Regulation - LGIC

Proposed amendments to the effective date of changes to allow Private Label Products to be funded under the Ontario Drug Benefit (ODB) Program and Designated as Interchangeable Products on the ODB Formulary

Regulation Number(s):
Ontario Regulation 201/96 (under ODBA)
Regulation 935 (under DIDFA)
Bill or Act:
Ontario Drug Benefit Act (ODBA), Drug Interchangeability and Dispensing Fee Act (DIDFA)
Summary of Proposal:
As part of the government's commitment to the Open for Business/Red Tape Reduction initiative in 2019, amendments were made to Ontario Regulation 201/96 under the Ontario Drug Benefit Act (ODBA) and Regulation 935 under the Drug Interchangeability and Dispensing Fee Act (DIDFA) to allow private label products (PLPs) to be designated as listed drug products under the ODBA and as interchangeable products under DIDFA (the "PLP changes"), with an effective date of July 1, 2020.

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 amending the commencement date of the approved regulatory changes for PLPs to allow PLPs to be funded through the ODB Program and designated as interchangeable products before July 1st, 2020.

The current proposal, if approved, would change the effective date of the regulatory changes for PLPs from July 1, 2020 to April 1, 2020.

Expediting the commencement date of the PLP changes would make PLPs eligible for public funding under the ODB Program sooner and make it easier for Ontario pharmacies to sell PLPs to private and cash paying clients sooner, which could help offset the potential of a shortage of certain drug products.
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 change to the effective date of the regulatory changes for PLPs from July 1, 2020 to April 1, 2020.

Since the approval of the PLP changes in 2019, the ministry has been working with PLP companies to facilitate the implementation of these regulatory amendments.
Further Information:
Proposal Number:
20-HLTC013
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