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Ontario Drug Benefit Act

R.S.O. 1990, CHAPTER O.10

Historical version for the period May 20, 2004 to June 16, 2004.

Amended by: 1996, c. 1, Sched. G, ss. 1-18; 1997, c. 25, Sched. E, s. 9; 2002, c. 18, Sched. I, s. 18; 2004, c. 3, Sched. A, s. 95.

CONTENTS

1.

Definitions

2.

Eligible persons

3.

Application of this Act

4.

Billing restricted

5.

Payment of claim of operator

6.

Amount Minister to pay

8.

Unlisted drugs, special case

9.

Agreement re listed substance

10.

Refusal to dispense prohibited

11.

Opting out

11.1

Order suspending operator’s right to payment

11.2

Order suspending physician’s right to payment

11.3

Claim from eligible person

12.

Minister to consult

13.

Collection of personal information

14.

Inspectors

15.

Offence

16.

Conditions for listing

17.

Pharmaceutical products

18.

Regulations

19.

Decisions about listing, delisting

20.

Delisting

21.

Advisors

22.

Drug benefit price

23.

Conditions of payment

Definitions

1. In this Act,

“designated” means designated by the regulations; (“désigné”)

drug” means a drug as defined in subsection 117 (1) of the Drug and Pharmacies Regulation Act; (“médicament”)

“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; (“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”)

“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”)

“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.

Eligible persons

2. (1) A person who is a member of a designated class of persons is an eligible person. R.S.O. 1990, c. O.10, s. 2 (1).

Persons deemed eligible persons

(2) This Act applies to persons entitled to receive drug benefits under the Family Benefits Act, the Ontario Disability Support Program Act, 1997 and the Ontario Works Act, 1997 as if those persons were eligible persons. 1997, c. 25, Sched. E, s. 9.

Application of this Act

3. This Act applies in respect of the supplying of listed drug products for eligible persons unless that supplying is an insured service as defined in the Health Insurance Act. R.S.O. 1990, c. O.10, s. 3; 1996, c. 1, Sched. G, s. 3.

Billing restricted

4. (1) No operator of a pharmacy shall charge, or accept payment from, a person other than the Minister in respect of supplying a listed drug product for an eligible person pursuant to a prescription except as provided under this Act.

Same

(2) No physician shall charge, or accept payment from, a person other than the Minister in respect of supplying a listed drug product for an eligible person except as provided under this Act.

Billing permitted, co-payment

(3) An operator of a pharmacy may charge, or accept payment from, a person in respect of supplying a listed drug product in an amount not greater than the maximum co-payment the Minister is permitted to subtract under subsection 6 (1).

Exception

(4) If the operator of a pharmacy dispenses a listed drug product that is interchangeable with other listed drug products and the particular drug product is dispensed because it is specifically requested by the eligible person or by the person presenting the prescription or because the prescription directs that there be no substitutions, subsections 6 (3) and (4) do not apply and the operator of the pharmacy may charge, or accept payment from, a person other than the Minister, in addition to other amounts authorized under this Act, in an amount not exceeding the amount determined under subsection (5).

Same

(5) The amount referred to in subsection (4) shall be determined as follows:

1. Add the drug benefit price of the drug product dispensed and the mark-up referred to in paragraph 3 of subsection 6 (1).

2. Add the drug benefit price determined under paragraph 2 of subsection 6 (1) and the mark-up referred to in paragraph 3 of that subsection.

3. Determine the difference between the amount determined under paragraph 1 and the amount determined under paragraph 2.

4. If the acquisition cost, for the operator of the pharmacy, of the drug product dispensed is greater than the sum of the drug benefit price for that product and the mark-up referred to in paragraph 3 of subsection 6 (1), determine the amount by which they differ.

5. The amount referred to in subsection (4) is the sum of the amount determined under paragraph 3 and the amount determined under paragraph 4.

Non-application

(6) Subsections (4) and (5) do not apply to the operator of a pharmacy who supplies a listed drug product for an eligible person pursuant to a prescription that includes a direction that there be no substitutions and that meets the prescribed conditions.

Non-application

(7) Subsections (1) and (2) do not apply to an operator of a pharmacy or a physician who supplies a listed drug product for an eligible person without knowing or having reasonable grounds to believe that the person is an eligible person. 1996, c. 1, Sched. G, s. 4.

Payment of claim of operator

5. (1) An operator of a pharmacy who submits to the Minister a claim for payment in respect of supplying a listed drug product for an eligible person pursuant to a prescription is entitled to be paid by the Minister the amount provided for under section 6. R.S.O. 1990, c. O.10, s. 5 (1); 1996, c. 1, Sched. G, s. 5 (1).

Agreement re price

(2) The Minister may pay an operator of a pharmacy an amount different from the amount provided for under section 6 in respect of a claim under subsection (1) if the Minister has a written agreement to that effect with the operator. R.S.O. 1990, c. O.10, s. 5 (2).

Payment of claim of physician

(3) A physician who submits to the Minister a claim for payment in respect of supplying a listed drug product for an eligible person is entitled to be paid by the Minister the amount provided for by the regulations. R.S.O. 1990, c. O.10, s. 5 (3); 1996, c. 1, Sched. G, s. 5 (2).

Submission of claim

(4) A person’s entitlement under subsection (1) or (3) does not arise unless the person submits the claim in the manner prescribed by the regulations and includes in it the information prescribed by the regulations. 1996, c. 1, Sched. G, s. 5 (3).

Deemed authorization

(5) Eligible persons shall be deemed to have authorized persons submitting claims under subsection (1) or (3) to include in the claims the information mentioned in subsection (4). R.S.O. 1990, c. O.10, s. 5 (5).

Note: Effective November 1, 2004, subsection (5) is repealed by the Statutes of Ontario, 2004, chapter 3, Schedule A, subsection 95 (1). See: 2004, c. 3, Sched. A, ss. 95 (1), 99 (2).

Amount Minister to pay

6.  (1) The amount the Minister shall pay under subsection 5 (1) in respect of a listed drug product is the amount calculated by adding the amounts determined under paragraphs 1, 2 and 3 and subtracting from that total the maximum co-payment that may be charged in respect of the supplying of a listed drug product for an eligible person, as provided for in the regulations:

1. The dispensing fee determined under subsection (2).

2. The drug benefit price prescribed by the regulations for the drug product but, if there are other listed drug products that are interchangeable with the drug product, the drug benefit price shall be deemed to be the lowest of the drug benefit prices prescribed by the regulations for the drug product and the listed drug products that are interchangeable with it.

3. The mark up on that price prescribed by the regulations. 1996, c. 1, Sched. G, s. 6 (1).

Dispensing fee

(2) The dispensing fee the Minister shall pay to operators of pharmacies under subsection (1) for dispensing listed drug products for eligible persons shall be,

(a) where the pharmacy is operated in a hospital approved as a public hospital under the Public Hospitals Act, the amount prescribed by the regulations;

(b) where the listed drug product does not require a prescription for sale and is designated as one to which this clause applies, no dispensing fee; and

(c) in all other cases, the lesser of,

(i) the dispensing fee prescribed by the regulations, and

(ii) the amount the operator sets under subsection 6 (1) of the Drug Interchangeability and Dispensing Fee Act. R.S.O. 1990, c. O.10, s. 6 (2); 1996, c. 1, Sched. G, s. 6 (2-5).

Same, high acquisition cost

(3) If the acquisition cost of a listed drug product for an operator of a pharmacy is greater than the sum of the drug benefit price for the drug product determined under paragraph 2 of subsection (1) and the mark up on that price, referred to in paragraph 3 of subsection (1), the Minister shall also pay, under subsection 5 (1), the difference between the acquisition cost for the drug product and that sum.

Interchangeable products

(4) For the purpose of subsection (3), if an operator of a pharmacy dispenses a listed drug product that is interchangeable with other listed drug products, the acquisition cost of the listed drug product that is dispensed is the lowest acquisition cost from among the drug product dispensed and the listed drug products in the operator’s inventory that are interchangeable with the drug product.

No substitution prescription

(5) If a listed drug product is supplied pursuant to a prescription that includes a direction that there be no substitutions and that meets the prescribed conditions, subsections (3) and (4) do not apply and the Minister shall also pay, under subsection 5 (1), the amount determined under subsection 4 (5). 1996, c. 1, Sched. G, s. 6 (6).

7. Repealed: 1996, c. 1, Sched. G, s. 7 (1).

Note: No process under section 7 initiated or under way on or before January 30, 1996 shall continue after that day. See: 1996, c. 1, Sched. G, s. 7 (2).

Unlisted drugs, special case

8. (1) If a physician informs the Minister that the proper treatment of a patient who is an eligible person requires the administration of a drug for which there is not a listed drug product, the Minister may make this Act apply in respect of the supplying of that drug as if it were a listed drug product by so notifying the physician. R.S.O. 1990, c. O.10, s. 8 (1).

Same

(1.1) The drug benefit price of a drug referred to in subsection (1) shall be the amount provided for by the regulations.

Listed drugs, special case

(1.2) If a physician informs the Minister that the proper treatment of a patient who is an eligible person requires the administration of a drug for which there are one or more listed drug products but for which the prescribed conditions for payment under section 23 are not satisfied, the Minister may make this Act apply in respect of the supplying of those listed drug products as if the conditions were satisfied. 1996, c. 1, Sched. G, s. 8 (1).

Notice to operator

(2) An operator of a pharmacy is not liable for contravening this Act or the regulations in respect of supplying a drug referred to in subsection (1) or a listed drug product referred to in subsection (1.2) unless the operator has received notice from the physician or from the Minister that this Act applies to that supplying. R.S.O. 1990, c. O.10, s. 8 (2); 1996, c. 1, Sched. G, s. 8 (2).

Agreement re listed substance

9. (1) The Minister may make an agreement with a supplier of a listed substance, providing for payment of a specified amount for supplying the listed substance to an eligible person under the direction of a physician.

Supplier not to charge

(2) Except as the agreement authorizes, the supplier shall not charge, or accept payment from, any person other than the Minister for supplying the listed substance to an eligible person under the direction of a physician.

Exception

(3) Subsection (2) does not apply to a supplier of a listed substance who supplies the listed substance to an eligible person without knowing or having reasonable grounds to believe that the person is an eligible person. R.S.O. 1990, c. O.10, s. 9.

Refusal to dispense prohibited

10. No operator of a pharmacy shall refuse to supply a listed drug product for an eligible person in order to avoid the operation of a provision of this Act but an operator may refuse to supply a listed drug product for an eligible person if the proper exercise of professional judgment so requires. R.S.O. 1990, c. O.10, s. 10; 1996, c. 1, Sched. G, s. 9.

Opting out

11. (1) An operator of a pharmacy may notify the Minister that the operator elects not to accept payment from the Minister under section 5. R.S.O. 1990, c. O.10, s. 11 (1).

Idem

(2) Beginning ninety days after the day the Minister receives the notice under subsection (1), the operator is not entitled to payment from the Minister under section 5 and is not required to supply listed drug products for eligible persons under section 10. R.S.O. 1990, c. O.10, s. 11 (2); 1996, c. 1, Sched. G, s. 10.

Order suspending operator’s right to payment

11.1 (1) If the Minister believes on reasonable grounds that with respect to a pharmacy there has been a breach of a condition that is prescribed by the regulations or agreed to by the operator of the pharmacy, the Minister may make an order suspending the operator of the pharmacy from being entitled to receive payment from the Minister under this Act.

Effect of order

(2) Beginning on the day set out in the order, the operator is not entitled to payment by the Minister under this Act.

Same

(3) Beginning on the day set out in the order, the operator may charge, or accept payment from, a person other than the Minister in an amount not exceeding the sum of,

(a) the amount the Minister would have paid under this Act, absent the order; and

(b) the amount the operator could have charged under this Act, absent the order.

Scope of order

(4) An order may relate to all the pharmacies operated by the operator or only to some of them, as set out in the order.

Service of order

(5) An order may be served on the operator or upon any person employed, or apparently employed, at any pharmacy to which the order applies.

Rescinding of order

(6) The Minister may rescind an order upon conditions agreed to by the operator of the pharmacy or without conditions.

Agreement to conditions

(7) The Minister and an operator of a pharmacy may enter into an agreement that the operator of the pharmacy will abide by conditions set out in the agreement even if no order has been made under this section. 1996, c. 1, Sched. G, s. 11.

Order suspending physician’s right to payment

11.2 (1) If the Minister believes on reasonable grounds that a physician has breached a condition that is prescribed by the regulations or agreed to by the physician with respect to dispensing drugs, the Minister may make an order suspending the physician from being entitled to receive payment under this Act.

Effect of order

(2) Beginning on the day set out in the order, the physician is not entitled to payment by the Minister under this Act.

Same

(3) Beginning on the day set out in the order, the physician may charge, or accept payment from, a person other than the Minister in an amount not exceeding the sum of,

(a) the amount the Minister would have paid under this Act, absent the order; and

(b) the amount the physician could have charged under this Act, absent the order.

Service of order

(4) An order may be served on the physician or upon any person employed, or apparently employed, at the physician’s office.

Rescinding of order

(5) The Minister may rescind an order upon conditions agreed to by the physician or without conditions.

Agreement to conditions

(6) The Minister and a physician may enter into an agreement that the physician will abide by conditions set out in the agreement even if no order has been made under this section. 1996, c. 1, Sched. G, s. 11.

Claim from eligible person

11.3 (1) An eligible person who submits to the Minister a claim for payment in respect of the supply of a listed drug product is entitled to be paid by the Minister the amount the Minister would have paid to an operator of a pharmacy or a physician absent an order under section 11.1 or 11.2.

Same

(2) The entitlement of an eligible person under subsection (1) is subject to this Act and the regulations to the same extent as the entitlement of an operator of a pharmacy or a physician would be, absent the order under section 11.1 or 11.2.

Submission of claim

(3) A person’s entitlement under subsection (1) does not arise unless the person submits the claim in the manner prescribed by the regulations and includes in it the information prescribed by the regulations. 1996, c. 1, Sched. G, s. 11.

Minister to consult

12. The Minister may consult with persons or organizations representing eligible persons, manufacturers of listed drug products, operators of pharmacies, physicians and suppliers of listed substances with respect to the amounts payable by the Minister and other matters of mutual concern arising out of this Act and the regulations. R.S.O. 1990, c. O.10, s. 12.

Collection of personal information

13. (1) The Minister may directly or indirectly collect personal information, subject to such conditions as may be prescribed, for purposes related to the administration of this Act or for such other purposes as may be prescribed. 1996, c. 1, Sched. G, s. 12.

Use of personal information

(2) The Minister may use personal information, subject to such conditions as may be prescribed, for purposes related to the administration of this Act or for such other purposes as may be prescribed. 1996, c. 1, Sched. G, s. 12.

Disclosure

(3) The Minister shall disclose personal information if all prescribed conditions have been met and the disclosure is necessary for purposes related to the administration of this Act or for such other purposes as may be prescribed. However, the Minister shall not disclose the information if, in his or her opinion, the disclosure is not necessary for those purposes. 1996, c. 1, Sched. G, s. 12.

Agreements

(4) Subject to such conditions as may be prescribed, the Minister may enter into agreements to collect, use or disclose personal information for purposes related to the administration of this Act or for such other purposes as may be prescribed. 1996, c. 1, Sched. G, s. 12.

Same

(5) An agreement under subsection (4) shall provide that personal information collected or disclosed under the agreement will be used only,

(a) to verify the accuracy of information held or exchanged by a party to the agreement;

(b) to administer or enforce a law administered by a party to the agreement;

(c) for a purpose prescribed by regulation under subsection (4). 1996, c. 1, Sched. G, s. 12.

Confidentiality

(6) An agreement under subsection (4) shall provide that personal information collected, used or disclosed under it is confidential and shall establish mechanisms for maintaining the confidentiality of the information. 1996, c. 1, Sched. G, s. 12.

Obligation

(7) Before disclosing personal information obtained under the Act or under an agreement, the person who obtained it shall delete from it all names and identifying numbers, symbols or other particulars assigned to individuals unless,

(a) disclosure of the names or other identifying information is necessary for the purposes described in subsection (3) or (4); or

(b) disclosure of the names or other identifying information is otherwise authorized under the Freedom of Information and Protection of Privacy Act. 1996, c. 1, Sched. G, s. 12.

Note: Effective November 1, 2004, clause (b) is repealed by the Statutes of Ontario, 2004, chapter 3, Schedule A, subsection 95 (2) and the following substituted:

(b) disclosure of the names or other identifying information is otherwise authorized under the Freedom of Information and Protection of Privacy Act or the Personal Health Information Protection Act, 2004.

See: 2004, c. 3, Sched. A, ss. 95 (2), 99 (2).

Inspectors

14. (1) The Minister may appoint inspectors for the purposes of this section.

Examine books

(2) An inspector may examine any records, in whatever form, in the possession or under the control of an operator of a pharmacy or a physician, if the inspector believes on reasonable grounds that the records will assist the inspector in determining the accuracy and completeness of a claim for payment of the operator or physician or of information they are required to submit under this Act or the regulations, or in determining whether they have complied with this Act and the regulations.

Idem

(3) An inspector may examine records, in whatever form, in the possession or under the control of a wholesaler or manufacturer, if the inspector believes on reasonable grounds that the records will assist the inspector in determining the accuracy and completeness of a claim for payment of an operator of a pharmacy or physician or in determining whether the wholesaler or manufacturer have complied with this Act and the regulations.

Copies

(4) In carrying out an inspection under subsection (2), the inspector may, upon giving a receipt for it, take away a record for the purpose of making a copy, but the copy shall be made and the record shall be returned as promptly as reasonably possible.

Idem

(5) In carrying out an inspection under subsection (3), the inspector may, upon giving a receipt therefor, take away a sales record or a marketing record or both for the purpose of making a copy, but the copy shall be made and the record shall be returned as promptly as reasonably possible.

Entry

(6) An inspector may at any reasonable time, on producing proper identification, enter business premises where the inspector believes a record referred to in subsection (2) or (3) may be located for the purpose of an inspection. R.S.O. 1990, c. O.10, s. 14.

Offence

15. (1) A person is guilty of an offence if the person,

(a) charges a person more than is permitted under this Act;

(b) submits to the Minister a claim for payment where the Minister is not required to make any payment or where the claim is in excess of the amount the Minister is required to pay;

(c) contravenes subsection 9 (2) (supplier charges contrary to agreement);

(d) contravenes section 10 (refuses to dispense);

(e) refuses to submit information required to be submitted under this Act or knowingly furnishes false or incomplete information to the Ministry in connection with the administration of this Act; or

(f) obstructs a person carrying out an inspection under section 14. 2002, c. 18, Sched. I, s. 18.

Penalty, individual

(2) Subject to subsections (5) and (6), an individual who is convicted of an offence under subsection (1) is liable,

(a) for a first offence, to a fine of not more than $25,000 or to imprisonment for a term of not more than 12 months, or to both;

(b) for a subsequent offence, to a fine of not more than $50,000 or to imprisonment for a term of not more than 12 months, or to both. 2002, c. 18, Sched. I, s. 18.

Same, corporation

(3) Subject to subsections (5) and (6), a corporation that is convicted of an offence under subsection (1) is liable to a fine of not more than $50,000 for a first offence and to a fine of not more than $200,000 for a subsequent offence. 2002, c. 18, Sched. I, s. 18.

Same, officers and directors

(4) Subject to subsections (5) and (6), an officer or director of a corporation who authorizes or permits the corporation to contravene subsection (1) is guilty of an offence and on conviction is liable to a fine of not more than $50,000 for a first offence and to a fine of not more than $200,000 for a subsequent offence. 2002, c. 18, Sched. I, s. 18.

Minimum penalty

(5) The minimum penalty for each offence under clause (1) (a) is two times the difference between the amount that was charged to or accepted from a person other than the Minister and the amount permitted under this Act. 2002, c. 18, Sched. I, s. 18.

Same

(6) The minimum penalty for each offence under clause (1) (b) is two times the difference between the amount for which a claim was submitted to the Minister and the amount the Minister is required to pay. 2002, c. 18, Sched. I, s. 18.

Compensation or restitution

(7) The court that convicts a person of an offence under this section may, in addition to any other penalty, order that the person pay compensation or make restitution to any person who suffered a loss as a result of the offence. 2002, c. 18, Sched. I, s. 18.

No limitation

(8) Section 76 of the Provincial Offences Act does not apply to a prosecution under this section. 2002, c. 18, Sched. I, s. 18.

Conditions for listing

16. (1) A manufacturer of a drug product that is designated or being considered for designation as a listed drug product shall,

(a) supply that drug product for the same price to all purchasers in Ontario, other than public hospitals purchasing solely for use in the treatment of patients and out-patients in the hospital, where the purchasers purchase the same quantity of individual units of the drug product in the same dosage form and strength; and

(b) give to the Minister, on request, the information prescribed by the regulations concerning the production and sale of the drug product.

Idem

(2) Where a manufacturer of a drug product contravenes this section or obstructs a person carrying out an inspection under section 14, the Lieutenant Governor in Council may refuse to designate the drug product as a listed drug product, or, where it is already so designated, may remove that designation. R.S.O. 1990, c. O.10, s. 16.

Pharmaceutical products

17. (1) This Act applies with necessary modifications in respect of designated pharmaceutical products and, for the purpose, a designated pharmaceutical product shall be deemed to be a listed drug product. R.S.O. 1990, c. O.10, s. 17 (1).

Same

(2) The drug benefit price of a designated pharmaceutical product shall be the amount provided for by the regulations.

Same

(3) Sections 16 and 22 do not apply for the purposes of this section. 1996, c. 1, Sched. G, s. 14.

Regulations

18. (1) The Lieutenant Governor in Council may make regulations,

(a) designating eligible classes of persons for the purposes of section 2;

(b) prescribing conditions to be met for a drug product to be designated as a listed drug product;

(b.1) prescribing conditions to be met for a listed drug product to continue to be designated as a listed drug product;

(c) designating a product as a listed drug product where the Lieutenant Governor in Council considers it advisable in the public interest to do so, but a product shall not be so designated if it or its manufacturer has not met the conditions described in clause (b);

(d) designating substances other than drugs that are listed substances;

(e) respecting physicians charging, or accepting payment from, persons for the purposes of subsection 4 (2);

(e.1) prescribing the manner of determining acquisition costs of drug products, for the purposes of subsections 4 (5), 6 (3) and 6 (4);

(e.1.1) prescribing conditions for the purposes of subsections 4 (6) and 6 (5);

(e.2) respecting amounts an operator of a pharmacy may charge or accept from a person other than the Minister under this Act in addition to those provided for in this Act;

(e.3) respecting amounts the Minister shall pay physicians under subsection 5 (3);

(f) prescribing the manner in which a claim referred to in subsection 5 (4) must be submitted and prescribing the information to be included in such a claim;

(g) subject to section 22, prescribing the drug benefit price for listed drug products;

(g.1) prescribing a percentage mark up of the drug benefit price that the Minister will pay under subsection 6 (1);

(g.2) respecting the maximum co-payment for the purposes of subsection 6 (1);

(g.3) prescribing an amount for the purposes of clause 6 (2) (a);

(g.4) prescribing the dispensing fee for the purpose of subclause 6 (2) (c) (i);

(g.5) exempting any drug product or class of drug product from the application of subsections 6 (3) and (4);

(g.6) limiting the amount of a drug product supplied for an eligible person at one time or within a period of time that the Minister is required to pay for under this Act;

(h) requiring operators of pharmacies and manufacturers and wholesalers of listed drug products to file reports to the Minister concerning the cost to operators of pharmacies and wholesalers of purchasing any drugs and prescribing the information to be included in such reports and the frequency with which such reports are to be made;

(i) requiring operators of pharmacies and physicians to retain specified records respecting their purchase of drugs for the purposes of this Act and prescribing the period of time those records shall be retained;

(j) Repealed: 1996, c. 1, Sched. G, s. 15 (7).

(k) designating listed drug products that do not require a prescription for sale for the purpose of clause 6 (2) (b);

(k.1) respecting the drug benefit price or the determination of the drug benefit price of a drug for the purpose of subsection 8 (1.1);

(k.2) respecting conditions under which the Minister may make an order under subsection 11.1 (1);

(k.3) respecting conditions under which the Minister may make an order under subsection 11.2 (1);

(k.4) prescribing the manner in which a claim referred to in subsection 11.3 (3) must be submitted and prescribing the information to be included in such a claim;

(k.5) respecting purposes for which personal information may be collected, used or disclosed under subsection 13 (1), (2) or (3) and for which agreements may be entered into under subsection 13 (4);

(k.6) prescribing conditions under which the Minister may collect or use personal information under subsection 13 (1) or (2), conditions under which the Minister shall disclose personal information under subsection 13 (3) and conditions under which the Minister may enter into agreements under subsection 13 (4);

(l) designating pharmaceutical products for the purpose of section 17 and respecting the drug benefit price or the determination of the drug benefit price for each of them;

(m) respecting any matter considered necessary or advisable to carry out the intent and purposes of this Act. R.S.O. 1990, c. O.10, s. 18 (1); 1996, c. 1, Sched. G, s. 15 (1-9).

Eligible classes

(2) Without restricting the generality of clause (1) (a), a regulation under that clause may include distinctions based on income, family status and expenses incurred, including expenses incurred in the purchase of listed drug products and may provide for eligibility to be based on family units, and for the purpose may define “family unit”.

Conditions for listing

(3) Without restricting the generality of clause (1) (b) or (b.1), a regulation under one of those clauses may prescribe conditions relating to the drug benefit price of the drug product or other drug products or the price charged to operators of pharmacies for the drug product or other drug products.

Distinguish operators, physicians

(4) A regulation may distinguish between operators of pharmacies and dispensing physicians and may treat them differently.

Co-payments

(5) Without limiting the generality of clause (1) (g.2), a regulation made under that clause may,

(a) prescribe a specified amount as a co-payment, provide for a means of calculating the amount, provide that the dispensing fee under subsection 6 (2) is the amount of the co-payment or otherwise provide for the amount of co-payment;

(b) provide for different co-payments for different classes of persons or drugs;

(c) provide that no co-payment or a different co-payment is to be charged after a person has been charged co-payments that total an amount provided for by the regulations in a specified period;

(d) provide that the co-payment include any amount up to the full amount otherwise payable by the Minister;

(e) treat different classes of eligible persons differently; and

(f) for the purpose of clause (e), make distinctions based on income, family status, general expenses incurred and expenses incurred in the purchase of listed drug products. 1996, c. 1, Sched. G, s. 15 (10).

Regulations

(6) A regulation made under this section may be general or particular in its application.

Retroactive

(7) A regulation is, if it so provides, effective with reference to a period before it is filed. R.S.O. 1990, c. O.10, s. 18 (6, 7).

Decisions about listing, delisting

19. In deciding whether or not to designate a drug product as a listed drug product under clause 18 (1) (c) or to remove such a designation, the Lieutenant Governor in Council may consider any matter the Lieutenant Governor in Council considers advisable in the public interest, including, without limiting the generality of the foregoing, the drug benefit price of the drug product or other drug products or the price charged to operators of pharmacies for the drug product or other drug products. 1996, c. 1, Sched. G, s. 16.

Delisting

20. (1) The Lieutenant Governor in Council may remove the designation of a drug product as a listed drug product even if none of the conditions prescribed under clause 18 (1) (b.1) are breached, if the Lieutenant Governor in Council considers it advisable in the public interest to do so.

Effect of breach of continuing conditions

(2) Despite a breach of a condition prescribed under clause 18 (1) (b.1), a drug product does not cease to be designated as a listed drug product until its designation as a listed drug product is removed. 1996, c. 1, Sched. G, s. 16.

Advisors

21. The Minister or any body or official who advises the Minister or the Lieutenant Governor in Council with respect to anything under this Act may, in formulating such advice, consider anything the Minister or Lieutenant Governor in Council may consider. 1996, c. 1, Sched. G, s. 16.

Drug benefit price

22. (1) The drug benefit price prescribed under clause 18 (1) (g) for a drug product when it becomes a listed drug product shall be the amount submitted by the manufacturer and agreed to by the Minister for listing the drug product.

Minister’s agreement

(2) In deciding whether to agree to an amount submitted by the manufacturer, the Minister may consider any matter the Minister considers advisable in the public interest, including, without limiting the generality of the foregoing, the drug benefit price of other drug products or the price charged to operators of pharmacies for the drug product or other drug products.

Requested changes in price

(3) A regulation under clause 18 (1) (g) may raise or lower the drug benefit price of a listed drug product if the manufacturer agrees to the change and the Lieutenant Governor in Council considers it advisable in the public interest to do so.

Price at coming into force

(4) The initial drug benefit price of a drug product that is a listed drug product at the time this section comes into force shall be deemed to be the best available price of the drug product set out in Part IV of the Formulary, as defined in section 1 of Regulation 868 of the Revised Regulations of Ontario, 1990, as that section existed on the day before this section comes into force. 1996, c. 1, Sched. G, s. 17.

Conditions of payment

23. (1) The Lieutenant Governor in Council may make regulations requiring that for a specified drug product or class of drug products specified clinical criteria must be met for the Minister to pay an amount in respect of the supplying of that drug product or class of drug products for a specified patient or class of patients.

Clinical criteria

(2) Without limiting the generality of subsection (1), clinical criteria may include,

(a) considerations relating to the use or the possibility of the use of other drug products or therapies for a particular patient or class of patients;

(b) a requirement that the use of a drug product for a particular patient or class of patients require a prescription from a physician or class of physicians prescribed by the regulations;

(c) a requirement that a specified person or an expert panel recommend or approve the use of a drug product for a particular patient or class of patients.

When clinical criteria not met

(3) If an operator of a pharmacy supplies a drug product for an eligible person and, because of a regulation under this section, the Minister is not required to pay an amount in respect of that supply, the operator may charge or accept payment from a person other than the Minister in an amount equal to the sum of,

(a) the amount the Minister would have paid under this Act, absent the regulation; and

(b) the amount the operator could have charged under this Act, absent the regulation.

Exception

(4) Subsection (3) does not apply if, under section 8, the Minister makes this Act apply in respect of the supplying of the drug product for the eligible person. 1996, c. 1, Sched. G, s. 18.

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