Canada: Pharma In Brief - Amendments To The Food And Drug Regulations Ban Access To "Restricted Drugs" Under The Special Access Programme

Summary

On October 4 2013, the Minister of Health announced that, pursuant to the introduction of new regulations, physicians will no longer be able to prescribe diacetylmorphine, also known as heroin, and other "restricted drugs" to their patients through Health Canada's Special Access Programme. The Regulations Amending Certain Regulations Relating to Access to Restricted Drugs, affect certain provisions of the Food and Drug Regulations, the Narcotic Control Regulations, and the New Classes of Practitioners Prescribed Regulations and came into force on October 2, 2013. 1,2,3

Background

The Special Access Programme ("SAP") allows physicians to request access to drugs that have not received market authorization in Canada. Under the SAP and upon receipt of Health Canada authorization, manufacturers are authorized to sell a non-marketed drug to practitioners in Canada for the purpose of treating patients with serious or life-threatening conditions where conventional therapies are unsuitable, unavailable or have failed.4

The Minister's announcement to ban access to heroin and other "restricted drugs" under the SAP came shortly after Health Canada authorized doctors in British Columbia to prescribe heroin under the SAP to certain patients who have not responded to conventional opioid addiction treatment.  Under the new regulations, drugs such as heroin, unauthorized forms of cocaine, and other restricted drugs, such as LSD, ecstacy, 'magic' mushrooms and 'bath salts', will no longer be authorized for individual patient use under the SAP.

The amendments apply going forward from the date of coming into force, including application to outstanding SAP requests that had not been authorized as of that day.  The amendments will not affect clinical trials or university research under the Controlled Drugs and Substances Act.

Amendments to the Regulations

Special Access Programme

The authority of the SAP is found under sections C.08.010(1) and C.08.011 of the Food and Drug Regulations. Part C of the Food and Drug Regulations pertains to the regulation of drugs in Canada. More specifically, Division 8 of Part C regulates the approval and sale of new drugs in Canada, including the sale of a new drug for emergency treatment. In respect of a non-marketed drug requested under the SAP, subsection C.08.010(1) states that a letter of authorization may be issued to authorize the sale of a new drug to a requesting practitioner for use in the emergency treatment of a patient under their care. This section has been amended by adding subsection C.08.010(1.1), which states that a letter of authorization under the SAP will not be issued for a new drug that contains a restricted drug, as defined in section J.01.001 of the Regulations.

"Restricted Drugs"

The new regulations represent a shift in regulatory oversight of heroin from the Narcotic Control Regulations to the Food and Drug Regulations. The Narcotic Control Regulations, made under the Controlled Drug and Substances Act, regulates the possession, sale and use of a narcotic in Canada.  Part J of the Food and Drug Regulations regulates the use and possession of "restricted drugs" in Canada, which can only be used for scientific and research purposes.

Diacetylmorphine, also known as heroin, was added to the Schedule of "restricted drugs"  in Part J of the Food and Drug Regulations and concurrently removed from the Narcotic Control Regulations. The definition of a "restricted drug" under section J.01.001 of the Food and Drug Regulations is also amended to include cocaine (benzoylmethylecgonine), any of its salts, or anything that contains cocaine, excluding a drug that has been authorized for sale under Division 1 Part C of the Regulations. Consequently, adding heroin and unauthorized forms of cocaine to the Schedule of "restricted drugs" in Part J of the Food and Drug Regulations means that these drugs can only be used for authorized scientific and research activities in Canada.

Link to regulations:

Regulations Amending Certain Regulations Relating to Access to Restricted Drugs, SOR/2013-172

Footnotes

1 Food and Drug Regulations, C.R.C., c.870.

2 Narcotic Control Regulations, C.R.C., c.1041.

3 New Classes of Practitioners Regulations, SOR/2012-230.

4 Health Canada Guidance Document for Industry and Practitioners - Special Access Programme for Drugs, January 30, 2008, online: http://www.hc-sc.gc.ca/dhp-mps/acces/drugs-drogues/sapg3_pasg3-eng.php.

Norton Rose Fulbright Canada LLP

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