Today, we’re looking at developments from the European Union and changes to the laws governing the telehealth prescribing of ketamine.

But first, a message from our friends at Beckley Retreats:

Beckley Retreats has assembled a world-class team of facilitators with decades of experience in both psychotherapy and indigenous wisdom traditions.

Together they’ve designed an 11-week program that includes a weeklong psilocybin retreat and a comprehensive preparation and integration period on either end of the retreat.

Beckley Retreats Spring & Summer retreats in Jamaica and the Netherlands have been announced and are filling up fast!

Beckley Retreats Schedule

To learn more about the science-backed power of psilocybin ceremonies in a supportive retreat setting, please join an upcoming live group Q&A or book a discovery call with the team!

Book a Discovery Call

Brave Old World: Psychedelic Policy Momentum in Europe

The last four months have seen several significant psychedelic policy reform efforts transpire.

First, we had Colorado voters’ approval of the Natural Medicines Health Act on the November ballot. The NMHA decriminalized several psychedelics immediately and mandated the state Department of Regulatory Agencies establish a framework for a legalized psychedelic therapy system, similar to Oregon, over the next two years.

In January, Oregon’s psilocybin services initiative went into effect as registration was opened to applicants for service centers, manufacturers, and facilitators.

In February, perhaps the most significant psychedelic policy reform to date, Australia’s Therapeutics Goods Administration announced that MDMA and psilocybin would be rescheduled in July, thereby making them available as licensed medicines for prescription by authorized prescribe prescribers.

But what about the Old World?

A few weeks ago, a headline from Politico caught my attention: Europe needs faster action on magic mushroom, MDMA therapies, urge MEPs.

Last month, the highly influential medical journal, The Lancet, published The therapeutic potential of psychedelics: the European regulatory perspective.

And this week, the EMCDDA — European Monitoring Centre for Drugs and Drug Addiction organized a “Technical meeting on the medical use of psychedelic substances: opportunities and concerns” with about 20 European psychedelic scientific and policy experts.

The significance of the event was captured by Tadeusz Horwat— the founder of the Psychedelic Access and Research Europe Alliance (PAREA), a policy and advocacy group that is educating and informing European politicians and institutions on the promise and nuances of psychedelic research and therapy on LinkedIn:

"It is a game changer to have this meeting organized by the EU body (which next year will expand its mandate significantly, ceasing to be just a monitoring centre and becoming the EU Drug Agency). And it is a great satisfaction for PAREA– last year we engaged with the EMCDDA leadership, inviting the agency to prioritize the area of medical use of psychedelics. Earlier this month, the EMCDDA was also asked to play a more active role by a cross-party coalition of Members of the European Parliament (see more here:https://lnkd.in/dq_g8_ma). I’m terribly pleased that the EMCDDA is taking the lead since they have a brilliant pool of in-house experts: the field is in good hands, the EU machinery is set in motion and I'm sure it will eventually result in robust and people-centred regulations."

Also in February, several Members of the European Parliament (MEPs) sent official letters to the European Medicines Agency (EMA) and the EMCDDA asking these two agencies to work together to develop strategies and technical reports that would bring stakeholders around Europe to prepare for the Psychedelic Medicine Paradigm.

Ultimately, the sense from speaking with Horwat and the recent developments is that European institutions are taking psychedelic medicine seriously, and they are coming to understand both the promise and the challenges of psychedelics as licensed therapies and the need for far more infrastructure than most new drugs that come on to the market.

And with the European Union being a global regulator, the policy, guidelines, and infrastructure European institutions develop could become an international benchmark.

Subscribe now

DEA’s New Rules Impact Ketamine Telehealth

As we’ve covered previously, a federal law called the Ryan Haight Act (RHA) requires doctors to meet with their patients in person before prescribing controlled substances. It was passed in 2008 when telehealth was just getting started.

But, during the COVID-19 pandemic, the Federal Public Health Emergency put the RHA’s requirements on hold, allowing a slew of telehealth Ketamine prescribing companies to emerge.

With the end of the Public Health Emergency coming to an end, so will the waiver that allowed this practice.

But last week, the DEA proposed permanent rules for Telemedicine prescribing of scheduled substances that will not kill the DTC ketamine market but make the business model more challenging.

The reinstated RHA will still require an in-person consultation unless patients have already seen another doctor in person who referred them to the telehealth company. Patients with a telehealth relationship established during the pandemic might also be exempt from the in-person consultation requirement.

The most significant disruption to this model will be that providers can only prescribe up to a 30-day supply through telehealth. If they don’t evaluate patients in person within 30 days of the first prescription, they can’t prescribe any more through telehealth.

The DEA is taking public comments for the next 30 days, and it’s presumed that if these proposed rules hold up, they are not restrictive enough to kill the Direct to Consumer ketamine model but merely modify it, perhaps for the better.

Subscribe now

Further Reading

Beckley Psytech receives FDA Investigational New Drug (IND) approval for Phase IIb study

Psychedelic Retreat Operator Synthesis Apparently Dissolves

A Tale of Two Strategies: Does COMPASS Have the Right One?

Breakthrough study discovers that psychedelics breach our neurons

Anorexia is the deadliest psychiatric disorder. Could psychedelics help?

Subscribe now

That’s it for this week. Thanks for reading!

Zach

The Trip Report by Beckley Waves

Psychedelic Policy in Europe & A New Era for…