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04 November 2020
On 16 September 2020 the minister of health approved the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19, which introduces a new pathway to expedite the authorisation for importing, selling and advertising COVID-19 drugs. Accompanying the interim order are an Explanatory note, a Notice, a Guidance document for Information and application requirements for drugs authorised under the Interim Order and an FAQ.
The interim order covers various types of drug, including vaccines and veterinary drugs, but excludes:
The guidance document states that:
Although COVID-19 is understood to be primarily a human disease and the SARS-CoV-2 virus is thought to spread mainly from person-to-person, COVID-19 is a new disease and its impacts on animal health may not be fully known at this time… It is therefore important for Health Canada to be able to issue expedited authorization for the import or sale of veterinary drugs should a need for them arise as a result of COVID-19.
The interim order pathway introduces the following mechanisms for Health Canada to expedite the availability of COVID-19 drugs in Canada:
Details on how to submit an application for authorisation are outlined in the guidance document. Health Canada requested comments on the guidance document by 8 October 2020.
The interim order is generally limited to applications from manufacturers of innovator COVID-19 drugs. However, a manufacturer of a generic or biosimilar drug may submit an application for authorisation for a COVID-19 drug on the basis of a direct or indirect comparison to another drug if the manufacturer first notifies the minister of the manufacturer's intention to submit such an application and provides information to the minister which establishes the following:
On receipt of such information, the minister must notify the innovator, which can make representations respecting its ability to supply the Canadian market. The minister then makes a determination regarding the insufficient quantities issue and whether the generic or biosimilar submission will be accepted. If the 'sufficient quantities' requirement is not met and a generic or biosimilar submission is therefore accepted, innovators should note that once an authorisation for a generic or biosimilar under the interim order is issued, even if insufficient supply ceases to be an issue, authorisation will not be revoked. The potential need to issue authorisations for generic and biosimilar products will be limited to products used to treat COVID-19 and not vaccines, which are considered to be unique and can be provided only by innovators.
The interim order also introduces a mechanism to import into Canada drugs that show promise for treating or preventing COVID-19. This mechanism (known as pre-positioning) allows promising treatments to be placed in Canadian facilities before their authorisation to allow for quicker distribution after authorisation. The use of pre-positioning is restricted to promising COVID-19 drugs for which the government has entered into a procurement contract with the manufacturer. Use of the drug cannot occur until after market authorization from Health Canada is obtained.
One advantage of proceeding under the interim order instead of the regular Food and Drug Regulations pathway is that applications are not subject to the fees that apply when an applicant seeks market authorisation for a drug under the regular regime.
As for intellectual property, according to the guidance document, products authorised under the interim order will not be eligible:
However, such authorisations will not preclude data protection or the ability to list patents on the Patent Register for that product if approved after the interim order expires. Further, the PMNOC Regulations will not apply to generic or biosimilar applications under the interim order. The interim order has no impact on rights under the Patent Act (for further details please see "Final PMPRB guidelines released").
From a labelling perspective, depending on the data submitted to support an authorisation under the interim order and any associated terms and conditions, applicants may be asked to include a 'warning statement' such as: "Health Canada has authorised the sale of this COVID-19 drug based on limited clinical testing in humans and/or quality information."
No look-alike sound-alike assessment will be required.
Once approved by the governor in council, the interim order will be valid for only one year from the day on which it was signed by the minister, and product authorisations issued under the interim order will be valid only while the interim order is in effect. However, Health Canada is developing transition measures to avoid disruptions when the interim order ends.
Health Canada will maintain the following four lists on the government's website in relation to this interim order:
In addition, Health Canada will publish summaries of the rationales for various decisions relating to the interim order, including the decision to authorise a product and add a product to one of the above lists. Health Canada will also make publicly available, on Health Canada's clinical information portal, the safety and efficacy evidence relied on to issue a market authorisation under the interim order (for further details please see "Final regulations addressing public release of clinical information now in force").
For further information on this topic please contact Nancy Pei or Alice Tseng at Smart & Biggar by telephone (+1 416 593 5514) or email (firstname.lastname@example.org or email@example.com). The Smart & Biggar website can be accessed at www.smart-biggar.ca.
The materials contained on this website are for general information purposes only and are subject to the disclaimer.
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