Regulation - LGIC

Aligning Ontario's rules for determining brand reference prices with the national approach

Regulation Number(s):
Ontario Regulation 201/96 (under ODBA)
Bill or Act:
Ontario Drug Benefit Act (ODBA)
Summary of Proposal:
Currently, Ontario's rules for brand reference prices used to calculate the price of a generic product on the Ontario Drug Benefit (ODB) Formulary are misaligned with the rest of Canada. This misalignment has acted as a barrier to the listing of some generic drug products on the ODB Formulary.

Given the recent developments in the status of COVID-19, pharmaceutical manufacturers and retailers are experiencing an unprecedented surge in demand. They have expressed concerns to the ministry about possible disruptions in the pharmaceutical supply chain should these demand levels continue, which could lead to drug shortages.

In order to offset the possibility of drug shortages in the province, the ministry is proposing regulatory amendments to Ontario Regulation 201/96 under the ODBA to align Ontario's rules for determining brand reference prices with the national approach used by the pCPA.

The ministry is proposing an effective date of April 1, 2020 for the proposed regulatory amendments.
Analysis of Regulatory Impact:
The ministry does not anticipate incremental direct compliance costs to business under the domains of fees to government, upfront/ongoing operating costs and administrative costs, as a result of the proposed changes.

No adverse impact to Ontarians is anticipated. ODB Program recipients could have publicly funded access to a greater number of generic drugs, which would help offset any potential drug shortages due to COVID-19.
Further Information:
Proposal Number:
20-HLTC014
Posting Date:
March 30, 2020
Comments Due Date:
March 31, 2020
Contact Address:
Ministry of Health
Drugs and Devices Division
5700 Yonge St., 3rd Floor
Toronto ON M2M 4K5