Sarah Pennington

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Drug reimbursement: CADTH publishes procedures on time-limited reimbursement

By Sarah Pennington, Christopher A. Guerreiro and Kristin Wall on October 24, 2023 Posted in Pharmaceuticals and life sciences

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

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

By Sarah Pennington, John Greiss and Kristin Wall on August 3, 2023 Posted in Pharmaceuticals and life sciences

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

Drug price negotiations: pCPA consulting on a Temporary Access Process (pTAP)

By Sarah Pennington and Kristin Wall on July 19, 2023 Posted in Pharmaceuticals and life sciences

The pan-Canadian Pharmaceutical Alliance (pCPA) has recently published a set of principles and conditions for a pCPA Temporary Access Process (pTAP) which will inform the negotiation process and potential product listing agreements (PLAs) for drug products following the Canada Drug and Health Technology Agency (CADTH) time-limited recommendation pathway. CADTH Time-Limited Reimbursement Recommendations Starting in the … Continue reading

Health Canada releases updated Certificate of Supplementary Protection guidance

By Sarah Pennington, Paul Jorgensen and Kristin Wall on May 29, 2023 Posted in Pharmaceuticals and life sciences

On May 12, 2023, Health Canada announced the release of an updated version of the Guidance Document: Certificates of Supplementary Protection (CSP Guidance). The CSP Guidance was revised to reflect amendments to the definition of “authorization for sale” in the Certificate of Supplementary Protection Regulations (CSP Regulations) and to reflect changes to Health Canada’s administrative … Continue reading

Canada announces its first-ever national strategy for drugs for rare diseases

By Sarah Pennington, Paul Jorgensen and Kristin Wall on March 27, 2023 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

On March 22, 2023, Canada’s federal government announced its first-ever National Strategy for Drugs for Rare Diseases, including an investment of up to $1.5 billion over three years to help increase drug access and affordability. Investments made as part of the National Strategy The lion’s share of the federal government’s investment – up to $1.4 … Continue reading

Ontario introduces biosimilar transition policy

By Sarah Pennington, Paul Jorgensen and Kristin Wall on January 11, 2023 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

On December 20, 2022, the government of Ontario announced a new policy to expand the use of biosimilar drugs in the province. Patients receiving coverage under the Ontario Drug Benefit (ODB) program for eight originator biologic drugs will be required to transition to the biosimilar version by December 29, 2023. During the transition period from … Continue reading

Generic not required to address Patent Register when reference innovator drug is no longer marketed in Canada

By Sarah Pennington, Christopher A. Guerreiro and Kristin Wall on September 7, 2022 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

On August 17, 2022, the Federal Court dismissed applications for judicial review regarding the product-specificity requirements for addressing patents listed on the Patent Register under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). Background This case concerns biosimilar presentations of an AbbVie Corporation and AbbVie Biotechnology Ltd. (collectively, AbbVie) product, HUMIRA (adalimumab), sought to … Continue reading

Government of Canada invests in clinical trial development in Canada through the Clinical Trials Fund

By Sarah Pennington, Christopher A. Guerreiro and Kristin Wall on June 26, 2022 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

On June 22, 2022, the Canadian Institutes of Health Research (CIHR) announced the launch of the Clinical Trials Fund (CTF), which will inject funding into Canada’s clinical trials environment. The government’s goals include reinforcing Canada’s clinical trials infrastructure so as to improve the health and safety of all Canadians while also ensuring that Canada is … Continue reading

New interim order continues expedited authorization pathway for COVID-19 medical devices

By Sarah Pennington, John Greiss and Kristin Wall on March 21, 2022 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

The Minister of Health has issued a new interim order regarding expedited authorizations for COVID-19-related medical devices. Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (IO No. 3) maintains all of the flexibilities of its predecessor, including the consideration of urgent public health needs (UPHN). … Continue reading

Federal Court finds patent valid, but rejects infringement claims in a PM(NOC) action regarding risedronate

By Sarah Pennington, Christopher A. Guerreiro and Kristin Wall on March 9, 2022 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Federal Court has decided an infringement action concerning risedronate products under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court dismissed allegations of anticipation based on prior art, as well as arguments that the asserted claims were invalid due to lack of demonstrated utility, insufficiency of disclosure, and/or overbreadth. However, the Court … Continue reading

CADTH advisory panel consults on framework for pan-Canadian formulary

By Sarah Pennington, Paul Jorgensen and Kristin Wall on February 2, 2022 Posted in Uncategorized

In a recently published discussion paper, an Advisory Panel (the Panel) convened by the Canadian Agency for Drugs and Technologies in Health (CADTH) presents a proposed framework for a potential pan-Canadian formulary. The Panel is asking for feedback on the framework with an online questionnaire. The feedback will inform a stakeholder session in spring 2022 … Continue reading

FCA upholds patent validity, rejects argument that a soundly predicted invention must be obvious

By Sarah Pennington, Christopher A. Guerreiro, Brian R. Daley and Kristin Wall on January 10, 2022 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Federal Court of Appeal (FCA) has affirmed a decision of the Federal Court (FC) finding that a patent concerning glatiramer acetate (GA) is valid and would be infringed under the Patented Medicines (Notice of Compliance) Regulations. Background As we previously reported, the FC decision concerned allegations by Teva Canada Innovation and Teva Canada Limited … Continue reading

Health Canada’s proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations

By Sarah Pennington and Kristin Wall on August 9, 2021 Posted in Life sciences and healthcare

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations (FDR) and the Medical Devices Regulations in the spring of 2022. The proposed amendments are intended to modernize the Canadian therapeutic product regulatory system at every stage of products’ lifecycles from authorization to post-market. … Continue reading

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

By Sarah Pennington, John Greiss and Kristin Wall on July 22, 2021 Posted in Life sciences and healthcare

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 … Continue reading

Food and Drug Regulations amended: COVID-19 drugs and vaccines transitioned out of interim order framework

By John Greiss, Sarah Pennington and Kristin Wall on April 13, 2021 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Food and Drug Regulations (FDR) have been amended to allow for continued expedited review of COVID-19 drugs (including vaccines) while transitioning to authorizations by way of a full notice of compliance (NOC) under the FDR. Certain provisions of the amendments came into force on March 18, 2021, while others will come into force on … Continue reading

Health Canada consults on proposed guidelines for the use of electronic media in prescription drug labelling

By Sarah Pennington, John Greiss and Randy Sutton on March 18, 2021 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

Health Canada is seeking input from industry stakeholders on a new draft guidance document that discusses the use of electronic media in prescription drug labelling. The intent of the draft guidance document is to describe Health Canada’s expectations for manufacturers who distribute prescription drug information through an electronic means, such as a website or mobile … Continue reading

Federal Court of Appeal upholds one of the last prohibition orders under the old PM(NOC) Regulations

By Sarah Pennington, David Yi and Kristin Wall on March 9, 2021 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Federal Court of Appeal has affirmed one of the last judgments granting a prohibition order under subsection 6(1) of the pre-September 2017 Patented Medicines (Notice of Compliance) Regulations (the PM(NOC) Regulations). The Court of Appeal upheld the prohibition order despite a decision in a subsequent action under the amended PM(NOC) Regulations finding that the … Continue reading

Bill C-213, An Act to enact the Canada Pharmacare Act: rejected by Parliament

By Sarah Pennington, Christopher A. Guerreiro and Kristin Wall on March 1, 2021 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

On February 24, 2021, Parliament voted down Bill C-213, which would have enacted the Canada Pharmacare Act. The Private Member’s Bill was first introduced a year ago, re-introduced in September 2020 after Parliament’s prorogation, and defeated at Second Reading. The Canada Pharmacare Act set out a series of criteria and conditions that would have been … Continue reading

Divided success in PM(NOC) actions regarding glatiramer acetate

By Sarah Pennington, Christopher A. Guerreiro and Pharma in Brief team on January 17, 2021 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Federal Court has decided two infringement actions concerning glatiramer acetate products under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court dismissed allegations of anticipation based upon “speculative” prior art and rejected an argument that there was insufficient disclosure to satisfy the test for sound prediction. However, the Court found one of … Continue reading

Health Canada finalizes regulations relating to sale of unapproved drugs for emergency treatment under the Special Access Program

By Sarah Pennington, John Greiss and Kristin Wall on October 29, 2020 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

Regulatory amendments to the Food and Drug Regulations (FDR) and the Natural Health Products Regulations (NHPR) were published in Canada Gazette (Part II) on October 14, 2020. We previously reported on these changes, which seek to reduce the administrative burden associated with the Special Access Program (SAP) (for human drugs) and the Emergency Drug Release … Continue reading

New Interim Order to address COVID-19-related drug shortages in Canada

By Sarah Pennington, John Greiss and Kristin Wall on October 25, 2020 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

On October 16, 2020, the Minister of Health (the Minister) signed the Interim Order Respecting the Prevention and Alleviation of Shortages of Drugs in Relation to Covid-19 (the IO), which introduces new tools for the Minister to address actual or potential drug shortages caused, or exacerbated, by COVID-19. The scope of the IO excludes shortages of veterinary … Continue reading

National Pharmacare Update

By Sarah Pennington and Kristin Wall on October 4, 2020 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

On September 23, 2020, the government identified national pharmacare, a national program to fund prescription drugs in Canada, as a continued priority in the Speech from the Throne (the Speech) to open the Second Session of the 43rd Parliament of Canada. As we reported, the federal government previously announced funding for the implementation of certain … Continue reading

Health Canada collaborates with international partners to address pandemic

By Sarah Pennington and Kristin Wall on May 7, 2020 Posted in Uncategorized

Health Canada recently published a notice to industry detailing its collaborations with international partners during the COVID-19 pandemic. These cooperative efforts aim to ensure that Canadians’ health product needs are being met quickly and effectively during the outbreak, and that Canada’s policies and regulatory strategies are consistent with those in force around the world. Collaboration … Continue reading

Health Canada releases Guidance Document addressing the Plain Language Labelling Regulations requirements for non-prescription drug products

By Sarah Pennington, John Greiss and Randy Sutton on April 15, 2020 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

Health Canada recently published a new Guidance Document that provides information on how Health Canada interprets and applies the 2014 Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) (colloquially known as the Plain Language Labelling Regulations or PLL Regulations) for non-prescription (i.e. over-the-counter or OTC) drug … Continue reading