new recycling obligations for pharmaceutical laboratories: principle of extended producer responsibility extended to the pharmaceutical industry | Knowledge

On June 1, 2022, the Quebec government enacted the Regulation to amend the Regulation respecting the recovery and reclamation of products by enterprises [PDF] (the regulation”). This regulation subjects several new products, including pharmaceutical products, 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 context

The Regulation respecting the recovery and reclamation of products by enterprises requires that the companies concerned set up a system for recovering and reclaiming their products or become members of an organization recognized by RECYC-QUÉBEC whose function is to set up a system for recovering and reclaiming products on behalf of of its members.

Initially, EPR applied to manufacturers or producers of the following six product categories:

  • appliances and air conditioning
  • oils, antifreeze, coolants, their containers and filters, and other similar products
  • mercury lamps
  • paints and their containers
  • Battery
  • electronic products

Extended range

On October 13, 2021, the Government of Quebec published a draft regulation amending the Regulation respecting the recovery and reclamation of products by enterprises, as well as a related regulation impact assessment [PDF] (available in French only), to extend its application to a variety of new products, including pharmaceuticals.

The Government of Quebec then enacted the Regulation on June 1, 2022. It now confirms that EPR applies to pharmaceutical products sold in a community pharmacy or veterinary clinic.

More specifically, the Regulations provide for the application of 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 or veterinary pharmacy. clinical.[1] The new rules also apply to sharp 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 collection and safe disposal services for these products throughout Quebec. The Regulation provides that companies must implement their recovery and reclamation program no later than June 30, 2024.

The regulations also provide for the extension of the application of EPR to manufacturers of refrigeration appliances used to store anything other than food and drink, which includes laboratory refrigeration appliances. In this case, the companies concerned must implement their recovery and recovery program no later than June 30, 2023.

Any company that violates these obligations may be subject to 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 establishments.