Reorganize & Fund Rare Disease Adv. Council.

GENERAL ASSEMBLY OF NORTH CAROLINA
SESSION 2025
H 1
HOUSE BILL 525

Short Title: Reorganize & Fund Rare Disease Adv. Council. (Public)
Sponsors: Representatives Carney, Lambeth, Belk, and Cunningham (Primary Sponsors).
For a complete list of sponsors, refer to the North Carolina General Assembly web site.
Referred to: Appropriations, if favorable, Rules, Calendar, and Operations of the House
March 27, 2025
*H525-v-1*
A BILL TO BE ENTITLED 1
AN ACT REVISING THE COMPOSITION AND DUTIES OF THE ADVISORY C OUNCIL 2
ON RARE DISEASES; TR ANSFERRING THE COUNCIL TO THE DEPARTMENT OF 3
HEALTH AND HUMAN SER VICES; AND APPROPRIA TING FUNDS TO THE 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES TO COVER THE OPERATING 5
EXPENSES OF THE COUNCIL. 6
The General Assembly of North Carolina enacts: 7
SECTION 1. Part 6 of Article 1B of Chapter 130A of the General Statutes reads as 8
rewritten: 9
"Part 6. Taylor's Law Establishing the Advisory Council on Rare Diseases. 10
"§ 130A-33.65. Advisory Council on Rare Diseases; membership; terms; compensation; 11
meetings; quorum. 12
(a) Short Title. – This Part shall be known as Taylor 's Law Establishing the Advisory 13
Council on Rare Diseases. 14
(a1) Establishment of Advisory Council. – There is established the Advisory Council on 15
Rare Diseases within the School of Medicine of the University of North Carolina at Chapel Hill 16
Department of Health and Human Services to advise the Governor, the Secretary, and the General 17
Assembly on research, diagnosis, treatment, and education relating to rare diseases. This Part 18
shall be known as Taylor's Law Establishing the Advisory Council on Rare Diseases. For 19
purposes of this Part, "rare disease" has the same meaning as provided in 21 U.S.C. § 360bb. 20
(b) Advisory Council Membership. – The advisory council shall consist of 19 members 21
to be appointed as follows: 22
(1) Upon the recommendation of the Dean of the School of Medicine of t he 23
University of North Carolina at Chapel Hill, the The Secretary shall appoint 24
members to the advisory council as follows:the following 15 members: 25
a. A physician Two physicians licensed and practicing in this State with 26
experience researching, diagnosing, or treating rare diseases. 27
b. A medical researcher with experience conducting research concerning 28
rare diseases. 29
c. A One registered nurse or advanced practice registered nurse licensed 30
and practicing in the State with experience treating rare diseases. 31
d. One rare diseases survivor. 32
e. One member who represents a rare diseases foundation. 33
General Assembly Of North Carolina Session 2025
Page 2 House Bill 525-First Edition
f. One representative researcher from each an academic research 1
institution in this State that receives any grant funding for rare diseases 2
research. 3
g. One parent of a childhood rare disease survivor. 4
h. One hospital administrator , or the hospital administrator 's designee, 5
representing a hospital in the State that provides care to persons 6
diagnosed with a rare disease. 7
i. Two persons age 18 or older who have been diagnosed with a rare 8
disease. 9
j. Two persons age 18 o r older who are, or were previously, caregivers 10
to a person diagnosed with a rare disease. 11
k. One representative of a rare disease patient organization that operates 12
in the State. 13
l. One pharmacist licensed and practicing in this State with knowledge 14
and experience regarding drugs used to treat rare diseases. 15
m. One representative of the life sciences , biotechnology, or 16
biopharmaceutical industry that either focus es on research efforts 17
related to th e development of therapeutic products for persons 18
diagnosed with a rare disease or has demonstratable understanding of 19
the path to commercialization of such products. 20
n. Two representatives of a health benefit plan or health insurer , at least 21
one of whom is a representative of a North Carolina Medicaid 22
Managed Care health plan. 23
o. One genetic counselor with experience providing services to persons 24
diagnosed with a rare disease or caregivers of persons diagnosed with 25
a rare disease. 26
(2) The chairs of the Joint Legislative Oversight Committee on Health and Human 27
Services, or the chairs' designees, shall serve on the advisory council. A 28
member of the advisory council who is designated by the chairs of the Joint 29
Legislative Oversight Com mittee on Health and Human Services may be a 30
member of the General Assembly. 31
(2a) One member appointed by the President Pro Tempore of the Senate. 32
(2b) One member appointed by the Speaker of the House of Representatives. 33
(2c) One member appointed by the Governor. 34
(3) The Secretary, or the Secretary's designee, shall serve as an ex officio, 35
nonvoting member of the advisory council. 36
(c) Members Length of Terms. – All initial members appointed pursuant to subsection 37
(b) of this section to the advisory council shall serve for a term of three years, and no member 38
initial member, except for the initial physician member s and the initial member representing a 39
rare disease patient organization , shall serve more than three consecutive terms. The initial 40
physician members and the initial member representing a rare disease patient or ganization may 41
serve for up to four consecutive terms. Thereafter, members appointed by the President Pro 42
Tempore of the Senate , the Speaker of the House of Representatives, and the Governor shall 43
serve for a term of two years; and members appointed by the Secretary shall serve for a term of 44
two, three, or four years, as determined by the chair of the advisory council. 45
(c1) Vacancies and Removals. – Any appointment to fill a vacancy on the advisory council 46
created by the resignation, dismissal, death, or disability of a member shall be filled by the 47
appointing authority for the balance of the unexpired term. Each appointing authority may 48
remove any member appointed by that appointing authority for misfeasance, malfeasance, or 49
nonfeasance. 50
General Assembly Of North Carolina Session 2025
House Bill 525-First Edition Page 3
(d) Per Diem and Expenses. – Members of the advisory council shall receive per diem 1
and necessary travel and subsistence expenses in accordance with the provisions of G.S . 138-5 2
or G.S. 138-6 or travel and subsistence expenses in accordance with the provisions of 3
G.S. 120-3.1, as applicable. 4
(e) Administrative Support. – All administrative support and other services required by 5
the advisory council shall be provided by the School of Medicine of the University of North 6
Carolina at Chapel Hill.Department. 7
(f) Upon the recommendation of the Dean of the School of Medicine of the University 8
of North Carolina at Chapel Hill, Selection of Chair. – The Secretary shall select the chair of the 9
advisory council from among the members of the council. The chair shall serve in this position 10
until the expiration of his or her term. 11
(g) The chair shall convene the first meeting of the advisory council no later than October 12
1, 2015. Meetings and Quorum. – A majority of the council members shall constitute a quorum. 13
A majority vote of a quorum shall be required for any official action of the advisory council. 14
Following the first meeting, the advisory council shall meet at least quarterly . The advisory 15
council may meet more frequently upon the call of the chair or upon the request of a majority of 16
council members. 17
"§ 130A-33.66. Advisory Council on Rare Diseases; powers and duties; reports. 18
The advisory council shall have the following powers and duties: 19
(1) Advise on coordinating the Governor, the Secretary, and the General 20
Assembly on all of the following: 21
a. Coordination of statewide efforts for the to study of the incidence of 22
rare diseases within the State and the status of the rare disease 23
community. 24
b. Coordination of statewide efforts to increase public awareness and 25
understanding of rare diseases. 26
c. Identification of p olicy issues related to rare diseases and the 27
advancement of policy initiatives related to rare diseases at the State 28
and federal levels. 29
d. The appropriation of State funds to facilitate increased public 30
awareness of and improved treatment for rare diseases. 31
(2) Report to the Secretary, the Governor, and the Joint Legislative Oversight 32
Committee on Health and Human Services Services, and the Fiscal Research 33
Division on behalf of the General Assembly not later than January 1, 2016, 34
and annually thereafter, on the activities of the advisory council and its 35
findings and recommendations regarding rare disease research an d care in 36
North Carolina, including any recommendations for statutory changes and 37
amendments to the structure, organization, and powers or duties of the 38
advisory council. 39
(3) In consultation with accredited medical schools, accredited schools of public 40
health, and hospitals licensed to operate in the State that provide care to 41
persons diagnosed with a rare disease, develop resources or recommendations 42
regarding quality of and access to treatment and services available within the 43
State for persons diagnosed with a rare disease. 44
(4) Advise and consult with the Department, the North Carolina Drug Utilization 45
Review Board , and the Medicaid Preferred Drug List Review Panel in 46
developing recommendations, resources, and programs relating to the 47
diagnosis and treatment of rare diseases. 48
(5) Identify additional relevant areas for the advisory council to study and 49
evaluate." 50
General Assembly Of North Carolina Session 2025
Page 4 House Bill 525-First Edition
SECTION 2. Effective July 1, 2025, there is appropriated from the General Fund to 1
the Department of Health and Human Services the sum of two hundred fifty thousand dollars 2
($250,000) in recurring funds for the 2025 -2026 fiscal year and the sum of two hundred fifty 3
thousand dollars ($250,000) in recurring funds for the 2026 -2027 fiscal year to be allocated to 4
cover the operating expenses of the Advisory Council on Rare Diseases authorized by Section 1 5
of this act. 6
SECTION 3. Except as otherwise provided, this act is effective when it becomes 7
law. 8