Pangaea Express: Proposed Amendments to Private Label Products in Ontario
On October 29, 2018, the Ministry of Health and Long-Term Care, Drugs and Devices Division announced proposed amendments for the dispensing of private label drug products in Ontario.
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.
Ontario is the only jurisdiction with legislated restrictions on private label generics so these proposed amendments would bring Ontario in line with other provinces and territories in Canada.
The Ministry is also proposing two regulatory initiatives along with these amendments to the Ontario Drug Benefit Act (ODBA) and the Drug Interchangeability and Dispensing Fee Act (DIDFA):
- A condition requiring private label products 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.
- Limit the percentage of private label products that a wholesaler and/or pharmacy affiliated with the private label company, can purchase and sell.
The Ministry is seeking feedback on these initiatives and invite written comments before November 27, 2018.
This first condition will be a significant win for generic drug manufacturers already set up in the province. The definition of “fabricated” may need to be spelled out further - i.e. what proportion of the manufacturing process will need to be carried out in Ontario?
The second initiative is similar to regulations in Quebec, with Bill 148, that stipulates pharmacies can not purchase more than 50% of their generic drugs from one manufacturer – though in Ontario, the limit of private label products has not been identified.
For more information or questions, please contact Marla Weingarten.