News & Analysis as of

Pharmacies Canada

Smart & Biggar

PMPRB publishes scoping paper for consultation on guidelines, and invites stakeholder feedback

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As we have previously reported, the Patented Medicine Prices Review Board (PMPRB) announced that it will launch the first phase of consultations on new guidelines. On November 10, 2023, the PMPRB published its Scoping Paper...more

Bennett Jones LLP

The Lack of Present Injuries and Reliable Scientific Evidence Proves Fatal in North American Pharmaceutical

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After reports were made regarding the presence of nitrosamines in certain pharmaceutical products in 2018 and 2019, and subsequent precautionary regulatory action was taken, an avalanche of litigation commenced in Canada and...more

Smart & Biggar

Special Access Program and Emergency Drug Release Program amendments in force

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On September 28, 2020, the Regulations Amending Certain Regulations Made under the Food and Drugs Act (Sale of a New Drug for Emergency Treatment) (Regulations) came into force. Health Canada subsequently published a Notice,...more

King & Spalding

FDA Finalizes Rule and Guidance to Implement Safe Importation Action Plan Aimed at Lowering Prescription Drug Prices

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On September 24, 2020, FDA announced that it was taking action to help lower prescription drug prices by issuing a final rule and a final guidance aimed at facilitating the safe importation of certain prescription drugs....more

Smart & Biggar

COVID-19 Update: CIPO, Federal Courts, Health Canada

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This article was last updated on July 10, 2020. In view of COVID-19, we have compiled a list of important updates as it relates to the pandemic and its impact on Life Sciences. We will continue to update this page as new...more

Hogan Lovells

Coronavirus: The Hill and the Headlines – COVID-19 D.C. Update – July 2020 #5

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In Washington: The Trump administration continues to pressure local officials to open its schools for children to return to class, as the Department of Education Secretary Betsy DeVos threatened to cut federal funding to...more

Smart & Biggar

From regulatory flexibility to reimbursement changes, how Canadian regulators and payers are managing the COVID-19 crisis

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UPDATE: The Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 was made on March 1, 2021 and repeals and replaces the Interim Order Respecting Drugs, Medical...more

Smart & Biggar

Rebate Update: Amendments to Ontario Regulations remove cap on Ordinary Commercial Term Benefits and restrictions on Private Label...

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In November 2019, we highlighted the key proposed amendments to Regulations made under the Ontario Drug Benefit Act (ODBA) and the Drug Interchangeability and Dispensing Fee Act (DIDFA). The proposed amendments aim to reduce...more

Smart & Biggar

2019 Highlights in Canadian Life Sciences IP and Regulatory Law

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In 2019, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review top developments below: 1) PMPRB: Amendments to Regulations will come into force July 1, 2020, court...more

Smart & Biggar

Proposed amendments to Ontario Regulations to streamline administrative process, change OCT payment limit, and reduce government...

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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

Shumaker, Loop & Kendrick, LLP

Client Alert: Update on Florida’s Canadian Prescription Drug Importation Program

This year, Florida Governor Ron DeSantis signed into law a bill that creates Florida Statute Section 381.02035, which establishes the Canadian Prescription Drug Importation Program within the Agency for Health Care...more

Smart & Biggar

Rx IP Update - February 2019

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Orders of prohibition relating to polymorphic form patent for PRISTIQ upheld on appeal - As previously reported, the Federal Court, in a pair of decisions, granted orders prohibiting Apotex and Teva from marketing their...more

Smart & Biggar

Costco Pharmacies receive $7.25M penalty for accepting drug rebates

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On February 1, 2019, the Ontario Ministry of Health and Long-Term Care (“Ministry”) announced that CWC Pharmacies (Ontario) Ltd. (“Costco Pharmacies”), a subsidiary of Costco, was ordered to pay an Administrative Monetary...more

Smart & Biggar

CADTH releases Environmental Scan on International Policies on Use of Biosimilars

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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

Smart & Biggar

Rx IP Update - 2018 Mid-Year Highlights in Canadian Life Sciences IP

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In this special mid-year edition, we take a look at the major highlights in Canadian life sciences and intellectual property law that we have reported on over the last six months, starting with one of the most closely-watched...more

Smart & Biggar

Rx IP Update - May 2018

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An Update on Vanessa’s Law - This is a special update on the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) which was approved on November 6, 2014 (as previously reported), amending the Food and Drugs Act...more

Smart & Biggar

Rx IP Update - March 2018

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No Section 8 Liability for Valid and Infringed Patent in NEXIUM Proceeding - What happens when a patentee is unsuccessful in a prohibition application under the Patented Medicines (Notice of Compliance) (PMNOC)...more

Jones Day

Senators Urge the Administration to Certify Imports of Prescription Drugs from Canada, Pharmaceutical & Medical Device Update,...

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On May 15, 2017, Sens. Charles Grassley (R-IA), John McCain (R-AZ), and Amy Klobuchar (D-MN) sent a letter to the Office of Management and Budget ("OMB") Director Mick Mulvaney prompting him to work with the Department of...more

Smart & Biggar

Rx IP Update - June 2017

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Supreme Court of Canada News - SCC denies Apotex leave to appeal omeprazole infringement decision. On June 1, 2017, the Supreme Court dismissed Apotex’s application for leave to appeal (docket no. 37478) the Federal Court...more

Blake, Cassels & Graydon LLP

Superior Court of Québec Confirms Validity of Percentage Royalties Paid by Pharmacist-Owners to Franchisor

The Superior Court of Québec (Court), presided by Justice M. Monast, recently ruled on an important point of contention for franchise pharmacies, by confirming the validity of a percentage royalty clause contained in a...more

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