O. Reg. 320/07: GENERAL, Filed July 4, 2007 under Ontario Drug Benefit Act, R.S.O. 1990, c. O.10
ontario regulation 320/07
made under the
ontario drug benefit act
Made: June 27, 2007
Filed: July 4, 2007
Published on e-Laws: July 5, 2007
Printed in The Ontario Gazette: July 21, 2007
Amending O. Reg. 201/96
(General)
1. Subsection 1 (1) of Ontario Regulation 201/96 is amended by adding the following definition:
“drug cost amount” means the quantity of a drug product multiplied by the drug benefit price of the drug product;
2. (1) Subsection 12 (1) of the Regulation is amended by adding the following clause:
(f) certification in writing that no rebate as defined in subsection 11.5 (18) of the Act has been provided to a person listed in subsection 11.5 (1) of the Act with respect to the product contrary to the Act since Health Canada approved the product for sale in Canada;
(2) Section 12 of the Regulation is amended by adding the following subsection:
(8.1) It is a condition of being listed as a listed drug product that the manufacturer must not have provided a rebate as defined in subsection 11.5 (18) of the Act to a person listed in subsection 11.5 (1) of the Act with respect to the product contrary to the Act since Health Canada approved the product for sale in Canada.
3. (1) Paragraph 5 of subsection 12.1 (1) of the Regulation is amended by striking out “6 and 6.1” and substituting “6, 6.1 and 6.2”.
(2) Paragraph 5 of subsection 12.1 (1) of the Regulation, as amended by subsection (1), is amended by striking out “6, 6.1 and 6.2” and substituting “6 and 6.1”.
(3) Subsection 12.1 (1) of the Regulation is amended by adding the following paragraph:
6.2 Paragraph 5 does not apply with respect to a product that has been designated as interchangeable with an original product where there is evidence satisfactory to the executive officer that:
i. the product was designated as a listed drug product on or before April 1, 1994,
ii. the product is one of no more than two drug products that has been designated as interchangeable with an original product and is a listed drug product,
iii. the manufacturer is unable to supply the drug product at the drug benefit price due to increased manufacturing costs, including raw material costs, but not due to professional allowances, sales and marketing expenses, or legal costs, which evidence must be supported by the certification of two officers of the manufacturer, and
iv. removing the product’s listing would result in significant patient safety or access concerns, or significant increased costs to the Government of Ontario.
(4) Paragraph 6.2 of subsection 12 (1) of the Regulation, as made by subsection (3), is revoked.
(5) Subsection 12.1 (3) of the Regulation is amended by striking out “6 or 6.1” and substituting “6, 6.1 or 6.2”.
(6) Subsection 12.1 (3) of the Regulation, as amended by subsection (5), is amended by striking out “6, 6.1 or 6.2” and substituting “6 or 6.1”.
4. (1) Paragraph 15 of subsection 25 (1) of the Regulation is amended by striking out “drug benefit price” and substituting “drug cost amount”.
(2) Paragraph 1 of subsection 25 (3) of the Regulation is amended by striking out “A calculation of the” at the beginning and substituting “The”.
(3) Paragraph 1 of subsection 25 (4) of the Regulation is amended by striking out “drug benefit price” and substituting “drug cost amount”.
(4) Paragraph 2 of subsection 25 (4) of the Regulation is revoked.
5. Subsection 28 (2) of the Regulation is amended by adding the following paragraphs:
4. The drug identification number of the listed drug product supplied.
5. The quantity of the listed drug product supplied.
6. Section 29.1 of the Regulation is revoked.
7. (1) Subject to subsection (2), this Regulation comes into force on the day it is filed.
(2) Subsections 3 (2), (4) and (6) come into force on July 12, 2007.