On October 19, 2023, the Ontario government proposed regulatory amendments that may eliminate the need to submit certain clinical studies and evidence when requesting that a “well-established drug” be (i) listed or (ii) designated as interchangeable on Ontario’s publicly-funded formulary. The government is seeking feedback on the proposed amendments.
A manufacturer can apply to have a drug product listed on Ontario’s Formulary for coverage under the Ontario Drug Benefit (ODB) program. For a generic or biosimilar product, the manufacturer may also apply to have the drug product designated on the Formulary as interchangeable with the original brand product.
- Requirements for obtaining a listing are set out in O. Reg. 201/96 under the Ontario Drug Benefit Act (ODBA Regulations).
- Requirements for obtaining an interchangeability designation are set out in Reg. 935 under the Drug Interchangeability and Dispensing Fee Act (DIDFA Regulations).
Under these Regulations, subject to certain exceptions, a condition for a strength and dosage form of a drug product to be listed or designated as interchangeable is the submission of prescribed clinical studies and evidence. The prescribed information is submitted to the executive officer who administers the Formulary.
The Ontario government is proposing amendments to the ODBA Regulations and the DIDFA Regulations that would create a new exception to having to submit clinical studies and evidence in order to obtain a Formulary listing or interchangeability designation. In both Regulations, the new exception would apply where the drug product is “not a new drug as defined in the Food and Drug Regulations”.
- The definition of “new drug” in the Food and Drug Regulations is multipart, but generally relates to a drug product — including its substances, combinations, and uses — that has not been sold “for sufficient time and in sufficient quantity to establish in Canada” its safety and effectiveness. Generally, the Food and Drug Regulations impose additional requirements for a “new drug” to obtain marketing approval.
For the new exception to apply, the executive officer would have to be satisfied:
- For listing: The product is safe, therapeutically effective or efficacious, and appropriate for public funding; and
- For interchangeability: The product is interchangeable with the original product. In addition, the original product must not be available for the prescribed comparative studies.
According to the Ontario government, if implemented, the amendments would remove barriers in the Formulary approval process and “improve Ontarians’ access to publicly funded drugs under the ODB program and lower cost generic drugs”.
Comments to the Ministry of Health are due December 3, 2023.
- Post about the proposed amendments on Ontario’s Regulatory Registry