Ontario Drug Benefit Act, R.S.O. 1990, c. O.10

JurisdictionOntario

Ontario Drug Benefit Act

R.S.O. 1990, Chapter O.10

Consolidation Period: From January 1, 2022 to the e-Laws currency date.

Last amendment: 2021, c. 25, Sched. 18.

CONTENTS

Principles

0.1 In this Act, the following principles are recognized:

1. The public drug system aims to meet the needs of Ontarians, as patients, consumers and taxpayers.

2. The public drug system aims to involve consumers and patients in a meaningful way.

3. The public drug system aims to operate transparently to the extent possible for all persons with an interest in the system, including, without being limited to, patients, health care practitioners, consumers, manufacturers, wholesalers and pharmacies.

4. The public drug system aims to consistently achieve value-for-money and ensure the best use of resources at every level of the system.

5. Funding decisions for drugs are to be made on the best clinical and economic evidence available, and will be openly communicated in as timely a manner as possible. 2006, c. 14, s. 5.

Section Amendments with date in force (d/m/y)

2006, c. 14, s. 5 - 01/10/2006

Definitions

1 (1) In this Act,

“authorized prescriber” means a physician, registered nurse in the extended class, a prescribed person or a member of a prescribed class; (prescripteur autorisé)

“designated” means designated in the Formulary by the executive officer; (“désigné”)

“drug” means a drug as defined in the Drug and Pharmacies Regulation Act, and includes,

(a) any substance designated as a listed drug product before section 16 of the Traditional Chinese Medicine Act, 2006 came into force, and

(b) any substance that was supplied under this Act by virtue of section 16 before section 16 of the Traditional Chinese Medicine Act, 2006 came into force; (“médicament”)

“executive officer” means the executive officer of the Ontario public drug programs appointed under section 1.1; (“administrateur”)

“Formulary” means the Formulary that the executive officer is required to keep, maintain and publish under section 1.2; (“Formulaire des médicaments”)

“inspector” means a person appointed under section 14; (“inspecteur”)

“interchangeable”, when describing a drug product, means a drug or combination of drugs identified by a specific product name or manufacturer and designated under the Drug Interchangeability and Dispensing Fee Act as interchangeable with one or more other such products; (“interchangeable”)

“listed drug product” means a drug or combination of drugs in a particular dosage form and strength identified by a specific product name or manufacturer and designated as a listed drug product; (“produit médicamenteux énuméré”)

“listed substance” means a substance, other than a drug, designated as a listed substance; (“substance énumérée”)

“Minister” means the Minister of Health and Long-Term Care or any other member of the Executive Council to whom the administration of this Act is assigned under the Executive Council Act; (“ministre”)

“operator of a pharmacy” means,

(a) the holder of a certificate of accreditation for the operation of a pharmacy under section 139 of the Drug and Pharmacies Regulation Act, or

(b) the operator of a pharmacy operated in or by a hospital that is a public hospital under the Public Hospitals Act; (“exploitant d’une pharmacie”)

“physician” means a member of the College of Physicians and Surgeons of Ontario; (“médecin”)

“prescribed” means prescribed in the regulations; (“prescrit”)

“prescription” means a direction from a person authorized to prescribe drugs within the scope of his or her practice of a health discipline directing the dispensing of a drug or mixture of drugs for a specified person; (“ordonnance”)

“registered nurse in the extended class” means a registered nurse who holds an extended certificate of registration under the Nursing Act, 1991; (“infirmière autorisée ou infirmier autorisé de la catégorie supérieure”)

“regulations” means the regulations made under this Act. (“règlements”) R.S.O. 1990, c. O.10, s. 1; 1996, c. 1, Sched. G, s. 2; 2006, c. 14, s. 6 (1-4); 2006, c. 19, Sched. L, s. 11 (2); 2006, c. 27, s. 17; 2017, c. 11, Sched. 4, s. 1.

No therapeutic substitution

(2) Nothing in this Act shall be construed to permit therapeutic substitution. 2006, c. 14, s. 6 (5).

Section Amendments with date in force (d/m/y)

1996, c. 1, Sched. G, s. 2 (1-5) - 27/05/1996

2006, c. 14, s. 6 (1-5) - 01/10/2006; 2006, c. 19, Sched. L, s. 11 (2) - 22/06/2006; 2006, c. 27, s. 17 - 20/12/2006

2007, c. 10, Sched. L, s. 31 - 04/06/2007

2017, c. 11, Sched. 4, s. 1 - 01/07/2017

Executive officer

1.1 (1) The Lieutenant Governor in Council shall appoint an executive officer for the Ontario public drug programs. 2006, c. 14, s. 7.

Functions and powers

(2) Subject to this Act and the regulations, it is the function of the executive officer, and he or she has the power, to perform any functions or duties that he or she may have under this Act and the regulations, under the Drug Interchangeability and Dispensing Fee Act and its regulations and under any other Act or regulation, and without in any way restricting the generality of the foregoing,

(a) to administer the Ontario public drug programs;

(b) to keep, maintain and publish the Formulary;

(c) to make this Act apply in respect of the supplying of drugs that are not listed drug products as provided for in section 16;

(d) to designate products as listed drug products, listed substances and designated pharmaceutical products for the purposes of this Act, and to remove or modify those designations;

(e) to designate products as interchangeable with other products under the Drug Interchangeability and Dispensing Fee Act, and to remove or modify those designations;

(f) to negotiate agreements with manufacturers of drug products, agree with manufacturers as to the drug benefit price of listed drug products, negotiate drug benefit prices for listed substances with suppliers, and set drug benefit prices for designated pharmaceutical products;

(g) to require any information that may or must be provided to the executive officer under this Act or the regulations or any other Act or regulation to be in a format that is satisfactory to the executive officer;

(h) to make payments under the Ontario public drug programs;

(i) to establish clinical criteria under section 23; and

(j) to pay operators of pharmacies for professional services, and to determine the amount of such payments subject to the prescribed conditions, if any. 2006, c. 14, s. 7.

(3) Repealed: 2019, c. 14, Sched. 11, s. 1.

Transitional

(4) An agreement concerning the Ontario drug programs to which the Minister was a party and that was in effect immediately before October 1, 2006 continues in force, with the executive officer substituted for the Minister, until it is terminated under its terms. 2006, c. 14, s. 7.

Review process

(5) The Minister shall establish a process to review,

(a) recommendations made to the executive officer in respect of his or her functions under clause (2) (d) concerning the designation of products as listed drug products; and

(b) decisions made by the executive officer not to designate a product as a listed drug product under clause (2) (d) where a recommendation to designate has been made by a body that advises the executive officer. 2006, c. 14, s. 7.

Publication

(6) The Minister shall publish the details of the process established under subsection (5) on the website of the Ministry and in any other format the Minister considers advisable. 2006, c. 14, s. 7.

Non-application of SPPA

(7) The Statutory Powers Procedure Act does not apply to a review carried out under the process established by the Minister under subsection (5). 2006, c. 14, s. 7.

Non-application of SPPA

(8) The Statutory Powers Procedure Act does not apply to any decision or action of the executive officer under this Act. 2006, c. 14, s. 7.

Regulations

(9) The Lieutenant Governor in Council may make regulations,

(a) clarifying, modifying or restricting the functions and powers of the executive officer;

(b) providing for additional functions and powers of the executive officer. 2006, c. 14, s. 7.

Section Amendments with date in force (d/m/y)

2006, c. 14, s. 7 - 01/10/2006

2019, c. 14, Sched. 11, s. 1 - 01/04/2016

Formulary

1.2 (1) The executive officer shall keep, maintain and publish a Formulary. 2006, c. 14, s. 7.

Contents

(2) The Formulary shall set out,

(a) the listed drug products and listed substances for the purposes of this Act;

(b) the drug benefit price for listed drug products, listed substances and designated pharmaceutical products;

(c) the products that are designated as interchangeable for the purposes of the Drug Interchangeability and Dispensing Fee Act; and

(d) any other information required under this or any other Act. 2006, c. 14, s. 7.

Other information

(3) In addition to anything mentioned in subsection (2), the Formulary may set out any other information or material the executive officer considers necessary or advisable. 2006, c. 14, s. 7.

Publication

(4) The executive officer shall publish the Formulary on the website of the Ministry and may publish it in any other format the executive officer considers advisable. 2006, c. 14, s. 7.

Where conflict

(5) In the event of a conflict between what is posted on the Ministry’s website under subsection (4) and what is posted in another format, the Ministry’s website prevails. 2006, c. 14, s. 7.

Section Amendments with date in force (d/m/y)

2006, c. 14, s. 7 - 01/10/2006

Listing

1.3 (1) A drug product becomes a listed drug product on the effective date of its being designated in the Formulary as a listed drug product, and ceases to be a listed drug product on the effective date of that designation being removed. 2006, c. 14, s. 7.

Requirements for listing

(2) The executive officer may designate a drug product in the Formulary as a listed...

To continue reading

Request your trial

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT