The federal government has proposed changes to the Food and Drugs Act (FDA) that would allow the Minister of Health (Minister) to classify products as foods, drugs, cosmetics, devices, or “advanced therapeutic products”; require authorizations to conduct clinical trials; and modify Health Canada’s inspection powers.
These changes are included in an omnibus budget bill, the Budget Implementation Act, 2019, No 1 (Bill C-97). Bill C-97 was introduced and received its first reading in the House of Commons on April 8, 2019. Second reading in the House commenced on April 10, 2019.
Classification of products
The FDA regulates various products including food, drugs, cosmetics, and devices (collectively Regulated Products, each of which is defined in the FDA). The proposed amendments introduce two changes in this regard:
- Power to designate classification. If the Minister believes that a thing (or class of things) could be captured under two or more Regulated Product definitions, the Minister would be authorised to order that the thing (or class of things) be designated as a single type of Regulated Product. The effect of such designation is that, for the purposes of the FDA — including the regulatory requirements — it will be considered to be that type of Regulated Product. The proposed amendments also provide factors to be considered in making such a designation.
- New class: “advanced therapeutic products”. The proposed amendments create a new class of therapeutic products called “advanced therapeutic products” that will be contained in Schedule “G”. Generally speaking, products in this category will represent an emerging or innovative technological, scientific or medical development. The Minister may designate a thing (or a class of things) as an advanced therapeutic product after considering enumerated factors such as the degree of uncertainty respecting risks and benefits and the extent to which existing legal frameworks are adequate to prevent injury to health. The Minister may also remove these products from Schedule “G” at a later time. Advanced therapeutic products will require authorizations (by license or ministerial order) before they can be imported, sold, manufactured, prepared, preserved, packaged, labelled, stored, or tested.
The proposed amendments would prohibit clinical trials for drug, device, or prescribed food for a special dietary purpose unless an authorization has been issued, and the study is conducted in compliance with any terms and conditions imposed by that authorization. The holder of such an authorization must also publish prescribed information about the trial in a prescribed time and manner.
Persons already authorized to import a drug, positron-emitting radiopharmaceutical, natural health product, or Class II–IV medical device for the purpose of a clinical trial as of the date the new provisions come into force will be deemed to hold an authorization in respect of that product for the purpose of the proposed amendments.
The proposed amendments would replace the current “powers of inspector” provision. The new provisions provide, in part, that:
- An inspector may order a person to provide any document, information or sample to the inspector;
- An inspector may enter any place in which they believe on reasonable grounds that regulated activities are occurring, regulated products are located, or activities could be conducted under an authorization for which an application is under consideration. Accessing remotely by telecommunication is considered entering for the purposes of an inspection;
- Inspection powers will include examination, copying, removing, testing, taking samples, taking photographs, seizing and detaining; and
- A warrant will be required to enter a dwelling-house.
The proposed amendments give powers to the Minister to order persons to take any remedial measures the Minister considers necessary if the Minister has reasonable grounds to believe that person has or will contravene the FDA.
Coming into force
The clinical trials provisions will come into force on a date fixed by order in council. Other provisions will come into force on the date that Bill C-97 comes into force.