Harvard Law’s Revolutionary Psychedelic Research Project

In the summer of 2021, Harvard Law School launched a psychedelic research initiative that could alter how society views psychedelics.

Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School launched the Project on Psychedelics Law and Regulation (POPLAR). This project is a three-year research initiative examining possible and emerging ethical, legal, and social implications of psychedelics research, business, and therapeutic use. POPLAR is the first academic initiative focused on psychedelics law and policy, fields that are rising in importance as promising results revealing the benefits of psychedelic drug therapy continue to emerge.

What are Psychedelics?

Psychedelics (also known as hallucinogens) are a diverse group of powerful psychoactive substances that are known for altering human perception, mood, and numerous cognitive processes. Some of these substances are found naturally in certain organisms, and others are synthesized in pharmaceutical laboratories. Because of their effects on human perception and cognition, psychedelics are known to shift the ways individuals understand themselves, others, and the world more generally. This cognitive change is particularly helpful for disrupting the inflexible thought patterns that characterize certain mental illnesses.

Certain psychedelics have been used in many sociocultural and ritual contexts by indigenous cultures for millennia. Nevertheless, the US Drug Enforcement Administration (DEA) classifies psychedelics as Schedule I controlled substances, a category of drugs with sufficient potential for abuse and no accepted medical use. However, results from numerous studies in animals and humans have found psychedelics to be generally physiologically safe and non-addictive. POPLAR may raise discussions about the reclassification of psychedelics.

Recent developments in medical research on the therapeutic application of psychedelic substances, such as psilocybin or MDMA, have incited international movements to decriminalize and legalize certain psychedelics. This push is because of their effectiveness in treating mental health conditions. Numerous clinical trials have shown that psychedelics can have remarkable success in treating depression, anxiety, addiction, and post-traumatic stress disorder. The evidence has shown enough promise that the United States FDA has even recognized substances such as MDMA and psilocybin as  “breakthrough therapies” for PTSD and treatment-resistant depression. These promising results have further attracted the interest of numerous companies and investors anticipating the explosive growth of the market for psychedelics, which is expected to reach $6.85 billion in the US by 2027.

How POPLAR Contributes to Psychedelic Research 

With the proliferation of clinical research centers, increased private investment in drug development, and expanding legal acceptance, medical knowledge about psychedelic therapy is rapidly developing. Nevertheless, research on policy, law, and socioeconomic impacts of the new market for psychedelics has been relatively underexplored. Recognizing that legal and ethical scholarship was at risk of falling behind the rapidly progressing clinical research, researchers at Harvard Law sought to establish a program dedicated to promoting safety, innovation, and equity within the emerging psychedelics industry. POPLAR is intended to fill the gap in contemporary psychedelics research by providing academically informed perspectives addressing major short-term and long-term promises and challenges.

POPLAR focuses on conducting original research on psychedelics law directed toward federal lawmakers and administrative agencies involved in drug policy. Complicated regulatory and legal issues regarding drug patents, scheduling, medical insurance coverage and more will become increasingly relevant as psychedelic treatment becomes more available. Therefore, extensive consideration of these legal and regulatory concerns will be essential for policymakers’ ability to make informed decisions. As part of an academic institution, POPLAR scholars will not actively litigate these issues, but they will instead conduct thorough investigative research on law, ethics, and policy and produce published work on their examinations in various media suited to different audiences in the form of blog posts and podcasts, as well as lengthy academic articles. 

Some Ethical and Legal Dilemmas in Psychedelic Research

The POPLAR team recognizes the innate human aspect of their research and is thoroughly considering the following moral, ethical, and legal questions.

Intellectual property rights

What standards will dictate whether a psychedelic drug formula is truly new or if a product is too similar to previous work? POPLAR scholars aim to define the patentable range of chemical compound variations.

Biopiracy

Biopiracy exploits local traditional knowledge to create profitable products without compensating or acknowledging the cultural contributors. This exploitation often magnifies power inequalities that perpetuate the domination of affluent nations and companies over less-wealthy populations. Commercial enterprises generate enormous profits by extracting local knowledge about the properties of native biological or chemical resources from indigenous people and developing countries. In examining these profits, researchers with POPLAR aim to inform forthcoming standards of responsibility for product developers whose discoveries are derived from cultural knowledge about certain biochemical commodities.

Research funding

The DEA continues to limit the amount of psilocybin and other psychedelics that can be produced each year. Additionally, it is difficult to secure federal funding for research. Therefore, under current laws, significantly wealthy private companies will have a major advantage because they will have the resources needed to fund this research. POPLAR researchers are concerned that, without progressive changes to regulation, already powerful drug companies will be able to monopolize the psychedelics market because of their already powerful positions in the drug research sector.

Equal access

Psychedelic treatment will also likely be expensive. These expenses mean many low-income populations will be unable to receive the medical benefits these treatments provide. POPLAR makes it part of its mission to address the issues that arise when psychedelic therapy gains increased medical acceptance. As a result, the new treatments can be available to the people who need them with low cost. The researchers are also concerned that the low-income marginalized communities, which have been devastated by the War on Drugs, will continue to suffer the injustices of drug prohibition by lacking access to medical applications of psychedelic drugs.

A New Approach to Progressive Psychedelic Research

While top universities are joining the movement to open psychedelic research centers, they have not yet moved to academically consider the ethical, socioeconomic, and legal implications of this emerging industry. With POPLAR, Harvard Law stands out among the major movements in the field of psychedelic therapy by contributing to critical research addressing the ethical, legal, and social importance of psychedelics innovation, commerce, and therapeutics. With serious research anticipating the ethical impact of the psychedelics industry underway, it is clear that the option of psychedelic therapy for mental health conditions is becoming an even more proximate – and with the assistance of POPLAR, hopefully ethically just – reality.