New Guide On ‘How To Regulate Psychedelics’ Lays Out Four-Tiered Model Focused Specifically On Nonmedical Use

A new guidebook examines possible avenues to regulating the nonmedical use of psychedelics, including psilocybin, LSD, DMT and mescaline, encouraging policymakers to take a thoughtful, evidence-based approach to regulation—one that authors say is too often overlooked amid the “madness” of the global drug war.

“Regulating risky products and behaviors is just one of those things that governments around the world have been doing for generations, for centuries. And in many ways, they’re very good at it,” said Steve Rolles, senior policy analyst at the UK-based Transform Drug Policy Foundation, which published the new guide on Tuesday. Governments already weigh risks and benefits of all sorts of things, he noted, including pharmaceuticals, dangerous sports, consumer electronics, building materials and more.

“What Transform’s done with this book, and a lot of our work historically, is just apply that regulatory logic and that regulatory scholarship to a set of products and behaviors that have historically existed outside of regulatory thinking because of the madness of the war on drugs,” Rolles explained. “So it’s basically just applying social policy thinking and logic to this novel set of drugs and psychedelics.”

Most public policy discourse on psychedelics these days, Rolles noted, focuses on their medical use to treat conditions such as PTSD, depression and substance use disorders. But nonmedical use—including for recreation, religion and personal development—”has not received a great deal of attention,” he said, “and that’s one of the reasons we thought this book was needed.”

The focus on medical and therapeutic uses for psychedelics has driven public debate and fueled significant research, noted Ester Kincova, Transform’s public affairs and policy manager, but it also risks overlooking opportunities for reform around other types of use.

“There is a risk that this could lead to a space in which legitimate access to psychedelics is narrowly confined to the medical space,” she said. “People who are using psychedelics for other reasons may end up being left out.”

The 124-page document, titled “How to Regulate Psychedelics: A Practical Guide,” details four main tiers of psychedelics regulation. It advises against treating drugs like any other consumer product, for example by limiting advertising and establishing guidelines for who can supervise facilitated use. Transform has previously published similar guides around cannabis, cocaine, MDMA and amphetamines.

The four tiers of proposed psychedelics regulation begin with what’s essentially noncommercial legalization, allowing for home cultivation, foraging and not-for-profit sharing. It echoes the “grow, gather, gift” model advocated by many local psychedelics reformers in the U.S.

As the tiers progress, they involve more interventions by regulators, such as through licensing and antimonopoly protections.

The second tier is modeled after membership-based social clubs, nonprofit entities that provide regulated drug access to a limited number of members.

“We propose this model based on the cannabis social clubs that have been pioneered in Spain,” Kincova explained. “Although this is a relatively new and evolving model, there are several examples of established practices in Spain, Uruguay, Malta and other jurisdictions.” A centralized regulatory authority would license the clubs, which could potentially produce or import substances for distribution.

The third and fourth tiers of regulation in Transform’s new guidebook deal with commercial drug markets. At the third level are licensed production and retail businesses, which would be regulated in ways meant to promote public safety and reduce drugs’ appeal to children. Advertising would be mostly forbidden, with only safety and potency information on product packaging, and infused edibles designed to look like candy or other appealing treats would be forbidden.

“Generally we don’t think there should be any marketing or branding,” Rolles said. “Our things was, if you start to put any design elements on it, you’re going to influence people’s experience… So let’s just keep it as simple and functional as possible.”

As for infused edibles, he called them “a terrible idea,” noting the confusion caused in some markets by cannabis edibles that resemble everyday consumer snacks. “If you really like sweets,” Rolles said, “just buy some fucking Haribo.”

Rolles likened the third tier to more tightly regulated retail marijuana markets, such as Quebec’s state-run stores.

The fourth regulator tier deals with facilitated use of psychedelics, an approach used in some therapeutic systems, such as in Oregon. Transform says such activities require establishing an institutional regulatory framework.

“We think there is an issue of a duty of care for people who are having guided experiences that really requires properly trained and licensed practitioners administering and supervising this kind of use,” Rolles said, noting that facilitated use can raise vulnerability and exploitation concerns or even lead to health emergencies. Steps also need to be taken, he said, to curb false or misleading medical claims.

Rolles said he believes the four tiers can “operate happily in parallel” to accommodate a variety of circumstances and cultural practices. Regulators might permit home cultivation or foraging of psilocybin mushrooms, for example, while also regulating facilitated use of LSD or DMT at commercial facilities.

In addition to setting rules, Transform says regulators must monitor markets as they develop and track social indicators of health and drug use, both before and after any policy change.

One theme the Transform authors touched on repeatedly at Tuesday’s presentation was the role of commercial businesses in the psychedelic space. While the proposed regulatory models do contemplate for-profit entities, they also recommend noteworthy limits, including on branding and advertising, product packaging and market share.

“A vast amount of speculative investor capital is already flowing into the psychedelics market,” Kincova said, “and therefore any policy design must be alive to this risk and ensure any future regulatory frameworks for psychedelics are designed to prevent the emergence of these monopolies.”

Such steps might include limiting the number of production or retail licenses any one entity can control, as some legal cannabis markets already do, or establishing alternative, noncommercial models.

Embedded in any regulatory model should be strong equity and justice provisions, the Transform guide says.

“One of the key elements of any new emerging market is that it’s an opportunity to be ambitious about how you set it out,” Kincova said on Tuesday. “We believe equity programs should be available across all spectrums of these models.”

Equity programs should include removal of financial barriers for equity applicants, prioritizing them in the licensing process and providing them wraparound services such as legal, accounting and workforce training assistance. “All of these are extremely vital,” Kincova said, “but they also must be underpinned by continuous review of these programs to ensure that they are achieving their stated outcomes.”

On the topic of international drug treaties, which some observers have raised as potential obstacles to countries changing their domestic approach to regulating substances such as marijuana, Rolles said the compacts wouldn’t stand in the way of regulated markets for plant-based psychedelics, although there may be issues around synthetics such as LSD.

Transform’s new guidebook is available in print and as a free PDF at the organization’s website.

Rolles said the document is targeted at policymakers but will likely be of interest to anyone interested in what comes after the drug war.

“It’s not enough just to say the war on drugs is rubbish,” he said. “You can’t just get rid of it. You have to have something to replace it, and it has to be something credible, coherent, you know, that fits in with policymakers’ value systems and something that they can sell to their citizens and their electorate.”

Transform’s guidance comes less than a month after a coalition of international advocates called to end prohibition and instead legalize and regulate all drugs. That report, produced in partnership with the National Coalition for Drug Legalization (NCDL), Students for Sensible Drug Policy (SSDP) and Law Enforcement Action Partnership (LEAP), argued that “a legal and regulated market for drugs is likely to produce less dangerous outcomes for both society at large and the individuals who choose to consume drugs.”

Another report published last month by the International Coalition on Drug Policy Reform and Environmental Justice attacked the global drug war from an entirely different perspective, arguing that prohibition has ravaged critical ecosystems, undermined efforts to combat climate change and caught up vulnerable populations in a cycle of poverty and prosecution.

All three documents come amid a changing global mindset around substances. A United Nations agency report in September highlighted human rights concerns raised by the war on drugs, urging member states to shift from punitive drug-control policies to an approach rooted in public health. Dealing with drugs as a criminal problem, it said, is causing further harm.

UN experts and global leaders echoed those points in June as part of World Drug Day.

In 2019, the UN Chief Executives Board, which represents 31 UN agencies including the UN Office on Drugs and Crime (UNODC), adopted a position stipulating that member states should pursue science-based, health-oriented drug policies “including the decriminalization of drug possession for personal use.”

Latin American and Caribbean countries also recently agreed to rethink the drug war. Under the current, punitive approach, “the expected results have not been obtained when combating the world drug problem, leaving in many cases the underlying problems to be solved and exploiting and exacerbating vulnerabilities of our territories and societies,” according to a joint statement issued by 19 nations.

Nevertheless, a recent report by the organization Harm Reduction International found that wealthy countries gave nearly $1 billion to further the global drug war.

Photo courtesy of Wikimedia/Mädi.