By: Matt Fischer
On November 29, 2018, Florida Representative Chuck Clemons proposed house bill 65 (“HB 65”) that would significantly tighten regulation on the use of stem cells. If the stem cell bill is signed into law, Florida will join other states (e.g. California, Texas and Washington) in passing some type of stem cell regulation. While some bills around the country have centered the regulation on informing prospective customers of the risks associated with these treatments, HB 65 takes a more stringent approach with the threat of criminal exposure and includes certain protections for providers in the form of a “right-to-try” law.
Some of the highlights of HB 65 include:
- Creates a new statute (i.e. 385.301) requiring “investigational stem cell” treatments to be administered directly by a licensed and certified physician to a patient that has been diagnosed with a severe chronic disease or terminal illness
- Directs the Florida Department of Health to establish rules necessary to administer the new statute by January 1, 2020
- Amends Florida Statute § 873.01 to make purchasing and selling stem cells a second-degree felony
- Limits the location of providing investigational stem treatments to specific locations with oversight by an institutional review board
- Requires eligible patients to sign a written informed consent form and permits the Florida Department of Health to adopt a form by rule for the informed consent
- Prohibits a licensing board or state entity from taking action against a physician’s license under certain circumstances or from interfering with an eligible patient’s access to or use of a stem cell treatment
Notably, legislation was previously proposed at the beginning of 2018 (“HB 1185”); however, the bill failed to make it out of the appropriations committee. When comparing it to the previous stem cell bill, HB 65 takes a more stringent regulatory stance. HB 1185 focused more on the registration and inspection of clinics offering stem cell treatments. It also was aimed at addressing advertisements placed by clinics.
The proposed enactment date of HB 65 is July 1, 2019. If this new legislation is enacted, providers must understand that they could face substantially increased penalties including potential criminal exposure if the law is not followed. Given these consequences, seeking experienced legal representation is more critical than ever.
