The psychedelic industry has boomed in the last two years, and with it, the number of patents and research papers on psychedelics has multiplied. The movement to decriminalize or legalize psychedelic substances, meanwhile, has gained momentum across North America, with legislators filing policy reforms in multiple states in the U.S.
To explain the surge with data, a quick search on PubMed brings you to a bar graph hinting at the rise in published research work on psilocybin, ketamine, or psychedelics in general. For instance, there were 139 papers published on psilocybin in 2020 as compared to 71 in 2019. So far, 118 studies appear in a search for this year on their website. Scientists and researchers have established a strong foundation for the psychedelic industry to continue expanding, becoming a legitimate market for treating mental health concerns.
All this so far lacks a regulatory body, or a cohesive set of laws to govern and give direction to this unique industry in the making.
The Project on Psychedelics Law and Regulations, or POPLAR — a Harvard Law School research initiative — is now working on that aspect. The three-year-long project at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics would build evidence-based psychedelic law and policy, five decades after these substances were banned under the Controlled Substances Act.
POPLAR would work on tackling major issues, now a part of the mainstream conversation surrounding psychedelics. Among these are questions about ethics in psychedelic research, growing controversies around intellectual property law, equity in the industry, and the role of psychedelics in treating mental health issues.
“There are a lot of research centers cropping up around the country, but they’re all focused on medical research. There’s nothing focused on the law, policy, and ethics.” says Dr. Mason Marks, Senior Fellow and Project Lead on POPLAR at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.
It all started with positive responses to academic panels on psychedelics, Dr. Marks shared, that he organized as a part of his joint fellowship with Edmond J. Safra Center for Ethics at Harvard University and the Petrie-Flom Center last year.
“I was a little concerned that they might be met with criticism because there’s still a lot of stigma surrounding psychedelics. And sometimes, I think, they’re seen as not being a serious topic worth investigating,” Dr. Marks said.
He continues, “But because these panels we held were so well received, I thought it might be interesting to have a more permanent program at Harvard.”
While officially announced on June 30, Dr. Marks shared that the initiative was at work months before.
Dr. Marks is also a part of the Oregon Psilocybin Advisory Board (OPAB), which is working to carve out the administrative regulations for that state’s legal psilocybin-assisted therapy model.
POPLAR’s Multi-Purpose Plan
Patents have become a hot topic of discussion. It’s hard to miss the news on growing conflicts on intellectual property for psychedelics, ethics and equity.
“There’s a lot of concern that if patents are granted too liberally on psychedelics, that could have a harmful effect on research and development, and competition in that area,” says Dr. Marks.
In general, patents are granted to inventors for creating new and useful technologies. While patent manipulation — or patent capitalism — has been a persistent issue with pharma players, advocates are concerned that similar practice in the psychedelic industry would lead to a lack of affordability, and high costs for the treatment.
While some argue that patents increase innovation, or bring net gain, there’s enough evidence of ‘thicketing’, or ‘evergreening’ techniques used to manipulate patents and block competition from smaller firms in the pharma industry. For instance, making minor changes to already existing drugs — even down the colour of the drug — helps them keep their products ‘evergreen’ and save their monopoly on the formulation.
“I think it is clear that in healthcare, especially in the past decade or so, we’ve seen patented medications being sold for increasingly high prices,” Dr. Marks says. “That’s concerning when you look at mental health care where patents have been allowed for a long time, yet we’ve seen very little innovation in that area,” he adds. “If patents are supposed to produce such great innovation, why have we not seen significant innovation and improvement in mental health treatments?”
In a tweet first emerging from patent lawyer Graham Pechenik’s Twitter handle in June, it was noted how a company patented LSD to treat food allergies without actually conducting any experiments. While patent law technically allows owning an invention before it is invented, Dr. Marks shared that a quick Google research would show that “similar methods have been described” in a paper first published in the 1960s.
“I think a lot of people are coming to the conclusion that patents on psychedelics could potentially have a negative effect on innovation in the psychedelic area where innovation is so badly needed,” Dr. Marks hints. Referring to the LSD patent case, he adds, “There’s a reason to believe that patents on psychedelics could be more harmful to the industry.”
As its primary goal, the POPLAR initiative will take a closer look at the patents in the space and study challenges unique to psychedelics. This coincides with its secondary goal of reviewing and interpreting existing research for an easier understanding, which may serve as a resource for public and government officials.
“In the patent area, we would look at all these patents and interpret what exactly do these trends mean for this emerging industry? We’ll review all these different patents that may not be of the highest quality, and what exactly does that mean for the future of psychedelics in the US,” Dr. Marks shared.
The POPLAR initiative would work as a bridging gap between scientific research and public consciousness by interpreting necessary law and policy for psychedelics. Dr. Marks says that early-stage studies have established that psychedelics have potential benefits and associated risks. Now, more studies are continuing to reinforce that information.
“There’s a lot of details that need to be worked out,” he says. “But I think what really needs to be done is trying to figure out how to translate that information into law, and advance the law.”
More Plans: Unlocking Federal Funding, Insurance Coverage, Updating Controlled Substance Act
Oregon set a precedent by legalizing psilocybin-assisted therapy via a ballot measure in November 2020. It was a step in the right direction, establishing grounds for the ongoing psychedelic revolution in the regulatory space, but the work is still in progress.
This means there’s a lot to unpack while figuring out a legal framework, and if done right, it would open doors to other succeeding changes including federal research funding, rescheduling psychedelics and insurance coverage for psychedelic-assisted therapy in the U.S. More importantly, the state’s first-of-its-kind psilocybin therapy model would be under scrutiny for its success or failure around crucial issues such as equity and the affordability of treatments.
Dr. Marks, as an active member of Oregon’s psilocybin board, shares, “Access and equity in the emerging psychedelics industries is a real concern of mine. I know I’m not terribly optimistic about insurance coverage in Oregon.”
As psychedelics continue to exist as Schedule I substances under the Controlled Substances Act, it will be hard for insurance companies to take the risk. “I think a prerequisite might be rescheduling before it [becomes] a realistic possibility to get insurance companies to cover the administration of substances like psilocybin,” Dr. Marks says.
“[The] problem is that would likely be a very limited rescheduling, like, only for the FDA approved therapies,” he continues. “I see that as a problem because it’s really indefensible to maintain psilocybin in Schedule I. That’s an area worth investigating because I do see that as probably being the quickest way to resolve a lot of these problems, like problems with federal funding, with access, and the problem with insurance coverage,” Dr. Marks explains.
But first, the POPLAR group is focused on getting federal funding for psychedelic research “which has been off-limits for far too long,” Dr. Marks says. “I think at this point, the potential of these substances is so great. They’re not going to solve every problem in mental health, of course, but they are the most promising innovation to come along in a very long time,” he adds.
Texas became the most recent state to approve a law to study the potentials of psychedelic substances — psilocybin, MDMA, and ketamine — for the treatment of mental health issues in military veterans. Connecticut’s governor also signed a bill that included psilocybin research in its bill. There are similar bills in other states including New York State, Maine and Massachusetts. Much of the current research is being funded by private enterprises.
POPLAR will be hosting academic events and roundtable discussions in the fall, inviting stakeholders from the industry, while also carrying out a rigorous review of psychedelic research and its social implications.