On January 10, 2022, the Canadian Competition Bureau (the Bureau) and Health Canada’s Health Products and Food Branch (the HPFB) issued a joint notice to stakeholders on their continued collaboration to support Canadians’ access to safe, effective, and affordable pharmaceuticals and biologics.
Although the Bureau and HPFB are independent entities, they have complementary mandates in the pharmaceutical sector. The Bureau is responsible for administering and enforcing the Competition Act, which includes addressing competition issues for the pharmaceutical industry. While the HPFB regulates, evaluates, and monitors therapeutic products available in Canada under the Food and Drugs Act. This overlap has led to past collaboration on several issues, including mergers and acquisitions, deceptive and misleading claims, and claims of abuse of dominance.
As part of their goal for continued collaboration, both entities plan to maintain a channel of communication to ensure the mutual success of their policy objectives. This includes having the Bureau report to the HPFB on aspects of the pharmaceutical regulatory framework that may impact competition, and the HPFB providing feedback to the Bureau when competition-related issues may result in problems for access to medicines.
The Bureau and HPFB have also committed to working together on Bureau-led enforcement actions, such as when generic pharmaceutical companies report having difficulty obtaining reference samples from branded drug manufacturers. These samples are necessary for generic companies to perform testing for regulatory approval and any difficulties in obtaining samples would delay market launch, with corresponding impact on drug availability. Both the Bureau and HPFB have released guidance for providing access to reference samples and plan to continue working together to monitor and address issues in this area. Based on the extent of guidance documents made available from both entities, branded drug manufacturers are advised to anticipate that the Bureau will treat any explanation for delay in supplying reference products with a high degree of skepticism.
Summary By: Imtiaz Karamat
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