Question Period Note: Canada-EU Comprehensive Economic and Trade Agreement (CETA) and Rapid Testing for COVID-19

While CETA includes provisions designed to facilitate the approval process for new medical and pharmaceutical products, each party retains full authority to regulate these products in its territory.

• CETA is one of the most comprehensive trade agreements that both Canada and the European Union have implemented and it is delivering tremendous opportunities and positive results for Canadians.
• The CETA includes provisions that are intended to facilitate the approval of products from, and destined for, the EU.
• At the same time, each party retains the right to regulate under the CETA. Specifically, the CETA does not affect Health Canada's authority to regulate and approve the sale of COVID-19 rapid tests in Canada.
• We have given more funds and resources to Health Canada to authorize the sale of new technologies coming on the market. We need to make sure that every step of the way we are putting the health of Canadians at the forefront.
• We will continue to work with partners around the world as we continue to authorize the sale products, including medical devices that Canadians need.

The CETA includes provisions intended to facilitate trade between Canada and the EU by simplifying the testing and certification process required to access each market. The Protocol on the mutual acceptance of results of conformity assessment is designed to allow Canadian products to be tested to EU requirements, and vice versa, in certain agreed product categories. This is expected to save time and money for exporters. Medical devices are not currently covered under the Protocol but are listed as a product category to be considered for future inclusion.

Relevant CETA provisions are also included in the Protocol on the mutual recognition of the compliance and enforcement programme regarding good manufacturing practices for pharmaceutical products. "Good manufacturing practices" (GMP) refers to the framework that manufacturers must adopt to ensure that their products do not pose a health and safety risk to consumers. In the context of pharmaceuticals, this means drugs that are consistently produced and controlled to meet the quality standards appropriate to their intended use. It is important to note that the Protocol does not relate to the drug approval process. The Protocol's central objective is to reduce the number of duplicative visits and certification requirements faced by pharmaceutical manufacturers that sell their products in both Canada and the EU. As a result of the mutual recognition achieved under the Protocol, regulators in the EU will be able to rely on the certifications granted by Canadian regulators for certain products, and vice versa.

Bottom line: CETA does not oblige Canada to accept EU standards or safety certifications for medical devices such as the rapid test for COVID-19. CETA contains mechanisms to streamline the approval process for certain EU goods but decisions ultimately remain with Canadian regulators.

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