Mr. Speaker, from the moment our government was told about the reported under-dosing of certain chemotherapy drugs in Ontario and in New Brunswick, we took the situation very seriously. We supported the provincial government's investigation into this incident and we accept the findings of the Thiessen report.
We agree that compounding-like activities conducted by third parties, such as Marchese Hospital Solutions, require more effective regulatory oversight, and we are determined that Canadians will have tough, effective regulations for drug safety.
While this work is ongoing, Health Canada has given direction to companies providing these types of services to ensure that they have oversight in place to protect patients' safety.
This direction states that admixing and compounding activities are done within a hospital, meeting provincial regulatory requirements; are done outside of a hospital, as a service under the supervision of a provincially licensed pharmacist; or, in the third instance, are done in a manner that meets the licensing and manufacturing requirements of the Food and Drugs Act and the Food and Drug Regulations.
Canadians can be assured that organizations following these directions have the appropriate oversight in place to help ensure the safety and effectiveness of health products prepared in this way.
The facts that emerged surrounding the under-dosing incident in Ontario highlighted how the practice of pharmacy has changed and evolved to include new drug preparation and purchasing models.
The regulation of traditional drug compounding is premised on the issuance of a prescription by a health care practitioner for a single drug to a single patient as part of the practice of pharmacy, and as such, it is in the realm of provincial and territorial jurisdiction. The regulation of drug manufacturing requirements and processes most often undertaken by pharmaceutical companies is in the realm of the federal government.
Under new drug preparation models, compounding-like activities are being conducted in dedicated facilities by third parties outside a health care setting for many patients at once and often without a specific prescription. This type of activity can be described as a hybrid of compounding and manufacturing.
As I said, Health Canada has taken on a leadership role in addressing this issue and is developing a proposal for a federal approach for these compounding-like activities. Our objective is to enhance the oversight of these practices for the safety of all Canadians: for my family, for members' families, for families across Canada. Federal oversight would focus on the quality of products and would include additional requirements such as labelling and reporting and enhancing patient safety.
Moving forward, it is important that we continue our collaborative, thoughtful approach with provinces, territories, and other partners to avoid unintended consequences in developing the new approach.
We also want to create an approach that respects both the federal role in drug safety and the provincial and territorial role in the safe use of drugs, particularly because of the diversity of approaches in the oversight of these activities across Canada.