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Mathieu Gagné Associé/Partner Montréal

Mathieu Gagné

Partner Fasken
Jurisdiction Quebec, 1997
Language(s) French, English
Office(s) Montréal


Author of “Drug and Health Products Law in Canada” with a Doctor of Law degree, Mathieu Gagné is specialized 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.


Client Work

Date Client

Career & 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


Fasken Institute



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

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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