Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages): SOR/2021-199

Canada Gazette, Part II, Volume 155, Number 18

Registration
SOR/2021-199 August 12, 2021

FOOD AND DRUGS ACT
PATENT ACT

P.C. 2021-869 August 11, 2021

Whereas, pursuant to subsection 30(1.3)footnote a of the Food and Drugs Actfootnote b, the Minister of Health has taken into account existing information management systems, with a view to not recommending the making of regulations that would impose unnecessary administrative burdens;

Therefore, Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, makes the annexed Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) pursuant to

Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages)

Food and Drugs Act

Food and Drug Regulations

1 (1) The portion of section C.01.014.8 of the Food and Drug Regulationsfootnote 1 before the first definition is replaced by the following:

C.01.014.8 The following definitions apply in this section and in sections C.01.014.9 to C.01.014.14.

(2) The definition shortge in section C.01.014.8 of the Regulations is replaced by the following:

shortage,
in respect of a drug, means a situation in which the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for the drug is unable to meet the demand for the drug in Canada. (pénurie)

2 Section C.01.014.9 of the Regulations is amended by adding the following after subsection (4):

(5) This section does not apply in respect of a shortage of a drug that results from a decision by the manufacturer to discontinue its sale.

3 The Regulations are amended by adding the following after section C.01.014.11:

C.01.014.12 (1) The Minister may request that the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for a drug — or any person who holds an establishment licence in respect of a drug — provide the Minister with information that is in their control if the Minister has reasonable grounds to believe that

  • (a) there is a shortage or risk of shortage of the drug;
  • (b) the information is necessary to establish or assess
    • (i) the existence of a shortage or risk of shortage of the drug,
    • (ii) the reason for a shortage or risk of shortage of the drug,
    • (iii) the effects or potential effects on human health of a shortage of the drug, or
    • (iv) measures that could be taken to prevent or alleviate a shortage of the drug; and
  • (c) the manufacturer or licensee will not provide the information without a legal obligation to do so.

(2) The manufacturer or licensee shall provide the requested information electronically in a format specified by or acceptable to the Minister within the time limit specified by the Minister.

C.01.014.13 No person who holds an establishment licence shall distribute a drug for consumption or use outside Canada unless the licensee has reasonable grounds to believe that the distribution will not cause or exacerbate a shortage of the drug.

C.01.014.14 (1) If a person who holds an establishment licence distributes a drug for consumption or use outside Canada, the licensee shall immediately create a detailed record of the information that they relied on to determine that the distribution of the drug is not prohibited by section C.01.014.13.

(2) The licensee shall retain the record for at least one year after the latest expiration date of the drug that they distributed.

4 Paragraph C.01.020.1(2)(c) of the Regulations is replaced by the following:

  • (c) in the case of a drug imported under subsection C.10.001(2) or section C.10.006, the identifying code or number of the drug, if any, assigned in the country in which the drug was authorized for sale;

5 The Regulations are amended by adding the following after section C.10.003:

C.10.004 (1) The following definitions apply in this section and in sections C.10.005 to C.10.011.

designated drug
means a drug that is set out in the List of Drugs for Exceptional Importation and Sale. (drogue désignée)
drug
means any of the following drugs for human use:
  • (a) drugs included in Schedule I, II, III, IV or V to the Controlled Drugs and Substances Act;
  • (b) prescription drugs;
  • (c) drugs that are listed in Schedule C or D to the Act; and
  • (d) drugs that are permitted to be sold without a prescription but that are to be administered only under the supervision of a practitioner. (drogue)
foreign regulatory authority
has the same meaning as in subsection C.10.001(1). (autorité réglementaire étrangère)
List of Drugs for Exceptional Importation and Sale
means the List of Drugs for Exceptional Importation and Sale that is published by the Government of Canada on its website, as amended from time to time. (Liste des drogues destinées aux importations et aux ventes exceptionnelles)

(2) In sections C.10.006 and C.10.009, batch certificate, fabricate, MRA country, package/label and recognized building have the same meanings as in subsection C.01A.001(1).

C.10.005 (1) The Minister may add a drug to the List of Drugs for Exceptional Importation and Sale only if the Minister has reasonable grounds to believe that

  • (a) there is a shortage or risk of shortage of another drug for which a notice of compliance has been issued under section C.08.004 or C.08.004.01 or for which a drug identification number has been assigned under subsection C.01.014.2(1); and
  • (b) the drug to be added to that list can be substituted for the drug referred to in paragraph (a).

(2) In subsection (1), shortage has the same meaning as in section C.01.014.8.

C.10.006 (1) A person who holds an establishment licence that authorizes the importation of a drug may import a designated drug if the following conditions are met:

  • (a) the licensee provides the Minister, electronically in a format specified by or acceptable to the Minister and not later than the third business day before the day on which the designated drug is imported, with a notification that contains the following information:
    • (i) the licensee's name and contact information,
    • (ii) the name and contact information of each fabricator, packager/labeller and tester of the designated drug and the address of each building in which it is fabricated, packaged/labelled or tested,
    • (iii) in respect of the designated drug,
      • (A) its brand name,
      • (B) its medicinal ingredients,
      • (C) its dosage form,
      • (D) its strength,
      • (E) its route of administration,
      • (F) its identifying code or number, if any, assigned in the country in which it is authorized for sale, and
      • (G) a detailed description of its conditions of use,
    • (iv) the intended port of entry into Canada,
    • (v) the estimated date of arrival of the shipment of the designated drug, and
    • (vi) the total quantity of the designated drug that is intended to be imported on the date referred to in subparagraph (v);
  • (b) the designated drug is authorized to be sold by a foreign regulatory authority within its jurisdiction;
  • (c) the designated drug is in the same category as the category for which the establishment licence was issued;
  • (d) the following information is set out in the List of Drugs for Exceptional Importation and Sale in respect of the designated drug:
    • (i) the licensee's name,
    • (ii) the information referred to in clauses (a)(iii)(A) to (F),
    • (iii) the name of the foreign regulatory authority referred to in paragraph (b), and
    • (iv) the date after which it may no longer be imported;
  • (e) the lot number of the designated drug is set out in the list referred to in paragraph (d), if applicable;
  • (f) the total quantity of the designated drug that the licensee imports does not exceed the maximum limit specified in the list referred to in paragraph (d) in respect of the drug, if applicable;
  • (g) the designated drug is imported on or before the date referred to in subparagraph (d)(iv); and
  • (h) the licensee has prepared a plan that specifies the measures to be taken in order for the licensee to comply with section C.10.011.

(2) In subsection (1), business day means a day other than

  • (a) a Saturday; or
  • (b) a Sunday or other holiday.

C.10.007 Sections A.01.040, A.01.044 and C.01.004.1 do not apply in respect of the importation, under section C.10.006, of a designated drug by a person who holds an establishment licence.

C.10.008 (1) Subject to sections C.10.009 and C.10.010, a sale of a designated drug that is imported under section C.10.006 is exempt from the following provisions:

  • (a) sections A.01.015, A.01.017 and A.01.051; and
  • (b) the provisions of Part C other than
    • (i) sections C.01.016, C.01.017, C.01.019 to C.01.020.1, C.01.040.3 to C.01.049.1 and C.01.051,
    • (ii) the provisions of Divisions 1A and 2, and
    • (iii) this section and sections C.10.009 to C.10.011.

(2) For greater certainty, for the purposes of section C.01.016, the manufacturer of a designated drug is required to comply only with the requirements set out in sections C.01.017 and C.01.019 in respect of the drug.

(3) Subsections (1) and (2) cease to apply in respect of the sale of a designated drug on its expiration date.

C.10.009 (1) Section C.02.019 does not apply to a person who holds an establishment licence in respect of a designated drug that they import under section C.10.006.

(2) The licensee shall perform the finished product testing on a sample of the designated drug that is taken either

  • (a) after receipt of each lot or batch of the designated drug on their premises in Canada; or
  • (b) before receipt of each lot or batch of the designated drug on their premises in Canada if the following conditions are met:
    • (i) the licensee has evidence satisfactory to the Minister to demonstrate that lots or batches of the designated drug sold to them by the vendor of the lot or batch are consistently manufactured in accordance with and consistently comply with the specifications for that drug, and
    • (ii) the designated drug has not been transported or stored under conditions that may affect its compliance with the specifications for that drug.

(3) In subsection (2), a reference to specifications is a reference to the specifications with which the designated drug is required to comply within the jurisdiction of the foreign regulatory authority referred to in paragraph C.10.006(1)(b).

(4) If the licensee receives on their premises in Canada a lot or batch of a designated drug whose useful life is more than 30 days, they shall visually inspect the lot or batch to confirm the identity of the product.

(5) Subsections (2) and (4) do not apply to the licensee if the designated drug is fabricated, packaged/labelled and tested in an MRA country at a recognized building and the following conditions are met:

  • (a) the address of the building is set out in their establishment licence; and
  • (b) they retain a copy of the batch certificate for each lot or batch of the designated drug that they receive for at least one year after the expiration date of the lot or batch.

(6) In this section, specifications has the same meaning as in section C.02.002.

C.10.010 (1) A person who holds an establishment license and who imports a designated drug under section C.10.006 is required to comply with paragraphs C.02.020(1)(a), (b) and (d) in respect of the drug but is not required to maintain the records referred to in those paragraphs on their premises in Canada.

(2) The Minister may request that the licensee provide to the Minister any of the records referred to in paragraphs C.02.020(1)(a), (b) or (d) in respect of the designated drug.

(3) The licensee shall provide the requested records electronically in a format specified by or acceptable to the Minister within the time limit specified by the Minister.

C.10.011 (1) A person who holds an establishment licence shall not sell a designated drug that they imported under section C.10.006 unless they ensure that the information referred to in clause C.10.006(1)(a)(iii)(G) is available in English and French and in a manner that permits the safe use of the drug.

(2) The licensee shall ensure that the information is available in accordance with subsection (1) until at least the end of the day on the latest expiration date of the designated drug that they imported.

Medical Devices Regulations

6 Section 1 of the Medical Devices Regulationsfootnote 2 is amended by adding the following in alphabetical order:

business day
means a day other than
  • (a) a Saturday; or
  • (b) a Sunday or other holiday. (jour ouvrable)
shortage,
in respect of a medical device, means a situation in which the manufacturer of the device is unable to meet the demand for the device in Canada. (pénurie)

7 The Regulations are amended by adding the following after section 62.2:

Shortages

62.21 The following definitions apply in this section and in sections 62.22 to 62.26.

List of Medical Devices – Notification of Shortages
means the List of Medical Devices – Notification of Shortages that is published by the Government of Canada on its website, as amended from time to time. (Liste d'instruments médicaux – avis de pénuries)
specified medical device
means a medical device that belongs to a category of medical devices that is set out in the List of Medical Devices – Notification of Shortages. (instrument médical inscrit)

62.22 The Minister may add a category of medical devices to the List of Medical Devices – Notification of Shortages only if the Minister has reasonable grounds to believe that a shortage of a device that belongs to the category presents or may present a risk of injury to human health.

62.23 (1) Subject to subsections (2), (7) and (9), if a shortage of a specified medical device exists or is likely to occur, the manufacturer of the device and, in the case of a Class I device, the importer of the device shall each provide the following information to the Minister electronically in a format specified by or acceptable to the Minister:

  • (a) the name and contact information of the manufacturer and, if the information is provided by the importer, the name and contact information of the importer;
  • (b) in the case of a Class II, III or IV device, the medical device licence number;
  • (c) the identifier of the device, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;
  • (d) the name of the device, including, if applicable, the model name, in English and French;
  • (e) a description of the device and of its packaging and an indication of whether it is a single-use device;
  • (f) the date when the shortage began or is anticipated to begin;
  • (g) the anticipated date when the manufacturer will be able to meet the demand for the device if that date can be anticipated;
  • (h) the reason for the shortage; and
  • (i) a summary of the information that the manufacturer or importer relied on to determine that a shortage of the device exists or is likely to occur.

(2) If the manufacturer of a specified medical device decides to discontinue the sale of the device in Canada, the following rules apply:

  • (a) the manufacturer or importer is required to provide only the information referred to in paragraphs (1)(a) to (f) in respect of the shortage that results from the decision and shall also provide under subsection (1) the reason for the discontinuation; and
  • (b) paragraph 4(a) does not apply to the manufacturer.

(3) For greater certainty, subsections (1) and (2) do not remove the requirement for a manufacturer that is the holder of a medical device licence to inform the Minister under subsection 43(3).

(4) Subject to subsection (8), the information that is required under subsection (1) shall be provided

  • (a) if the manufacturer or importer did not anticipate the shortage, within five business days after the day on which the manufacturer or importer becomes aware of it; and
  • (b) if the manufacturer or importer anticipates that there will be a shortage, within five business days after the day on which the manufacturer or importer anticipates it.

(5) If any of the information that was provided under subsection (1) changes, the manufacturer or importer shall provide the new information to the Minister electronically in a format specified by or acceptable to the Minister within two business days after the day on which the manufacturer or importer makes or becomes aware of the change.

(6) Within two business days after the day on which the manufacturer is again able to meet the demand for the specified medical device, the manufacturer or importer shall notify the Minister electronically in a format specified by or acceptable to the Minister of the manufacturer's ability to do so.

(7) The manufacturer or importer need not provide the information that is required under subsection (1) if, within the applicable period referred to in paragraph (4)(a) or (b), the manufacturer or importer anticipates that the manufacturer will be able to meet the demand for the specified medical device within 30 days after the day on which the manufacturer or importer anticipated or became aware of the shortage.

(8) Despite subsection (7), if the manufacturer or importer subsequently concludes that the manufacturer will be unable to meet the demand within the 30-day period, the manufacturer or the importer shall provide the information that is required under subsection (1) within five business days after the day on which the manufacturer or importer reaches that conclusion.

(9) The manufacturer or importer need not provide the information that is required under subsection (1) if the manufacturer

  • (a) is also the manufacturer of another medical device that can be substituted for the specified medical device in respect of which a shortage exists or is likely to occur; and
  • (b) is able to meet the demand for the substitute medical device.

62.24 (1) Despite section 62.23, the manufacturer of a specified medical device may permit the importer of the device to provide the information that is required under that section on the manufacturer's behalf if the information that the manufacturer and importer must provide is identical.

(2) The manufacturer shall notify the Minister electronically in a format specified by or acceptable to the Minister if the manufacturer has permitted the importer to provide the information on the manufacturer's behalf.

62.25 (1) The Minister shall publish, on the Government of Canada website, the information that the Minister receives under section 62.23, other than the information referred to in subparagraph 62.23(1)(i).

(2) Subsection (1) does not apply if the Minister has reasonable grounds to believe that a situation, in respect of which information was provided under section 62.23, does not constitute a shortage.

62.26 (1) The Minister may request that the manufacturer of a medical device — or any importer or distributor of a medical device — provide the Minister with information that is in their control if the Minister has reasonable grounds to believe that

  • (a) there is a shortage or risk of shortage of the device;
  • (b) a shortage of the device presents or may present a risk of injury to human health;
  • (c) the information is necessary to establish or assess
    • (i) the existence of a shortage or risk of shortage of the device,
    • (ii) the reason for a shortage or risk of shortage of the device,
    • (iii) the effects or potential effects on human health of a shortage of the device, or
    • (iv) measures that could be taken to prevent or alleviate a shortage of the device; and
  • (d) the manufacturer, importer or distributor will not provide the information without a legal obligation to do so.

(2) The manufacturer, importer or distributor shall provide the requested information electronically in a format specified by or acceptable to the Minister within the time limit specified by the Minister.

62.27 The following definitions apply in this section and in sections 62.28 to 62.32.

designated medical device
means a medical device that is set out in the List of Medical Devices for Exceptional Importation and Sale. (instrument médical désigné)
List of Medical Devices for Exceptional Importation and Sale
means the List of Medical Devices for Exceptional Importation and Sale that is published by the Government of Canada on its website, as amended from time to time. (Liste d'instruments médicaux destinés aux importations et aux ventes exceptionnelles)

62.28 The Minister may add a medical device to the List of Medical Devices for Exceptional Importation and Sale only if the Minister has reasonable grounds to believe that

  • (a) there is a shortage or risk of shortage of another medical device; and
  • (b) the device to be added to that list can be substituted for the device referred to in paragraph (a).

62.29 The holder of an establishment licence may import a designated medical device if the following conditions are met:

  • (a) the holder provides the Minister, electronically in a format specified by or acceptable to the Minister and not later than the fifth business day before the day on which the designated medical device is imported, with a notification that contains the following information:
    • (i) the holder's name and contact information,
    • (ii) in respect of the designated medical device,
      • (A) its name and the name of each of its components, parts and accessories, including, if applicable, the model name,
      • (B) its identifier, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family,
      • (C) the name and contact information of the manufacturer of the device as it appears on the device label,
      • (D) the name and address of the establishment where it is manufactured, if different from the information referred to in clause (C), and
      • (E) a detailed description of the medical conditions, purposes and uses for which it is manufactured, sold or represented, as well as its performance specifications if those specifications are necessary for proper use,
    • (iii) the intended port of entry into Canada,
    • (iv) the estimated date of arrival of the shipment of the designated medical device, and
    • (v) the total number of units of the designated medical device that are intended to be imported on the date referred to in subparagraph (iv);
  • (b) the designated medical device is authorized to be sold by a regulatory agency within its jurisdiction or, if the device is not required to be authorized by a regulatory agency within its jurisdiction, the device complies with the applicable legal requirements within its jurisdiction;
  • (c) the following information is set out in the List of Medical Devices for Exceptional Importation and Sale in respect of the designated medical device:
    • (i) its name,
    • (ii) its class,
    • (iii) the name of its manufacturer,
    • (iv) the establishment licence number of the holder,
    • (v) the name of the regulatory agency referred to in paragraph (b), and
    • (vi) the date after which it may no longer be imported;
  • (d) the total number of units of the designated medical device that the holder imports does not exceed the maximum limit specified in the list referred to in paragraph (c) in respect of the device, if applicable;
  • (e) the designated medical device is imported on or before the date referred to in subparagraph (c)(vi); and
  • (f) the holder has prepared a plan that specifies the measures to be taken in order for the holder to comply with section 62.32.

62.3 Sections 21 to 21.2 and 26 do not apply to the importation, under section 62.29, of a designated medical device by the holder of an establishment licence.

62.31 (1) The provisions of these Regulations — other than this section and sections 44 to 62.2, and 62.32 to 65.1 — do not apply to the sale of a designated medical device that is imported under section 62.29.

(2) Subsection (1) ceases to apply to the sale of a designated medical device on the earlier of

  • (a) the expiry date of the designated medical device, if the device has one, and
  • (b) the end of the two-year period that begins on the day that follows the date referred to in subparagraph 62.29(c)(vi).

62.32 (1) The holder of an establishment licence shall not sell a designated medical device that they imported under section 62.29 unless they ensure that the information referred to in clause 62.29(a)(ii)(E) is available in English and French and in a manner that permits the safe use of the device.

(2) Subject to subsection (3), the holder shall ensure that the information is available in accordance with subsection (1) until at least the end of the day on the latest expiry date of the designated medical devices that they imported.

(3) If the designated medical device does not have an expiry date, the holder shall ensure that the information is available in accordance with subsection (1) until at least the expiration of the period that corresponds to the projected useful life of whichever of the devices that they imported has the latest projected useful life.

Patent Act

Certificate of Supplementary Protection Regulations

8 Subsection 1(2) of the Certificate of Supplementary Protection Regulationsfootnote 3 is replaced by the following:

Definition of authorization for sale

(2) In these Regulations and for the purposes of section 104 of the Act, authorization for sale means an authorization under the Food and Drugs Act, or any predecessor enactment relating to the same subject-matter, that permits the sale of a drug in Canada, but does not include an interim order permitting the sale of a drug under section 30.1 of that Act, a certificate issued under section C.08.015 of the Food and Drug Regulations, an exemption permitting the sale of a drug under subsection C.10.002(1) or C.10.008(1) of those Regulations, an authorization under section C.05.006, C.05.008 or C.08.010 of those Regulations or section 67 or 71 of the Natural Health Products Regulations.

Transitional Provisions

9 A person who holds an establishment licence and who created a record in accordance with the Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply), made by the Minister of Health on November 27, 2020 and published in Part I of the Canada Gazette on December 12, 2020, must retain the record in accordance with subsection C.01.014.14(2) of the Food and Drug Regulations.

10 (1) In this section and in sections 11 to 15, Exceptional Importation and Shortages Interim Order No. 2 means the Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19, made by the Minister of Health on March 1, 2021 and published in Part I of the Canada Gazette on March 20, 2021.

(2) In sections 11 to 15, designated biocide, designated drug, designated food for a special dietary purpose, designated hand sanitizer and designated medical device have the same meaning as in the Exceptional Importation and Shortages Interim Order No. 2.

11 (1) Section C.10.008 of the Food and Drug Regulations applies in respect of a designated drug that was imported under the Exceptional Importation and Shortages Interim Order No. 2.

(2) Sections C.10.009 to C.10.011 of those Regulations apply to a person that holds an establishment licence in respect of a designated drug that they imported under that Interim Order.

12 (1) Subject to subsection (2), subsections C.10.008(1) and (2) of the Food and Drug Regulations apply in respect of a designated biocide that was imported under the Exceptional Importation and Shortages Interim Order No. 2.

(2) For the purposes of subsection (1), that subsection C.10.008(1) is to be read without reference to

  • (a) sections A.01.015 and A.01.017 in paragraph C.10.008(1)(a);
  • (b) sections C.01.040.3 to C.01.049.1 in subparagraph C.10.008(1)(b)(i);
  • (c) subparagraph C.10.008(1)(b)(ii); and
  • (d) sections C.10.009 to C.10.011 in subparagraph C.10.008(1)(b)(iii).

(3) Subsection (1) ceases to apply on December 31, 2022 in respect of the sale of a designated biocide, other than at retail sale, that was imported under the Exceptional Importation and Shortages Interim Order No. 2.

(4) An importer must not sell a designated biocide that they imported under that Interim Order unless they ensure that the information referred to in paragraph 12(2)(d) of that Interim Order is available in English and French and in a manner that permits the safe use of the biocide.

(5) The importer must ensure that the information is available in accordance with subsection (4) until at least the expiration of the period that corresponds to the useful life of whichever of the designated biocides that they imported has the latest useful life.

13 (1) Section 62.31 of the Medical Devices Regulations applies in respect of a designated medical device that was imported under the Exceptional Importation and Shortages Interim Order No. 2.

(2) Section 62.32 of those Regulations applies to the holder of an establishment licence in respect of a designated medical device that they imported under that Interim Order.

14 (1) Sections A.01.014 and A.01.016 of the Food and Drug Regulations, the provisions of Part B of those Regulations — other than sections B.24.100 and B.24.300 — and the provisions of Part D of those Regulations do not apply in respect of the sale of a designated food for a special dietary purpose that was imported under the Exceptional Importation and Shortages Interim Order No. 2.

(2) A sale of a designated food for a special dietary purpose that was imported under the Interim Order is exempt from paragraphs 4(1)(a) and (d) of the Food and Drugs Act in respect of the use or presence of any of the substances or materials referred to in paragraphs 24(2)(a) to (g) of that Interim Order.

(3) Subsections (1) and (2) cease to apply in respect of the sale of a designated food for a special dietary purpose on the food's expiration date.

(4) An importer must not sell a designated food for a special dietary purpose that they imported under the Exceptional Importation and Shortages Interim Order No. 2 No. 2 unless they ensure that the information referred to in subparagraphs 25(2)(e)(ii) to (vii) of that Interim Order is available in English and French and in a manner that permits the safe preparation and use of the food.

(5) The importer shall ensure that the information is available in accordance with subsection (4) until at least the end of the day on the latest expiration date of the designated food for a special dietary purpose that they imported.

(6) In this section, expiration date has the same meaning as in section B.25.001 of the Food and Drug Regulations.

15 A person who, immediately before the Exceptional Importation and Shortages Interim Order No. 2 ceased to have effect, was permitted, under subsection 30(2) of that Interim Order, to conduct an activity in respect of a designated hand sanitizer may continue to do so without holding an establishment licence that authorizes them to do so until the earliest of

  • (a) the occurrence of one of the circumstances referred to in paragraphs 30(2)(a) to (c) of that Interim Order, and
  • (b) September 1, 2023.

Coming into Force

16 (1) Subject to subsections (2) and (3), these Regulations come into force on the day following the day on which the Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19, made by the Minister of Health on March 1, 2021 and published in Part I of the Canada Gazette on March 20, 2021, ceases to have effect.

(2) Subsection 1(1) and sections 3 and 9 come into force on the day following the day on which the Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply), made by the Minister of Health on November 27, 2020 and published in Part I of the Canada Gazette on December 12, 2020, ceases to have effect.

(3) Subsection 1(2) and section 2 come into force on the day on which these Regulations are registered.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Executive summary

Issues: Therapeutic product shortages are an immediate, pressing challenge to the health of Canadians. Health Canada has limited regulatory tools to address shortages and Canadians may see reduced access to certain products in shortage.

Description: The amendments introduce exceptional importation frameworks to the Food and Drug Regulations and the Medical Devices Regulations to promote access to drugs and medical devices in exceptional circumstances. The frameworks allow the Minister to permit importation and sale of products that do not fully meet Canadian regulatory requirements, but that are manufactured to comparable quality standards, to address a shortage or an anticipated shortage.

The amendments also allow importers and sellers of exceptionally imported biocides and foods for a special dietary purpose to exhaust stock in Canada by specifying final dates for importation and sale for these products.

As well, these amendments provide Health Canada with additional tools to assess existing or potential shortages of drugs or medical devices. These include a power to compel information from industry about a shortage and a power to require manufacturers and importers to report shortages, including discontinuances of certain medical devices that may lead to a shortage of specified medical devices.

The amendments temporarily extend regulatory flexibilities related to drug establishment licences for drug-based hand sanitizers. This extension permits persons conducting licensable activities related to hand sanitizers without a Drug Establishment License to continue doing so until September 1, 2023, or until a decision is made on their Drug Establishment License application, whichever is sooner.

Finally, the amendments prohibit drug establishment licence holders from selling certain drugs intended for the Canadian market for consumption or use outside of Canada if that sale could cause or exacerbate a shortage.

Rationale: Amendments to the regulations are necessary to provide Health Canada with tools to help prevent or alleviate therapeutic product shortages. Shortages of therapeutic products are a long-standing issue and Canada is particularly vulnerable given its smaller market size and heavy reliance on foreign imports. The COVID-19 pandemic has created global supply challenges and caused an unprecedented demand for certain products. This situation has contributed to a further increase in drug and medical device shortages in Canada. Currently, the only permanent regulatory tool to address drug shortages is the mandatory requirement for manufacturers to report drug shortages. There are no permanent regulatory tools to address medical device shortages.

Health Canada's interim orders addressing shortages will expire in 2021 and 2022. While the provisions of these interim orders were introduced on a temporary basis, they are needed permanently to help ensure that Canadians continue to have access to the therapeutic products they need. Without them, Canada will have limited tools to monitor, prevent, and alleviate shortages. Targeted consultations indicate that industry and health system stakeholders are supportive of the government's approach.

The benefits of the amendments are expected to significantly outweigh their costs. The amendments will provide total benefits of $63,392,000 per year or $445,241,000 over 10 years using a 7% discount factor. The cost to industry is expected to be $112,200 per year or $788,000 over 10 years using a 7% discount factor. The cost to government is expected to be $760,000 per year or $5,338,000 over 10 years using a 7% discount factor.

In the near term, these amendments will allow the government to better support healthcare systems across Canada to recover from the effects of the COVID-19 pandemic on global supply chains. In the longer term, new powers to monitor, prevent, and alleviate shortages will reduce the time spent by healthcare professionals and patients searching for substitutes for a product in shortage. These powers will also help prevent adverse outcomes that could arise from cancelling or deferring treatments or from using substitute products that may be less effective.

Issues

Health Canada has a mandate to administer the law which has as its aim the protection of the health and safety of Canadians. Therapeutic product shortages pose a significant risk to the health of Canadians by negatively affecting their ability to access the drugs and medical devices they need. Currently, the only permanent regulatory tool to address drug shortages is the mandatory requirement for manufacturers to report drug shortages. Permanent regulatory tools do not currently exist to support Health Canada's work to address medical device shortages.

Health Canada's interim orders addressing therapeutic product shortages will expire in 2021 and 2022. While these provisions were introduced on a temporary basis, they are needed permanently to help ensure that Canadians continue to have access to the therapeutic products they need.

Background

Therapeutic product shortages are a complex and growing problem worldwide. A therapeutic product is defined as a drug or device or any combination of drugs and devices, but does not include a natural health product within the meaning of the Natural Health Products Regulations. A shortage is a situation in which an authorization holder of a drug or manufacturer of a medical device is unable to meet the demand for its product. Shortages can arise from a range of circumstances, such as manufacturing disruptions, difficulties accessing raw materials, stockpiling, increases in demand, and unforeseen events affecting the global supply chain.

Drugs and medical devices play an integral role in delivering timely and effective patient care. Shortages of these therapeutic products can contribute to adverse patient outcomes and cause harm to Canadians. Shortages may require a patient to use a less effective substitute treatment, discontinue treatment, or ration the products used for their treatment. Therapeutic product shortages also burden the healthcare system when healthcare practitioners spend extra time finding substitute treatments or devices to compensate for a shortage of the preferred treatment or device.

In 2021, Parliament made amendments to the Food and Drugs Act providing the Governor in Council with new regulation-making authorities related to therapeutic product shortages as part of An Act to implement certain provisions of the economic statement tabled in Parliament on November 30, 2020 and other measures. These amendments

  • provide the Governor in Council with regulation-making authority to help prevent or mitigate shortages of therapeutic products, such as drugs and medical devices; and
  • provide the Governor in Council with regulation-making authority to seek additional information from companies about food, drugs, or medical devices to, for example, assess the safety of those products and confirm that products are safe for Canadians.

These authorities allow Health Canada to build on existing shortage management tools and put in place more robust tools to help prevent or alleviate shortages.

Drug shortages in Canada

Canada is particularly vulnerable to drug shortages

All countries are susceptible to drug shortages due to the complex and interconnected nature of drug supply chains and the concentration of active pharmaceutical ingredient production in a small number of countries, such as India and China. Since 2017, 10%–15% of drugs marketed in Canada have been in shortage at any given time and almost half (44%) of marketed drugs have experienced at least one shortage. This situation is related to Canada's smaller market share and heavy reliance on imports. Approximately 83% of drug manufacturing activity is conducted outside of Canada, and 68% of drugs in final dosage form are imported. Many of these imports are from single suppliers, making Canada particularly vulnerable to unforeseen events that disrupt manufacturing and distribution.

The COVID-19 pandemic has exacerbated drug shortages in Canada

The COVID-19 pandemic has created global supply challenges and caused an unprecedented demand for certain drugs. This has put additional pressure on the supply of finished drug products and raw materials. The pharmaceutical industry has had to adapt quickly to address these changes in demand.

This situation has contributed to increased drug shortages in Canada. During the early months of the pandemic, there were 592 shortages reported in Canada compared to 441 during the same months in 2019. In 2020, there were 47 Tier 3 drug shortages compared to 10 Tier 3 shortages in 2019. Tier 3 drug shortages are shortages that have the greatest potential impact on the health of Canadians.

Additional demands created by foreign importation frameworks have the potential to negatively impact drug shortages in Canada

On November 30, 2020, a United States rule entitled Importation of Prescription Drugs came into effect. The rule permits licensed United States pharmacists or wholesalers, working within a state-sponsored program, to import in bulk certain prescription drugs intended for the Canadian market. The stated purpose is to reduce high drug prices in the United States. If prescription drugs intended for the Canadian market were to be imported into the United States in bulk, it could further exacerbate the existing problem of drug shortages in Canada, putting the health of Canadians at risk. The Government of Canada continues to work with the United States to understand its implementation plans and to mitigate any risks posed by the rule to the health and safety of Canadians.

Addressing drug shortages in Canada is a government priority

Some drug shortages can pose risks to the health and safety of Canadians as a result of compromised or delayed medical procedures, medication errors, and substitutions with alternative treatments that are not as safe or that are less effective. These interruptions can have significant negative implications for health. A survey of healthcare professionals conducted in 2012 found that 64% of physicians reported that drug shortages had consequences for their patients, while 41% of pharmacists reported that their patients' health had been compromised by shortages.

The 2019 Minister of Health mandate letter directed the Minister to take action to address drug shortages and ensure that Canadians have access to the medicines that they need. Moreover, the supplementary mandate letter in 2021 included working to accelerate steps to achieve a national, universal pharmacare program. An effective universal pharmacare system depends on reliable access to medicines for Canadians.

Health Canada plays a lead role in advancing tools to address drug shortages in collaboration with a wide range of stakeholders. Addressing drug shortages requires partnership among many stakeholders, including provinces and territories, industry, healthcare professionals, patient organizations, and the federal government. Health Canada's activities involve determining the status of a shortage, coordinating information-sharing between parties, and identifying mitigation strategies. Health Canada also co-chairs the Multi-Stakeholder Steering Committee on Drug Shortages — which includes representation from some provincial governments, industry associations, associations of healthcare providers, and patient advocacy organizations — to develop and promote tools and processes that help address drug shortages.

In 2017, amendments to the Food and Drug Regulations entered into force requiring manufacturers to report drug shortages and discontinuances on the Drug shortages homepage. There is no other existing requirement in legislation or permanent regulation directly related to drug shortages.

Medical device shortages in Canada

Health Canada was developing the medical device shortage reporting program prior to the COVID-19 pandemic

Prior to the COVID-19 pandemic, Health Canada was working to improve voluntary reporting of medical device shortages by manufacturers and provinces and territories. As of February 2020, the department had developed a process to support a formal, single-window approach for voluntary reporting and publication of medical device shortages. Implementation of this process was put on hold due to the COVID-19 pandemic.

Without additional regulations, Health Canada has few tools and resources to monitor medical device shortages

Unlike drug shortages, Health Canada does not require regulated parties to report medical device shortages in Canada. Historically, the department monitored medical device shortages through voluntary reports received from industry. Voluntary reporting resulted in incomplete information about the number of medical device shortages experienced in Canada and the contributing causes. From 2015 to early 2020, Health Canada was voluntarily made aware of 40 shortages; 50% of these reports were provided by industry, while 35% arose from provinces and territories. The remaining 15% were reported by other stakeholders.

There are significant challenges when reporting medical device shortages. The medical device supply chain is difficult to monitor, since different components, accessories, or parts may be sourced from different manufacturers, any of which may experience a shortage. As well, medical devices are often sterilized in facilities other than those where they are manufactured, creating additional supply chain concerns. The complexity of the supply chain makes it difficult to collect timely and reliable information regarding shortages and their origins without additional tools.

Health Canada's temporary measures to urgently address therapeutic product shortages

To address the significant risk to health posed by shortages in 2020 and 2021, the Minister of Health took action by making interim orders to help monitor, prevent, and alleviate shortages of drugs, medical devices, biocides, and foods for a special dietary purpose. The interim orders were made by the Minister using the power granted pursuant to the Food and Drugs Act. This includes the Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 (March 1, 2021) and the Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply) [November 27, 2020]. These interim orders will expire one year from the dates they were made.

Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19

On March 1, 2021, the Minister of Health made the Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 (Exceptional Importation and Shortages Interim Order No. 2). This interim order was approved by the Administrator of the Government of Canada in Council on March 15, 2021. This interim order repealed and replaced the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 (Exceptional Importation and Shortages Interim Order No. 1) that was approved by the Governor in Council on April 8, 2020.

The Exceptional Importation and Shortages Interim Order No. 2 permits the exceptional importation of specified drugs, medical devices, biocides (disinfectants),footnote 4 and foods for a special dietary purpose that may not fully meet Canadian regulatory requirements, but are manufactured according to comparable standards. Products eligible for importation are specified on publicly available lists that are incorporated by reference into the interim order. Importers are required to ensure information supporting the safe use of the product is available in both official languages. This framework has been used to allow the exceptional import of 61 drugs, 265 medical devices, 281 biocides, and 2 foods for a special dietary purpose.

This interim order also introduced a mandatory shortage reporting framework for medical devices that are specified on an incorporated by reference list. As of March 2021, 292 confirmed medical device shortages were published on the List of Medical Device Shortages. As well, this interim order gives the Minister the power to require information about a medical device shortage from manufacturers, distributors, and importers of medical devices if the information is not provided voluntarily.

Finally, this interim order includes transition provisions for drug establishment licence flexibilities to allow persons conducting licensable activities related to drug-based hand sanitizers to continue doing so while their drug establishment licence application is under review. The transition provisions also allow time for companies that make and sell drug-based hand sanitizers to come into compliance with establishment licensing requirements. Market signals and feedback received from industry suggest that the domestic supply for biocides is stabilizing and that exceptional importation is no longer needed to meet the current demand.

Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply)

On November 27, 2020, the Minister of Health made the Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply) [the Safeguarding Interim Order]. This interim order was approved by the Governor in Council on December 4, 2020. Under this interim order, certain drugs intended for the Canadian market are prohibited from being sold for consumption or use outside of Canada if that sale could cause or exacerbate a drug shortage. Sale of drugs intended for the Canadian market for consumption outside Canada continues to be permitted if the seller determines that the sale will not cause or exacerbate a shortage. The seller must maintain a record of this determination.

This interim order also gives the Minister the power to require information about a drug shortage from manufacturers and drug establishment licence holders if the information is not provided voluntarily.

Certificate of Supplementary Protection Regulations

Certificates of supplementary protection (CSP) provide additional sui generis protection for drugs containing a new medicinal ingredient, or a new combination of medicinal ingredients, protected by an eligible patent. This protection is intended to partly compensate for time spent in research and obtaining marketing authorization. The types of authorizations that can give rise to CSP eligibility are informed by the definition of “authorization for sale” in the Certificate of Supplementary Protection Regulations. The definition excludes certain limited purpose authorizations.

Objective

The objectives of these amendments are to limit risks to Canadians' health by maintaining the Government of Canada's ability to help monitor, prevent, and alleviate therapeutic product shortages and to support the Minister of Health's 2019 mandate commitment to ensure that Canadians have access to the medicines they need.

Description

The Food and Drug Regulations and the Medical Devices Regulations are amended to maintain a number of the powers from the interim orders made to address shortages since March 2020. In addition, a consequential amendment is made to the Certificate of Supplementary Protection Regulations.

Exceptional importation and sale frameworks

The amendments introduce exceptional importation frameworks for drugs to the Food and Drug Regulations and for medical devices to the Medical Devices Regulations. These frameworks allow the Minister to address a shortage or anticipated shortage by permitting the importation and sale of products that do not fully meet Canadian regulatory requirements for market authorization. To be eligible for exceptional importation, these products must be manufactured to quality standards comparable to those in force for Canadian products. Products eligible for exceptional importation and sale are identified on lists of designated drugs and medical devices maintained by Health Canada, incorporated by reference into the Food and Drug Regulations and Medical Devices Regulations. The use of documents incorporated by reference is consistent with authorities granted by section 30.5 of the Food and Drugs Act.

Exceptional importation and sale of drugs

Drugs brought to Canada via exceptional importation are exempted from compliance with certain provisions of the Food and Drug Regulations, but remain subject to provisions related to drug establishment licences, good manufacturing practices, recalls, and issue-related summary reporting of adverse drug reactions and serious adverse drug reactions. As with other drugs, hospitals are required to submit reports of serious adverse drug reactions associated with a drug that was exceptionally imported, including the identifying code or number of the drug, if any, assigned in the country in which the drug was authorized for sale.

Under the amendments, a drug is permitted for exceptional importation if the drug is set out on the List of Drugs for Exceptional Importation and Sale. The Minister may add a drug to the list, if the Minister has reasonable grounds to believe that

  • a Canadian drug is in shortage or at risk of going into shortage; and
  • the drug to be imported can be substituted for the Canadian drug that is in shortage or at risk of going into shortage.

Exceptional importation of the drug is permitted until the end date set out on the list. The Minister determines the duration permitted for exceptional importation of a drug on a case-by-case basis. The Minister is also able to specify in advance a number of batches, doses, to describe the amount of product permitted for import. Importers are required to notify the Minister and to provide key identifying information about the drug at least three business days in advance of each importation. The Minister is allowed to request records or evidence from regulated parties in relation to the safety of imported drugs, including master production documents.

An importer of a drug who sells it is under an obligation to ensure that information supporting the safe use of the drug is available in both English and French for as long as the drug is legal for sale in Canada.

A drug imported under this framework is legal for sale in Canada until its expiration date. Any drug that was already imported under the Exceptional Importation and Shortages Interim Order No. 2 also remains legal for sale until its expiration date.

Exceptional importation and sale of medical devices

Medical devices brought to Canada via exceptional importation are exempted from certain provisions of the Medical Devices Regulations, but remain subject to provisions related to establishment licences, mandatory problem reporting, incident reporting and recalls. Under the amendments, a medical device is permitted for exceptional importation and sale if the medical device is set out on the List of Medical Devices for Exceptional Importation and Sale. The Minister may add a medical device to the list if the Minister has reasonable grounds to believe that

  • the Canadian version of the medical device is in shortage or at risk of going into shortage; and
  • the medical device to be imported can be substituted for the Canadian version that is in shortage or at risk of going into shortage.

A shortage exists if the manufacturer of a device cannot meet the Canadian demand for the device.

Exceptional importation of the medical device is permitted until the end date set out on the list. The Minister determines the duration permitted for exceptional importation of the medical device on a case-by-case basis. The Minister is also able to specify in advance a specific number of units permitted for import and sale. The importer is required to notify the Minister and to provide key identifying information at least five business days in advance of each importation. The importer is under an obligation to ensure that information supporting the safe use of the medical device is available in both English and French.

A medical device imported using this framework can be sold until its expiry date or until two years after the final permitted date of importation, whichever is sooner. Any medical device that was already imported under the Exceptional Importation and Shortages Interim Order No. 2 can also continue to be sold under the same conditions as a product imported under these amendments.

Sale of biocides and foods for a special dietary purpose imported under the Exceptional Importation and Shortages Interim Order No. 2

Exceptional importation for biocides and foods for a special dietary purpose will no longer be permitted after the Exceptional Importation and Shortages Interim Order No. 2 expires. Biocides imported under the interim order may continue to be sold to retail facilities until December 31, 2022, and retail sale will be permitted until the product in stock has been exhausted. Importers must continue to give information to support the safe use of exceptionally imported biocides available for the duration of its useful life or until the product expires.

Foods for a special dietary purpose imported under the interim order may continue to be sold until their expiration date.

Mandatory reporting of specified medical device shortages

A requirement for manufacturers and importers to report shortages and anticipated shortages of specified medical devices is introduced under the Medical Devices Regulations. Manufacturers of devices and importers of Class I devices specified on the incorporated by reference List of Medical Devices – Notification of Shortages are required to report shortages and anticipated shortages of the specified device or type of device. These amendments allow the Minister to place specific devices or types of devices on the list if a shortage presents or may present a risk of injury to human health.

Under the amendments, a medical device shortage is defined as a situation where a manufacturer cannot meet demand for a device in Canada. The amendments further clarify that any discontinuance of a specified medical device that is likely to cause a shortage must be reported.

Manufacturers of all classes of medical devices are required to report if a shortage exists or is anticipated for a device they manufacture that is on the incorporated by reference list. Importers of specified medical devices are only required to report shortages of Class I medical devices. The report must be made in a manner that is specified or acceptable to the Minister and must include certain key information, including the name and contact information of the manufacturer and importer, the name of the device in both French and English, and a description of the information used to determine that a shortage exists.

If a manufacturer or an importer is required to report, that report must be submitted within five business days after the day on which they become aware that a shortage exists or is determined to be anticipated. A discontinuance of a medical device is considered to be a type of anticipated shortage.

The Minister is required to publish the information received on a Government of Canada website. This requirement to publish is waived if the Minister has reasonable grounds to believe that a shortage does not exist. For example, the requirement to publish may be waived in a case where a report is submitted in error, or if the follow-up by Health Canada determines that a shortage does not exist.

The amendments provide for two situations under which a regulated party does not have to provide a report:

  • if a manufacturer or importer anticipates that the manufacturer will be able to meet demand within 30 days of the day they anticipated or became aware of the shortage; or
  • if the manufacturer is able to meet the demand for a different medical device that they manufacture which can be substituted for the device in shortage.

Safeguarding the drug supply

The amendments prohibit drug establishment licence holders from selling certain drugs intended for the Canadian market for consumption or use outside of Canada if that sale could cause or exacerbate a shortage in Canada.

A drug establishment licence holder wishing to sell a drug intended for the Canadian market outside of Canada is required to make a determination that the sale would not cause a shortage or exacerbate an existing shortage. The drug establishment licence holder is required to retain a record of that determination until one year after the expiry of the drug.

Requests for information

The amendments allow the Minister to request information from regulated parties that the Minister may require to assess a drug or a medical device shortage.

The Minister is authorized to require that a drug establishment licence holder or medical device manufacturer, importer, or distributor provide information within their control that is needed to establish or assess

  • the existence of a shortage or risk of a shortage;
  • the reasons for a shortage or risk of a shortage;
  • the effects or potential effects on human health of a shortage; or
  • measures that could be taken to prevent or alleviate a shortage.

This power can be used only if the Minister has reasonable grounds to believe that the person would not provide the information without a legal obligation to do so. This power will only be used in respect of both drugs and medical devices in rare circumstances where information about a shortage is urgently needed to alleviate a risk of injury to human health. This power has been limited in respect of drugs to categories of drugs for which a shortage could pose a risk of injury to health. A similar approach could not be used for medical devices because medical devices are categorized differently. For this reason, an additional limitation has been placed on this power in respect of medical devices such that it can only be used in respect of a shortage that could pose a risk of injury to human health.

The person is under an obligation to provide the requested information electronically in a format specified by or acceptable to the Minister within a time limit specified by the Minister.

Extension of flexibilities related to drug establishment licences for drug-based hand sanitizers

Under these amendments, persons who have submitted an application for a drug establishment licence before September 1, 2021, are allowed to continue conducting licensable activities related to drug-based hand sanitizers until Health Canada has made a decision regarding the application, the person withdraws the application, or until September 1, 2023, whichever is sooner. By September 1, 2023, all persons are required to hold a drug establishment licence to conduct licensable activities in relation to drug-based hand sanitizers.

Exclusion from definition of “authorization for sale” under the Certificate of Supplementary Protection Regulations

Subsection C.10.008(1) of the Food and Drug Regulations sets out flexibilities governing the sale of a drug that has been imported under the exceptional importation framework. This is considered to be a limited purpose authorization. Consistent with the other exclusions of limited purpose authorizations in the Certificate of Supplementary Protection Regulations, the definition of “authorization for sale” is being amended to exclude a circumstance where an exceptionally imported drug has been permitted for sale under subsection C.10.008(1).

Regulatory development

Consultation

Health Canada has conducted stakeholder consultations on these amendments as well as existing interim orders that are similar. Health Canada sought stakeholders' input on these amendments on numerous occasions since March 2020. Stakeholder engagement took place via regular engagement and compliance promotion sessions with industry partners, as well as targeted stakeholder consultations. These engagements addressed both the Safeguarding Interim Order and the Exceptional Importation and Shortages Interim Order No. 2, as well as Health Canada's intention to move interim order powers into permanent regulations.

Safeguarding the drug supply

On March 9, 2020, the Government of Canada submitted comments during the United States consultation process to publicly document Canada's opposition to the proposed rule entitled Importation of Prescription Drugs. That rule proposed a plan to allow state-sponsored programs to import in bulk certain drugs intended for the Canadian market into the United States to reduce drug costs for the American consumer. Canada signalled that bulk importation is not an effective solution to high drug prices in the United States and that it could exacerbate drug shortages in Canada. The comments also made it clear that the Government of Canada would take the necessary measures to safeguard Canada's drug supply.

On December 15, 2020, Health Canada also held compliance promotion sessions with drug establishment licence holders and members of the Multi-Stakeholder Steering Committee on Drug Shortages in connection with the Safeguarding Interim Order, which was made on November 27, 2020. The aim of the session was to help improve industry's understanding of their new obligations and minimize non-compliance with the Safeguarding Interim Order.

Addressing shortages of drugs and medical devices

On June 4, 2020, and September 3, 2020, Health Canada held formal consultations with pharmaceutical industry associations to discuss the industry's experience with existing regulatory approaches to COVID-19 related drug shortages, including the Exceptional Importation and Shortages Interim Order No. 1. Health Canada solicited feedback on a proposal to add a power to compel information related to therapeutic product shortages via amendments to the Food and Drug Regulations and the Medical Devices Regulations.

Between January and February 2021, targeted consultations on these amendments, and the Minister's plan to make the Exceptional Importation and Shortages Interim Order No. 2, were held with

  • provincial and territorial governments;
  • other federal departments and agencies;
  • industry associations;
  • health advocacy stakeholders;
  • healthcare professionals;
  • other representatives from importers and manufacturers; and
  • academics.

Health Canada also invited comments and feedback from the public via a Notice to industry published on its website on January 22, 2021.

Health Canada's approach to biocides

In January and February 2021, Heath Canada consulted stakeholders on the exceptional importation framework for biocides. Under these amendments, exceptional importation of biocides will end on March 1, 2022. Biocides imported under the interim order may continue to be sold to retail facilities until December 31, 2022, and retail sale will be permitted until the product in stock has been exhausted. This approach has been adopted to avoid product wastage and prevent financial losses for industry. Stakeholders were informed of Health Canada's approach through an email notice in summer 2021.

Stakeholder feedback

Safeguarding the drug supply

Stakeholders expressed appreciation for briefings concerning the Safeguarding Interim Order. They were supportive of the government taking action regarding foreign bulk importation programs. Health Canada also received multiple statements of support for powers granted under the Safeguarding Interim Order.

Addressing shortages of drugs and medical devices

Stakeholder feedback has been published in a report available on the department's website. Stakeholders expressed support for exceptional importation of therapeutic products and did not raise concerns about mandatory reporting of medical device shortages.

Stakeholder feedback has been largely positive and has noted the importance of strong coordination between the department and industry partners. Industry stakeholders provided positive feedback on regulatory flexibilities made possible by the amendments, as well as the department's transparency, for example, by publishing the List of Tier 3 Drug Shortages. Health Canada did not receive any feedback opposing the ending of the exceptional importation of foods for a special dietary purpose.

The amendments are very similar to provisions in force through interim orders that have been in place for some time. Health Canada has had the opportunity to become familiar with the use of these provisions, to identify areas for improvement, and to consult on them as part of these amendments. Throughout the consultation process, stakeholders did not identify significant concerns with the interim orders or with these amendments, which are expected to have a low impact on industry. For these reasons prepublication in the Canada Gazette, Part I, was not necessary.

Health Canada's response to stakeholders concerns

Some stakeholders requested that Health Canada provide greater clarity on issues specific to exceptional importation. Some drug industry stakeholders sought clarification on how long products would remain legal for sale after being imported. These amendments address this feedback by specifying timelines for exceptional importation of drugs and medical devices. The amendments further specify that an imported drug or medical device is legal for sale until its expiration date or, in the case of a medical device that does not have an expiration date, until two years after importation.

A selection of stakeholders also requested clarification on a new requirement to provide safety information for imported products in English and in French. Health Canada has addressed these questions in guidance documents that will be published prior to the coming into force of these regulations.

No opposition from stakeholders was received about the plan to continue the mandatory shortage reporting framework for medical devices. The Exceptional Importation and Shortages Interim Order No. 2 incorporated stakeholders feedback by exempting back orders of less than 30 days from the requirement to report a medical device shortage.

Modern treaty obligations and Indigenous engagement and consultation

The amendments are not expected to impact treaties with the Indigenous peoples of Canada. Health Canada conducted an initial assessment that examined the geographical scope and subject matter of the initiative in relation to modern treaties in effect and did not identify any potential modern treaty impacts.

Instrument choice

A range of regulatory and non-regulatory options were considered in the development of these amendments.

Return to pre-COVID-19 regulatory state

The option of allowing interim orders addressing therapeutic product shortages to expire was considered. This option was rejected because the Food and Drug Regulations and the Medical Devices Regulations, in their current state, do not have effective shortage mitigation measures for drugs and medical devices, and do not provide for reporting mechanisms for medical device shortages. The need for these types of provisions had been recognized prior to the pandemic, and they have proven to be highly useful since the implementation of the interim orders.

Therapeutic product shortages are a long-term health concern that predates the COVID-19 pandemic and will remain a concern into the future. Health Canada had already identified the following regulatory gaps prior to the pandemic:

  • voluntary reporting of medical device shortages to Health Canada had proven insufficient to capture the information needed to mitigate risks to health arising from shortages;
  • the use of enforcement discretion to permit exceptional importation was already deemed to be unsustainable because of the frequency of its use and the lack of regulatory certainty and transparency for industry; and
  • powers available under the Food and Drug Regulations and the Medical Devices Regulations were understood to be insufficient to monitor, prevent, and alleviate shortages in the future.

Amendments to the Food and Drug Regulations and the Medical Devices Regulations will allow Health Canada to address shortages more proactively and systematically. Formal regulatory frameworks for exceptional importation increase regulatory oversight, as well as predictability and transparency for industry.

In addition, allowing these powers to end while the pandemic is ongoing would unnecessarily jeopardize the health of Canadians and burden the health system's recovery from the COVID-19 pandemic. During the pandemic, healthcare services were restructured in the interest of safety and to create surge capacity for necessary services. This has led to delays in key services, like surgery. It is anticipated that the transition out of the pandemic will increase demand for services that were put on hold and for therapeutic products needed to provide them, such as anaesthetic or antiparalytic drugs, or certain key medical devices. Hospitals, pharmacies, and patients experienced shortages of some of these products during the pandemic, which could pose even greater harm to Canadians if demand for those products increases. Canada's transition out of the pandemic would be made more challenging if Health Canada lost its powers to monitor, prevent, and alleviate shortages.

Allowing these powers to expire suddenly or without transitional provisions would also impose regulatory burdens on industry partners that have adapted their businesses to help resolve shortages related to the pandemic. For example, industry partners who have participated in exceptional importation would incur losses if their imported products could no longer be sold.

Finally, the option of allowing these powers to expire would not align with the approach taken by other countries. Countries including the United States, the United Kingdom, Ireland, France, Japan, and Australia have taken lessons learned from the pandemic into consideration and are developing partnerships, regulatory frameworks, and other long-term solutions to address shortages of key therapeutic products.

Extending interim order powers

The option of extending interim order powers by remaking existing interim orders was considered. This option was rejected because the COVID-19 pandemic has highlighted pre-existing shortcomings in Canada's regulatory framework that could inhibit Canada's ability to monitor, prevent, or alleviate therapeutic product shortages in the future.

In the past, Health Canada has used an interim order to increase the supply of individual products in acute shortage for a limited span of time (the Interim Order Respecting Epinephrine Auto-injectors). In that case, an individualized approach was effective in reducing the risk posed by a national shortage of a widely used product. However, interim orders do not support a long-term and sustainable approach to preventing and alleviating therapeutic product shortages that may occur in the future. The continued use of interim orders to address therapeutic product shortages would be inefficient, given steady increases in the number and duration of shortages.

Provisions related to safeguarding the Canadian drug supply are also necessary to address shortcomings in Canada's regulatory framework. Permanent amendments that safeguard the Canadian drug supply are needed to ensure that Canada's regulatory framework can help to prevent shortages driven by foreign bulk importation programs.

For all these provisions, an approach based on short-term interim orders lacks transparency for both domestic and international stakeholders. Manufacturers, importers, and distributors benefit from a landscape where the rules are clearly specified in advance.

Use of enforcement discretion

Regulators may exercise discretion with regards to how to enforce the law, such as by deprioritizing enforcement for certain provisions in low-risk contexts. Given the health risks posed by drug shortages, reliance on enforcement discretion was one way Health Canada allowed for the exceptional importation and sale of drugs prior to COVID-19. The option of continuing to exclusively use enforcement discretion to allow exceptional importation and sale of drugs and medical devices on a case-by-case basis was considered.

This option was rejected because therapeutic product shortages are a growing global problem that cannot be solved only through enforcement discretion. The overuse of enforcement discretion can limit transparency for stakeholders and create the appearance of an unequal playing field for industry. The improved transparency that has resulted from the exceptional importation and sale framework has been repeatedly commended by stakeholders.

Moreover, enforcement discretion would not resolve other gaps in the regulations related to shortages. For example, enforcement discretion would not promote Canada's efforts to safeguard the Canadian drug supply or resolve information gaps regarding drug and medical device shortages.

Regulatory analysis

Benefits and costs

An analysis of the reported costs and benefits determined that the amendments will have a low-cost impact on the drugs and medical device industry. This section provides a description of the methodology used in the analysis, a quantitative and qualitative depiction of costs, and a listing of potential direct benefits due to the regulatory package. There are no new costs expected for Canadians, and limited costs for industry and the Government of Canada. Costs and benefits of the regulations are determined by incremental differences between two future scenarios, one where the interim orders cease to be in force and the previous regulatory framework returns (the baseline) versus one where this proposal is made into a regulation (regulatory scenario).

Data collection

Surveys and questionnaires were drafted and distributed to various stakeholders. A survey was used to understand how the amendments could have a positive or negative impact on Canadian industry and healthcare professionals. The survey was sent to industry stakeholders and associations representing health system partners, including importers, manufacturers, and pharmacist associations. The survey was distributed on January 22, 2021, and responses were submitted to Health Canada by March 1, 2021.

Respondents were asked various questions about their experience with the interim orders made in 2020 to help prevent and alleviate shortages of drugs, medical devices, and disinfectants (further referred to as biocides). The survey was divided into three sections with information specific to drugs, medical devices, and biocides. Organizations that dealt with non-prescription drug hand sanitizers were also consulted. However, these amendments do not impose any new costs on this latter group, as they only extend existing timelines, as described above under the heading Extension of flexibilities related to drug establishment licences for drug-based hand sanitizers, to prevent burden on industry. Respondents were encouraged to complete whichever sections were relevant to their business.

The survey yielded 71 total responses, with some respondents participating in more than one industry. Thirty-eight respondents were in the drugs industry, 16 organizations dealt with biocides or drug-based hand sanitizers, and 36 organizations were involved with medical devices. All respondents that dealt with drugs or biocides and drug-based sanitizers self-identified as Canadian-based organizations. In comparison, 4 of the 36 organizations from the medical device industry were non-Canadian based organizations. There were no pharmacists' associations that responded to the survey.

While the industry survey results did not yield statistically significant quantitative data, some of the information obtained from industry surveys and internal questionnaires provides the basis for the cost estimates presented below.

Costs

Canadians

There are no direct costs expected for Canadians as a result of this regulatory proposal.

Industry

Industry costs include four components:

  • the costs of exceptional importation of specified drugs and medical devices;
  • the costs of compliance with mandatory reporting requirements for medical device shortages;
  • the costs of compliance with information requirements; and
  • the costs of compliance with the prohibition against distributing drugs intended for the Canadian market if doing so would cause or exacerbate a shortage.
(1) Exceptional importation of drugs and medical devices

A survey of businesses using exceptional importation asked respondents to report the costs of using exceptional importation to sell drugs, biocides, and medical devices in Canada. The survey did not return enough responses to develop statistically significant estimates of industry costs. Accordingly, the survey evidence presented below should be considered anecdotal.

The use of exceptional importation imposes costs on industry. These costs derive from the administrative expenses of submitting a proposal to Health Canada and providing key information, as well as the expense of ensuring that information to support the safe use of products is available to Canadians in both official languages. Survey respondents estimated that the expenses of using exceptional importation would be approximately $150,000 per participating organization, per year. Respondents did not specify how many products this amount covered.

However, participation in exceptional importation does not impose new costs on industry when compared to the normal costs of importation under the Food and Drug Regulations and Medical Devices Regulations. As described in the benefits section below, survey respondents reported that their use of exceptional importation in 2020–2021 led to an average profit greater than $1.65 million per business organization. It can be assumed that businesses would not use the exceptional importation option if it costs more than the alternative regulatory process. Consequently, the incremental cost of exceptional importation for industry is considered to be exceeded by the benefits to industry.

In addition, new costs may be imposed on pharmacists for exceptionally imported drugs. Exceptionally imported drugs can be dispensed by both hospital pharmacists and community pharmacists. The stakeholder survey attempted to find the costs to pharmacists as a result of dispensing exceptionally imported products. However, the survey yielded no responses.

It is expected that there will be little to no burden on hospital pharmacists by having to provide additional information to health practitioners for administering the exceptionally imported drug in a hospital setting. Healthcare practitioners are generally knowledgeable about dosages, labelling, and potential side effects, and are unlikely to rely heavily on supplementary information from importers, reducing the burden of these regulations in hospitals.

Community pharmacies are likely to rely more heavily on supplementary information because dispensing of pharmaceuticals in the community requires that patients be knowledgeable about how to use the medicines they are dispensed. Community pharmacies are therefore more likely to rely on verbal or printed instructions that can be conveyed to patients.

To calculate a cost to community pharmacists, a cost estimate based on the average wage of pharmacists in Canada and an average printing cost of four cents per page was used. The resulting estimate found that the additional cost of dispensing an exceptionally imported drug by pharmacists is expected to be less than $10,000 per year for all exceptionally imported drugs dispensed. While there are some costs involved for pharmacists, it is expected that the cost will be easily outweighed by the time saved by not having to search for alternative options when a drug is in shortage. Further details will be provided in the benefits section.

The total incremental cost to industry as a result of the exceptional importation option is only the cost to community pharmacists, as the other costs for importers and manufactures are expected to result in a net benefit due to the optional nature of the exceptional importation framework.

(2) Compliance with mandatory reporting requirements for medical device shortages

The amendments require manufacturers and importers of medical devices, identified on the List of Medical Devices - Notification of Shortages, to notify Health Canada of any anticipated or actual shortages of applicable products. This obligation imposes new costs on manufacturers and importers of medical devices.

In 2014, the United States Food and Drug Administration determined the cost of electronically reporting a drug shortage by a distributor was 224 USD per notification. In developing this estimate, the United States Food and Drug Administration assumed that reporting would take two hours of a regulatory affairs manager's time at a median wage of 112 USD per hour. Using this estimate as a proxy, mandatory reports will cost 315 CAD (2021 dollars) per report. Based on Health Canada's experience with voluntary reporting of medical device shortages, the department estimates that in future years, the number of medical device shortages subject to mandatory reporting requirements will be approximately 20% of the number reported during the COVID-19 pandemic. In fiscal year 2020, Health Canada received 517 total reports as a result of mandatory medical device shortage reporting requirements. It is therefore assumed that there will be roughly 103 shortage reports per year in the future.

Under these assumptions, the cost to industry of mandatory medical device shortage reporting will be approximately $32,500 per year ($315 per report × 103 shortage reports per year).

(3) Compliance with information requests

Under the amendments, the Minister may compel drug establishment licence holders and medical device manufacturers, importers, and distributors to provide Health Canada with information necessary to assess, prevent, or alleviate a shortage.

The department places a priority on collaboration and partnership with industry and assumes that current business practices in place for providing the information voluntarily will continue. It is also assumed that the amendments will not require businesses to produce new information — only to provide information that they already have in their possession. It is expected the cost of these provisions to industry will be low.

From the stakeholder survey, 70% of organizations stated that the cost of a mandatory request would be equal to the cost of responding to a voluntary request for information. The remaining 30% of organizations surveyed stated that complying with a mandatory request for information would generate new costs compared to a voluntary request for information. Firms that responded to the survey estimated the cost of responding to a voluntary request would be $4,000 on average. Firms that stated a mandatory request for information would increase their costs estimated that compliance would cost on average $1,500 more than a voluntary request for information.

The survey asked stakeholders if they had already been asked to provide information voluntarily. About 24% of drug establishment licence holders and 12% of medical device establishment licence holders indicated that they had. Respondents completed the survey based on their experience since January 2020, which corresponds to the heightened activity of the COVID-19 pandemic. Since there are approximately 1 000 drug establishment licence holders and 6 000 medical device establishment licence holders, it is assumed that 240 drug establishment licence holders (1 000 × 24%) and 720 medical device establishment licence holders (6 000 × 12%), for a total of 960 licence holders, would be asked to provide information over that period. The same assumption that a non-COVID year is equal to 20% of a COVID year is used to estimate that approximately 200 licence holders would be asked for information (both voluntary and mandatory) in a given year.

It is assumed that 5% of the 200 estimated requests would be mandatory. The provisions to compel information are subject to several criteria that must be satisfied. Therefore, a conservative estimate of 5% is reasonable to reflect the small number of instances where Health Canada would be able to compel a licence holder to provide information. The number of possible mandatory requests is estimated to be 10 (200 voluntary requests × 5%) per year. The estimated cost of responding to these mandatory requests is approximately $44,500 ([$4,000 × 7 requests] + [$5,500 × 3 requests]).

(4) Compliance with the prohibition against selling drugs intended for the Canadian market

The prohibition provision would limit market opportunities for drug establishment licence holders who wish to sell drugs intended for the Canadian market for consumption outside Canada. The prohibition is limited and only applies to certain drugs that are in shortage, or at risk of being in shortage. If an organization determines that selling their product will not cause or exacerbate a shortage in Canada, the organization is able to sell that drug outside of Canada.

To comply with the amendments, organizations will have to incur the cost of making a shortage determination and maintaining a record of that decision for at least one year beyond the expiry date of the drug. The survey found that 8% of organizations that dealt with drug products indicated that they would consider selling drugs intended for the Canadian market to a foreign country. Since there are approximately 1 000 drug establishment licence holders, it is estimated that approximately 80 organizations (1 000 drug establishment licence holders × 8%) may decide to sell drugs intended for the Canadian market to a foreign market. It should be noted that these organizations could still sell drugs intended for the Canadian market for consumption outside of Canada, as long as doing so would not cause or exacerbate a shortage. The prohibition against selling drugs outside of Canada would therefore apply to only a small proportion of the 80 organizations estimated to be interested in potentially exporting drugs intended for the Canadian market.

The cost of determining if exporting drugs could cause or exacerbate a shortage and maintaining records is estimated to be similar to reporting a drug shortage as described above under the heading Compliance with mandatory reporting requirements for medical device shortages. This cost is estimated to be 315 CAD per report. Assuming that all 80 drug establishment licence holders participate in this option, the total estimated cost of compliance is $25,200 (80 licence holders × $315).

Further, there is a possibility that companies that want to use this option may be limited by potential shortages that could occur in Canada, thus missing out on potential market opportunities in the United States or other countries. In cases where a prohibition was determined to be applicable, this would restrict impacted businesses' market access, which consecutively may lower profitability as compared to the baseline scenario. The degree of this impact is difficult to determine and any estimates would be highly uncertain given the number of unknown factors involved. However, it should be highlighted that only restricting exports in cases where a risk of shortage has been identified is a lower-cost option as compared to an outright restriction on any export.

Total industry costs

Based on the above costs, it is estimated that the total cost of administering the amendments for industry will be $112,200 per year.

Government

The comprehensive costs to the government of administering the amendments fall into four categories:

  • the costs of administering an exceptional importation program for drugs and medical devices;
  • the costs of administering a mandatory reporting program for shortages of selected medical devices;
  • the costs of compelling information from industry; and
  • the cost of promoting compliance and enforcing the prohibition against selling drugs outside of Canada if that sale could cause or exacerbate a shortage.

The cost to government for these programs is expected to be higher during the COVID-19 pandemic than it will be post-pandemic. It is expected that the costs of these programs will decline as supply chains stabilize and the demand for products associated with COVID-19 declines. Therefore, it is assumed that future costs incurred would be 20% of cost incurred under the interim orders during the COVID-19 pandemic.

(1) Administering exceptional importation of drugs and medical devices

The costs of administering the exceptional importation of drugs and medical devices derive from the expense of designating products for exceptional importation, promoting industry compliance, and conducting enforcement activities where necessary.

In order to designate products for exceptional importation, Health Canada considers proposals for importation, conducts risk assessments, posts products to the incorporated by reference lists, and processes import notifications. In addition, Health Canada performs a compliance and enforcement function through secondary reviews of exceptional importation applications, issuance of recall notices (if needed), and maintaining the incorporated-by-reference lists.

The total number of drugs and medical devices designated for exceptional importation through the Exceptional Importation and Shortages Interim Order No. 1 and Exceptional Importation and Shortages Interim Order No. 2 in fiscal year 2020 was 314. Based on Health Canada's pre-pandemic experience with shortages, it is assumed that the number of products designated for exceptional importation in the future will be around 20% of those products under the interim order. Under these assumptions, the cost to government associated with administering the exceptional importation program for drugs and medical devices is estimated to be approximately $88,000 per year. These costs will be managed within current Health Canada funding levels.

(2) Administering a mandatory reporting program for shortages of selected medical devices

The costs of administering mandatory medical device shortage reporting fall into four categories:

  • maintaining the list of specified devices;
  • following up with manufacturers;
  • processing and posting the notification of a shortage; and
  • managing high-risk files.

The costs of these activities are driven by the number of shortage reports received by Health Canada. The following are costs for mandatory medical device shortage reports only, as drug shortages currently have mandatory reporting requirements.

In fiscal year 2020, 517 shortage reports were received by Health Canada. Based on Health Canada's experience with voluntary reporting of medical device shortages, the department estimates that in future years, the number of medical device shortages subject to mandatory reporting requirements will be approximately 20% of the number reported during the COVID-19 pandemic. Under this assumption, Health Canada expects to receive approximately 103 medical device shortage reports per year.

In fiscal year 2020, a total of 292 medical device shortages were posted to Health Canada's published List of Medical Device Shortages. Health Canada assumes that the number of postings will decline in the same proportion as the predicted decline in shortage notifications. Furthermore, it is assumed that Health Canada will need to manage three high-risk files per year. Under these assumptions, it is expected that the cost to government of administering a mandatory shortage reporting program for medical devices will be approximately $645,000 per year. Again, these costs will be managed with current Health Canada funding levels.

(3) Compelling information from industry

Health Canada places a priority on collaboration and partnership with industry. The amendments include a provision to allow the Minister to compel information in certain circumstances. Under the amendments, there are multiple conditions that must exist for the Minister to compel information from a stakeholder and it is estimated that mandatory requests would rarely be used. The use of mandatory information requests results in some costs to government, which include determining the need for issuing a mandatory information request, issuing a request, and reviewing the response to an information request.

Mandatory requests for information under the interim orders have never been used for drugs or medical devices and it is expected that their use in the future will be rare. Health Canada estimates that mandatory requests for information will cost the department approximately $700 per request and it is assumed that there will be 10 mandatory requests per year. The actual number of mandatory requests is difficult to estimate, though 10 requests should be viewed as a conservative estimate. Under this assumption, the cost to government of issuing mandatory requests for information is estimated to be approximately $7,000 per year ($700 per request × 10 requests). These costs will be managed within current funding levels.

(4) Compliance and enforcement of the prohibition against selling drugs outside of Canada that may cause or exacerbate a shortage

The prohibition against selling drugs intended for the Canadian market outside of Canada will increase Health Canada's compliance verification and enforcement costs. These costs are difficult to estimate, since foreign countries did not permit the importation of drugs intended for the Canadian market until recently, and there is no data available on the extent of bulk exports of Canadian-labelled drugs. Therefore, recent experience from the interim order was used to estimate these costs, even though the information is limited.

Since November 2020, Health Canada has not reviewed any cases of drug sale outside of Canada. As international experiences change and organizations become more aware of these new requirements, the number of cases requiring compliance verification and enforcement activities may rise over time.

As noted, 8% of drug establishment licence holders surveyed stated that they would consider selling drugs that were originally intended for the Canadian market outside of Canada. There are roughly 1 000 drug establishment licence holders in Canada. Assuming that the organizations surveyed are a reasonable estimate of the population of drug establishment licence holders, it can be estimated that 80 firms will consider selling drugs outside of Canada.

It is estimated than only 5% of these firms will engage in activities that will require some form of compliance promotion or enforcement action from Health Canada. Therefore, the department could expect to conduct 4 (80 firms × 5%) compliance promotion or enforcement activities per year. Health Canada estimates that the cost of monitoring compliance and issuing enforcement will be around $5,000 per compliance promotion or enforcement action. It is estimated that the cost of the prohibition to government will be approximately $20,000 ($5,000 per compliance and enforcement action × 4 instances) per year. These costs will be managed within current Health Canada funding levels.

Total government costs

Based on the above costs, it is estimated that the total cost of administering the amendments will be $760,000 per year, excluding the temporary amendments in relation to biocides and foods for a special dietary purpose. These costs will be absorbed by Health Canada using existing resources.

Benefits

The amendments will benefit Canadians by improving Health Canada's ability to monitor, prevent and alleviate shortages of therapeutic products as well as reduce the risk of mortality related to shortages. These benefits are expected to be significant.

Drugs and medical devices in shortage represent a variety of products that differ in routes of administration, strengths and other factors that may be used for different situations. The conditions they treat may vary in severity, such as those that are life-threatening and those that cause significant threat to quality of life. Some therapeutic products have easily substituted alternative options, some substitutes are difficult for patients to switch to for various reasons, and some are a niche and the only option available. Certain drugs are used in combination with several other drugs, while some are used in isolation. Given that there is a large variety in products and patient outcomes, the incremental benefits are difficult to measure. Thus, quantifiable benefits are represented through the average of patient outcomes.

(1) Exceptional importation

The amendments pertaining to the exceptional importation of specified drugs and medical devices will expand the number of products an importer would be able to sell, allowing industry to increase their supply of products and revenues, should an importer choose this option.

Exceptional importation will have positive net benefits for industry assuming importers choose this option. Because exceptional importation is a voluntary mechanism to import and sell drugs and medical devices, industry stakeholders will only use this option if they expect it to be profitable. Stakeholders using exceptional importation under the Exceptional Importation and Shortages Interim Order No. 1 reported that the use of exceptional importation yielded a net profit greater than $1.65 million per participating organization. However, this number must be taken as anecdotal, because the survey did not yield enough responses to be representative of the industry as a whole.

Assuming that the exceptional importation option provides positive benefits to industry and that firms continue to use the option as they have under the interim order, Canadians will benefit through an increase in the supply of therapeutic products that are in shortage or at risk of shortage. An increase in therapeutic products entering the Canadian market during shortages will provide Canadians with access to substitute products that they otherwise would not be able to access. In turn, this may mitigate against adverse events from shortages impacting their treatments. Although this benefit is assumed to be significant, Health Canada cannot accurately estimate the value of the exceptional importation option for industry, given the voluntary nature of the program.

There are expected to be various benefits to pharmacists from dispensing exceptionally imported drugs. As seen in a 2018 survey of pharmacists in Canada conducted by the Canadian Pharmacist's Association, the survey found that shortage management generally takes between 1% and 20% of pharmacists' time per shift. Additionally, the Canadian Journal of Hospital Pharmacy published an article in 2019 that found ranges of time it took hospital pharmacists to manage a single shortage. Using these ranges, Health Canada has estimated that the average time spent managing a shortage by hospital pharmacists is approximately 15 minutes per shortage. Preventing and alleviating shortages may serve to reduce the amount of time spent on shortage management and allow healthcare professionals and patients to use that time for other activities. The time saved is expected to exceed the cost of dispensing exceptionally imported drugs. Assuming that a product being exceptionally imported eliminates the need to spend time managing a single shortage, the total benefits for pharmacists could be as high as $180,000 per year in time saved.

The benefits for Canadians are expected to be significant. In order for a drug to be considered for exceptional importation, it must be in Tier 3 shortage. In order to be deemed a Tier 3 shortage, a requirement is that the drug in question has to be medically necessary, meaning it has a significant impact on quality of life, or even preventing risk of death. Therefore, the very nature of Tier 3 drug shortages means that the drugs eligible for exceptional importation will have a significant impact on reducing risk and/or improving quality of life.

An analysis of a 2021 peer-reviewed article in the Canadian Medical Association Journal on a single drug shortage in Canada during the COVID-19 pandemic allowed Health Canada to estimate the potential reduction in risk from exceptional importation of this drug product. Using internally collected data, the amount of potential lives saved from mitigating this shortage was estimated to be around 75 lives during the COVID-19 pandemic from this single drug.

This benefit can be quantified using a value of a statistical life (VSL) calculation. A VSL is an aggregate value of risk reduction per statistical life. Using this example as a proxy for the benefits of all exceptionally imported products, the estimated amount of risk reduction from this amendment is estimated to be the equivalent of 7.5 VSL on average for all drug products in a non-COVID year, using internally collected data. The Treasury Board Secretariat provides a 2007 VSL estimate of $6.5 million which would be approximated to $8.21 million in 2021. The value of 7.5 VSL in statistical risk reductions per year is therefore rounded to approximately $61.57 million per year ($8.21 million per one VSL × 7.5 VSL per year).

(2) Mandatory reporting program for shortages of specified medical devices

Mandatory shortage reporting of specified medical devices is expected to lessen the occurrence of medical device shortages, mitigate the impact of these shortages, and improve patient outcomes. Mandatory reporting of selected medical devices allows Health Canada to have better awareness of supply issues for specified medical devices and can help mitigate against potential shortages before they occur. The prevention of medical device shortages can improve patient outcomes by avoiding adverse events that may follow from a shortage.

Mandatory reporting of selected medical device shortages is also expected to promote openness and transparency about the availability of specified medical devices. Providing healthcare practitioners, procurement agencies, and patients with up-to-date information on anticipated and actual shortages will allow those parties to make timely and informed decisions about the procurement and use of selected medical devices. This will serve to help minimize the costs of medical device shortages and their impact on patient care.

This benefit can be quantified using a VSL calculation. From an internal questionnaire, mandatory medical device shortage reporting during the COVID-19 pandemic resulted in approximately 2% of shortages being mitigated. Estimating these effects in a non-COVID year, the estimated benefits from avoiding these shortages are expected to be 0.2 VSL per year at a quantifiable benefit of approximately $1.64 million per year ($8.21 million per one VSL × 0.2 VSL per year).

(3) Compelling information from industry

The ability for the Minister to request information in relation to a drug or medical device shortage will see some positive benefits for Canadians, as it permits Health Canada to access information that may be crucial to informing its response to mitigating a potential or actual shortage. Health Canada can only use this power if the Minister has reasons to believe that the industry would not supply the information voluntarily.

(4) Prohibition against selling drugs outside of Canada that may cause or exacerbate a shortage

The prohibition against selling drugs outside of Canada that may cause or exacerbate a shortage is expected to provide benefits to Canadians by preventing shortages attributable to the bulk export of drugs. Safeguarding existing stocks of drugs in shortage or at risk of shortage will further provide benefits to Canadians.

Transitional amendments

Biocides and foods for a special dietary purpose transitional provisions

As a transitional measure to ensure that Canada's supply of biocides and foods for a special dietary purpose stabilizes, and to give industry time to adjust, these products have been excluded from the above estimates. The estimates for these products are separate from the remaining estimates because the amendments related to them are only in place for a limited time, and do not have the same 10-year time horizon as the other amendments.

Costs

The amendments do not impose new costs on Canadians.

These products were imported under the previous interim orders and, as such, they are not associated with any cost to industry.

The cost to government would be minimal, as the government would maintain normal oversight for these products for the transition period.

Benefits

The transitional measure will allow organizations that have exceptionally imported these products to sell to retail facilities, for a period of 10 months, which can then be sold as usual. Liquidating products that have already been imported into Canada will mitigate losses from non-compliant products no longer eligible for exceptional importation.

Drug-based hand sanitizers transitional provisions

As a transitional measure, some organizations that have submitted an application for a drug establishment licence are allowed to conduct licensable activities in relation to drug-based hand sanitizers until Health Canada has made a decision regarding the application, the sponsor withdraws the application, or until September 1, 2023, whichever is sooner.

Costs

The amendments to not impose new costs on Canadians.

These products were imported under the previous interim orders and, as a result, they are not associated with any cost to industry.

The cost to government will be minimal, as the government will maintain normal oversight for these products during the transition period.

Benefits

The transitional measure will allow organizations to continue conducting licensable activities related to drug-based hand sanitizers. This will allow for applications to be processed in relation to drug-based hand sanitizers without hindering licensable activities of an organization.

Summary totals

Summary total quantifiable benefits

The estimated benefits that were quantifiable equals $63 million per year, with a net present value over 10 years of $445.2 million (discounted at 7%). These estimates include the value of the reduction in risks to Canadians, as a whole, estimated to be the equivalent of 7.7 VSL per year over 10 years, as well as the estimated 15 minutes saved by pharmacists when a drug shortage is prevented as a result of the exceptional importation. This encompasses the inclusion of biocides and foods for a special dietary purpose in the amendments.

Summary total cost-benefit statement

The total quantifiable costs of the temporary amendments in relation to biocides and foods for a special dietary purpose is expected to be approximately $0 for the duration of the amendments. The total quantifiable costs as a result of the permanent amendments are expected to be approximately $862,200 per year.

Including both the temporary and permanent amendments, the total quantifiable cost is approximately $872,200 per year, which is equivalent to $6,126,000 as a net present value over 10 years (discounted at 7%). This cost will be offset by a number of qualitative and quantitative benefits that will reduce the risk on life, increase the products available to Canadians and remove unnecessary burden to industry.

Table 1: Cost-benefit statement (in 2021 dollars) including absorbed costs
  • Number of years: 10 years (2022 to 2031)
  • Base year for costing: 2021
  • Present value base year: 2022
  • Discount rate: 7%
Monetized costs
Impacted Stakeholders Description of Cost Base Year 2022 Final Year 2031 Total (Present Value) Annualized Value
Government Total government costs (administrative, enforcement) $760,000 $760,000 $5,338,000 $760,000
Industry Total industry costs (compliance, administrative) $112,200 $112,200 $788,000 $112,200
Canadians Total costs to Canadians $0 $0 $0 $0
All stakeholders Total costs $872,200 $872,200 $6,126,000 $872,200
Monetized benefits
Impacted Stakeholders Description of Benefit Base Year 2022 Final Year 2031 Total (Present Value) Annualized Value
Industry Pharmacists' time saved $180,000 $180,000 $1,264,000 $180,000
Canadians 7.5 VSL per exceptional importation $61,570,000 $61,570,000 $432,445,000 $61,570,000
0.2 VSL per shortage reporting $1,642,000 $1,642,000 $11,532,000 $1,642,000
All stakeholders Total benefits $63,392,000 $63,392,000 $445,241,000 $63,392,000
Summary of monetized costs and benefits
Impacts Base Year 2022 Final Year 2031 Total (Present Value) Annualized Value
Total costs $872,200 $872,200 $6,126,000 $872,200
Total benefits $63,392,000 $63,392,000 $445,241,000 $63,392,000
Net benefit $62,519,800 $62,519,800 $439,115,000 $62,519,800

Small business lens

Analysis under the small business lens concluded that the amendments would impact small businesses.

Forty-seven of the organizations surveyed for this project self-identified as a small business based on the definition of a small business being “any business, including its affiliates, which has fewer than 100 employees or generates between $30,000 and $5 million in annual gross revenue.”

From all of the organizations that responded to the survey,

  • 25 of 38 organizations that dealt with drugs self-identified as a small business;
  • 14 of 16 from those that dealt with biocides and drug-based hand sanitizers self-identified as a small business; and
  • 25 of 36 from those that dealt with medical devices self-identified as a small business.

Some self-declared small businesses dealt in more than one of these industries.

Exceptional importation of drugs

Costs to community pharmacies are attributable to explaining patient safety information on exceptionally imported drugs. Community pharmacies will likely rely on verbal or printed instructions to convey information on the safety of exceptionally imported products. The incurred costs of community pharmacies are less than $10,000 per year for all exceptionally imported drugs dispensed. This is based on a cost estimate of the average wage of pharmacists in Canada and an average printing cost of four cents per page.

Health Canada designed the exceptional importation framework to minimize the impact on community pharmacies. Importers are required to make information required to support the safe use of imported drugs available in both French and English. Accordingly, the burden on community pharmacists is limited to the costs of printing and explaining these materials to patients. These costs are expected to be much lower than the costs of managing shortages that would result if exceptionally imported drugs were not available.

Mandatory reporting of medical devices shortages

New costs for small businesses are attributable to reporting obligations for regulated parties in the medical-devices industries. After these amendments come into force, medical device manufacturers and importers will be required to report shortages and discontinuances of specified medical devices at an estimated total industry cost of $32,500 per year.

Health Canada has taken steps to mitigate the impact of these amendments on small businesses by modifying its operational approach to medical device shortage reporting. In contrast to the approach used prior to the COVID-19 pandemic, Health Canada has adopted a single-window access model for medical device shortage reports. This serves to streamline the reporting process and avoid duplicate reports.

Health Canada has also adapted these regulations to stakeholder needs by modifying information requirements in medical device shortage reporting. Under interim orders in force between March 31, 2020, and March 1, 2022, Health Canada has routinely requested information from industry on a voluntary basis to confirm shortage reports. These amendments now require importers and manufacturers of medical devices to provide information in their initial shortage reports that would otherwise be sought during the initial follow up. This reduces Health Canada's reliance on follow-up information requests and possible use of the power to compel information. This has the advantage of lowering industry compliance costs.

Health Canada has also reduced the burden of these amendments on industry by reviewing shortage reporting requirements for importers of medical devices. Under the Exceptional Importation and Shortages Interim Order No. 2, manufacturers and importers of all classes of medical devices were required to submit medical device shortage reports. This resulted in duplicate reports from manufacturers and importers of Class II–IV medical devices which increased burden on industry, but which were not always useful for identifying shortages. Under these amendments, importers are only required to report shortages of Class I medical devices.

Power to compel information

Drug establishment licence holders and medical device manufacturers, importers, and distributors will be required to provide information on shortages when a request is made by the Minister, costing the industry an estimated $44,500 per year.

Health Canada has taken steps to mitigate the impacts of these amendments on small businesses by designing the Regulations to minimize administrative burden. The power to compel information by the Minister can only be exercised under limited conditions. The power cannot be used unless the information is required to confirm the existence of a shortage or the risk of a shortage, assess the shortage, or develop measures to address the shortage. Moreover, the power can only be used when the Minister has reasonable grounds to believe that the regulated party would not provide this information voluntarily.

As noted above, information requirements for mandatory medical device shortage reporting have been modified to reduce Health Canada's reliance on information requests and the power to compel information. This has the advantage of lowering industry compliance costs.

Compliance with the prohibition against selling drugs outside of Canada

If a drug establishment licence holder wants to sell drugs outside of Canada, they will be required to make a determination of whether the exportation will cause or exacerbate a shortage in Canada. These actions will cost industry an estimated $25,200 per year.

Health Canada designed the prohibition narrowly in order to limit costs for drug establishment licence holders, including small businesses. The provisions of these amendments concerned with safeguarding the drug supply were written to apply only to those drugs where sale for consumption or use outside of Canada could cause a shortage or exacerbate an existing shortage. If sale would not cause or exacerbate a shortage, drug establishment licence holders are permitted to sell drugs outside of Canada.

Record-keeping requirements were also written narrowly to minimize costs for small businesses. Under these amendments, drug establishment licence holders selling drugs outside of Canada are only required to retain records of their determination that sale would not cause or exacerbate a shortage for one year after the expiration of the product that is sold. This standard has been developed to be consistent with other record-keeping requirements required under good manufacturing practices in an effort to lower burdens for market participants, including small businesses.

One-for-one rule

The amendments create new provisions within existing sections of the Food and Drug Regulations and the Medical Devices Regulations. These new rules create a new incremental administrative burden on holders of drug establishment licences.

For the purposes of the one-for-one rule, administrative costs are considered separately from compliance costs. The Policy on Limiting Regulatory Burden on Business defines compliance costs as “up-front capital costs and ongoing maintenance and training costs that businesses incur when complying with a regulation.” The Red Tape Reduction Act defines administrative burden as “anything that is necessary to demonstrate compliance with a regulation, including the collecting, processing, reporting and retaining of information and the completing of forms.” The one-for-one rule requires that new, incremental administrative burdens on business are offset within two years.

The new administrative burdens for drug establishment licence holders relate to the need to create and retain records. A drug establishment licence holder wishing to sell a drug intended for the Canadian market outside of Canada is required to make a determination that the sale would not cause a shortage or exacerbate an existing shortage. The drug establishment licence holder is required to retain a record of that determination until one year after the expiry of the drug.

The cost of determining whether selling outside of Canada would lead to a shortage or not was estimated in the cost-benefit analysis section above. The administrative costs are assumed to be half the total estimated time in the cost-benefit section above for the purposes of the one-for-one rule because the determination of a shortage would be essential to the Regulations achieving their objective and are thus considered the compliance costs and are not included in this section, while the record-keeping requirements are considered administrative in nature and are included.

In this section, the two hours of a regulatory affairs manager's time is assumed to be split evenly between determining if their organization will cause or exacerbate a shortage and maintain a record of the decision. As such, it is assumed one hour will be for administrative costs and the other hour will be for compliance costs. The method used for estimating administrative burden is established by the Red Tape Reduction Regulations, which stipulate that one-for-one values are reported using 2012 prices, discounted to a base year of 2012, and reported as an annualized amount. When applying these parameters, these amendments increase administrative burden by an annualized total of $6,854.

Since the amendments will result in administrative burden, the one-for-one rule applies, and administrative burdens are considered an “IN” under the rule. The incremental administrative cost of these Regulations will be offset by an equivalent reduction in the administrative credits available within the health portfolio.

Regulatory cooperation and alignment

Canada's regulatory approach to exceptional importation is consistent with approaches taken in other countries, including the United States, France, and Australia. Canada's approach to safeguarding the domestic drug supply is similar to approaches taken in France and the United Kingdom, which have prohibitions in place to protect their supply of drugs.

Health Canada is exploring opportunities to collaborate with other regulators (for example, the United States, the United Kingdom, France, Ireland, Japan, and Australia) on mandatory reporting of medical device shortages. The department's activities in this area are currently limited to information-sharing because these programs are relatively new in Canada and the United States and do not yet exist in other countries. Regulatory cooperation and alignment will be central in these conversations as they evolve over time.

Strategic environmental assessment

In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a preliminary scan concluded that a strategic environmental assessment is not required.

Gender-based analysis plus (GBA+)

These amendments are expected to broadly benefit the health of all Canadians who use, or may use, drugs and medical devices. The amendments are not expected to disadvantage Canadians based on their gender, race, culture, or other personal or group characteristics.

Canadians who are particularly reliant on drugs or medical devices may benefit the most from Health Canada's improved capacity to prevent and alleviate shortages. A number of factors can influence the need for therapeutic products, including, but not limited to, age, sex, disabilities, and underlying conditions. For example, therapeutic product use rises with age, in part because older Canadians are more susceptible to chronic conditions that require drugs and/or medical devices to manage these conditions. Incidents of chronic conditions that require prolonged use of therapeutic products are more common among women over 65, as women tend to have longer life expectancies than men.

The burden of shortages may not fall equally on all groups. The broad term “socioeconomic status” is used to integrate a wide range of personal characteristics, which together help define a person's social or economic position relative to others. The burden of injury or illness disproportionately affects people with lower socioeconomic status, who face greater health risks, have fewer resources to maintain and improve their health, and who are more likely to face barriers to accessing health products and services. Challenges leading to those inequalities include unstable employment or inflexible working conditions, social or geographical isolation, or inadequate housing conditions. Improving Health Canada's response to shortages may help improve access to therapeutic products and reduce existing inequities in this regard. As a result, it is anticipated that this regulatory proposal could indirectly benefit groups with lower socioeconomic status.

Rationale

Interim orders made in 2020 and 2021 allowed Health Canada to take immediate action against significant risks posed by therapeutic product shortages. While the COVID-19 pandemic made it necessary to implement these measures on an urgent basis, the need for these measures was apparent before March 2020. The interim order powers have been useful in addressing shortages since they were deployed beginning in March 2020, but they do not serve as a long-term solution for ensuring that Canadians have access to the drugs and medical devices that they need. Amendments to the Food and Drug Regulations and the Medical Devices Regulations are necessary to continue to provide the department with the tools necessary to help prevent or alleviate therapeutic product shortages in the future. Targeted consultations have suggested that stakeholders in industry and the broader health system are supportive of the government's approach.

It is expected that the costs to regulated parties will be small. Exceptional importation of therapeutic products is expected to create no net new costs on industry because it is a voluntary program. New powers to compel information in respect of shortages are only to be used in situations where a regulated party declines to provide that information voluntarily, which is anticipated to be rare due to the collaborative relationship between Health Canada and industry partners in addressing shortages. Mandatory reporting of medical device shortages will impose new compliance costs, but only for importers of Class I medical devices and manufacturers of specified medical devices published on the List of Medical Devices – Notification of Shortages incorporated-by-reference list.

Many of the benefits of these amendments are not quantifiable, but as a whole, they are expected to significantly outweigh their costs. In the near term, these amendments will allow the federal government to better support healthcare systems across Canada to recover from the effects of the COVID-19 pandemic on global supply chains. In the longer term, new powers to monitor, prevent and alleviate shortages will reduce the time spent by healthcare professionals and patients searching for substitutes for a product in shortage. These powers will also help prevent adverse outcomes that could arise from cancelling or deferring treatments or using substitute products.

In drafting these amendments, care was taken to minimize operational impacts on hospitals in accordance with subsection 30(1.3) of the Food and Drugs Act, which reads

“Before recommending to the Governor in Council that a regulation be made […], the Minister shall take into account existing information management systems, with a view to not recommending the making of regulations that would impose unnecessary administrative burdens.”

Implementation, compliance and enforcement, and service standards

Implementation

These amendments come into force in two phases. Amendments that prohibit the sale of drugs intended for the Canadian market outside of Canada that could cause or exacerbate a shortage and allow the Minister to compel information in respect of drug shortages come into force on November 27, 2021. Amendments relating to the exceptional importation and sale of drugs and medical devices, the Certificate of Supplementary Protection Regulations, mandatory reporting of specified medical device shortages, the power to compel information in respect of medical device shortages, and transition provisions related to biocides and foods for a special dietary purpose will come into force on March 1, 2022. This schedule promotes transparency and allows for a coherent transfer of temporary provisions from interim orders that expire on those dates into the Food and Drug Regulations and the Medical Devices Regulations on a permanent basis.

Health Canada is building on processes developed during the implementation of the Exceptional Importation and Shortages Interim Order No. 2 and the Safeguarding Interim Order. These activities include

  • publishing industry guidance on exceptional importation of drugs and medical devices prior to the coming into force of these regulations;
  • continuing to publish incorporated-by-reference lists, including the List of Drugs for Exceptional Importation and Sale, the List of Medical Devices for Exceptional Importation and Sale, and the List of Medical Devices – Notification of Shortages;
  • continuing to publish reports of medical device shortages;
  • identifying resources within the department for compliance, promotion and enforcement activities; and
  • identifying resources to enable the department to partake in mitigation measures for shortages alongside industry, healthcare stakeholders, and other levels of government, as well as to assess and prioritize appropriate mitigation efforts within the department, when required.

A guidance document explaining the details and procedures for reporting medical device shortages, including discontinuances, under the Medical Devices Regulations will be published by Health Canada prior to the coming into force of these regulations. This document will be readily available to regulated parties and describes their obligations to report medical device discontinuances. It also includes additional information to help regulated parties understand how to comply with the requirements.

The department uses a Performance Information Profile to measure and track the success of Health Canada's Pharmaceutical Drugs Program. The department's progress in incorporating interim order tools into strategies to mitigate and prevent drug shortages is reported on annually through the Performance Information Profile process. The Performance Information Profile highlights the implementation of strategies to prevent and mitigate drug shortages as a medium-term program result for Health Canada. Health Canada will measure its success using tools made available by interim orders to help prevent and alleviate drug shortages by measuring the percentage of tools incorporated into drug shortage strategies. The results will be comprehensively tracked in keeping with the Policy on Results.

As well, the department regularly conducts audit and evaluation activities to assess the effectiveness of Health Canada programs. The department's Pharmaceutical Drugs Program, which will administer the amendments, is scheduled to be assessed in January 2023. An evaluation of Health Canada's Medical Devices Program is scheduled to launch in December 2023.

Compliance and enforcement

Regulated parties including drug establishment licence holders, drug identification number holders, and medical device manufacturers, importers, and distributors are responsible for ensuring that they comply with the applicable requirements of the Food and Drugs Act and its regulations. In implementing these amendments, Health Canada is building on current operations to facilitate compliance, including using the department's existing exceptional importation notification system and its single window access model for medical device shortage notification. These will benefit the regulated industries and Health Canada by

  • facilitating the publication and update of information on shortages;
  • reducing delays in exceptional importation and sale due to incorrectly completed forms; and
  • supporting the timely provision of information for compliance verification and enforcement actions regarding exceptionally imported products in Canada.

Compliance with these amendments will be assessed and enforced in accordance with Health Canada's Compliance and enforcement policy for health products (POL-0001). This policy describes the department's national compliance and enforcement approach for health products regulated under the Food and Drugs Act. The policy uses an evidence- and risk-based approach that emphasizes fairness, consistency, impartiality, and transparency to help protect the safety of the public and prevent deception that would create a false or misleading impression in relation to health products. Compliance and enforcement activities may include

  • active prevention of problems through compliance promotion;
  • targeted oversight of risks through proactive compliance; and
  • rapid response and enforcement to address detected public health risks.

Compliance and enforcement responses are proportionate to the identified risk posed to the health and safety of Canadians. Health Canada chooses the actions and tools that are most appropriate for the situation, based on an assessment of available evidence and risks pertaining to the situation.

Contact

Catherine Hudon
Director
Policy and Regulatory Strategies Directorate
Regulatory Operations and Enforcement Branch
Health Canada
Telephone: 613‑946‑6220
Email: hc.prsd-questionsdspr.sc@canada.ca