smart & Biggar/Fetherstonhaugh
  • Canada
  • 12 June 2019

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.

Procedural decisions under PMNOC Regulations: common validity issues and naming of defendants
Smart & Biggar/Fetherstonhaugh
  • Canada
  • 12 June 2019

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.

New oncology initiative and Health Canada study on biosimilar drugs
Smart & Biggar/Fetherstonhaugh
  • Canada
  • 05 June 2019

The new pan-Canadian Oncology Biosimilars Initiative aims to ensure appropriate implementation and cost-effective use of therapeutic oncology biosimilars. Separately, Health Canada recently announced that it is collaborating with the Drug Safety and Effectiveness Network on a project to study patients with certain diseases who are taking biologic drugs. The study aims to compare the safety and effectiveness of biosimilar drugs to the reference biologic drug.

Health Canada invites submissions containing high-quality, real-world evidence
Smart & Biggar/Fetherstonhaugh
  • Canada
  • 05 June 2019

Health Canada recently released a notice inviting drug submissions containing high-quality, real-world evidence along with a document providing principles for the collection and evaluation of real-world evidence. A further joint document regarding the use of real-world evidence is expected to be published later in 2019.

Bill C-97: amendments to Food and Drugs Act establish framework for advanced therapeutic products
Smart & Biggar/Fetherstonhaugh
  • Canada
  • 29 May 2019

Bill C-97, which was recently introduced in the House of Commons, includes proposed amendments to the Food and Drugs Act to introduce a new framework for advanced therapeutic products, including a new licensing framework. It is expected that advanced therapeutic products may include the regulation of newer technologies, such as cell and gene therapies, 3D printing and novel drug delivery methods.

Proposed amendments to Food and Drug Regulations
Smart & Biggar/Fetherstonhaugh
  • Canada
  • 29 May 2019

Health Canada recently released its proposed Regulations Amending the Food and Drug Regulations (Improving Access to Generics). The proposed regulations clarify and codify Health Canada's expectations and policies regarding differences in the form of medicinal ingredients in generic drug products that are eligible for submission under the abbreviated new drug submission pathway by introducing a regulatory definition for 'therapeutically active component'.

On the (Quebec health) record: Quebec government liable for patent infringement
Smart & Biggar/Fetherstonhaugh
  • Canada
  • 22 May 2019

In a digital-age David versus Goliath case, the Federal Court recently held that the Quebec government had infringed two patents owned by Dr Luc Bessette relating to a shared medical records system that he had invented 20 years ago. This is the first time that the Quebec government has been held liable for patent infringement and the decision provides important guidance to institutions, enterprises and inventors alike.

Amendments to Patented Medicines Regulations expected to come into force no earlier than Spring 2020
Smart & Biggar/Fetherstonhaugh
  • Canada
  • 22 May 2019

Health Canada recently released its Forward Regulatory Plan 2019-2021: Regulations Amending the Patented Medicines Regulations. This brief document provides a high-level overview of the anticipated amendments released in draft form on 2 December 2017, the expected impact of these amendments and the consultation process.

PMPRB publishes 2017 Meds Entry Watch
Smart & Biggar/Fetherstonhaugh
  • Canada
  • 15 May 2019

The Patented Medicine Prices Review Board recently announced the publication of the 2017 edition of Meds Entry Watch. According to the notice, this publication provides information on new medicines entering Canadian and international markets and examines the availability, sales, uptake, pricing and treatment costs of new medicines that were approved by the US Food and Drug Administration, the European Medicines Agency and Health Canada in 2016 and 2017.

Supreme Court denies Apotex leave to appeal decision regarding India facilities
Smart & Biggar/Fetherstonhaugh
  • Canada
  • 15 May 2019

In 2018 the Federal Court of Appeal dismissed Apotex's appeal of a judicial review decision of the Therapeutic Products Directorate (TPD), finding that the Federal Court made no reviewable error in its conclusion that the TPD's decision was not improperly motivated. The Supreme Court recently dismissed Apotex's application for leave to appeal.

Quebec Court of Appeal overturns decision to delist Remicade from Quebec's List of Medications
Smart & Biggar/Fetherstonhaugh
  • Canada
  • 08 May 2019

The Quebec Court of Appeal recently found the minister of health and social services's decision to delist Janssen's Remicade from Quebec's List of Medications to be invalid and ordered the minister to reinstate the drug on the list. The court concluded that the minister had violated procedural fairness and should have given Janssen formal notice and an opportunity to respond before making the change.

Health Canada launches e-learning tool for understanding pre-market regulatory requirements
Smart & Biggar/Fetherstonhaugh
  • Canada
  • 08 May 2019

Health Canada recently launched its e-learning tool for understanding pre-market regulatory requirements for medical devices. Among other things, the tool will provide targeted guidance to enable greater consistency in the understanding, interpretation and application of the Food and Drugs Act, the Medical Devices Regulations and their related policies and guidelines.

Health Canada and CADTH launch new initiative to provide early parallel scientific advice
Smart & Biggar/Fetherstonhaugh
  • Canada
  • 01 May 2019

Health Canada and the Canadian Agency for Drugs and Technologies in Health (CADTH) recently launch a new initiative to provide early parallel scientific advice. The initiative will enable Health Canada and the CADTH to collaborate and share perspectives while each formulating independent advice regarding a sponsor's specific drug development plan. It will also give sponsors the opportunity to hold joint meetings with Health Canada and the CADTH to discuss their advice.

Pharmacare advisory council delivers initial recommendations
Smart & Biggar/Fetherstonhaugh
  • Canada
  • 01 May 2019

In March 2019 the Advisory Council on the Implementation of National Pharmacare delivered its interim report with three initial recommendations: create a national drug agency to oversee national pharmacare, develop a comprehensive, evidence-based list of prescribed drugs to harmonise coverage across Canada; and invest in data on prescription drugs and IT systems. The federal government subsequently delivered the 2019 Federal Budget, which reflects these recommendations.

Final regulations addressing public release of clinical information now in force
Smart & Biggar/Fetherstonhaugh
  • Canada
  • 24 April 2019

The final Regulations Amending the Food and Drug Regulations and Regulations Amending the Medical Devices Regulations recently came into force. Their objective is to provide public access to clinical information submitted to Health Canada for drugs for human use and medical device applications. As a result of the regulations, Health Canada published (among other things) a guidance document to help explain aspects of the new regulations, such as the procedures to prepare information for release.

Court of Appeal dismisses appeal of judgment awarding Apotex damages
Smart & Biggar/Fetherstonhaugh
  • Canada
  • 17 April 2019

In December 2017 Apotex was awarded more than C$11 million in damages and pre-judgment interest for losses resulting from delays in the US Food and Drug Administration's approval of its amoxicillin-clavulanic acid and levodopa-carbidopa products, which had been caused by contractual breaches and negligence on the part of MDS Pharma Services (MDS). However, the Ontario Court of Appeal recently dismissed MDS's appeal and Apotex's cross-appeal of that judgment.

Apotex seeks leave from Supreme Court of Canada in cefaclor damages action
Smart & Biggar/Fetherstonhaugh
  • Canada
  • 17 April 2019

The Federal Court of Appeal recently allowed in part Apotex's appeal of a decision awarding Eli Lilly more than C$100 million for Apotex's infringement of eight process patents relating to the antibiotic cefaclor. The court rejected Apotex's argument that a non-infringing alternative would have been available to Apotex during the relevant period. The case was remitted to the Federal Court for reconsideration on the issue of prejudgment interest; Apotex has applied to the Supreme Court of Canada for leave to appeal.

Costco Pharmacies receives C$7.25 million penalty for accepting drug rebates
Smart & Biggar/Fetherstonhaugh
  • Canada
  • 10 April 2019

The Ontario Ministry of Health and Long-Term Care recently announced that CWC Pharmacies (Ontario) Ltd (Costco Pharmacies), a subsidiary of Costco, has been ordered to pay an administrative monetary penalty of C$7.25 million for accepting payments from certain generic manufacturers which had violated the prohibition on drug rebates.

Proposed changes to OHIP+ programme
Smart & Biggar/Fetherstonhaugh
  • Canada
  • 03 April 2019

The OHIP+ programme was implemented by the Province of Ontario to provide free prescription drug coverage for all children and youths (ie, individuals aged 24 and under), regardless of family income or whether they have private insurance. However, under proposed amendments to Ontario Regulation 201/96 made under the Ontario Drug Benefit Act, only children and youths without private insurance will continue to receive coverage through the OHIP+ programme.

Health Canada publishes guidance document on post-market drug benefit-risk assessments
Smart & Biggar/Fetherstonhaugh
  • Canada
  • 27 March 2019

Health Canada recently published its "Overview of the format and content for post-market drug benefit-risk assessment in Canada – guidance document". The objective of the guidance document is to assist market authorisation holders in developing a post-market benefit-risk assessment for a marketed drug when requested.

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