Topic: Pharmaceuticals and life sciences

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

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 products.

The Guidance Document, entitled Questions and Answers: Plain Language Labelling Regulations for Non-prescription Drugs (the Guidance Document), is effective as of April 1, 2020.  It identifies information that will support requirements mandated under the PLL Regulations, and points to other FAQs, … Continue Reading

Health Canada issues Interim Order to address shortages of health products

Health Canada has published an Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 (the Interim Order). This Interim Order allows Health Canada and the Canadian Food Inspection Agency to address critical supply issues in an expedited manner when shortages occur. It was signed by the Minister on March 30, 2020.

The Interim Order allows the Minister to permit the exceptional importation and sale of: (1) drugs, including biocide drugs (such as hand sanitizers and disinfectants) but not natural health products (NHPs); (2) medical devices; and (3) foods for … Continue Reading

Quebec maintains drug evaluation activities for listing purposes and launches clinical trials

In this post, the Pharma in Brief team reports on two recent developments in the Quebec regulatory landscape related to the COVID-19 crisis.

Adjustments to submission procedure for applications for listing of innovative drugs and blood products on formulary

On April 6, 2020, Quebec’s Institut national d’excellence en santé et en services sociaux (INESSS) issued a notice to drug manufacturers and blood system product manufacturers describing temporary measures implemented recently to avoid processing backlogs for applications for listing on Quebec’s formulary during the COVID-19 crisis. As of March 30, 2020, manufacturers of innovative drugs or blood products can … Continue Reading

Federal Court issues first decision on patent term restoration – Minister’s decision denying certificate of supplementary protection (CSP) is unreasonable

On April 7, 2020, the Federal Court issued a decision in Canada’s first judicial review under the Patent Act and new Certificate of Supplementary Protection Regulations (CSP Regulations). It is the first decision issued under this regime, and also one of the first decisions to apply the Supreme Court of Canada’s new standard of review framework set out in Canada (Minister of Citizenship and Immigration) v Vavilov, 2019 SCC 65 (Vavilov).

The judicial review application was brought by GlaxoSmithKline Biologicals S.A. (GSK) in respect of an August 3, 2018 decision (Decision) … Continue Reading

Canada completes domestic ratification of CUSMA

Canada has completed domestic ratification of the Canada-United States-Mexico Agreement (CUSMA, also referred to as USMCA or new NAFTA). As we reported, Canada introduced Bill C-4 to implement CUSMA on January 29, 2020 and it received royal assent as the Canada-United States-Mexico Agreement Implementation Act (CUSMA Implementation Act) on March 13, 2020.

No coming-into-force date for CUSMA has been set. Deputy Prime Minister Chrystia Freeland stated: “The Canadian government will continue to work with the United States and Mexican governments to determine an ‘entry into force’ date that is mutually beneficial” and that she … Continue Reading

Ontario introduces formulary changes for generic drugs to mitigate risk of drug shortages

On March 30, 2020, the Ontario government launched two one-day consultations on changes to regulations concerning the listing of generic drug products under the Ontario Drug Benefit Act (ODBA) and the Drug Interchangeability and Dispensing Fee Act (DIDFA). These consultations end March 31, 2020.

Both changes are said to be needed to help mitigate the risk of drug shortages in Ontario during the COVID-19 pandemic.

Private-label generics eligible for listing

As we previously reported, the Ontario government took steps late last year to permit the listing of private-label generic drugs on the provincial drug … Continue Reading

Coulda, Shoulda, but Not Likely Woulda: Federal Court of Appeal affirms finding that generic would not have used a non-infringing alternative

The Federal Court of Appeal has affirmed the Federal Court’s decision awarding an accounting of profits to ADIR and Servier Canada Inc. (Servier), concluding that Apotex Inc. and Apotex Pharmachem Inc. (Apotex) would not have used a non-infringing alternative (NIA).

Background

In 2008, the Federal Court found that Servier’s patent for the drug perindopril was valid and infringed by Apotex. Apotex’s liability was affirmed on appeal. A trial on an accounting of profits ensued and Apotex was ordered to remit the aggregate amount of C$61 million plus interest. In a first appeal by Apotex, … Continue Reading

New Federal initiatives to combat pandemic: Patent Act amended to allow limited government use of patented inventions for public health emergencies

On March 25, 2020, the Canadian Government passed into law Bill C-13, An Act respecting certain measures in response to COVID-19, following emergency sittings of Parliament and the Senate. Bill C-13 amends both the Patent Act and the Food and Drugs Act and may have implications for the pharmaceutical industry.

Patent Act – Limited government use of patented inventions for public health emergencies (s. 19.4)

A new stand-alone provision has been added to the Patent Act: section 19.4. This section allows the Minister of Health to apply for government authorization to make, construct, use, and sell a … Continue Reading

Ontario and Quebec Introduce Changes to Pharmacy Practice and Highlight the Drug Supply Chain as an Essential Service

Changes Affecting Ontario

The Government of Ontario has made changes to the Ontario Drug Benefit (ODB) Program in an effort to reduce the risk of drug shortages in the province during the COVID-19 outbreak. Effective immediately, ODB eligible drugs are subject to the following changes to rules on dispensing and fees:

  • The dispensing of medication is limited to no more than a 30-days’ supply. Dispensers may use professional judgment to provide a longer supply in exceptional cases, but should not exceed the patient’s usual supply
  • Prescriptions should not be refilled more than 10 days in advance of a patient depleting
Continue Reading

PM(NOC) Statutory Deadlines Still Applicable

As we reported, the Federal Court (FC) has suspended its hearings scheduled between March 16, 2020 and April 17, 2020 (the Suspension Period) sine die. Proceedings brought in accordance with the Patented Medicines (Notice of Compliance) Regulations (Regulations) fall under the FC’s jurisdiction. However, certain deadlines related to these proceedings are set by the Regulations themselves. Such ‘statutory’ deadlines are not subject to the FC’s Suspension Period.

As the FC states in its recent FAQ on its COVID-19 Practice Direction and Order, the deadline for commencing a proceeding pursuant to section 6 of the … Continue Reading

COVID-19: Health Canada simplifies regulatory requirements for COVID-19-related products

Health Canada is taking measures to help expedite the importation and sale of certain licensed products required to combat COVID-19.

Expedited review of Health Product Submissions and Applications

Health Canada has announced that it will expedite the review of any COVID-19 related vaccines, therapeutic products and other health product submissions and applications. Until a vaccine or therapeutic product is available on the Canadian market, the Special Access Program will continue to be available for COVID-19 related treatments.

Submissions or applications to Health Canada should be directed to the appropriate bureau using the contact information found on this page.

Diagnostic Continue Reading

COVID-19: Sharing information for licensed health products during a pandemic

The public health call for social distancing to help curb the COVID-19 pandemic has no doubt already affected how companies will be sharing information about pharmaceuticals and other licensed health products with healthcare professionals (HCPs), patients, and the public. As industry plays its part in keeping sales representatives and medical science liaisons (MSLs) home to help “flatten the curve”, many interactions between HCPs and companies are moving to the virtual world. At the same time, HCPs will look to the industry to provide timely and accurate information through their medical teams or patient support programs (PSPs) about how to manage … Continue Reading

Bill C-4: New CUSMA Implementation Act Received Royal Assent

On March 13, 2020, the Government passed Bill C-4 to implement the Canada-United States-Mexico Agreement (CUSMA). Canada will be the third and final party to ratify the treaty.

The Bill, sponsored by Deputy Prime Minister Freeland, was introduced on January 29, 2020. The Bill was recently expedited in order to ensure that it passed before both Houses adjourned at the end of the week over concerns regarding the spread of COVID-19.

As we reported, Bill C-4 does not contain any amendments to the Patent Act. Canada is still expected to amend the Patent Act to include … Continue Reading

COVID-19: Health Canada Issues Bulletin Confirming Obligations of DEL Holders

In light of recent developments relating to the to the 2019 novel coronavirus (COVID-19), Health Canada recently sent a reminder to all Drug Establishment License (DEL) holders of their obligations under the Food and Drug Regulations (FDR) regarding reporting of events that could affect operations and lead to shortages or issues affecting quality, safety, and efficacy of products.

The bulletin reminded DEL holders of their obligations to notify or report to Health Canada any events that could have an impact on pharmaceutical operations. Specifically, a DEL holder should notify Health Canada within 15 days if an event occurs that could … Continue Reading

Federal Court invalidates Health Canada’s decision to disclose records in response to ATI request

The Federal Court has invalidated Health Canada’s decision to disclose records pertaining to a veterinary pharmaceutical product, Fortekor Flavour Tabs (Fortekor), pursuant to the Access to Information Act (the Act). Health Canada defended its decision on the basis that the information contained in the records was “part of public domain information”. On judicial review, the Court agreed with the applicant, Elanco Canada Limited (Elanco), that Health Canada’s argument was based on unsubstantiated information, relating to different medications, with different compounds, in different jurisdictions.

Background

Through the veterinary drug submission process, Elanco provided Health Canada with … Continue Reading

Patent owner files its own pleading in a PM(NOC) action

The Federal Court granted leave to the United States of America (USA), in its capacity as co-owner of a patent, to file its own pleading in an action under s 6(1) of the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations). The USA was permitted to respond to the defendant’s (Apotex Inc.) allegations of invalidity, including by making new and different allegations than those made by the plaintiff. 

Background

This decision arose in the context of Allergan Inc.’s (Allergan) action against Apotex under s 6(1) of the PM(NOC) Regulations concerning ulipristal acetate. Allergan licenses … Continue Reading

Health Canada Provides Guidance on Regulation of Software as a Medical Device (SaMD)

On December 18, 2019, Health Canada published a new Guidance Document Software as a Medical Device (SaMD): Definition and Classification (Guidance Document). The Guidance Document explains what products would be regulated as SaMD under the Food and Drugs Act (Act) and the Medical Devices Regulations (Regulations) as well as information on classification of SaMD.

What Constitutes SaMD

Not all software falls within the scope of the Act and Regulations. The Guidance Document provides current interpretations of what constitutes a “device” or “medical device” in the Act and Regulations (including by reference to the definition … Continue Reading

Pharma in Brief: The 2019 Year in Review

In this article, the Pharma in Brief team curated the most significant topics we covered during 2019.

The Canadian pharma and life sciences space saw many developments in 2019. These included major policy initiatives and regulatory changes affecting the industry, driven in part by three high-profile federal objectives: lowering drug prices to move towards national pharmacare, replacing the North American Free Trade Agreement (NAFTA), and changes to drug approval pathways.

There were few pharmaceutical patent decisions released in 2019 but plenty of activity in the Courts, as the first actions under the new Patented Medicines (Notice of Compliance) Continue Reading

Ontario reduces restrictions on ordinary commercial term benefits and private label products

The Ontario Ministry of Health and Long-Term Care (the Ministry) introduced changes to regulations (collectively, the Regulations) made under the Ontario Drug Benefit Act (ODBA) and the Drug Interchangeability and Dispensing Fee Act (DIDFA). These changes will remove the financial caps on ordinary commercial term (OCT) payments made by drug manufacturers to pharmacies and allow private label products to be listed as benefits or be designated as “interchangeable”. The amendments to the Regulations come into force on January 1, 2020. 

Removal of OCT benefit financial cap

OCT benefits are payments made between … Continue Reading

Amended CUSMA no longer extends data protection for biologics

On December 10, 2019, Canada, the United States, and Mexico agreed to amend the Canada-United States-Mexico Agreement (CUSMA, also referred to as USMCA) as the trade agreement proceeds toward ratification in each country. Among other changes, the amended CUSMA no longer requires Canada to extend data protection for biologics to 10 years from the 8 years currently provided under Canadian law.

Changes to the CUSMA

As we reported, the previous version of CUSMA required two notable changes to Canadian law concerning pharmaceuticals and biologics:

  • Extended data protection for biologics. CUSMA previously required Canada to provide a
Continue Reading

PMPRB extends consultation on new Draft Guidelines implementing amendments to the Patented Medicines Regulations

The Patented Medicine Prices Review aboard (PMPRB) has extended the deadline for written submissions on new Draft Guidelines until January 31, 2020. Originally, the consultation was scheduled to run until January 20, 2020.

Background

As we reported, the Board proposed Draft Guidelines to replace its existing price-review practices, including the Compendium of Policies, Guidelines and Procedures. The changes are intended to implement the recent amendments to the Patented Medicines Regulations, which come into force on July 1, 2020. The PMPRB released the Draft Guidelines on November 21, 2019.

Consultation update

According to a December 10, … Continue Reading

Federal Court dismisses motion for determination of an issue of law under the new PM(NOC) Regulations

The Federal Court dismissed Pharmascience Inc.’s (Pharmascience) motion to determine a question of law on the issue of whether a first person can commence an action under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) for a drug for which there are no patents listed on the patent register. The Court held that the facts required to determine the motion were contested so answering the question of law would not determine the dispute as between the parties. It also stated that, in the context of the PM(NOC) Regulations, such motions may … Continue Reading

Federal Court refuses to allow fifth generic to join common trial on validity

The Federal Court has denied a motion by Dr. Reddy’s Laboratories’ (Dr. Reddy’s) seeking to participate in a common validity issues trial in actions concerning four other generic versions of the same drug under the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations).

Background

As we reported, the Federal Court has made a number of orders concerning common validity trials in actions commenced by Bayer Inc. (Bayer) under the PM(NOC) Regulations in respect of generic versions of XARELTO (rivaroxaban). The common validity issues in these earlier actions against Apotex Inc., Teva Canada Limited, … Continue Reading

PMPRB launches 60-day consultation on new Draft Guidelines following amendments to the Patented Medicines Regulations

Today, the PMPRB launched a consultation on Draft Guidelines intended to implement recent amendments to the Patented Medicines Regulations. The PMPRB also released a Q&A-style Consultation Backgrounder. Interested parties have 60 days, until January 20, 2020, to make submissions on the Draft Guidelines.

Background

As we reported, the Government released final amendments to the Patented Medicines Regulations on August 9, 2019. These amendments are scheduled to come into force on July 1, 2020 and are intended to lower the prices of patented medicines in Canada. They include: (1) new factors for assessing excessive pricing, (2) new … Continue Reading

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