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.
- 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.