18 (1) The Lieutenant Governor in Council may make regulations, (0.a)  defining any word or expression used in this Act but not defined in this Act; (0.a.1) governing professional services for the purposes of clause 1.1 (2) (j), including defining “professional services”, governing payments that may be made for professional services, including governing to whom payments may be made, and prescribing conditions to which the executive officer is subject in making payments for professional services; (a)  prescribing 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conditions to be met for a listed drug product to continue to be designated as a listed drug product; (c), (d) Repealed:  2006, c. 14, s. 27 (3). (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 (4), and prescribing conditions for the purposes of paragraph 4 of subsection 4 (5) and for the purposes of subsection 6 (3); (e.1.1) prescribing conditions for the purposes of subsections 4 (6) and 6 (5); (e.1.2) prescribing classes of eligible persons and setting out requirements for the purposes of subsection 5 (2); (e.2)  respecting amounts an operator of a pharmacy may charge or accept from a person other than the executive officer under this Act in addition to those provided for in this Act; (e.3)  respecting amounts the executive officer 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referred to in subsection 5 (4) must be submitted and prescribing the information to be included in such a claim; (g)  Repealed:  2006, c. 14, s. 27 (8). (g.1)  prescribing the mark-up of the drug benefit price the executive officer will pay under subsection 6 (1); (g.2)  respecting the maximum co-payment for the purposes of subsection 6 (1); (g.3)  governing the manner in which the executive officer determines any additional amount to be subtracted under subsection 6 (1); (g.4)  prescribing the dispensing fee and conditions for the payment of the dispensing fee for the purposes 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 executive officer is required to pay for under this Act; (h)  Repealed:  2006, c. 14, s. 27 (13). (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)  Repealed:  2006, c. 14, s. 27 (14). (k.1)  respecting how drug benefit prices are to be calculated for the purposes of section 16; (k.2)  respecting conditions under which the executive officer may make an order under subsection 11.1 (1); (k.3)  respecting conditions under which the executive officer 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.5.1) clarifying the definition of “rebate” in section 11.5, including providing that certain benefits are not rebates, prescribing benefits for the purpose of that definition, clarifying how the calculations are to be made in that section and defining “ordinary commercial terms” for the purposes of that definition, including setting limits on ordinary commercial terms; (k.6)  prescribing conditions under which the Minister and the executive officer may collect or use personal information under subsection 13 (1) or (2), conditions under which the Minister and the executive officer shall disclose personal information under subsection 13 (3) and conditions under which the Minister and the executive officer may enter into agreements under subsection 13 (4); (l)  Repealed:  2006, c. 14, s. 27 (20). (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); 2006, c. 14, s. 27 (1-20); 2010, c. 1, Sched. 21, s. 2; 2017, c. 8, Sched. 24, s. 2 (1, 2); 2019, c. 15, Sched. 28, s. 2 (1). Authorized prescribers (1.1) The Minister may make regulations prescribing persons or classes of persons for the purpose of the definition of “authorized prescriber” in subsection 1 (1). 2017, c. 11, Sched. 4, s. 5 (1). (1.2), (1.3) Repealed: 2006, c. 14, s. 27 (21). 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”.  1996, c. 1, Sched. G, s. 15 (10). 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.  1996, c. 1, Sched. G, s. 15 (10). Distinguish operators, physicians (4) A regulation may distinguish between operators of pharmacies and dispensing physicians and may treat them differently.  1996, c. 1, Sched. G, s. 15 (10). Distinguishing mark-ups, dispensing fees (4.1) Without restricting the generality of clauses (1) (g.1) and (g.4), regulations under those clauses may establish different classes of pharmacies or operators of pharmacies and may provide for different mark-ups or dispensing fees with respect to different classes of pharmacies or operators of pharmacies.  2009, c. 26, s. 19 (8). 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 executive officer; (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); 2006, c. 14, s. 27 (22). Regulations (6) A regulation made under this section may be general or particular in its application.  R.S.O. 1990, c. O.10, s. 18 (6). 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 (7). Public consultation before making regulations (8) The Lieutenant Governor in Council shall not make any regulation under clause (1) (0.a), (0.a.1), (b), (b.1), (e.1), (e.1.2), (g.1), (g.3), (g.4), (k.1) or (k.5.1) and the Minister shall not make any regulation under subsection (1.1) unless, (a)  the Minister has published a notice of the proposed regulation on the website of the Ministry and in any other format the Minister considers advisable; (b)  the notice complies with the requirements of this section; (c)  the time periods specified in the notice, during which members of the public may exercise a right described in clause (9) (b) or (c), have expired; (d)  the Minister has considered whatever comments and submissions that members of the public have made on the proposed regulation in accordance with clause (9) (b) or (c); and (e)  in the case of regulations made by the Lieutenant Governor in Council, the Minister has reported to the Lieutenant Governor in Council on what, if any, changes to the proposed regulation the Minister considers appropriate. 2006, c. 14, s. 27 (23); 2017, c. 8, Sched. 24, s. 2 (3, 4); 2017, c. 11, Sched. 4, s. 5 (2, 3); 2019, c. 15, Sched. 28, s. 2 (2). Contents of notice (9) The notice mentioned in clause (8) (a) shall contain, (a)  a description of the proposed regulation and the text of it; (b)  a statement of the time period during which members of the public may submit written comments on the proposed regulation to the Minister and the manner in which and the address to which the comments must be submitted; (c)  a description of whatever other rights, in addition to the right described in clause (b), that members of the public have to make submissions on the proposed regulation and the manner in which and the time period during which those rights must be exercised; (d)  a statement of where and when members of the public may review written information about the proposed regulation; and (e)  all other information that the Minister considers appropriate.  2006, c. 14, s. 27 (23). Time period for comments (10) The time period mentioned in clauses (9) (b) and (c) shall be at least 30 days after the Minister gives the notice mentioned in clause (8) (a) unless the Minister shortens the time period in accordance with subsection (11).  2006, c. 14, s. 27 (23). Shorter time period for comments (11) The Minister may shorten the time period if, in the Minister’s opinion, (a)  the urgency of the situation requires it; (b)  the proposed regulation clarifies the intent or operation of this Act or the regulations; or (c)  the proposed regulation is of a minor or technical nature.  2006, c. 14, s. 27 (23). Discretion to make regulations, Minister (11.1) After considering the comments and submissions mentioned in clause (8) (d), the Minister, without further notice under subsection (8), may make the proposed regulation under subsection (1.1) with the changes that the Minister considers appropriate, whether or not those changes are mentioned in the comments and submissions. 2017, c. 11, Sched. 4, s. 5 (4). Discretion to make regulations (12) Upon receiving the Minister’s report mentioned in clause (8) (e), the Lieutenant Governor in Council, without further notice under subsection (8), may make the proposed regulation with the changes that the Lieutenant Governor in Council considers appropriate, whether or not those changes are mentioned in the Minister’s report.  2006, c. 14, s. 27 (23); 2017, c. 11, Sched. 4, s. 5 (5). No review (13) Subject to subsection (14), a court shall not review any action, decision, failure to take action or failure to make a decision by the Lieutenant Governor in Council or the Minister under subsections (8) to (12).  2006, c. 14, s. 27 (23). Exception (14) Any person resident in Ontario may make an application for judicial review under the Judicial Review Procedure Act on the grounds that the Minister has not taken a step required by subsections (8) to (12).  2006, c. 14, s. 27 (23). Time for application (15) No person shall make an application under subsection (14) with respect to a regulation later than 21 days after the day on which the Minister publishes a notice with respect to the regulation under clause (8) (a).  2006, c. 14, s. 27 (23). Rolling incorporation (16) A regulation made under subsection (1) that incorporates another document by reference may provide that the reference to the document includes amendments made to the document from time to time after the regulation is made. 2017, c. 11, Sched. 4, s. 5 (6). Section Amendments with date in force (d/m/y) 1996, c. 1, Sched. G, s. 15 (1-4, 6-10) - 27/05/1996; 1996, c. 1, Sched. G, s. 15 (5) - 30/01/1996 2004, c. 7, s. 14 (1) - 17/06/2004 2006, c. 14, s. 27 (1-22) - 01/10/2006; 2006, c. 14, s. 27 (23) - 20/06/2006 2009, c. 26, s. 19 (8) - 15/03/2010 2010, c. 1, Sched. 21, s. 2 - 01/07/2010 2017, c. 8, Sched. 24, s. 2 (1, 3) - 01/09/2017; 2017, c. 8, Sched. 24, s. 2 (2, 4) - 01/09/2019; 2017, c. 11, Sched. 4, s. 5 (1-6) - 01/07/2017 2019, c. 15, Sched. 28, s. 2 (1, 2) - 01/01/2020