O. Reg. 115/15: GENERAL

Link to law: http://www.ontario.ca/laws/regulation/r15115
Published: 2015-05-15

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ontario regulation 115/15

made under the

Ontario Drug Benefit Act

Made: May 13, 2015
Filed: May 15, 2015
Published on e-Laws: May 15, 2015
Printed in The Ontario Gazette: May 30, 2015


Amending O. Reg. 201/96

(GENERAL)

1. (1) Subsection 11 (1) of Ontario Regulation 201/96 is amended by striking out “section 12” in the portion before paragraph 1 and substituting “section 6 of Regulation 935 of the Revised Regulations of Ontario, 1990 (General) made under that Act”.

(2) Paragraph 1 of subsection 11 (1) of the Regulation is amended by striking out “clause 12 (1) (d)” in the portion before subparagraph i and substituting “clause 6 (1) (d) of Regulation 935 of the Revised Regulations of Ontario, 1990”.

(3) Subparagraph 1 i of subsection 11 (1) of the Regulation is revoked and the following substituted:

i. less than or equal to 25 per cent of the drug benefit price of the original product as set out in the Formulary,

A. on the date the product is first proposed for designation as a listed drug product, if no more than two products have already been designated as interchangeable with the original product, or

B. on the date when the third product became designated as interchangeable with the original product, if three or more products have already been designated as interchangeable with the original product, or

(4) Paragraph 2 of subsection 11 (1) of the Regulation is revoked and the following substituted:

2. If the original product was but is no longer a listed drug product, the drug benefit price of the product proposed to the executive officer under clause 6 (1) (d) of Regulation 935 of the Revised Regulations of Ontario, 1990 must be less than or equal to 25 per cent of the highest drug benefit price of the original product that was set out in the Formulary before its removal.

(5) Subsections 11 (3) and (4) of the Regulation are revoked and the following substituted:

(3) Where the circumstances described in subsection (2) exist, but subject to subsections (3.1), (3.2) and (3.3), the drug benefit price of the product proposed to the executive officer must be,

(a) less than or equal to 75 per cent of the drug benefit price of the original product as set out in the Formulary on the date the product is first proposed for designation as a listed drug product;

(b) if the drug benefit price of the original product has been reduced by more than 20 per cent in the 24-month period before the date on which the product is proposed for designation as a listed drug product, less than or equal to 75 per cent of the drug benefit price of the original product as set out in the Formulary immediately before the drug benefit price of the original product was first reduced; or

(c) if the original product was but is no longer a listed drug product, less than or equal to 75 per cent of the highest drug benefit price of the original product that was set out in the Formulary before its removal.

(3.1) Where the circumstances described in subsection (2) exist and there is evidence satisfactory to the executive officer that there is another product listed, sold or available for sale that is interchangeable with the original product outside Ontario but within Canada, the references to “75 per cent” in subsection (3) shall be read as “50 per cent”.

(3.2) The references to “75 per cent” in subsection (3) shall be read as “85 per cent” where the circumstances described in subsection (2) exist and no agreement exists respecting the payment of a volume discount or other amount by the manufacturer in respect of the original product either,

(a) between the executive officer and the manufacturer of the relevant original product; or

(b) between the government or other appropriate authority in any province or territory outside Ontario but within Canada and the manufacturer of the relevant original product.

(3.3) The exceptions set out in subsections (2), (3), (3.1) and (3.2) do not apply where there is evidence satisfactory to the executive officer that there are two or more other products listed, sold or available for sale that are interchangeable with the original product outside Ontario but within Canada, in addition to the product proposed to be designated as interchangeable with the original product in Ontario and, for greater certainty, in those circumstances, the provisions of paragraphs 1 and 2 of subsection (1) apply.

(4) Paragraphs 1 and 2 of subsection (1) do not apply where, after designation of the proposed product, there would be only two drug products designated as interchangeable with an original drug product.

(4.1) Where the circumstances described in subsection (4) exist, but subject to subsection (4.2), the drug benefit price of a product proposed to the executive officer must be,

(a) less than or equal to 50 per cent of the drug benefit price of the original product as set out in the Formulary on the date the product is first proposed for designation as a listed drug product;

(b) if the drug benefit price of the original product has been reduced by more than 20 per cent in the 24-month period before the date on which the product is proposed for designation as a listed drug product, less than or equal to 50 per cent of the drug benefit price of the original product as set out in the Formulary immediately before the drug benefit price of the original product was first reduced; or

(c) if the original product was but is no longer a listed drug product, less than or equal to 50 per cent of the highest drug benefit price of the original product that was set out in the Formulary before its removal.

(4.2) The exceptions set out in subsections (4) and (4.1) do not apply where there is evidence satisfactory to the executive officer that there is another product listed, sold or available for sale that is interchangeable with the original product outside Ontario but within Canada, in addition to the two that are or are proposed to be designated as interchangeable with the original product in Ontario and, for greater certainty, in those circumstances, the provisions of paragraphs 1 and 2 of subsection (1) apply.

(4.3) For greater certainty, nothing in this section shall be interpreted as limiting the authority of the executive officer to maintain an agreement described in subsection 12 (7) or paragraph 7 of subsection 12.1 (1) with the manufacturer of an original product.

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

5. Subject to paragraphs 6.1 to 6.8, 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.

(2) Paragraph 6.1 of subsection 12.1 (1) of the Regulation is revoked and the following substituted:

6.1 Paragraph 5 does not apply with respect to a product that was designated as interchangeable with an original product on or before March 31, 2013, where there is evidence satisfactory to the executive officer that,

i. the product is the only drug product of its type that is designated as interchangeable with an original drug product, and has been so designated for at least two years, and

ii. removing the product’s listing would result in significant patient safety or access concerns, or significant increased costs to the Government of Ontario.

(3) Subsection 12.1 (1) of the Regulation is amended by adding the following paragraphs:

6.3 If the circumstances described in subsections 11 (2) and (3.2) existed at the time the drug product was submitted for designation, but the executive officer, or in the case of a province or territory outside Ontario but within Canada, the government or other appropriate authority of the province or territory, has since entered into an agreement with the manufacturer of the relevant original product respecting the payment of a volume discount or other amount by the manufacturer in respect of the original product, then on and from the effective date of that agreement, the drug benefit price of the product may not be more than 75 per cent of that of the original product upon which its drug benefit price is based, as of the date when the product was first proposed for designation as interchangeable.

6.4 If the circumstances described in subsection 11 (2) existed at the time the drug product was submitted for designation, but the drug product ceases to be the only drug product of its type that has been designated as interchangeable with an original drug product in Ontario or another product becomes interchangeable with the original product outside Ontario but within Canada, then on and from the date that the ceasing or becoming interchangeable occurs, the drug benefit price of the product may not be more than 50 per cent of that of the original product upon which its drug benefit price is based, as of,

i. in the case of a product that ceases to be the only drug product of its type that has been designated as interchangeable with an original drug product in Ontario, the date of the ceasing, or

ii. in the case where another product becomes interchangeable with the original product outside Ontario but within Canada, the date when the product was first proposed for designation as interchangeable.

6.5 If the circumstances described in subsection 11 (4) existed at the time the drug product was submitted for designation, but more than two drug products of its type become designated as interchangeable with an original drug product in Ontario or another product becomes interchangeable with the original product outside Ontario but within Canada, then on and from the relevant date, the drug benefit price of the product may not be more than,

i. 25 per cent of that of the original product upon which its drug benefit price is based, as of the date when the third drug product of the type became designated as interchangeable or 35 per cent in the case of a product that is not a solid dosage form, in the case where more than two drug products of its type become designated as interchangeable with an original drug product in Ontario, or

ii. 25 per cent of that of the original product upon which its drug benefit price is based, as of the date when the product was first proposed for designation as interchangeable or 35 per cent in the case of a product that is not a solid dosage form, in the case where another product becomes interchangeable with the original product outside Ontario but within Canada.

6.6 Paragraphs 6.3 to 6.5 do not apply where the circumstances described in paragraph 6.2 exist.

6.7 Subject to paragraph 6.2, and for greater certainty, if at any time three or more drug products are designated as interchangeable with an original product under the Drug Interchangeability and Dispensing Fee Act or are otherwise available interchangeably with the original product within Canada, then from the time the third product becomes or is designated as interchangeable, none of the price exceptions in this subsection shall apply with respect to any of the drug products listed in Ontario, and the drug benefit price from that time shall be no higher than,

i. 25 per cent of that of the original product, as of the date when the third drug product of the type became designated as interchangeable or 35 per cent in the case of a product that is not a solid dosage form, in the case where three or more drug products are designated as interchangeable with an original product under the Drug Interchangeability and Dispensing Fee Act,

ii. 25 per cent of that of the original product, as of the date when the second drug product of the type became designated as interchangeable or 35 per cent in the case of a product that is not a solid dosage form, in the case where two drug products are designated as interchangeable with an original product under the Drug Interchangeability and Dispensing Fee Act, and one or more other products become interchangeable with the original product outside of Ontario but within Canada, or

iii. 25 per cent of that of the original product, as of the date when the product was first proposed for designation as interchangeable, or 35 per cent in the case of a product that is not a solid dosage form in the case where the product is the only product of its type designated as interchangeable with the original product under the Drug Interchangeability and Dispensing Fee Act, and two or more other products become interchangeable with the original product outside Ontario but within Canada.

6.8 Paragraphs 6.3 to 6.7 apply to a product designated as interchangeable on or after April 1, 2013.

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

(4) Despite anything else in this section, if the circumstances described in subsection 11 (2) existed at the time the drug product was submitted for designation and 120 days before the second anniversary of the designation, paragraph 6.4 of subsection (1) does not apply, then the executive officer may, in the executive officer’s sole discretion, review the drug benefit price of the product and agree to continue to list the product at the price at which it was designated or propose a lower drug benefit price.

(5) If the executive officer commences a review of the drug benefit price of a product under subsection (4), then it is a condition of continuing to be designated as a listed drug product that the manufacturer of the product, within a reasonable time period specified by the executive officer, provide the executive officer with any information that the executive officer considers necessary for reviewing the drug benefit price of the product, including, but without being limited to,

(a) raw material costs;

(b) manufacturing costs;

(c) cost of goods sold;

(d) the price of the product in comparable jurisdictions outside of Canada; and

(e) specialized labour costs or unique market conditions that might result in significant patient safety or access concerns or significant cost increases to the Government of Ontario if the product is not continued to be listed at the same drug benefit price.

(6) The executive officer shall remove the designation of the product if, following the executive officer’s review of the drug benefit price of the product under subsection (4), the executive officer and the manufacturer cannot agree on a price within 60 days of the executive officer receiving all of the information mentioned in subsection (5) that the executive officer considers necessary to make the decision.

(7) Subsections (4), (5) and (6) apply to a product designated as interchangeable on or after April 1, 2013.

(8) For the purposes of this section, in determining the price of an original product as of the applicable date, the executive officer may make the adjustments set out in subsection (9) in determining the price of the original product in the case of an interchangeable product, where,

(a) the original product has not been a listed drug product or has not been sold in Ontario for at least 10 years; and

(b) the interchangeable product is one of no more than two listed drug products that are designated as interchangeable with the original product.

(9) The adjustments mentioned in subsection (8) are as follows:

1. Determine the highest drug benefit price at which the original product was listed.

2. Commencing in the year in which the original product ceased to be listed or sold in Ontario, add an amount to reflect the average increase in consumer prices shown in Statistics Canada’s Consumer Price Index for Ontario (All Items) for each succeeding year to,

i. a maximum of 10 years, or

ii. a number of years determined by the executive officer that exceeds 10, where the executive officer is satisfied that it is in the public interest to make such a determination.

Commencement

3. This Regulation is deemed to have come into force on April 1, 2013.