RELATING TO HEALTH AND SAFETY -- TERMINAL PATIENTS' RIGHT TO TRY ACT
H8329 creates a new chapter in Rhode Island health law called the Terminal Patients’ Right to Try Act. The bill is designed to expand access for terminally ill and certain seriously ill patients to investigational drugs, biologics, devices, and individualized treatments that have completed phase one clinical testing but have not been approved for general use by the FDA. It defines eligible patients, eligible facilities, and several access pathways, including company-sponsored clinical trials, single-patient protocols, compassionate use, expanded access, off-label use, telehealth prescreening, and remote signing of consent documents.
The bill also allows eligible patients to use innovative medical devices for diagnostic purposes, not just treatment, and authorizes telehealth prescreening for patients in any state or jurisdiction when the provider is physically located in Rhode Island. It further provides that remote signing of informed consent is legally effective if statutory conditions are met. The Department of Health would be directed to adopt implementing regulations, and the act would take effect on January 1, 2027.
The bill would add a new chapter to Title 23 of the Rhode Island General Laws and would create statutory protections and procedures for access to investigational therapies for terminally ill patients. It would also grant immunity from suit to manufacturers, pharmacists, healthcare facilities, healthcare providers, and others involved in care when the bill’s conditions are satisfied, and it would authorize injunctive relief and attorneys’ fees for patients or providers who challenge violations by regulatory or law enforcement authorities. In practical terms, the measure would expand state-law protections beyond existing federal access pathways by expressly recognizing telehealth prescreening, remote consent, and diagnostic use of innovative devices, while limiting liability for compliant participants.
Based on the bill text and the absence of recorded committee testimony or votes, the overall sentiment appears supportive of expanding patient access to experimental or last-resort treatments. The stated legislative purpose emphasizes removing barriers, encouraging innovation, and making Rhode Island more attractive for clinical trials and development of new therapies. The bill’s structure suggests a pro-access, pro-research approach centered on patient choice and provider protection.
The main policy tension in the bill is between expanding access to investigational treatments and preserving safeguards around patient safety, informed consent, and regulatory oversight. Potential points of concern include the broad immunity provisions, the ability to use investigational therapies outside traditional trial settings, and the bill’s restrictions on regulatory or law enforcement action. Another likely area of debate is whether telehealth prescreening and remote signing sufficiently protect vulnerable patients, especially minors or patients lacking capacity, while still allowing timely access to treatment. No specific objections or supporters are recorded in the provided materials.