Alberta Psychedelic Sunrise – Again – Part 2

Part 2 – How Will the MHSPR Regulate Psychedelics in Alberta?

Disclaimer:?This is not legal advice.

In Part 1 of this article, I wrote about the big picture implications of an Order in Council published called The Mental Health Services Protection Amendment Regulation, AR 351/2022 amending the Mental Health Services Protection Regulation (the “MHSPR”) (AR 114/2021) in another post published immediately prior to this one.?The Order in Council is scheduled to become law on January 16, 2023.

The Order in Council is enclosed with this article.?The Order in Council touches on a few points, including addiction, all of which are important but not the focus of this article.?Therapeutic use of psychedelics are addressed is in “Part 3”, which starts on page 20.?The Mental Health Services Protection Act (SA 2018 c M-13.2) and the current MHSPR are easy to find online:?https://kings-printer.alberta.ca/_index.cfm.

These are some of the details about how the MHSPR will regulate therapeutic use of psychedelics in Alberta.

Scope

All service providers (i.e. clinics) that provide psychedelic drug treatment services in Alberta will need a licence.?Psychedelic drug treatment services are any services to treat a psychiatric disorder using a designated psychedelic drug.?

The initial list of designated psychedelic drugs is, in the order presented in the Order in Council:?MDMA, ketamine, LSD, mescaline, DMT, 5-MeO-DMT, psilocin and psilocybin.?Presumably this list will be expanded as various compounds advance through clinical trials an are closer to being used in licence holder clinics.

Psychedelic assisted psychotherapy, using a psychedelic dose (defined to mean just what it sounds like), is an important subset of psychedelic drug treatment services.?Psychedelic drug treatment services do include non-psychedelic doses of designated psychedelic drugs, subject to fewer requirements than psychedelic doses of designated psychedelic drugs.

The distinction between a psychedelic and non-psychedelic dose of a designated psychedelic drug is made with reference to (a) the prescriber’s assessment of the patient, (b) the information available, if any, in relation to the dose of a particular designated psychedelic drug, and (c) other criteria set out by the Standards.

The MHSPR provide for creation of the Psychedelic Drug Treatment Services Standards (the “Standards”), which will be approved by the Minister of Health and published from time to time.?In addition to the many specific points listed below, the Standards may also require any additional prescribed reporting requirements, additional services, policies, procedures, review schedules, and record keeping practices.?As is often the case with regulation of specialized professions or industries, the Standards will be key to understanding the practical and effective scope of MHSPR regulation of service providers.?The Standards have not yet published, and it is not clear how the Standards will be prepared.

Requirements

Psychiatrists are the foundation of any service provider holding a licence to offer and provide psychedelic drug treatment services under the MHSPR.?Each licence holder must appoint a medical director to oversee all clinically related aspects of the psychedelic drug treatment services.?The medical director must be a psychiatrist and must be trained as required by the Standards.

Only psychiatrists who are trained in accordance with the Standards may prescribe a designated psychedelic drug – regardless of whether a psychedelic dose or a non-psychedelic dose is being prescribed.???Other physicians who hold the qualifications, training and experience required by the Standards may also prescribe designated psychedelic drugs provided that they do so after and with ongoing consultation with a psychiatrist as required in the Standards.

Administration of a designated psychedelic drug at a psychedelic dose must take place in a facility of a service provider, a hospital, or other accredited medical facility.?The patient must be monitored, treated and cared for while the patient is in an altered state of consciousness and for any additional time if directed by the prescriber of the drug.?No specific requirements of the facilities are listed, but the MHSPR require any licence holder to meet all requirements of the Standards, which could include infrastructure requirements of the facility,

Any psychotherapy provided in associated with psychedelic assisted psychotherapy must be provided by one or more of a psychotherapist, physician, psychologist, registered nurse, registered psychiatric nurse or social worker.?Other than for psychiatrists or clinical psychologists these healthcare practitioners must either hold a graduate degree or have five years of experience along with a positive assessment by the medical director.?Any such healthcare professionals must also comply with any requirements in the Standards.

Self-administration is only authorized outside the context of psychedelic assisted psychotherapy and at non-psychedelic doses.?Any outpatient prescriptions for a non-psychedelic dose must include a direction respecting the quantity of the drug that may be dispensed or sold at any time, and the intervals between dispensation or sale.?The prescription must take into consideration the potential for overuse of the drug.?To be clear, all prescriptions of non-psychedelic doses of designated psychedelic drugs must still be made by a psychiatrist or physician working with a psychiatrist, in either case practicing in association with or as a licence holder.

Exceptions

Some activity with psychedelics is expressly outside any requirement to hold a licence.

Hosting a clinical trial for activities that would otherwise require a licence is exempt from the requirement to hold a licence, provided that any conditions imposed by a research ethics board are respected and that no trial subjects are charged for participation.?However, the service provider (apparently regardless of whether or not they are a licence holder – the amended MHSPR are not express on this point) must report certain information related to the clinical trial.

Use of ketamine other than for psychedelic assisted psychotherapy is not subject to the MHSPR.

Compounding, dispensing or selling designated psychedelic drugs are each exempt from the requirement to hold a licence.?Pharmacies formulating ketamine for use in psychedelic assisted psychotherapy would not require a licence under the MHSPR.?However, some reporting and other requirements do apply to pharmacies related to designated psychedelic drugs.

Patients who are at or near end of life may receive care in their home or other location that including a psychedelic dose of a designated psychedelic drug.?The remainder of the requirements of the MHSPR and the Standards remain applicable.

SAP or Not to Be?

Access to psychedelic drugs through the special access program (the “SAP”), and the likely associated psychotherapy, may be within the scope of “psychedelic drug treatment services” and subject to the MHSPR once after the Order in Council becomes effective.?However, depending on whether the Minister interprets applications for special access to be “prescriptions” or not, it could be that the SAP applications themselves are subject to fewer restrictions than post-market authorization prescriptions of psychedelics.?This approach may be seen as consistent with the fact that SAP applications require significant information from the requesting physician.

The same interpretation point would apply to writing medical documents or otherwise accessing any kind of medical access that may in the future be available to psilocybin if efforts like those by TheraPsil or the Psychedelic Association of Canada are successful in moving Canada toward a medical access system for psilocybin, regulated similarly to cannabis but under the Controlled Drugs and Substances Act (the “CDSA”), in compliance with UN Conventions.?However, in either case, whether SAP or medical access, and for that matter also pursuant to any authorization to possess issued under subsection 56(1) of the CDSA, it is likely that after the MHSPR are amended in Alberta, a licence would be needed to provide the psychedelic assisted psychotherapy surrounding psilocybin access, regardless of how the psilocybin is accessed (other than though a clinical trial).

For a general overview with less detail, please see Part 1 of this Article, which also published today.?I am happy to connect on Canadian and international law related to cannabis, and to psychedelics and other controlled substances.

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