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 patentee or former patentee;

• (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 patentee or former patentee; 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 patentee or former patentee 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 patentee or former patentee 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• (g) [Repealed, SOR/2008-70, s. 4]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) If the medicine is for human use and contains a controlled substance as defined in the Controlled Drugs and Substances Act or a substance listed or described in Schedule C or D to the Food and Drugs Act or Schedule F to the Food and Drug Regulations, the information referred to in subsection (1) shall be provided

• (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) If the medicine is for human use and does not contain a controlled substance as defined in the Controlled Drugs and Substances Act or does not contain a substance listed or described in Schedule C or D to the Food and Drugs Act or in Schedule F to the Food and Drug Regulations or is a medicine for veterinary use, 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 to the Board within 30 days after the date on which the Board sends a request in response to a complaint respecting the price of the medicine, and during the two years following the request, within 30 days after each six-month period.

(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 patentee or former patentee to a person with whom they do not deal at arm’s length or to another patentee or former patentee.

(6) If the patentee or former patentee 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 paragraphs 80(1)(a) or (2)(a) of the Act, the patentee or former patentee 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 patentee or former patentee 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 that is agreed on by the patentee or former patentee and the appropriate regulatory authority of the country in which the medicine is sold by the patentee.

(10) [Repealed, SOR/2008-70, s. 4]