12.1 (1) A manufacturer shall not provide a rebate to wholesalers, operators of pharmacies, or companies that own, operate or franchise pharmacies, or to their directors, officers, employees or agents, (a) for any interchangeable product; or (b) for any product in respect of which the manufacturer has made an application to the executive officer for designation as an interchangeable product, while that application is being considered.  2006, c. 14, s. 3. Extended definition of “manufacturer” (2) For the purposes of this section and in section 12.2, unless the context requires otherwise, “manufacturer” includes a supplier, distributor, broker or agent of a manufacturer, except in, (a) clause (1) (b) of this section, (b) paragraph 2 of subsection (8) of this section, (c) subsection (10) of this section, and (d) clauses (b) and (c) of the definition of “drug benefit price” in subsection (14) of this section.  2006, c. 14, s. 3. May not accept rebate (3) No wholesaler, operator, company, director, officer, employee or agent mentioned in subsection (1) shall accept a rebate that is mentioned in subsection (1), either directly or indirectly.  2006, c. 14, s. 3. Executive officer may make order (4) If the executive officer believes, on reasonable grounds, that a manufacturer is not complying with subsection (1), the executive officer may make an order requiring the manufacturer to pay to the Minister of Finance the amount calculated under subsection (5).  2006, c. 14, s. 3. Calculation (5) For the purposes of this section, the following rules apply to calculating the amount that is to be paid under subsection (4): 1. The amount shall be calculated by determining the difference between the expected value of all units of the drug products purchased and the actual cost of acquiring those units by the wholesaler, operator of a pharmacy, or company that owns, operates or franchises pharmacies. 2. The expected value mentioned in paragraph 1 shall be determined by multiplying the drug benefit price by the volume of units provided by the manufacturer or wholesaler for all the products. 3. The actual cost of acquiring those products mentioned in paragraph 1 shall be determined by subtracting the monetary value of the rebate from the amount paid for all the products by the wholesaler, operator of a pharmacy, or company that owns, operates or franchises pharmacies.  2006, c. 14, s. 3. Reconsideration (6) Within 14 days of being served with the order, the manufacturer may submit evidence to the executive officer as to its compliance with subsection (1), or that the amount calculated under subsection (5) is not correct, and the executive officer shall reconsider the order based on that evidence.  2006, c. 14, s. 3. Actions of executive officer after reconsideration (7) After reconsidering the order, the executive officer may do one of the following, and shall promptly serve the manufacturer with notice of his or her decision: 1. Affirm the order. 2. Rescind the order. 3. Vary the order.  2006, c. 14, s. 3. Executive officer may act (8) Where a manufacturer has not complied with an order under subsection (4) within 14 days of being served with it, or has submitted evidence within 14 days under subsection (6) and the order has been affirmed or varied under subsection (7) and the manufacturer has not complied with the affirmed or varied order within 14 days of being served with it, the executive officer may either issue a further order under subsection (4) requiring the manufacturer to pay a revised amount calculated under subsection (5), or do either or both of the following: 1. If the drug that is the subject of the order is an interchangeable product, remove its designation. 2. Not make further designations of any of the manufacturer’s products as interchangeable under this Act, or as listed drug products under section 1.3 of the Ontario Drug Benefit Act, nor consider any of its products for approval under section 16 of that Act, until such time as the executive officer is of the opinion that the manufacturer is no longer offering the rebate.  2006, c. 14, s. 3. Limit on reconsideration (9) Subsections (6) and (7) do not apply to a further order mentioned in subsection (8).  2006, c. 14, s. 3. Required notice (10) Where the executive officer proposes to act under paragraph 2 of subsection (8), the executive officer shall serve the manufacturer with at least 30 days notice.  2006, c. 14, s. 3. Executive officer order where rebate accepted (11) Where the executive officer believes, on reasonable grounds, that a person has accepted a rebate contrary to subsection (3), the executive officer may make an order requiring the person to pay to the Minister of Finance the amount calculated under subsection (5).  2006, c. 14, s. 3. Reconsideration (12) Subsections (6) and (7), subsection (8), other than paragraphs 1 and 2, and subsection (9) apply with any necessary modifications where an order has been made under subsection (11).  2006, c. 14, s. 3. Lesser amount (13) Despite any other provision of this section, the executive officer may, in an order under subsection (4) or (11), require the manufacturer or other person to pay an amount less than the amount calculated under subsection (5) and, where the executive officer does so, the following apply: 1. The executive officer shall set out in the order both the lesser amount and how it was calculated. 2. Any right of reconsideration that applies with respect to a calculation under subsection (5) applies with respect to the calculation under paragraph 1.  2006, c. 14, s. 3. Definitions (14) In this section, “drug benefit price” means, with respect to a product, (a) its drug benefit price under the Ontario Drug Benefit Act, (b) in the case of a product that is not a benefit under the Ontario Drug Benefit Act, a price submitted by the manufacturer under the regulations that has been posted by the executive officer in the Formulary, or (c) in the case of a product mentioned in clause (1) (b), the price submitted by the manufacturer; (“prix au titre du régime de médicaments”) “rebate”, subject to the regulations, includes, without being limited to, currency, a discount, refund, trip, free goods or any other prescribed benefit, but does not include something provided in accordance with ordinary commercial terms. (“rabais”)  2006, c. 14, s. 3; 2010, c. 1, Sched. 5, s. 1 (1). Regulations (15) The Lieutenant Governor in Council may make regulations clarifying the definition of “rebate” in this section, 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 this section and defining “ordinary commercial terms” for the purposes of that definition, including setting limits on ordinary commercial terms.  2010, c. 1, Sched. 5, s. 1 (2). Section Amendments with date in force (d/m/y) 2006, c. 14, s. 3
- 01/10/2006 2010, c. 1, Sched. 5, s. 1 (1, 2) - 01/04/2013