O. Reg. 321/07: GENERAL

 

ontario regulation 321/07

made under the

drug interchangeability and dispensing fee 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 Reg. 935 of R.R.O. 1990

(General)

1. (1) Subsection 6 (1) of Regulation 935 of the Revised Regulations of Ontario, 1990 is amended by adding the following clause:

(f) certification in writing that no rebate as defined in subsection 12.1 (14) of the Act has been provided to a person listed in subsection 12.1 (1) of the Act with respect to the product contrary to the Act since Health Canada approved the product for sale in Canada;

(2) Subsection 6 (5.1) of the Regulation is amended by adding “on or after February 15, 2005” after “Health Canada”.

2. (1) Paragraph 4 of subsection 8 (1) of the Regulation is amended by striking out “5 and 5.1” and substituting “5, 5.1 and 5.2”.

(2) Paragraph 4 of subsection 8 (1) of the Regulation, as amended by subsection (1), is amended by striking out “5, 5.1 and 5.2” and substituting “5 and 5.1”.

(3) Subsection 8 (1) of the Regulation is amended by adding the following paragraphs:

5.2 Paragraph 4 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 under the Ontario Drug Benefit Act 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.

. . . . .

8. The manufacturer must not have provided a rebate as defined in subsection 12.1 (14) of the Act to a person listed in subsection 12.1 (1) of the Act with respect to the product contrary to the Act since Health Canada approved the product for sale in Canada.

(4) Paragraph 5.2 of subsection 8 (1) of the Regulation, as made by subsection (3), is revoked.

(5) Subsection 8 (3) of the Regulation is amended by striking out “5 or 5.1” and substituting “5, 5.1 or 5.2”.

(6) Subsection 8 (3) of the Regulation, as amended by subsection (5), is amended by striking out “5, 5.1 or 5.2” and substituting “5 or 5.1”.

3. (1) Subject to subsection (2), this Regulation comes into force on the day it is filed.

(2) Subsections 2 (2), (4) and (6) come into force on July 12, 2007.