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ontario regulation 436/19

made under the

Ontario Drug Benefit Act

Made: December 12, 2019
Filed: December 13, 2019
Published on e-Laws: December 13, 2019
Printed in The Ontario Gazette: December 28, 2019

Amending O. Reg. 201/96

(GENERAL)

1. Subsection 1 (1) of Ontario Regulation 201/96 is amended by adding the following definitions:

“biologic drug product” means a drug derived from living organisms or their cells;

“biosimilar product” means a biologic drug product that has been approved for sale in Canada by Health Canada based on information comparing the biosimilar product to an original biologic product;

“generic line extension drug product” means a drug product with the same active ingredient or ingredients in the same or similar dosage form as an original product, but in a strength for which no original product exists;

“original biologic product” means the original source of a biologic drug product in a particular strength and dosage form;

2. (1) Subclause 12 (1) (a) (i) of the Regulation is amended by striking out “a copy of the product’s drug notification form issued by Health Canada”.

(2) Section 12 of the Regulation is amended by adding the following subsection:

(2.2) Clauses (1) (h) and (i) do not apply to the manufacturer of a biosimilar product if the executive officer is satisfied that the product is safe, therapeutically effective or efficacious, and appropriate for public funding, having regard to,

(a) its approval for sale in Canada by Health Canada;

(b) the availability or funding of other drug products that treat the same or similar indications, including the original biologic product; and

(c) any other information available to the executive officer.

(3) Subsection 12 (5.1) of the Regulation is revoked and the following substituted:

(5.1) Clauses (1) (h) and (i) do not apply to a generic line extension drug product if the executive officer is satisfied that the product is safe, therapeutically effective or efficacious, and appropriate for public funding, having regard to,

(a) its approval for sale in Canada by Health Canada; and

(b) any other information available to the executive officer.

(4) Section 12 of the Regulation is amended by adding the following subsection:

(5.2) A manufacturer is exempt from complying with clauses 1 (a), (e), (h) and (i) where the executive officer is satisfied that,

(a) there is a shortage of a listed drug product, or a drug to which the executive officer has made the Act apply under section 16 of the Act, with the same or similar active ingredients or therapeutic use as the drug product; and

(b) the exemption is in the public interest having regard to the urgency of the situation, significant patient safety or access concerns and the cost impact to the Government of Ontario, as well as to the safety and therapeutic effectiveness or efficacy of the drug product.

3. (1) Paragraph 5 of subsection 12.1 (1) of the Regulation is revoked and the following substituted:

5. Subject to paragraphs 6.1 to 6.5, if the product has been designated as interchangeable under the Drug Interchangeability and Dispensing Fee Act the drug benefit price of the product may not be more than the price that could be proposed to the executive officer under section 11 if a proposal was being made with respect to the drug product for the first time.

(2) Paragraphs 6.3 to 6.8 of subsection 12.1 (1) of the Regulation are revoked and the following substituted:

6.3 In the case of a drug product that was designated as interchangeable under the Drug Interchangeability and Dispensing Fee Act before April 1, 2013, the drug benefit price of the product may not be more than the price that could have been proposed to the executive officer under section 11 as it read on March 31, 2013.

6.4 Despite paragraph 6.3, paragraph 5 applies to a drug product that was designated as interchangeable under the Drug Interchangeability and Dispensing Fee Act before April 1, 2013 if, on or after April 1, 2018,

i. another product is designated as interchangeable with the original product, or another product becomes interchangeable with the original product outside Ontario but within Canada, or

ii. another product that was designated as interchangeable with the original product or another product that was interchangeable with the original product outside Ontario but within Canada is removed from the market.

6.5 When applying paragraph 5, the executive officer may adjust the drug benefit price of the original product upon which the drug benefit price of the interchangeable product is based, having regard to the price of the original product in other provinces and territories and to the historical drug benefit price of the original product on the Formulary or a price that was agreed to by the executive officer and the manufacturer under section 15. However, in doing so, the executive officer shall not change the actual drug benefit price of the original product on the Formulary.

(3) Subsections 12.1 (4) to (7) of the Regulation are revoked.

(4) Section 12.1 of the Regulation is amended by adding the following subsection:

(10) Paragraphs 2 and 3 of subsection (1) do not apply with respect to a drug product or drug that is the subject of an exemption under subsection 12 (5.2).

4. The definition of “Manual” in subsection 23 (1) of the Regulation is revoked and the following substituted:

“Manual” means the Ontario Drug Programs Reference Manual dated November 27, 2019, available on a website of the Ontario government, as amended from time to time.

5. Paragraph 2 of subsection 24 (2) of the Regulation is amended by striking out “seven days” and substituting “90 days”.

Commencement

6. (1) Subject to subsections (2) to (5), this Regulation comes into force on the day it is filed.

(2) Subsections 3 (1) and (2) shall be deemed to have come into force on April 1, 2018.

(3) Subsections 2 (4) and 3 (4) shall be deemed to have come into force on November 1, 2019.

(4) Section 1, subsections 2 (1), (2) and (3) and 3 (3) and section 4 come into force on the later of January 1, 2020 and the day this Regulation is filed.

(5) Section 5 comes into force on the later of April 1, 2020 and the day this Regulation is filed.