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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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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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Deciphering the Term Sheet: Valuation

This article is the first in a series of articles that will delve into the most important terms in investment Term Sheets for early-stage companies.

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November 2016 Deal Round-Up

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

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Tips for First-Time Investment Fundraisers

The first time a venture seeks external fundraising, often from an angel investor or venture capital firm, is a major milestone. The following suggests some tactical tools for reaching out to, and getting the attention and interest of, these investors:

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