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. Enacted July 3, 2014. Section 3 is effective upon adoption of rules pursuant to Section 4 of the act. The remainder is effective July 3, 2014.
Bill Summaries: H1220 HOPE 4 HALEY AND FRIENDS.
Summary date: Jul 3 2014 - View Summary
Summary date: Jun 26 2014 - View Summary
Senate amendment makes the following changes to the 4th edition:
Amends the effective date of the act, providing that Section 3, enacting new GS 90-94.1, of the act becomes effective when the rules pursuant to Section 4 of the act are adopted (previously, was effective October 1, 2014). Provides that the remainder of the act is effective when it becomes law (previously, was effective July 1, 2014).
Summary date: Jun 25 2014 - View Summary
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).
House amendment makes the following changes to the 2nd edition:
Makes clarifying changes providing that UNC-Chapel Hill can conduct research on hemp and Duke and Wake Forest University are encouraged to conduct research on hemp extract (previously, encouraged all three to conduct such research).
House committee substitute makes the following changes to the 2nd edition:
Makes technical changes.
Summary date: May 27 2014 - View Summary
Enacts new GS 90-94.1 to allow an individual to possess or use hemp extract (as defined in the act) free from criminal penalty if the individual (1) possess or uses the extract only to treat intractable epilepsy; (2) possesses, in close proximity to the extract, a certificate of analysis indicating the hemp extract's ingredients; and (3) has a current hemp extract registration card issued by the Department of Health and Human Services (DHHS). Allows an individual lawfully possessing hemp extract to administer the extract to another person under the individual's care without criminal penalty if (1) the individual is the person's caregiver and (2) the individual is registered with DHHS to administer the extract. Effective October 1, 2014.
Enacts new Article 5G, Compassionate Use Registration Act, in GS Chapter 90, to require DHHS, in coordination with recommendations from the Department of Public Safety, toestablish the form and content of compassionate use registration cards (registration card) to be issued to qualified individuals. Requires issuance of a registration card, valid for one year, to an individual who meets the five specified criteria, including providing a statement from a neurologist that says the patient meets specified criteria related to epilepsy, and the individual pays a fee (not to exceed $50). Provides the conditions under which a registration card may be renewed. Requires DHHS to create a registry for the registration of neurologists, caregivers, and patients that is accessible to law enforcement agencies. Requires that the registry prevent an active registration of a patient by multiple neurologists and sets minimum information that must be included in the database. Requires DHHS to contact the county department of health where the patient resides and provide (1) the registrant's name and address and (2) identifying information contained on the registration card. Allows neurologists, on a case-by-case basis, to approve of dispensation to a registrant hemp oil acquired from another jurisdiction. Provides immunity from arrest or prosecution for a neurologist for approving or recommending the use of hemp oil or providing a written statement or health records to DHHS for the use of hemp oil. Requires a neurologist signing a statement (as needed to obtain a registration card) to (1) keep a record of the evaluation and observation of a patient under the neurologist's care and (2) transmit the record to DHHS upon request. Provides that all medical records received or maintained by DHHS under this Article are confidential. Requires DHHS to adopt rules to implement the Article. Requires DHHS to establish and adopt rules to implement the act by October 1, 2014.
Encourages UNC-Chapel Hill, Duke, and Wake Forest University to research hemp oil development, production, and use for the treatment of seizure disorders and to participate in any ongoing or future clinical studies or trials.
Unless otherwise noted, the act becomes effective June 30, 2014.