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Strategies for Issuers with Cannabis-Related Activities in the U.S.

On August 17, 2017, the TMX Group issued a statement announcing that it has engaged with the Canadian Securities Administrators regarding the clearing of securities of issuers with cannabis-related activities (including assets and operations) in the U.S. Although the TMX Group’s general position on companies engaging in such activities has been a source of speculation and uncertainty for some time, the announcement highlighted specific uncertainty about whether the TMX Group, which is the parent company of The Canadian Depository for Securities Limited ("CDS"), might make the securities of issuers with cannabis-related activities in the U.S. ineligible for clearing and settlement through CDSX. Although no such action has been taken or articulated, such action could materially impede the ability to trade in the securities of issuers with cannabis-related activities in the U.S. and thus have a chilling effect on the listing and financing of such issuers.

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LCBO to Control Retail and Online Cannabis Sales in Ontario

Yasir Naqvi, Attorney General, Charles Sousa, Minister of Finance and Dr. Eric Hoskins, Minister of Health and Long-Term Care, announced Ontario’s planned approach to the federal legalization of cannabis as proposed by Bill C-45, the Cannabis Act, this morning. Bill C-45 left significant discretion to the provinces for determining the appropriate distribution, sale and retailing of cannabis.

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Ontario Conducts Public Consultation on Cannabis Legalization

On April 13, 2017, the Government of Canada released Bill C-45, the Cannabis Act, which, as discussed in a prior blog post, deferred significant discretion to the provinces with respect to the distribution, sale and retailing of cannabis.

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Alternative Financing Options in the Cannabis Industry

The recent developments in Canadian cannabis policy and legislation have sparked significant investment in licensed cannabis producers. Until recently, equity financing has been the primary form of financing, with Canadian cannabis companies raising approximately $1 billion over the past twelve months.

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Regulatory Change to Address Antimicrobial Resistance

On May 17th 2017, Health Canada announced changes to the Food and Drug Regulations regarding the use of antimicrobial drugs in animals. These changes, along with other ongoing initiatives, aim to address the increasing health concern posed by antimicrobial resistance. Microorganisms (such as bacteria, fungi, viruses and parasites) could develop resistance after exposure to antimicrobial drugs and render medicines ineffective against infections. This resistance increases the risk of infections in many important medical procedures such as organ transplantation, chemotherapy, diabetes management and major surgery.

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Disclosure Requirements for Non-Venture Issuers Regarding Women in Board and Executive Officer Positions – A Review

On June 7, 2017, the Canadian news cycle addressed cannabis industry insider criticism at the dearth of women on boards and in senior management positions at Canadian cannabis companies, with reports suggesting that 5% of board seats at publicly traded marijuana producers are occupied by women.

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Major Changes Proposed to Canada's Patented Medicines Regulations

On May 16, 2017, the Federal Minister of Health, the Hon. Jane Philpott announced a number of proposed regulatory changes to the Patented Medicines Regulations (the "Regulations"). The proposed regulations are being implemented with the primary intent of "protecting Canadians from excessive drug prices"1. The proposed modernization framework constitutes the most significant suite of regulatory changes in twenty years. As noted in our blog post dated July 1, 2016, these proposed changes are part of ongoing reform to Canada's regulatory framework relating to patented drug prices. 

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Health Canada Improvements to the Licensing of Cannabis Production under the ACMPR

On May 26, 2017, Health Canada announced significant developments to the licensing process under the Access to Cannabis for Medical Purposes Regulations (ACMPR). As the medical cannabis industry continues to evolve, the Government of Canada has updated its licensing regime in order to streamline the process and enable increased production.

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Growing Pains: The emerging role of IP in selling Canadian cannabis

Licensed producers and others looking to enter Canada’s medical or recreational cannabis industry should be thinking about how they will distinguish their business, products and services from others, in what will undoubtedly become a crowded and competitive marketplace. Intellectual property protection available under Canadian and foreign laws should be an important part of that strategy.

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Health Canada Implements Mandatory Pesticide Testing of Cannabis

Health Canada has announced that it will require licensed cannabis producers to conduct mandatory testing of all cannabis products destined for sale for the presence of unauthorized pesticides.

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New Proposed Regulations Would Establish Mechanism to Import and Sell Unauthorized Drugs For an Urgent Public Need

Health Canada has recently proposed amendments to the Food and Drug Regulations to allow the importation and sale of drugs for an urgent public health need.  These proposed amendments would allow the importation of drug products that are not yet authorized for sale in Canada in the following circumstances:

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Draft Cannabis Act Released by Canadian Federal Government

Today the federal government released Bill C-45, the draft Cannabis Act. If enacted, this will make Canada the first G7 country to legalize recreational cannabis. Cannabis will remain illegal as the bill moves through the legislative process. If it is approved by Parliament, the bill could become law with a target date of no later than July 2018, according to the Government of Canada.

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Judge Phelan’s Comments for the Pharmaceutical Industry: Apotex Inc. v Canada (Minister of Health)

In Apotex Inc. v Canada (Minister of Health) (“Apotex”), the Federal Court (the “Court”) provided some guidance with respect to the procedure pharmaceutical companies should undertake to obtain a Notice of Compliance (“NOC”). Overall, the Court’s findings suggest that pharmaceutical companies should put their best foot forward in their application or on appeal in front of expert panels considering or reconsidering their applications because overturning an expert panel’s decision is often difficult with Courts showing deference to expert panels.

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Mandatory Reporting of Drug Shortages and Discontinuances

As of March 14 2017, regulatory amendments implementing certain drug supply reporting requirements have come into force in Canada.  Although industry had established its own voluntary reporting system and website for this purpose in 2012, the newly implemented regulatory changes make such reporting mandatory and establish a new website.   

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Exporting Cannabis from Canada

A Licensed Producer (LP) can obtain a permit from the federal Minister of Health to export cannabis internationally from Canada to a single and specified importer. While export permits can currently only be used to export cannabis for medical purposes, some LPs are committing considerable resources on their international exportation efforts because of the current and potential future international opportunities within the global cannabis market. Additional regulatory information regarding cannabis exportation can be found in Subdivision G of the Access to Cannabis for Medical Purposes Regulations (ACMPR). 

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Proposed Changes In Personal Use Importation of Pest Control Products

Earlier this week, Health Canada announced proposed changes to the Pest Control Products Regulations that would limit the ability of individuals to import unregistered pesticides for personal use.

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Have Your Say on Federal Food Regulatory Change: Consultation Open On Draft Safe Food For Canadians Regulations

In January 2017, draft regulations under the Safe Food For Canadians Act (which was passed in November 2012) were published.  The draft Regulations can be found here.

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Health Canada Announces Random Testing of Medical Cannabis for Prohibited Pest Control Product Use

In an announcement earlier today, Health Canada advised that it will be conducting random testing of medical cannabis products produced by licensed producers. 

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Canada’s Excessive Pricing Regulations Survive Another Constitutional Challenge

The Patented Medicine Prices Review Board (the “PMPRB”) commenced a proceeding against Alexion Pharmaceuticals Inc. (“Alexion”) in respect of Alexion’s drug, SOLIRIS (eculizumab), which is used to treat rare and devastating blood and genetic conditions. The PMPRB claimed and successfully argued that Alexion was selling Soliris at an excessive price, under sections 82 and 85 of the Patent Act.

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To Engage or Not to Engage: Guidance on Motions to Strike a Within Application

The Federal Court has reaffirmed and clarified how a pharmaceutical brand company should respond to a generic company’s motion to strike an application for abuse of process under s. 6(5)(b) of the Patented Medicines (Notice of Compliance) Regulations.

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Time to Change Food Labels

On December 14, the Honourable Jane Philpott, Minister of Health, announced amendments to the Food and Drug Regulations regarding the nutrition facts table and list of ingredients on packaged foods.  As discussed in our October 2016 blog post, the amendments are part of the Government of Canada’s Vision for a Healthy Canada initiative.

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Health Canada Releases New Biosimilar Biologic Drugs Guidance Document

Health Canada has recently released the revised Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs (the “Guidance Document”), replacing the March 2010 Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics. The Guidance Document is meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations, but does not have the force of law. The Guidance Document is one of the primary resources provided by Health Canada regarding approval of biosimilars.

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One Step Closer to Legalization of Marijuana in Canada: Release of Task Force Recommendations for Regulation of Cannabis

The Task Force on Cannabis Legalization and Regulation publicly released its report today outlining its recommendations on the Legalization and Regulation of Cannabis in Canada. 

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Canada Introduces Vaping Legislation

On November 22nd, new legislation was introduced (Bill S-5) that proposes significant changes to the Tobacco Act to institute regulation of vaping products and implement other changes to the regulation of tobacco products.

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Food For Thought: Changes Impacting the Content, Labelling and Marketing of Food Products in Canada Announced

Canada’s Minister of Health has announced the launch of a new Healthy Eating Strategy that will impact manufacturers, distributors and retailers of food products in Canada. This initiative proposes to implement changes to the way that foods are produced, labelled and marketed in an effort to address obesity, diabetes, heart disease and other chronic health conditions.

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Sep 28, 2016
TAGS: Regulatory
A New Regulatory Regime For E-Cigarettes? Health Canada Announces Plans to Introduce Vaping Legislation

Yesterday, the federal government announced that it would be tabling legislation with respect to vaping products. Health Canada’s announcement in this regard can be found here.

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Sep 7, 2016
TAGS: Regulatory
Changes Could Be Coming in Canada’s Regulation of Self-Care Products: Your Chance to Weigh In!

Health Canada is undertaking a public consultation on its regulation of self-care products (non-prescription drugs, natural health products and cosmetics). This is part of a larger consultation on the Framework for Consumer Health Products, started in 2014.

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Regulating Risk: Keeping You Up-To-Date on Product Regulation - September 2016

Here’s a look at what’s new with product regulation and oversight in Canada.

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Amendment to PMPRB Compendium of Policies, Guidelines and Procedures Takes Effect

On September 1, 2016, the Patented Medicine Prices Review Board (the “PMPRB” or the “Board”), Canada’s independent quasi-judicial patented drug price watchdog, implemented an amendment (the “Amendment”) to section C.11 “Review of Prices of New Patented Drug Products at Introduction” of the Compendium of Policies, Guidelines and Procedures (the “Guidelines”)1. The Amendment brings an incremental but important change to the Guidelines, of which patentees in the pharmaceutical, biotechnology, and healthcare industries should be aware.

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The Ongoing Evolution of Canada’s Regulation of Marijuana

In the ongoing evolution of Canada’s marijuana laws, this summer, Health Canada implemented the new Access to Cannabis for Medical Purposes Regulations (“ACMPR”).  The ACMPR came into force on August 24, 2016 (replacing the old Marihuana for Medical Purposes Regulations) and provide increased access for Canadians who have been authorized by their healthcare practitioners to use cannabis for medical purposes.

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An Opportunity to Reshape Patented Medicines Regulation in Canada

The Patented Medicine Prices Review Board (the “PMPRB” or the “Board”) is currently canvassing stakeholder input on its Discussion Paper1 released on June 24, 2016, as part of an initiative to reform and modernize its regulatory framework.  

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Regulating Risk: Keeping You Up-To-Date on Product Regulation - May 2016

Here’s a look at what’s new with the Canada Consumer Product Safety Act and regulations to the Food and Drugs Act and Controlled Drugs and Substances Act.

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