Patented Medicines Regulations (SOR/94-688)

AMENDMENTS NOT IN FORCE

• — SOR/2019-298, s. 1, as amended by SOR/2020-126, s. 1

  • 1 The Patented Medicines RegulationsFootnote ¹ are amended by adding the following after section 2:

    • Return to footnote ¹SOR/94-688; SOR/2008-70, s. 1

    Non-application of Certain Provisions

    • 2.1 Sections 4.1 to 4.4 do not apply to any medicine for which a drug identification number has been assigned under the Food and Drug Regulations before August 21, 2019.

• — SOR/2019-298, s. 2, as amended by SOR/2021-116, s. 4

  • • 2 (1) Paragraph 3(1)(g) of the French version of the Regulations is replaced by the following:

      • g) l’identification numérique attribuée à chaque forme posologique et à chaque concentration du médicament conformément au Règlement sur les aliments et drogues;

    • (2) Section 3 of the Regulations is amended by adding the following after subsection (3):

      • (3.1) Despite subsection (3), in each of the following cases, the information referred to in subsection (1) shall be provided within 30 days after the day on which the Board sends a request for the rights holder to provide that information:

        • (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.

• — SOR/2019-298, s. 3, as amended by SOR/2021-116, ss. 5(1) and (2)

  • • 3 (1) Paragraph 4(1)(e) of the French version of the Regulations is replaced by the following:

      • e) l’identification numérique attribuée conformément au Règlement sur les aliments et drogues ou, à défaut, toute autre identification numérique attribuée à chaque forme posologique et à chaque concentration du médicament du titulaire de droits ou de l’ancien titulaire de droits;

    • (2) The portion of subsection 4(2) of the Regulations before paragraph (a) is replaced by the following:

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

    • (3) Subsection 4(3) of the Regulations is replaced by the following:

      • (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) Paragraphs 4(4)(a) and (b) of the Regulations are replaced by the following:

      • (a) in calculating the average price per package of a medicine, the actual price obtained by the patentee shall be used, taking into account any adjustments that are made by the patentee or any party that directly or indirectly purchases the medicine or reimburses for the purchase of the medicine and any reduction given to any party in the form of free goods, free services, gifts or any other benefit of a like nature; and

      • (b) in calculating the net revenue from sales in respect of each dosage form, strength and package size in which the medicine was sold in final dosage form, the actual revenue obtained by the patentee shall be used, taking into account any adjustments that are made by the patentee or any party that directly or indirectly purchases the medicine or reimburses for the purchase of the medicine and any reduction given to any party in the form of free goods, free services, gifts or any other benefit of a like nature.

• — SOR/2019-298, s. 4, as amended by SOR/2020-126, s. 2, SOR/2020-298, s. 1, SOR/2021-116, s. 6, SOR/2021-162, s. 1 and SOR/2021-273, s. 1

  • 4 The Regulations are amended by adding the following after section 4:

    • • 4.1 (1) For the purposes of paragraphs 80(1)(d) and 2(d) of the Act, in respect of the factor referred to in paragraph 4.4(a), the rights holder shall provide to the Board every cost-utility analysis prepared by a publicly funded Canadian organization, if published and communicated to the rights holder, for which the outcomes are expressed as the cost per quality-adjusted life year for each indication that is the subject of the analysis.

      • (2) The rights holder shall provide to the Board any information about the medicine that was redacted from a published analysis.

      • (3) An analysis shall be provided

        • (a) if the analysis is published before the day on which the medicine is first offered for sale in Canada, within 30 days after that day; or

        • (b) if the analysis is not published before the day on which the medicine is first offered for sale in Canada, within 30 days after the day on which it is published.

      • (4) Despite subsection (3), in the case of a medicine that is offered for sale in Canada before July 1, 2022, an analysis shall be provided

        • (a) if the analysis is published before July 1, 2022, by July 30, 2022; or

        • (b) if the analysis is not published before July 1, 2022, within 30 days after the day on which it is published.

      • (5) An analysis shall be provided to the Board only if any cost for the medicine as identified in the analysis is or would be, when that cost is pro-rated to account for that medicine’s use over a 12‐month period, greater than or equal to 50 per cent of the gross domestic product per capita in Canada at the time of publication of the analysis.

    • • 4.2 (1) For the purposes of paragraphs 80(1)(d) and (2)(d) of the Act, in respect of the factor referred to in paragraph 4.4(b), the rights holder shall provide to the Board the estimated maximum use of the medicine in Canada, as measured by the total quantity of the medicine in final dosage form expected to be sold.

      • (2) The rights holder shall provide to the Board the period of time used for the estimate of the maximum use of the medicine.

      • (3) The rights holder shall provide to the Board the estimated maximum use of the medicine within 30 days after the day on which the medicine is first offered for sale in Canada.

      • (4) Despite subsection (3), in the case of a medicine that is offered for sale in Canada before July 1, 2022, the most recent version of the estimated maximum use of the medicine shall be provided

        • (a) if the medicine is first offered for sale in Canada during the period beginning on July 1, 2019 and ending on June 30, 2022, by July 30, 2022; or

        • (b) if the medicine is first offered for sale in Canada before July 1, 2019, but the Minister of Health assigns a drug identification number under the Food and Drug Regulations

          • (i) during the period beginning on August 21, 2019 and ending on June 30, 2022, by July 30, 2022, or

          • (ii) after June 30, 2022, within 30 days after the day on which the drug identification number is assigned.

      • (5) The rights holder shall update the estimated maximum use of the medicine within 30 days after the day on which the Minister of Health issues a notice of compliance approving a new or modified therapeutic use of the medicine.

    • • 4.3 (1) Despite subsections 4.1(3) and (4) and 4.2(3) and (4), in each of the following cases, the information referred to in subsections 4.1(1) and (2) and 4.2(1) and (2) shall be provided within 30 days after the day on which the Board sends a request for the rights holder to provide that information:

        • (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.

      • (2) The requirements of subsection 4.2(5) apply in respect of the information provided under subsection (1).

    Other Factors to be Considered — Excessive Prices

    • 4.4 For the purposes of paragraph 85(1)(e) of the Act, the other factors that the Board shall take into consideration to determine whether a medicine that is sold in any market in Canada after June 30, 2022 is being or has been sold at an excessive price are the following:

      • (a) the medicine’s pharmacoeconomic value in Canada;

      • (b) the size of the market for the medicine in Canada; and

      • (c) the gross domestic product in Canada and the gross domestic product per capita in Canada.

• — SOR/2019-298, s. 5

  • 5 Paragraph 5(3)(a) of the French version of the Regulations is replaced by the following:

    • a) auxquels une identification numérique a été attribuée conformément au Règlement sur les aliments et drogues ou ceux qui ont été approuvés pour la vente à un chercheur compétent conformément à ce règlement;

• — SOR/2019-298, s. 6

  • 6 The schedule to the Regulations is replaced by the schedule set out in the schedule to these Regulations.

    SCHEDULE(Subparagraph 4(1)(f)(iii))

    • Australia

      Australie

    • Belgium

      Belgique

    • France

      France

    • Germany

      Allemagne

    • Italy

      Italie

    • Japan

      Japon

    • Netherlands

      Pays-Bas

    • Norway

      Norvège

    • Spain

      Espagne

    • Sweden

      Suède

    • United Kingdom

      Royaume-Uni

• — SOR/2021-116, s. 5(3)

  • • 5 (3) Subsection 3(4) of the Regulations is amended by replacing the paragraphs 4(4)(a) and (b) that it enacts with the following:

      • (a) in calculating the average price per package of a medicine, the actual price obtained by the rights holder shall be used, taking into account any adjustments that are made by the rights holder or any party that directly or indirectly purchases the medicine or reimburses for the purchase of the medicine and any reduction given to any party in the form of free goods, free services, gifts or any other benefit of a like nature; and

      • (b) in calculating the net revenue from sales in respect of each dosage form, strength and package size in which the medicine was sold in final dosage form, the actual revenue obtained by the rights holder shall be used, taking into account any adjustments that are made by the rights holder or any party that directly or indirectly purchases the medicine or reimburses for the purchase of the medicine and any reduction given to any party in the form of free goods, free services, gifts or any other benefit of a like nature.