On September 16, 2020, the Minister of Health signed an Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (the Interim Order) which provides new regulatory pathways to expedite the approval of COVID-19 drugs and vaccines that have not yet been approved for sale in Canada. It also allows for addition of new indications related to COVID-19 that are not included in a currently-marketed product’s authorization.
The Interim Order establishes alternative pathways to the standard regulatory review process which helps expedite the authorization of eligible products.
- Manufacturers will be permitted to submit safety and efficacy information on a rolling basis throughout the course of the application review and as it becomes available.
- The Minister can impose or amend terms and conditions on the authorization at any time while it is in effect.
- For products authorized by a foreign regulatory authority, the Minister will maintain a List of Foreign Drugs shown to provide benefit in the context of COVID-19. Applicants for products on this list may submit a more abbreviated application for authorization.
- For products already marketed in Canada, either the manufacturer or the Minister may initiate the process to add the product to the List of New Drugs for Expanded Indication.
The standard regulatory review process also continues to be a valid market entry pathway.
Intellectual Property Protection
According to Health Canada, “the Interim Order does not include explicit intellectual property protections for innovative drugs submitted for authorization through this process”. Health Canada has stated that transitional and other mechanisms will be available to preserve these rights.
- Drugs will be eligible to receive data protection, patent linkage protection under the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations), and Certificate of Supplementary Protection once the Interim Order expires.
- An application cannot be made under the standard regulatory review process for a COVID-19 claim based on a “direct or indirect comparison” to a drug authorized under the Interim Order.
- Applications based on a direct or indirect comparison to a COVID-19 drug will only be accepted if the reference drug is not available on the Canadian market in sufficient quantities to address urgent public health needs related to COVID-19. Prior to accepting such an application, the Minister is required to notify the reference drug manufacturer and consider any representations on reference drug availability. If the Minister determines that the reference drug is not available in sufficient quantities, the comparison application may be submitted.
The Interim Order otherwise has no impact on rights provided under the Patent Act.
The PMPRB intends for the price of medicines approved through the Interim Order to only be subject to review or investigation following a specific complaint from the Minister or any of her provincial or territorial counterparts during the term of the Interim Order. Upon the expiry or repeal of the Interim Order, absent a pre-existing complaint, price reviews for these medicines will be based on the prevailing domestic and international list prices, and not on the prices at introduction.
Term and Transition Plans
The Interim Order, once approved by the Governor-in-Council, will be valid for a one-year term from the day it is signed by the Minister. Product authorizations issued under this Interim Order will only be valid while the Interim Order is in effect.
Health Canada is developing transition measures to avoid disruptions for the ongoing authorization of drugs upon the expiry of the Interim Order.
Other Changes Under the Interim Order
- Pre-positioning: Early importation or “pre-positioning” may be allowed prior to Canadian market authorization to facilitate immediate distribution of a promising COVID-19 drug. Pre-positioning can only occur where the Chief Public Health Officer of Canada has notified the Minister of a need to pre-position a COVID-19 drug and the Government of Canada has a procurement agreement for the purchase of the drug.
- DEL: The Interim Order also introduces an option for drug establishment licences (DEL) to be issued or amended in order to meet the needs of manufacturers responsible for COVID-19 drugs. The Minister may allow for the modification of certain GMP requirements and may at any time impose certain terms and conditions on DELs granted through this mechanism. All applications will be assessed in an expedited manner.
- Safety and efficacy evidence: Health Canada will make publicly available the safety and efficacy evidence relied upon to issue an authorization under the Interim Order. This information will be released for non-commercial purposes only.
- Marketing: Bilingual labeling requirements, advertising prohibitions, and adverse drug reaction, recall, and shortage reporting obligations required under the Food and Drug Regulations remain largely the same.
Health Canada has also published a Guidance Document to further describe the application of the Interim Order.