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Canada’s amendment allowing patients access to psychedelics welcomed

Authorised patients will now be able to access psychedelics through the country’s Special Access Program, marking “greater change to come”.

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Canada's amendment allowing patients access to psychedelics welcomed

The Canadian Government has amended regulation in order to allow patients to access psychedelic medicines such as psilocybin and MDMA.

Canada’s Special Access Program (SAP) will now enable physicians the right to request access to psychedelic-assisted psychotherapy for patients, which will be reviewed on a case-by-case basis.

The Canadian psychedelics industry has welcomed the news as a positive development for patients, noting that it will prevent psychedelic medicines following the path of cannabis – which has ended up with a lack of clinical research – and that it recognises the growing evidence base supporting the efficacy of psychedelics.

Published in the government’s official newspaper, the Canada Gazette, the regulation amendments relate to the Controlled Drugs and Substances Act and the Food and Drugs Act.

The amendments are expected to benefit patients with serious or life-threatening conditions, says the government. Patients will be granted this access when “other therapies have failed, are unsuitable, or are unavailable in Canada.”

The change is a response to requests to remove restrictions on the compounds as evidence has been emerging in recent years regarding the therapeutic potential of psychedelic medicines. 

In particular, substances such as psilocybin and MDMA have been granted Breakthrough Therapy designation by the United States Food and Drug Administration (FDA) for conditions such as treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD).

Implementation of the amendments was confirmed after a 60-day consultation with healthcare professionals, organisations, researchers, academics, licensed dealers and the general public regarding the government’s intent to restore access to these restricted drugs. It has stated it received written feedback from 392 respondents. 

In the publication, the government says: “Overall, nearly all comments were supportive of the proposed regulatory amendments and/or increasing access to psychedelic substances more broadly. 

“The Department received very little opposition to the proposal, making up less than 2 per cent of all responses.”

Kelsey Ramsden, CEO of Vancouver-based MINDCURE, which is carrying out a first-of-its-kind study investigating MDMA-assisted psychotherapy for treating female Hypoactive Sexual Desire Disorder (HSDD), commented: “For emergency patients, this news means gaining access to life changing mental health care. This can be truly transformative for both the patient in their ability to live out their last days, as well as for their families and supporting communities.

See also  Research to investigate MDMA psychotherapy for female sexual disorder

“For MINDCURE, it confirms that leaders in Federal Health Policy acknowledge the promise of psychedelics. Assuming they will stay strong with implementing the emergency-only approvals, it confirms that we will not be going down the slippery slope of recreational use that cannabis saw, which resulted (for cannabis) in a lack of funding for true drug development and clinical research. 

“The balance between keeping clinical trials as the only regulatory route to market with a very small number of emergency access cases will be pivotal. I am confident that emergency-only will be maintained.

“Health Canada is open to psychedelics, and they want to see the clinical research proof come out to support widespread use. This means those of us conducting clinical research programmes are in the best position to be able to develop drugs that will change the paradigm of care in mental health.”

“Reversing the prohibition on accessing restricted drugs does not guarantee that requests for psychedelic restricted medicines will be authorised through the Special Access Programme,” commented Dr Evan Wood, CMO at Vancouver-based Numinus Wellness, which is hosting an extension of the MAPS-sponsored trial exploring MDMA-assisted therapy for PTSD.

“All requests will continue to be assessed on a case-by-case basis, taking into consideration the level of evidence regarding the safety and efficacy for the proposed use, as well as the patient’s condition and their clinical status.

See also  Extension of MDMA PTSD study to be hosted by Numinus

“Numinus will be working closely with Health Canada to understand the regulatory change and, where appropriate, support appropriate SAP requests. We are currently operating clinics with appropriately established psychedelic-assisted psychotherapy infrastructure and trained therapists and physicians to support patients with special access requests. 

“We are closely following updates from Health Canada on the SAP amendment and will follow their guidance and regulations consistent with the updated SAP Guidance document. We are well positioned to support our affiliated physicians and clients with SAP requests.

“Numinus believes this is only the beginning of greater change to come, it signifies an important step towards creating expanded safe access to treatment and care in the mental health sector through psychedelic-assisted psychotherapy. 

“Greater accessibility is something Numinus has stood behind since we started and will continue to support and advocate for.”

See also  Canadian psychedelics firm Numinus in pole position to attract investors

Dr Douglas Cook, CMO at Dimensions and chairperson and head of neurosurgery at Queen’s University, Kingston, Ontario, stated: “Patients in urgent and life threatening circumstances who have failed to improve with traditional therapies will have the SAP as an option to access psychedelic therapies that are showing promise in palliative care and in a number of mental health indications.”

Dimensions carries out psychedelic-assisted therapy programmes supported by neuroscientific research.

“The application will be submitted on behalf of the patient by a physician who will summarise the need and justification for treatment. The turn around time is rapid and once approved a patient will be able to source medicine from a licensed dealer. This process is a welcome option to help those in dire need of options for otherwise unresponsive diseases.

“Dimensions firmly believes that psychedelics have the potential to alleviate suffering for a number of mental health and medical indications. We further believe that psychedelic therapy is optimally delivered in a safe, comfortable setting with trained professionals to set intentions of therapy, guide the experience and follow up after. 

“To this end, Dimensions is looking forward to the opportunity to host individuals who have obtained psychedelics through the SAP in retreat and ceremony. Our goal will be to provide groups of patients with common diagnoses and intentions in retreat. Furthermore, our medical team will be able to assist patients, in partnership with their primary caregivers, in obtaining SAP approval.

“Dimensions lauds Health Canada for opening the SAP program for psychedelic therapies. This decision recognises the growing evidence base supporting the efficacy of psychedelics in end-of-life care and for several mental health and medical indications.

“Moving forward Dimensions will continue to support rigorous science and strong regulatory oversight in completing clinical trials and preclinical studies to further define the mechanisms, safety and efficacy of psychedelics for various indications.”

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Policy

Now is the time for psychedelic access, says campaigner

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Now is the time for psychedelic access, says campaigner

Activists in Oakland recently filed a ballot put forward by Dave Hodges seeking to legalise safe and legal access to psychedelics for therapeutic uses. 

In the face of critics, Hodges has said now is the time for safe access to psychedelics.

The Psychedelic Wellness & Healing Initiative would enable the sale, possession and use of psychedelics for therapeutic purposes if passed. Psychedelics that would be allowed under the ballot include Psilocybin, MDMA, DMT, and Mescaline.

If passed, the initiative would give doctors and mental health specialists the right to recommend psychedelics to ease the debilitating symptoms of a range of problems, including obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), depression, anxiety, addiction, suicidality and traumatic brain injury (TBI), among others.

Hodges has said: “Now is the time for safe, controlled medical access for patients in need. The way to solve the problem is not by continuing to ignore it.” 

Hodges’ solution is to create a structure for use that includes proper dosages and access to experts who can help users benefit from appropriate treatment.

The updated initiative language emphasises safety, and gives doctors and mental health specialists the right to recommend psychedelics to ease the debilitating symptoms of a range of conditions.

Research by the University of Michigan and Columbia University shows non-LSD hallucinogenic use on the rise and Hodges has stated that increase means that the initiative providing guidelines for use is needed more than ever. 

Hodges said he hopes Californians will read the initiative, share their thoughts about it over the holiday week and offer feedback via the initiative website, PW4CA.com, by 27 November, 2023, the deadline for modifications.

“Now is the time to provide medical and therapeutic access to psychedelics,” Hodges said. “The way to do this is through the initiative.”

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Policy

Transform Drugs releases groundbreaking book: How to regulate psychedelics

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Transform Drugs releases book: How to regulate psychedelics

UK charity Transform Drug Policy Foundation has published a new book ‘How to Regulate Psychedelics: A Practical Guide’ that sets out how psychedelics can be legalised and regulated for non-medical adult use.

While an increasing amount of research is pointing to the potentially beneficial effects of psychedelic treatment on mental health conditions, many people across the globe are using psychedelics outside of the clinical setting.

The book includes a set of proposals for post-prohibition policies, covering psychedelics including psilocybin, LSD, DMT and Mescaline. 

Previously, Transform’s guides on regulating stimulants and cannabis have been used to advise governments around the world on drug policy. This book seeks to inform the debates on psychedelic drug reforms taking place across the world.

Co-author and Public Affairs and Policy Manager at Transform Drug Policy Foundation, Ester Kincová, stated: “Despite psychedelic drugs being illegal, their non-medical use within society has been steadily increasing. 

“Punitive enforcement has not decreased use or eliminated supply, but it has made use more unsafe. 

“Legalising and regulating psychedelics is a pragmatic move to reduce harm. This is no longer a theoretical debate, states in the US are already recognising the need and  making moves to regulate for non-medical adult use.”

Scientific Chair of Drug Science, Professor David Nutt, added: “Once again Transform have come up with a well thought out and practical plan for the regulation of another group of currently illegal drugs – in this case psychedelics. 

“Their ideas would be both easy to implement and to engage with and will, if adopted, radically enhance the safe use of these remarkable agents.”

Proposals for regulation

The book includes a four-tiered regulation model “that attempts to manage the variety of psychedelic preparations and the different ways in which they are used”.

These include:

  • Private use, home cultivation, foraging and not-for-profit sharing.
  • Membership-based non-for-profit associations for plant-based products.
  • Licensed production and retail adaptable to different products and environments
  • Regulated commercial guided or supervised use

Additionally, a decriminalisation model is proposed which suggests that possession for personal use should no longer be an offence of any kind or be subject to any sanctions; Drugs for personal use should not be confiscated; cultivation of small amounts of plant-based drugs for personal use should be decriminalised, among other suggestions.

The book also includes topics such as embedding social justice, equity and human rights into policy design, how to think about psychedelics regulation, why regulate psychedelics and why now, and psychedelics and the UN drug treaties.

To read the book, please visit transformdrugs.org/.

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Policy

Oakland ballot seeks to legalise medical psychedelics

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Oakland ballot seeks to legalise medical psychedelics

Activists in Oakland have filed a ballot that seeks to legalise safe and legal access to psychedelics for therapeutic uses. 

The Psychedelic Wellness & Healing Initiative would enable the sale, possession and use of psychedelics for therapeutic purposes if passed. Psychedelics that would be allowed under the ballot include Psilocybin, MDMA, DMT, and Mescaline.

If passed, the initiative would give doctors and mental health specialists the right to recommend psychedelics to ease the debilitating symptoms of a range of problems, including obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), depression, anxiety, addiction, suicidality and traumatic brain injury (TBI), among others.

See also  Australia reschedules psilocybin and MDMA

Additionally, it would create a statewide framework for regulating the possession, use, cultivation and production of substances for medical and therapeutic use.

The initiative has been introduced by proponent and founder of the Oakland-based Church of Ambrosia, Dave Hodges, to the California Attorney General’s office for the 2024 ballot, and will need 546,651 valid signatures to qualify.

See also  CDPRG discusses the UK's Reschedule Psilocybin campaign

The filing follows California Governor Gavin Newsom’s recent veto of Senate Bill 58, the bill that sought to decriminalise the use of certain psychedelic drugs. 

Hodges emphasised that SB58 would have been a step forward, but that it had major flaws concerning its lack of provisions to ensure access, public safety and quality control. That veto, Hodges said, compelled him to move quickly on the initiative filing.

When the California Attorney General certifies the initiative for circulation, backers will have about four and a half months to gather the required signatures for ballot placement. 

Signature collecting will begin in early December.

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