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Committee questions state role in clinical‑trial consortium for investigational therapies; bill rolled for more work
Summary
Members pressed sponsors of HB 2075 on who would own intellectual property, who would manufacture and benefit from trial results and whether Tennessee funds would subsidize out‑of‑state research; witnesses said 2% of IP revenue would go to the state and Tennessee participants could be included. Sponsor rolled the bill to the heel for further work.
House Bill 2075, described by its sponsor as the Helping Open Pathways Act, would establish a state council to oversee participation by Tennessee academic medical centers and hospitals in FDA‑authorized clinical trials for investigational therapies (including trials studying ibogaine‑type treatments for opioid use disorder and PTSD) as part of a multi‑state consortium.
Representative Hill and other members pressed witnesses on a set of commercial and governance questions: who would own intellectual property developed through consortium activity, who would manufacture and distribute any eventual therapy, whether state funds would effectively subsidize research led by out‑of‑state entities, and how revenue would be shared should a therapy reach commercialization.
Witnesses who identified themselves on the record addressed those concerns: Alex West, a retired Navy SEAL and mental‑health practitioner, said the bill envisions an investment model and that the state would receive a share of revenue; Ricky Harris said the text identifies a 2% share of IP revenue to return to the state to reinvest in mental‑health programs; Dr. William Dennis said the model intends to enable Tennessee residents and institutions to participate in the trials.
Members asked for more detail on ownership, the council’s decisionmaking authority, and whether Tennessee institutions or out‑of‑state partners would run trials and manufacturing. In response to those outstanding questions, the sponsor asked to roll HB 2075 to the heel of the calendar so the council and ownership provisions can be clarified. The bill was rolled.
