In a since-deleted tweet from March, Ronan Levy, the co-founder of a ketamine-assisted therapy company called Field Trip Health, wrote, “If I were to visualize what I think letting lawyers predict the future of #psychedelics would look like, it would probably look something like this.” Then, he posted a .gif of a man attempting to swing at a golf ball, missing, and toppling over.
Lawyers are no stranger to jokes made at their expense. And when it comes to psychedelics, it might have once seemed an odd pairing to imagine psychonauts and suits teaming up—but not anymore.
Psychedelics are no longer confined to the underground, whether therapeutically or recreationally. With large-scale clinical trials for MDMA and psilocybin showing promise for PTSD and treatment-resistant depression, and multiple states considering decriminalization or regulated use, psychedelics are being confronted with a number of confusing regulatory and legal issues regarding patents and for-profit companies, scheduling, regulation, insurance coverage, FDA exclusivity, and more.
How will patents on psychedelics affect cost or access in the future? Which kinds of psychedelic patents are eligible and which are not? How will clinical trial outcomes affect Drug Enforcement Administration (DEA) scheduling of psychedelics, and vice versa? How will Measure 109, which allows for licensed and regulated psilocybin use in Oregon, conflict or co-exist with for-profit companies? The answers to these questions will largely shape what psychedelic use looks like in the U.S. going forward, and while top universities have continued to open psychedelic research centers, there hasn’t been one that focuses solely on psychedelics and the law—until now.
Announced today, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School will be launching a three-year project dedicated to studying psychedelic legal issues. The Project on Psychedelics Law and Regulation, or POPLAR, will be the first such center of its kind, and is another milestone in the mainstreaming of psychedelics.
POPLAR was funded by a grant from the Saisei Foundation, the foundation of podcast host and author Tim Ferriss, continuing the prominent role of philanthropy in the psychedelic field. Matt Mullenweg, the founder and CEO of Automattic and co-founder of Wordpress, is providing half of the funds for POPLAR via the Saisei Foundation. Ferriss has previously invested millions in psychedelic research, most recently as a private donor to the new Neuroscape Psychedelics Division at the University of California, San Francisco, led by psychedelic researcher Robin Carhart-Harris, formerly of Imperial College.
“The law and regulations determine the rules of the game," Ferriss told Motherboard in an email. "Right now, the good actors have one arm tied behind their backs, and the bad actors have few constraints."
POPLAR will be led by I. Glenn Cohen, the faculty director of the Petrie-Flom Center, and Mason Marks, who teaches at the UNH Franklin Pierce School of Law and serves on the Oregon Psilocybin Advisory Board. (Marks has also written for Motherboard.) The Petrie-Flom Center is one of the oldest health law and policy academic centers in the U.S.; Cohen said it has typically focused its research on emerging topics that pose ethical, legal, and regulatory questions that are brand new and that could affect healthcare—a description that matches psychedelic to a T.
POPLAR will be addressing a wide variety of subjects, Cohen said, but several stand out as ones that have recently been hotly debated. For example, when it comes to intellectual property, what kinds of psychedelic patents can and will be granted for psychedelic compounds or therapies? What are the boundaries to determining when a psychedelic invention is truly new, and when it's too similar to previous work?
“The challenges associated with psychedelics and intellectual property are of particular importance because they could shape the entire ecosystem and related industries for decades to come," Ferriss said. "Some companies are staking their claim to psychedelic therapies by acquiring broad patent rights, which could impede research, raise the cost of treatments, and restrict access."
POPLAR will be researching precedents on how small changes to chemical compounds can or can’t make a molecule patentable—a discussion relevant to the patents held by mental health company Compass Pathways, and its synthetic form of psilocybin, COMP360.
“We’re also interested in the larger topic of bioprospecting and biopiracy,” Cohen said. “The ways in which what is traditionally indigenous knowledge or indigenous populations' kind of culture may be commercialized as part of this process and whether there are ways of thinking about these communities and the role that they have.”
Also on the top of their to-research list: whether nondisclosure agreements are being used to prevent psychedelic researchers from revealing relationships with private industry, and digging into the questions around insurance coverage. While it’s been said by Compass Pathways' funder Christian Angermayer that a medical route for psychedelic treatments is the best way to ensure insurance coverage, coverage for mental health treatments, especially therapy, is not a guarantee in the U.S. POPLAR will also research the potential use of psychedelics to address the opioid crisis and post-traumatic stress disorder, Marks said, but from a policy perspective.
“The project will also have a line of research devoted to the use of psychedelics to resolve trauma associated with sexual violence,” Ferriss said. “It is crucial to expand this underexplored area of research, and I sadly have a personal connection to this topic as a childhood victim of abuse.”
POPLAR will be an academic institution, meaning it won’t be actively litigating or advocating on these issues; it will be doing research-driven deep dives, and publishing its findings. Cohen said the center plans to put out a variety of materials for different audiences, from 3,000 word law review articles to blog posts and podcasts.
“We are very much academics,” Cohen said. “We want people to feel as though we are an honest broker on the subject; we're not working for a company, we're not working for a legislature, we're not working for the DEA." Still, past work from the Petrie-Flom Center has found its way into legal briefs, and recently, the FDA cited its research in guidance on how to regulate artificial intelligence in medical devices.
“I hope these stakeholders will use the project as a source for high-quality, evidence-based research to inform psychedelics regulation,” Ferriss said. “For anyone who is confused by the deluge of noise in the psychedelic sphere, my hope is that POPLAR will become a trusted source of signal: well-researched and informed perspectives on the biggest short-term and long-term opportunities and challenges.”
This kind of information is not something that we can rely solely on companies and organizations to provide to the public and regulating agencies on their own, according to Marks. “Many companies will have a vested interest in maintaining the status quo,” he said. “If a company can get permission from DEA to conduct trials on various psychedelics and at the same time potentially have certain patents granted in psychedelics, they can effectively have several forms of government granted monopolies and be quite content.”
That's the risk of letting things take their natural course, Cohen said. “I can understand that this is a community that might say, ‘Gosh man, really? Lawyers? You guys are the worst," Cohen said. "But this is a moment where a little bit more interaction with the legal community might actually pay dividends.”
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