OVERVIEW & EXPERTISE

 

Canada is home to the third-largest number of biopharmaceutical companies worldwide and a thriving medical devices sector. Businesses in the highly regulated health products industries need counsel with broad expertise in marketing, regulatory, intellectual property (IP), product liability, commercial law, litigation and class actions. Blakes possesses that skill set and more.

Our dedicated Marketing & Health Regulatory team is accomplished at navigating clients through Canada’s stringent federal and provincial regulatory requirements while enabling them to focus on their businesses.

With offices throughout Canada, we have significant experience advising some of the leading Canadian and multinational pharmaceutical companies that develop and manufacture prescription and over-the-counter pharmaceuticals, medical devices, natural health products, dietary supplements and cosmetics. They trust us because of our ability to offer guidance on a broad range of matters impacting their businesses, including their regulatory, marketing and public relations challenges.

We advise on federal and provincial regulatory and marketing compliance issues affecting companies in the health products industry. We have significant expertise acting as an intermediary between companies and regulatory/self-regulatory officials, advising on the interpretation of legislation, administrative and policy matters.

Our regulatory and marketing compliance work includes:

  • licensing of products and establishments
  • pricing and reimbursement (rebate and pricing restrictions, formulary listing agreements, agreements with hospital buying groups)
  • regulatory matters relating to safety with respect to recalls, health professional communications, adverse events and public advisories
  • various aspects of clinical research, including negotiation of clinical trial agreements as well as requirements for informed consent
  • operating policies relating to privacy and handling of information in health product companies
  • advice on Patented Medicine Prices Review Board issues
  • drug import and export issues
  • grey marketing of health products
  • health-care compliance (e.g., Rx&D, PAAB and MEDEC codes of conduct)
  • conflict of interest issues and interactions with health-care professionals
  • advertising and marketing programs and trade disputes
  • off-label marketing issues
  • public relations activities
  • access-to-information matters, including submissions in response to access-to-information requests and access-to-information litigation

The Marketing & Health Regulatory group also has substantial experience conducting due diligence audits of marketed health products and programs for the clients' internal control purposes and as part of corporate acquisitions and sales. We also have experience drafting and negotiating all forms of agreements related to health-care products and services.


Representative Matters

  • Counsel to multinational pharmaceutical and medical device companies on regulatory issues, including importation, licensing, promotion and sale of products.
  • Advising numerous pharmaceutical and other manufacturers on product listing agreements with provincial insurers and other entities, including rebate and interchangeability issues.
  • Counsel to pharmaceutical and medical device clients on advertising and marketing issues, including direct-to-consumer advertising campaigns, communications to the media, off-label matters, and marketing and advertising activities directed to health-care professionals, including Rx&D, MEDEC and PAAB compliance.
  • Counsel to pharmaceutical and other health-industry clients on clinical study matters, including clinical trial and clinical research organization agreements and informed consents.
  • Advising pharmaceutical and medical device manufacturers on issues relating to the unauthorized sale of their products by Internet pharmacies, including regulatory regime governing such sale and options to require Internet pharmacies to cease and desist unauthorized sale.
  • Advising orphan drug manufacturers regarding the regulatory regime on the reimbursement of orphan drugs, the strategy to get orphan drugs reimbursed and issues once public insurers agree to reimburse orphan drugs.
  • Advised pharmaceutical and other health-industry clients regarding compliance with federal and provincial privacy laws, including patient privacy and rights to access medical records.
 

 PEOPLE

 
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Associate | Montréal
Montréal: 514-982-4297
Areas of Expertise: Corporate & Commercial, Technology, Cannabis, Cybersecurity, Privacy & Data Protection, Technology & Innovation, FinTech, Trademarks, Anti-Spam, Mergers & Acquisitions, IP Licensing & Agreements
Partner | Toronto
Toronto: 416-863-2295
Areas of Expertise: Competition & Antitrust, Foreign Investment, Abuse of Dominance & Reviewable Matters, Criminal Investigations & Prosecutions, Competition Litigation, Competition Law Compliance, Merger Review & Control, Misleading Advertising & Promotions, SIR/E-Discovery, Drones
Associate | Toronto
Toronto: 416-863-2239
Areas of Expertise: Competition & Antitrust, Merger Review & Control, Criminal Investigations & Prosecutions, Competition Litigation, Abuse of Dominance & Reviewable Matters, Misleading Advertising & Promotions
Partner | Montréal
Montréal: 514-982-4031
Areas of Expertise: Anti-Spam, Health Products, IP Licensing & Agreements, Technology, Privacy & Data Protection, Life Sciences, Retail, Food, Beverage & Agribusiness, Cybersecurity, Public & Political Law, Consumer Protection, Autonomous & Connected Vehicles
Counsel | Montréal
Montréal: 514-982-4017
Areas of Expertise: Consumer/Retail Financial Services, Residential Mortgage Business, Payments, Marketing & Advertising, Banking, Insurance, Reinsurance, Lobbying, Financial Services, FinTech, Consumer Protection, Financial Services Regulatory
Partner | Toronto
Toronto: 416-863-4262
Areas of Expertise: Competition & Antitrust, Foreign Investment, China, Europe, United States, Competition Litigation, Abuse of Dominance & Reviewable Matters, Criminal Investigations & Prosecutions, Competition Law Compliance, SIR/E-Discovery, Merger Review & Control, Misleading Advertising & Promotions, Japan, Pension Funds, Investment Funds, Investment Vehicles, Cybersecurity, Public & Political Law
Partner | Toronto, Ottawa
Toronto: 416-863-2387
Ottawa: 613-788-2211
Areas of Expertise: Competition Litigation, Litigation & Dispute Resolution, Copyright, Competition & Antitrust, Abuse of Dominance & Reviewable Matters, Criminal Investigations & Prosecutions, Competition Law Compliance, SIR/E-Discovery, Merger Review & Control, Misleading Advertising & Promotions, Foreign Investment, Public & Political Law
Partner | Toronto
Toronto: 416-863-2352
Areas of Expertise: Competition & Antitrust, Foreign Investment, International Trade, China, Abuse of Dominance & Reviewable Matters, Criminal Investigations & Prosecutions, Competition Law Compliance, SIR/E-Discovery, Merger Review & Control, Misleading Advertising & Promotions, Consumer Protection
Associate | Toronto
Toronto: 416-863-2794
Areas of Expertise: Marketing & Advertising, Privacy & Data Protection, Intellectual Property
Partner | Toronto
Toronto: 416-863-4187
Areas of Expertise: Merger Review & Control, Misleading Advertising & Promotions, Competition Litigation, Foreign Investment, Abuse of Dominance & Reviewable Matters, Competition & Antitrust, Criminal Investigations & Prosecutions, Competition Law Compliance, SIR/E-Discovery
Partner | Montréal
Montréal: 514-982-5020
Areas of Expertise: Corporate & Commercial, Life Sciences, Technology, Intellectual Property, Mergers & Acquisitions, IP Licensing & Agreements, Anti-Spam, Cannabis
Partner | Toronto
Toronto: 416-863-3283
Areas of Expertise: Competition & Antitrust, Marketing & Advertising, Life Sciences, Class Actions, Foreign Investment, Competition Litigation, Abuse of Dominance & Reviewable Matters, Criminal Investigations & Prosecutions, Competition Law Compliance, Merger Review & Control, Misleading Advertising & Promotions, SIR/E-Discovery
Partner | Toronto
Toronto: 416-863-3082
Areas of Expertise: Class Actions, Product Liability, Life Sciences, Marketing & Advertising, Litigation & Dispute Resolution, Retail, Food, Beverage & Agribusiness, Automotive, Consumer Protection
Partner | Toronto
Toronto: 416-863-4265
Areas of Expertise: Intellectual Property, Marketing & Advertising, Life Sciences, Privacy & Data Protection, Anti-Spam, Misleading Advertising & Promotions, Health Products, Food, Beverage & Agribusiness, Retail, Life Sciences, Consumer Protection
Partner | Toronto
Toronto: 416-863-4023
Areas of Expertise: Competition & Antitrust, Merger Review & Control, Foreign Investment, Abuse of Dominance & Reviewable Matters, Criminal Investigations & Prosecutions, Misleading Advertising & Promotions, Competition Litigation, SIR/E-Discovery
Associate | Toronto
Toronto: 416-863-3053
Areas of Expertise: Privacy & Data Protection, Marketing & Advertising, Cybersecurity, Freedom of Information, Technology & Innovation
Partner | Toronto
Toronto: 416-863-3161
Areas of Expertise: Intellectual Property, Marketing & Advertising, Life Sciences, Privacy & Data Protection, Cybersecurity and Data Breach Response & Litigation, Cybersecurity, Drones, Consumer Protection, Competition & Antitrust
Associate | Toronto
Toronto: 416-863-2673
Areas of Expertise: Competition & Antitrust, Merger Review & Control, Criminal Investigations & Prosecutions, Competition Litigation, Abuse of Dominance & Reviewable Matters, Misleading Advertising & Promotions
Partner | Toronto
Toronto: 416-863-3327
Areas of Expertise: Competition & Antitrust, Foreign Investment, International Trade, China, Abuse of Dominance & Reviewable Matters, Criminal Investigations & Prosecutions, Competition Law Compliance, SIR/E-Discovery, Merger Review & Control, Misleading Advertising & Promotions, Pension Funds, Investment Funds, Investment Vehicles
Office Managing Partner | Montréal
Montréal: 514-982-4014
Areas of Expertise: Class Actions, Product Liability, Securities Litigation, Business Crimes, Investigations & Compliance, Capital Markets, Competition Litigation, Misleading Advertising & Promotions, Arbitration, Automotive, Equity Capital Markets, Cybersecurity and Data Breach Response & Litigation
Partner | Toronto
Toronto: 416-863-2765
Areas of Expertise: Health Products, Anti-Spam, Trademarks, Life Sciences, Food, Beverage & Agribusiness, Retail, Marketing & Advertising, Misleading Advertising & Promotions, Consumer Protection, Competition & Antitrust
Partner | Toronto
Toronto: 416-863-4164
Areas of Expertise: Competition & Antitrust, Foreign Investment, Abuse of Dominance & Reviewable Matters, Criminal Investigations & Prosecutions, Competition Litigation, Competition Law Compliance, SIR/E-Discovery, Merger Review & Control, Misleading Advertising & Promotions, Sports
Associate | Toronto
Toronto: 416-863-2990
Areas of Expertise: Intellectual Property, Marketing & Advertising
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