ontario regulation 355/08

made under the

ontario drug benefit act

Made: October 15, 2008
Filed: October 16, 2008
Published on e-Laws: October 20, 2008
Printed in The Ontario Gazette: November 1, 2008


Amending O. Reg. 201/96

(General)

1. (1) Paragraph 2 of subsection 11 (1) of Ontario Regulation 201/96 is amended by striking out “if the product is an original product that was but is no longer a listed drug product” and substituting “if the original product was but is no longer a listed drug product”.

(2) Section 11 of the Regulation is amended by adding the following subsection:

(5) Upon the application of the manufacturer, the executive officer may re-designate a drug product that was designated on the Formulary before December 31, 2007, and whose designation was removed by either of the amendments to the Formulary known as Update 8 to Edition 40, effective January 15, 2008, or Update 8A to Edition 40, effective January 17, 2008, subject to the following:

1. The submission requirements set out in subsection 12 (1) shall be deemed to have been met with respect to the product.

2. The conditions for continued listing set out in section 12.1 must be met with respect to the product.

3. The criteria established by the executive officer under section 12.2 must be met with respect to the product.

2. Subsection 12 (6) of the Regulation is amended by striking out “that is designated” and substituting “that is proposed to be designated”.

3. (1) Paragraph 5 of subsection 12.1 (1) of the Regulation is amended by striking out “paragraphs 6 and 6.1” and substituting “paragraphs 6, 6.1 and 6.2”.

(2) Paragraph 6 of subsection 12.1 (1) of the Regulation is amended by adding at the end “This paragraph applies only with respect to the version of the Formulary known as Edition No. 39, published on October 23, 2006”.

(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 the manufacturer of the interchangeable product has submitted evidence satisfactory to the executive officer of substantial raw material cost increases, and the executive officer is satisfied that the criteria established under section 12.2 have been met establishing that it is in the public interest that the interchangeable product be listed at a higher drug benefit price, but in no case may the interchangeable product be priced higher than the original product.

(4) Subsection 12.1 (3) of the Regulation is amended by striking out “paragraph 6 or 6.1” and substituting “paragraph 6, 6.1 or 6.2”.

4. The Regulation is amended by adding the following section:

Establishing Criteria

12.2 Pursuant to subsection 1.1 (9) of the Act, it is provided that,

(a) the executive officer has the power to establish criteria that must be met for the purposes of paragraph 6.2 of subsection 12.1 (1) in order to establish that it is in the public interest to list a drug product at a higher drug benefit price; and

(b) the executive officer shall publish those criteria on the Ministry website.

5. This Regulation comes into force on the day it is filed.