Proposal to Amend Ontario Regulation 201/96 under the Ontario Drug Benefit Act and Regulation 935 under the Drug Interchangeability and Dispensing Fee Act

The Ministry of Health and Long-Term Care is proposing to reform the Ontario Drug Benefit (ODB) program in order to make it more efficient, effective and sustainable.

Proposed amendments to the Ontario Regulation 201/96 made under the Ontario Drug Benefit Act would take effect on October 1, 2015 and include the following:

• Reduce the mark-up percentage from 8% to 6% for drug costs greater than or equal to $1000 per claim.
• Reduce dispensing fees paid to pharmacies for supplying listed drug products to long-term care home residents by $1.26.
• Establish a limit on the number of dispensing fees to allow for a maximum of 5 dispensing fees billed per year per patient per chronic therapy drug.
• Require patients to try more than one generic before the brand product is reimbursed by the ministry as a “no substitution” claim.

Proposed amendments to section 6 of Regulation 935 made under the Drug Interchangeability and Dispensing Fee Act include the following:

• With respect to aqueous solutions that are currently exempt from the in vivo bioequivalence study requirement in section 6(1)(h) of the Regulation, remove the requirement that the aqueous solutions must be the “same volume” as the original product, and replace it with a requirement that the aqueous solution be the “same strength” as the original product.
• Exempt dermatological products from the in vivo bioequivalence study requirement in section 6(1)(h).
• Exempt products with a transdermal route of administration for systemic effect from the in vivo bioequivalence study requirement in clause 6(1)(h).

For more details, please see the Notice from the Executive Officer, dated July 23, 2015:
http://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/eo_communiq.aspx

Please visit the following website for a copy of the draft regulations that propose to amend Ontario Regulation 201/96 and Regulation 935:
http://www.ontariocanada.com/registry/view.do?postingId=19202&language=en

Interested parties can provide written comments on the proposed changes to the regulations to be received on or before August 24, 2015 at 5:00 p.m. EST.

Please submit your written comments to:

Executive Officer, Ontario Public Drug Programs
Ministry of Health and Long-Term Care
80 Grosvenor Street, 9th Floor
Hepburn Block, Queen’s Park
Toronto ON
M7A 1R3
Fax: 416-325-6647
E-mail: PublicDrugPrgrms.moh@ontario.ca