Pharmaceutical antitrust—Canada—Q&A guide

The following Life Sciences practice note provides comprehensive and up to date legal information covering:

  • Pharmaceutical antitrust—Canada—Q&A guide
  • 1. What is the applicable regulatory framework for the authorisation, pricing and marketing of pharmaceutical products, including generic drugs?
  • 2. Which authorities are entrusted with enforcing these rules?
  • 3. Are drug prices subject to regulatory control?
  • 4. Is the distribution of pharmaceutical products subject to a specific framework or legislation? Do the rules differ depending on the distribution channel?
  • 5. Which aspects of the regulatory framework are most directly relevant to the application of competition law to the pharmaceutical sector?
  • 6. What are the main competition law provisions and which authorities are responsible for enforcing them?
  • 7. What actions can competition authorities take to tackle anticompetitive conduct or agreements in the pharmaceutical sector and what remedies can they impose?
  • 8. Can remedies be sought through private enforcement by a party that claims to have suffered harm from anticompetitive conduct or agreements implemented by pharmaceutical companies? What form would such remedies typically take and how can they be obtained?
  • 9. Can the antitrust authority conduct sector-wide inquiries? If so, have such inquiries ever been conducted into the pharmaceutical sector and, if so, what was the main outcome?
  • More...

Pharmaceutical antitrust—Canada—Q&A guide

This Practice Note contains a jurisdiction-specific Q&A guide to pharmaceutical antitrust in Canada published as part of the Lexology Getting the Deal Through series by Law Business Research (published: May 2020).

Authors: Norton Rose Fulbright—Erin Brown; Kevin Ackhurst; Stephen Nattrass; John Greiss

1. What is the applicable regulatory framework for the authorisation, pricing and marketing of pharmaceutical products, including generic drugs?

Pharmaceutical products are regulated under the Food and Drugs Act and associated regulations. To be marketed in Canada, drugs require pre-market authorisation from Health Canada. Innovative pharmaceutical companies submit a new drug submission (NDS) to Health Canada that contains data on the safety and effectiveness of the new product. If Health Canada is satisfied that the NDS complies with the regulatory requirements, as well as the overall safety and effectiveness of the product, Health Canada will authorise its sale, and issue a notice of compliance (NOC) and a drug identification number (DIN).

Generic manufacturers may also submit an NDS or they may file an abbreviated new drug submission (ANDS) that demonstrates bioequivalence to a marketed Canadian reference product. If the ANDS references a product with a patent listed on the Patent Register, the Patented Medicines (Notice of Compliance) Regulations (PM(NOC)) require the generic manufacturer to demonstrate patent invalidity or non-infringement before receiving its NOC and DIN.

Pricing

The pricing of certain drugs is regulated by the Patented

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