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Quebec Introduces the Quebec Cannabis Regulation Act

On November 16, 2017, the Government of Quebec released its proposed cannabis legislation, Bill 157, an act to constitute the Société Québécoise du Cannabis (the SQC), to enact the Cannabis Regulation Act and to amend various highway safety-related provisions (the Act). The Act elaborates on the Quebec Government’s plan to establish the SQC, a subsidiary of the Société des alcools du Québec, as the sole distributor of cannabis in the province. If passed, the Act will lay the foundations for a stricter cannabis regime as compared with other provinces.

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Manitoba Announces Distribution and Retail Model for Cannabis in the Province

On November 7, 2017 the Premier of Manitoba announced the proposed model of cannabis distribution throughout the province when the Federal Cannabis Act comes into force on July 1, 2018. Unlike the Ontario and Quebec models, whereby the liquor control bodies in each province have been designated as distributors and retailers of cannabis, the model in Manitoba is considered a hybrid retail and distribution, carving out roles for both the public and private sector.

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Ontario Introduces the Ontario Cannabis Act, 2017

On November 1, 2017, the Government of Ontario released its proposed cannabis legislation, Bill 174, Cannabis, Smoke-Free Ontario and Road Safety Statute Law Amendment Act (the Act). The substance of this bill is Ontario’s Cannabis Act, 2017, but the bill also details amendments to related legislation in the form of a new Smoke Free Ontario Act, 2017 and amended Highway Traffic Act. If passed, the Act would regulate the use and distribution of recreational cannabis in Ontario upon the enacting of the federal Cannabis Act in July 2018.

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Federal Government Introduces its Cannabis Tax Proposal; Alberta Unveils Proposed Provincial Framework

On Tuesday, October 3, 2017 the Government of Canada unveiled its proposal for a federal excise tax on the sale of cannabis. Under the proposal, a $1 tax would be levied on prices up to and including $10 per gram and a 10% tax would be levied on prices over $10 per gram. The proposal is for the tax revenues to be evenly split between the Federal and Provincial Governments.

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Liquor Control Board to Distribute Cannabis in Quebec

On September 29, 2017, government sources confirmed to Radio-Canada that Quebec's liquor board, the Société des alcools du Québec or Quebec Alcohol Corporation (SAQ), will oversee the distribution of recreational cannabis in the province following legalization in July 2018. Sources also confirmed that the legal age to purchase cannabis in Quebec will be set at 18, aligning it with both the mandatory minimum age proposed by the Government of Canada in Bill C-45 and with the province’s minimum drinking age. 

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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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Cameron Mingay Discusses Potential Marijuana Supply Crunch with Bloomberg

With the legalization of recreational marijuana in Canada slated to occur within the next 12 months, a looming concern is whether Canada's supply will meet its demand. In a recent Bloomberg article, Cameron Mingay discusses practical realities associated with ramping up legal marijuana production in Canada.

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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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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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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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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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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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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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October 2016 Deal Round-Up

A monthly round-up of a selection of major Canadian deals in the life sciences and healthcare sector.

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New US$500 Million Global Life Sciences Venture Fund Launched

Quark Venture Inc., a Canadian based venture firm, and GF Securities Company Limited, a China based investment bank, have recently launched a US$500 million life sciences venture capital fund. The fund will be based out of Vancouver, and is expected to focus on building a diversified portfolio of innovative biotechnology, pharmaceutical, and life sciences companies. It is now the largest life science fund in Canada and has already committed US$100 million into various life sciences companies.

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A Case that Could Determine the Future of Health Care in Canada

On September 6, 2016, the British Columbia Supreme Court began hearing a case (“Cambie”) that could have far-reaching effects on the face of health care in Canada.

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