SENATE, No. 2028

The Commonwealth of Massachusetts

In the Year Two Thousand and Five.

AN ACT PROMOTING STEM CELL RESEARCH

Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority of the same, as follows:

SECTION 1.

The General Laws are hereby amended by inserting after chapter 111K the following chapter:-

Chapter 111L.
PROMOTION OF THE BIOTECHNOLOGY INDUSTRY IN THE COMMONWEALTH

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; and
(b) the extraordinary biomedical scientists working in Massachusetts 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 this field; and
(c) it shall be the policy of the commonwealth to actively foster research and therapies in the life sciences and regenerative medicine by permitting research and clinical applications involving the derivation and use of human embryonic stem cells, human embryonic germ cells, placental and umbilical cord cells, and any human adult stem cells, including research and clinical applications involving somatic cell nuclear transplantation. It shall further be the policy of the commonwealth to prohibit human reproductive cloning.

Section 2. For the purposes of this chapter, the following words shall have the following meanings unless the context clearly requires otherwise:

"Advisory board," the Massachusetts stem cell research advisory board.
"Donated to medicine", a pre-implantation embryo originating from an in vitro process or human embryonic germ cells, when, for purposes of biomedical research or medical care or treatment, the persons contributing genetic material do so in the absence of financial inducement and after fulfillment of the requirements of a duly appointed institutional review board concerning informed consent.
"Fertilization", the process whereby the male sperm and the female oocyte unite to form an embryo.
"Financial inducement", any valuable consideration, excluding: (i) reimbursement for reasonable costs incurred in connection with a donation; and (ii) reasonable compensation to a donor from whom an oocyte or somatic cell is recovered for the time, burden and risk of such recovery and the preparation for it. Whether costs or compensation are reasonable shall be determined by a duly appointed institutional review board, provided the determination is made with due diligence and in good faith.
"Human adult stem cell", an undifferentiated cell found in the differentiated tissue in adult humans which can renew itself and differentiate to yield specialized cell types.
"Human embryonic germ cell", a gamete, such as an egg or a sperm cell, or one of its antecedent cells.
"Human embryonic stem cell", a pluripotent human stem cell derived from a pre-implantation embryo.
"Human reproductive cloning", creating, or attempting to create, a human being by transferring a nucleus of a human cell from any source into a human or non-human egg cell from which the nucleus has been removed for the purpose of creating a human being, and implanting the resulting product into a uterus or uterine-like environment to initiate pregnancy and a possible birth.
"Informed consent", consent for the donation of embryos or other participation in research pursuant to this chapter, which complies with requirements of a duly appointed institutional review board.
"Institution", any organization, corporation, or institution that conducts human embryonic stem cell research.
"Institutional review board" or "IRB", a board that has a minimum of five members who meet regularly to review research applying the standards of 45 CFR Part 46 and/or 21 CFR Parts 50 and 56.
"In vitro", in an artificial environment, referring to a process or reaction occurring therein, as in a test tube or culture medium.
"In vitro fertilization", an assisted reproductive technique in which fertilization is accomplished outside of the body.
"Person", any natural person, corporation, association, partnership, institute, or other legal entity.
"Pre-implantation embryo", any in vitro human embryo whether formed by fertilization, somatic cell nuclear transfer or other means, which has not experienced more than 14 days of development; provided, that such length of time does not include any interval in which such development has been suspended, such as through freezing.
"Parthenogenesis", the development of an egg without fertilization.
"Somatic cell nuclear transfer", replacement of the nucleus of an egg with the nucleus from any other non-reproductive human cell.
"Uterus", a muscular organ of a woman in which the ovum is deposited and the embryo and fetus are developed, or fallopian tube.
"Uterine-like environment", any replicate of the uterus used for the purpose of sustaining an embryo through birth and creating a human being.

Section 3.

(a) Research and clinical applications involving the derivation and use of human embryonic stem cells, human embryonic germ cells, human adult stem cells from any source, somatic cell nuclear transplantation, umbilical cord stem cells, and placental cells shall be permitted in the commonwealth in accordance with this chapter.
(b) (i) No person shall use a pre-implantation human embryo donated to medicine in scientific research or other kind of experimentation or study for the derivation of human embryonic stem cells without the prior written approval, and continuing review on at least an annual basis, of a duly appointed IRB setting forth the IRB's approval of the research, experimentation or study. The written approval shall contain a detailed description of the research, experimentation or study by attachment of a protocol or other writing and shall be maintained as a permanent record by the IRB or the hospital or other entity for which the IRB act.
(ii) No person shall knowingly purchase or sell any pre-implantation embryo for human embryonic stem cell research for valuable consideration. For purposes of this subsection, "valuable consideration'' excludes reasonable payments associated with storage, quality control, preservation, processing or transportation of such pre-implantation embryos donated to medicine.
(c) Human reproductive cloning is hereby prohibited. Accordingly, a pre-implantation embryo donated to medicine for purposes of human embryonic stem cell research, pursuant to this section, shall not be transferred to a uterus or a uterine-like environment. Nothing in this chapter shall prohibit or regulate the use of in vitro fertilization for reproductive purposes.
(d) A person who knowingly violates subsection (b) in such person's use, purchase, or sale of a pre-implantation embryo as provided shall be punished by imprisonment in a jail or house of correction for not less than 1 year nor more than 2 years or by imprisonment in the state prison for not more than 5 years or by the imposition of a fine of not more than $100,000. A person who violates subsection (c) shall be punished by imprisonment in a jail or house of correction for not less than 1 year nor more than 2 years or by imprisonment in the state prison for not more than 10 years or by the imposition of a fine of up to $1,000,000.

Section 4.

(a) For the purposes of reporting to the governor, president of the senate, and speaker of the house of representatives on the status of human embryonic stem cell research and proposing modifications to the regulation of such research, there shall be a Massachusetts stem cell research advisory board. The advisory board shall consist of 7 members, all of whom shall be residents of the commonwealth. The members shall be professionally qualified and collectively experienced in the fields of science, including but not limited to, knowledge of cell differentiation, nuclear reprogramming, tissue formation and regeneration, stem cell biology, developmental biology, regenerative medicine, related biomedical and research fields, medical ethics, and biotechnology, and shall include one community member. Three members shall be appointed by the president of the senate, 3 appointed by the speaker of the house of representatives, and the 1 community member shall be appointed by the governor.
(b) Original members of the advisory board shall have staggered terms of 1 to 3 years, and from then on the members' terms shall be for 3 years.
(c) Any person who conducts scientific research, experimentation, or study that involves the creation or use of pre-implantation embryos in relation to human embryonic stem cell research, shall submit an annual report to the advisory board providing a summary of the research approved during that calendar year and a statement representing that the research was reviewed in accordance with the section 3. Nothing in this chapter shall require the disclosure of trade secrets or other confidential or proprietary information.
(d) The advisory board shall meet periodically, and no less than twice each year. All meetings shall be public.
(e) The advisory board shall keep a public record of all meetings, votes, and other business.
(f) The advisory board shall review the annual reports from persons conducting scientific research, experimentation, or study that involves the creation or use of pre-implantation embryos in relation to human embryonic stem cell research. The advisory board may require submission of a copy of the federal-wide assurance from the institutions whose IRBs review pre-implantation embryo research relating to human embryonic stem cell research.(g) Based on its review of the annual reports submitted, the advisory board shall submit to the governor, senate president, and speaker of the house by January 31 of each year an annual report of the current state of pre-implantation embryo research relating to human embryonic stem cell research in the commonwealth. The advisory board may include recommendations, if any, regarding the modification of regulations concerning human embryonic stem cell research.
(h) The advisory board shall receive administrative support from the department of public health.

Section 5.

(a) An employee shall not be required to conduct scientific research, experimentation, or study that involves the creation or use of pre-implantation embryos in relation to human embryonic stem cell research to the extent that such research conflicts with the bona fide religious practices and beliefs of the employee.
(b) A physician or other health care provider who treats a patient for infertility shall provide the patient with timely, relevant and appropriate information sufficient to allow that patient to make an informed and voluntary choice regarding the disposition of any pre-implantation embryos remaining following said treatment. The physician shall present the patient with the options of storing, donating to another person, donating for research purposes, or otherwise disposing of or destroying any unused pre-implantation embryos, as appropriate.
(c) An institution conducting human embryonic stem cell research shall not take any retaliatory action against its employee because its employee:

(i) discloses or threatens to disclose to a manager or a public body an activity, policy or practice of the institution conducting embryonic stem cell research, or of another institution conducting such research with whom the employee's institution has a business relationship, that the employee reasonably believes is in violation of sections three (3) to six (6), inclusive; or
(ii) objects to, or refuses to participate in any activity, policy or practice that the employee reasonably believes is in violation of sections three (3) to six (6), inclusive.

(d) For purposes of this section:

(i) "Retaliatory action" means the discharge, suspension, demotion, harassment, denial of promotion, layoff or other adverse action taken against an employee affecting the terms and conditions of employment.
(ii) "Manager" means an individual to whom an institution conducting human embryonic stem cell research has given the authority to direct and control the work performance of the affected employee, who has authority to take corrective action regarding a violation of a law, rule, regulation, activity, or policy.
(iii) The protection against retaliatory action in this section 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 sections three (3) to six (6), inclusive, to the attention of a manager of the employee's institution by written notice and has afforded such institution a reasonable opportunity to correct the activity, policy or practice.
(iv) The protection against retaliatory action in this section shall not apply to the public disclosure of confidential or proprietary information, trade secrets, or other confidential materials.

(e) Any employee aggrieved by a violation of this section may, within 2 years, file a complaint with the attorney general, who may bring an action in the name of the commonwealth against any institution conducting human embryonic stem cell research that has violated subsection (c).

Section 6.

(a) The department of public health, in this section called the department, shall issue a license authorizing an institution to conduct somatic cell nuclear transfer, within 30 days after the applying institution (i) pays a fee of not more than $200 to the department, and (ii) provides documentation to the department demonstrating that the institution has or has arranged for a duly appointed IRB that shall review the institution's experimentation, study, and procedures involving somatic cell nuclear transfer.
(b) No person shall conduct somatic cell nuclear transfer at any institution that does not have a license issued pursuant to this section.
(c) All licenses issued pursuant to this act shall expire on December 31 of the third year after the date of issuance. Any holder of a license shall be entitled to have such license renewed for a 3-year term by the department, upon the payment of a renewal fee of not more than $200. On November 1 of each year, the department shall send written notice to this effect to every licensed institution, whose license shall expire that calendar year, and shall enclose with each notice a proper blank form for such renewal. If the blank form properly filled out, together with the fee, shall not on or before December 31 of each year be received by the department from any institution so notified, the department shall strike from the register the name of such institution; but at any time thereafter, any institution, upon submission to the department of proof of satisfactory compliance with the procedures and guidelines contained within this section, may have its name restored by it upon the payment to the department of all accrued renewal fees, together with a reinstatement fee of not more than $200.
(d) The department shall keep an official record of the names of all licensed institutions and of all money received and disbursed by it, and a duplicate thereof shall be open to public inspection in the office of the state secretary.

SECTION 2. 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 the following paragraph:-

For the purposes of this section, fetus shall include a neonate and an embryo, but shall exclude a pre-implantation embryo as defined in section 2.

3. Subsection (a) IV of said section 12J of said chapter 112, as so appearing, is hereby amended by striking out the second sentence.