Vol. 151, No. 26 — December 27, 2017

Registration

SOR/2017-275 December 8, 2017

CONTROLLED DRUGS AND SUBSTANCES ACT

P.C. 2017-1521 December 8, 2017

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to section 60 (see footnote a) of the Controlled Drugs and Substances Act (see footnote b), considering that it is necessary in the public interest, makes the annexed Order Amending Schedule I to the Controlled Drugs and Substances Act (123l-ioflupane).

Order Amending Schedule I to the Controlled Drugs and Substances Act (123l-ioflupane)

Amendment

1 Item 2 of Schedule I to the Controlled Drugs and Substances Act (see footnote 1) is amended by adding the following after subitem (3):

Coming into Force

2 This Order comes into force on the day on which it is registered.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Order or the Regulations.)

Issues

123I-ioflupane is the active pharmaceutical ingredient in the diagnostic radiopharmaceutical DaTscan, which is used to differentiate Parkinsonian Syndromes (PS) (see footnote 2) from essential tremor (ET). (see footnote 3)

Because all forms of ioflupane are cocaine derivatives, including the radio-labelled 123I-ioflupane, they are subject to the controls of the Controlled Drugs and Substances Act (CDSA).

In recent years, stakeholders have expressed interest in conducting activities with 123I-ioflupane in Canada for diagnostic purposes in health care settings and for further research on PS and ET. They have stressed the need to remove this substance from the controls of the CDSA citing the substance’s extremely low risk of diversion, its important clinical function, and have noted that current controls constitute a barrier impeding important medical research and testing procedures.

Background

DaTscan is marketed in the United States (U.S.) under the trademark name DaTscanTM and in Europe (under the trademark name DaTSCANTM), and is available in over 30 countries, including the United Kingdom and Israel. In September 2015, the U.S. removed 123I-ioflupane from the schedules of the U.S. Controlled Substances Act due to its low potential for misuse. Currently, the substance is not manufactured or marketed in Canada.

In response to stakeholders’ requests to remove 123I-ioflupane from the controls of the CDSA, Health Canada conducted a full review of the substance to assess whether its control is still warranted.

Health Canada’s review of the substance found no evidence indicating that 123I-ioflupane is being used illicitly in Canada, and that 123I-ioflupane has an extremely low risk of misuse or diversion. Key supporting findings include the fact that

Given these findings, Health Canada determined that control of 123I-ioflupane under the CDSA is not necessary.

Objectives

The objective of this amendment is to ensure that the substance 123I-ioflupane, which does not pose a risk for abuse or diversion, is no longer subject to the controls of the CDSA.

Description

The Order modifies the listing of coca under item 2 of Schedule I to the CDSA by adding the wording “but not including 123I-ioflupane.” Similarly, the amending regulations modify item 2 of the Schedule to the Narcotic Control Regulations (NCR) by adding the same language, “but not including 123I-ioflupane.” Excluding 123I-ioflupane from the requirements of the CDSA and the NCR will facilitate access for future diagnostic use and clinical trials in Canada.

All other forms of ioflupane remain controlled under the CDSA and its regulations.

“One-for-One” Rule

123I-ioflupane is not manufactured, marketed or used in Canada. Excluding the substance from the controls of the CDSA will not result in any changes in administrative cost burden to any Canadian businesses. As a result, the “One-for-One” Rule does not apply.

Small business lens

Since excluding the substance from the controls of the CDSA will not impose any costs on businesses, the small business lens does not apply.

Consultation

On April 21, 2017, Health Canada published a notice to interested parties in the Canada Gazette, Part I, informing stakeholders of the Department’s intent to make the above-noted regulatory amendments and provided stakeholders with a 30-day comment period. Five comments were received, one of which was from a manufacturer enquiring about the timing for the regulatory amendment. The remaining four comments came from research institutions and were supportive of the initiative.

Rationale

Given the substance’s legitimate use and extremely low risk of misuse or diversion, excluding 123I-ioflupane from Schedule I, item 2 to the CDSA and from item 2 of the Schedule to the NCR is an effective way to allow access to the substance without imposing additional burden on stakeholders. These amendments ensure that 123I-ioflupane is no longer subject to the controls of the CDSA and respond positively to stakeholders’ requests. As a result of these amendments, stakeholders wanting to conduct activities with 123I-ioflupane will no longer be required to have a licence or an exemption under the CDSA.

Implementation, enforcement and service standards

As part of the implementation of these amendments, Health Canada will notify stakeholders of the changes to Schedule I to the CDSA and Schedule I to the NCR. Information is also provided on Health Canada’s website.

These regulatory amendments come into force on the date of their publication in the Canada Gazette, Part II.

Contact

Louise Lazar
Healthy Environments and Consumer Safety Branch
Health Canada
Main Stats Building
150 Tunney’s Pasture Driveway
Ottawa, Ontario
K1A 0K9
Email: OCS_regulatorypolicy-BSC_politiquereglementaire@hc-sc.gc.ca