On January 10, 2022, the Competition Bureau and Health Canada's Health Products and Food Branch (HPFB) issued a joint notice in support of a new intra-government alliance. As stated in the notice, the two agencies recognize that they have important roles to play in "ensuring that Canadians have access to needed, safe and effective medicines."
Of particular importance to this alliance is a joint effort regarding access to samples of reference products by generic drug manufacturers. According to Health Canada, generic companies have made claims of facing difficulties and delays in obtaining samples of brand name drugs required to support regulatory authorization. The Competition Bureau and the HPFB state that they have committed to general information sharing, cooperation on Competition Bureau enforcement actions, preparing impact studies on regulatory frameworks, and providing HPFB feedback on Competition Bureau related issues that impact access to medicines for Canadians.
In June 2019, the HPFB released a Clarifying Notice that outlined how Risk Management Plans (RMPs) required by Health Canada are not intended to restrict access to Canadian Reference Products (CRPs) for generic drug manufacturers for the purpose of conducting comparative testing. Accordingly, brand name drug manufacturers cannot utilize RMP mechanisms to prevent generic drug manufacturers from conducting comparative testing; product samples must be provided.
The Competition Bureau has previously issued statements in December 2018 and April 2020 regarding its investigations into the alleged practices of brand name drug manufacturers restricting access to samples of reference products. As a result, the Competition Bureau states that it continues to monitor the industry for any conduct that prevents or delays the supply of samples of reference products to generic manufacturers. The Competition Bureau also states that it has the authority under the Competition Act to investigate and address conduct that may be deemed inappropriate with respect to access to reference products.
Given this new alliance, brand name drug manufacturers should anticipate that any claims of failure to supply reference samples to generic or biosimilar manufacturers in a timely manner will be carefully scrutinized.
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