Whereas, The deferred operation of this act would tend to defeat its purpose, which is immediately to provide for the orderly transition of the biologic laboratories of the state laboratory institute, so-called, from the department of public health to the University of Massachusetts so as to enable said laboratories to maintain their public purpose, preserve their ability to compete in an increasingly competitive marketplace and maximize their value to the commonwealth, it is hereby declared to be an emergency law, necessary for immediate preservation of the public health and convenience.
Be it enacted by the Senate and House of Representatives
in General Court assembled, and by the authority of the same,
SECTION 1. Chapter 75 of the General Laws, as appearing in the 1994 Official Edition, is hereby amended by adding the following new section:-
Section 43. (a) There is hereby established the University of Massachusetts biologic laboratories. The purpose of said laboratories shall be the research, development and production of childhood vaccines and biologic products designed to reduce or prevent morbidity and mortality in the commonwealth, including but not limited to those products which may be of little or no interest to commercial manufacturers and are therefore otherwise substantially unavailable to the citizens of the commonwealth. The biologic laboratories shall operate pursuant to this chapter and in accordance with regulations promulgated thereunder.
(b) There shall be an advisory board to advise the president and the board of trustees of the university with respect to the operation of the biologic laboratories. The advisory board shall meet at least twice per year, and at such other times as are necessary to effectuate its purpose. The advisory board shall consist of the following members: the commissioner of public health or his designee, the director of the childhood immunization program of the department of public health, the deans of the medical school and the school of public health of the university or their designees, and at least three but not more than five additional members appointed by the president of the university, including a consumer and a practicing pediatrician or other physician specializing in family medicine. Each advisory board member appointed by the president of the university shall serve for a term of five years, provided, however, that in making initial appointments, the president shall appoint one or two members for a term of three years and one or two members for a term of four years. Appointed members of the advisory board shall be eligible for reappointment and may be removed by the president of the university during their terms for cause.
(c) The university shall obtain liability insurance sufficient to indemnify the commonwealth, the university and the biologic laboratories, and their officers and employees, for any liability arising from the out-of-state sale, distribution and use of laboratory products, and to indemnify the commonwealth for any liability arising under chapter two hundred and fifty-eight as a result of any activities of the laboratories.
(d) The board of trustees may authorize the biologic laboratories to enter into agreements with private parties with respect to the research, development and production of vaccines and other biologic products; provided, however, that the board, in consultation with the advisory board, shall develop and follow written criteria for affording a preference to private companies that agree to conduct such research, development or production, or a substantial portion thereof, in the commonwealth.
(e) Any trade secret or other proprietary information of the biologic laboratories shall be exempt from the definition of public records in clause twenty-sixth of section seven of chapter four.
(f) The director of the biologic laboratories shall submit to the clerks of the senate and the house of representatives a detailed report of the activities of the laboratories within ninety days after the end of each fiscal year. Said report shall include for the prior fiscal year a description of the patents and licenses received, agreements entered into, the status of existing agreements, royalties and other benefits received as a result of the work of the biologic laboratories, expenditures, current assets and liabilities of the laboratories, one-year and five-year financial plans and identification of current and projected revenues and expenses, anticipated capital expenditures and start-up expenses.
Said report shall include an accounting statement detailing the receipts and expenditures, including obligations whether paid or unpaid, of appropriated funds for the prior fiscal year and shall include projections of the amount of appropriated funds required for the next three years.
Pursuant to section twelve of chapter eleven, the department of the state auditor shall conduct an audit of the biologic laboratories no less than once every two years.
(g) The university shall maintain on its books a separate account for the biologic laboratories. All revenues generated by the activities of the biologic laboratories shall be deposited in a separate special trust established pursuant to section eleven; provided, however, that expenditures made from said trust fund shall be exclusively for the purposes of the biologic laboratories established in subsection (a).
(h) The advisory board shall be consulted prior to the appointment of a chief executive officer of the biologic laboratories. The chief executive officer shall present budgets, staffing plans, operating plans and production plans to the advisory board for its review and comment.
SECTION 2. On and after January first, nineteen hundred and ninety-seven, or such earlier date as may be agreed pursuant to section three, for the purpose of section forty-three of chapter seventy-five of the General Laws, the University of Massachusetts biologic laboratories shall include those laboratories within the state laboratory institute, so-called, formerly within the department of public health which, prior to the effective date of this act, researched, developed and produced vaccines and other biologic products.
SECTION 3. (a) On or before January first, nineteen hundred and ninety-seven, the university and the department of public health shall enter into a written agreement for the permanent transfer of control to or use by the university of such facilities, space, equipment and other property, including intellectual property rights, as may be necessary or appropriate to fulfill the purposes of this act. Said transfer or change of use shall occur on January first, nineteen hundred and ninety-seven, or such earlier date as may be agreed by the department of public health and the university. Intellectual property as used in this section shall include, but not be limited to, the federal Food and Drug Administration (FDA) Establishment License # 64 to manufacture drugs, any supplements to such license that the FDA has awarded or may award in conjunction with product licenses, all FDA product licenses and all patents, copyrights, and records, notes and other documents related to the development of vaccines and immune globulins. Said agreement shall include provision for fair reimbursement to the department by the university for out-of-pocket costs associated with the university's on-going access or use of facilities under the control of the department. Said agreement shall also provide for full and fair reimbursement to the commonwealth for any access or use of said property that may granted to any private parties, and shall be consistent with the requirements of law. Said agreement shall be provided on a timely basis prior to its execution or effective date, whichever is earlier, to the inspector general, for his prompt review and written comments. The university and the department of public health shall not execute said agreement until they have reviewed any written comments from the inspector general.
Said agreement shall be subject to the prior review and approval of the secretary of administration and finance.
(b) Employees of the commonwealth employed at the biologic laboratories within the state laboratory institute of the department of public health as of January first, nineteen hundred and ninety-seven, or such earlier date as may be agreed pursuant to subsection (a), shall become employees of the university, with no impairment of status, wages, seniority, retirement or other rights or benefits, subject to the requirements of chapter one hundred and fifty E; provided, however, that the employees to be so transferred or their collective bargaining representatives shall be given at least thirty days advance written notice of such transfer; provided, further, that on or after the effective date of such transfer, said employees shall be subject to such policies of the university as have been duly adopted pursuant to section fourteen A of chapter seventy-five; provided, further, that such policies shall not be applied to said employees unless and until such policies have been reviewed and commented on by the inspector general, and the university has thereafter provided adequate notice and an opportunity to bargain with the collective bargaining representatives of the affected employees, pursuant to chapter one hundred and fifty-one E, with respect to the impact of applying said policies to said employees. Said employees shall retain the rights and obligations of any collective bargaining agreements applicable to them at the time of transfer, and shall continue to be represented by the employee organizations which are parties to such agreements until such time as said employees may elect to be otherwise represented or until such time as another employee representative is otherwise certified in accordance with the provisions of chapter one hundred and fifty E.
(c) On January first, nineteen hundred and ninety-seven, or such earlier date as may be agreed pursuant to subsection (a), the university shall assume all rights, obligations and duties under existing contracts, agreements, memoranda of understanding, leases or other legal requirements to which the biologic laboratories of the department of public health are parties. All royalties, revenues and other payments due to the commonwealth under said agreements and memoranda shall continue to be paid to the commonwealth. No existing right, claim to royalties, revenues or other payments, or remedy, whether contested or uncontested, shall be lost, impaired or in any way affected by this act, and nothing in this act shall diminish or otherwise adversely affect the proprietary interest, if any, of the commonwealth in any patent issued prior to the effective date of this act by the United States Patent and Trademark Office to any person currently or formerly employed on either a full or part-time basis at the state biologic laboratories.
(d) Effective January first, nineteen hundred and ninety-seven, or such earlier date as may be agreed pursuant to subsection (a), the comptroller shall transfer to the account established for the biological laboratories within the university the balance of all state funds for the fiscal year ending June thirty-first, nineteen hundred and ninety-seven previously appropriated to the department of public health for research, development or production of childhood vaccines and other biologics products by the biologics laboratories, and said funds shall be available for expenditure by the university for the purposes for which the funds were originally appropriated and for the purposes of this act.
SECTION 4. The university and the commissioner of public health shall submit to the clerks of the senate and house of representatives on or before November fifteenth, nineteen hundred and ninety-six proposals for any amendments to the provisions of this act which are necessary and appropriate to fulfill the purposes of this act in a manner most consistent with the public interest, including any necessary or appropriate amendments to the requirements contained in sections two and three.
SECTION 5. Notwithstanding any general or special law to the contrary, at any such time as a new facility is needed by the University of Massachusetts biologic laboratories for the research, development or production of biologic products, such facility shall be located on at the Boston State Hospital campus in the Dorchester-Mattapan section of Boston, unless the president and the board of trustees of the university make a written determination, supported by specific factual findings, that such location is substantially less cost efficient or substantially less appropriate for operational reasons than an alternative site in the commonwealth.