SENATE, No. 2027

The Commonwealth of Massachusetts

In the Year Two Thousand and Five.

AN ACT RELATIVE TO BIOTECHNOLOGY.

SECTION 1. The General Court finds and declares that:

(a) human embryonic stem cell research, and other research in the life sciences and regenerative medicine present a significant chance of yielding fundamental biological knowledge from which may emanate therapies to relieve, on a large scale, human suffering from disease and injury;

(b) the extraordinary biomedical scientists working in the Commonwealth within institutions of higher education, research institutes, hospitals, biotechnology companies and pharmaceutical companies can contribute significantly to the welfare of mankind by performing outstanding research in these fields; and

(c) it shall be the policy of the Commonwealth to actively foster research and therapies in the life sciences and regenerative medicine by authorizing research and clinical applications involving the derivation and use of human embryonic stem cells, placental and umbilical cord cells and human adult stem cells, including research and clinical applications involving somatic cell nuclear transplantation.

SECTION 2. The General Laws are hereby amended by inserting after Chapter 111I the following chapter:-

Chapter 111J
REGULATION OF THE BIOTECHNOLOGY INDUSTRY IN THE COMMONWEALTH

Section 1. As used in this chapter the following words shall have the following meanings:-

"Adult Stem Cell", an undifferentiated cell found in a differentiated tissue that can renew itself and differentiate to yield specialized cell types of the tissue from which it originated.

"Asexual Reproduction", reproduction not initiated by the union of an oocyte and sperm.

"Blastocyst", a preimplantation embryo consisting of cells that are organized into an inner and outer cell layer surrounding a fluid filled cavity. The cells of the inner layer, from which embryonic stem cells are derived, consist of undifferentiated cells that have the potential to become any type of cell in the human body.

"Commissioner", the commissioner of the department of public health.

"Council", the biomedical research advisory council.

"Department", the department of public health.

"Donated to Research", when, in the absence of remuneration, and after fulfillment of the requirements of applicable federal and state law concerning informed consent, the person or persons from whose cells the embryo has originated or will originate gives the embryo or cells to another person with the limitations that the recipient(s) shall use the extant or resultant embryo in biomedical research, and shall not transfer the embryo to a uterus or nurture the embryo beyond fourteen days development.

"Embryo", an organism of the species homo-sapiens from the single cell stage to eight weeks development whether formed by fertilization, somatic cell nuclear transfer, parthenogenesis, or other means.

"Extracorporeal embryo", an embryo formed and maintained outside of the human body.

"Fertilization", the process whereby the male and female gametes unite to form an embryo.

"Gametes", a sperm or oocyte.

"Informed Consent", the written consent of the donor or patient obtained in accordance with the "donated for research" requirements and of 45 CFR 46.116 and 45 CFR 46.117, as may be amended from time to time.

"Institution", a corporation, association, partnership, nonprofit organization, or other legal entity which appoints or retains an Institutional Review Board to approve research authorized by this chapter.

"Institutional Review Board", a board established in accordance with the requirements of 45 CFR 46 Subpart A, as may be amended from time to time.

"In vitro fertilization", an assisted reproduction technique in which fertilization is accomplished outside of the human body.

"Person", any natural person, corporation, association, partnership or other legal entity.

"Placental Cells", cells derived from the placenta.

"Reproductive Cloning", the asexual genetic replication of a human being by transferring an extracorporeal embryo that has been created by somatic cell nuclear transfer into a uterus or substitute for a uterus with the purpose of creating a human fetus or a human child.

"Somatic Cell", a nongamete cell obtained or derived from a living or deceased human being.

"Somatic Cell Nuclear Transfer", the technique in which the nucleus of an oocyte is replaced with the nucleus of a somatic cell and stimulated to divide until it reaches the blastocyst stage from which stem cells can be derived.

"Umbilical Cord Stem Cells", cells derived from an umbilical cord.

"Uterus", includes a uterus, an artificial uterus, or fallopian tube.

"Valuable Consideration", includes any interest, profit or benefit of value, but shall not include reasonable payment for the removal, processing, disposal, preservation, quality control, storage, transplantation, or implantation of gametes, embryonic or cadeveric fetal tissue.

Section 2.

(a) Research involving the derivation and use of human embryonic stem cells, including somatic cell nuclear transfer, human adult stem cells from any source, umbilical cord stem cells, and placental cells shall be permitted. Said research shall only be conducted upon the written approval of a duly authorized Institutional Review Board. The written approval of the Institutional Review Board shall include a detailed description of the research, experimentation or study to be conducted and a detailed description of the research or a copy of the protocol all of which shall be maintained as a permanent record by such Board or by the hospital or institution for which the Board acts. In addition to the approval process described above, the Institutional Review Board shall consider the ethical and medical implications of the proposed research.

(b) An institution may be liable if an Institutional Review Board appointed by said institution knowingly votes to authorize research prohibited by this statute. The Department of Public Health may assess a civil administrative penalty of not more than one hundred thousand dollars after an adjudicatory proceeding conducted pursuant to the provisions of chapter 30A.

(c) No person shall knowingly engage in, or directly or indirectly assist in, research that violates the provisions of this section. A person who violates the provisions of this section shall be punished by imprisonment in a jail or house of correction for not less than one year nor more than two and one-half years or by imprisonment in the state prison for not more than five years and by the imposition of a fine of up to one hundred thousand dollars.

Section 3. A physician or other health care provider who treats a patient with in vitro fertilization therapy shall provide the patient with timely information sufficient to allow that patient to make an informed and voluntary choice regarding the disposition of any extracorporeal embryos or gametes remaining following said treatment.
A patient to whom information is provided pursuant to paragraph 1 of this section shall be presented with the option of storing, donating to another person for reproduction, donating for research purposes, or otherwise disposing of any unused extracorporeal embryos or gametes. A person who elects to donate any extracorporeal embryos or gametes remaining after receiving in vitro fertilization therapy shall provide informed consent for said donation.

Section 4.

(a) Any hospital or medical facility licensed pursuant to chapter 111 shall make known to a maternity patient the option of donating the blood extracted from the umbilical cord or placenta of the patient's newborn child to a certified public cord blood bank. Said hospital or medical facility, unless it is medically inadvisable, and only after the informed consent of the patient is obtained, shall permit said patient to arrange for the donation of the blood extracted from the umbilical cord or placenta of the patient's newborn child to a certified public cord blood bank. A patient who donates umbilical cord or placental blood to a public cord blood bank shall not receive any valuable consideration for said donation. Nothing in this section shall prohibit a maternity patient from donating or storing blood extracted from the umbilical cord or placenta of said patient's newborn child to a private umbilical cord blood bank.

(b) A hospital or hospital employee, including a physician, nurse, or other medical staff, shall not be required to collect umbilical cord or placental blood if said collection conflicts with the bona fide religious practices and beliefs of the hospital or hospital employee.

Section 5. No person shall knowingly engage in, or directly or indirectly assist in, reproductive or attempted reproductive cloning of a human being. No person shall purchase, sell, transfer, or otherwise obtain human embryonic, gametic or cadaveric fetal tissue for the purpose of reproductive cloning. A person who violates the provisions of this section shall be punished by imprisonment in a jail or house of correction for not less than five years nor more than ten years or by imprisonment in the state prison for not more than ten years and by a fine of up to one million dollars.

Section 6. No person shall knowingly and for valuable consideration purchase, sell, transfer, or otherwise obtain human embryos, gametes, or cadaveric fetal tissue for research purposes. Nothing in this section shall prohibit a person from banking or donating their gametes for personal future use, or from donating their gametes to another person or from donating their gametes for research.

A person shall not knowingly create an embryo with the sole intent of donating said embryo for research. This provision shall not prohibit the creation of an extracorporeal embryo by somatic cell nuclear transfer for the purpose of deriving embryonic stem cells.

A person who violates the provisions of this section shall be punished by imprisonment in a jail or house of correction for not less than one year nor more than two and one-half years or by imprisonment in the state prison for not more than five years and by the imposition of a fine of up to one hundred thousand dollars.

Section 7. (a) As used in this section, the following words shall have the following meanings:--

(i) "Employee'', any individual who performs services for and under the control and direction of an employer for wages or other remuneration.
(ii) "Employer'', any individual, partnership, association, corporation or any person or group of persons acting directly or indirectly on behalf of, and shall also include any public or privately owned corporation, all branches of state and federal government, or the several counties and municipalities thereof, or any other political subdivision of the state, or any special district, or any authority, commission, or board or any other agency or instrumentality thereof. Employer shall also include agents, contractors or subcontractors of an employer.
(iii) "Public body'',

(a) the United States Congress, any state legislature, including the general court, or any popularly elected local government body, or any member or employee thereof;
(b) any federal, state or local judiciary, or any member or employee thereof, or any grand or petit jury;
(c) any federal, state or local regulatory, administrative or public agency or authority, or instrumentality thereof;
(d) any federal, state or local law enforcement agency, prosecutorial office, or police or peace officer; or
(e) any division, board, bureau, office, committee or commission of any of the public bodies described in the above paragraphs of this subsection.

(iv) "Supervisor'', any individual to whom an employer has given the authority to direct and control the work performance of the affected employee, who has authority to take corrective action regarding the violation of the law, rule or regulation of which the employee complains, or who has been designated by the employer on the notice required under subsection (h).
(v) "Retaliatory action'', the discharge, suspension or demotion of an employee, or other adverse employment action taken against an employee in the terms and conditions of employment.

(b) An employer shall not take any retaliatory action against an employee because the employee does any of the following:

(i) Discloses, or threatens to disclose to a supervisor or to a public body an activity, policy or practice of the employer, or of another employer with whom the employee's employer has a business relationship, that the employee reasonably believes is in violation of a law, or a rule or regulation promulgated pursuant to law, or which the employee reasonably believes poses a risk to public health, safety or the environment;
(ii) Provides information to, or testifies before, any public body conducting an investigation, hearing or inquiry into any violation of law, or a rule or regulation promulgated pursuant to law, or activity, policy or practice which the employee reasonably believes poses a risk to public health, safety or the environment by the employer, or by another employer with whom the employee's employer has a business relationship; or
(iii) Objects to, or refuses to participate in any activity, policy or practice which the employee reasonably believes is in violation of a law, or a rule or regulation promulgated pursuant to law, or which the employee reasonably believes poses a risk to public health, safety or the environment.

(c)

(i) Except as provided in paragraph (ii), the protection against retaliatory action provided by subsection (b) (i) shall not apply to an employee who makes a disclosure to a public body unless the employee has brought the activity, policy or practice in violation of a law, or a rule or regulation promulgated pursuant to law, or which the employee reasonably believes poses a risk to public health, safety or the environment, to the attention of a supervisor of the employee by written notice and has afforded the employer a reasonable opportunity to correct the activity, policy or practice.
(ii) An employee is not required to comply with paragraph (i) if he: (a) is reasonably certain that the activity, policy or practice is known to one or more supervisors of the employer and the situation is emergency in nature; (b) reasonably fears physical harm as a result of the disclosure provided; or (c) makes the disclosure to a public body as defined in clause (b) or (d) of the definition for "public body'' in subsection (a) for the purpose of providing evidence of what the employee reasonably believes to be a crime.

(d) Any employee or former employee aggrieved of a violation of this section may, within two years, institute a civil action in the superior court. Any party to said action shall be entitled to claim a jury trial. All remedies available in common law tort actions shall be available to prevailing plaintiffs. These remedies are in addition to any legal or equitable relief provided herein. The court may:
(i) issue temporary restraining orders or preliminary or permanent injunctions to restrain continued violation of this section;
(ii) reinstate the employee to the same position held before the retaliatory action, or to an equivalent position;
(iii) reinstate full fringe benefits and seniority rights to the employee;
(iv) compensate the employee for three times the lost wages, benefits and other remuneration, and interest thereon; and
(v) order payment by the employer of reasonable costs, and attorneys' fees.

(e)(i) Except as provided in paragraph (ii), in any action brought by an employee under subsection (d), if the court finds said action was without basis in law or in fact, the court may award reasonable attorneys' fees and court costs to the employer.

(f) An employee shall not be assessed attorneys' fees under paragraph (i) if, after exercising reasonable and diligent efforts after filing a suit, the employee moves to dismiss the action against the employer, or files a notice agreeing to a voluntary dismissal, within a reasonable time after determining that the employer would not be found liable for damages.

(g) Nothing in this section shall be deemed to diminish the rights, privileges or remedies of any employee under any other federal or state law or regulation, or under any collective bargaining agreement or employment contract; except that the institution of a private action in accordance with subsection (d) shall be deemed a waiver by the plaintiff of the rights and remedies available to him, for the actions of the employer, under any other contract, collective bargaining agreement, state law, rule or regulation, or under the common law.

(h) An employer shall conspicuously display notices reasonably designed to inform its employees of their protection and obligations under this section, and use other appropriate means to keep its employees so informed. Each notice posted pursuant to this subsection shall include the name of the person or persons the employer has designated to receive written notifications pursuant to subsection (c).

Section 8. (a) There is hereby established a biomedical research advisory council. Said council shall consist of 15 members including 5 appointed by the governor; one of whom shall be the Secretary of Health and Human Services, or his designee; one of whom shall be the Commissioner of the Department of Public Health, or his designee; one of whom shall be a scientist affiliated with the University of Massachusetts Medical School who has experience in biomedical research in the fields of cell differentiation, nuclear programming, tissue formation and regeneration, stem cell biology, developmental biology, regenerative medicine, or a related fields; one of whom shall be a physician licensed to practice in the Commonwealth; and one of whom shall have expertise in medical ethics and is affiliated with the University of Massachusetts; 5 appointed by the President of the Senate, one of whom shall be a scientist with experience in biomedical research in the fields of cell differentiation, nuclear programming, tissue formation and regeneration, stem cell biology, developmental biology, regenerative medicine, or related fields; one of whom shall be a physician licensed to practice in the Commonwealth; one of whom shall have expertise in medical ethics; one of whom shall be a member of the Massachusetts bar with a background in legal issues related to biotechnology, stem cell research, in vitro fertilization, or health law; and one of whom shall be a member of the public; 5 appointed by the Speaker of the House, one of whom shall be a scientist with experience in biomedical research in the fields of cell differentiation, nuclear programming, tissue formation and regeneration, stem cell biology, developmental biology, regenerative medicine, or related fields; one of whom shall be a member of the Massachusetts bar with a background in legal issues related to biotechnology, stem cell research, in vitro fertilization, or health law; one of whom shall be a member of the public; one of whom shall be a representative of the Biotechnology Center of Excellence Corporation; and one of whom shall be a person with a background in economic development.

(b) The council shall make recommendations to the General Court regarding changes to this chapter, as well as any other chapter of the general laws, or regulations promulgated pursuant thereto, necessary to promote scientific inquiry and protect human subjects.

(c) The council shall submit an annual report of its findings, conclusions, proposals, and recommendations as provided in subpart (b) of this section no later than the first day of January. Said report shall be submitted to the president of the senate, the speaker of the house, the house and senate chairs of the joint committee on economic development and emerging technologies, the clerk of the senate and the clerk of the house.

(d) Each member of the council shall serve without compensation for a term of three years, or until his successor is appointed. A chairman of the council shall be elected annually from the membership. The department shall provide administrative support to the council as requested.

Section 9. The department, with the advice of the biomedical research advisory council, shall enforce the provisions of this chapter and shall adopt regulations, which shall be consistent with any existing federal regulations relative to biomedical research, relating to the administration and enforcement of this chapter.

SECTION 3. Subsection (a) I of section 12J of Chapter 112 of the General Laws, as appearing in the 2002 Official Edition, is hereby amended by adding at the end thereof the following:- For the purposes of this section, fetus shall include a neonate and an embryo, but shall exclude a donated extracorporeal embryo created by somatic cell nuclear transfer pursuant to section 2 of chapter 111J or an extracorporeal embryo donated for research pursuant to section 3 of chapter 111J.

SECTION 4. Subsection (a) IV of section 12J of Chapter 112 of the General Laws, as so appearing, is hereby amended by striking out, in line 38, the . and inserting in place thereof the following:- , but shall exclude a donated extracorporeal embryo created by somatic cell nuclear transfer pursuant to section 2 of chapter 111J or an extracorporeal embryo donated for research pursuant to section 3 of chapter 111J.

SECTION 5. Subsection (a) VI of section 12J of Chapter 112 of the General Laws, as so appearing, is hereby amended by striking out, in line 59, the words "District Attorney for the county in which the hospital or other institution for which the board acts, is located." and inserting in place thereof the following:- Attorney General of the Commonwealth.

SECTION 6. Subsection (a) VII of section 12J of Chapter 112 of the General Laws, as so appearing, is hereby amended by striking out, in line 75, the words "District Attorney" and inserting in place thereof the following:- Attorney General

SECTION 7. Subsection (b) I of section 12J of Chapter 112 of the General Laws, as so appearing, is hereby amended by striking out, in line 82, the words "District Attorney for the district where said procedure is performed" and inserting in place thereof the following:- Attorney General

SECTION 8. Subsection (b) I of section 12J of Chapter 112 of the General Laws, as so appearing, is hereby amended by striking out, in line 91, the words "District Attorney" and inserting in place thereof the following:- Attorney General

SECTION 9. Subsection (b) I of section 12J of Chapter 112 of the General Laws, as so appearing, is hereby amended by striking out, in line 98, the words "District Attorney" and inserting in place thereof the following:- Attorney General

SECTION 10. Subsection (b) II of section 12J of Chapter 112 of the General Laws, as so appearing, is hereby amended by striking out, in line 111, the words "District Attorney for the district where the procedure is performed" and inserting in place thereof the following:- Attorney General

SECTION 11. Subsection (b) II of section 12J of Chapter 112 of the General Laws, as so appearing, is hereby amended by striking out, in line 116, the words "District Attorney" and inserting in place thereof the following:- Attorney General

SECTION 12. Subsection (b) II of section 12J of Chapter 112 of the General Laws, as so appearing, is hereby amended by striking out, in line 118, the words "District Attorney" and inserting in place thereof the following:- Attorney General

SECTION 13. Subsection (b) III of section 12J of Chapter 112 of the General Laws, as so appearing, is hereby amended by striking out, in line 127, the words "District Attorney" and inserting in place thereof the following:- Attorney General

SECTION 14. Subsection (b) VII of section 12J of Chapter 112 of the General Laws, as so appearing, is hereby amended by striking out, in line 165, the words "District Attorney" and inserting in place thereof the following:- Attorney General

SECTION 15. Subsection (b) VII of section 12J of Chapter 112 of the General Laws, as so appearing, is hereby amended by striking out, in line 173, the words "District Attorney" and inserting in place thereof the following:- Attorney General

SECTION 16. Section 12K of Chapter 112 of the General Laws as appearing in the 2002 Official Edition, is hereby amended by striking out, in line 15, the word "fertilization" and inserting in place thereof the following words:- implantation of the embryo in the uterus…….

SECTION 17. Section 7 of Chapter 113 of the General Laws, as appearing in the 2002 Official Edition is hereby amended by striking out, in line 21, the word "parts." and inserting in place thereof the following words:- "parts"; provided however, that any gametes, as that term is defined in section 1 of chapter 111J, shall be donated in accordance with provisions of said chapter 111J.

SECTION 18. Notwithstanding any general or special law to the contrary, the biomedical research advisory council created pursuant to section 2 of this chapter shall make recommendations to the commissioner on proposed regulations for biomedical research, including research involving the derivation or use of embryonic stem cells in the Commonwealth no later than January 31, 2006.

SECTION 19. Notwithstanding any general or special law to the contrary, the biomedical research advisory council created pursuant to section 2 of this chapter shall investigate the feasibility of establishing a public placental and umbilical cord blood bank at the University of Massachusetts Medical School or other appropriate institution within the Commonwealth. The council shall report its findings, together with any proposed legislation, to the house and senate chairs of the joint committee on economic development and emerging technologies and to the house and senate chairs of the joint committee on health care financing no later than January 31, 2006.

SECTION 20. Notwithstanding any general or special law to the contrary, the Governor shall appoint the members of the biomedical research advisory council created pursuant to section 2 of this chapter no later than July 31, 2005. If, as of August 1, 2005, the Council shall consist of fewer than fifteen members, the Attorney General is authorized and directed to appoint such members, no later than September 1, 2005 so that the council consists of fifteen members as provided in chapter 111J.

SECTION 21. Notwithstanding any general or special law to the contrary, the Department of Public Health shall promulgate regulations required pursuant to section 2 of this chapter no later than July 31, 2006.

SECTION 22. Notwithstanding any general or special law to the contrary, the President of the University of Massachusetts, or his designee, shall appoint a commission to analyze and investigate the feasibility of establishing an Institute for Regenerative Medicine at the University of Massachusetts Medical School. Said analysis and investigation shall include the potential cost of establishing such an institute as well as the potential scientific, economic and social benefits such an institute may have upon the Commonwealth. The commission shall submit a final report detailing its recommendations, including any proposed legislation, to the house and senate chairs of the joint committee on economic development and emerging technologies and to the house and senate chairs of the joint committee on health care financing no later than January 31, 2006.