GENERAL ASSEMBLY OF NORTH CAROLINA

SESSION 2015

H                                                                                                                                                   2

HOUSE BILL 766

Committee Substitute Favorable 4/22/15

Short Title:        Amend CBD Oil Statute.	(Public)
Sponsors:
Referred to:

April 15, 2015

A BILL TO BE ENTITLED

AN ACT amending the exemption for use or possession of hemp extract and authorizing certain neurologists to use hemp extract as an alternative treatment for intractable epilepsy without participating in a pilot study.

The General Assembly of North Carolina enacts:

SECTION 1.  G.S. 90‑94.1(a) reads as rewritten:

"(a)       As used in this section, "hemp extract" means an extract from a cannabis plant, or a mixture or preparation containing cannabis plant material, that has all of the following characteristics:

(1)        Is composed of less than three‑tenths five‑tenths of one percent (0.3%) (0.5%) tetrahydrocannabinol by weight.

(2)        Is composed of at least ten five percent (10%) (5%) cannabidiol by weight.

(3)        Contains no other psychoactive substance."

SECTION 2.  G.S. 90‑113.100 reads as rewritten:

"§ 90‑113.100.  Short title.

(a)        This act may be cited as the "North Carolina Epilepsy Alternative Treatment Act."

(b)        The purpose of this act is to permit medical professionals to conduct limited‑scope, evidence‑based studies exploring the safety and efficacy of treating treat intractable epilepsy using hemp extract.

(c)        The General Assembly finds the following:

(1) There that there are children in this State suffering from intractable epilepsy for which currently available treatment options have been ineffective. Hemp extract shows promise in treating children with intractable epilepsy.

(2) Additional study of the use of hemp extract for the treatment of intractable epilepsy should be undertaken, and the medical research universities of the State of North Carolina are well‑suited for this type of clinical exploration."

SECTION 3.  G.S. 90‑113.101 reads as rewritten:

"§ 90‑113.101.  Definitions.

…

(g)        Neurologist. – An individual who is licensed under Article 1 of Chapter 90 of the General Statutes, who is board certified in neurology, and is affiliated with the neurology department at one or more of the following universities:hospitals licensed in this State.

(1) The University of North Carolina at Chapel Hill.

(2) East Carolina University.

(3) Duke University.

(4) Wake Forest University.

(h)        Patient. – A person who has been diagnosed by a neurologist with intractable epilepsy.

(i) Pilot Study. – An evidence‑based investigation of the safety and efficacy of treating intractable epilepsy using hemp extract conducted by one or more neurologists registered pursuant to this Article."

SECTION 4.  G.S. 90‑113.102 reads as rewritten:

"§ 90‑113.102.  Intractable Epilepsy Alternative Treatment Pilot Study database; departmental duties.

(a)        The Department shall create a secure, electronic, and online Intractable Epilepsy Alternative Treatment Pilot Study database registry for the registration of pilot studies, neurologists, caregivers, and patients as provided by this Article. The registry must be accessible to law enforcement agencies in order to verify registration of caregivers. The registry must prevent an active registration of a patient by multiple neurologists. At a minimum, the database shall consist of the following:

(1)        The name and address of each registered caregiver and the name of the pilot study the caregiver is associated with.caregiver.

(2)        The name and address of each registered patient and the name of the pilot study the patient is associated with.patient.

(3)        The name, address, and qualifying institutional hospital affiliation of neurologists conducting pilot studies approving, recommending, or providing hemp extract as an alternative treatment for intractable epilepsy pursuant to this Article.

(4) The name, institutional affiliation, affiliated registered neurologists, and parameters of pilot studies.

(b)        The Department shall contact the county department of health where the patient resides and provide the following information:

(1)        The name and address of the registered caregiver.

(2)        Identifying information contained on the caregiver registration card."

SECTION 5.  G.S. 90‑113.103 reads as rewritten:

"§ 90‑113.103.  Registration of pilot studies and neurologists.

(a)        A neurologist seeking to conduct a pilot study approve, recommend, or provide hemp extract for one or more patients as an alternative treatment to intractable epilepsy pursuant to this Article shall submit an application to the Department providing all of the following information:

(1)        The name of the pilot study.neurologist.

(2)        The affiliated research institution.name of the hospital with which the neurologist is affiliated.

(3) The scientific and clinical parameters of the study.

(4)        The An explanation of the treatment protocols established for approving, recommending, or providing hemp extract as an alternative treatment for intractable epilepsy to ensure patient safety.

(5) The name and address of the one or more neurologists associated with the pilot study.

(6)        Any other information deemed necessary by the Department to determine the safety and evidence‑based nature of the pilot study.protect patient safety.

(b)        The Department shall examine applications received pursuant to subsection (a) of this section and register in the database the proposed pilot studies that neurologists the Department certifies follow minimal scientific methods and protect patient safety.certifies to approve, recommend, or provide hemp extract for one or more patients as an alternative treatment for intractable epilepsy pursuant to this Article.

(c) The Department may monitor registered pilot studies to ensure continued adherence to patient safety protocols and the scientific parameters of the study."

SECTION 6.  G.S. 90‑113.104 reads as rewritten:

"§ 90‑113.104.  Caregiver registration card; application; fees.

(a)        The Department shall, in coordination with recommendations from the Department of Public Safety, establish the form and content of caregiver registration cards to be issued to individuals who satisfy the requirements set forth in this section.

(b)        The Department shall issue a caregiver registration card, valid for a period of one year from issuance, to an individual who satisfies all of the following criteria:

(1)        Is at least 18 years of age.

(2)        Is a resident of North Carolina.

(3)        Provides the Department with a statement signed by a neurologist conducting a pilot study that satisfies all of the following:

a.         Demonstrates that a patient in the caregiver's care satisfies all of the following criteria:

1.         Has been examined and is under the care of the neurologist.

2.         Suffers from intractable epilepsy.

3.         May benefit from treatment with hemp extract.

4. Is eligible for inclusion in the registered pilot study.

b.         Contains a recommendation for the use of hemp extract for treatment of intractable epilepsy as part of a registered pilot study.epilepsy.

c.         Is consistent with records received from the neurologist, concerning the patient, contained in the database described in G.S. 90‑113.102.

(4)        Pays the Department a fee, not to exceed fifty dollars ($50.00), established by the Department under G.S. 90‑113.106.

(5)        Submits an application to the Department that contains all of the following:

a.         The caregiver's name and address.

b.         The patient's name and address.

c.         A copy of the caregiver's valid government‑issued photo identification.

d.         Any additional information the Department finds necessary to implement this Article.

(c)        The Department shall renew a caregiver registration card upon certification from the caregiver and the neurologist that all information initially provided to the Department under subsection (b) of this section is current or has been updated to reflect any changes. The Department shall charge a fee for renewal of a caregiver registration card, not to exceed twenty‑five dollars ($25.00), established under G.S. 90‑113.106."

SECTION 7.  G.S. 90‑113.105 reads as rewritten:

"§ 90‑113.105.  Immunity for neurologists; medical records.

(a)        On a case‑by‑case basis, neurologists conducting a registered pilot study may approve of dispensation to a registered caregiver, as approved by this Article, hemp extract acquired from another jurisdiction.

(b)        A neurologist shall not be subject to arrest or prosecution, penalized or disciplined in any manner, or denied any right or privilege for approving or recommending the use of hemp extract or providing a written statement or health records to the Department for the use of hemp extract pursuant to this Article.

(c)        A neurologist conducting a registered pilot study who signs a statement as described in G.S. 90‑113.104(b)(3) shall do the following:

(1)        Keep a record of the evaluation and observation of a patient under the neurologist's care, including the patient's response to hemp extract treatment.

(2)        Transmit the record described in subdivision (1) of this subsection to the Department upon request.

(d)        All medical records received or maintained by the Department pursuant to this Article are confidential and may not be disclosed to the public. Nothing in this Article is intended to alter the provisions of G.S. 8‑53 or G.S. 8‑53.1."

SECTION 8.  This act is effective when it becomes law.