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Mathieu Gagné, Partner | Co-Leader, Life Sciences

Mathieu Gagné

Partner | Co-Leader, Life Sciences Fasken
Jurisdiction Québec, 1997
Language(s) French, English
Office(s) Montréal
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Overview

Author of “Drug and Health Products Law in Canada” with a Doctor of Law degree, Mathieu Gagné is recognized as a leading lawyer in drug and other health products (medical devices, cosmetics, natural health products, etc.) related laws.

He advises and represents various stakeholders in the health and life sciences sector.

Mathieu has a unique knowledge of the legal framework governing drugs and other health products, from their inception in the lab to their consumption. Well within his area of expertise are the various standards governing the pharmaceutical life cycle and requiring compliance by industry stakeholders, such as pharmaceutical and biotech companies, researchers, ethics committees, wholesalers, distributors, pharmacies, health professionals, healthcare establishments, consumers and governments. His expertise also covers public law, business law as well as litigation (product liability, judicial review, class actions, etc.).

Mathieu has counselled many major international pharmaceutical companies on drug insurance plans, clinical trials, drug pricing and reimbursement, business practices, recalls, and other issues related to the approval, marketing, advertising, manufacturing and distribution of drugs in Canada. He has also counselled various pharmaceutical clients regarding negotiations with government authorities and the settlement of claims by alternative means to the judicial process. He has advised researchers and biotech companies on matters concerning clinical trials, pharmaceutical patents, financing and technology transfers.

Former associate professor at the Université du Québec à Montréal's management and technology department, Mathieu was also actively involved in the global arena as a researcher part of an international drug research team. This team of researchers from different backgrounds (law, economics, marketing, etc.) analyzed different countries' drug legislation. He is also a member of the science committee of the international conference on the Pharmaceutical Life Cycle held in Montréal (2005 and 2007), Milan (2009) and Paris (2011). Furthermore, he works with the boards, advisory and ethics committees of various health sector companies and organizations.

Called to the Bar in 1997, Mathieu is a prolific author whose doctorate dissertation on drug regulation was described as "a major contribution to the advancement of law" and was awarded by the Association des professeurs de droit du Québec the title of "Best doctorate dissertation" (2005-2006). He has participated in editing collective works; he has written many articles for legal reviews, and he has published a 1500 page book titled Drug and Health Products Law in Canada, now considered to be an essential reference work in health law.

Mathieu’s expertise as one of the top life science lawyer has been recognized by numerous legal directories, including Chambers Canada, Who’s Who Legal, Canadian Legal Lexpert Directory and Best Lawyers.

Achievements

Client Work

  • Constitutional challenge in the Superior Court of Québec attacking controversial amendments to the Patented Medicines Regulations and the validity of the existing PMPRB regime under the Patent Act, [Case - Merck Canada Inc., Janssen Inc., Servier Canada Inc., Boehringer Ingelheim Canada Ltd/Ltée, Bayer Canada Inc., Theratechnologies Inc., and an additional (Confidential) pharmaceutical company], Constitutional challenge in the Superior Court of Québec.
  • Cambrex Corporation acquires Halo Pharmaceuticals for US$425 million, [Deal - Cambrex Corporation], Cambrex Corporation (NYSE: CBM), a leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), acquired Halo Pharma, a leading dosage form Contract Development and Manufacturing Organization (CDMO) located in Whippany, New Jersey and Mirabel, Québec, Can...
  • Liquidation of gestion Éric Savard in the context of a company's Creditors Arrangement Act, [Deal - Essilor Group Canada Inc.], The CCAA proceeding was unique as Mr. Éric Savard, a director and sole shareholder of the Savard Group, was removed from office as director as the Court was satisfied that he was unreasonably impairing the CCAA proceeding and acting inappropriately as director in the circumstances (Section 11.5 of the CCAA). The Monitor was given enhanced powers, namely to act in place of Mr. Savard. These powers were akin to the powers of a Receiver.​
  • Assisting a pharmaceutical manufacturer manage advertising complaints before PAAB and Health Canada, [Deal - Confidential Client], Fasken was retained by a pharmaceutical manufacturer to assist with advertising complaints across multiple adjudicative structures, including, Health Canada and the Pharmaceutical Advertising Advisory Board (PAAB).    Fasken team was composed of Mathieu Gagné, Jean-Raphaël Champagne and Dara Jo...
  • Representing a global medical device manufacture in connection with a recall by Health Canada, [Deal - Confidential Client], Fasken was retained by a major global manufacturer with various aspects relating to a Type II recall by Health Canada of its medical device (in Canada and the U.S.).As a result of Fasken’s guidance, the company was able to continue to commercialize their medical devices throughout the recall proc...
  • Advising on a novel e-commerce drug distribution platform, [Deal - Confidential Client], Fasken was retained by a major pharmaceutical manufacturer to advise on a novel e-commerce platform for the distribution of non-prescription drugs and natural health products.Fasken provided a comprehensive analysis of the legal landscape across Canada in order to inform the development of the e-...
  • Advising on market entry of a private label medical device, [Deal - Confidential Client], Fasken was engaged by a multinational pharmaceutical company when the company first contemplated Canadian market entry of its medical devices.The company required advice on the optimal manufacturing and distribution approach for its device to be used by healthcare professionals in the field. Fask...
  • Advising on companion diagnostic programs and reimbursement, [Deal - Pharmaceutical manufacturer], Fasken was retained by several pharmaceutical manufacturers to assist with the implementation of novel patient support program that provide healthcare institutions with companion diagnostics that could be used in determining the efficacy of a drug for a particular patient. In particular, companio...
  • Representing a major medical device manufacturer in a Health Canada Stop-Sale, [Deal - Confidential Client], Fasken was retained by a major medical device manufacturer to assist with various aspects relating to a stop sale and device re-classification by Health Canada of one of its most important medical device licences (marketing authorization). The objective was to create a regulatory action plan to e...

Career & Education

Education

  • LLD Université Laval
  • LLM Université Laval
  • LLB Université Laval

Memberships & Affiliations

  • Management and technologies department of the Université du Québec à Montréal, Associate professor
  • Major Collaborative Research Program on the Pharmaceutical Life Cycle (SSHRSC), Researcher
  • Barreau du Québec, Member
  • Canadian Bar Association, Member

Knowledge

Events

News

Publications

  • The PMPRB : Where are we now? What’s Next? , 3/24/2022
  • When is Software a Medical Device?, 5/17/2019
  • Getting the Deal Through: Healthcare Enforcement & Litigation 2016 (Canada), 11/2/2015
Article, Co-Author When is Software a Medical Device? Electronic Healthcare Law Review, LexisNexis, Volume 8, No. 4, May 2019, pages 44-45
Getting the Deal Through: Healthcare Enforcement & Litigation 2016 (Canada)

Speaking Engagements

  • Last Developments and Tendencies in Canada - Pharmaceutical Regulations, 6/21/2021
  • Canadian Legal & Compliance issues, 5/2/2018
  • New Regulations to the Patent Act, 2/26/2018
Speaker Last Developments and Tendencies in Canada - Pharmaceutical Regulations Pharmaceuticals Compliance Congress
Speaker Canadian Legal & Compliance issues
Speaker New Regulations to the Patent Act Structured on-the-job training

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