Reducing Regulatory Burden for Private Label Products
O. Reg. 201/96 (ODBA) and Reg. 935 (DIDFA)
Bill or Act:
Ontario Drug Benefit Act (ODBA) and Drug Interchangeability and Dispensing Fee Act (DIDFA)
Summary of Proposal:
The proposed regulatory amendments, if approved, would allow private label products to be designated as listed drug products under the Ontario Drug Benefit Act, or interchangeable products under the Drug Interchangeability and Dispensing Fee Act, if other existing conditions in the regulations are met.
Private label products are drugs that a manufacturer associated with a wholesaler or pharmacy chain markets under their own trademark or label, but does not fabricate. Rather than fabricate the drug themselves, the private label manufacturer purchases the drug from an existing drug fabricator.
Currently, private label products are not eligible for designation as listed drug products under the Ontario Drug Benefit Act, meaning that they are not eligible for public funding under the Ontario Drug Benefit program.
Private label products are also not currently eligible for designation as an interchangeable product under the Drug Interchangeability and Dispensing Fee Act. Without a designation of interchangeability, pharmacists cannot easily dispense private label products to private and cash paying clients. A pharmacist would only be permitted to dispense a private label product if the prescription authorized the dispensing of the specific private label brand.
Ontario is the only Canadian jurisdiction which restricts private label products from being designated as a listed drug product, or designated as an interchangeable product. The proposed revocation of these provisions would align Ontario's position on private label products with the other provinces and territories.
The proposed regulatory amendments, if approved, would reduce a regulatory burden for private label companies by removing the requirement for the private label manufacturer to fabricate the drug, in whole or in part. It would also ensure that Ontario's position on private label products is aligned with the other provinces and territories in Canada.
The ministry is proposing that the proposed regulatory amendments, if approved, would come into force at a future date.
In light of the potential impact of the proposed regulatory amendments on the generic manufacturing sector, the MOHLTC is also seeking feedback on the following two regulatory initiatives:
1. Impose a condition that requires a private label product to be fabricated in Ontario, in order to be designated as a listed drug product under the Ontario Drug Benefit Act or as an interchangeable product under the Drug Interchangeability and Dispensing Fee Act.
2. Limit the percentage of private label products that a wholesaler and/or pharmacy affiliated with the private label company, can purchase and sell.
The second regulatory initiative described above may require amendments to Ontario legislation. The regulatory initiative would be conditional on the passage of any such legislative amendments.
Analysis of Regulatory Impact:
A Regulatory Impact Assessment is currently underway
October 29, 2018
Comments Due Date:
November 27, 2018
Ministry of Health & Long-Term Care
Drugs and Devices Division
5700 Yonge St., 3rd Floor
Toronto ON M2M 4K5