Bill Text: NJ A1665 | 2016-2017 | Regular Session | Introduced
Bill Title: Creates Clinical Trials Working Group.
Spectrum: Partisan Bill (Democrat 3-0)
Status: (Introduced - Dead) 2016-01-27 - Introduced, Referred to Assembly Health and Senior Services Committee [A1665 Detail]
Download: New_Jersey-2016-A1665-Introduced.html
STATE OF NEW JERSEY
217th LEGISLATURE
PRE-FILED FOR INTRODUCTION IN THE 2016 SESSION
Sponsored by:
Assemblyman GARY S. SCHAER
District 36 (Bergen and Passaic)
Assemblyman TIM EUSTACE
District 38 (Bergen and Passaic)
Assemblyman DANIEL R. BENSON
District 14 (Mercer and Middlesex)
SYNOPSIS
Creates Clinical Trials Working Group.
CURRENT VERSION OF TEXT
Introduced Pending Technical Review by Legislative Counsel.
An Act creating a Clinical Trials Working Group.
Be It Enacted by the Senate and General Assembly of the State of New Jersey:
1. The Legislature finds and declares that historically, while New Jersey has been at the forefront of pharmaceutical research, development and manufacturing, when it comes time in the development of new drugs and pharmaceuticals to test them in a clinical setting, the companies that have developed those products have traditionally found it necessary to go out of State - to the medical centers of New York City and Philadelphia in particular - to run clinical trials. The Legislature further finds and declares that, with the modern-day wealth of institutions of higher education in the State, and the number of world class teaching and research hospitals in the State, some of which are connected to those institutions of higher education, more of those clinical trials should be staying in-State, through the collaborative efforts of the pharmaceutical manufacturers and the universities and hospitals which operate here in New Jersey.
2. There is established a Clinical Trials Working Group, hereinafter referred to as the "working group."
a. The working group shall be comprised of 15 members, as follows:
(1) four members from the higher education community, to include one member from Rutgers, the State University of New Jersey appointed by the President thereof, one member from Rowan University appointed by the President thereof, one member from the Rutgers Cancer Institute of New Jersey appointed by the director thereof, and one member representing an independent institution of higher education in New Jersey, to be appointed by the Governor;
(2) three members from New Jersey hospitals, to include one member from the staff of University Hospital appointed by the board of directors of the University Hospital, and two members to be appointed by the Senate President upon the recommendation of the New Jersey Hospital Association, one of whom shall represent a hospital from the northern geographic region of the State and one of whom shall represent a hospital from the southern geographic region of the State;
(3) four members representing pharmaceutical manufacturing companies in the State, which companies shall be members of the HealthCare Institute of New Jersey, which shall make recommendations as to these members. Of these four members, one shall be appointed by the Governor, one shall be appointed by the Speaker of the General Assembly, one shall be appointed by the Minority Leader of the General Assembly, and one shall be appointed by the Minority Leader of the Senate;
(4) two members representing
biotech companies operating in the State, which companies shall be members of
BioNJ, which shall make recommendations as to these members. One of these
members shall be appointed by the Speaker of the General Assembly and one shall
be appointed by the Minority Leader of the
Senate; and
(5) the Secretary of Higher Education and the Commissioner of Health, who shall serve ex-officio.
Vacancies in the membership of the working group shall be filled in the same manner as the original appointments were made.
b. The working group shall organize as soon as may be practicable after the appointment of a majority of its members and shall select a chairperson, from among the members representing pharmaceutical manufacturing companies in the State.
c. The members shall serve without compensation but shall be reimbursed for necessary expenses incurred in the performance of their duties and within the limits of funds made available to the working group.
d. The working group may meet and hold hearings at the places it designates during the sessions or recesses of the Legislature.
e. The working group shall be entitled to call to its assistance and avail itself of the services of the Office of Legislative Services, as it may require.
3. It shall be the duty of the working group to: study the reasons why historically, New Jersey's substantial pharmaceutical industry in general and the many New Jersey based pharmaceutical manufacturing companies in particular have had to look outside the State to find appropriate clinical trials for the drugs and medications they are developing and testing; identify any obstacles to collaborations between the public and private sectors, the higher education and health care communities, and the pharmaceutical industry in attempting to undertake such collaborations; and to make recommendations as to how the State, and its public and private institutions of higher education and health care facilities can be encouraged to collaborate in such endeavors and ways to eliminate such obstacles and facilitate such endeavors.
4. The working group shall
issue its report within six months of it initial meeting. The report shall be
submitted to the Governor, and to the Legislature pursuant to section 2 of
P.L.1991, c.164 (C.52:14-19.1). The report shall include the findings,
conclusions and recommendations of the working group for legislative or
administrative action, including, in particular, any recommendations for
legislation which would have, as its purpose, the undertaking of more clinical
trials within the State. The working group shall expire on the 30th
day after submitting its report.
5. This act shall take effect immediately.
STATEMENT
This bill creates the Clinical Trials Working Group to study why historically, New Jersey's pharmaceutical industry has had to look outside the State to find appropriate clinical trials for the drugs and medications which it develops and tests.
The working group will be made up of public and private sector representatives, some appointed from among the institutions and organizations they represent, and others to be appointed by the Governor or leadership of the Legislature.
In particular, the working group is charged with identifying obstacles to collaborations between the public and private sectors, the higher education and health care communities, and the pharmaceutical industry in attempting to undertake such collaborations; recommending ways in which the State, and its public and private institutions higher education and health care facilities, can be encouraged to collaborate in such endeavors; and ways to eliminate such obstacles and facilitate such endeavors.
The working group shall issue its report within six months of its initial meeting. The report shall be submitted to the Governor and the Legislature and include the findings, conclusions and recommendations of the working group for legislative or administrative action, including, in particular, any recommendations for legislation which would have, as its purpose, the undertaking of more clinical trials within the State.