Pharma in Brief

Government releases final amendments to the PMPRB’s Patented Medicines Regulations to lower the prices of patented medicines

By Christopher A. Guerreiro, Kristin Wall & Brian R. Daley on August 13, 2019

The Government is moving forward with changes to the PMPRB intended to lower the prices of patented medicines in Canada in order to lay the foundation for National Pharmacare. The changes are set out in final amendments to the Patented Medicines Regulations that were released on Friday, August 9, 2019. The amendments will come into force on July 1, 2020. Once the amendments come into force, the PMPRB will use a different basket of price…

Pharma in Brief

Competition Bureau issues statement regarding off-label use of vaccines

By Ian Trimble, Kevin Ackhurst, Richard Wagner & David Yi on July 29, 2019

The Competition Bureau (Bureau) recently conducted a preliminary investigation into possible competition concerns arising from a proposal to include a clause in a procurement contract that would restrict off-label use of a vaccine. The Bureau concluded that there was no abuse of dominance as the provision was not included in the procurement contract; however, it issued a statement providing guidance on off-label use of vaccinations. After outlining vaccine approval and reimbursement, and administration of immunization…

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Health Canada consulting on clinical trial requirements and “new class” of advanced therapeutic products

By Ian Trimble, Christopher A. Guerreiro & Sara Zborovski on July 24, 2019

As we reported, the Budget Implementation Act, 2019 (BIA) paved the way for changes to the regulation of clinical trials and created a new class of “advanced therapeutic products” (ATPs) regulated by Health Canada. Health Canada is consulting on what it should consider in developing regulations for clinical trials and implementing the approval pathway for ATPs until August 30, 2019. Background The BIA received Royal Assent on June 21, 2019. The changes to clinical…

Pharma in Brief

Health Canada consulting on draft guidance distinguishing promotional and non-promotional activities for health products

By Meghan Allard, Veronique Barry, Ian Trimble & Sara Zborovski on July 22, 2019

Health Canada is consulting on a draft guidance document entitled The Distinction Between Promotional and Non-promotional Messages and Activities for Health Products (Draft Guidance), which is intended to replace the current 1996 policy entitled The Distinction Between Advertising and Other Activities (Current Policy). Copies of the Draft Guidance are available from Health Canada on request; comments can be submitted until September 3, 2019. Background As with the Current Policy, the Draft Guidance is intended to…

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Federal Court of Appeal agrees that the PMPRB incorrectly applied the patent-pertaining analysis

By Christopher A. Guerreiro, Brian R. Daley & Kristin Wall on July 9, 2019

The Federal Court of Appeal has provided new guidance on the proper approach to the “patent pertaining” analysis used by the Patented Medicine Prices Review Board (PMPRB or Board), including on the identification of the medicine and the invention of the patent, in a case concerning Differin®. Having provided this guidance, the Court of Appeal set aside the judgment under appeal and remanded the final determination of whether or not the patent in question pertains to Differin® to the Board.…

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Patent Act Infringement Actions Cannot be Joined to PM(NOC) Infringement Actions During NOC Prohibition Period

By Kassandra Shortt, Christopher A. Guerreiro & Jordana Sanft on June 25, 2019

The Federal Court recently confirmed that an infringement action under the Patent Act cannot be joined with an infringement action under the Patented Medicines (Notice of Compliance) Regulations (the Regulations) while the Regulations prohibit the Minister from granting a NOC. The Court stated that an infringement action under the Patent Act could instead be brought in a separate proceeding. With cooperation between the parties and simultaneous scheduling of the trial of common issues, separate Patent Act…

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Health Canada proposes updates relating to sale of unapproved drugs for emergency treatment

By Ian Trimble & Sara Zborovski on June 4, 2019

Amendments have been proposed to the Food and Drug Regulations that relate to the sale of drugs that have not been approved in Canada for emergency treatment. These amendments update the Special Access Program (SAP) and create a mechanism whereby drugs can be purchased for immediate use or stockpiled for public health or Canadian Armed Forces (CAF) emergencies. I. Changes to the SAP The proposed amendments are intended to streamline the application process for practitioners…

Pharma in Brief

CUSMA Implementation Bill Introduced

By Kassandra Shortt, Christopher A. Guerreiro & Kristin Wall on June 4, 2019

On May 29, 2019, the federal government introduced Bill C‑100 to implement the new trilateral trade deal known as the Canada-United States-Mexico Agreement (CUSMA, also referred to as USMCA), making Canada the first of the three member countries to introduce legislation that would ratify the treaty. CUSMA provides more protections for biologic and innovative pharmaceuticals under Canadian law. However, the treaty does not require the immediate adoption of these new protections and none of them…

Pharma in Brief

Quebec Court of Appeal confirms CPA does not apply to the sale of prescription drugs

By Dominic Dupoy on May 15, 2019

In a May 8 decision, the Quebec Court of Appeal confirmed that the Quebec Consumer Protection Act (CPA) does not apply to the sale of prescription drugs. The decision, Brousseau v Laboratoires Abbott limitée, 2019 QCCA 801 provides critical guidance on the liability regime in Quebec for manufacturers of pharmaceutical products facing product liability claims. A French version of this post follows. Relevant facts Abbott Laboratories manufactured a drug commercialized under the name Biaxin®. Abbott…

Pharma in Brief

Federal Court of Appeal affirms cancellation of reconsideration of ANDS for Apo-omeprazole

By Kassandra Shortt & Judith Robinson on May 2, 2019

The Federal Court of Appeal has dismissed an appeal by Apotex Inc. (Apotex) in its unsuccessful application for judicial review of a decision by the Minister of Health (the Minister) to cancel the reconsideration of approval for Apo-omeprazole. Background As we reported, the Minister revoked Apotex’s Notice of Compliance (NOC) for Apo-omeprazole and declined to issue the NOC again in 2013 due to inadequate evidence of bioequivalence in its Abbreviated New Drug Submission. Apotex…

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Blog Authors

Government releases final amendments to the PMPRB’s Patented Medicines Regulations to lower the prices of patented medicines

Competition Bureau issues statement regarding off-label use of vaccines

Health Canada consulting on clinical trial requirements and “new class” of advanced therapeutic products

Health Canada consulting on draft guidance distinguishing promotional and non-promotional activities for health products

Federal Court of Appeal agrees that the PMPRB incorrectly applied the patent-pertaining analysis

Patent Act Infringement Actions Cannot be Joined to PM(NOC) Infringement Actions During NOC Prohibition Period

Health Canada proposes updates relating to sale of unapproved drugs for emergency treatment

CUSMA Implementation Bill Introduced

Quebec Court of Appeal confirms CPA does not apply to the sale of prescription drugs

Federal Court of Appeal affirms cancellation of reconsideration of ANDS for Apo-omeprazole

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