CADTH convenes Advisory Panel on a pan-Canadian prescription drug list

CADTH has convened a pan-Canadian Advisory Panel on a Framework for a Prescription Drug List (the Panel). The Panel will provide recommendations on developing a potential pan-Canadian prescription drug list (or formulary). Stakeholder consultations are scheduled to take place in the fall and winter of 2021, leading to a final public report setting out the Panel’s non-binding recommendations in April 2022.

Mandate and membership of the Panel

According to CADTH, the Panel’s recommendations are intended to contribute to discussions on a potential pan-Canadian prescription drug list. The mandate of the Panel is to:

  • Recommend principles and a framework for
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PMPRB Guidelines update: consultation on changes re delayed implementation

The Patented Medicine Prices Review Board (PMPRB) has launched a consultation on proposed changes to its new Guidelines (the New Guidelines). These changes include revisions to the price tests for some medicines marketed prior to the anticipated coming-into-force date of the New Guidelines.

The PMPRB has indicated that these changes are intended to account for delays in the coming-into-force date of amendments of the Patented Medicines Regulations (the Regulations). As we reported, the New Guidelines have already been updated once to account for earlier delays to these amendments. Following a further delay, most of … Continue Reading

Certain COVID-19 medical devices no longer hold urgent public health need status under Interim Order No. 2

Health Canada has issued a notice explaining a policy change to the review of applications for COVID-19 medical devices. As of July 16, 2021, Health Canada is no longer accepting applications for certain categories of medical devices under Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (IO No. 2) if there is no longer an urgent public health need (UPHN) for those devices. The notice states that there is no longer an UPHN for thermometers and ventilators.

Background

As we reported, IO No. 2 (enacted … Continue Reading

Consultation on proposed amendments to Patent Rules

The Government of Canada has proposed a series of amendments to the Patent Rules intended to keep Canada compliant with its obligations under the Canada-United States-Mexico Agreement (CUSMA) and the Patent Cooperation Treaty (PCT). As part of the proposal, the Canada Gazette published a Regulatory Impact Analysis Statement on July 3, 2021, summarizing the changes and their anticipated impact. Interested persons have a short window in which to make representations concerning the proposed amendments.

We invite you to read our team’s in-depth IP Monitor publication on the proposed amendments, which discusses topics including a number of … Continue Reading

PMPRB Update: delayed implementation of Patented Medicines Regulations amendments and new Guidelines

Changes to the Patented Medicine Prices Review Board (PMPRB) regime, contained in pending amendments to the Patented Medicines Regulations, have been delayed until January 1, 2022. These amendments form the basis for new PMPRB Guidelines, which are scheduled to come into force at the same time as the amendments.

The amendments contain a number of changes affecting the PMPRB’s review of patented medicine prices. These include new mandatory factors to be considered by the Board, such as pharmacoeconomic value; a requirement to include “adjustments” when computing average transaction prices reported to the Board; and a revised … Continue Reading

Amendments to the Federal Courts Rules

On June 17, 2021, a series of amendments to the Federal Courts Rules (the Amended Rules), were registered and came into force. On July 7, 2021, the Amended Rules were officially published in the Canada Gazette Part II.

Key Changes and Additions:

The Amended Rules include the following key changes and additions:

  1. The monetary relief limit for actions brought under the simplified procedure and heard before a prothonotary has been raised from $50,000 to $100,000.
  2. The deadline for delivery of a statement of defence is now 30 days from service of the statement of claim for defendants in
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Generic allowed to plead new grounds of invalidity not raised in the Notice of Allegation

The Federal Court of Appeal (FCA) has confirmed that in an infringement action under the Patented Medicines (Notice of Compliance) Regulations, the “second person” (i.e., generic/biosimilar) is not precluded from pleading invalidity allegations in its Statement of Defence beyond those that were raised in its notice of allegation (NOA). While new allegations may not be appropriate in every case, nor without consequence for the second person in a subsequent section 8 claim, they are not categorically prohibited.

Background 

The underlying Federal Court (FC) decision concerned a motion by a section 6 … Continue Reading

CSP Amendments to the PMPRB Regime: Jurisdiction of Patented Medicine Prices Review Board to Include Medicines Protected by Certificates of Supplementary Protection

A suite of amendments to the Patent Act and the Patented Medicines Regulations (the Regulations) will soon require holders of Certificates of Supplementary Protection (CSPs) to report information to the Patented Medicine Prices Review Board (PMPRB) on substantially the same terms and conditions as would be reported by patentees.

Regulations amending the Regulations, which will come into force on June 30, 2021, were recently published in the Canada Gazette, Part II. The corresponding amendments to the Patent Act are also set to come into force on this date.

Certificates of Supplementary Protection

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Federal Court of Appeal Gradually Phases Out Suspension Period

The Federal Court of Appeal (FCA) has begun to gradually restore filing deadlines in appeals before the Court that were subject to the Court’s Suspension Period.

Under the Suspension Period system, the progress of individual appeals has been managed by “selecting” and “deselecting” them from a Selected Files list. As we previously reported, the FCA began to gradually lift the Suspension Period in June 2020 before reinstating it on April 21, 2021. As a result, many appeals were deselected from the list.

On June 17, 2021, the FCA announced that the Deselected Files would begin to reappear … Continue Reading

Federal Court quashes NOC in dispute over Data Protection Provisions

The Federal Court has quashed a notice of compliance (NOC) issued to Médunik Canada (Médunik) for its amifampridine product, RUZURGI, over an issue concerning data protection for another amifampridine product.

The Minister provided no reasons for its issuance of the NOC, and the Court found that the Certified Tribunal Record (CTR) outlining the decision-making process did not allow the Court to determine how the Minister interpreted section C.08.004.1 of the Food and Drug Regulations (the Data Protection Provisions).  The Court found that the decision was therefore unreasonable and remanded the matter back to … Continue Reading

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