Psychedelic Drug Policy Reform in 2021

A Year in Review

Part of our Psychedelics 2021: A Year in Review Series


While this Review focuses on 2021, it’s difficult to contextualise the levels of psychedelic drug policy reform witnessed this year without appreciating the gravitas of events in late 2020. 2020 was a groundbreaking year for psychedelics decriminalisation and legalisation efforts, with the U.S. leading the pack with significant activity at both the local and state level. The twin successes of Oregon’s Measure 109 and Washington, D.C.’s Initiative 81, to create legal access to psilocybin-assisted therapy and to decriminalise psychedelics, respectively, propelled psychedelics decriminalisation and legalisation efforts to the mainstream.

Here at Psilocybin Alpha, our readership increased in quantity and diversity almost overnight following these successes at the ballot box. In response to these initiatives we were now being contacted by—and seeing subscribers from—journalists of all stripes; entrepreneurs looking to launch biotechs or retreats; investment banks looking to keep tabs on the emerging industry; therapists hoping to offer this new modality as part of their practice; and more.

We also observed psychedelic companies, and their executives, scramble to find a line and toe it. Many chose to publicly celebrate Oregon’s Measure 109, with Field Trip’ Ronan Levy exclaiming, “what an incredible accomplishment,” when discussing the results with Psilocybin Alpha. Other executives have been more hesitant to condone the Measure, while others still have been accused of drumming up opposition to the measure.

As individuals and companies try to find their feet in this rapidly changing legal and public opinion landscape, the pace of drug policy reform efforts has not slowed in 2021. The aforementioned Initiative 81 came into effect in D.C., with psychedelics de facto decriminalised, and Oregon Psilocybin Services, housed within the Oregon Health Authority, is making progress toward implementing Measure 109 through the two-year development process that ends December 31, 2022.

Beyond progress updates on these two landmark initiatives, 2021 saw a flurry of policy reform efforts across the world. As advocates and decision-makers pressed for changes to antiquated drug policies, ending the prohibition and criminalization of psychedelic drug use appeared in political agendas all over the world. 

Here are some of 2021’s most significant developments from the U.S., Canada, UK and Australia.

United States

This year we have seen an explosion of psychedelic drug policy reform initiatives in the U.S. that follow a variety of templates: some call for decriminalisation of psychedelics in some manner, others for legalisation. Others, still, call for state-funded research into psychedelic-assisted therapies or other specific actions.

Perhaps the best way of conveying the sheer volume and diversity of efforts underway is to review our Psychedelic Legalization & Decriminalization Tracker, produced in collaboration with Calyx Law and Emerge Law. A majority of the efforts visualised in the tracker were initiated in 2021.

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Texas Bill Mandates State Research Into Psychedelics

While liberal states and cities have no doubt led the charge, as was the case with marijuana, some initiatives have a surprisingly bipartisan flavour.

Take Texas, for example. Former GOP Governor Rick Perry joined Democrat Alex Dominguez to back House Bill 1802, which was enacted into law on June 18th, came into effect on September 1st and expires in two years.

HB 1802 requires the Department of State Health Services to evaluate the therapeutic efficacy of psychedelics including MDMA and psilocybin for the treatment of depression, anxiety, PTSD, migraine and other conditions. The report, which is to be submitted by December 1, 2022, is to involve a clinical trial of psilocybin for PTSD in veterans, with $1.4m in funding allocated.

In November, Perry appeared on stage alongside Tim Ferriss and Rick Doblin at a gala in support of Veterans Exploring Treatment Solutions (VETS), a non-profit dedicated to assisting U.S. veterans seeking psychedelic-assisted therapies. This appearance drives home just how important the narrative surrounding veterans is to some corners of the psychedelic renaissance, and has certainly been central to building a bipartisan agenda around their acceptance.

We highlight Texas’ HB1802, and Rick Perry’s involvement, for two reasons. Firstly, and as aforementioned, because it succeeded in a decidedly Republican state, and was openly supported by prominent Republicans like Rick Perry. It’s also forming a model for other Republican states, such as Florida, where politicians have now introduced similar bills (SB348 and HB193). Secondly, it’s not a decriminalisation or legalisation initiative, but rather an effort to mandate state governments to support research into psychedelic therapies.

In response to the success of the Bill, the Center for Psychedelic Research and Therapy was launched at the University of Texas at Austin’s Dell Medical School. We spoke to the Co-Director, Dr. Greg Fonzo, who explained that the centre will “advance the application of psychedelics for the treatment of mental health disorders through impactful clinical research.”

Emphasising the centre’s focus on veterans, Fonzo explained that the first of its kind in Texas facility will aim to “improve the health of those suffering from severe depression, anxiety and PTSD through psychedelic-assisted psychotherapy and research focused heavily on military veterans and adults affected by early childhood trauma.”

Why might people feel the need to mandate this research at the State level? Well, Alexandria Ocasio-Cortez’s attempt to lift barriers on federal research into psychedelics via an amendment was defeated for a second time this year in a 285-140 vote. But, it’s important to compare this margin of defeat to when the amendment was put to vote in 2019, when it was defeated 331-91. “I am undeterred,” explained Ocasio-Cortez, “I’ll keep bringing it up until the times catch up.”

The Verdict: Texas House Bill 1802, which requires the State’s health agency to evaluate the therapeutic efficacy of psychedelics, is remarkable for a number of reasons, not least its success in a firmly Republican state. It also propelled the launch of a new Center for Psychedelic Research and Therapy at the University of Texas at Austin, and has provided a cookie cutter template for like-minded states such as Florida.

California Moves Closer Towards Decriminalisation

The most populous state in the U.S. captured a great deal of attention with the introduction of Senate Bill 519 (SB 519) which would decriminalise the possession of some psychedelic drugs in the golden state.

Notably, and importantly, the bill explicitly excludes peyote, and as such both peyote and mescaline will remain illegal in the state. The reasoning for this exclusion is to ensure that the endangered plant remains available for use in Native American spiritual practices.

We followed the early passage of SB 519 closely as it passed a number of key California State Assembly Committees, including the Committee on Public Safety where it passed by a 5-3 vote. Senator Scott Wiener, who authored the Bill, claimed that psychedelics are “fixing people’s brains,” and was supported by witnesses including veterans group Heroic Hearts and MAPS’ Ismail Ali.

The Bill didn’t proceed unscathed, however, and was watered-down by a number of amendments conceded by Wiener. Perhaps most notably, a clause that mandated the expungement of historic convictions related to the possession of psychedelics was removed from the Bill. Ketamine was also removed from the Bill, at the request of the Committee on Public Safety.

Then, in late August Senator Wiener announced that the Bill had been put on pause. The Bill is still “alive & well,” the Senator explained on Twitter, but it has been paused until 2022. The Senator explained that, “over the next year [a] coalition of veterans, parents, healthcare professionals and others will continue to work hard to earn the support of Assembly Members.”

The Verdict: SB 519, which would decriminalise many psychedelics in California, drew a great deal of attention this year. While the Bill has now been put on pause, the fact that it passed a number of key Assembly Committees is a feat in itself, and many will be closely watching SB 519 as it is reintroduced for consideration in 2022.

A Wealth of Other Initiatives

Events in Texas and California are but two examples. Over the past year, U.S. states and municipalities have proposed, introduced, and voted on a range of laws governing psychedelics. Decriminalisation and legalisation initiatives were undertaken across 20 states, many of which prioritised the need to reduce or eliminate criminal penalties for psychedelic possession and increase access for therapeutics purposes. 

Visit our Psychedelics Legalisation & Decriminalisation Tracker to stay up-to-date with the latest developments on this front, which include:

  • Connecticut SB 1083 (Working Group)
  • Florida SB 348 and HB 193
  • Texas HB 1082
  • Hawaii SB 738 and House Concurrent Resolution 174
  • Iowa HF 459, HF 636, HF 480
  • Kansas HB 2288
  • Maine SP 496 and HP 713 (rejected)
  • Massachusetts
  • Michigan Policy Directive 2021-06 (Ann Arbour), SB The 631, and Proposal E (Detroit)
  • Missouri HB 1176
  • New Jersey SB S3256
  • New York Bill No. A7928
  • Oregon Measure 110
  • Pennsylvania HB 1959
  • Rhode Island SB 604
  • Vermont House Bill H.309 & H.422
  • Virginia HJ530
  • Washington SB 5476 (into effect) and Resolution 320321 (Seattle)
  • West Virginia HB 3113

Beyond state-level efforts, many reform advocates found success at the local level. According to Emerge Law’s Sean Clancy, “targeted local government measures with smaller footprints achieved more political success” in 2021.

The Verdict: What a year it’s been for psychedelic drug policy reform in the U.S. On the whole, we agree with Emerge Law’s Sean Clancy, who told Psilocybin Alpha: “2021 revealed mixed success among a small handful of state lawmakers who aimed at psychedelic drug decriminalization or legalization – in contrast, targeted local government measures with smaller footprints achieved more political success.”


Health Canada Grants Further Section 56 Exemptions

In 2021, Health Canada continued to affirm its commitment to providing psilocybin access exemptions to patients in need. Most recently, Canada’s new Minister of Health granted his first three exemptions for psilocybin under Section 56. This (admittedly modest) batch of exemptions was particularly important, not just because it signalled the incoming Health Minister’s openness to the process, because they were granted to patients who are not palliative, or in receipt of a terminal diagnosis.

We spoke to TheraPsil, a Canadian non-profit that works closely with physicians and patients to advocate for compassionate access to psilocybin. To date, the organisation has helped 47 individuals access psilocybin for a number of therapeutic needs via the Section 56 exemption route. 

Spencer Hawkswell, TheraPsil’s CEO, told us that “2021 was a year for the Canadian history books.” According to Hawkswell, 81 Canadians were granted access to legal psilocybin therapy in 2021. 62 of these were patients (47 of which were supported by TheraPsil) and 19 were health care practitioners (all of which were supported by TheraPsil).

Despite these successes, Hawkswell was keen to note that these cohorts represent a relatively small number of those who might benefit from psilocybin therapy. “While the successes of the past year are certainly to be celebrated, so many Canadians still wait months for their exemptions and all 81 Canadians who have/had exemptions were forced to find their psilocybin mushrooms underground/illicitly,” he explained.

The Verdict: These case-by-case exemptions are certainly important for the individuals that received them, but long wait times and the relatively small number of recipients indicate the insufficiency of such a piecemeal process. Nonetheless, the willingness of Health Canada to grant such exemptions, including the country’s new Minister of Health, demonstrates a pragmatic stance by the regulator, which will hopefully be reflected in further reforms in the coming months and years.

Health Canada Amends Special Access Program to Allow Consideration of Psychedelics and Other Restricted Drugs

Just days after we spoke with TheraPsil’s CEO, news broke that Health Canada will amend its Special Access Program to allow for drugs like MDMA and psilocybin to be considered.

We covered this news in late 2020, when Health Canada first signalled its intent to make such an amendment. Just as 2021 drew to a close, and just over a year after our first reporting on the matter, Numinus broke the news that the amendments will come into effect on January 5th, 2022.

In 2013, an amendment to the Food and Drug Regulations (section C.08.010) saw restricted drugs—including psychedelics like MDMA and Psilocybin—explicitly excluded from the SAP. Under this amendment, clinical trials were the only route through which patients could access these drugs. The new amendment restores potential access to restricted drugs. This could afford Canadians access to potentially life-saving medications and therapies prior to their formal approval and routine provision. 

Once the relevant subsection is repealed on January 5th, restricted drugs will be treated in the same manner as all other controlled substances when considered under the SAP, that is: practitioners can request these drugs for patients with serious or life-threatening conditions where other therapies have failed, aren’t suitable, or aren’t available in Canada.

This reversal does not guarantee that restricted drugs will be approved via a SAP application, but rather that they will be treated in the same manner as all other controlled substances.

The Verdict: This amendment represents the latest in a string of progressive moves by Health Canada, and will allow psychedelics to be considered for access via the Special Access Program (SAP). However, much will remain open to debate, such as the point at which other therapies are deemed to have ‘failed’ or to not be ‘suitable,’ which are prerequisites for an SAP application.

United Kingdom

Boris Johnson Considers Rescheduling Psilocybin

In October 2021 news broke that UK Prime Minister Boris Johnson is set to “consider calls to legalise magic mushroom drug psilocybin” (BBC). The BBC headline, which featured the word ‘legalise,’ overstates the proposed change, which is a rescheduling rather than legalisation.

During Prime Minister’s Questions (a weekly fixture in UK Parliament where MPs pitch questions to the PM), conservative MP Crispin Blunt urged Johnson to reschedule psilocybin to enable further research into the drug’s therapeutic potential.

In response to the question, the Prime Minister said that he would get back to Blunt “as soon as possible.” His full response to Blunt was as follows:

“I can say that we will consider the Advisory Council on the Misuse of Drugs recent advice on reducing barriers to research with controlled drugs such as the one he describes, and we will be getting back to him as soon as possible.” (watch here).

Speaking to the Express in September, Crispin Blunt claimed that the Prime Minister had assured him in May that psilocybin would be rescheduled. However, no such action has yet occurred.

Regardless, the fact that these debates are playing out on the floor of the UK Parliament is remarkable, and promising. But, the Conservative Drug Policy Reform Group (CDPRG) warns that continued engagement with Ministers is necessary in order to secure the rescheduling. Speaking to Psilocybin Alpha, CDPRG’s Timmy Davis said:

“It is of course exciting to hear the Prime Minister Boris Johnson saying in the House of Commons that he will consider the evidence for the rescheduling of psilocybin as to facilitate medical research in the UK, but in the context of the Home Office’s position regarding psilocybin we know that this must be presaged by continued engagement with the realities of the regulations by Ministers to get this right.”

The Verdict: There’s plenty of misplaced hype here, which isn’t helped by shoddy editorial standards at the BBC. What is being proposed is a rescheduling, not legalisation, of psilocybin in the UK, which would reduce barriers to research. Action by the Home Office to enact such a rescheduling is long overdue, according to insiders who claim the Prime Minister approved the action in principle earlier this year.

A Post-Brexit Focus on R&D Spending and Streamlining May Favour Psychedelics Companies

Tom McDonald, CEO of London-based psychedelics company Clerkenwell Health, told Psilocybin Alpha that while the aforementioned movement to reschedule psilocybin “is gaining traction within civil society”, “the real action is within the regulatory bodies of the state.”

Alluding to broader strategic initiatives underway in post-Brexit Britain, McDonald explained that the UK government has embarked on “the fastest increase in R&D spending ever.”

“The clinical trial system as well as the broader innovation system is being transformed, as is the regulator, to become an enabler of innovation,” McDonald noted. “These changes create an increasingly frictionless pathway that will allow developers of psychedelic drugs to undertake speedier and more cost-effective research processes in the UK.”

This is certainly evidenced in recent actions by regulators such as the Medicines and Healthcare products Regulatory Agency’s (MHRA), which issued new guidance on the use of real-world data in clinical trials, and the National Institute for Health and Care Excellence (NICE) which issued its first update to guidelines on the treatment of depression for over a decade this year.

In concrete terms, we have seen these innovations in UK drug development regulations manifest in a fast-track designation for Small Pharma’s DMT therapy candidate, which is discussed later in our Research and Clinical Trials section.

The Verdict: As the UK seeks to find its edge in a post-Brexit world, nurturing its biotech industry has emerged as a clear focus. This bodes well for psychedelic researchers and companies, who may benefit from streamlined drug development routes such as the Innovative Licensing and Access Pathway (ILAP) and pragmatic approaches to research and clinical trials such as the employment of real-world data.


Australian Regulators Reject Psilocybin and MDMA Rescheduling

In late 2020, a proposal was submitted to the Australian Therapeutic Goods Administration (TGA), the regulatory body in charge of the country’s drug scheduling, to reclassify psilocybin and MDMA fromprohibited substances tocontrolledmedicines. Following two rounds of consideration, the TGA ultimately rejected the rescheduling efforts in mid-December, citing the emergent nature of evidence and explaining that “the therapeutic value… has not been established.”

The Verdict: We would have been surprised if the TGA had taken the decision to reschedule psilocybin and MDMA at this stage, which would be out of kilter with other similar countries. However, this has put the issue firmly on the national agenda in the land down under.

Federal Government Carves Out $15m For Psychedelics Research

It’s not all bad news for psychedelics advocates in Oz, though. Just weeks after the proposal was initially rejected in Spring 2021, the federal government announced a $15m grant program to support research into psychedelics, including MDMA-assisted psychotherapy.

The Verdict: This capital injection into psychedelic research was welcomed by researchers. Beyond its cash value, it sends a strong message that Australia is open for psychedelics research.

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