In a significant move aimed at overhauling Puerto Rico’s approach to severe mental health and substance use disorders, Gov. Jenniffer González-Colón signed an executive order Tuesday, August 4, designed to transform the U.S. territory into a pioneering hub for clinical research on emerging medical therapies, including the investigational use of ibogaine.

Executive Order 2026-037 will create a comprehensive assessment to establish a “Pilot Clinical Research Program for Emerging Therapies.” The program would lay the groundwork for clinical trials involving novel and historically restricted therapeutic compounds, prioritizing scientific rigor and strict adherence to both state and federal regulatory frameworks.

The administration cited the island's ongoing battle with complex mental health challenges, neurodegenerative diseases, and escalating substance use disorders as the primary catalyst for the new public policy. Recognizing that existing treatments often fall short for vulnerable populations, the government is looking toward novel compounds like ibogaine — a psychoactive alkaloid from the African iboga shrub currently being studied for its potential to interrupt severe opioid and substance-use addictions — as well as other emerging therapeutics, like psilocybin and MDMA.

“Scientific innovation represents an opportunity to transform the future of Puerto Rico’s healthcare system,” González-Colón said during a signing ceremony at La Fortaleza, the governor’s official residence. “Our responsibility is to prepare the island to participate in the research that will define tomorrow’s treatments, always with the highest standards of scientific rigor, ethics, and regulatory compliance.”

“Through this Executive Order, we are moving toward making Puerto Rico a leader in clinical research and opening new opportunities for our patients, researchers, healthcare professionals, and veterans,” she added.

Under the new directive, the Puerto Rico Department of Health is tasked with leading a strategic effort to build out the scientific, regulatory, and operational infrastructure required to host cutting-edge, multicenter clinical trials. The order highlights that Puerto Rico already possesses a robust foundation to support this endeavor, citing the island’s strong academic, hospital, and scientific infrastructure, which includes major universities, established research centers, and highly trained medical professionals.

Advocacy organizations across the island, including the Colectivo Psicodélico de Puerto Rico (also known as the Puerto Rico Psychedelic Collective), heralded the executive order as a watershed moment for Puerto Rico’s psychedelic ambitions. 

“As a psychedelic community, we celebrate this executive order as a meaningful signal that Puerto Rico’s government is beginning to take seriously the emerging evidence base around psychedelic therapies: Dr. Juliana Millán Torres, founder of the CPPR, told Psychedelic State(s) of America. “The archipelago is catching up to a global movement, and that fills us with hope.” . 

To ensure the program adheres to the highest medical, scientific, and ethical standards, the executive order mandates the creation of a specialized Scientific and Regulatory Advisory Committee housed within the Department of Health. The governor will directly appoint the committee’s members, who will be drawn from a diverse pool of government officials and subject matter experts.

The advisory body will feature specialists in clinical research, public health, bioethics, pharmacology, neurology, psychiatry, psychology, and regulatory affairs. These advisors will be charged with evaluating current scientific evidence surrounding emerging therapies; assessing the logistical, clinical, ethical, and financial viability of the pilot program; and identifying necessary upgrades to the island’s physical infrastructure and medical workforce training.

Furthermore, the committee will be responsible for drafting a Strategic Agenda to bolster clinical research across Puerto Rico, pinpointing priority areas for scientific inquiry, and fostering collaborative research opportunities with public, private, academic, and federal entities.

Underpinning this clinical research initiative is Puerto Rico’s formidable $50 billion pharmaceutical legacy, which has long cemented the island as an indispensable anchor in the broader medical supply chain across the United States as well as North and South America. Sustaining tens of thousands of local STEM and manufacturing jobs, the territory's medical equipment and life sciences export sector is a global powerhouse that currently produces roughly 90% of the world’s pacemakers, alongside massive quantities of contact lenses, insulin pumps, and glucose monitors. Puerto Rico's robust, world-class manufacturing infrastructure provides a well-established foundation to support the administration's ambitious pivot toward cutting-edge clinical trials and emerging therapeutics.

The executive order places significant focus on Puerto Rican military veterans. The Department of Health is explicitly instructed to coordinate with the Office of the Puerto Rico Veterans Advocate to “facilitate educational initiatives and explore potential avenues for veterans to safely participate in the clinical trials.” Any participation would be strictly governed by rigorous eligibility criteria, available scientific evidence, and necessary regulatory authorizations.

The territory’s new public policy also references a broader federal directive to align the pilot program’s objectives with. The order links Puerto Rico’s efforts with an executive order signed by President Donald J. Trump back in April, which aims to accelerate the development of innovative medical treatments for serious mental illnesses by fostering cooperation among government agencies, the private sector, and research institutions.

The order lands amid political turmoil for González-Colón. The Department of Justice recently halted a major election-fraud investigation involving her 2024 campaign. According to an investigation by ProPublica, federal narcotics agents had gathered solid evidence that "Los Tiburones," a notorious Puerto Rican prison gang, allegedly coerced addicted inmates into voting for González-Colón during the gubernatorial primary by offering narcotics in exchange for their support, while simultaneously threatening violence and withholding drugs from those who refused. 

To achieve the ambitious goals outlined in the executive order, the Puerto Rico Department of Health is authorized to coordinate its efforts across a wide array of state and federal bodies. The order encourages direct collaboration with university networks, hospital systems, nonprofit organizations, and crucial federal partners. 

The order also states that the directive does not authorize the widespread or routine clinical use of emerging psychedelic therapies, including ibogaine, psilocybin, MDMA, or any other compounds currently under investigational status. Instead, the administration emphasized that the singular purpose of the directive is to fortify the scientific and institutional readiness of Puerto Rico’s healthcare system. 

Looking ahead, the newly established Scientific and Regulatory Advisory Committee will operate on a strict reporting timeline. The panel is required to submit initial progress reports to the Department of Health, culminating in a final report detailing its findings and recommendations. Gov. González-Colón will then review the committee's assessment to determine appropriate administrative actions and subsequent public policy measures required to launch the pilot program.

Advocates on the ground aren’t slowing down anytime soon, as many plan to work directly with the forthcoming advisory committees to ensure the program’s regulatory refinement and implementation process is as equitable as possible. 

“It’s an exciting time to continue doing the work that needs to be done in service of a shared purpose, work that will hopefully ripple out into every part of our islands,” said Millán Torres.

“The momentum is here to be embraced by the public, healthcare providers, researchers, community members, and everyone contributing in the psychedelic space, as we build this future together.”

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