Bill Summary for H 1220 (2013-2014)
|View NCGA Bill Details||2013-2014 Session|
A BILL TO BE ENTITLED AN ACT TO CREATE AN INTRACTABLE EPILEPSY ALTERNATIVE TREATMENT PILOT STUDY PROGRAM AND REGISTRY FOR THE SCIENTIFIC INVESTIGATION OF THE SAFETY AND EFFICACY OF HEMP EXTRACT TREATMENT FOR INTRACTABLE EPILEPSY.Intro. by McElraft, Avila, Carney, Fulghum.
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Senate committee substitute makes the following changes to the 3rd edition.
Changes the long title.
Provides that East Carolina University can also conduct research on hemp extract development and production for seizure disorder treatment.
Amends proposed GS Chapter 90, Article 5G, renaming the Article as Epilepsy Alternative Treatment Act (previously, Compassionate Use Registration Act). Makes conforming changes. Provides that the purpose of the act is to permit medical professionals to conduct limited-scope, evidence-based studies on the treatment of intractable epilepsy with hemp extract. Sets out findings of the General Assembly, including that hemp extract has shown promise in treating children with intractable epilepsy. Provides for a pilot study on the safety and efficacy of treating intractable epilepsy with hemp extract by one or more registered neurologists by which those afflicted with intractable epilepsy can receive hemp extract for treatment through a series of registrations and studies. Only through a registered pilot study and neurologist will hemp extract be dispensed. Makes technical and conforming changes to the definitions section.
Amends previous subsection titled Compassionate use database; Departmental duties (now, Intractable Epilepsy Alternative Treatment Pilot Study database; Departmental duties) to reflect the newly established Intractable Epilepsy Alternative Treatment Pilot Study. Establishes a database registry for the registration of pilot studies, neurologists, caregivers, and patients. Makes conforming changes.
Enacts new GS 90-113.103, Registration of pilot studies and neurologists, setting out required information that must be submitted by neurologists wanting to conduct a pilot study, including the scientific and clinical parameters of the study and the protocols established to ensure patient safety. Provides that the Department of Health and Human Services (DHHS) must examine study applications and register the pilot programs in the database if it is determined the study follows minimum scientific methods and that it protects patients.
Makes technical and conforming changes to provisions for caregiver registration cards, applications, and fees and provisions which provide for immunity for neurologists and medical records.
Directs DHHS to establish and adopt temporary rules to implement the provisions of this act no later than October 1 , 2014.
Unless otherwise specified, the act will become effective on July 1, 2014 (was, June 30, 2014).