The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School has announced a new research initiative, the Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. This three-year project will promote safety, innovation, and equity in psychedelics research, commerce, and therapeutics. It is supported by a generous grant from the Saisei Foundation.

Despite a longstanding prohibition on psychedelics dating back to the 1970s, scientific and public interest in these substances is growing. Clinical trials repeatedly demonstrate their promise for treating mood, anxiety, and substance use disorders.

In 2017, the FDA designated MDMA a breakthrough therapy for post-traumatic stress disorder, and in 2018 the agency recognized psilocybin as a breakthrough for treatment-resistant depression. These designations indicate that psychedelics may be substantial improvements over existing treatments for mental illness.

While psychedelic therapies make their way through the drug development pipeline, seven U.S. cities and the state of Oregon have decriminalized them, and last November, Oregon voters legalized the supervised administration of psilocybin. At least eight other states are considering similar legislation to legalize or decriminalize psychedelics.

Due to their therapeutic and commercial potential, the U.S. market for psychedelics is projected to reach $6.85 billion by 2027, attracting a significant number of for-profit companies and investors. However, despite the proliferation of clinical research centers, increasing private investment in psychedelic drug development, and widespread state and local decriminalization, there is a relative lack of research on the ethical, legal, and social implications of psychedelics research, commerce, and therapeutics.

POPLAR is the first academic initiative focused on psychedelics law and policy, positioned to be a global leader for research and education in this space.

“Right now, there are a handful of psychedelics research centers at universities around the country. However, they are focused on clinical research,” said Mason Marks, Senior Fellow and Project Lead on the Project on Psychedelics Law and Regulation at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. “There is no systematic research being done on psychedelics law, and POPLAR will fill this gap.”

[Related: A Q&A with Mason Marks on the new psychedelics law and regulation initiative]

Professor Marks, an authority on controlled substance regulation, also teaches Drug Law and Pharmaceutical Innovation at the UNH Franklin Pierce School of Law and serves on the Oregon Psilocybin Advisory Board, which advises the Oregon Health Authority on creating the first statewide industry for psilocybin services.

The POPLAR team will advance evidence-based psychedelics regulation through research in five key areas: ethics in psychedelics research and therapeutics, challenges at the intersection of psychedelics and intellectual property law, opportunities for federal support of psychedelics research, access to psychedelic therapies and equity in emerging psychedelics industries, and the role of psychedelics in healing trauma.

“Preliminary research suggests that psychedelics could hold major benefits for people experiencing trauma and post-traumatic stress disorder,” said Jeannie Suk Gersen ’02, John H. Watson Jr. Professor of Law at Harvard Law School. “By analyzing social, legal, and political barriers to access in this context, we hope to advance the understanding of their potential impact as therapeutics.”

The project will address these areas by publishing academic research; hosting academic events and roundtables with experts from industry, government, and academia; educating courts, legislators, government agencies, and the public; partnering with clinical researchers to help them navigate legal and ethical roadblocks in their work; and training the next generation of thought leaders in this emerging field.

“The Petrie-Flom Center is excited to add POPLAR to its research portfolio,” said I. Glenn Cohen, Faculty Director of the Petrie-Flom Center, James A. Attwood and Leslie Williams Professor of Law, and Deputy Dean at Harvard Law School. “In addition to developing the field of psychedelics law and policy, this innovative work will have broad implications for drug policy, pharmaceutical development, and intellectual property law more generally.”

POPLAR is led by I. Glenn Cohen, Faculty Director of the Petrie-Flom Center, James A. Attwood and Leslie Williams Professor of Law, and Deputy Dean; Mason Marks, Senior Fellow and Project Lead on the Project on Psychedelics Law and Regulation at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, Assistant Professor of Law at the University of New Hampshire Franklin Pierce School of Law (starting Fall 2021), and Affiliated Fellow at the Information Society Project at Yale Law School; and Jeannie Suk Gersen ’02, John H. Watson, Jr. Professor of Law, Harvard Law School; with support from Carmel Shachar, Executive Director of the Petrie-Flom Center.

For more information, visit the Petrie-Flom Center online.