Introduction

The psychedelic industry is experiencing a “renaissance,” with novel therapies and medicinal breakthroughs capturing widespread attention. According to psychiatrist and consciousness researcher Stanislov Grof, psychedelics, when “used responsibly and with proper caution, would be for psychiatry what the microscope is to the study of biology and medicine or the telescope for astronomy.” From the exploration of psilocybin-assisted therapy for mental health disorders to the investigation of ibogaine as a potential treatment for addiction, researchers and entrepreneurs are tapping into the therapeutic potential of psychedelic substances in unprecedented ways.

However, amidst this wave of innovation, concerns have emerged regarding the treatment of indigenous communities. Despite their traditional knowledge serving as the foundation for many of these developments, there is growing concern that the communities are being left behind or exploited. As the psychedelic ecosystem continues to evolve, it is imperative to address these concerns and ensure that indigenous communities are properly consulted, respected, and compensated for their contributions.

The introduction of psilocybin, derived from Psilocybe mushrooms, to Western society by American researcher Dr. Robert Wasson is often cited as a warning of the grave risks associated with exploitation and appropriation of indigenous knowledge. In 1955, Wasson traveled to Huautla de Jiménez, Oaxaca, Mexico where he met Maria Sabina, a Mazatec curandera, a traditional healer, who taught him about the healing properties of Psilocybe mushrooms used in Mazatec ceremonies. Despite promises of secrecy, Wasson violated the trust of the curandera and published an expose in 1957 in Life Magazine without consent or compensation to Maria Sabina. The article led to a frenzy of tourists, scientists, and researchers flooding Huautla de Jiménez. As a result, Maria faced immense backlash from the local community which led to the arson of Maria’s home.    Maria was briefly jailed after being accused of selling marijuana. Wasson himself expressed regret stating, “Yet what I have done gives me nightmares: I have unleashed on lovely Huautla a torrent of commercial exploitation of the vilest kind.

Despite Wasson’s regret, his actions fueled an exploitative dynamic between Western researchers and the indigenous community which continues today as chemical compounds from Psilocybe mushrooms have sparked numerous patent applications, including those for depression treatment. In 2020, Compass Pathways Plc, a leading pharmaceutical company specializing in psilocybin for depression therapy, went public and is now valued at nearly $1 billion. However, the Mazatec indigenous community, custodians of these remedies for centuries, have not benefited from any of these patents.

In response to mounting concerns regarding the impact of biopiracy, the Nagoya Protocol presents a promising opportunity to address the concerns surrounding indigenous rights in the psychedelic industry. The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization (“Nagoya Protocol” or “Protocol”) was adopted in 2010 as a supplementary agreement to the United Nations Convention on Biological Diversity (“CBD”).  The Protocol’s framework for promoting equitable benefit-sharing and protecting indigenous rights is garnering attention in psychedelic advocacy circles.  The Protocol seeks to ensure that the communities and countries who serve as stewards of genetic resources, like the Mazatec of the Psilocybe mushrooms, receive a portion of any benefits that arise from research conducted with those resources. Though prominent countries engaging in the psychedelic pharmaceutical arena, namely the United States, Canada, and Australia, have yet to adopt the Protocol, its track record in protecting indigenous communities with other medicines underscores its potential to empower indigenous communities in the psychedelic ecosystem.

The intersection between psychedelics, indigenous rights, and the Nagoya Protocol presents a complex landscape highlighting the potential of international law to play a pivotal role in balancing the need for scientific advancement with critical protection of the environment and indigenous communities. This article aims to explore these intersections, beginning with an overview of the emerging psychedelic landscape, considering both the promising findings of psychedelic research, alongside growing concerns regarding the treatment of indigenous knowledge. The article will introduce the Nagoya Protocol, followed by an examination of indigenous rights within its framework. The article will assess the application of the Nagoya Protocol to challenges in psychedelics, arguing that it holds potential as a tool to create pathways for harmonizing indigenous rights and psychedelic research.

Developments in the Psychedelic Industry 

Scientific and public fascination with psychedelics is burgeoning as these substances gain greater acceptance in mainstream society. This surge in interest has ushered in a new era of unprecedented scientific, legal, and political engagement, often referred to as the “psychedelic renaissance.” Academic institutions are researching the powerful therapeutic impacts of psychedelics on depression, anxiety, substance abuse, and PTSD, among other disorders. In 2017 the FDA recognized MDMA as a breakthrough therapy for PTSD. In 2018,  the FDA designated psilocybin-assisted psychotherapy as a breakthrough therapy for treatment resistant depression. In 2024, the FDA granted LSD breakthrough therapy status as a treatment for general anxiety disorder. The Covid-19 pandemic influenced the momentum of the burgeoning psychedelic movement. The pandemic shed light on critical gaps existing in healthcare infrastructure and cultivated newfound awareness of the global mental health crisis.

The awareness of the gaps in available treatment, alongside promising clinical trial results, has  increased investment and commercialization efforts in the psychedelic space. Pharmaceutical companies, biotech startups, research institutions, and investors are pouring millions of dollars into psychedelic research and development, betting on the transformative impact these therapies could have on mental health care. According to the World Health Organization, mental disorders are the leading cause of disability. After the pandemic, there was an estimated 25-27% increase in the prevalence of depression and anxiety around the world with studies finding that in the US, 41.5% of adults exhibited symptoms of depression or anxiety. This represents a market poised to exceed $200 billion in the USA alone.

The United States is not unique in exploring the therapeutic potential of psychedelics. From Prince Harry’s public statements regarding his use of psychedelic mushrooms for mental health to the launching of the UK’s first psychedelic clinic in London, a global re-envisioning of mental health treatment is underway in which psychedelics have a key role to play. In October 2022, Alberta became the first province in Canada to regulate psychedelics for therapeutic use. In February 2023, Australia became the first country to legalize the prescription of psilocybin and MDMA in a controlled medical setting as treatment for PTSD and treatment-resistant depression.

While the recent surge in the recognition of psychedelics’ therapeutic potential may seem novel to the Western world, indigenous communities have long stewarded these substances as sacred medicine. Now, they confront the looming risks of exploitation and appropriation. Advocates fear that calls for proper recognition or compensation for indigenous communities will be drowned out in the fast moving current of the growing psychedelic industry.

Concerns of Indigenous Exploitation in the Psychedelic Industry

Psychedelics have been used for millennia by indigenous communities around the world as traditional medicine in religious ceremonies and rituals. The use of psychoactive plants can be traced to religious rituals of indigenous communities from the Americas like the Atzecs, Mayans, and Incas to Africa’s Bwiti people. Traditional indigenous medicine relies on a comprehensive approach to healthcare, which encompasses spiritual rituals, herbal remedies, and communal support systems. These communities have stewarded the plant medicine and held sacred knowledge about the therapeutic properties of plants such as psilocybin, ibogaine, and peyote for centuries. It is their knowledge which serves as a foundation for present scientific developments and clinical achievements of psychedelic- assisted therapy. Despite their critical contribution, modern medicine often fails to acknowledge these origins as it increasingly recognizes the therapeutic potential of psychedelic substances in treating various psychological disorders. As a result, indigenous communities have received little to no acknowledgement or benefit.

The exploitation of indigenous knowledge and resources in the psychedelic industry raises significant ethical and legal concerns, particularly in the context of bioprospecting and biopiracy. Bioprospecting is a feature in the development of pharmaceuticals and refers to the exploration and commercialization of biological resources for pharmaceutical, agricultural, or industrial purposes—often with the aim of discovering new drugs or other valuable products. Though it is not inherently concerning, when conducted without the free, prior, and informed consent of indigenous communities, bioprospecting can lead to biopiracy—the use of bioprospecting to gain exclusive intellectual property rights without benefits for, and often at the expense of, the indigenous populations.

The appropriation and exploitation often leads to severe consequences for local indigenous populations who are unable to benefit from the medical advancements or economic benefits sourcing from the biodiversity and indigenous knowledge of their own communities. Further, biopiracy can also result in the diminishment of biodiverse resources that are at the heart of already established ethnomedicine and health care practices. In the case of psychedelics, instances of unauthorized collection, patenting, and commercialization of indigenous plants, such as Psilocybe mushrooms, have been reported. This raises  questions about intellectual property rights, benefit-sharing, and ethical research practices. Further, advocates argue that these practices not only undermine the rights and sovereignty of indigenous peoples, but also perpetuate a legacy of colonialism and exploitation.

The Nagoya Protocol and the Protection of Indigenous Rights

To address these concerns and promote equitable relationships between private sector entities and indigenous communities, the implementation of legal mechanisms such as the Nagoya Protocol is crucial. The Nagoya Protocol was adopted in 2010 in Nagoya, Japan as a supplementary agreement to the United Nations Convention on Biological Diversity (“CBD”). Entering into force in 2014, the Protocol provides a transparent legal framework for the implementation of the CBD’s aim of ensuring the fair and equitable sharing of benefits arising out of the utilization of genetic resources. To date, it has been ratified by 141 countries,  with the United States and Canada—countries pioneering the psychedelic industry—notably missing from the list.

Central to the Nagoya Protocol is the principle that indigenous peoples have the right to manage and derive benefits from their traditional knowledge and genetic resources. The Protocol sets out obligations for parties to take measures in relation to access to genetic resources, benefit-sharing, and compliance. Under the Protocol, countries independently determine the implementation of Nagoya. The actor desiring access to genetic resources (“User”) must seek prior and informed consent from the host country (“Provider”). Once they obtain consent, negotiations ensue to reach mutually agreed terms-including the benefits they might share. Benefits might be monetary or non-monetary, such as technology transfer and capacity-building initiatives. Further, the Nagoya Protocol encompasses scenarios including  possibilities of long-term commercial utilization, even if researchers do not have the present intent to pursue commercialization. Thus, with prior informed consent and negotiations, the User is able to obtain access to genetic resources and traditional knowledge, while ensuring equitable benefit-sharing with local stakeholders.

Through the intentional inclusion of indigenous communities, the Protocol provides communities a critical voice in the development of partnerships with Western countries. For example, HG&H Pharmaceuticals developed the drug Zembrin from Sceletium tortuosum, a plant discovered and used traditionally by the San community indigenous to South Africa. In compliance with the Nagoya Protocol, HG&G sought to recognize and compensate the San people. The formal prior informed consent benefit-sharing agreement (BSA) between HG&G and the South African San Council (SASC) was Africa’s second BSA. The first BSA was between the SASC and the Council for Scientific and Industrial Research (CSIR) concerning the appetite-suppressant properties of the Hoodia succulent. While the San received milestone payments to the San Hoodia Trust, a commercial product was never developed, thus preventing receipt of the agreed upon royalty payments. In contrast, the 2008 Zembrin agreement with HG&H marked the first BSA to result in a successful commercial product, enabling the San to receive  from the use of their traditional knowledge.

As part of the Zembrin agreement, HG&H committed to only use cultivated plant material rather than the threatened wild plant stocks. Further, Zembrin remains the sole Sceletium product to carry the logo of its indigenous beneficiaries. HG&G’s collaboration underscores the potential for pharmaceutical companies, like those in the psychedelic arena, to foster scientific innovation, promote sustainable development, and uphold ethical standards in partnership with local communities under the Nagoya Protocol.

The Nagoya Protocol & the Psychedelic Industry

Implementing the Nagoya Protocol in the psychedelic industry would have significant implications for relationships between private sector entities and indigenous communities. It would establish clear obligations for private sector entities, ensuring that indigenous communities are properly consulted and compensated for the use of their traditional knowledge. Furthermore, it would empower indigenous communities to participate in and benefit from the development and commercialization of psychedelic therapies.

The psychedelic industry’s compliance with the Nagoya Protocol would be immensely beneficial for cases like ibogaine, a psychedelic compound that has gained significant attention for its groundbreaking use as a treatment for substance abuse and its potential as a cure for America’s opioid crisis. Recent trials have produced promising results. In a 2017 study, roughly 80% of participants found that ibogaine either completely eradicated or significantly alleviated their withdrawal symptoms. Further, half of the participants reported diminished opioid cravings, and 30% abstained from opioids post-treatment. Ibogaine, made from the root bark of the Tabernanthe iboga plant, is indigenous to Central and West Africa, primarily Gabon, Cameroon and Congo. It has been used by spiritual practitioners of the Bwiti religion for thousands of years as medicine and as a sacrament in traditional ceremonies.

After Western researchers in the 1960’s learned about the powerful properties of ibogaine as an addiction treatment, clinical trials ensued, and led to a wave of researchers and biotech companies seeking to profit off of the “discovery” with little to no benefit to, or acknowledgement of, the Bwiti people. Nearly all of the iboga and ibogaine used by clinics in the West is illegally harvested and trafficked out of Gabon through Cameroon. With a thriving black market in which a kilogram of raw iboga root sells averagely for $2,000, and clinics are able to charge between $5,000 to $15,000 for a single therapeutic session, some advocates have coined ibogaine as the “blood diamond” of psychedelics.

In response to the growing demand for ibogaine and the environmental and cultural consequences for the Bwiti people, Gabon became the first country to ratify the Nagoya Protocol in 2011. Under the Protocol, the government identifies iboga as a genetic resource and protects its use and benefit for the Bwiti people. The Protocol translated into regulatory action in 2019 when the Gabonese government took action to halt the export of iboga, instituting the requirement for permits to be obtained from the Ministry of Forestry and the Environment.

After the ban, in 2020, Blessings of the Forest (“BOTF”) signed a five-year agreement with the government, establishing itself as the first entity in Gabon authorized to develop fair trade products in collaboration with the government. BOTF’s objective is to cultivate a fair and sustainable public iboga industry guided by the principles of the Nagoya Protocol. The program seeks to establish an equitable and environmentally sustainable iboga industry that prioritizes accessibility to iboga for indigenous communities who rely on it, while also fostering the development of an international market with benefit-sharing at its core.

The story of Gabon and ibogaine highlights both the promise and challenges of the Nagoya Protocol. On one hand, Gabon’s efforts have not effectively curbed the trafficking of iboga, nor have companies holding patents for ibogaine without permits or reciprocity agreements faced consequences. On the other hand, the Protocol and BOTF’s program is a step in the right direction of protecting the rights of the Bwiti people. For example, BOTF’s program led to the creation of Terragnosis, a Canadian company established to source and distribute iboga traded in accordance with the Protocol. And in May 2023, the first-ever Nagoya Protocol-compliant export of iboga from Gabon was sent to Filament Health Corp, a clinical stage psychedelic development company in Vancouver, Canada. Gabon’s efforts serve as a model for companies seeking to develop medicine derived from other psychedelic compounds, like Ayahuasca or Peyote, on how to do so ethically and in compliance with Nagoya. It also underscores the importance for Provider countries to go beyond the act of ratifying the Nagoya Protocol, and instead undertake concrete actions to establish programs aimed at implementing the Protocol’s requirements.

Conclusion

While the burgeoning psychedelic industry presents immense promise for revolutionizing mental health care, it also brings to the forefront critical concerns regarding the appropriation of indigenous knowledge and the exploitation of indigenous communities. The story of Gabon’s efforts to regulate the iboga industry under the Nagoya Protocol showcase the potential for legal frameworks to protect indigenous rights and promote equitable benefit-sharing. However, it also underscores the need for concrete actions and meaningful implementation beyond mere ratification.

Further, within the current psychedelic ecosystem, the Nagoya Protocol alone cannot ensure timely industry-wide compliance with ethical practices and indigenous reciprocity. Meaningful change requires a fundamental industry transformation, anchored in a commitment to ethical responsibility and respectful partnerships with indigenous communities. This entails prioritizing benefit-sharing, environmental conservation, and upholding indigenous sovereignty. Companies can take steps such as implementing robust internal policies for indigenous consultation and benefit-sharing, as well as undertaking capacity-building initiatives to empower indigenous participation in decision-making and economic benefits from psychedelic research and development. In doing so, the industry can strive towards a more equitable and sustainable future for all stakeholders involved in the psychedelic ecosystem.

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Karina Bashir is an attorney and thought leader with a specialized focus on the intersection of law, business ethics, and psychedelics. As counsel with Antithesis Law, PC, she provides guidance on a range of core business and regulatory services. Karina also advises and collaborates with impactful organizations in the psychedelics industry to develop and improve business best practices.