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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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Eli Lilly and Company v Government of Canada: Solidifying the Sovereignty of Canadian Courts

Recently, a Chapter 11 NAFTA tribunal (the “Tribunal”) decided not to interfere with the Canadian Courts’ treatment of utility in the context of patent law. The Tribunal noted that Canadian patent law had not experienced a dramatic shift through the Canadian Courts’ treatment of utility, and that the application of utility in Canada was neither arbitrary nor discriminatory. 

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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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Key Takeaways from the 2017 Cantech Investment Conference

On January 18, 2017, investors, analysts, and entrepreneurs converged on the Metro Toronto Convention Centre for the 2017 Cantech Investment Conference. Exhibitors at the conference spanned a number of industries from cybersecurity to specialty finance to cannabis.

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Cameron Mingay Discusses Divesting for Growth

In the pharmaceutical and biotechnology industry, strategic acquisitions and consolidation are often pointed to as the prevailing trends. However, divestment of non-core business units has become an important tool to drive strategic growth across all industries, including in the life sciences sector.

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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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