jswizzle3737/ontario_laws_and_regs huggingface dataset:
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
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
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 drug product where the executive officer considers it to be in the public interest to do so, but shall not do so if the prescribed conditions under clause 18 (1) (b) have not been met.  2006, c. 14, s. 7. Modification (3) Any modification of a designation takes place on the effective date of its being designated in the Formulary as a modification.  2006, c. 14, s. 7. Transitional (4) A drug product that was a listed drug product immediately before October 1, 2006 continues to be a listed drug product until it is removed from the Formulary as a listed drug product under this section.  2006, c. 14, s. 7. Section Amendments with date in force (d/m/y) 2006, c. 14, s. 7 - 01/10/2006 1.4 Repealed: 2021, c. 25, Sched. 18, s. 1. Section Amendments with date in force (d/m/y) 2006, c. 14, s. 7 - 01/10/2006 2021, c. 25, Sched. 18, s. 1 - 01/01/2022 1.5 Repealed: 2021, c. 25, Sched. 18, s. 2. Section Amendments with date in force (d/m/y) 2006, c. 14, s. 8 - 01/10/2006 2021, c. 25, Sched. 18, s. 2 - 01/01/2022
2 (1) A person who is a member of a prescribed class of persons is an eligible person.  R.S.O. 1990, c. O.10, s. 2 (1); 2006, c. 14, s. 9. Persons deemed eligible persons (2) This Act applies to persons entitled to receive drug benefits under 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; 2017, c. 11, Sched. 4, s. 2. Section Amendments with date in force (d/m/y) 1997, c. 25, Sched. E, s. 9 - 01/07/1998 2006, c. 14, s. 9 - 01/10/2006 2017, c. 11, Sched. 4, s. 2 - 01/07/2017
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. Section Amendments with date in force (d/m/y) 1996, c. 1, Sched. G, s. 3 - 27/05/1996
4.1 (1) If an operator of a pharmacy or a physician wishes to receive payment from the executive officer under this Act, the operator or physician shall apply to the executive officer for billing privileges.  2009, c. 26, s. 19 (1). Granting of privileges (2) The executive officer may grant billing privileges to an operator or physician who has applied under subsection (1) where the executive officer is of the opinion it is in the public interest to do so, after considering any matter that he or she considers to be appropriate.  2009, c. 26, s. 19 (1). Agreements (3) The executive officer may make it a condition of granting billing privileges under subsection (2) that the operator or physician enter into an agreement with the executive officer containing any provisions that the executive officer considers necessary or desirable in the public interest in the particular case.  2009, c. 26, s. 19 (1). Transitional (4) Where an operator of a pharmacy or a physician received payment from the executive officer under this Act before the coming into force of this section, the following rules apply: 1.  The operator is deemed to have been granted billing privileges under subsection (2), but only in respect of a pharmacy that, before the coming into force of this section, supplied drug products for which the operator received payment, and only if, immediately before the coming into force of this section, there was no order under section 11.1 in effect respecting the operator. 2.  The physician is deemed to have been granted billing privileges under subsection (2). 3.  The executive officer may require the operator or physician to enter into an agreement described in subsection (3) as a condition of continuing to receive payment from the executive officer under this Act.  2009, c. 26, s. 19 (1). Section Amendments with date in force (d/m/y) 2009, c. 26, s. 19 (1) - 15/03/2010
5 (1) Subject to subsection (2), an operator of a pharmacy who has been granted billing privileges under subsection 4.1 (2) and who submits to the executive officer 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 executive officer the amount provided for under section 6.  2009, c. 26, s. 19 (2). Alternative payments (2) The executive officer may pay the operator of a pharmacy an amount different from the amount provided for under section 6 in respect of a claim or claims under subsection (1) for prescribed classes of eligible persons, subject to any prescribed requirements.  2006, c. 14, s. 11 (1). Transitional (2.1) Any agreement that was in place under subsection (2), as it existed before October 1, 2006, that was in effect immediately before that date continues in force, with the executive officer substituted for the Minister, until it is terminated under its terms.  2006, c. 14, s. 11 (1). Payment of claim of physician (3) A physician who has been granted billing privileges under subsection 4.1 (2) and who submits to the executive officer a claim for payment in respect of supplying a listed drug product for an eligible person is entitled to be paid by the executive officer 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); 2006, c. 14, s. 11 (2); 2009, c. 26, s. 19 (3). 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). (5) Repealed:  2004, c. 3, Sched. A, s. 95 (1). Section Amendments with date in force (d/m/y) 1996, c. 1, Sched. G, s. 5 (1-3) - 27/05/1996 2004, c. 3, Sched. A, s. 95 (1) - 01/11/2004 2006, c. 14, s. 11 (1, 2) - 01/10/2006 2009, c. 26, s. 19 (2, 3) - 15/03/2010
9 (1) The executive officer 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 an authorized prescriber.  R.S.O. 1990, c. O.10, s. 9 (1); 2006, c. 14, s. 14 (1); 2017, c. 11, Sched. 4, s. 3. Supplier not to charge (2) Except as the agreement authorizes, the supplier shall not charge, or accept payment from, any person other than the executive officer for supplying the listed substance to an eligible person under the direction of an authorized prescriber.  R.S.O. 1990, c. O.10, s. 9 (2); 2006, c. 14, s. 14 (2); 2017, c. 11, Sched. 4, s. 3. 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 (3). Section Amendments with date in force (d/m/y) 2006, c. 14, s. 14 (1, 2) - 01/10/2006 2017, c. 11, Sched. 4, s. 3 - 01/07/2017
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. Section Amendments with date in force (d/m/y) 1996, c. 1, Sched. G, s. 9 - 27/05/1996
11 (1) An operator of a pharmacy who has been granted billing privileges under subsection 4.1 (2) may notify the executive officer that the operator elects not to accept payment from the executive officer under section 5.  R.S.O. 1990, c. O.10, s. 11 (1); 2006, c. 14, s. 15 (1); 2009, c. 26, s. 19 (6). Idem (2) Beginning ninety days after the day the executive officer receives the notice under subsection (1), the operator is not entitled to payment from the executive officer 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; 2006, c. 14 s. 15 (2). Section Amendments with date in force (d/m/y) 1996, c. 1, Sched. G, s. 10 - 27/05/1996 2006, c. 14, s. 15 (1, 2) - 01/10/2006 2009, c. 26, s. 19 (6) - 15/03/2010
11.1 (1) If the executive officer 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 executive officer may make an order suspending the operator of the pharmacy from being entitled to receive payment from the executive officer under this Act.  1996, c. 1, Sched. G, s. 11; 2006, c. 14, s. 16 (1). Effect of order (2) Beginning on the day set out in the order, the operator is not entitled to payment by the executive officer under this Act.  1996, c. 1, Sched. G, s. 11; 2006, c. 14, s. 16 (2). Same (3) Beginning on the day set out in the order, the operator may charge, or accept payment from, a person other than the executive officer in an amount not exceeding the sum of, (a)  the amount the executive officer would have paid under this Act, absent the order; and (b)  the amount the operator could have charged under this Act, absent the order.  1996, c. 1, Sched. G, s. 11; 2006, c. 14, s. 16 (3). 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.  1996, c. 1, Sched. G, s. 11. 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.  1996, c. 1, Sched. G, s. 11. Rescinding of order (6) The executive officer may rescind an order upon conditions agreed to by the operator of the pharmacy or without conditions.  1996, c. 1, Sched. G, s. 11; 2006, c. 14, s. 16 (4). Agreement to conditions (7) The executive officer 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; 2006, c. 14, s. 16 (5). Section Amendments with date in force (d/m/y) 1996, c. 1, Sched. G, s. 11 - 27/05/1996 2006, c. 14, s. 16 (1-5) - 01/10/2006
11.2 (1) If the executive officer 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 executive officer may make an order suspending the physician from being entitled to receive payment under this Act.  1996, c. 1, Sched. G, s. 11; 2006, c. 14, s. 17 (1). Effect of order (2) Beginning on the day set out in the order, the physician is not entitled to payment by the executive officer under this Act.  1996, c. 1, Sched. G, s. 11; 2006, c. 14, s. 17 (2). Same (3) Beginning on the day set out in the order, the physician may charge, or accept payment from, a person other than the executive officer in an amount not exceeding the sum of, (a)  the amount the executive officer would have paid under this Act, absent the order; and (b)  the amount the physician could have charged under this Act, absent the order.  1996, c. 1, Sched. G, s. 11; 2006, c. 14, s. 17 (3). 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.  1996, c. 1, Sched. G, s. 11. Rescinding of order (5) The executive officer may rescind an order upon conditions agreed to by the physician or without conditions.  1996, c. 1, Sched. G, s. 11; 2006, c. 14, s. 17 (4). Agreement to conditions (6) The executive officer 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; 2006, c. 14, s. 17 (5). Section Amendments with date in force (d/m/y) 1996, c. 1, Sched. G, s. 11 - 27/05/1996 2006, c. 14, s. 17 (1-5) - 01/10/2006
11.3 (1) Where an eligible person obtains a listed drug product from a pharmacy or a physician and, for any reason, the operator of the pharmacy or the physician is not entitled to payment from the executive officer under this Act, the eligible person may submit to the executive officer a claim for payment in respect of the supply of a listed drug product and is entitled to be paid by the executive officer the amount the executive officer would have otherwise paid to an operator of a pharmacy or a physician who was entitled to payment.  2009, c. 26, s. 19 (7). 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, subject to any necessary modification.  2009, c. 26, s. 19 (7). 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. Section Amendments with date in force (d/m/y) 1996, c. 1, Sched. G, s. 11 - 27/05/1996 2006, c. 14, s. 18 - 01/10/2006 2009, c. 26, s. 19 (7) - 15/03/2010
11.6 (1) The following rules apply with regard to an order made or a notice given by the executive officer under section 11.4 or 11.5: 1.  The order or notice must be in writing, and set out in brief the reason for which it is made. 2.  An order must set out how any amount required to be paid under the order was calculated, and specify any right of reconsideration that is available and the time within which the reconsideration is available. 3.  In the case of an order or notice under section 11.4 or an order or notice under section 11.5 that applies to a manufacturer, the order or notice may be served by leaving a copy of the document with an officer, director or agent of the manufacturer, or with an individual at any place of business of the manufacturer who appears to be in control or management of the place of business. 4.  In the case of an order or notice under section 11.5 that applies to a person mentioned in subsection 11.5 (3), the order or notice may be served by leaving a copy of the document with the person if the person is an individual, or with an officer, director or agent of the person, or with an individual at any place of business of the person mentioned in subsection 11.5 (3) who appears to be in control or management of the place of business. 5.  An order must specify the time period with respect to which the order is made, which may include a time period with respect to which a previous order was made, if the previous order has not been complied with. 6.  An order must set out the time period in which the manufacturer or person mentioned in subsection 11.5 (3) is required to comply with the order. 7.  An order must specify the consequences for failing to comply with the order.  2006, c. 14, s. 19. Same, publication of enforcement action (2) The executive officer may publish on the Ministry’s website the corporate names of manufacturers or any other persons against whom the executive officer has taken action under section 11.4 or 11.5 and may also publish any information he or she considers appropriate about the action that has been taken.  2006, c. 14, s. 19. No appeal (3) There is no appeal from a decision or action of the executive officer under section 11.4 or 11.5, except as provided for in those sections.  2006, c. 14, s. 19. Section Amendments with date in force (d/m/y) 2006, c. 14, s. 19 - 01/10/2006
12 The Minister and the executive officer may consult with persons or organizations representing eligible persons, manufacturers, operators of pharmacies, physicians, suppliers of listed substances, wholesalers and companies that own, operate or franchise pharmacies with respect to the amounts payable under this Act and other matters of mutual concern arising out of this Act and the regulations, and the Drug Interchangeability and Dispensing Fee Act and its regulations.  2006, c. 14, s. 20. Section Amendments with date in force (d/m/y) 2006, c. 14, s. 20 - 01/10/2006
13 (1) The Minister and the executive officer 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; 2006, c. 14, s. 21 (1). Use of personal information (2) The Minister and the executive officer 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; 2006, c. 14, s. 21 (2). Disclosure (3) The Minister and the executive officer shall disclose personal information, subject to such conditions as may be prescribed, if the disclosure is necessary for purposes related to the administration of this Act or for such other purposes as may be prescribed, but shall not disclose the information if, in his or her opinion, the disclosure is not necessary for those purposes. 2017, c. 25, Sched. 7, s. 1. Agreements (4) Subject to such conditions as may be prescribed, the Minister and the executive officer 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; 2006, c. 14, s. 21 (4). 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 or the Personal Health Information Protection Act, 2004.  1996, c. 1, Sched. G, s. 12; 2004, c. 3, Sched. A, s. 95 (2). Section Amendments with date in force (d/m/y) 1996, c. 1, Sched. G, s. 12 - 01/03/1996 2004, c. 3, Sched. A, s. 95 (2) - 01/11/2004 2006, c. 14, s. 21 (1-4) - 01/10/2006 2017, c. 25, Sched. 7, s. 1 - 12/12/2017
13.1 (1) For the purposes of determining compliance with this Act or the regulations or with the Drug Interchangeability and Dispensing Fee Act and its regulations, the executive officer may require a manufacturer, wholesaler, supplier of a listed substance, operator of a pharmacy or a company that owns, operates or franchises pharmacies to provide information other than personal information to the executive officer, either in response to a specific request, or at regular intervals.  2006, c. 14, s. 22. Time and form (2) The executive officer may specify the time at which and the form in which the information must be provided.  2006, c. 14, s. 22. Publication (3) Where the executive officer requires that information be provided at regular intervals, the executive officer shall publish the manner and form that are required on the website of the Ministry, and may publish them in any other format that he or she considers advisable.  2006, c. 14, s. 22. Compliance required (4) The manufacturer, wholesaler, supplier of listed substances, operator of a pharmacy or company that owns, operates or franchises pharmacies shall comply with every requirement to provide information under this section.  2006, c. 14, s. 22. Where conflict (5) In the event of a conflict between what is posted on the Ministry’s website under subsection (3) and what is posted in another format, the Ministry’s website prevails.  2006, c. 14, s. 22. Section Amendments with date in force (d/m/y) 2006, c. 14, s. 22 - 01/10/2006
14 (1) The Minister may appoint inspectors for the purposes of this section.  R.S.O. 1990, c. O.10, s. 14 (1). 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.  R.S.O. 1990, c. O.10, s. 14 (2). Same (3) An inspector may examine records, in whatever form, in the possession or under the control of a wholesaler, manufacturer, supplier of a listed substance, operator of a pharmacy or a company that owns, operates or franchises pharmacies, 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 has complied with this Act and the regulations.  2006, c. 14, s. 23. Copies (4) In carrying out an inspection under this section, the inspector may, upon giving a receipt for it, take away a record, including a sales or a marketing 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.  2006, c. 14, s. 23. (5) Repealed:  2006, c. 14, s. 23. 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 (6). Section Amendments with date in force (d/m/y) 2006, c. 14, s. 23 - 01/10/2006
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 executive officer a claim for payment where the executive officer is not required to make any payment or where the claim is in excess of the amount the executive officer 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 the Drug Interchangeability and Dispensing Fee Act; or (f)  obstructs a person carrying out an inspection under section 14.  2002, c. 18, Sched. I, s. 18; 2006, c. 14, s. 24 (1, 2). 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 executive officer and the amount permitted under this Act.  2002, c. 18, Sched. I, s. 18; 2006, c. 14, s. 24 (3). 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 executive officer and the amount the executive officer is required to pay.  2006, c. 14, s. 24 (4). 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. Section Amendments with date in force (d/m/y) 1996, c. 1, Sched. G, s. 13 (1-3) - 27/05/1996 2002, c. 18, Sched. I, s. 18 - 26/11/2002 2006, c. 14, s. 24 (1-4) - 01/10/2006
16 (1) If an authorized prescriber informs the executive officer 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 executive officer 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 prescriber. 2017, c. 11, Sched. 4, s. 4. Same (2) The drug benefit price of a drug referred to in subsection (1) shall be the amount determined by the executive officer in accordance with the regulations.  2006, c. 14, s. 25. Listed drugs, special case (3) If an authorized prescriber informs the executive officer 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 conditions for payment under section 23 are not satisfied, the executive officer may make this Act apply in respect of the supplying of those listed drug products as if the conditions were satisfied. 2017, c. 11, Sched. 4, s. 4. Notice to operator (4) 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 (3) unless the operator has received notice from the authorized prescriber or from the executive officer that this Act applies to that supplying. 2017, c. 11, Sched. 4, s. 4. Retroactivity (5) Where the executive officer may make this Act apply in respect of the supplying of a drug or a listed drug product under this section, the executive officer may make that application retroactive to a date determined by the executive officer.  2006, c. 14, s. 25. Section Amendments with date in force (d/m/y) 2006, c. 14, s. 25 - 01/10/2006 2017, c. 11, Sched. 4, s. 4 - 01/07/2017
19 In deciding whether or not to designate a drug product as a listed drug product or to remove such a designation, the executive officer may consider anything he or she 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.  2006, c. 14, s. 28. Section Amendments with date in force (d/m/y) 1996, c. 1, Sched. G, s. 16 - 27/05/1996 2004, c. 7, s. 14 (2) - 17/06/2004 2006, c. 14, s. 28 - 01/10/2006
20 (1) The executive officer may remove a drug product’s designation as a listed drug product even if none of the conditions prescribed under clause 18 (1) (b.1) are breached, if he or she considers it advisable in the public interest to do so.  2006, c. 14, s. 28. 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 a listed drug product until its designation as a listed drug product is removed.  2006, c. 14, s. 28. Section Amendments with date in force (d/m/y) 1996, c. 1, Sched. G, s. 16 - 27/05/1996 2004, c. 7, s. 14 (2) - 17/06/2004 2006, c. 14, s. 28 - 01/10/2006
21 The Minister, the executive officer or any body or official who advises the Minister, the executive officer or the Lieutenant Governor in Council with respect to anything under this Act may, in formulating such advice, consider anything the Minister, the executive officer or Lieutenant Governor in Council may consider.  2006, c. 14, s. 28. Section Amendments with date in force (d/m/y) 1996, c. 1, Sched. G, s. 16 - 27/05/1996 2006, c. 14, s. 28 - 01/10/2006
23 (1) The executive officer may require that, in respect of a specified drug product or class of drug products, specified clinical criteria must be met for the executive officer to pay an amount in respect of the supplying of that drug product or class of drug products for particular patients or a particular class of patients.  2006, c. 14, s. 28. Publication (2) Where the executive officer specifies anything under subsection (1), he or she shall publish it in the Formulary.  2006, c. 14, s. 28. Clinical criteria (3) 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 particular patients or a particular class of patients; (b)  a requirement that the use of a drug product for particular patients or a particular class of patients require a prescription from a prescriber or member of a class of prescribers specified by the executive officer; (c)  a requirement that a specified person or an expert panel recommend or approve the use of a drug product for particular patients or a particular class of patients.  2006, c. 14, s. 28; 2017, c. 25, Sched. 7, s. 2. When clinical criteria not met (4) If an operator of a pharmacy supplies a drug product for an eligible person and, because of the criteria set under this section, the executive officer 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 executive officer in an amount equal to the sum of, (a)  the amount the executive officer would have paid under this Act, absent the criteria; and (b)  the amount the operator could have charged under this Act, absent the criteria.  2006, c. 14, s. 28. Exception (5) Subsection (4) does not apply if, under section 16, the executive officer makes this Act apply in respect of the supplying of the drug product for the eligible person.  2006, c. 14, s. 28. Section Amendments with date in force (d/m/y) 1996, c. 1, Sched. G, s. 18 - 27/05/1996 2006, c. 14, s. 28 - 01/10/2006 2017, c. 25, Sched. 7, s. 2 - 12/12/2017 ______________  Français