Bill Text: NY A02631 | 2015-2016 | General Assembly | Amended
Bill Title: Creates the lupus research enhancement program; creates the lupus research enhancement fund.
Spectrum: Partisan Bill (Democrat 5-0)
Status: (Introduced - Dead) 2016-06-13 - print number 2631a [A02631 Detail]
Download: New_York-2015-A02631-Amended.html
STATE OF NEW YORK ________________________________________________________________________ 2631--A 2015-2016 Regular Sessions IN ASSEMBLY January 20, 2015 ___________ Introduced by M. of A. PEOPLES-STOKES, BRINDISI, TITONE, THIELE, McDO- NALD -- read once and referred to the Committee on Health -- recommit- ted to the Committee on Health in accordance with Assembly Rule 3, sec. 2 -- reported and referred to the Committee on Ways and Means -- committee discharged, bill amended, ordered reprinted as amended and recommitted to said committee AN ACT to amend the public health law, in relation to creating the lupus research enhancement program; and to amend the state finance law, in relation to creating the lupus research enhancement fund The People of the State of New York, represented in Senate and Assem- bly, do enact as follows: 1 Section 1. Article 2 of the public health law is amended by adding a 2 new title 4-A to read as follows: 3 TITLE IV-A 4 LUPUS RESEARCH ENHANCEMENT ACT 5 Section 256. Short title. 6 256-a. Legislative intent. 7 256-b. Definition. 8 256-c. Lupus research enhancement program. 9 256-d. Lupus research advisory council. 10 256-e. Lupus research enhancement fund. 11 § 256. Short title. This title shall be known and may be cited as the 12 "lupus research enhancement act". 13 § 256-a. Legislative intent. 1. The legislature hereby finds the 14 following: 15 (a) Lupus is a serious, complex, debilitating autoimmune disease that 16 can cause inflammation and tissue damage to virtually any organ system 17 in the body, including the skin, joints, other connective tissue, blood 18 and blood vessels, heart, lungs, kidney, and brain. EXPLANATION--Matter in italics (underscored) is new; matter in brackets [] is old law to be omitted. LBD01842-03-6A. 2631--A 2 1 (b) The Lupus Foundation of America, Inc. estimates that approximately 2 1.5 to two million Americans live with some form of lupus; lupus affects 3 women nine times more often than men and eighty percent of newly diag- 4 nosed cases of lupus develop among women of childbearing age. 5 (c) Lupus disproportionately affects women of color - it is two to 6 three times more common among African-Americans, Hispanics, Asians and 7 Native Americans and is generally more prevalent in minority populations 8 - a health disparity that remains unexplained. According to the Centers 9 for Disease Control and Prevention the rate of lupus mortality has 10 increased since the late nineteen seventies and is higher among older 11 African-American women. 12 (d) No new drugs have been approved by the U.S. Food and Drug Adminis- 13 tration specifically for lupus in nearly forty years, and while current 14 treatments for the disease can be effective, they can lead to damaging 15 side effects. 16 (e) The pain and fatigue associated with lupus can threaten people's 17 ability to live independently, make it difficult to maintain employment 18 and lead normal lives, and one in five people with lupus is disabled by 19 the disease, and consequently receives support from government programs, 20 including medicare, medicaid, social security disability, and social 21 security supplemental income. 22 (f) The estimated average annual cost of medical treatment for an 23 individual with lupus can range between ten thousand dollars and thirty 24 thousand dollars; for people who have the most serious form of lupus, 25 medical costs can greatly exceed this amount, causing a significant 26 economic, emotional and social burden to the entire family and society. 27 (g) More than half of the people with lupus suffer four or more years 28 and visit three or more physicians before obtaining a diagnosis of 29 lupus; early diagnosis of and commencement of treatment for lupus can 30 prevent or reduce serious organ damage, disability, and death. 31 (h) Despite the magnitude of lupus and its impact on individuals and 32 families, health professional and public understanding of lupus remains 33 low; only one of five Americans can provide even basic information about 34 lupus, and awareness of lupus is lowest among adults ages eighteen to 35 thirty-four - the age group most likely to develop symptoms of lupus. 36 (i) Lupus is a significant national health issue that deserves a 37 comprehensive and coordinated response by state and federal governments 38 with involvement of the health care provider, patient, and public health 39 communities. 40 2. The purposes of this title are: 41 (a) To promote basic and clinical research programs designed to reduce 42 or prevent suffering from lupus, by providing additional funding to 43 state academic medical institutions within the state currently conduct- 44 ing or having an interest in conducting basic and clinical, social, 45 translational, technological, epidemiological, and behavioral research 46 on lupus. Such activities may include: 47 (i) investigating the pathogenesis and physiology of lupus; 48 (ii) identifying and validating lupus biomarkers; 49 (iii) enhancing the statewide infrastructure to conduct clinical 50 trials of potential new lupus therapies; 51 (iv) developing or improving diagnostic tests for early detection of 52 lupus; and 53 (v) developing novel therapies to treat lupus. 54 (b) To establish a multidisciplinary lupus research advisory council 55 to monitor progress and make granting recommendations to the department.A. 2631--A 3 1 § 256-b. Definition. As used in this title, "program" shall mean the 2 lupus research enhancement program created pursuant to section two 3 hundred fifty-six-c of this title. 4 § 256-c. Lupus research enhancement program. 1. The commissioner shall 5 establish within the department a lupus research enhancement program 6 through which the department shall make grants to state academic medical 7 institutions within the state currently conducting or having an interest 8 in conducting basic and clinical, social, translational, technological, 9 epidemiological, and behavioral research on lupus. 10 2. All research funds shall be awarded on the basis of the research 11 priorities established for the program and the scientific merit of the 12 proposed research, as determined by an open, competitive peer review 13 process that ensures objectivity, consistency, and high quality. All 14 investigators, regardless of affiliation, shall have equal access and 15 opportunity to compete for program funds. 16 3. The peer review process for the selection of research grants 17 awarded under this program shall be modeled generally on that used by 18 the national institutes of health in its grant making process. 19 4. An awardee shall be awarded grants for the full cost, both direct 20 and indirect, of conducting the sponsored research consistent with those 21 federal guidelines governing all federal research grants and contracts. 22 All intellectual property assets developed under this program shall be 23 treated in accordance with state and federal law. 24 5. In establishing its research priorities, the state shall consult 25 with the lupus research advisory council and consider a broad range of 26 cross-disciplinary lupus research, including, but not limited to, 27 research into the cause, cure, and diagnosis of lupus; translational and 28 technological research, including research to develop improved diagnos- 29 tic tests; research regarding the cultural, economic, and legal barriers 30 to accessing the health care system for early detection and treatment of 31 lupus; and research examining the health disparities seen in the inci- 32 dence and prevalence of lupus. 33 § 256-d. Lupus research advisory council. 1. Operations. (a) The coun- 34 cil shall be comprised of fifteen members representing a broad range of 35 expertise and experience. 36 (b) Individuals and organizations may submit nominations to the 37 commissioner through the council. 38 (c) Each appointed council member should have familiarity with lupus 39 and issues that surround lupus and be one of the following: health and 40 medical professional with expertise in lupus; an individual with lupus; 41 a representative from a local or county health department; or a recog- 42 nized expert in the provision of health services to women, lupus 43 research or health disparities. 44 (d) The council shall be comprised as follows: 45 (i) at least three individuals with lupus; 46 (ii) no more than two representatives from the department; 47 (iii) at least five individuals from lupus nonprofit health organiza- 48 tions; and 49 (iv) at least five scientists or clinicians with experience in lupus 50 and who participate in various fields of scientific endeavor, including, 51 but not limited to, the fields of biomedical research, social, transla- 52 tional, behavioral and epidemiological research, and public health. 53 (e) All members of the council shall be appointed by the commissioner 54 and the commissioner shall choose from among the fifteen council members 55 one member to serve as chair.A. 2631--A 4 1 (f) All members of the council shall serve terms of two years each. 2 Members can be named to serve a total of two terms and terms can be 3 consecutive. 4 (g) Members shall serve without compensation, but shall be entitled to 5 actual, necessary expenses incurred in the performance of their business 6 as members of the council. 7 (h) A majority of the members of the council shall constitute a 8 quorum. A majority vote of a quorum shall be required for any official 9 action of the council. 10 (i) The council shall meet at the call of the chair, but not less than 11 four times per year. 12 2. Functions. The lupus research advisory council shall: 13 (a) review submitted grant applications and make recommendations to 14 the commissioner, and the commissioner shall, at his or her discretion, 15 grant approval of applications for grants from those applications recom- 16 mended by the council (if a council member submits an application for a 17 grant from the lupus research and education fund, he or she will be 18 prohibited from reviewing and making a recommendation on the applica- 19 tion); 20 (b) consult with the national institutes of health, centers for 21 disease control and prevention, the agency for healthcare research and 22 quality, the national academy of sciences (institute of medicine), lupus 23 advocacy groups, and other organizations or entities which may be 24 involved in lupus research to solicit both information regarding lupus 25 research projects that are currently being conducted and recommendations 26 for future research projects; and 27 (c) shall transmit annually on or before December thirty-first, a 28 report to the legislature on grants made, grants in progress, program 29 accomplishments, and future program directions. Each report shall 30 include, but not be limited to, the following information: 31 (i) the number and dollar amounts of research grants, including the 32 amount allocated to indirect costs; 33 (ii) the subject of research grants; 34 (iii) the relationship between federal and state funding for lupus 35 research; 36 (iv) the relationship between each project and the overall strategy of 37 the research program; 38 (v) a summary of research findings including discussion of promising 39 new areas; 40 (vi) the institutions and campuses receiving grant awards; and 41 (vii) the first annual report shall include an evaluation and recom- 42 mendations concerning the desirability and feasibility of requiring 43 for-profit grantees to compensate the state in the event that a grant 44 results in the development of a profit-making product. This evaluation 45 shall include, but not be limited to, the costs and benefits of requir- 46 ing a for-profit grantee to repay the grant, to provide the product at 47 cost to state programs serving low-income lupus patients, and to pay the 48 state a percentage of the royalties derived from the product. 49 3. Contributions. The secretary of the lupus research advisory council 50 may accept grants, services, and property from the federal government, 51 foundations, organizations, medical schools, and other entities as may 52 be available for the purposes of fulfilling the obligations of this 53 program. Any such funds shall supplement and not supplant appropriations 54 provided for the implementation of this article.A. 2631--A 5 1 4. Waivers. The secretary of the lupus research advisory council shall 2 seek any federal waiver or waivers that may be necessary to maximize 3 funds from the federal government to implement this program. 4 § 256-e. Lupus research enhancement fund. All moneys received pursuant 5 to section two hundred fifty-six-c of this title shall be credited to 6 the fund, as established by section ninety-five-i of the state finance 7 law. The commissioner shall use the fund to administer the lupus 8 research enhancement program and to make grants to awardees pursuant to 9 section two hundred fifty-six-c of this title. 10 § 2. The state finance law is amended by adding a new section 95-i to 11 read as follows: 12 § 95-i. Lupus research enhancement fund. 1. There is hereby estab- 13 lished in the joint custody of the commissioner of taxation and finance 14 and the comptroller, a special fund to be known as the "lupus research 15 enhancement fund". 16 2. Such fund shall consist of all monies appropriated for the purpose 17 of such fund and any grant, gift or bequest made to the lupus research 18 enhancement program as established by title four-A of article two of the 19 public health law. 20 3. Moneys of the fund shall be available for grants through the lupus 21 research enhancement program advisory council and for the expenses of 22 the lupus research enhancement program advisory council, and shall be 23 expended only for the purposes spelled out in sections two hundred 24 fifty-six-c and two hundred fifty-six-d of the public health law. 25 4. Moneys in the lupus research enhancement fund shall be kept sepa- 26 rate and shall not be commingled with any other moneys in the custody of 27 the commissioner of taxation and finance and the comptroller. 28 5. The moneys of the fund shall be paid out on the audit and warrant 29 of the comptroller on vouchers certified or approved by the commissioner 30 of health, or by an officer or employee of the department of health 31 designated by such commissioner. 32 § 3. This act shall take effect immediately.
