Conference Description

A major sea change seems likely on the legal treatment of psychedelic medicines – including psilocybin, a substance produced by many species of fungi, 3,4-Methyl​enedioxy​methamphetamine (MDMA), a synthetic substance colloquially referred to as ecstasy, and mescaline, produced by several species of cactus, including peyote, a sacrament of Native American churches. As Phase II and III psychedelic trials near completion, the FDA may soon approve psychedelic medicines for treating post-traumatic stress disorder and treatment-resistant depression. This represents a paradigm shift for the agency, which recently released draft guidance on conducting psychedelic clinical trials.

At the same time, other federal agencies are changing their attitudes toward psychedelics, and Congress is considering reducing barriers to psychedelic research.

With these changes come a myriad of legal and ethical issues. This conference, which will seed a book, seeks to explore the law and policy challenges and opportunities resulting from increased clinical research, private investment, and political interest in psychedelic medicines.

This year’s conference is organized by the Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center in collaboration with Mason Marks, Florida Bar Health Law Section Professor at the Florida State University College of Law and Senior Fellow and Project Lead on the Project on Psychedelics Law and Regulation at the Petrie-Flom Center, Amy Lynn McGuire, Leon Jaworski Professor of Biomedical Ethics and Director, Center for Medical Ethics and Health Policy at Baylor College of Medicine, and the Baylor College of Medicine Ethical Legal Implications of PSychedelics In Society (ELIPSIS) Program with support of the Saisei Foundation, Tim Ferriss and Matt Mullenweg.

Agenda

9-9:15am, Welcome Remarks

• I. Glenn Cohen, Petrie-Flom Center Faculty Director, James A. Attwood and Leslie Williams Professor of Law, and Deputy Dean, Harvard Law School
• Mason Marks, Florida Bar Health Law Section Professor, Florida State University College of Law and Senior Fellow and Project Lead on the Project on Psychedelics Law and Regulation, Petrie-Flom Center
• Amy Lynn McGuire, Leon Jaworski Professor of Biomedical Ethics and Director, Center for Medical Ethics and Health Policy at Baylor College of Medicine
• Susannah Baruch, Executive Director, The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School

9:15-10:35am, Panel one: Psychedelics in medical and therapeutic practice

• Moderator: Rebecca Weintraub Brendel, Director, Harvard Medical School Center for Bioethics, Director, Master of Science in Bioethics Degree Program, and Associate Professor of Psychiatry, Harvard Medical School
• From efficacy to effectiveness: Evaluating psychedelic randomized controlled trials for trustworthy evidence-based policy
  Eduardo Schenberg, Presidente, Instituto Phaneros
• Set, setting & standard of care: Exploring medical malpractice in psychedelic-assisted therapy
  Logan Fahrenkopf, Incoming Associate, Wilson Sonsini Goodrich & Rosati
• Experiential training for psychedelic therapists? Legal and licensure-related challenges for psychedelic-assisted therapy training programs
  Franklin King, Psychiatrist and Director of Training and Education, Massachusetts General Hospital Center for Neuroscience of Psychedelics

10:35-11:35am, Panel two: Human rights, constitutional rights, cognitive liberty

• Moderator: I. Glenn Cohen, Petrie-Flom Center Faculty Director, James A. Attwood and Leslie Williams Professor of Law, and Deputy Dean, Harvard Law School
• Freedom of thinking and becoming: Psychedelics, the Forum Internum, and Article 18 UDHR/ICCPR
  Dr. Jan Christoph Bublitz, University of Hamburg
• Constitutional dimensions of Psychedelic Law
  Mason Marks, Florida Bar Health Law Section Professor, Florida State University College of Law and Senior Fellow and Project Lead on the Project on Psychedelics Law and Regulation, Petrie-Flom Center
  Robert Mikos, LaRoche Family Chair in Law, Vanderbilt University Law School
• Cognitive liberty in an era of psychedelic biomedicalization
  Logan Neitzke-Spruill, Postdoctoral Associate, Center for Medical Ethics & Health Policy, Baylor College of Medicine

11:35-11:50am, Break

11:50am-12:50pm, Panel three: Cross-cultural, indigenous, and spiritual use

• Moderator: Amy Lynn McGuire, Leon Jaworski Professor of Biomedical Ethics and Director, Center for Medical Ethics and Health Policy at Baylor College of Medicine
• Bridging worlds: Enabling cross-cultural respect for the bioethical use of ayahuasca
  Daiara Tukano, Indigenous activist, independent journalist and artist
  Maria Fernanda Gebara, Yorenka Tasorentsi Institute
• The law and policy of psychedelic chaplaincy
  Victoria Litman, Adjunct Professor of Law, Roger Williams University School of Law and Suffolk University Law School and Project on Psychedelics Law and Regulation (POPLAR) Affiliated Researcher, Petrie-Flom Center
• Psychedelic medical policy: Addressing utopian and religious potential
  Matthew Johnson, Senior Investigator, Center for Psilocybin Research and Treatment, Sheppard Pratt

12:50-1:50pm, Lunch

1:50-2:50pm, Panel four: Research, innovation, and patents

• Moderator: Mason Marks, Florida Bar Health Law Section Professor, Florida State University College of Law and Senior Fellow and Project Lead on the Project on Psychedelics Law and Regulation, Petrie-Flom Center
• Between scheduling and science: Revising the federal analogues act to further psychedelic research
  Robert T. Rush, Law Office of Robert T. Rush
• Psychedelics through a patent lens
  Andrew Gilden, Associate Professor of Law, Willamette University College of Law
  Sarah R. Wasserman Rajec, Professor of Law, William & Mary Law School
• Artificial Intelligence in Drug Development of Psychedelics
  Leonard Pickard, Affiliated Researcher, The Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; Former research associate in neurobiology, Harvard Medical School; Harvard fellow in drug policy, Harvard Kennedy School of Government; and and Deputy Director of the Drug Policy Analysis Program, UCLA

2:50-3:05pm, Break

3:05-4:45pm, Panel five: Legalization and access

• Moderator: Susannah Baruch, Executive Director, The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School
• Can psychedelics trigger psychotic disorders in young people? Towards evidence-based public policy for risk management in psychedelic legalization
  Hyun Jung Kim, Founder and Director of Psychiatric Training and Outreach, Clinical High Risk for Psychosis (CHR-p) Program; Child and Adolescent Psychiatrist, Division of Psychotic Disorders, McLean Hospital; and Instructor in Psychiatry, Harvard Medical School
• Beyond the trip: A legal odyssey charting the course for psychedelic innovation through law and policy 
  Shahin Shams, Data Curator, Porta Sophia
• The ghosts of psychedelic science: Haunting and moral repair
  Phoebe Friesen, Assistant Professor, Biomedical Ethics Unit and the Department of Social Studies of Medicine, McGill University
• Legal pathways to promote access to safe and effective psychedelic medicines
  Xinping Hu, LLM, Harvard Law School
  Christopher Robertson, Associate Dean for Strategic Initiatives and Professor of Law, BU School of Law and Professor of Health Law, Policy and Management, BU School of Public Health
  Alison Bateman-House, Assistant Professor, Department of Population Health, NYU Lagone Health
  Holly Fernandez Lynch, Assistant Professor of Medical Ethics and Assistant Professor of Law (secondary), University of Pennsylvania
• Lessons from cannabis: Envisioning a better regulatory structure for psychedelic therapies 
  Lewis A. Grossman, Ann Loeb Bronfman Professor of Law And Affiliate Professor Of History, Washington College of Law
• Interrogating calls for access and equity in the psychedelics industry
  Neşe Devenot, Senior Lecturer, University Writing Program, John Hopkins Krieger School of Arts and Sciences and Affiliated Researcher, The Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School
  Ifetayo Harvey, Executive Director, People of Color Psychedelic Collective and Affiliated Researcher, The Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School

4:45-5pm, Closing

• I. Glenn Cohen, Petrie-Flom Center Faculty Director, James A. Attwood and Leslie Williams Professor of Law, and Deputy Dean, Harvard Law School
• Mason Marks, Florida Bar Health Law Section Professor, Florida State University College of Law and Senior Fellow and Project Lead on the Project on Psychedelics Law and Regulation, Petrie-Flom Center
• Amy Lynn McGuire, Leon Jaworski Professor of Biomedical Ethics and Director, Center for Medical Ethics and Health Policy at Baylor College of Medicine
• Susannah Baruch, Executive Director, The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School

Sponsored by the Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, with support from the Saisei Foundation, Tim Ferriss, Matt Mullenweg, and the Oswald DeN. Cammann Fund at Harvard University