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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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March 2017 Deal Round-Up

The following is a selection of major deals in the life science space that closed or were announced as closed in March 2017.

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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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February 2017 Deal Round-Up

The following is a selection of major deals in the life science space that closed or were announced as closed in February 2017.

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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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Canada’s Cannabis Opportunity in the Era of Trump

Although the United States government’s attitudes toward cannabis have eased in recent years, the election of President Donald Trump has generated renewed uncertainty surrounding the future of the U.S. cannabis market. Canada, conversely, will very likely soon be one of the first industrialized countries with fully legalized recreational and medical cannabis, and investment in the Canadian cannabis market has been unprecedented. Unburdened by the U.S.’s significant political and legal uncertainty, Canada has an opportunity to expedite its already rapid industry development to position itself as a global leader in the market for legal recreational and medical cannabis products.  

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January 2017 Deal Round-Up

The following is a summary of major deals in the life science space that closed or were announced as closed in January 2017. Vancouver-based Quark Venture Inc., through its Global Health Sciences Venture Fund, continued to be an active investor, with investments made both in Canada and the United States in the month of January 2017.

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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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The Academies Release Major Report on Cannabis and Cannabis-derived Products

The National Academies of Sciences, Engineering, and Medicine has released a major US government-funded report entitled "The Health Effects of Cannabis and Cannabinoids: The Current States of Evidence and Recommendations for Research" (the "Report") outlining benefits and harms associated with cannabis on a range of public health and safety issues. Cannabis scientific and medical research has historically been impeded because of its illegality, stigma, and related challenges, so the report represents a major positive step towards providing guidance and evidence-based research for physicians, researchers, and patients alike.

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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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December 2016 Deal Round-Up

The following is a summary of major deals in the life science space that closed or were announced in December 2016. 

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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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