11.4 (1) A manufacturer shall not sell a listed drug product, for the purpose of supplying a drug product under this Act, for a price that is higher than its drug benefit price as listed in the Formulary.  2006, c. 14, s. 19. Agreement not to exceed drug benefit price (2) A manufacturer, in agreeing to a drug benefit price with the executive officer under section 22, shall agree to comply with subsection (1).  2006, c. 14, s. 19. Executive officer may make order (3) 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 (4).  2006, c. 14, s. 19. How amount calculated (4) The amount that the manufacturer is required to pay under subsection (3) is the amount determined by the formula: A = Q (P – DBP) where, “A”  is the amount to be paid by the manufacturer, “P”  is the price for which the manufacturer is selling the listed drug product, “DBP” is the drug benefit price, and “Q”  is the number of units of the listed drug product sold at the higher price. 2006, c. 14, s. 19. Reconsideration (5) Within 14 days of being served with an order under subsection (3), the manufacturer may submit evidence to the executive officer as to its compliance with subsection (1), or that the amount calculated under subsection (4) is not correct, and the executive officer shall reconsider the order based on that evidence.  2006, c. 14, s. 19. Actions of executive officer after reconsideration (6) 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. 19. Executive officer may act (7) Where a manufacturer has not complied with an order under subsection (3) within 14 days of being served with it, or has submitted evidence within 14 days under subsection (5) and the order has been affirmed or varied under subsection (6) 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 (3) requiring the manufacturer to pay a revised amount calculated under subsection (4), or do either or both of the following: 1.  Remove the designation of the drug that is the subject of the order as a listed drug product. 2.  Not make further designations of any of the manufacturer’s drug products as listed drug products under section 1.3, nor consider any of its drug products for approval under section 16, nor designate any of its products as interchangeable under the Drug Interchangeability and Dispensing Fee Act until such time as the executive officer is of the opinion that the manufacturer is selling the drug product for the drug benefit price.  2006, c. 14, s. 19. Limit on reconsideration (8) Subsections (5) and (6) do not apply to a further order mentioned in subsection (7).  2006, c. 14, s. 19. Required notice (9) Where the executive officer proposes to act under paragraph 2 of subsection (7), the executive officer shall serve the manufacturer with at least 30 days notice.  2006, c. 14, s. 19. Section Amendments with date in force (d/m/y) 2006, c. 14, s. 19 - 01/10/2006