Services
The firm provides experienced legal counsel to healthcare companies doing business in Canada. Its clients commercialize products that are regulated by Canada’s Food & Drugs Act, such as prescription medicines (patented and off-patent), OTC drugs, medical devices, nutritional products, cosmetics, and natural health products. Primary areas of practice are commercial, regulatory, and intellectual property law.
Commercial Law
The firm possesses deep and broad expertise in commercial law related to products regulated by the Food & Drugs Act. This is the cornerstone of its practice.
The firm advises clients on all aspects of commercial transactions, including drafting and negotiating complex agreements such as licensing, distribution, manufacturing, and supply contracts.
The firm also provides strategic counsel on advertising & promotional material, in a variety of media, destined for healthcare professionals, patients, and the general public.
Leveraging decades of experience, the firm ensures that agreements are tailored to meet business objectives while mitigating risks and ensuring compliance with Canadian legal and regulatory frameworks. This expertise positions the firm as a trusted partner in advancing clients' commercial success.
Advertising & Promotion
Legal review of promotional material in all media, ensuring compliance with applicable laws, professional order codes of ethics for doctors and pharmacists; industry codes such as the IMC Code, PAAB, and the ASC Code; as well as company policies.
We also assist in meeting Health Canada’s regulatory requirements for advertising, including comparative advertising of prescription drugs and the distinction between advertising and other activities.
Clinical Research
Legal review of all Clinical Research-related agreements, including Clinical Study/Clinical Trial Agreements (CSA/CTS), Sponsored Research Agreements, Patient Brochures, Informed Consent Forms (ICF), Investigator Agreements, Contract Research Organization (CRO) Agreements. Our productive working relationships with legal counterparts at sites and institutions expedites the legal review process.
Commercial Contracts
Service Agreements with service providers, including Healthcare Professionals (HCPs), Hospital & GPO RFPs, Wholesaler/Logistics Services Provider Agreements, and contracts with industry partners throughout the supply chain. Our in-house counsel approach ensures only important legal risks are addressed with pragmatic solutions, ensuring business keeps moving smoothly.
Patient Support Programs (PSPs)
The firm provides specialized legal counsel to manufacturers with Patient Support Programs (PSPs) in Canada. These programs operate within a complex regulatory framework that includes federal and provincial privacy laws, healthcare compliance standards, and industry-specific codes of conduct. The firm advises on structuring PSPs to ensure compliance with laws governing the collection and use of patient personal information and health data. From drafting robust agreements with service providers, to navigating data-sharing arrangements and regulatory audits, to ensuring compliance with drug advertising and pricing regulations.
Privacy Law
Comprehensive legal guidance to navigate the dual regulatory framework of federal and provincial privacy laws. At the federal level, the Personal Information Protection and Electronic Documents Act (PIPEDA) sets baseline standards for handling personal information. Provincially, laws such as Ontario’s Personal Health Information Protection Act (PHIPA) govern the collection, use, and disclosure of personal health information. The firm helps clients understand and comply with these overlapping regimes, ensuring data practices meet strict confidentiality standards. From privacy audits to breach response strategies, to serving as the company’s designated Privacy Officer in Canada, the firm helps protect sensitive information and maintain compliance.
Product Listing Agreements
Expert legal counsel on Product Listing Agreements (PLAs) for manufacturers navigating Canada’s complex reimbursement landscape. Services include negotiating Letters of Intent with the pan-Canadian Pharmaceutical Alliance (pCPA) and drafting PLAs with federal and provincial public insurers, as well as private insurers. The firm advises on pricing, compliance, and implementation strategies to align with regulatory and contractual requirements, ensuring seamless market access and reimbursement for therapeutic products.
Regulatory
Our firm offers unparalleled legal expertise in regulatory law concerning therapeutic products in Canada. With over two decades of experience, we guide healthcare companies through the intricate regulatory landscape, ensuring compliance with Health Canada’s stringent requirements. From product licensing and clinical trials to marketing authorization and post-market surveillance & drug shortage reporting, we provide strategic legal advice that addresses every phase of the product lifecycle.
Our deep understanding of the regulatory framework, combined with a practical approach, helps clients navigate challenges and mitigate risks, enabling them to bring therapeutic products to market efficiently and with confidence.
Access to Information Act
The firm advises manufacturers on safeguarding sensitive commercial, financial, and technical information in the custody of provincial governments and Health Canada under Canada’s **Access to Information Act** and provincial freedom of information laws. The firm assists in identifying and asserting applicable exemptions to disclosure, such as those protecting trade secrets and competitive information, and provides strategic counsel during the submission of confidential data to government bodies. Whether responding to access requests or preemptively structuring submissions to minimize risks, the firm ensures clients’ sensitive information remains protected while maintaining compliance with applicable transparency requirements.
Clinical Research
Legal review of all Clinical Research-related agreements, including Clinical Study/Clinical Trial Agreements (CSA/CTS), Sponsored Research Agreements, Patient Brochures, Informed Consent Forms (ICF), Investigator Agreements, Contract Research Organization (CRO) Agreements.
Contract Manufacturing
The firm provides specialized legal services to support manufacturers in navigating the complexities of contract manufacturing agreements. Leveraging an extensive network of contract manufacturing sites, the firm offers strategic counsel on drafting, negotiating, and managing manufacturing and supply agreements to ensure compliance with Canadian regulatory requirements and industry standards. The firm advises on critical issues such as intellectual property protection, quality assurance obligations, liability allocation, and termination provisions. With expertise in the therapeutic products sector, the firm helps clients secure reliable manufacturing partnerships that meet their production needs while mitigating risks and safeguarding their business interests.
Packaging & Labelling
There are three principal pieces of Federal legislation that regulate packaging and labeling of therapeutic products. The Food and Drugs Act has very specific guidelines for the labeling and packaging of all healthcare products. For the consumer healthcare market, the Consumer Packaging and Labelling Act also has important regulatory requirements. Also, the Competition Bureau, a federal agency, imposes standards of its own regarding net quantities for products' packaging and labeling. The firm advises manufacturers to comply with Canadian regulatory requirements for packaging & labelling of its products.
Pharmacovigilence
The firm provides comprehensive legal counsel on pharmacovigilance compliance, helping manufacturers of therapeutic products navigate their obligations under Canadian law. Services include advising on the establishment and operation of pharmacovigilance systems, drafting agreements with third-party service providers, and ensuring compliance with Health Canada’s Good Pharmacovigilance Practices (GVP) guidelines. The firm assists with adverse event reporting requirements, risk management plans, and post-market surveillance obligations. Whether addressing regulatory inspections or developing policies to align with global pharmacovigilance standards, the firm delivers practical solutions to help clients maintain patient safety, regulatory compliance, and reputational integrity in the healthcare industry.
Quality Assurance
The firm offers legal counsel on quality assurance matters to manufacturers of therapeutic products, ensuring compliance with Health Canada’s Good Manufacturing Practices (GMP) and other regulatory standards. Services include drafting and reviewing quality agreements, advising on inspection readiness, and addressing non-compliance findings. The firm helps clients establish robust quality systems, manage supplier relationships, and mitigate risks associated with product quality, ensuring safe and effective products reach the market while maintaining regulatory compliance.
Special Access Program
The firm provides expert legal counsel on Health Canada’s Special Access Program (SAP), which permits access to non-marketed therapeutic products for patients with serious or life-threatening conditions. The firm advises manufacturers on navigating the regulatory requirements for SAP submissions, including eligibility criteria, physician requests, and product supply obligations. Services include drafting compliant agreements for the provision of SAP products, addressing liability and indemnity concerns, and ensuring adherence to Health Canada’s guidelines. With a deep understanding of this critical program, the firm helps clients support healthcare providers and patients while maintaining compliance with regulatory and ethical standards.
Intellectual Property
Strategic guidance to companies commercializing therapeutic products in Canada. With expertise in IP licensing, the firm negotiates and drafts agreements that protect innovations while optimizing commercial opportunities. The firm advises on product lifecycle management strategies, including authorized generics, supply agreements, and leveraging data protection and Certificates of Supplementary Protection (CSPs) to extend market exclusivity. The firm provides counsel on navigating the Patented Medicines (Notice of Compliance) Regulations (PM(NOC)), ensuring robust protection and compliance. We help clients safeguard their IP assets and maximize value throughout the product lifecycle.
IP Licensing
The firm’s intellectual property licensing practice focuses on negotiating term sheets, drafting licensing agreements, and managing strategic alliances. The firm provides expert guidance on structuring partnerships to protect IP rights, ensure compliance, and maximize commercial value for clients in the therapeutic products industry.
Lifecycle Management
Expertise includes lifecycle management legal counsel, particularly relating to loss of exclusivity. This includes negotiating authorized generic manufacturing and supply agreements to optimize market positioning. With a focus on regulatory compliance and commercial strategy, the firm provides practical guidance to help clients protect and extend the value of their innovations.
Patented Medicines
The firm specializes in maximizing intellectual property protection for patented medicines under Canada’s Patented Medicines (Notice of Compliance) Regulations (PM(NOC)), ensuring robust strategies for patent linkage and litigation. The firm advises on data protection under the Food and Drug Regulations, as well as obtaining and leveraging Certificates of Supplementary Protection (CSPs) to extend market exclusivity.
