Patented Medicines Regulations

4 (1) For the purposes of paragraphs 80(1)(b) and (2)(b) of the Act, information identifying the medicine and concerning the price of the medicine shall indicate

• (a) the identity of the rights holder or former rights holder;

• (b) the generic name and brand name of the medicine;

• (c) the date on which the medicine is first sold in Canada;

• (d) the day or period, referred to in subsection (2) or (3), to which the information pertains;

• (e) the drug identification number assigned under the Food and Drug Regulations in respect of the medicine or, if no drug identification number has been assigned, any other identification number assigned in respect of each dosage form and strength of the medicine of the rights holder or former rights holder; and

• (f) in respect of the day or period referred to in paragraph (d),

  • (i) the quantity of the medicine sold in final dosage form and either the average price per package or the net revenue from sales in respect of each dosage form, strength and package size in which the medicine was sold by the rights holder or former rights holder to each class of customer in each province and territory,

  • (ii) the publicly available ex-factory price for each dosage form, strength and package size in which the medicine was sold by the rights holder or former rights holder to each class of customer in each province and territory, and

  • (iii) if the medicine is being sold in one or more of the countries set out in the schedule, the publicly available ex-factory price for each dosage form, strength and package size in which the medicine was sold to each class of customer in each of those countries.

• (g) [Repealed, SOR/2008-70, s. 4]

(2) The information referred to in subsection (1) shall be provided to the Board

• (a) for the day on which the medicine is first sold in Canada, within 30 days after that day; and

• (b) for each six-month period beginning on January 1 and July 1 in a year, within 30 days after the end of the period.

(3) Despite subsection (2), in each of the following cases, the information referred to in subsection (1), for each six-month period beginning on January 1 and July 1 of each year, shall be provided within 30 days after the day on which the Board sends a request for the rights holder to provide that information and, during the two years following the request, within 30 days after the end of each six-month period:

• (a) the medicine is not a prescription drug as defined in section A.01.010 of the Food and Drug Regulations and is not a drug described in Schedule D to the Food and Drugs Act;

• (b) the medicine contains a controlled substance as defined in subsection 2(1) of the Controlled Drugs and Substances Act, the sale or provision of which does not require a prescription under that Act;

• (c) a notice of compliance has been issued in respect of the medicine on the basis of information and material contained in a submission filed under section C.08.002.1 of the Food and Drug Regulations;

• (d) the medicine is for veterinary use.

(4) For the purposes of subparagraph (1)(f)(i),

• (a) in calculating the average price per package of medicine, the actual price after any reduction given as a promotion or in the form of rebates, discounts, refunds, free goods, free services, gifts or any other benefit of a like nature and after the deduction of the federal sales tax shall be used; and

• (b) in calculating the net revenue from sales of each dosage form, strength and package size in which the medicine was sold in final dosage form, the actual revenue after any reduction in the form of rebates, discounts, refunds, free goods, free services, gifts or any other benefit of a like nature and after the deduction of federal sales taxes shall be used.

(5) Subject to subsection (6), this section does not apply to medicine sold by a rights holder or former rights holder to a person with whom they do not deal at arm’s length or to another rights holder or former rights holder.

(6) If the rights holder or former rights holder sells the medicine to a person with whom they do not deal at arm’s length and who is not required to provide information under paragraph 80(1)(a) or (2)(a) of the Act, the rights holder or former rights holder shall provide the information required under paragraph (1)(f) in respect of any resale of the medicine by the person.

(7) For the purposes of subparagraph (1)(f)(iii), the price at which a medicine was sold in a country other than Canada shall be expressed in the currency of that country.

(8) For the purposes of this section, the Income Tax Act, as that Act read on December 1, 1987, applies, with any modifications that the circumstances require, in determining whether a rights holder or former rights holder is dealing at arm’s length with another person.

(9) For the purposes of this section, publicly available ex-factory price includes any price of a patented medicine or medicine protected by a certificate of supplementary protection that is agreed on by the rights holder or former rights holder and the appropriate regulatory authority of the country in which the medicine is sold by the rights holder.

(10) [Repealed, SOR/2008-70, s. 4]