Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Shortages and Discontinuation of Sale of Drugs and Medical Devices): SOR/2026-96

Canada Gazette, Part II, Volume 160, Number 12

Registration
SOR/2026-96 May 29, 2026

FOOD AND DRUGS ACT

P.C. 2026-504 May 29, 2026

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, makes the annexed Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Shortages and Discontinuation of Sale of Drugs and Medical Devices) under section 30footnote a of the Food and Drugs Actfootnote b.

Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Shortages and Discontinuation of Sale of Drugs and Medical Devices)

Food and Drug Regulations

1 (1) The definition discontinue in subsection C.01.001(1) of the Food and Drug Regulationsfootnote 1 is replaced by the following:

discontinue
means, in respect of the sale of a drug by 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, to permanently cease the sale of the drug in Canada; (cesser)

(2) Subsection C.01.001(1) of the Regulations is amended by adding the following in alphabetical order:

List of Drugs for the Purposes of Paragraphs (b) and (c) of the Definition drug in Subsection C.01.014.8(1)
means the List of Drugs for the Purposes of Paragraphs (b) and (c) of the Definition drug in Subsection C.01.014.8(1) of the Food and Drug Regulations that is published by the Government of Canada on its website, as amended from time to time; (Liste de drogues pour l’application des alinéas b) et c) de la définition de drogue au paragraphe C.01.014.8(1))
shortage
means, in respect of a drug, 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.01.014.7 of the Regulations is renumbered as subsection C.01.014.7(1) and is amended by adding the following:

(2) For greater certainty, subsection (1) does not remove the requirement for the manufacturer to post information under subsection C.01.014.91(1).

3 Section C.01.014.71 of the Regulations is replaced by the following:

C.01.014.71 If 12 months have elapsed since the day on 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 a drug — within the meaning of paragraph (a) of the definition drug in subsection C.01.014.8(1) — last sold the drug, the manufacturer shall so notify the Minister, in writing, within 30 days after the day on which that period ends.

4 Section C.01.014.8 of the Regulations is replaced by the following:

C.01.014.73 (1) The Minister may add a drug to Part 1 of the List of Drugs for the Purposes of Paragraphs (b) and (c) of the Definition drug in Subsection C.01.014.8(1) only if the Minister has reasonable grounds to believe that a shortage or the discontinuation of sale of the drug, if it were to occur, could present a risk of injury to human health.

(2) The Minister may add a class of drugs to Part 2 of the List of Drugs for the Purposes of Paragraphs (b) and (c) of the Definition drug in Subsection C.01.014.8(1) only if the Minister has reasonable grounds to believe that a shortage or the discontinuation of sale of any drug that belongs to that class, if it were to occur, could present a risk of injury to human health.

C.01.014.8 (1) In sections C.01.014.9 to C.01.014.95, other than in section C.01.014.93, drug means any of the following drugs for which a drug identification number has been assigned and not been cancelled:

(2) In sections C.01.014.9 and C.01.014.91, designated website means

5 (1) The portion of subsection C.01.014.9(1) of the Regulations before paragraph (b) is replaced by the following:

C.01.014.9 (1) Subject to subsection (5), if a shortage of a drug exists or is likely to occur, 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 shall post the following information in English and French on the designated website:

(2) Paragraph C.01.014.9(2)(b) of the English version of the Regulations is replaced by the following:

(3) Subsections C.01.014.9(3) and (4) of the Regulations are replaced by the following:

(3) If any of the information that was posted by the manufacturer changes, they shall update that information on the designated website within two days after the day on which they make or become aware of the change.

(4) Within two days after the day on which the manufacturer is able to meet the demand for the drug, they shall post information on the designated website to that effect.

6 (1) The portion of subsection C.01.014.10(1) of the Regulations before paragraph (b) is replaced by the following:

C.01.014.91 (1) If 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 decides to discontinue the sale of the drug, they shall post the following information in English and French on the designated website:

(2) Paragraphs C.01.014.91(2)(a) and (b) of the Regulations are replaced by the following:

(3) Subsection C.01.014.91(3) of the Regulations is replaced by the following:

(3) If any of the information that was posted by the manufacturer changes, they shall update that information on the designated website within five days after the day on which they make or become aware of the change.

(4) For greater certainty, subsection (1) does not remove the requirement for the manufacturer to inform the Minister under section C.01.014.7.

7 Section C.01.014.11 of the Regulations is replaced by the following:

C.01.014.92 If a person maintains a website under contract with His Majesty in right of Canada for the purpose of posting information under sections C.01.014.9 and C.01.014.91, the Minister shall ensure that a hyperlink to that website is on the Government of Canada website.

8 (1) The portion of subsection C.01.014.12(1) of the Regulations before paragraph (a) is replaced by the following:

C.01.014.93 (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 for which a drug identification number has been assigned and not been cancelled — provide the Minister with information that is in their control if the Minister has reasonable grounds to believe that

(2) Subsection C.01.014.93(1) of the Regulations is amended by adding the following after paragraph (a):

(3) Paragraph C.01.014.93(1)(b) of the Regulations is amended by striking out “or” at the end of subparagraph (iii) and by replacing subparagraph (iv) with the following:

(4) Subsection C.01.014.93(2) of the Regulations is replaced by the following:

(2) The manufacturer or licensee shall provide the requested information in the time, form and manner specified by the Minister.

9 Section C.01.014.13 of the Regulations is renumbered as section C.01.014.94.

10 Subsection C.01.014.14(1) of the Regulations is replaced by the following:

C.01.014.95 (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.01.014.94.

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

12 The Regulations are amended by adding the following before section C.10.001:

Drugs for an Urgent Public Health Need

13 Paragraph C.10.001(2)(b) of the Regulations is replaced by the following:

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

Drugs for Exceptional Importation and Sale

15 (1) The portion of subsection C.10.004(1) of the Regulations before the first definition is replaced by the following:

C.10.004 (1) The following definitions apply in this section and in sections C.10.005 to C.10.013.

(2) The definition drug in subsection C.10.004(1) of the Regulations is repealed.

(3) The definition designated drug in subsection C.10.004(1) of the Regulations is replaced by the following:

designated drug
means
  • (a) a drug that is set out in Part 1 of the List of Drugs for Exceptional Importation and Sale; and
  • (b) a lot or batch of a drug that is set out in Part 2 of that list. (drogue désignée)

(4) Subsection C.10.004(1) of the Regulations 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)

(5) Subsection C.10.004(2) of the Regulations is replaced by the following:

(2) In sections C.10.005 to C.10.013, batch certificate, fabricate, import, MRA country, package/label, recognized building and wholesaler have the same meanings as in subsection C.01A.001(1).

(3) In this section and sections C.10.006 and C.10.009,

(4) The definition expiration date in subsection C.01.001(1) does not apply in respect of a designated drug referred to in subsection C.10.007.4(1).

16 Section C.10.005 of the Regulations is replaced by the following:

C.10.005 (1) Subject to subsection (3), the Minister may add a drug that is fabricated outside Canada to Subpart 1 or 2 of Part 1 of the List of Drugs for Exceptional Importation and Sale only if

(2) Subject to subsection (3), the Minister may add a lot or batch of a drug that is fabricated in Canada to Subpart 1 or 2 of Part 2 of the List of Drugs for Exceptional Importation and Sale only if

(3) The Minister may add a drug to Subpart 2 of Part 1 of the List of Drugs for Exceptional Importation and Sale — or a lot or batch of a drug to Subpart 2 of Part 2 of that list — only if

C.10.005.1 For greater certainty, if a lot or batch of a drug is set out in Part 1 or 2 of the List of Drugs for Exceptional Importation and Sale, sections C.10.006 to C.10.013 apply only in respect of that lot or batch.

17 (1) The portion of subsection C.10.006(1) of the Regulations before subparagraph (a)(i) is replaced by the following:

C.10.006 (1) Despite sections A.01.040 and C.01.004.1, a person who holds an establishment licence that authorizes the importation of a drug may import a designated drug set out in Part 1 of the List of Drugs for Exceptional Importation and Sale if the following conditions are met:

(2) Paragraph C.10.006(1)(b) of the Regulations is replaced by the following:

(3) The portion of paragraph C.10.006(1)(d) of the Regulations before subparagraph (i) is replaced by the following:

(4) Subparagraphs C.10.006(1)(d)(iii) and (iv) of the Regulations are replaced by the following:

(5) Paragraphs C.10.006(1)(e) to (g) of the Regulations are replaced by the following:

(6) Subsection C.10.006(2) of the Regulations is repealed.

18 Section C.10.007 of the Regulations is replaced by the following:

C.10.007 Section A.01.044 does not apply in respect of the importation of a designated drug under section C.10.006.

C.10.007.1 (1) Despite sections C.01.003, C.01.014 and C.08.002 and subject to subsections (3), (4) and (6), a person who holds an establishment licence may sell a designated drug that is set out in Part 2 of the List of Drugs for Exceptional Importation and Sale for consumption or use in Canada if the conditions set out in subsection (2) are met and, as the case may be,

(2) The conditions are the following:

(3) The licensee shall not sell, in total, the designated drug in a quantity that exceeds the maximum limit referred to in subparagraph (2)(c)(iv), if applicable.

(4) The licensee shall not sell the designated drug after the date referred to in subparagraph (2)(c)(v), if applicable.

(5) The licensee shall ensure that the information referred to in clause (2)(a)(iii)(G) is available in accordance with paragraph (2)(d) until at least the latest expiration date of the designated drug that they sold.

(6) This section does not apply — in respect of a designated drug sold by the licensee under subsection (1) — to another person who holds an establishment licence and sells the drug.

C.10.007.2 Despite sections C.01.003, C.01.014 and C.08.002, the fabricator of a designated drug who is neither the distributor of the drug for consumption or use outside Canada nor a wholesaler of the drug may sell the drug for consumption or use in Canada only to that distributor or such a wholesaler.

C.10.007.3 Paragraph C.02.018(3)(c) does not apply to a person who holds an establishment licence in respect of a designated drug that they sell under subsection C.10.007.1(1) or section C.10.007.2.

C.10.007.4 (1) Subject to subsection (2), sections C.10.008 to C.10.013 apply in respect of

(2) Sections C.10.009 and C.10.010 do not apply in respect of a designated drug referred to in paragraph (1)(b).

19 (1) The portion of subsection C.10.008(1) of the Regulations before paragraph (b) is replaced by the following:

C.10.008 (1) Subject to subsection (3) and sections C.10.007.3, C.10.009, C.10.010 and C.10.010.2, a sale of a designated drug is exempt from the following provisions:

(2) Subparagraph C.10.008(1)(b)(i) of the Regulations is replaced by the following:

(3) Subparagraph C.10.008(1)(b)(iii) of the Regulations is replaced by the following:

20 (1) Subsection C.10.009(1) of the Regulations is replaced by the following:

C.10.009 (1) This section applies — but paragraph C.02.018(3)(c) and section C.02.019 do 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) Subparagraph C.10.009(2)(b)(i) of the Regulations is replaced by the following:

(3) Subsection C.10.009(3) of the Regulations is replaced by the following:

(3) The licensee shall possess or have immediate access to the specifications for the designated drug until at least the latest expiration date of the designated drug.

(4) Subsection C.10.009(6) of the Regulations is repealed.

21 Subsection C.10.010(3) of the Regulations is replaced by the following:

(3) The licensee shall provide the requested records in the time, form and manner specified by the Minister.

22 The Regulations are amended by adding the following after section C.10.010:

C.10.010.1 A person who holds an establishment licence and imports a designated drug under section C.10.006 — or a person who holds an establishment licence and sells a designated drug under subsection C.10.007.1(1) and is not the manufacturer of the drug — shall submit to the Minister, in the form and manner specified by the Minister, a report of all information relating to the following serious adverse drug reactions within 15 days after the day on which they receive or become aware of the information, whichever occurs first:

C.10.010.2 (1) Despite subsection C.01.050(4), section C.01.050 applies — in respect of a designated drug — to a person who holds an establishment licence and imports the drug under section C.10.006 or a person who holds an establishment licence and sells the drug under subsection C.10.007.1(1), with any necessary modifications.

(2) A reference to a foreign regulatory authority in the applicable paragraph of subsection C.01.050(2) includes a reference to the foreign regulatory authority referred to in subparagraph C.10.006(1)(d)(iii) or C.10.007.1(2)(c)(iii), as the case may be, if that foreign regulatory authority is not set out in any of Parts A to C of the List of Foreign Regulatory Authorities for the Purposes of Section C.01.050 of the Food and Drug Regulations, published by the Government of Canada on its website, as amended from time to time.

C.10.010.3 A drug that is removed from the List of Drugs for Exceptional Importation and Sale before the date referred to in subsection C.10.011(2) continues to be considered a designated drug for the purposes of sections C.10.010.1, C.10.010.2 and C.10.011 until that date.

C.10.010.4 (1) No person shall sell on a retail basis a designated drug that is set out in Subpart 1 of Part 1 or 2 of the List of Drugs for Exceptional Importation and Sale unless the information referred to in clause C.10.006(1)(a)(iii)(G) is available in English and French to the purchaser or consumer in any of the following manners:

(2) For the purposes of subsection (1), the English and French versions of the information referred to in clause C.10.006(1)(a)(iii)(G) need not be available in the same manner.

(3) Subsection (1) does not apply to the sale of a designated drug that is set out in Subpart 1 of Part 1 or 2 of the List of Drugs for Exceptional Importation and Sale by a pharmacist under a prescription, or by a practitioner.

23 Subsection C.10.011(2) of the Regulations is replaced by the following:

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

24 The Regulations are amended by adding the following after section C.10.011:

C.10.012 A person who holds an establishment licence in respect of a drug shall not sell a designated drug set out in Subpart 2 of Part 1 or 2 of the List of Drugs for Exceptional Importation and Sale except to a practitioner, a pharmacist, a hospital as defined in subsection C.01.020.1(4) or another person who holds an establishment licence in respect of a drug.

C.10.013 A pharmacist or a person working under a pharmacist’s supervision shall not sell a designated drug set out in Subpart 2 of Part 1 or 2 of the List of Drugs for Exceptional Importation and Sale on a retail basis unless the drug is not accessible to the public for self-selection.

Extended Expiration Dates

C.10.014 The following definitions apply in this section and in sections C.10.015 to C.10.021.

extended expiration date
means, in respect of a specified lot or batch, the date set out in column 2 of the List of Drugs with Extended Expiration Dates. (date limite d’utilisation reportée)
List of Drugs with Extended Expiration Dates
means the List of Drugs with Extended Expiration Dates that is published by the Government of Canada on its website, as amended from time to time. (Liste des drogues dont la date limite d’utilisation est reportée)
specified lot or batch
means a lot or batch of a drug set out in column 1 of the List of Drugs with Extended Expiration Dates. (lot ou lot de fabrication inscrit)

C.10.015 (1) The Minister may add a lot or batch of a drug to column 1 of the List of Drugs with Extended Expiration Dates and a date to column 2 of that list in relation to the lot or batch only if

(2) In subsection (1), specifications has the same meaning as in section C.02.002.

C.10.016 Sections C.10.017 to C.10.021 apply in respect of a specified lot or batch and its extended expiration date if the following information is also set out in the List of Drugs with Extended Expiration Dates:

C.10.017 Despite the definition expiration date in subsection C.01.001(1), a reference to an expiration date in the provisions of this Part — other than paragraph C.10.016(d) — is, in respect of a specified lot or batch, a reference to its extended expiration date.

C.10.018 Subparagraphs C.01.004(1)(c)(v) and (3)(b)(vii), paragraph C.04.009(2)(e) and subparagraph C.04.009(6)(a)(ix) do not apply in respect of a specified lot or batch.

C.10.019 Sections C.01.014 and C.08.003 do not apply in respect of a specified lot or batch if its extended expiration date is the only change in respect of the lot or batch that relates to the information previously provided to the Minister in connection with the drug.

C.10.020 (1) Within five days after the day on which a specified lot or batch is added to the List of Drugs with Extended Expiration Dates, 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 shall notify any person who holds an establishment licence and to whom they sold the lot or batch of its extended expiration date.

(2) Any person who holds an establishment licence, who has sold a specified lot or batch and who is notified of its extended expiration date shall, within five days after the day on which they are notified, notify any other person to whom they sold the lot or batch of that date.

C.10.021 No person shall sell a specified lot or batch after its extended expiration date.

25 The Regulations are amended by replacing “designated drug” with “drug” in the following provisions:

Medical Devices Regulations

26 Section 43 of the Medical Devices Regulationsfootnote 2 is amended by adding the following after subsection (3):

(4) For greater certainty, subsection (3) does not remove the requirement for the holder of a medical device licence to post information under subsection 62.241(1).

27 The heading before section 62.21 and sections 62.21 and 62.22 of the Regulations are replaced by the following:

Shortages and Discontinuation of Sale

62.21 (1) The following definitions apply in this section and in sections 62.22 to 62.25.

List of Medical Devices — Shortages and Discontinuation of Sale
means the List of Medical Devices — Shortages and Discontinuation of Sale that is published by the Government of Canada on its website, as amended from time to time. (Liste d’instruments médicaux — pénuries et cessation de la vente)
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 — Shortages and Discontinuation of Sale. (instrument médical inscrit)

(2) In sections 62.23 and 62.241, designated website means

62.211 Sections 62.23 to 62.242 do not apply to

62.22 The Minister may add a category of medical devices to the List of Medical Devices — Shortages and Discontinuation of Sale only if the Minister has reasonable grounds to believe that a shortage, or discontinuation of sale in Canada, of any device that belongs to that category, if it were to occur, could present a risk of injury to human health.

28 (1) The portion of subsection 62.23(1) of the Regulations before paragraph (b) is replaced by the following:

62.23 (1) Subject to subsections (5) and (7), 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 post the following information in English and French on the designated website:

(2) Paragraph 62.23(1)(d) of the Regulations is replaced by the following:

(3) Subsection 62.23(1) of the Regulations is amended by striking out “and” at the end of paragraph (h), by adding “and” at the end of paragraph (g) and by repealing paragraph (i).

(4) Subsections 62.23(2) to (9) of the Regulations are replaced by the following:

(2) Subject to subsection (6), the manufacturer or importer shall post the information

(3) If any of the information that was posted under subsection (1) changes, the manufacturer or importer shall update that information on the designated website within two days after the day on which the manufacturer or importer makes or becomes aware of the change.

(4) Within two 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 post information on the designated website to that effect.

(5) The manufacturer or importer is not required to post information on the designated website in respect of a specified medical device if, within the applicable period referred to in any of paragraphs (2)(a) to (c), the manufacturer or importer anticipates that the manufacturer will be able to meet the demand for the device within 30 days after

(6) Despite subsection (5), if the manufacturer or importer subsequently determines that the manufacturer will be unable to meet the demand for the specified medical device within the 30-day period, the manufacturer or the importer shall post the information that is required under subsection (1) on the designated website within five days after the day on which the manufacturer or importer makes that determination.

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

29 Sections 62.24 and 62.25 of the Regulations are replaced by the following:

62.24 (1) Despite section 62.23, the manufacturer of a specified medical device may permit the importer of the device to post the information that is required under that section on the manufacturer’s behalf.

(2) The manufacturer shall notify the Minister, in the form and manner specified by the Minister, if the manufacturer has permitted the importer to post the information on the manufacturer’s behalf.

62.241 (1) Subject to subsection (5), if the manufacturer of a specified medical device or, in the case of a Class I device, the importer of the device decides to discontinue the sale of the device in Canada, the manufacturer or importer shall post the following information in English and French on the designated website:

(2) For greater certainty, subsection (1) does not remove the requirement for

(3) The manufacturer or importer shall post the information

(4) If any of the information that was posted under subsection (1) changes, the manufacturer or importer shall update that information on the designated website within five days after the day on which the manufacturer or importer makes or becomes aware of the change.

(5) The manufacturer or importer is not required to post information on the designated website in respect of a specified medical device if the manufacturer

62.242 (1) Despite section 62.241, the manufacturer of a specified medical device may permit the importer of the device to post the information that is required under that section on the manufacturer’s behalf.

(2) The manufacturer shall notify the Minister, in the form and manner specified by the Minister, if the manufacturer has permitted the importer to post the information on the manufacturer’s behalf.

62.25 If a person maintains a website under contract with His Majesty in right of Canada for the purpose of posting information under sections 62.23 and 62.241, the Minister shall ensure that a hyperlink to that website is on the Government of Canada website.

30 (1) Paragraph 62.26(1)(a) of the French version of the Regulations is replaced by the following:

(2) Paragraph 62.26(1)(b) of the Regulations is replaced by the following:

(3) Subparagraphs 62.26(1)(c)(i) to (iii) of the French version of the Regulations are replaced by the following:

(4) Paragraph 62.26(1)(c) of the Regulations is amended by striking out “or” at the end of subparagraph (iii) and by replacing subparagraph (iv) with the following:

(5) Subsection 62.26(2) of the Regulations is replaced by the following:

(2) The manufacturer, importer or distributor shall provide the requested information in the time, form and manner specified by the Minister.

31 (1) The portion of section 62.27 of the Regulations before the first definition is replaced by the following:

62.27 The following definitions apply in this section and in sections 62.28 to 62.321.

(2) The definition designated medical device in section 62.27 of the Regulations is replaced by the following:

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)

32 (1) The portion of section 62.28 of the Regulations before paragraph (a) is replaced by the following:

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

(2) Section 62.28 of the Regulations is amended by striking out “and” at the end of paragraph (a) and by adding the following after that paragraph:

(3) Section 62.28 of the Regulations is amended by adding “and” at the end of paragraph (b) and by adding the following after that paragraph:

33 (1) The portion of section 62.29 of the Regulations before subparagraph (a)(i) is replaced by the following:

62.29 Despite sections 21 and 26, the holder of an establishment licence may import a designated medical device if the following conditions are met:

(2) Paragraph 62.29(b) of the Regulations is repealed.

(3) The portion of paragraph 62.29(c) of the Regulations before subparagraph (i) is replaced by the following:

(4) Subparagraphs 62.29(c)(i) to (iii) of the English version of the Regulations are replaced by the following:

(5) Subparagraphs 62.29(c)(v) and (vi) of the Regulations are replaced by the following:

(6) Paragraphs 62.29(d) and (e) of the Regulations are replaced by the following:

34 Section 62.3 of the Regulations is replaced by the following:

62.3 Sections 21.1 and 21.2 do not apply in respect of the importation of a designated medical device under section 62.29.

35 The Regulations are amended by adding the following after section 62.31:

62.311 (1) No person shall sell a designated medical device that is intended to be sold to the general public on a retail basis unless the information referred to in clause 62.29(a)(ii)(E) is available in English and French to the purchaser or consumer in any of the following manners:

(2) For the purposes of subsection (1), the English and French versions of the information referred to in clause 62.29(a)(ii)(E) need not be available in the same manner.

36 Subsection 62.32(2) of the Regulations is replaced by the following:

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

37 The Regulations are amended by adding the following after section 62.32:

62.321 If the holder of an establishment licence receives or becomes aware of the following information in respect of a designated medical device that they imported under section 62.29, the holder shall notify the Minister, in the form and manner specified by the Minister, no later than 72 hours after they receive or become aware of the information, whichever occurs first:

62.322 (1) Section 61.2 applies — in respect of a designated medical device — to a person who holds an establishment licence and imports the medical device under section 62.29, with any necessary modifications.

(2) A reference to a regulatory agency in paragraphs 61.2(2)(a) to (c) includes a reference to the regulatory agency referred to in paragraph 62.28(c) if that regulatory agency is not set out in the List of Regulatory Agencies for the Purposes of Sections 61.2 and 68.3 of the Medical Devices Regulations, published by the Government of Canada on its website, as amended from time to time.

62.323 A medical device that is removed from the List of Medical Devices for Exceptional Importation and Sale before the date referred to in subsection 62.32(2) or the expiration of the period referred to in subsection 62.32(3), as the case may be, continues to be considered a designated medical device for the purposes of sections 62.32 to 62.322 until that date or the expiration of that period.

38 The heading before section 68.25 of the Regulations is replaced by the following:

Discontinuation of Sale

39 Section 68.25 of the Regulations is renumbered as subsection 68.25(1) and is amended by adding the following:

(2) For greater certainty, subsection (1) does not remove the requirement for the holder to post information under subsection 62.241(1).

40 The Regulations are amended by replacing “designated medical device” with “device” in the following provisions:

41 The English version of the Regulations is amended by replacing “discontinuance” with “discontinuation” in the following provisions:

Regulations Amending the Food and Drug Regulations (Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19)

42 Paragraph 20(b) of the Regulations Amending the Food and Drug Regulations (Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19)footnote 3 is replaced by the following:

Coming into Force

43 (1) Subject to subsection (2), these Regulations come into force on the day on which they are published in the Canada Gazette, Part II.

(2) Sections 26 to 29 and 39 come into force on the first anniversary of the day on which these Regulations are published in the Canada Gazette, Part II.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Executive summary

Issues: Drug and medical device shortages continue to present a risk to the health of people in Canada, which highlights the need to continue strengthening Canada’s regulatory frameworks for preventing and mitigating harmful interruptions to the access to drugs and medical devices.

Description: The new measures, comprising amendments to the Food and Drug Regulations and Medical Devices Regulations, will help Health Canada, and its provincial/territorial partners and stakeholders, respond to shortages when they occur and mitigate the harm shortages pose to public health.

In respect of drugs, the amendments

  • allow the Minister to expand the scope of drugs that would be subject to regulations governing shortages and allow the Minister to require information be provided on shortages of a wider range of drugs in certain circumstances; and
  • allow the Minister to increase the supply of drugs available to address a shortage by extending the expiration dates for Canadian-authorized drugs in certain circumstances.

In respect of both drugs and medical devices, the amendments

  • update exceptional importation frameworks to allow them to be used in a broader range of circumstances while mitigating safety risks to the greatest extent possible; and
  • improve regulatory frameworks for reporting of drug and medical device shortages and discontinuations.

Rationale: Drug and medical device shortages can have an immediate negative impact on the health of people in Canada. Shortages may cause a patient to use a less effective substitute drug or medical device, ration products used in their care, or cease the use of a needed product, which can all result in harm to the patient through suboptimal or interrupted treatment. In collaboration with provincial/territorial partners and stakeholders, Health Canada uses a range of tools to monitor and mitigate the impacts of drug and medical device shortages when they occur. These tools are effective, but recent serious shortages have illustrated that new and refined regulatory tools are needed to manage shortage risks.

Health Canada has consulted widely and the amendments to the Food and Drug Regulations and the Medical Devices Regulations are made in consideration of stakeholder concerns with shifting trade relationships and heightened economic pressures. These amendments are similar to steps taken by international regulatory counterparts, like the United States, France and Australia.

Overall, Health Canada works collaboratively with its partners and stakeholders to reduce shortage risks and respond to shortages that occur. These amendments will strengthen these efforts to better monitor shortages of drugs and medical devices and respond more efficiently to shortages when they occur. Health Canada will have better and more timely access to information needed to respond to a shortage and have tools to mitigate shortages in a broader range of circumstances.

The total quantifiable costs of the amendments are approximately $728,000 per year (annualized), or $5.1 million in present value (PV) over 10 periods (discounted at 7%). These costs will be offset by a number of qualitative and quantitative benefits. Extending the expiration dates for Canadian-authorized drugs in certain circumstances, expanding the exceptional importation and sale framework for specified drugs and medical devices and expanding the urgent public health need framework will all increase products entering the Canadian market during shortages, or other health emergencies, and provide people in Canada with access to substitute products that they otherwise would not have. The monetized benefits are estimated at $245,000 per year (annualized) or $1.7 million PV over 10 periods (discounted at 7%). Overall, the net monetized impact is estimated at $3.4 million PV in costs over 10 periods or $483,000 per year (annualized).

Issues

The problem of drug and medical device shortages poses a risk to the health of people in Canada by negatively affecting their ability to access the drugs and medical devices they need.

Regulations made in 2016 and 2021 improved Health Canada’s ability to prevent and mitigate shortages. However, ongoing weaknesses in global medical supply chains highlight a need to better protect people from risks to health posed by shortages. The Department’s experience with existing regulations helps to identify opportunities to refine and add to its tools, including the frameworks that govern the reporting of shortages and discontinuations, as well as the exceptional importation of drugs and medical devices.

Background

Drug and medical device shortages in Canada

For the purposes of this document, “drugs” refers to drugs for human and veterinary use regulated under the Food and Drug Regulations, such as pharmaceuticals, biologics and radiopharmaceuticals, and does not include natural health products or biocides.

Drug and medical device shortages are a complex and growing problem worldwide. A shortage is a situation in which a market authorization holder of a drug or a manufacturer of a medical device is unable to meet the demand for its product in Canada. Shortages can arise from a range of circumstances, such as interruptions to manufacturing or distribution, product recalls, difficulties accessing raw materials, holding excessive inventory, rapid increases in demand, major geopolitical developments and environmental events.

Drugs and medical devices play an integral role in delivering timely and effective patient care. Shortages of these products can contribute to adverse patient outcomes and cause harm. Shortages may require a patient to use a less effective substitute drugfootnote 4 or medical device, ration products used in their carefootnote 5 or cease use of a needed product. These actions can all result in harm to a patient through suboptimal treatment or an interruption to treatment. Shortages may lead patients to use atypical means of procuring products that can increase the harm to health (e.g. purchasing unauthorized products online or from a person not authorized to sell health products). Further, treatment errors may occur when the patient uses a less familiar product, which can lead to harm to health. Drug and medical device shortages also burden the health care system when health care practitioners are required to spend time on finding alternatives, additional patient monitoring and, in the case of medical devices, learning to use alternative treatments or medical devices.

The harms caused by a shortage can range from relatively mild to life-threatening in nature. This depends on factors like the severity of the injury or disease being treated, the public health importance of the disease and the availability of a substitute product. The impact of a shortage depends on the individual risk to health, the size of the population being treated and the total unmet demand.

Shortages impact all major drug classes and a wide range of medical devices. Since 2017, 10%–15% of drugs marketed in Canada are in shortage at any given time, and over half (55%) of marketed drugs have experienced at least one shortage. For example, in March 2026, 1 068 (9%) drugs marketed in Canada were in shortage and, of these, 20 were considered to be critical, national shortages. In March 2026, 39 medical devices subject to the mandatory shortage reporting framework were in shortage.footnote 6

There is evidence from population health and demographic trends that Canada’s need for drugs and medical devices will continue to grow as the population ages and the number of people impacted by chronic diseases increases. This may lead to the problem of shortages worsening over time. Major drivers of this trend involve increased diagnosis and treatment of chronic diseases. For example, it is expected that Canada’s senior population, which accounts for nearly two thirds of publicly funded drug spending,footnote 7 will increase by 68% from 2017 to 2037.footnote 8 Although similar data are not available for medical devices, medical devices are widely understood to be crucial in managing chronic diseases that disproportionately affect older individuals.

Drug and medical device shortage reporting

In 2016, Health Canada advanced regulations to require market authorization holders for certain drugs to report shortages and discontinuations of their products on a third-party operated website under contract to the Department. In 2020 and 2021, the Government introduced a similar framework to mandate reporting to Health Canada of select medical device shortages that are specified on a list incorporated by reference. Medical device shortage reports are currently published by Health Canada on its website.

These frameworks are both used in the Department’s ongoing surveillance of drug and medical device shortages, but there are differences in the way those frameworks are written and administered. In particular, medical device shortage reporting requirements apply to a narrower set of products and are reported to Health Canada, which are processed and published by the Department.

These reporting frameworks provide the Department and its stakeholders with information about which products are in shortage and how long those shortages are expected to last. They also provide information on drug and medical device discontinuations. This information is used by governments, industry, clinicians and patients to determine whether the reported shortages and discontinuations could affect them and develop plans to mitigate their worst effects.

Preventing and mitigating shortages

Health Canada leads a range of activities to help prevent and mitigate shortages of drugs and medical devices. Historically, these activities have involved working alongside supply chain stakeholders to increase production of products in shortage, to conserve existing supplies or to source substitutes during times of shortage. The Department also leads or co-chairs formal committee structures that engage provinces and territories, industry, health care practitioners and the patient community to facilitate information sharing about potential and actual shortages and mobilize collective response when shortages occur.

In 2020 and 2021, the Food and Drugs Act was amended and new regulations were made through interim ordersfootnote 9, footnote 10, footnote 11 and permanent regulations designed to help prevent drug and medical device shortages and alleviate them when they occur. These regulations

Weakness in medical supply chains

In 2020, the COVID-19 pandemic had widespread effects on global supply chains, including medical supply chains. The pandemic underscored a number of existing and emerging vulnerabilities in global supply chains for many critical products, including drugs and their ingredients. For instance, the concentration of active pharmaceutical ingredient production and raw materials in a few foreign jurisdictions combined with export trade restrictions and transportation disruptions threatened access to needed drugs in Canada and worldwide. Limited supply chain visibility, unforeseen demand spikes, inadequate buffer stock and just-in-time delivery methods further contributed to global supply chain pressures and constrained availability of key drugs and medical devices. This resulted in a significant spike in shortages in Canadafootnote 12 and around the world.footnote 13

Despite global progress towards reducing the worst effects of the pandemic-related disruptions, global medical supply chains have remained fragile. For example, the number of concurrent critical and national drug shortages in Canada (classified as “Tier 3 shortages”) has not significantly improved from its peak, despite the easing of the pandemic.footnote 14

In the medium and long term, there is also evidence that the situation is being exacerbated by increasing extreme weather events. For example,

In addition to weather events, shifting geopolitical and trade relationships in recent years have introduced additional uncertainty in the supply chain, further putting access to health products at risk.

Weaknesses in medical supply chains have been felt across Canada and around the world. By 2022, Canada began to experience shortages in categories of health products that had not previously required active intervention by Health Canada, including pediatric antibiotics, over-the-counter analgesics, cough and cold medications and infant formulas.footnote 18, footnote 19 These shortages raised significant public attention and concern.

The average length of a shortage in Canada is 98 days,footnote 20 but lead times to change production schedules can be much longer. Manufacturers and other supply chain players can help to limit and/or prevent the impact of shortages by proactively identifying, prioritizing and implementing strategies to mitigate risks within their own control. Recent publications have demonstrated that proactively assessing risks to drug manufacturing processes and supply chains, coupled with an understanding of market vulnerabilities, have enabled stakeholders to support robust operations that help prevent shortages.This research further notes that proactive risk assessment has enabled some stakeholders to predict and prevent supply disruptions that could potentially lead to a shortage.footnote 21, footnote 22 Thus, the likelihood of a shortage occurring can be decreased by assessing shortage risks and implementing robust quality management systems that explicitly consider and address these risks.

As well, holding additional stock is an effective mechanism to help maintain the availability of a necessary product when there are rapid and unexpected fluctuations in supply or demand for the product. Safety stock is an inventory practice of holding additional stock to protect against supply chain uncertainties and shortages.footnote 23 The industrial engineering literature demonstrates how holding safety stock is an effective mechanism to address unpredictable spikes in demand and issues with supply chains. Specifically, there is an increased likelihood that shipment delays or disruptions will result in a shortage if a company does not hold safety stock.footnote 24 This practice can also be important for preventing stockouts from occurring, which would be a complete depletion or interruption of supply. Safety stock inventories are one of the few tools that can prevent the majority of stockouts.footnote 25

International response to weaknesses in medical supply chains

In response to health risks posed by ongoing problems in global medical supply chains, several countries have adopted or are developing new policy or regulatory approaches to preserve access to drugs and medical devices within their borders.

Reporting and monitoring

Many other jurisdictions have frameworks for mandatory drug shortage reporting and some have medical device shortage reporting. These are typically posted publicly. For example,

Mitigating the impacts of a shortage

During a shortage, there are some measures that can be used to improve access to the remaining supply or increase the supply available. For example,

Reducing shortage risk

In addition to mitigation of the impacts of shortages that do occur, there are measures that can help to reduce the likelihood of a shortage occurring. These measures can help to identify potential points of failure in the supply chain or soften the impacts of rapid changes to supply or demand. For example,

Objective

The objective of the amendments to the Food and Drug Regulations and the Medical Devices Regulations is to better protect people in Canada from the harms posed by drug and medical device shortages. The intended effect of these amendments is to provide Health Canada and its regulated parties, stakeholders and provincial/territorial partners with better tools to prevent, mitigate and respond to drug and medical device shortages.

Description

The Food and Drug Regulations and the Medical Devices Regulations will be amended to

These measures are described in greater detail below.

Scope of drugs subject to shortage regulations

The existing scope of the shortage regulations includes controlled substances on Schedules I to V of the Controlled Drugs and Substances Act, prescription drugs on the Prescription Drug List, radiopharmaceuticals in Schedule C of the Food and Drugs Act, biologics in Schedule D of the Food and Drugs Act and drugs that are permitted to be sold without a prescription but are administered only under the supervision of a practitioner.

These amendments expand the scope of these regulations by incorporating by reference a List of Drugs for the Purposes of Section C.01.014.8 of the Food and Drug Regulations (Expanded Scope List). Using a document incorporated by reference allows the scope of the shortage regulations to be adapted according to changing circumstances and targets only the drugs that meet the conditions set out in the amendments. The use of documents incorporated by reference is consistent with authorities granted by section 30.5 of the Food and Drugs Act.

The Expanded Scope List applies certain regulatory obligations to additional drugs that are not currently in scope of the shortage framework. This list will be maintained on a Government of Canada website.

Under the amendments, the Minister of Health has the authority to add a drug or class of drugs to the Expanded Scope List if the Minister has reasonable grounds to believe that a shortage or the discontinuation of sale of that drug or that class of drugs could present a risk of injury to human health. This list will generally be amended only after consultation with stakeholders, in line with Health Canada’s Incorporation by Reference Policy. Advance notice will be given to regulated parties to allow them time to come into compliance with their new obligations related to this list.

In particular, drugs added to the Expanded Scope List would be subject to the following provisions of the Food and Drug Regulations:

Some shortage frameworks that apply under the current scope are no longer limited to the drugs in scope for shortage reporting. For example, the amendments also expand the Minister’s authority to require information about drug shortages so that it applies to any drug which could present a risk of injury to human health if it is in shortage, including over-the-counter drugs. A drug no longer needs to be in scope of the other shortage regulations for the Minister to use this authority to request information. The scope is similarly expanded for exceptional importation and sale, which is outlined in the relevant section below.

Authority to extend drug expiration dates to address shortages

These amendments incorporate by reference into the Food and Drug Regulations a List of Drugs with Extended Expiration Dates (Extended Expiration Dates List) maintained on a Government of Canada website, which the Minister may amend from time to time. Lots or batches of drugs added to this list would be permitted for sale until the extended expiration date specified on this list. This would provide the Minister with an additional tool to help address drug shortages.

Under the amendments, the Minister of Health has the authority to add any lot or batch to this list if

Health Canada would consult with the market authorization holder before any changes are made to the list. The change would take effect immediately to avoid delays in responding to the shortage. This is similar to the approach taken with amending the List of Drugs for Exceptional Importation and Sale.

In the case where the Minister adds a lot or batch of a drug to the list, the market authorization holder of that lot or batch would be required to notify, within five days, any establishment licence holder they sell to that the expiration date was extended. In the case where an establishment licence holder that has sold a lot or batch of a drug on the list has been notified of the extended expiration date, they would be required to notify any person that they sell to within five days of being notified themselves.

Updates to exceptional importation and sale frameworks for drugs and medical devices

These amendments update the Food and Drug Regulations and the Medical Devices Regulations to improve the exceptional importation and sale frameworks for drugs and medical devices.

In respect of drugs, the Food and Drug Regulations are amended to provide the Minister with new regulatory tools to address drug shortages in a broader range of circumstances. The amendments modify the framework for the exceptional importation and sale of drugs specified in Part C, Division 10 of these Regulations to allow it to be used in a broader range of circumstances, while mitigating safety risks to the greatest extent possible. In particular, the amendments

In respect of medical devices, the Medical Devices Regulations are amended to clarify the scope of the exceptional importation framework for medical devices. In particular, the amendments revise section 62.28 of these Regulations to clarify that the Minister may only add a medical device to the List of Medical Devices for Exceptional Importation and Sale if the Minister has reasonable grounds to believe that there is a risk of injury to health from an actual or anticipated shortage.

Following the consultation at prepublication, the amendments were updated to better align with the drug framework. These updates

Updates to reporting frameworks for drug and medical device shortages and discontinuations

These amendments improve existing requirements for the reporting of drug and medical device shortages and discontinuations.

In the case of drugs, Health Canada now has more flexibility in relation to designating the website where shortages must be reported. As well, provisions are added to require market authorization holders of drugs to provide earlier notice of their decision to discontinue a drug authorized for sale in Canada. The existing requirement at subsection C.01.014.10(2) of the Food and Drug Regulations to report a discontinuation at least 6 months ahead of the discontinuation is replaced with a requirement to report a discontinuation at least 12 months in advance of discontinuing sales. If the decision is made less than 12 months in advance, the discontinuation is required to be reported within 5 days of the decision being made. This will provide interested parties, like Health Canada, hospitals, clinicians, patients and industry, with more advance notice of drug discontinuations and allow them to make appropriate transition plans. In addition, the requirement to update discontinuation reports within 2 days when information in the report changes is extended to 5 days. This will provide drug market authorization holders with additional time to update their reports, now that discontinuation reports are required 12 months in advance.

In the case of medical devices, provisions are added to clarify, simplify and refine existing shortage reporting requirements for manufacturers of specified Class I–IV medical devices and importers of specified Class I medical devices. These changes are intended to clarify regulatory requirements for regulated parties, simplify when a shortage needs to be reported and make the shortage reporting framework for medical devices less burdensome. The amendments to the Medical Devices Regulations:

Following the consultation at prepublication, the amendments were updated to better align with current practices. These updates

Urgent public health need framework

Health Canada has other frameworks that help meet the need for certain drugs to address demand for public health reasons. The urgent public health need framework in sections C.10.001 to C.10.003 of the Food and Drug Regulations enables access to drugs which have been authorized for sale in certain foreign jurisdictions, but are not available in Canada, to address urgent public health needs. This pathway is intended for public health events that are exceptional in nature and that are occurring (or imminent) and require immediate action.

Currently, only drugs that are authorized for sale in the United States, Switzerland or the European Union may be accessed using this framework. The United Kingdom was part of the European Union when the urgent public health need framework was originally made. Following the consultation at prepublication, these amendments were added to once again extend the framework to apply to drugs that are authorized for sale in the United Kingdom and help ensure access to needed drugs for people in Canada.

Regulatory development

Consultation

Stakeholders’ engagement

Since November 2022, Health Canada has sought feedback in various forums from a wide range of stakeholders affected by drug and medical device shortages. Taken together, the Department has received feedback from industry, health care professionals, advocacy organizations, provincial/territorial governments, international regulatory counterparts, Indigenous groups and communities, academics and members of the public. This feedback was received via the following sources:

Public consultation
Summer 2023 public consultation

In summer 2023, Health Canada conducted a public consultation focused on identifying strategies to prevent drug and other health product shortages and mitigate their impacts. The consultation received over 160 submissions, including from industry (45%), the general public (22%), health care professionals (15%), patient advocacy groups (8%), not-for-profit organizations (6%), academia (3%), provinces and territories (1%) and Indigenous groups (1%). The percentages listed above do not add to 100% due to rounding.

The Department received feedback in four areas: improved communication and transparency, agile regulatory toolbox, greater supply chain visibility and enhanced response to supply and demand. Much of the feedback received in the consultation proposed regulatory actions, including improvements in shortage reporting and commentary on strategies to prevent or address harms caused by shortages, like shortage prevention and mitigation plans. In December 2023, Health Canada published a report summarizing feedback received from the public consultation.

Notice of intent

In summer 2024, Health Canada conducted a public consultation on the proposed amendments. This proposal was also referenced in a four-year health product shortages plan published concurrently with the beginning of the consultation period in June 2024. The consultation received 38 submissions from industry (50%), health care professionals (18%), not-for-profit organizations (11%), the general public (8%), provinces and territories (5%), patient advocacy groups (5%) and academia (3%). Health Canada also administered a stakeholder survey to understand how the amendments could have a positive or negative impact on Canadian industry and health care professionals. The survey was sent to industry stakeholders and associations representing health care professionals, including importers, manufacturers and pharmacist associations. The survey was distributed on June 25, 2024, and responses were submitted to Health Canada by July 25, 2024.

Regarding the proposed amendments to the Food and Drug Regulations, stakeholders were generally in favour of the requirements for earlier drug discontinuation reporting and for the expanded scope of the shortage regulations. Stakeholders noted that additional reporting requires resources, that it is not always possible to report discontinuations 12 months in advance and that 2 days is not enough time to make changes to shortage and discontinuation reports. Stakeholders were generally supportive of expiration date extensions and of the changes to the exceptional importation and sale framework. Some stakeholders expressed support for new requirements governing safety stocks, demand surge reporting and shortage prevention and mitigation plans. Others noted that new requirements for holding safety stocks, shortage prevention and mitigation plans and demand surge reporting could present significant administrative and financial burdens. Stakeholders also noted that safety stock requirements could lead to waste and that demand surge reporting could lead to noisy data on shortage signals.

This proposal was adjusted to respond to stakeholder feedback by providing additional time to make changes to discontinuation reports. As well, many aspects of the obligations proposed for consultation in the Canada Gazette, Part I, in December 2024 aligned with stakeholder comments and addressed some of their concerns. For example, the new requirements for shortage prevention and mitigation plans and demand surge reporting were targeted to a narrower scope of drugs that could present serious risk to human health when in shortage. The safety stock requirements were also further narrowed to drugs that could present serious and imminent risk to human health when in shortage. This further minimized the burden so that it would only apply to the market authorization holders of drugs that have the greatest risk of harm if in shortage.

Health Canada also received feedback on the proposed amendments to the Medical Devices Regulations. Industry stakeholders expressed concerns about the removal of the 30-day backorder exemption for shortage reporting and inclusion of all discontinuations as reportable, noting that these changes could result in unnecessary reporting. Health Canada responded to these comments by leaving the 30-day backorder exemption as it is in the existing regulations. As well, the parameters of discontinuation reporting were revised to help prevent unnecessary reports when an updated product is made available. Specifically, all discontinuations need to be reported unless the discontinued device is being replaced with a compatible version.

Regulatory proposal

On December 28, 2024, Health Canada published its regulatory proposal in the Canada Gazette, Part I, for public consultation. In total, the Department received 65 submissions through the Online Regulatory Consultation System (ORCS) platform and by email. The submissions were from industry (52%), individuals (24%), health care associations (10%), patient advocates (6%), foreign organizations (4%), health care practitioners (1%) and provinces and territories (1%). The percentages listed above do not add to 100% due to rounding.

Regarding the proposed amendments to the Food and Drug Regulations, stakeholders were generally supportive of the expanded scope of shortage regulations, and the amendments to drug shortage and discontinuation reporting and exceptional importation and sale. Industry stakeholders mainly expressed concern that new requirements for safety stock, shortage prevention and mitigation plans and demand surge reporting would introduce significant burden. Stakeholders suggested instead that measures should be adopted to improve market diversity, such as regulatory flexibilities, or to offset the cost of the new burden with economic incentives. Stakeholders were in favour of efforts to limit the burden of the obligations by limiting requirements to certain drugs with higher shortage risk.

For the proposed amendments to the Medical Devices Regulations, stakeholders flagged that the proposed obligation to maintain procedures for medical device shortage and discontinuation reporting would require significant industry resources and could lead to market exit. Industry also commented on possible improvements to the reporting framework, such as suggesting that importers for Class II–IV medical devices should be able to report a shortage on behalf of the manufacturer.

This regulatory proposal was adjusted to respond to a changing economic climate and to stakeholder feedback by removing the new Food and Drug Regulations requirements for safety stock, shortage prevention and mitigation plans, and demand surge reporting, as well as the new Medical Devices Regulations requirements for documented procedures for shortage reporting. Improvements to the medical device reporting framework are also incorporated into the regulations based on stakeholder comment (as noted in the “Description” section above). All feedback received will be retained and used to support policy and regulatory development in the future, as appropriate.

Indigenous engagement, consultation and modern treaty obligations

Following the completion of the assessment of modern treaty implications, no adverse impacts on potential or established Indigenous or treaty rights, which are recognized and affirmed in section 35 of the Constitution Act, 1982, were identified.

Instrument choice

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

Enforcement discretion

Health Canada considered an approach where elements of this proposal would be advanced by relying on enforcement discretion to introduce flexibilities that could help to increase the available supply of a drug during a shortage.

The term “enforcement discretion” refers to the discretion that public authorities have to choose which enforcement action, along a continuum, will best address a particular situation in light of their statutory mandate. There are a range of actions that may be reasonably taken by a regulator in response to a particular situation based on prioritization of resources and/or relying on a risk-based approach. Health Canada’s enforcement discretion is exercised in accordance with its protection of health and safety statutory mandate under the Food and Drugs Act. On a case-by-case basis, Health Canada may deprioritize the enforcement of certain provisions where there is a pressing public health need and where the risks of doing so are low or can be appropriately mitigated.

This approach was rejected on the basis that routine use of enforcement discretion can undermine principles of transparency and predictability in the application of regulations. Also, this approach would not encourage the development of tools that are useful to help prevent and mitigate shortage risks.

Voluntary action by stakeholders

Under this approach, Health Canada would rely only on stakeholder action to reduce the risk of shortages. The Department would encourage regulated parties to develop and maintain shortage prevention and mitigation plans and safety stocks, and would encourage distributors to report surges in demand to Health Canada.

This approach was rejected for the initial proposal because of Health Canada’s concerns that relying on voluntary action could result in a patchwork system that would not adequately protect people in Canada from harm. Regulatory action would ensure that safety stocks and shortage prevention and mitigation plans are in place to prevent shortages from causing serious and/or imminent harm to people in Canada.

New regulatory obligations

In the initial proposal, the preferred option of regulatory amendments was to introduce new obligations in a targeted way for drugs that have the highest risk of injury to health when in shortage. This model would have allowed Health Canada to enforce compliance with specific actions that reduce the likelihood of shortages that pose a serious risk of injury to health or a serious and imminent risk of injury to health. However, these obligations would have introduced burden to stakeholders at a time of increased economic pressures for industry stakeholders.

Selected regulatory approach

Since the consultation on the proposed regulations, there have been significant changes to the geopolitical and economic landscape that threaten to make supply chains more vulnerable and increase the risk of shortages. In this context, the preferred option balances regulatory flexibility to support a nimble response to shortages while taking a cautious approach to introducing new obligations.

The preferred option introduces regulatory amendments to improve and expand the existing reporting frameworks and regulatory flexibilities based on experience with implementation of these measures. These amendments improve and expand the tools available to Health Canada to respond to a shortage by updating shortage reporting, exceptional importation and introducing expiration date extensions.

New obligations, such as safety stock, shortage prevention and mitigation plans and demand surge reporting, are not being introduced with the amendments to give more time to explore prevention measures and refine new voluntary actions before making a decision on any regulatory obligations. Health Canada recommends that industry stakeholders consider their shortage risks and work to prevent shortage where possible, including by holding additional stock to buffer against the impacts of shortages on the health of people in Canada.

Regulatory analysis

Benefits and costs

This section provides a description of the methodology used in the cost-benefit analysis, as well as a quantitative and qualitative depiction of the estimated costs and benefits due to the regulatory amendments. A full cost-benefit analysis report is available upon request by writing to hpsdpdcorr-corrdgppsdp@hc-sc.gc.ca.

This regulatory proposal was adjusted after prepublication in the Canada Gazette, Part I, to respond to a changing economic climate and to stakeholder feedback by removing the new Food and Drug Regulations requirements for safety stock, shortage prevention and mitigation plans, and demand surge reporting, as well as the new Medical Devices Regulations requirements for documented procedures for shortage reporting. In addition, an amendment was added to extend the urgent public health need framework to apply to drugs that are authorized for sale in the United Kingdom and to help ensure access to needed drugs for people in Canada. As such, the cost-benefit analysis has been updated to reflect the adjustments to the proposal.

In the Canada Gazette, Part I, the amendments related to the Minister’s authority to expand the scope of drugs subject to shortage regulations, the Minister’s authority to extend the expiration dates for drugs to address shortages, the updates to the exceptional importation and sale frameworks for drugs and medical devices, and the updates to the reporting frameworks for drug shortages and discontinuations were all proposed to come into force six months after the day the Regulations were published. These amendments will now come into force on the day they are published in the Canada Gazette, Part II. Furthermore, the amendments updating the reporting frameworks for medical device shortages and discontinuations were proposed in the Canada Gazette, Part I, to come into force on the first anniversary of the day the Regulations were published. In the Canada Gazette, Part II, the amendments related to updating the reporting frameworks for drug shortages and discontinuations will come into force on the day the Regulations are published, while the amendments related to updating the reporting frameworks for medical device shortages and discontinuations will remain the same and come into force on the first anniversary of the day the Regulations are published.

Baseline scenario versus regulatory scenario

The estimated costs and benefits of the regulatory amendments are determined by incremental differences between two future scenarios: one where the current regulatory framework (baseline scenario) does not change versus one where the modifications come into force (regulatory scenario). The purpose of the cost-benefit analysis is to compare the regulatory scenario against the baseline scenario and estimate the costs and benefits for three stakeholder groups: industry, the government of Canada and people in Canada.

In the baseline scenario, the Minister’s options are limited when responding to shortages. The regulatory amendments will empower the Minister to increase the supply of drugs available to address a shortage by extending the expiration dates for lots or batches of drugs in certain circumstances. In addition, the Minister will have the ability to expand the scope of drugs that will be subject to the regulations governing shortages, like over-the-counter drugs, to include these drugs in the shortage framework, including requirements for shortage reporting.

In the baseline scenario, the exceptional importation and sale frameworks for drugs are limited. In the regulatory scenario, updates to the drug’s exceptional importation and sale framework will allow the Department to broaden the scope of products and circumstances the framework can be applied to. This will allow Health Canada more flexibility when using these frameworks to help prevent and mitigate shortages of drugs.

Lastly, drug shortages and discontinuations are currently being reported to a website operated by a third party, while medical devices shortages and discontinuations are being published on a Health Canada website. In the regulatory scenario, the third-party operated website will be expanded and updated to include medical device shortage and discontinuation reporting.

Key assumptions:

In addition, the regulatory amendments will come into force in two phases. The following amendments come into force on the day they are published in the Canada Gazette, Part II:

The following amendments will come into force on the first anniversary of the day they are published in the Canada Gazette, Part II:

Data collection

In June 2024, Health Canada distributed two targeted drug and medical device external stakeholder surveys to all drug establishment licence, drug identification number, medical device establishment licence and medical device licence holders to determine the impact of some of the regulatory amendments. Health Canada received 89 survey responses from stakeholders in the drug industry and 346 survey responses from stakeholders in the medical device industry. The responses from these external stakeholder surveys have aided Health Canada in estimating the benefits and costs of the regulatory amendments.

Health Canada also used previous external stakeholder questionnaires and supplemented the analysis with previous survey findings to reduce the amount of requests to industry.

The additional number of drugs that could pose a risk of injury to human health if in shortage is outlined below. Each authorized drug product sold in Canada is assigned a drug identification number to uniquely identify each product and differentiate between doses, manufacturers or other characteristics. As such, there may be multiple authorized drugs that have the same medicinal ingredient and route of administration, but different drug identification numbers. The impact of these amendments is calculated based on the number of drugs specified at the level of drug identification number (DIN-drug) that will be in scope of the cost-benefit analysis. Health Canada used previous shortage experience and its internal database to determine the number of additional DIN-drugs that could pose a risk of injury to human health if in shortage.

Table 1: Estimated number of drugs in scope
Risk category Estimated number of drugs (medicinal ingredient/route of administration) Estimated number of DlN-drugs table b1 note a Source 
Drugs that could pose a risk of injury to human health if in shortage that are currently out of scope of the shortages regulations (e.g. over-the-counter) Up to 12 75 Experience with past shortages and clinical expert opinion matched to the drug identification number database

Table b1 note(s)

Table b1 note a

The term "DIN-drug" refers to the number of uniquely identified drug products authorized for sale in Canada that are described by the listed medicinal ingredient/route of administration.

Return to table b1 note a referrer
Costs to industry
Cost for over-the-counter drugs that are exceptionally imported to include information that allows for safe use

Over-the-counter drugs could be added to the List of Drugs for Exceptional Importation and Sale under the regulatory amendments. Importers of over-the-counter drugs that are exceptionally imported will be required to include information allowing for the safe use of the drug as part of the exceptional importation and sale framework. It is assumed that, in most cases, this will be in the form of a single sheet of printed paper that is assumed to cost $0.33 per unit.footnote 35

When the exceptional importation and sale framework was formalized in 2020, over-the-counter drugs were not included in the framework. Between that time and 2024, one shortage of an over-the-counter drug posed sufficient harm to people in Canada that Health Canada allowed foreign authorized products to be imported via enforcement discretion and sold to mitigate the shortage. As there has been one shortage over a four-year period, it is assumed that one of these shortages will happen once every four years.

During that specific shortage, Health Canada allowed 12 over-the-counter products for exceptional importation and sale, in respect of which 4.4 million units were imported into Canada.footnote 36 As previously mentioned above, Health Canada assumes that each unit of product sold will have to have a single sheet printed with the product to indicate information regarding the safe use of the product. Therefore, it is estimated that during one of these shortages, the annual cost for industry will be approximately $1.4 million. However, since the timing of one of these events is unknown, the cost has been spread over the four-year period to account for uncertainty. Therefore, the annualized cost of this amendment is expected to be approximately $357,000 per year.

Overall, including information to allow for safe use of a product is expected to cost organizations around $2.5 million (PV) over the 10-year period, discounted at 7% per year.

Cost of increased reporting due to removal of medical device exemptions

Currently, if an organization has a medical device named on the List of Medical Devices - Notification of Shortages and Discontinuation of Sale, they may be eligible for an exemption from medical device shortage reporting if the organization has a substitute medical device available. The amendment will remove this exemption, and organizations will now have to report shortages even if they have a substitute medical device available.

It is challenging to accurately estimate the number of past exemptions, since the exemptions are determined by organizations and do not require submitting an application to Health Canada if the medical device is on the List of Medical Devices - Notification of Shortages and Discontinuation of Sale. However, responses to an external survey and consultation with programs suggest that the number of shortages reported could be as high as four times the amount currently submitted. Internal data reveals that there are around 100 medical device shortages reported each year, on average. Therefore, Health Canada anticipates that the average number of reports it receives will grow from approximately 100 per year to around 400 per year, resulting in an additional 300 reports per year.

It is estimated that it will cost industry approximately $315 to report a single shortage based on a United States government report that estimated the cost of reporting shortages or discontinuations of drugs to be approximately $315 per notification. It is expected that the total annual cost to industry for reporting these medical device shortages is approximately $94,500 per year (300 medical device reports * $315). The additional reporting of medical device shortages that were previously exempt will come into force on the first anniversary of the day the Regulations are published, resulting in the associated cost beginning in the second year after publication.

Overall, it is expected that medical device establishment licence holders will incur an overall cost of $575,000 (PV), discounted at 7% per year over 10 years. The requirement to report is not being done to demonstrate compliance, so it is not considered an administrative burden for the purposes of the one-for-one rule.

Cost of serious adverse drug reaction reporting for exceptionally imported drugs

Importers of exceptionally imported drugs currently do not have to report serious adverse drug reactions. The amendments will require importers of exceptionally imported drugs to inform Health Canada if they become aware of a serious adverse drug reaction that has been reported in another jurisdiction related to the exceptionally imported drug. Based on data collected as part of the Regulations Amending the Food and Drug Regulations and the Medical Devices Regulations (Serious Adverse Drug Reaction Reporting - Hospitals), the administrative cost to provide each serious adverse drug reaction report is $341 and is reflected in the “one-for-one rule” section below.

Market authorization holders currently submit an average of 900 000 serious adverse drug reaction reports annually (including both domestic and foreign reported serious adverse drug reactions) for roughly 20 000 DIN-drugs; an average of 11 serious adverse drug reactions occur globally per DIN-drug. Expanding the scope by requiring the submission of a serious adverse drug reaction report for drugs that may be exceptionally imported is anticipated to increase this average by 218 serious adverse drug reactions each year. Therefore, this amendment is expected to cost industry around $74,000 within a given year. The total cost to industry to report serious adverse drug reaction reports is expected to be $520,000 (PV), discounted at 7% per year over 10 years.

Cost of reporting for over-the-counter drugs subject to shortage reporting regulations

All market authorization holders that sell controlled substances on schedules I to V of the Controlled Drugs and Substances Act, prescription drugs on the Prescription Drug List, radiopharmaceuticals in Schedule C of the Food and Drugs Act, biologics in Schedule D of the Food and Drugs Act and drugs that are permitted to be sold without a prescription, but are administered only under the supervision of a practitioner, are required to report shortages to a third-party website operating under contract to Health Canada. Over-the-counter drugs that fit the definition of drugs that pose a “risk of injury to human health” if in shortage will now be subject to shortage reporting if specified on a list incorporated by reference into the Regulations.

Health Canada programs have estimated that approximately 75 over-the-counter DIN-drugs could be included on an incorporated-by-reference list and be required to report if in shortage. Currently, approximately 29% of drugs subject to the shortage reporting requirement are reported to be in shortage each year. Applying the same ratio to the 75 over-the-counter DIN-drugs results in 22 new shortage reports (75 DIN-drugs * 29%). Therefore, the total ongoing cost to industry for new drugs subject to the shortage regulations is approximately $7,000 per year (22 new shortage reports * $315 per report).

Overall, the total cost to industry for the shortage reporting of new drugs subjected to the shortage requirements is $49,000 (PV), discounted at 7% per year over 10 years. The requirement to report is not being done to demonstrate compliance, so it is not considered an administrative burden for the purposes of the one-for-one rule.

Exceptional importation of drugs — reporting information in respect of any serious risk of injury to human health associated with foreign regulatory actions

Manufacturers of prescription drugs are currently required to notify Health Canada of any information they receive or become aware of (that applies to a product sold in Canada and represents a serious risk) with respect to risks identified in specified foreign jurisdictions, and within 72 hours of the moment they become aware of it. This information on foreign action includes risk communications issued, changes to label requested, recalls, reassessments, suspensions and revocations of authorization by the regulatory authorities specified. The amendments will require importers to also disclose such foreign actions to Health Canada concerning exceptionally imported drugs.

Internal data indicates that 20% of all prescription drugs listed on Health Canada’s Prescription Drug List involve industry submitting notifications of foreign action to Health Canada. There are currently around 20 active drugs on the List of Drugs for Exceptional Importation and Sale, suggesting that 4 will likely submit a notification of foreign action. Industry previously indicated that this activity costs an average of $1,573 per notification. Therefore, the annual cost to industry is expected to be around $6,300 per year.

Overall, it is expected that organizations required to notify Health Canada of foreign decisions will incur an overall cost of approximately $44,000 (PV), discounted at 7% per year over 10 years.

Notification of cancellation for exceptionally imported medical devices

The current exceptional importation scheme does not require importers of exceptionally imported medical devices to notify Health Canada if the exceptionally imported device is no longer authorized for sale in another jurisdiction. The amendments will require importers to disclose such foreign actions to Health Canada concerning exceptionally imported medical devices. Unlike drugs, Health Canada does not have consistent information on the frequency of imported medical devices losing their authorization in a foreign jurisdiction. Therefore, it is assumed that the frequency of foreign actions used for the exceptional importation of drugs, which is 20% of exceptionally imported drugs, can be applied as a proxy to exceptionally imported medical devices that will be required to notify Health Canada of such a foreign action.

There are around 25 medical devices per year that are on the List of Medical Devices for Exceptional Importation and Sale, suggesting that 5 will likely submit a notification of a foreign action. Industry previously indicated that this activity costs an average of $1,573 per notification. Therefore, the annual cost to industry is expected to be around $8,000 per year.

Overall, it is expected that organizations required to notify Health Canada of a foreign decision to cancel a medical device licence will incur an overall cost of approximately $56,000 (PV), discounted at 7% per year over 10 years.

Advanced reporting of discontinuations

The amendments will expand the current discontinuation reporting requirement from 6 months’ advance notice to 12 months’ advance notice. Currently, some market authorization holders may wait to report until a planned discontinuation is 6 months away. Under the regulatory amendments, market authorization holders may see an increase in compliance costs due to early reporting, but this cost to industry is expected to be low, if not negligible. Organizations are still currently required to report discontinuations, so while the timing of the burden has changed, the burden itself has not.

Extension of expiry dates

When there is a significant shortage, Health Canada works with industry to mitigate the impacts and increase the available supply of the drug, which could involve the extension of expiry dates. These regulatory amendments will formalize what is already being done. In addition, product information that is reviewed by Health Canada to extend the expiry dates is usually readily available to the manufacturer. Therefore, it is assumed that additional costs to industry will be minimal.

Costs to Government
Compliance and enforcement

The regulatory amendments are expected to increase compliance and enforcement activities. It is estimated that the increased activities will cost Health Canada approximately $5,000 per year or $35,000 (PV), discounted at 7% per year over 10 years.

Expansion of the third-party website

Currently, drug shortages and discontinuations are reported on a third-party website that is funded by the federal government. The regulatory amendments will require medical device shortage and discontinuation information to be submitted to the same third-party website. The contracted cost of developing the medical device portion of the third-party website is expected to cost approximately $500,000, with an increase of $9,400 per year (beginning in the second year) to the ongoing cost of the contract.

In addition, Health Canada is expected to incur a cost of approximately $84,000 per year over the first two years in full-time equivalent costs, and then, starting in year three, approximately $42,000 per year in full-time equivalent costs to integrate enhancements and changes during the initial setup and over time.

Overall, the cost of establishing and maintaining the third-party website is expected to be approximately $895,000 (PV), discounted at 7% per year over 10 years.

Cost to establish and maintain lists incorporated by reference

Health Canada will establish two new incorporated-by-reference lists (to expand the scope of drugs subject to shortage regulations, and to list drugs that have had their expiry dates extended by Health Canada) that will require website development. Health Canada expects to incur a one-time cost of around $15,000 per list incorporated by reference to establish the list and then an ongoing cost of around $10,000 per year to maintain a list.

Therefore, since two lists incorporated by reference are expected to be established for the regulatory amendments, Health Canada estimates that the lists incorporated by reference will have a one-time cost of around $30,000 to establish the lists and $20,000 ongoing costs to maintain the lists.

Overall, it is expected that the lists incorporated by reference will cost Health Canada approximately $150,000 (PV), discounted at 7% per year over 10 years.

Cost to evaluate serious adverse drug reaction reporting

Health Canada currently does not require importers of exceptionally imported drugs to report serious adverse drug reactions. The amendments will require importers of exceptionally imported drugs to inform the Minister if they become aware of a serious adverse drug reaction that has been reported in another jurisdiction related to the exceptionally imported drug.

Health Canada is expected to incur a cost of $40,000 per year to evaluate adverse drug reaction reports from exceptionally imported products. Overall, it is expected that the cost of evaluating additional adverse drug reaction reports is $281,000 (PV), discounted at 7% per year over 10 years.

Cost of adding drugs on the exceptional importation framework

The Minister will be able to add any drug to the List of Drugs for Exceptional Importation and Sale if the shortage or risk of shortage of another drug causes a risk of injury to human health and the drug to be added to that list can be substituted for the drug in shortage or causing risk. The regulatory amendments broaden the scope of the drugs that can be brought in through the exceptional importation framework, including over-the-counter drugs.

Since the beginning of the COVID-19 pandemic, Health Canada has seen an increase in the number of health product risk communications and patient safety reviews conducted related to drug shortages. Expanding the scope of drugs that can be listed for exceptional importation will increase the frequency of Health Canada conducting health product risk communications and patient safety reviews. However, it is only expected that a drug will be added to the List of Drugs for Exceptional Importation and Sale once every four years and is expected to have a negligible impact on Health Canada. Therefore, no incremental costs are assumed.

Benefits to industry
Benefit from sale of drugs under exceptional importation

The regulatory amendments pertaining to the exceptional importation and sale of specified drugs are expected to expand the number of foreign authorized products an organization will be able to sell, allowing industry to increase its supply of products and revenues, should an organization propose to sell foreign authorized products in response to a shortage.

It is difficult to estimate the benefit, since it would depend on the nature and duration of the shortage and the type and usage of the drug. In addition, the exceptional importation and sale of a drug are voluntary and, therefore, would only be done if the organization felt it was in their best interest.

Benefits to Government
Shortage reporting on a third-party website

Reporting medical device shortages to a third-party website is expected to benefit Health Canada by automating the collection and reporting of shortages. An internal survey determined the average amount of time that Health Canada is expecting to save from no longer performing extensive reviews that are required when reporting directly to Health Canada, which was estimated to be 37.2 hours per report on average.

It was previously estimated that Health Canada receives approximately 100 medical device shortage reports per year on average. This results in a cost savings of approximately $283,000 per year beginning in year two.

Overall, it is expected that the savings from automating the collection and reporting of medical device shortages will be approximately $1.7 million (PV), discounted at 7% per year over 10 years.

Benefits to people in Canada

It is expected that the regulatory amendments will benefit people in Canada by helping to mitigate drug and medical device shortages in Canada.

In the case of drugs, it is expected that the most significant benefit from these Regulations will be from the reduction in overall harm of shortages that pose a risk of injury to human health by allowing more drugs to enter the Canadian market and providing people in Canada with access to substitute products that they otherwise would not have.

In the case of medical devices, it is expected that the major benefit of these amendments will be from improvements to shortage reporting, which could allow for earlier action to mitigate the impacts of shortages.

Scope of drugs subject to shortage regulations

New and existing provisions of the regulations related to shortages are targeted to minimize regulatory burden on drugs with relatively low shortage risk. However, occasions may arise where the shortage risk associated with such a drug changes and becomes significant enough that intervention from Health Canada is warranted. For example, in 2022–2023, there were national shortages of pediatric analgesic drugs, which affected families across Canada.

By empowering the Minister to place additional drugs within the scope of regulations related to shortages, these Regulations will allow the Department to respond to such situations when they arise by making use of key regulatory tools (e.g. mandatory shortage reporting, exceptional importation, etc.) to protect the health of people in Canada.

Updates to exceptional importation and sale frameworks for drugs and medical devices

It is expected that the amendments to the exceptional importation and sale frameworks for drugs and medical devices will allow the Department to apply these frameworks to a wider range of products and circumstances. This will allow the Department to be more flexible in using the frameworks to mitigate shortages of drugs and medical devices.

It is expected that people in Canada will benefit through an increase in the supply of products that are in shortage or at risk of shortage. An increase in products entering the Canadian market during shortages will provide people in Canada with access to substitute products that they otherwise would not have.

Updates to reporting frameworks for drug and medical device shortages and discontinuations

It is expected that the amendments to reporting frameworks for drug and medical device shortages and discontinuations will have the benefit of improving the clarity and usability of shortage reporting platforms. This will allow people in Canada, including patients and medical practitioners, to more easily obtain reliable information about shortages of drugs and medical devices. As well, this information will support Health Canada, its provincial/territorial partners and industry in responding to such shortages when they occur, helping to mitigate the impacts on people in Canada.

Expanding the urgent public health need framework

The expansion of the urgent public health need framework to include the United Kingdom will allow accelerated access to a wider range of drugs that are not authorized for sale in Canada. The framework is specifically designed to enable rapid importation of foreign-authorized drugs when there is a public health emergency. Including the United Kingdom will further diversify the potential supply chain in support of the Regulations and helps ensure that people at risk in Canada might obtain the drugs they need in a timely manner. This improves their ability to receive continuous treatments and reduces interruptions.

Summary totals
Summary total

The monetized benefits are estimated at $245,000 per year (annualized), or $1.7 million (PV) over 10 years (discounted at 7%). This estimate includes the Government’s cost savings from no longer performing extensive reviews on medical device shortage reports reported directly to Health Canada. The total quantifiable costs are approximately $728,000 per year (annualized), or $5.1 million (PV) over 10 years (discounted at 7%). Overall, the net monetized impact is estimated at $483,000 per year (annualized), or $3.4 million (PV) in costs over 10 years.

Cost-benefit statement
Table 2: Monetized costs
Impacted stakeholder Description of cost Base year Other relevant years
(Year 2)		 Final year Total (PV) Annualized value
Industry Cost for over-the-counter drugs that are exceptionally imported to include information that allows for safe use $357,000 $357,000 $357,000 $2,500,000 $357,000
Cost of increased reporting due to removal of medical device exemptions $0 $94,500 $94,500 $575,000 $82,000
Cost of serious adverse drug reaction reporting for exceptionally imported drugs $74,000 $74,000 $74,000 $520,000 $74,000
Cost of reporting for over-the-counter drugs subject to shortage regulations $7,000 $7,000 $7,000 $49,000 $7,000
Exceptional importation of drugs — Reporting information in respect of any serious risk of injury to human health associated with foreign regulatory actions $6,300 $6,300 $6,300 $44,000 $6,300
Notification of cancellation for exceptionally imported medical devices $8,000 $8,000 $8,000 $56,000 $8,000
Total costs $452,300 $546,800 $546,800 $3,744,000 $534,300
Government Compliance and enforcement $5,000 $5,000 $5,000 $35,000 $5,000
Expansion of the third-party website $584,000 $93,400 $51,400 $895,000 $127,000
Cost to establish and maintain lists incorporated by reference $30,000 $20,000 $20,000 $150,000 $21,000
Cost to evaluate serious adverse drug reaction reporting $40,000 $40,000 $40,000 $281,000 $40,000
Total costs $659,000 $158,400 $116,400 $1,361,000 $193,000
All stakeholders Total costs $1,111,300 $705,200 $663,200 $5,105,000 $727,300
Table 3: Monetized benefits
Impacted stakeholder Description of benefit Base year Other relevant years
(Year 2)		 Final year Total (PV) Annualized value
Government Shortage reporting on a third-party website $0 $283,000 $283,000 $1,700,000 $245,000
All stakeholders Total benefits $0 $283,000 $283,000 $1,700,000 $245,000
Table 4: Summary of monetized costs and benefits
Impacts Base year Other relevant years Final year Total (PV) Annualized value
Total costs $1,111,300 $705,200 $663,200 $5,105,000 $727,300
Total benefits $0 $283,000 $283,000 $1,700,000 $245,000
NET COST $1,111,300 $422,200 $380,200 $3,405,000 $482,300
Quantified (non-monetized) and qualitative impacts
Positive impacts
Negative impacts

Small business lens

Although the amendments do not specifically address small businesses, the needs of small businesses were taken into consideration in the creation of the regulatory amendments. The amendments help to streamline existing processes and improve user experience for regulated parties, which will better enable small businesses to comply with shortage reporting requirements.

The number of small businesses was determined through surveys that were sent to all current drug establishment licence holders, medical device establishment licence holders and medical device licence holders. The surveys asked respondents if they were a small business according to the Treasury Board Secretariat’s definition (a business that has fewer than 100 employees or generates between $30,000 and $5 million in annual gross revenue).

Overall, there were 89 drug establishment licence holders that responded to the survey, with 24 organizations identifying as small businesses, which represents 27% of drug establishment licence holder respondents. In contrast, there were 348 medical device establishment licence and medical device licence holders that responded to the survey, with 175 organizations identifying as small businesses, which represents 50% of medical device establishment licence and medical device licence holder respondents.

In addition, and for specific provisions, the small business analysis relies on the self-identification of small businesses through their answers to the external survey questions and used as a representative sample of the industry. The following provides a summary of the costs for small businesses:

The full small business lens analysis can be found in the Cost-Benefit Analysis report and is available upon request by writing to hpsdpdcorr-corrdgppsdp@hc-sc.gc.ca.

Small business lens summary
Table 5: Costs
Administrative or compliance Description of cost Present value Annualized value
Administrative Cost for over-the-counter drugs that are exceptionally imported to include information that allows for safe use $351,000 $50,000
Compliance Cost of increase reporting due to removal of medical device reporting exemptions $276,000 $39,000
Administrative Cost of serious adverse drug reaction reporting for exceptionally imported drugs $79,000 $11,300
Compliance Cost of reporting for over-the-counter drugs subject to shortage reporting regulations $13,000 $1,900
Administrative   Exceptional importation of drugs — Reporting information in respect of any serious risk of injury to human health associated with foreign regulatory actions $11,000 $1,600
Notification of cancellation for exceptionally imported medical devices $34,000 $4,800
Total Total costs $764,000 $108,600
Table 6: Net impacts
Amount Present value Annualized value
Cost on all impacted small businesses $764,000 $108,600
Average cost on each impacted small business [Net impacts divided by number of impacted small businesses] $4,000 $600

One-for-one rule

The one-for-one rule applies, since there is an incremental increase in administrative burden on businesses. The amendments are considered burden “IN” under the rule, and no regulatory titles are repealed or introduced. The amendments will result in an annualized administrative total cost of approximately $131,220.

As per the Red Tape Reduction Regulations, the assessment of administrative impacts was conducted for a period of 10 years commencing from the publication of the Regulations. All values listed in this section are presented in 2012 dollars, discounted to 2012 at a rate of 7%.

For all administrative tasks, the average hourly wage (including overhead) of the responsible individual is estimated to be $37.68.

Cost for over-the-counter drugs that are exceptionally imported to include information that allows for safe use

The amendments related to exceptional importation of over-the-counter drugs represent an annualized total cost of $105,154. Up to three businesses would be required to provide safe use information for approximately 370 000 units of exceptionally imported products per year.

Cost of serious adverse drug reaction reporting for exceptionally imported drugs

The amendments related to reporting serious adverse drug reactions represent an annualized total cost of approximately $21,896. Health Canada estimates that industry will submit an additional 218 reports each year. The average wage (including overhead) of the responsible individual is estimated to be $37.68.

Exceptional importation of drugs — reporting information in respect of any serious risk of injury to human health associated with foreign regulatory actions

Internal data indicate that industry stakeholders historically submit an average of 298 notifications of foreign action per year, which corresponds to 20% of the total of 1 456 medicinal ingredients on the Prescription Drug List. There are currently around 20 active drugs on the List of Drugs for Exceptional Importation and Sale, suggesting that 4 will likely submit a notification of foreign action. The amendment related to organizations reporting information in respect of any serious injury to human health associated with foreign regulatory actions represents an annualized cost of $1,853. Up to four businesses would spend 31.71 hours to complete the task once per year. The average wage (including overhead) of the responsible individual is estimated to be $37.68.

Exceptional importation — notification of the cancellation of foreign authorized medical devices

The amendments will require importers of exceptionally imported medical devices to notify Health Canada within 72 hours of any information they receive or become aware of relating to an exceptionally imported medical device that is no longer authorized for sale in a foreign jurisdiction. Using drug notifications as a proxy, internal data indicate that drug industry stakeholders historically submit an average of 298 notifications of foreign action per year, which corresponds to 20% of the total of 1 456 medicinal ingredients on the Prescription Drug List. There are around 25 medical devices per year that are on the List of Medical Devices for Exceptional Importation and Sale, suggesting that 5 will likely submit a notification of foreign action.

The amendments related to notifying of a foreign medical device no longer being authorized represent an annualized total cost of $2,317. Up to five businesses would spend 31.71 hours to complete the task once per year. The average wage (including overhead) of the responsible individual is estimated to be $37.68.

Regulatory cooperation and alignment

On January 22, 2024, Organisation for Economic Co-operation and Development (OECD) member nations, including Canada, published a Declaration on Building Better Policies for More Resilient Health Systems. The declaration calls on the OECD and other international organizations to assist in efforts to tackle drug shortages and security of supply issues, including by considering regulation and stockpiling approaches.

In keeping with this declaration and good practices in regulatory design, the amendments are similar to initiatives underway in other jurisdictions.

Expiration date extension

The amendments allowing the Minister to extend the expiration date on certain lots and batches of drugs in order to mitigate a shortage are aligned with the use of expiration date extensions internationally.

To help with drug supply during a shortage, the United States Food and Drug Administration maintains a lot-specific list of products with extended use data. This list is based on data reviewed by the Administration and indicates lot numbers that can be used through the corresponding new expiration dates by patients and providers. The list does not recommend or require that listed products be relabelled with the new expiration dates and the Administration expects the product to be disposed of upon availability of replacement product.

Exceptional importation and urgent public health need frameworks

Australia allows the exceptional importation of unapproved critical drugs when that drug is in short supply, including due to a discontinuation of the drug.

Similarly, many countries can implement temporary measures to allow non-compliant or foreign-authorized products to be imported during an emergency. For example,

Shortage and discontinuation reporting

Shortage and discontinuation reporting requirements are common across OECD countries. However, reporting requirements differ across countries. For example, countries like Belgium and Norway require market authorization holders of all drugs to report anticipated or actual shortages. In other countries, like France, Australia and the United States, the reporting requirements only apply to the market authorization holders of specific drugs included in a predefined list. In the United States, reporting of medical device supply interruptions is required for certain medical devices during a public health emergency and otherwise encouraged on a voluntary basis.

The amendments enable the Minister to expand existing shortage-related requirements, such as required shortage reporting, to capture additional drug products (e.g. over-the-counter drugs). This is aligned with the practice of Australia, Finland, Sweden and Spain.

The amendments require reporting of discontinuations 12 months in advance of the discontinuation of a product. The change will provide Health Canada with more notice to respond to any possible impacts of the discontinuation. This differs from the practice of international comparators. However, the European Commission released a proposal in April 2023 that recommends member states to require market authorization holders to report discontinuations at least 12 months in advance.

Areas of cooperation with provinces and territories

Health Canada plays a leadership role in responding to shortages of drugs and medical devices, but better prevention and mitigation of shortages are the responsibility of many partners, including provincial and territorial governments and the health care community. Health Canada is responsible for regulating drugs and medical devices, while provincial and territorial governments are responsible for the management, organization and delivery of health care services for their residents. Areas of provincial and territorial responsibility that impact drug and medical device shortages include policy for health service organization and delivery influencing demand and demand forecasting to inform the manufacturing of drugs and medical devices, procurement of drugs and medical devices, and the regulation of health care professionals.

Health Canada works closely with provincial and territorial governments to address shortages of drugs and medical devices. When there is a shortage of critical and national importance, Health Canada coordinates information sharing with provincial and territorial governments as well as industry to help coordinate the conservation of the remaining supply, determine demand and supply gap and prioritize distribution of new supply. The Department also supports work done by provincial and territorial governments and regulatory bodies to introduce measures to mitigate the shortage, such as changing prescribing practices.

Health Canada will continue to engage with provincial and territorial governments through forums, such as the Multi-Stakeholder Steering Committee on Drug Shortages, the Medical Device Shortages Multi-Stakeholder Committee, and the federal/provincial/territorial tables to help ensure that the new regulations strengthen Canada’s collaborative shortage response.

Effects on the environment

In accordance with the Cabinet Directive on Strategic Environmental and Economic Assessment, a preliminary scan concluded that a strategic environmental assessment is not required.

Gender-based analysis plus

Health product shortages are a pan-Canadian issue with the potential to affect a broad range of demographic groups in Canada. The amendments are expected to broadly benefit the health of all people in Canada who use, or may use, drugs and medical devices. The amendments are not expected to disadvantage people in Canada based on their age, sex, gender, race, culture, or other socioeconomic or demographic characteristics.

People in Canada 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 (PDF) can influence the need for drugs and medical devices, including, but not limited to, age, sex, disabilities and underlying conditions. For example, prescription drug use rises with age, in part because older people in Canada are more likely to be diagnosed with chronic conditions that require treatment with such drugs. The incidence of chronic conditions that require prolonged use of drugs and medical devices is more common among women over 65, as women tend to have longer life expectancies than men.

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 are more likely to face barriers to accessing drugs and medical devices.footnote 38, footnote 39, footnote 40 Improving Health Canada’s response to shortages may help improve access to drugs and medical devices and potentially reduce existing inequities in this regard. As a result, it is anticipated that these regulatory amendments could indirectly benefit groups with lower socioeconomic status.

In addition to the general impacts of shortages, individual shortages may have a more targeted effect on a particular subpopulation. In keeping with the Government of Canada’s commitment to gender-based analysis plus (GBA+) in the development of policies, programs and legislation, Health Canada began conducting a GBA+ of all 37 drug shortages that were reviewed by the Tier Assignment Committee in 2022–2023 and had a national, critical impact on patients and the health care system. This GBA+ looked at the different impact these shortages had on factors, such as age, sex, gender, race, ethnicity, socioeconomic status, disability, sexual orientation, cultural background, migration status and geographic location. The GBA+ determined that 62% of these shortages disproportionately impacted one or more age groups, that 22% disproportionately impacted those residing in very rural or remote areas and that 11% disproportionately impacted women.

Implementation, compliance and enforcement, and service standards

Implementation

The amendments come into force in two phases.

The following amendments come into force on the day they are published in the Canada Gazette, Part II:

The amendments that update the reporting frameworks for medical device shortages and discontinuations will come into force on the first anniversary of the day they are published in the Canada Gazette, Part II.

This schedule will allow the Minister to make immediate use of authorities needed to respond to shortages when they happen, while giving market authorization holders and other regulated parties the time needed to adapt to new regulatory requirements.

The document incorporated by reference will be updated as needed and in keeping with the Health Canada Incorporation by Reference Policy. Part of this policy is to undertake a consultation process that is appropriate to the situation and purpose of the document.

Health Canada publishes guidance to support regulated parties in understanding and complying with regulations. The Department is publishing new guidance alongside these regulations to assist regulated parties in

The Department is publishing updated guidance alongside these regulations to reflect amended regulatory requirements, including

To implement the amendments, the Department will undertake several compliance promotion activities. These activities will aim to raise awareness and promote a high level of compliance as early as possible during the regulatory implementation process.

The Department uses a performance information profile to measure and track the success of Health Canada’s health product shortages program. This includes performance indicators that track the functionality of shortage reporting platforms, as well as industry compliance with regulatory requirements once an instance of non-compliance has been confirmed. The results will be comprehensively tracked in keeping with the policy on results. The Department also regularly conducts audit and evaluation activities to assess the effectiveness of Health Canada’s programs, including the Department’s health product shortages program.

Compliance and enforcement

Regulated parties, including drug establishment licence holders, drug market authorization 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.

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

Compliance and enforcement responses are proportionate to the identified risk posed to the health and safety of people in Canada. 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, including the health and safety risks posed by the non-compliance and the behaviours and compliance history of the regulated party.

Contact

Cynthia Colapinto
Director
Health Product Shortages Directorate
Health Canada
Telephone: 613‑462‑8871
Email: hpsdpdcorr-corrdgppsdp@hc-sc.gc.ca