Health Canada updates guidance on switching of a medicinal ingredient from prescription drug to non-prescription drug status

On April 21, 2022, Health Canada published its revised draft guidance on switching a medicinal ingredient from prescription to a non-prescription status (Guidance), which is open for a 60-day consultation period until June 20, 2022. The Guidance proposes a revised framework for the switching process, the first substantive update since publication of its existing guidance document in 2014¹.

What you need to know

• Application process, alignment with PDL principles and factors. A New Drug Submission (NDS) or a Supplementary New Drug Submission (SNDS) must be submitted to switch a prescription drug to non-prescription drug status. Non-prescription drug status includes a non-prescription drug (NPD) and a natural health product (NHP).
  • All applications for a switch must include a Prescription Drug List (PDL) Principles and Factors Assessment, to demonstrate that none of the PDL principles and factors applies to the proposed use of the medicinal ingredient after the switch.
• Assessment of strategy and risk before a switch. Manufacturers should consider data protection and patent listing strategies before filing a switch application. Only drugs governed by Division 8 of the Food and Drug Regulations are eligible to benefit from data protection and patent protections. Based on the Guidance, it is not clear how existing data protection and patent protection rights will be impacted once the switch application is approved.
• Third-party switch requests will trigger regulatory implications for products with the same ingredient. Companies that market a “switched” product that do not initiate switch applications may nevertheless be impacted by the decision of a third party to request a switch in status of a drug containing the same medicinal ingredient. 

The details

Switching requirements and process under the proposed revised framework

Under the proposed revised framework, the applicant must submit an NDS² or an SNDS³ for switching to an NPD or an NHP, as appropriate. All applications must include the necessary information on safety, efficacy and quality of the proposed product⁴, the “PDL Principles and Factors Assessment”⁵, and the proposed labelling. Inclusion of the PDL Principles and Factors Assessment is a new requirement under the proposed revised framework, where the applicant must demonstrate that none of the PDL principles and factors applies to the medicinal ingredient under the proposed conditions of use (i.e., that the product does not require practitioner oversight and is therefore appropriate for self-care).

Once Health Canada is satisfied with the NDS/SNDS, the existing PDL amendment process⁶ will be initiated. For switches to NPDs, Health Canada will issue a Drug Notification Form with the assigned DIN if applicable, and a NOC. For switches to NHPs, applicants must submit a Product Licence Application to obtain a Product Licence and the Natural Product Number (NPN), which will be issued once the applicant withdraws the NDS/SNDS.

Where Health Canada issues a negative decision for the switch application, the applicant may request a reconsideration of the decision by filing a Letter of Intent within 30 days of receiving such decision⁷.

Implications of the proposed revised framework

Data protection and patent protection

Manufacturers should consider data protection and patent listing strategies before filing a switch application. The Guidance provides that only drugs governed by Division 8 of the Food and Drug Regulations are eligible to benefit from data protection and that the switch of a prescription drug to a Division 8 NPD will not result in the granting of a new or additional term of data protection. However, the Guidance is not clear on whether submission of an NDS/SNDS to request a switch will terminate existing data protections for innovative drugs or if the new NPD will continue to receive the existing data protection granted to the innovative drug as a prescription drug prior to the switch.

Similarly, the Guidance states that only drugs governed by Division 8 of the Food and Drug Regulations are eligible to benefit from the Patented Medicines (Notice of Compliance) Regulations and that the switch of a prescription drug to a Division 8 NPD will not result in a new opportunity to submit a patent list for inclusion on Health Canada’s Patent Register (Canada’s “Orange Book” equivalent). However, the Guidance does not expressly state that listed patents would remain on the Patent Register for a “switched” product.  

Impact to non-applicants

A successful switch will result in an amendment to the PDL. As such, companies that market a product with a “switched” medicinal ingredient, but that did not initiate the switch, will be impacted by the amendment. Health Canada will inform the non-initiating manufacturer of their options, which may include filing an application to obtain product authorization of their product as a non-prescription status product as an NPD or an NHP—or ceasing sale of the prescription drug product.

If the non-initiating manufacturer is opposed to the switching of the medicinal ingredient from a prescription to a non-prescription status, the manufacturer will have the opportunity to respond to the “Notice of Consultation” published by Health Canada before a switch decision is made. Based on the comments received during the public consultation, Health Canada may decide to proceed, modify or no longer pursue the proposed amendment.

After the amendment to the PDL, companies may also file an NDS for NPDs or a Class III application for NHPs to obtain market authorizations of a new product containing the medicinal ingredient, as a non-prescription NPD or an NHP.

What’s next

Comments on the Guidance will be accepted by Health Canada until June 20, 2022⁸. Stakeholders seeking clarity on the switch process and procedures, including with respect to data protection and patent protection impacts, are encouraged to make submissions to Health Canada during this consultation period.

Following the submission deadline, Health Canada will review all feedback received during the consultation and publish a finalized Guidance document. It is currently anticipated that the finalized Guidance document will come into effect 60 days after its publication, when the new process for switching of medicinal ingredients from prescription to non-prescription status will also come into effect.