Governor González-Colón Advances New Public Policy to Strengthen Clinical Research and Position Puerto Rico as a Center for Emerging Therapies Innovation

La Fortaleza, San Juan, Puerto Rico – August 4, 2026 – As part of her commitment to strengthening Puerto Rico’s healthcare system and advancing scientific development, Governor Jenniffer González-Colón signed a new Executive Order establishing public policy aimed at strengthening clinical research, promoting the development of controlled clinical trials, and expanding the scientific capacity of Puerto Rico’s healthcare system in the field of emerging therapies.

The Governor signed Executive Order 2026-037 alongside Department of Health Secretary Víctor Ramos Otero; Dr. Catherine Oliver Franco, Executive Director of the Mental Health and Anti-Addiction Services Administration (ASSMCA); Attorney Agustín Montañez Allman, Puerto Rico’s Veterans Advocate; and representatives from private-sector healthcare organizations.

The initiative recognizes the need to prepare Puerto Rico to participate in cutting-edge clinical research in a responsible and competitive manner, consistent with available scientific evidence and applicable state and federal regulatory frameworks. The Executive Order also directs an assessment of the feasibility and advisability of establishing a Pilot Clinical Research Program for Emerging Therapies, with the goal of strengthening the Island’s scientific and regulatory infrastructure, without authorizing the routine clinical use of such therapies.

“Scientific innovation represents an opportunity to transform the future of Puerto Rico’s healthcare system. 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,” said Governor Jenniffer González-Colón.

The Executive Order highlights that Puerto Rico faces significant challenges related to mental health disorders, neurodegenerative diseases, substance use disorders, and other complex conditions. Therefore, strengthening scientific research represents a public policy priority.

The Order also recognizes that Puerto Rico has a strong academic, hospital, and scientific infrastructure, including universities, research centers, healthcare systems, and highly trained professionals who can serve as a foundation to expand the Island’s participation in national and international multicenter clinical trials.

As part of the new public policy, the Secretary of the Department of Health is directed to lead a comprehensive strategy to develop the scientific, regulatory, and operational capabilities necessary to strengthen clinical research in Puerto Rico. Responsibilities will include evaluating the feasibility of the pilot program, identifying federal and private funding opportunities, promoting strategic partnerships, and developing public policy recommendations for the Governor’s consideration.

The Executive Order also establishes a Scientific and Regulatory Advisory Committee within the Department of Health, whose members will be appointed by the Governor. The committee will include government representatives, experts in clinical research, public health, bioethics, pharmacology, neurology, psychiatry, psychology, regulatory affairs, and other related disciplines.

Among the committee’s responsibilities are evaluating available scientific evidence regarding emerging therapies; assessing the scientific, ethical, clinical, regulatory, and financial feasibility of a potential pilot program; identifying infrastructure, training, and workforce needs; recommending priority areas for research; developing a Strategic Agenda to strengthen clinical research in Puerto Rico; and promoting collaboration opportunities with public, private, academic, and federal entities.

The Executive Order further provides that the Department of Health may coordinate efforts with the Mental Health and Anti-Addiction Services Administration (ASSMCA), the Office of the Puerto Rico Veterans Advocate, universities, hospitals, nonprofit organizations, and federal agencies such as the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the Department of Veterans Affairs (VA), and the Drug Enforcement Administration (DEA), among others, to strengthen Puerto Rico’s research capabilities and access new opportunities for scientific collaboration and funding.

In recognition of the service of Puerto Rican veterans, the Executive Order establishes that the Department of Health will coordinate with the Office of the Puerto Rico Veterans Advocate on initiatives to facilitate veterans’ education and potential participation in clinical research, always in accordance with scientific evidence, eligibility criteria, and applicable regulatory authorizations.

The public policy also references an Executive Order issued by President Donald J. Trump aimed at accelerating the development of innovative medical treatments for serious mental illnesses by promoting collaboration among government agencies, academic institutions, and the private sector.

The new Executive Order expressly establishes that it does not authorize the widespread use of emerging therapies as part of clinical practice in Puerto Rico, including psychedelic therapies, ibogaine, psilocybin, MDMA, or other compounds that remain under investigation. Its purpose is to strengthen the scientific and institutional readiness of Puerto Rico’s healthcare system to participate in responsible clinical research and develop evidence-based recommendations for future public policy initiatives.

The Advisory Committee will have an initial period to submit progress reports and must provide a final report with its recommendations to the Department of Health. The report will subsequently be reviewed by the Governor to determine appropriate administrative actions and public policy measures.

Through this initiative, the Administration reaffirms its commitment to innovation, scientific research, strengthening the healthcare system, and developing new opportunities to position Puerto Rico as a center of excellence in clinical research and emerging therapies, while ensuring strict compliance with all applicable laws and regulations.

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