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 time period, referred to in subsection (2), to which the information pertains;

• (d) the drug identification number assigned under the Food and Drug Regulations or, where no drug identification number has been assigned, any other identification number assigned to each dosage form and strength of the medicine of the patentee or former patentee;

• (e) the quantity of the medicine sold and either the average price per package or the net revenue from sales of each dosage form, strength and package size in which the medicine was sold in final dosage form by the patentee or former patentee to each class of customer in each province during the periods referred to in subsection (2);

• (f) the publicly available ex-factory price for each dosage form, strength and package size of the medicine that was sold by the patentee or former patentee to each class of customer in each province during the periods referred to in subsection (2);

• (g) where the medicine is being sold in one or more of the countries set out in Schedule I, 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, during the periods referred to in subsection (2).

(2) The information referred to in subsection (1) shall be provided in respect of

• (a) the 30 day period following the date of the first sale in Canada of the medicine; and

• (b) each six month period commencing on January 1 and July 1 of each year.

(3) The information referred to in subsection (2) shall be provided within 30 days after the end of each period referred to in that subsection.

(4) For the purposes of paragraph (1)(e), 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 benefits of a like nature and after deduction of the federal sales tax shall be used.

(5) For the purposes of paragraph (1)(e), 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 benefits of a like nature and after deduction of federal sales taxes shall be used.

(6) Subject to subsection (7), this section does not apply in respect of medicine sold by the patentee or former patentee to any person with whom the patentee or former patentee does not deal at arm’s length, or to any other patentee or former patentee.

(7) Where the patentee or former patentee sells the medicine to a person with whom the patentee or former patentee does not deal at arm’s length and the person is not required to provide information pursuant to paragraphs 80(1)(a) and 80(2)(a) of the Act, the patentee or former patentee shall provide the information required under paragraphs (1)(e) to (g) in respect of any resale of the medicine by that person.

(8) For the purposes of paragraph (1)(g), the price at which a medicine was sold in a country other than Canada shall be expressed in the currency of that country.

(9) For the purposes of this section, the provisions of the Income Tax Act, as that Act read on December 1, 1987, apply with such modifications as the circumstances require, in determining whether a patentee or former patentee is dealing at arm’s length with another person.

(10) 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.