On June 1, 2022, the Government of Québec enacted the Regulation to amend the Regulation respecting the recovery and reclamation of products by enterprises [PDF] (the "Regulation"). This Regulation makes several new products including pharmaceutical products subject to extended producer responsibility.
Extended Producer Responsibility ("EPR") is an approach to recycling that requires producers, such as manufacturers, to take responsibility for the life cycle of the products they sell, including collection and/or recycling at the end of their useful life.
The Regulation respecting the recovery and reclamation of products by enterprises requires that affected companies set up a system for the recovery and reclamation of their products or become a member of an organization recognized by RECYC-QUÉBEC whose function is to implement a system for the recovery and reclamation of products on behalf of its members.
Initially, the EPR applied to manufacturers or producers of the following six product categories:
- household and air conditioning appliances
- oils, antifreeze, coolants, their containers and filters, and other similar products
- mercury lamps
- paints and their containers
- electronic products
On October 13, 2021, the Government of Québec published a draft regulation amending the Regulation respecting the recovery and reclamation of products by enterprises, as well as a related impact assessment [PDF] (available in French only), to extend its application to a variety of new products, including pharmaceutical products.
The Government of Québec then enacted the Regulation on June 1, 2022. This now confirms that the EPR applies to pharmaceutical products sold in a community pharmacy or veterinary clinic.
More specifically, the Regulation provides for the application of the EPR to any company marketing, acquiring or manufacturing drugs, including natural health products, in any form, whether prescription or over-the-counter, marketed or otherwise distributed in a community pharmacy or veterinary clinic.1 The new rules also apply to cutting or sharp objects used for medical purposes for the administration of a product such as syringes, blades and needles.
Thus, pharmaceutical companies will be required to offer and finance services that collect and safely dispose of these products throughout Québec. The Regulation provides that companies must implement their recovery and reclamation program no later than June 30, 2024.
The Regulation also provides for the extension of the application of the EPR to manufacturers of refrigeration appliances used to store anything other than food and beverages, which includes laboratory refrigeration appliances. In this case, the companies concerned must implement their recovery and reclamation program no later than June 30, 2023.
Any company that violates these obligations may be liable for a fine ranging from $7,500 to $1,500,000.
To Learn More
To find out if your company may be affected by the Regulation and the related obligations, do not hesitate to contact our Life Sciences team. Fasken's Life Sciences group has significant expertise in all aspects of pharmaceutical regulation and can guide you through these new obligations.
1 Please note that the Regulation also provides for a few exceptions, including products used by health professionals in certain health and social services institutions.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.