Vol. 150, No. 18 — September 7, 2016

Registration

SOR/2016-239 August 26, 2016

CONTROLLED DRUGS AND SUBSTANCES ACT

Regulations Amending Certain Regulations Made Under the Controlled Drugs and Substances Act (Access to Diacetylmorphine for Emergency Treatment)

P.C. 2016-759 August 26, 2016

His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 55(1) (see footnote a) of the Controlled Drugs and Substances Act (see footnote b), makes the annexed Regulations Amending Certain Regulations Made Under the Controlled Drugs and Substances Act (Access to Diacetylmorphine for Emergency Treatment).

Regulations Amending Certain Regulations Made Under the Controlled Drugs and Substances Act (Access to Diacetylmorphine for Emergency Treatment)

Food and Drug Regulations

1 Item 23 of Part I of the schedule to Part J of the Food and Drug Regulations (see footnote 1) is repealed.

Narcotic Control Regulations

2 (1) Paragraph (c) of the definition verbal prescription narcotic in subsection 2(1) of the Narcotic Control Regulations (see footnote 2) is replaced by the following:

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

diacetylmorphine (heroin) includes the salts of diacetylmorphine; (diacétylmorphine (héroïne))

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

4 (1) The portion of subsection 24(2) of the Regulations before paragraph (a) is replaced by the following:

(2) Subject to section 25, a licensed dealer may sell or provide any narcotic other than diacetylmorphine (heroin) or methadone to

(2) Section 24 of the Regulations is amended by adding the following after subsection (3):

(4) Subject to section 25, a licensed dealer may sell or provide diacetylmorphine (heroin) to

5 Subparagraph 27(2)(a)(i) of the Regulations is replaced by the following:

6 Section 53 of the Regulations is amended by adding the following after subsection (3):

(4) A practitioner of medicine, dentistry or veterinary medicine shall not administer diacetylmorphine (heroin) to an animal or to a person who is not an in-patient or out-patient of a hospital providing care or treatment to persons, and shall not prescribe, sell or provide diacetylmorphine (heroin) for an animal or such a person.

7 (1) Subsection 65(2) of the Regulations is replaced by the following:

(2) Subject to subsection (5), on receipt of a prescription or a written order, signed and dated by a practitioner, the person in charge of a hospital may permit a narcotic — other than fresh or dried marihuana or cannibis oil received from a licensed producer or diacetylmorphine (heroin) — to be administered to a person or an animal under treatment as an in-patient or out-patient of the hospital, or to be sold or provided for the person or to the person in charge of the animal.

(2) Subsection 65(4) of the Regulations is replaced by the following:

(4) Subject to subsection (5.1), the person in charge of a hospital may permit a narcotic — other than fresh or dried marihuana or cannibis oil received from a licensed producer or diacetylmorphine (heroin) — to be sold or provided, for emergency purposes, to a pharmacist on receipt of a written order signed and dated by the pharmacist.

(3) Section 65 of the Regulations is amended by adding the following after subsection (6):

(7) The person in charge of a hospital providing care or treatment to persons may permit diacetylmorphine (heroin) to be sold, provided or administered to a person under treatment as an in-patient or out-patient of the hospital on receipt of a prescription or a written order signed and dated by a practitioner of medicine or dentistry.

8 (1) Item 1 of the schedule to the Regulations is amended by adding the following after subitem (9):

(2) Subitem 1(33.1) of the schedule to the Regulations is repealed.

New Classes of Practitioners Regulations

9 (1) Paragraph 4(1)(c) of the New Classes of Practitioners Regulations (see footnote 3) is replaced by the following:

(2) Paragraph 4(2)(b) of the Regulations is replaced by the following:

Coming into Force

10 These Regulations come into force on the day on which they are registered.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Issues

Health Canada considers requests for access to non-marketed drugs by practitioners for emergency treatment for specific patients under the Special Access Programme (SAP). Regulatory changes introduced in 2013 through the Regulations Amending Certain Regulations Relating to Access to Restricted Drugs (SOR/2013-172) defined diacetylmorphine (heroin) as a “restricted drug” under Part J of the Food and Drug Regulations (FDR) and prohibited the issuance of letters of authorization by the SAP for any “restricted drug” as defined by Part J of the FDR.

A number of countries have allowed doctors to use diacetylmorphine-assisted treatment to support the small percentage of patients with opioid dependence who have not responded to other treatment options. There is also a significant body of scientific evidence supporting its use. As there may be a medical need for emergency access to diacetylmorphine, Health Canada has come to the conclusion that prohibiting access to diacetylmorphine for medical emergencies under the SAP is not in the public interest.

Background

Special Access Programme

The Special Access Programme (SAP) allows practitioners to request, in exceptional circumstances, access to non-marketed drugs for specific patients on a case-by-case basis. The SAP considers requests for emergency access to drugs for patients with serious or life-threatening conditions when conventional treatments have failed, are unsuitable, or are unavailable. Drugs accessed through the SAP are exempt from the Food and Drugs Act and the FDR. However, sales of controlled substances through the SAP are subject to the requirements of the Controlled Drugs and Substances Act (CDSA) and its related regulations.

Diacetylmorphine-assisted therapy

Diacetylmorphine-assisted therapy has been used in several European countries as a second-line treatment for opioid addicts who have repeatedly failed to respond to standard treatment. In the United Kingdom, diacetylmorphine is marketed for pain control. Supervised, medically prescribed diacetylmorphine is used in Switzerland, Germany, the Netherlands and Denmark for the treatment of chronic relapsing opioid dependence. In Switzerland, diacetylmorphine is fully paid by health insurance and access is controlled and regulated within a full clinical treatment framework. Spain and Belgium have approved diacetylmorphine for clinical research purposes. In the United States, diacetylmorphine is not available as a treatment and has not been approved for clinical research.

In Canada, diacetylmorphine was studied in two clinical trials: the North American Opiate Medication Initiative (NAOMI), which compared the use of diacetylmorphine to methadone from 2005 to 2008; and the Study to Assess Longer-term Opioid Medication Effectiveness (SALOME) which compared treatment with diacetylmorphine to hydromorphone from 2011 to 2015. The NAOMI study concluded that injectable diacetylmorphine was more effective than standard methadone treatment. However, due to the risks involved in treatment with diacetylmorphine, the authors stated that it should only be administered in a clinical setting where immediate medical attention is available. (see footnote 4) The SALOME study, published April 2016, indicated that hydromorphone, a marketed product in Canada, was found to be comparable to diacetylmorphine, suggesting that its use could be considered as an alternate treatment to diacetylmorphine where diacetylmorphine is not available. (see footnote 5)

There is scientific evidence supporting the use of diacetylmorphine-assisted therapy. A 2015 meta-analysis of six randomized control trials in six countries, (see footnote 6) including Canada, found that supervised diacetylmorphine therapy can significantly improve treatment outcomes compared to controls.

Access to diacetylmorphine-assisted therapy through the SAP

In October 2013, amendments were made that defined diacetylmorphine as a “restricted drug” under Part J of the FDR and prohibited the authorization of the sale of any restricted drug under the SAP. These amendments prevented the sale of diacetylmorphine through the SAP.

On November 13, 2013, a legal action was filed challenging the constitutional validity of these amendments. In mid-2014, the Supreme Court of British Columbia granted an interlocutory injunction permitting doctors of SALOME clinical trial participants to apply under the SAP to access diacetylmorphine until the matter was decided following the trial. In accordance with this ruling, Health Canada is processing SAP applications for diacetylmorphine received from health practitioners of SALOME participants under the previous regulatory framework.

Objective

The objective of these regulatory amendments is to allow for the consideration of applications made to the SAP for the sale of a specified quantity of diacetylmorphine for emergency treatment.

Description

The Regulations Amending Certain Regulations Relating to Access to Restricted Drugs (SOR/2013-172) prohibited access to all restricted drugs, including diacetylmorphine, under the SAP. However, these regulatory amendments distinguish diacetylmorphine from the other restricted drugs because there is a body of scientific evidence supporting its use as a treatment option for opioid addicts who have repeatedly failed to respond to standard replacement therapies. Furthermore, diacetylmorphine is used in a number of countries to support this specific population of opioid addicts. Removing diacetylmorphine from the schedule to Part J of the FDR will permit the consideration of applications for its sale for emergency treatment purposes under the SAP.

These regulatory amendments return the regulatory oversight of diacetylmorphine from Part J of the FDR to the Narcotic Control Regulations (NCR) by moving diacetylmorphine and its salts from the schedule to Part J of the FDR to the schedule to the NCR. All of the original additional controls over diacetylmorphine that were in place under the NCR and the New Classes of Practitioners Regulations before the 2013 amendments are reinstated (i.e. controls such as prohibiting verbal prescriptions for diacetylmorphine, prohibiting personal possession of diacetylmorphine by patients, and placing restrictions on the sale and provision of diacetylmorphine).

“One-for-One” Rule

The “One-for-One” Rule does not apply to these regulatory amendments, as there is no change in administrative costs to business.

Small business lens

The small business lens does not apply to these regulatory amendments, as there are no costs associated with the regulatory amendments.

Consultation

On May 14, 2016, Health Canada published a Notice to interested parties in the Canada Gazette, Part I, to notify stakeholders and the general public regarding these regulatory amendments. Sixty-one comments were received in response to the Notice; all were in support of the proposal. Comments were received from the general public, patients, parents, physicians, addiction counsellors and community workers, and patient associations. Many comments expressed concern over the rise in the number of deaths due to drug overdose in Canada and the need for innovative treatments to this problem. No comments of opposition were received.

Rationale

While restricted drugs listed in Part J of the FDR are generally recognized as having no therapeutic use, diacetylmorphine has known therapeutic uses. There is a body of research supporting the use of pharmaceutical grade diacetylmorphine to treat a group of patients with opioid dependence who have not responded to other treatments. In addition, a number of countries have allowed physicians to use diacetylmorphine-assisted treatment for these specific patients. Having access to diacetylmorphine will provide health practitioners with an additional treatment option to treat patients with opioid dependence who have not responded to traditional treatments. Treatment with diacetylmorphine in a comprehensive setting can lead to improved treatment outcomes and health benefits for these patients.

There are no costs associated with these regulatory amendments. Physicians currently applying to the SAP under the court injunction are expected to continue to apply to the programme for access to diacetylmorphine. Lastly, there are no incremental costs to industry and consumers with these Regulations.

Implementation, enforcement and service standards

These regulatory amendments came into force on the date of registration. As part of the implementation of these regulatory amendments, Health Canada will notify stakeholders of the changes and provide additional information on the Department’s Web site.

As is the case for all requests under the SAP, requests for special access to diacetylmorphine will be received, processed and decided upon in accordance with sections C.08.010 and C.08.011 of the FDR. Practitioners will be required to provide a clinical rationale that includes information such as the patient’s medical history, prognosis and treatments considered, failed or unsuitable. In addition, they will be asked to provide a rationale as to why diacetylmorphine is the best available option to treat the patient, along with specific data and/or references with respect to the use, safety and efficacy of diacetylmorphine.

The SAP considers the information provided for each request before deciding whether the authorization is appropriate and justified. The decision to authorize or deny a request is made on a case-by-case basis by taking into consideration the nature of the medical emergency, the availability of marketed alternatives and the information provided in support of the request regarding the use, safety and efficacy of the drug they wish to access.

Most requests are processed within 24 hours of receipt. However, given the mandate of the programme and the volume of requests received, requests are triaged to ensure that urgent matters take precedence over less urgent matters.

Contact

Anna Wheeler
Healthy Environments and Consumer Safety Branch
Health Canada
Main Stats Building
150 Tunney’s Pasture Driveway
Ottawa, Ontario
K1A 0T6
Email: OCS_regulatorypolicy-BSC_ politiquereglementaire@hc-sc.gc.ca