Pangaea Express: Interim Order to expedite approval for COVID-19 medicines
The Feds issued an Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (the Interim Order) September 16, 2020 that allows for the Minister of Health to expedite review of COVID-19 drugs in Canada using three routes:
a “rolling application” that allows the applicant to file information as it becomes available. This agile approach can be used in place of the usual requirements by the Food and Drug Regulations for substantial evidence of safety clinical effectiveness
drugs that are authorized for sale by a foreign regulatory authority and included on the List of Foreign Drugs
permitting the sale of a drug already authorized in Canada for an expanded indication related to COVID-19; a process that can be initiated with or without an application from the manufacturer (i.e. Under the Interim Order, the Minister has the power to expand an indication)
The Interim Order will also allow for the pre-positioning (importation prior to market authorization) of promising COVID-19 drugs. The Government of Canada must have entered into a contract for its procurement and the manufacturer must either have filed an application with Health Canada or with a foreign regulatory authority for market authorization. As well, establishment licenses will be processed and issued in an expedited manner.
The PMPRB has posted an update under the Consultations tab of the Draft Guidelines regarding the price of medicines on the List of Drugs for Exceptional Importation and Sale approved via this Interim Order for COVID-19. Prices will only be subject to a review or investigation following a specific complaint from the Minister of Health or her provincial or territorial counterparts. This complaint driven process will only be in place for the length of the Interim Order. Once the order has expired, price reviews for these medicines will be based on prevailing international and domestic list prices.
This Interim Order is a radical shift from the strict Food and Drug Regulations requirements re: safety and clinical effectiveness for a new drug approval. Even the NOC/c, where approval is based on the condition for further studies to verify the clinical benefit of an innovative product, is not nearly as agile as this rolling application process. The approval of the H1N1 vaccine back in 2009 used a similar approach.
Of interest to pet owners, the Feds included veterinary drugs in this Interim Order given reports of infected humans spreading the virus to their dogs and cats.