AN ACT revising the composition and duties of the advisory council on rare diseases.

The General Assembly of North Carolina enacts:

SECTION 1.(a)  Part 6 of Article 1B of Chapter 130A of the General Statutes reads as rewritten:

Part 6. Taylor's Law Establishing the Advisory Council on Rare Diseases.

§ 130A‑33.65.  Advisory Council on Rare Diseases; membership; terms; compensation; meetings; quorum.

(a)        Short Title. – This Part shall be known as Taylor's Law Establishing the Advisory Council on Rare Diseases.

(a1)      Establishment of Advisory Council. – There is established the Advisory Council on Rare Diseases within the School of Medicine of the University of North Carolina at Chapel Hill Department of Health and Human Services to advise the Governor, the Secretary, and the General Assembly on research, diagnosis, treatment, and education relating to rare diseases. This Part shall be known as Taylor's Law Establishing the Advisory Council on Rare Diseases. For purposes of this Part, rare disease has the same meaning as provided in 21 U.S.C. § 360bb.

(b)        Advisory Council Membership. – The advisory council shall consist of 22 members to be appointed as follows:

(1)        Upon the recommendation of the Dean of the School of Medicine of the University of North Carolina at Chapel Hill, the The Secretary shall appoint members to the advisory council as follows:the following 19 members:

a.         A physician Three physicians licensed and practicing in this State with experience researching, diagnosing, or treating rare diseases. One member shall serve for a term of four years, one member shall serve for a term of three years, and one member shall serve for a term of two years.

b.         A medical researcher with experience conducting research concerning rare diseases. This member shall serve for a term of two years.

c.         A registered nurse or advanced practice registered nurse licensed and practicing in the State with experience treating rare diseases. This member shall serve for a term of three years.

d.         One rare diseases survivor.

e.         One member who represents a rare diseases foundation.

f.          One representative from each academic research institution in this State that receives any grant funding for rare diseases research.

g.         One parent of a childhood rare disease survivor.

h.         Two hospital administrators representing hospitals in the State that provide care to persons diagnosed with a rare disease, or their designees. At least one of the hospital administrators appointed pursuant to this sub‑subdivision shall represent a hospital with a scope of service that focuses on the treatment of pediatric patients diagnosed with a rare disease. These members shall serve for a term of two years.

i.          Three persons age 18 or older who (i) have been diagnosed with a rare disease or (ii) are currently caregivers to a person diagnosed with a rare disease. These members shall serve for a term of four years.

j.          A representative of a rare disease patient organization that operates in the State. This member shall serve for a term of four years.

k.         A social worker licensed and practicing in this State with experience providing services to persons diagnosed with a rare disease. This member shall serve for a term of three years.

l.          A pharmacist licensed and practicing in this State with knowledge and experience regarding drugs used to treat rare diseases. This member shall serve for a term of two years.

m.        A licensed dentist practicing in this State with experience treating persons diagnosed with a rare disease. This member shall serve for a term of three years.

n.         Two representatives of the life sciences industry that either focus on research efforts related to the development of therapeutic products for persons diagnosed with a rare disease or have a demonstratable understanding of the path to commercialization of such products. At least one of these representatives shall be currently employed in the life sciences industry as a professional patient advocate. These members shall serve for a term of two years.

o.         A representative of the biotechnology industry. This member shall serve for a term of two years.

p.         A representative of a health benefit plan or health insurer. This member shall serve for a term of two years.

q.         A genetic counselor with experience providing services to persons diagnosed with a rare disease or caregivers of persons diagnosed with a rare disease. This member shall serve for a term of three years.

(2)        The chairs of the Joint Legislative Oversight Committee on Health and Human Services, or the chairs' designees, shall serve on the advisory council. A member of the advisory council who is designated by the chairs of the Joint Legislative Oversight Committee on Health and Human Services may shall be a member of the General Assembly.

(3)        The Secretary, or the Secretary's designee, shall serve as an ex officio, nonvoting member of the advisory council.

(c)        Members Length of Terms. – All initial members appointed pursuant to subsection (b) of this section to the advisory council shall serve for a term of three years, and no member initial member, except for the initial physician member, shall serve more than three consecutive terms. The initial physician member may serve for up to four consecutive terms. Thereafter, members appointed to the advisory council shall serve for the length of time specified in subsection (b) of this section.

(c1)      Vacancies and Removals. – Any appointment to fill a vacancy on the advisory council created by the resignation, dismissal, death, or disability of a member shall be filled by the appointing authority for the balance of the unexpired term. Each appointing authority may remove any member appointed by that appointing authority for misfeasance, malfeasance, or nonfeasance. As used in this section, the term appointing authority means the Secretary, in the case of members appointed by the Secretary; and the cochairs of the Joint Legislative Oversight Committee on Health and Human Services, in the case of members appointed by said cochairs.

(d)       Per Diem and Expenses. – Members of the advisory council shall receive per diem and necessary travel and subsistence expenses in accordance with the provisions of G.S. 138‑5 or G.S. 138‑6 or travel and subsistence expenses in accordance with the provisions of G.S. 120‑3.1, as applicable.

(e)        Administrative Support. – All administrative support and other services required by the advisory council shall be provided by the School of Medicine of the University of North Carolina at Chapel Hill.Department.

(f)        Upon the recommendation of the Dean of the School of Medicine of the University of North Carolina at Chapel Hill, the Secretary shall select the chair of the advisory council from among the members of the council.Selection of Chair. – The advisory council members shall elect a chair from among its members by a majority vote. The chair shall serve in this position until his or her term expires, or until a successor is elected by a majority vote of the advisory council members.

(g)        The chair shall convene the first meeting of the advisory council no later than October 1, 2015. Meetings and Quorum. – A majority of the council members shall constitute a quorum. A majority vote of a quorum shall be required for any official action of the advisory council. Following the first meeting, the advisory council shall meet at least quarterly. The advisory council may meet more frequently upon the call of the chair or upon the request of a majority of council members.

§ 130A‑33.66.  Advisory Council on Rare Diseases; powers and duties; reports.

The advisory council shall have the following powers and duties:

(1)        Advise coordinating the Governor, the Secretary, and the General Assembly on all of the following:

a.         Coordination of statewide efforts for the to study of the incidence of rare diseases within the State and the status of the rare disease community.

b.         Coordination of statewide efforts to increase public awareness and understanding of rare diseases.

c.         Identification of policy issues related to rare diseases and the advancement of policy initiatives related to rare diseases at the State and federal levels.

d.         The appropriation of State funds to facilitate increased public awareness of and improved treatment for rare diseases.

(2)        Report to the Secretary, the Governor, and the Joint Legislative Oversight Committee on Health and Human Services on behalf of the General Assembly not later than January 1, 2016, and annually thereafter, on the activities of the advisory council and its findings and recommendations regarding rare disease research and care in North Carolina, including any recommendations for statutory changes and amendments to the structure, organization, and powers or duties of the advisory council.

(3)        In consultation with accredited medical schools located in this State, accredited colleges and universities located in this State with master's level public health programs, and hospitals licensed to operate in this State that provide care to persons diagnosed with a rare disease, develop resources or recommendations regarding quality of and access to treatment and services available within North Carolina for persons diagnosed with a rare disease.

(4)        Advise and consult with the Department, the North Carolina Drug Utilization Review Board, and the Medicaid and NC Health Choice Preferred Drug List Review Panel in developing recommendations, resources, and programs relating to the diagnosis and treatment of rare diseases.

(5)        Identify additional relevant areas for the advisory council to study and evaluate.

SECTION 1.(b)  To minimize the impact of this act on the work of the Advisory Council on Rare Diseases:

(1)        By September 1, 2023, the Secretary of Health and Human Services shall appoint new members to the advisory council as authorized by subdivision (b)(1) of G.S. 130A‑33.65, as amended by this act;

(2)        By September 1, 2023, the cochairs of the Joint Legislative Oversight Committee on Health and Human Services shall appoint any designees to the advisory council as authorized by subdivision (b)(2) of G.S. 130A‑33.65, as amended by this act; and

(3)        By October 1, 2023, the chair of the Advisory Council on Rare Diseases shall convene the first meeting of the newly constituted advisory council.

SECTION 2.  This act is effective when it becomes law.