Regulation - LGIC
Proposed regulatory amendments under the Ontario Drug Benefit Act and the Drug Interchangeability and Dispensing Fee Act to modernize submission requirements for manufacturers of "well-established drugs"
Regulation Number(s):
O.Reg. 201/96, ODBA
Reg. 935, DIDFA
Reg. 935, DIDFA
Instrument Type:
Regulation - LGIC
Bill or Act:
Ontario Drug Benefit Acct
Summary of Proposal:
The Ministry is proposing regulatory amendments under the Ontario Drug Benefit Act (ODBA) and the Drug Interchangeability and Dispensing Fee Act (DIDFA) to modernize submission requirements for manufacturers of well-established brand and generic drugs.
Well-established drug products are those containing substances that have been sold in Canada for sufficient time and in sufficient quantity to establish their safety and effectiveness. Ontario's current submission requirements for manufacturers are not fully aligned with Health Canada's requirements for approving well-established drugs for sale in Canada. As a result, Ontario's requirements may prevent well-established drugs from being publicly funded under the Ontario Drug Benefit (ODB) program or designated as interchangeable in Ontario.
The proposed regulatory amendments would remove these barriers and further align Ontario's submission requirements with Health Canada's requirements for well-established drugs. The proposal would improve Ontarians' access to publicly funded drugs under the ODB program and lower cost generic drugs. Timely patient access to drugs will positively impact Ontarians, reducing the burden of illness and overall health care utilization.
Well-established drug products are those containing substances that have been sold in Canada for sufficient time and in sufficient quantity to establish their safety and effectiveness. Ontario's current submission requirements for manufacturers are not fully aligned with Health Canada's requirements for approving well-established drugs for sale in Canada. As a result, Ontario's requirements may prevent well-established drugs from being publicly funded under the Ontario Drug Benefit (ODB) program or designated as interchangeable in Ontario.
The proposed regulatory amendments would remove these barriers and further align Ontario's submission requirements with Health Canada's requirements for well-established drugs. The proposal would improve Ontarians' access to publicly funded drugs under the ODB program and lower cost generic drugs. Timely patient access to drugs will positively impact Ontarians, reducing the burden of illness and overall health care utilization.
Analysis of Regulatory Impact:
"Well-established drugs" are drug products containing substances that have been sold in Canada for sufficient time and in sufficient quantity to establish their safety and effectiveness.
Health Canada decides whether a drug product can be sold in Canada. Once a manufacturer receives Health Canada approval, the manufacturer's drug product may be sold in Canada.
In Ontario, manufacturers of brand and generic drugs must make submissions in order to have their drug products funded under the Ontario Drug Benefit (ODB) program. In the case of generic drug products, the submissions are also used to designate generic products as interchangeable with brand drug products. Once a generic product is designated as interchangeable with a brand product, it may be substituted for a brand product by Ontario pharmacies, unless the prescription directs otherwise.
Ontario's current submission requirements for manufacturers do not fully align with Health Canada's requirements for approving the sale of well-established drugs. This misalignment may pose a barrier for manufacturers seeking to have their well-established drugs funded under the ODB program or designated as interchangeable.
The proposal would also improve Ontarian's access to publicly funded drugs under the ODB program and lower cost generic drugs. Timely patient access to drugs will positively impact Ontarians, reducing the burden of illness and overall health care utilization.
There are no anticipated direct compliance costs, upfront or ongoing capital/operating costs to businesses, or fees that would occur as a result of the proposed regulatory amendments.
Health Canada decides whether a drug product can be sold in Canada. Once a manufacturer receives Health Canada approval, the manufacturer's drug product may be sold in Canada.
In Ontario, manufacturers of brand and generic drugs must make submissions in order to have their drug products funded under the Ontario Drug Benefit (ODB) program. In the case of generic drug products, the submissions are also used to designate generic products as interchangeable with brand drug products. Once a generic product is designated as interchangeable with a brand product, it may be substituted for a brand product by Ontario pharmacies, unless the prescription directs otherwise.
Ontario's current submission requirements for manufacturers do not fully align with Health Canada's requirements for approving the sale of well-established drugs. This misalignment may pose a barrier for manufacturers seeking to have their well-established drugs funded under the ODB program or designated as interchangeable.
The proposal would also improve Ontarian's access to publicly funded drugs under the ODB program and lower cost generic drugs. Timely patient access to drugs will positively impact Ontarians, reducing the burden of illness and overall health care utilization.
There are no anticipated direct compliance costs, upfront or ongoing capital/operating costs to businesses, or fees that would occur as a result of the proposed regulatory amendments.
Further Information:
Draft Regulation: O.Reg. 201/96, ODB Act
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Draft Regulation: Reg. 935, DIDFA
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Proposal Number:
23-HLTC056
Posting Date:
October 19, 2023
Comments Due Date:
December 3, 2023
Contact Address:
Drug Programs Policy and Strategy Branch
Health Programs and Delivery Division
Ministry of Health
5700 Yonge St., 3rd Floor,
Toronto ON, M2M 4K5
Email: DrugSubmissions.MOH@ontario.ca
Health Programs and Delivery Division
Ministry of Health
5700 Yonge St., 3rd Floor,
Toronto ON, M2M 4K5
Email: DrugSubmissions.MOH@ontario.ca