Ontario Drug Benefit Act
Loi sur le régime de médicaments de l’Ontario

ontario REGULATION 201/96

GENERAL

Consolidation Period: From March 29, 2018 to the e-Laws currency date.

Last amendment: 134/18.

Legislative History: 324/96, 336/96, 375/96, 386/96, 507/96, 508/96, 27/97, 110/97, 299/97, 83/98, 219/98, 221/98, 592/98, 612/98, 72/99, 74/99, 312/99, 332/99, 374/99, 401/99, 574/99, 588/99, 69/00, 202/00, 317/00, 324/00, 366/00, 495/00, 584/00, 16/01, 172/01, 358/01, 64/02, 214/02, 301/02, 375/02, 395/02, 88/03, 90/03, 290/03, 334/03, 338/03, 372/03, 60/04, 73/04, 184/04, 214/04, 276/04, 313/04, 318/04, 321/04, 359/04, 377/04, 7/05, 12/05, 34/05, 127/05, 156/05, 189/05, 191/05, 241/05, 334/05, 417/05, 459/05, 484/05, 489/05, 499/05, 544/05, 594/05, 645/05, 4/06, 39/06, 55/06, 80/06, 186/06, 202/06, 241/06, 355/06, 370/06, 395/06, 459/06, 556/06, 559/06, 320/07, 264/08, 355/08, 356/08, 94/09, 252/09, 104/10, 220/10, CTR 21 OC 10 - 1, 228/11, CTR 23 JL 12 - 7, 294/12, 20/13, CTR 27 MA 14 - 1, 115/15, 284/15, 93/16, 320/16, 115/17, 346/17, 347/17, 518/17, 53/18, 134/18.

This Regulation is made in English only.

CONTENTS

Sections
Definitions / 1
Eligible Persons / 2
Trillium Program / 3-8.-10
Conditions for Designation of Listed Drug Products / 11-12.0.2
Conditions to Continue to be a Designated Listed Drug Product / 12.1
Establishing Criteria / 12.2
Amounts Paid by Executive Officer / 13-17
Limits on Amounts Paid by Executive Officer / 18-20
Co-payment / 20.1-20.3
Amount Charged to Person Other Than Executive Officer / 21-22
Miscellaneous / 23-30
Table / Annual out-of-pocket expense to be exceeded to become eligible for trillium drug program (in $500 increments)
Schedule 2

Definitions

1.(1)In this Regulation,

“drug cost amount” means the quantity of a drug product multiplied by the drug benefit price of the drug product;

“extemporaneous preparation” means a drug or combination of drugs prepared or compounded in a pharmacy according to a prescription;

“Ministry” means the Ministry of Health and Long-Term Care;

“modified release dosage form” means a dosage form of a product that is formulated to control the level of the drug in the blood over a shorter or longer period of time than a conventional dosage form;

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

“spouse” means a person,

(a) to whom the person is married, or

(b) with whom the person is living in a conjugal relationship outside marriage, if the two persons,

(i) have cohabited for at least one year,

(ii) are together the parents of a child, or

(iii) have together entered into a cohabitation agreement under section 53 of the Family Law Act;

“unit” means a gram, millilitre, tablet, capsule or other appropriate unit of a listed drug product in a particular dosage form and strength. O.Reg. 201/96, s.1; O.Reg. 324/96, s.1; O.Reg. 336/96, s.1; O.Reg. 375/96, s.1; O.Reg. 508/96, s.1(1); O.Reg. 110/97, s.1; O.Reg. 299/97, s.1; O.Reg. 612/98, s.1; O.Reg. 72/99, s.1; O.Reg. 332/99, s.1; O.Reg. 401/99, s.1; O.Reg. 588/99, s. 1; O.Reg. 69/00, s.1; O.Reg. 202/00, s.1(1); O.Reg.366/00, s.1; O.Reg. 584/00, s.1; O.Reg. 16/01, s.1; O.Reg. 172/01, s.1(1); O.Reg. 358/01, s.1; O.Reg. 64/02, s.1; O.Reg. 214/02, s.1; O.Reg. 395/02, s.1; O.Reg. 88/03, s.1; O.Reg. 334/03, s.1; O.Reg. 60/04, s.1; O.Reg. 184/04, s.1; O.Reg. 321/04, s.1; O.Reg. 12/05, s.1; O.Reg. 191/05, s.1; O.Reg. 334/05, s.1; O.Reg. 484/05, s.1 (1); O.Reg. 645/05, s.1 (1); O.Reg. 55/06, s.1(1); O.Reg. 202/06, s.1; O.Reg. 459/06, s.1(1, 2); O.Reg. 320/07, s.1.

(1.1)The functions and powers of the executive officer set out in subsection 1.1 (2) of the Act include the power,

(a) to hold competitions for the purpose of selecting drug products that may be listed or continue to be listed as designated drug products on the Formulary or for any other purpose under the Act;

(b) to use the results of such competitions in exercising any of the executive officer’s powers under the Act, including designating or continuing to designate a drug product as a listed drug product under section 19 of the Act or removing such a designation under section 20 of the Act; and

(c) to enter into agreements that contain, among other things, provisions with respect to volume discounts and payments to the Minister of Finance. O.Reg. 356/08, s.1.

(1.2)The executive officer shall not, under section 16 of the Act, make the Act apply in respect of a drug that is a drug product described in subsection 12 (9) of this Regulation, unless the conditions set out in that subsection are met. O. Reg. 20/13, s. 1.

(2)For the purposes of subsection 1 (2) of the Act,

“therapeutic substitution” means the substitution of a drug that contains chemically different active ingredients that are considered to be therapeutically equivalent, without authorization from a person authorized to prescribe drugs within the scope of his or her practice of a health profession. O.Reg. 459/06, s.1(3).

(3)The executive officer may enter into agreements for the purposes of carrying out his or her functions under clause 1.1 (2) (a) of the Act. O.Reg. 459/06, s.1(3).

(4)The executive officer may, in writing, delegate his or her authority under clause 1.1 (2) (c), (f) or (g) of the Act or subsection 1 (3) of this Regulation to any person employed in the Ministry. O.Reg. 459/06, s.1(3).

(5)For greater clarity, the power of the executive officer under clause 1.1 (2) (f) of the Act to negotiate agreements includes the power to enter into such agreements that have been negotiated. O.Reg. 459/06, s.1(3).

(6)Revoked: O.Reg. 220/10, s.1(2).

(7)For the purposes of subsection 1.4 (2) of the Act,

“Association” means the Ontario Pharmacists’ Association. O.Reg. 459/06, s.1(3).

(8)For greater certainty, a benefit provided as a professional allowance before July 1, 2010 is a rebate and is not a professional allowance unless the manufacturer providing the benefit and the person receiving it report to the executive officer the amount of professional allowance paid or received in the same manner as provided in Schedule 3 of this Regulation as it read before July 1, 2010. O.Reg. 220/10, s.1(3).

(9), (10)Revoked: O.Reg. 220/10, s.1(3).

(11)For the purposes of section 11.5 of the Act, a “rebate” does not include the value of a benefit that is provided in accordance with ordinary commercial terms that meet all of the following conditions:

1. The benefit is provided in the ordinary course of business in the supply chain system of listed drug products that are designated as interchangeable under the Drug Interchangeability and Dispensing Fee Act between any of a manufacturer, a wholesaler, an operator of a pharmacy or a company that owns, operates or franchises pharmacies.

2. The value of the benefit is set out in a written agreement between any of a manufacturer, a wholesaler, an operator of a pharmacy and a company that owns, operates or franchises pharmacies.

3. The benefit relates to an ordinary commercial relationship that is any of the following:

i. A prompt payment discount.

ii. A volume discount.

iii. A distribution service fee.

4. The total value of any benefits does not exceed 10 per cent of the value of the listed drug products based on the drug benefit price in the Formulary and the number of units dispensed by a pharmacy and reimbursed under the Act.

5. A person who receives the benefit reports to the executive officer, if required by the executive officer to do so, the net selling price of the drug products representing the drug benefit price less the value of the benefits received. O.Reg. 220/10, s.1(4).

(12)For the purposes of section 11.5 of the Act, a “rebate” does not include the value of a benefit provided in accordance with ordinary commercial terms with respect to a listed drug product that is not interchangeable where the ordinary commercial terms are a discount for prompt payment. O.Reg. 220/10, s.1(4).

Eligible Persons

2.(1)Subject to subsections (2) and (3), the following classes of persons who are insured persons under the Health Insurance Act are designated as eligible classes of persons for the purposes of section 2 of the Act:

1. Persons who are receiving a professional service referred to in paragraph 1, 2, 3, 4, 5, 6, 8 or 9 of subsection 2 (7) of the Home Care and Community Services Act, 1994 that is provided or arranged by,

i. a local health integration network as defined in subsection 2 (1) of the Local Health System Integration Act, 2006, or

ii. an approved agency within the meaning of the Home Care and Community Services Act, 1994.

iii. Revoked: O. Reg. 115/17, s. 1 (2).

2. Persons who reside in homes licensed under section 5 of the Homes for Special Care Act.

3. Persons who are eligible for a pension under Part I of the Old Age Security Act (Canada).

3.1 Persons who are under 25 years of age.

4. Persons who have attained 65 years of age.

5. Residents of long-term care homes under the Long-Term Care Homes Act, 2007.

6. Persons who reside in homes that are part of the program of the Ministry known as the “Community Homes for Opportunity” program.

7. Revoked: O.Reg. 104/10, s.1(2).

O.Reg. 201/96, s.2(1); O.Reg. 252/09, s.1; O.Reg. 104/10, s.1; O. Reg. 115/17, s. 1; O. Reg. 347/17, s. 1; O. Reg. 518/17, s. 1.

(1.1)In addition to the classes listed in subsection (1), a person is prescribed as an eligible person for the purposes of section 2 of the Act if,

(a) the person is receiving basic income payments under the basic income pilot program administered by the Ministry of Community and Social Services; and

(b) immediately before receiving those payments, the person was entitled to receive drug benefits under the Ontario Works Act, 1997 or the Ontario Disability Support Program Act, 1997. O. Reg. 53/18, s. 1.

(2)A person is not a member of the class of persons referred to in paragraph 3 of subsection (1) until the first day of the month for which the person first receives payment of the pension. O.Reg. 201/96, s.2(2).

(3)A person is not a member of the class of persons referred to in paragraph 4 of subsection (1) until the latest of,

(a) the first day of the month following the month the person attains 65 years of age;

(b) the day that is five years earlier than the day the executive officer receives all the information required by the executive officer to confirm that the person has attained 65 years of age and that the person has been an insured person under the Health Insurance Act since the beginning of the five-year period; and

(c) the day the person becomes an insured person under the Health Insurance Act. O.Reg. 201/96, s.2(3); O.Reg. 459/06, s.2(1).

(4)Information received by the Minister before October 1, 2006 shall be deemed to have been received by the executive officer. O.Reg. 459/06, s.2(2).

Trillium Program

3.(0.1)In this section and in sections 4, 4.1 and 4.2,

“fiscal period” means the 12-month period that begins on August 1 of every year and ends on the following July 31;

“quarter” means, in relation to a fiscal period, a three-month period that begins on August 1, November 1, February 1 or May 1. O.Reg. 374/99, s.1(1).

(1)In addition to the classes listed in subsections 2 (1) and (1.1), persons who meet the following qualifications are designated as an eligible class of persons for the purposes of section 2 of the Act:

1. A person must be an insured person under the Health Insurance Act.

2. A person must be a member of a household unit whose members have collectively spent, in any quarter of a fiscal period, the amount determined in sections 4, 4.1 and 4.2, or more, on allowable expenses.

3. In order to become eligible, an application to become enrolled must be made to the executive officer on behalf of the person’s household unit and the executive officer must be satisfied that the members of the household unit have collectively spent the amount determined in accordance with sections 4, 4.1 and 4.2, or more, on allowable expenses in any quarter in a fiscal period. O.Reg. 201/96, s.3(1); O.Reg. 83/98, s.1(2); O.Reg. 374/99, s.1(2); O.Reg. 69/00, s.2(1, 2); O.Reg. 156/05, s.1(1); O.Reg. 459/06, s.3(1); O. Reg. 53/18, s. 2.

(2)A person becomes a member of the class of eligible persons referred to in subsection (1) after the beginning of each quarter of a fiscal period only once the members of his or her household unit have spent the amount determined under sections 4, 4.1 and 4.2 on allowable expenses and the person ceases to be a member of the class at the end of the quarter. O.Reg. 374/99, s.1(3); O.Reg. 69/00, s.2(3).

(3)Subject to subsection (3.1), an application under paragraph 3 of subsection (1) shall be made in the form provided by the executive officer and must include,

(a) receipts for allowable expenses as required by the form;

(b) information evidencing annual net income as required by the form;

(b.1) information evidencing the annual amount of income from the Universal Child Care Benefit program of the Government of Canada as required by the form;

(b.2) information evidencing the annual amount of taxable income withdrawn from Canadian Registered Disability Saving Plans as required by the form; and

(c) completion of the consents required by the form. O.Reg. 156/05, s.1(2); O.Reg. 459/06, s.3(2); O.Reg. 556/06, s.1; O.Reg. 94/09, s.1.

(3.1)Every application made under paragraph 3 of subsection (1) shall be deemed to be renewed every year, effective as of the first day of the fiscal period, unless,