On October 19, 2023, the Ontario Ministry of Health proposed regulatory amendments under the Ontario Drug Benefit Act (ODBA) and the Drug Interchangeability and Dispensing Fee Act (DIDFA) to align Ontario’s requirements for public funding and interchangeability with Health Canada’s requirements for the sale of “well-established drugs”. The Ontario Ministry of Health is seeking feedback on the proposed regulatory amendments until December 3, 2023.
In Canada, well-established drugs are not “new drugs” as defined in the Food and Drugs Regulations under the Food and Drugs Act; they have been sold in Canada for sufficient time and in sufficient quantity to establish their safety and efficacy.
The current Regulations under the ODBA (O Reg 201/96) and the DIDFA (RRO 1990, Reg 935) require submission of the following clinical evidence for each strength and dosage form of a drug product, notwithstanding well-established drug status granted by Health Canada:
- For public funding under the ODBA: clinical studies of the product’s therapeutic effectiveness or efficacy and safety including adverse reactions and existing studies comparing the product to others.
- For interchangeability under the DIDFA: comparative bioavailability studies, comparative clinical studies or other in vivo studies showing interchangeability of the product with the original product.
The proposed regulatory amendments will remove these requirements for well-established drugs, allowing approval subject to the following conditions:
- For public funding under the ODBA: the executive officer is satisfied that the product is safe, therapeutically effective or efficacious, and appropriate for public funding, having regard to its approval for sale in Canada by Health Canada and any other information available to the executive officer.
- For interchangeability under the DIDFA: the original product with which the manufacturer seeks its product to be designated as interchangeable is not available for the comparative bioavailability studies, comparative clinical studies, or other in vivo studies and the executive officer is satisfied that the product is interchangeable with the original product having regard to the product’s approval for sale in Canada by Health Canada.
The Ontario Ministry of Health indicates the amendments will remove barriers to funding and interchangeability, ultimately improving Ontarians’ access to publicly funded drugs and lowering the cost of generic drugs.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.
The preceding is intended as a timely update on Canadian intellectual property and life sciences regulatory law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.