Hot Topics in International Trade - Wood Chucks Chuck Canadian Lumber tariffs
Regulatory Ramblings: Episode 72 - Cultural Roots, Belonging, and the Fear of Change: What’s Next for Inclusion?
Daily Compliance News: June 24, 2025, The Questions, Questions, and More Questions Edition
Hot Topics in International Trade - Tariff Mitigation Strategies
Everything Compliance, Shout Outs and Rants: Episode 151, The What is Illegal DEI Edition
Daily Compliance News: March 7, 2025, The No Jail Time Edition
Adapting to Tariffs and Other Trade Policy Shifts Under the Trump Administration
A Brief Primer on Tariffs Under the Trump Administration
Protect, Prepare, Prevail: Navigating a Complex Cybersecurity World
Private M&A 2024: Key Trends and Forecasts
Patent Considerations in View of the Nearshoring Trends to the Americas
Examining E-Discovery in Competition Law
No Password Required: Education Lead at Semgrep and Former Czar for Canada’s Election Security
Shifting Dynamics in Private Equity
4 Key Takeaways | Major U.S. Supreme Court Trademark & Copyright Decisions
Hidden Traffic : New Human Trafficking and Child Labor Regulation in Canada with Sean Stephenson
[Podcast] Catching Up on Canadian Environmental Regulation
[Podcast] USMCA in Review, with C.J. Mahoney, Former Deputy U.S. Trade Representative
Episode 4 - USMCA and the trade relationship between the U.S.A, Mexico, & China
Five Questions, Five Answers: Electric Mobility Canada on Its Promises for a Cleaner Economy
On June 19, 2025, Canada’s Drug Agency (CDA) opened a public consultation on a proposed process for preparing a list of essential prescription drugs and related products. As required by the Pharmacare Act, the CDA must...more
In the Patented Medicine Prices Review Board (PMPRB)’s June 2025 NEWSletter, Acting Chairperson Anie Perrault confirms that the PMPRB plans on publishing its final Guidelines in summer 2025. This will mark the completion of...more
On March 6, 2025, the Patented Medicine Prices Review Board (PMPRB) announced that Thomas Digby stepped down from his role as Chairperson of the PMPRB. Vice-Chairperson Anie Perrault is now serving as acting Chairperson until...more
On February 27, 2025, the Government of Canada and Manitoba signed the first national pharmacare agreements under Canada’s Bill C-64, An Act respecting pharmacare (the “Pharmacare Act”), which received royal assent on October...more
On October 10, 2024, Canada’s Bill C-64, An Act respecting pharmacare (the “Pharmacare Act”) received Royal Assent. This legislation establishes a framework for a national universal pharmacare system, aiming to enhance the...more
A recent development with the Food and Drug Administration made us think of a song lyric from Florida native and Rock and Roll Hall of Famer, Tom Petty, “What lies ahead, [we] have no way of knowing.” As a kick-off to 2024,...more
On January 5, 2024 the Food and Drug Administration (FDA) issued its approval of the State of Florida’s proposal to import certain prescription drugs from Canada under the Section 804 Importation Program (SIP). This approval...more
On Jan. 5, the FDA authorized Florida’s Section 804 Implementation program (SIP), making Florida the first state to secure such approval. Generally, there are three pathways to importing a prescription drug into the United...more
Pharmaceutical manufacturers in Canada often enter into Product Listing Agreements (PLA), particularly with public payors, to facilitate their drug being reimbursed. It is common for PLAs to take the form of a first dollar...more
Inflation Reduction Act: Stakeholders and commentators continue to review H.R. 5376, the Inflation Reduction Act of 2022 (the Act), which became law on Aug. 16, 2022. Republican leaders on the House Energy & Commerce and...more
On January 11, 2022, the Patented Medicine Prices Review Board (PMPRB) released a report entitled Expensive Drugs for Rare Diseases: Canadian Trends and International Comparisons, 2011-2020 as part of the National...more
Since our last update in April 2021, there have been many developments regarding biosimilars in Canada (approvals, pending submissions, litigation, regulatory and market access). Biosimilars approved in Canada - Health...more
On October 27, 2020, the Patented Medicine Prices Review Board (PMPRB) released the National Drug Prescription Utilization System’s (NDPUIS) analytic study of the Canadian oncology market for 2010 to 2019. The study is...more
The following provides an overview of the many developments regarding biosimilars in Canada (approvals, pending submissions, regulatory, litigation and market access) that have taken place since our last update in October...more
CIHI: On December 17, the Canadian Institute for Health Information (CIHI) published statistics on drug spending, finding that in 2018, around 40% of drug spending was spent on 2% of beneficiaries. Out of this 2%, three out...more
In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...more
On October 28, 2019, the Ontario Ministry of Health and Long-Term Care (the Ministry) published proposed changes to Regulations made under the Ontario Drug Benefit Act (ODBA) and the Drug Interchangeability and Dispensing Fee...more
On November 21, 2019, the Patented Medicines Prices Review Board (“PMPRB”) released draft new Guidelines for consultation, together with a backgrounder. The new Guidelines are intended to operationalize the amended Patented...more
The PMPRB has released its CompassRx, 2017/18 Annual Public Drug Plan Expenditure Report and related news release reporting various statistics about prescription drug expenditures by Canadian public drug plans....more
At both the federal level and within Florida, there are the beginnings of the seeds of change regarding drug importation policies. President Trump and Governor DeSantis have both been HUGE supporters of drug importation as a...more
On August 21st, the long-awaited amendments to the Patented Medicines Regulations were published in Part II of the Canada Gazette. We have prepared an unofficial consolidated version of the Regulations incorporating the...more
On July 31, the Department of Health and Human Services (“HHS”) and the Food and Drug Administration (“FDA”) announced their latest plan to reduce the prices Americans pay for prescription drugs. The Safe Importation Action...more
Federal Court of Appeal requires PMPRB to re-determine whether patent ‘pertains to’ Galderma’s DIFFERIN - On June 28, 2019, the Federal Court of Appeal granted the appeal of the Patented Medicine Prices Review Board (PMPRB...more
In October 2018, the Canadian Agency for Drugs and Technologies in Health (CADTH) issued an interesting Environmental Scan on International Policies on the Appropriate Use of Biosimilar Drugs (Report). This Report outlines...more
While common among member countries of the Organisation for Economic Co-operation and Development (OECD), Canada does not have a national pharmacare program, i.e. a single system of public insurance coverage for prescription...more