Kristin Wall

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Pharmacare Update: Budget 2024

Canada’s federal 2024 budget has set aside $1.5 billion over five years to launch pharmacare, which will introduce national universal drug coverage to Canada. Background As we reported, on February 29, 2024, the federal government tabled Bill C-64, An Act respecting pharmacare (the Pharmacare Act). The Pharmacare Act outlines the first phase of a national … Continue reading

Drug pricing: PMPRB announces next steps in Guidelines consultation

The Patented Medicine Prices Review Board (PMPRB) has announced new details regarding the progress of its consultation on new price review Guidelines. Phase 2: Discussion Guide The next phase of the PMPRB’s consultation will begin in summer 2024 with the release of a Discussion Guide. As we reported, the first phase of the consultation launched with … Continue reading

Drug price negotiations: pCPA Temporary Access Process launched

The pan-Canadian Pharmaceutical Alliance (pCPA) has launched its Temporary Access Process (pTAP) to facilitate early market access to new drugs that were assessed under the time-limited reimbursement recommendation (TLR) pathway at the Canada Drug and Health Technology Agency (CADTH). The pCPA has published principles and conditions for the pTAP as well as information on its … Continue reading

National Pharmacare bill tabled

On February 29, 2024, the federal government tabled Bill C-64, An Act respecting pharmacare (the Pharmacare Act). The Pharmacare Act outlines the “foundational principles” for the first phase of a national universal drug coverage plan in Canada. The legislation includes a commitment to first launch diabetes medication and contraceptives coverage for Canadians through a universal, … Continue reading

Health Canada disclosing more information on pending generic drug submissions

On February 23, 2024, Health Canada published a Notice advising that it was making its review process for generic drug submissions more transparent.  Specifically, for generic drug submissions accepted into review on or after April 1, 2024, Health Canada will start disclosing: (i) the year and month that the submission was accepted for review; and … Continue reading

Drug pricing: PMPRB releases “What We Learned” Report on guidelines consultation

The Patented Medicine Prices Review Board (PMPRB or Board) has released a “What We Learned” Report (the Report), marking the next step along the path to new Guidelines. The Report was prepared by Phoenix Strategic Perspectives Inc., which was commissioned to facilitate consultation with stakeholders and report on the presentations and discussions. Overview As we … Continue reading

Federal Court finds trademark confusion between the names of two approved biologics

The Federal Court (FC) has found the brand name of a biologic drug to be confusingly similar to the brand name of a drug used to treat the same disorder, but with a different active ingredient. The application of the ordinary test for trademark confusion was not affected by the fact that the names of … Continue reading

Dormant drug status can trigger generic access to an alternate Canadian Reference Product

On January 26, 2024, Health Canada published a Notice concerning its application of the definition of Canadian Reference Product (CRP) in the Food and Drug Regulations (Regulations). The Notice advises that if an innovative drug is categorized as “Dormant” in Health Canada’s Drug Product Database, then a generic manufacturer can compare its drug against an … Continue reading

Federal Court upholds PMPRB jurisdiction based on “clinical similarities”

The Federal Court (FC) has refused to overturn a decision of the Patented Medicine Prices Review Board (PMPRB or Board) that found that a patent can pertain to a medicine based on “clinical similarities” to the invention—even if the patent does not actually encompass the medicine. The FC concluded that the Board’s decision was reasonable. Background This case … Continue reading

Pharma in Brief’s 2023 Year in Review and Trends for 2024

As you start the new year, allow us to recap 2023’s important legal and regulatory developments for Canadian pharma. We also flag what to watch out for in 2024.  The most significant legal development in 2023 was the introduction of a system of patent term adjustment (PTA). On the regulatory front, seemingly all of Canada’s … Continue reading

Florida approved to import Canadian prescription drugs

On January 5, 2024, the US Food and Drug Administration (FDA) approved Florida’s proposal to import prescription drugs from Canada. This is the first approval of a Section 804 Importation Program (SIP) by the FDA. Whether Florida is able to import drugs from Canada, including in light of Canadian regulations controlling drug exports, remains to … Continue reading

New Canadian Drug Agency formed, while National Pharmacare bill is delayed into 2024

The Government of Canada has announced the creation of the Canadian Drug Agency (CDA). According to the government, the CDA “will provide the dedicated leadership and coordination needed to make Canada’s drug system more sustainable and better prepared for the future, helping Canadians achieve better health outcomes.” As we reported, the genesis of the CDA … Continue reading

Thirty years of the Patented Medicines (Notice of Compliance) Regulations

This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations (Regulations), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators.  Since their genesis, the Regulations have been the focal point of most of the pharmaceutical patent litigation … Continue reading

What is a natural health product? Health Canada’s findings upheld by Federal Courts

In recent months, the Federal Courts have twice upheld Health Canada’s findings as to what is, and is not, a natural health product. The Courts’ decisions provide insight into how natural health products are distinguished, under federal law, from cosmetics and from drugs subject to the Food and Drug Regulations.  These distinctions are important as … Continue reading

Drug pricing: PMPRB releases scoping paper to consult on new Guidelines

The Patented Medicine Prices Review Board (PMPRB) has released a scoping paper on themes and questions to develop new price review Guidelines. The scoping paper also includes information on how stakeholders can participate in the consultation. The deadline for written submissions addressing the scoping paper is December 20, 2023. Background The PMPRB has not had a … Continue reading

Ontario proposes removing barrier to listing “well-established drugs” on its public formulary

On October 19, 2023, the Ontario government proposed regulatory amendments that may eliminate the need to submit certain clinical studies and evidence when requesting that a “well-established drug” be (i) listed or (ii) designated as interchangeable on Ontario’s publicly-funded formulary.  The government is seeking feedback on the proposed amendments. Background A manufacturer can apply to … Continue reading

Drug pricing: PMPRB announces framework for new guidelines consultation

The Patented Medicine Prices Review Board (PMPRB) has announced a framework for the launch of its consultation on new guidelines, beginning with a scoping paper to be published in advance of Policy Roundtable sessions to be held December 5 (English) and December 6 (French), 2023. The PMPRB has not had a full set of guidelines … Continue reading

Drug reimbursement: CADTH publishes procedures on time-limited reimbursement

Canada’s Drug and Health Technology Agency (CADTH) has published its procedures for a new time-limited reimbursement recommendation category. This recommendation category is intended to help provide earlier access to new therapies for severe, rare, or debilitating conditions where there is an unmet medical need. The pathway includes mechanisms to revisit the clinical and economic evidence … Continue reading

Federal Court: Transferring drug submission does not require re-serving Notice of Allegation

The Federal Court has upheld a decision of the Minister of Health (Minister) that the new owner of a biosimilar new drug submission (NDS) could adopt the notice of allegation (NOA) served by its predecessor.  Consequently, the new owner was properly added as a defendant to an on-going action under subsection 6(1) of the Patented … Continue reading

Drug pricing: PMPRB finalizes Interim Guidance amendments

The Patented Medicine Prices Review Board (PMPRB) has amended its Interim Guidance to address prices of “New Medicines”, implementing a review threshold based on “below the median” of the PMPRB11 countries (Median International Price, MIP). “New Medicines” are defined as patented medicines that did not receive a PMPRB ceiling price as of July 1, 2022. … Continue reading

Guidance on inventor discovery and “invention story” evidence in Canadian patent actions: Federal Court rules in favour of patentee

In three recent decisions, released in July and August, the Federal Court addressed questions concerning inventors and the “invention story” during Canadian patent litigation. The Court found that: (i) a patentee has no duty to facilitate inventor discovery; (ii) patentee’s counsel can object to questions during an inventor examination; and (iii) a patent challenger must … Continue reading

Federal Court finds that Health Canada breached procedural fairness by relying on an undisclosed internal guidance document

On August 8, 2023, the Federal Court overturned Health Canada’s decision that a cannabis product, Edison Jolts, was to be classified as edible cannabis and not cannabis extract.   The Court found that Health Canada had breached the duty of procedural fairness by relying on a product classification factor in an internal guidance document that Health … Continue reading

Patent term adjustment: Canada consults on proposed regulatory framework

On August 7, 2023, the Canadian Intellectual Property Office (CIPO) launched a consultation on proposed features of regulations on patent term adjustment (PTA) in Canada (the Consultation). The PTA system is intended to compensate patentees for “unreasonable delays” by CIPO in issuing a patent. The Consultation seeks feedback on proposals that would impact the length of … Continue reading

Drug advertising: Updated guidance from Health Canada on the distinction between advertising and other activities for health products

On July 31, 2023, Health Canada published its updated Guidance on distinction between advertising and other activities for health products (the Distinction Guidance). The Distinction Guidance outlines the factors that contribute to rendering a message or activity promotional in nature. Promotional messages and activities are subject to the advertising provisions of the Food and Drugs … Continue reading
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