Attorney General: Honorable J. Robert Galvin, M.D., MPH, 2006-025 Formal Opinion, Attorney General State of Connecticut

Attorney General's Opinion

Attorney General, Richard Blumenthal

November 13, 2006

Honorable J. Robert Galvin, M.D., MPH
Department of Public Health
410 Capitol Avenue - MS #13COM
P. O. Box 340308
Hartford, CT 06134-0308

Dear Commissioner Galvin:


         This is in response to your request for a formal opinion regarding Public Act No. 05-149:  An Act Permitting Stem Cell Research and Banning the Cloning of Human Beings.  Public Act No. 05-149 has now been codified in Chapter  368a of the Connecticut General Statutes.  Specifically, Conn. Gen. Stat. 19a-32d (c)(3) provides that any person who donates “human embryos or embryonic stem cells1 remaining after receiving infertility treatment, or unfertilized human eggs or human sperm,” shall not receive “direct or indirect payment.”

 

The Commissioner of Public Health is charged with enforcing the provisions of Conn. Gen. Stat. 19a-32d and may adopt regulations relating to the administration and enforcement of that statute.  You have requested our assistance to determine the applicability of the “direct or indirect payment” ban in this legislation to the following questions:

 

1.  Is coverage of the costs of infertility treatment by medical insurance a “payment” that would prevent donations made of eggs, sperm, human embryos or embryonic stem cells unused after infertility treatment if that treatment was covered by insurance?

 

2.  Are eggs or sperm which have been solicited and paid for, for use in in vitro fertilization, prohibited for use in stem cell research if they were unused in the in vitro procedure?

 

3.  Nuclear transfer requires “fresh” eggs.  Eggs that have been frozen or “banked” as in the in vitro process cannot be utilized for this process.  If eggs are donated directly for use in stem cell research, e.g. by a family member of a person with an illness, is it permissible under the law to offset any of the costs of the procedure or any adverse events?

 

Conn. Gen. Stat. 19a-32d provides, in pertinent part:

 

(b)  No person shall knowingly (1) engage or assist, directly or indirectly, in the cloning of a human being, (2) implant human embryos created by nuclear transfer into a uterus or a device similar to a uterus, or (3) facilitate human reproduction through clinical or other use of human embryos created by nuclear transfer.  Any person who violates the provisions of this subsection shall be fined not more than one hundred thousand dollars or imprisoned not more than ten years, or both.  Each violation of this subsection shall be a separate and distinct offense.

 

(c)(1)  A physician or other health care provider who is treating a patient for infertility shall provide the patient with timely, relevant and appropriate information sufficient to allow that person to make an informed and voluntary choice regarding the disposition of any embryos or embryonic stem cells remaining following an infertility treatment.

                        

(2)  A patient to whom information is provided pursuant to subdivision (1) of this subsection shall be presented with the option of storing, donating to another person, donating for research purposes, or otherwise disposing of any unused embryos or embryonic stem cells.

 

(3)  A person who elects to donate for stem cell research purposes any human embryos or embryonic stem cells remaining after receiving infertility treatment, or unfertilized human eggs or human sperm shall provide written consent for that donation and shall not receive direct or indirect payment for such human embryos, embryonic stem cells, unfertilized human eggs or human sperm.

 

In construing a statute, we make “a reasoned search for the intention of the legislature…we look to the words of the statute itself, to the legislative history and the circumstances surrounding its enactment, to the legislative policy it was designed to implement, and to its relationship to existing legislation and common law principles governing the same general subject matter.”  State v. Courchesne, 262 Conn. 537, 577, 816 A.2d 562 (2003).  See, State v. Patterson, 2005 Conn. Lexis 531 (Conn. December 20, 2005).

 

The plain language of section 19a-32d(c)(3) clearly prohibits "direct or indirect payment" for human embryos and embryonic stem cells remaining after infertility treatment. The statute, however, provides no information defining what constitutes direct or indirect payment, nor does the statute expressly address whether the payment prohibition includes payment for products procured initially for use in in vitro if they subsequently were donated for stem cell research.  The legislative history, however, does make clear that the legislature did not want to affect existing assisted reproductive practices. “[T]he prohibition against the sale of human embryos or embryonic stem cells is restricted to those embryos and embryonic stem cells that are remaining after receiving infertility treatment.”  SB 934 (House of Representatives May 31, 2005) p. 133 (Statement of Representative Cafero, agreed to by Representative Sayers).  “[T]his does not prohibit the sale of sperm, the sale of unfertilized eggs, for the purpose of in vitro fertilization, nor for the sale of fully fertilized embryos for the purpose of implantation.”  Id. at 172 (Statement of Rep. Sherer, agreed to by Rep. Sayers).  In speaking on the floor of the House of Representatives, Rep. Sherer stated:

 

There’s another industry in Connecticut, reproductive endocrinology and there’s an industry in law called assisted reproductive technology law that I don’t want to get put out of business by virtue of this Bill, so I really have to clarify this on behalf of the million or so babies that have been born through in vitro fertilization.

 

Id. at 173.

 

The law only restricts the sale of embryos remaining after receiving infertility treatment.  Id. at 143 (Statement of Rep. Cafero).2  Moreover, the law requires that individuals choosing to donate for research purposes any embryos or embryonic stem cells remaining after infertility treatment, or unfertilized human eggs or human sperm, must give written consent for such donation.  To facilitate voluntary choice, decisions related to the creation of embryos for infertility treatment are separate from decisions related to the donation of products for research purposes. The clear implication of the foregoing is that payments relating to or associated with infertility treatment are not prohibited by the statute.  Consequently, medical insurance coverage of the cost of infertility treatments is not a "payment" related to subsequent donations of residual products of such infertility treatments.

 

Similarly, the payment for unfertilized eggs and sperm or fertilized embryos for the purpose of implantation and in vitro fertilization is not prohibited and does not preclude subsequent donation, without payment, of such products for stem cell research at a later time.3

                                                                        

Your third question deals with nuclear transfers of eggs.  Nuclear transfers require unfertilized or “fresh” eggs.  The statute allows nuclear transfers for research purposes but “prohibits a person from implanting a human embryo created by nuclear transfer into a uterus, human, animal or artificial.”  SB 934 (House of Representatives May 31, 2005), p.5 (Statement of Rep. Sayers).  Conn. Gen. Stat. 19a-32d (b)(2).  Under section 19a-32d (c)(3), a person who elects to donate unfertilized human eggs for stem cell research shall not receive direct or indirect payment for them.  See SB 934 (House of Representatives May 31, 2005), pp. 6, 100 (Statements of Rep. Sayers) and p. 145 (Statement of Rep. Cafero); (Senate May 26, 2005), p. 14 (Statement of Sen. Murphy.) 

 

It is clear that the legislature intended to prohibit donors from receiving payment for donations of unfertilized eggs for nuclear transfers.  It is also clear that the legislature did not intend to prohibit or impede research on nuclear transfers.  Had it so intended, it would have plainly said so.  Donations of unfertilized eggs are the only means for conducting nuclear transfer research and it is unlikely that such donations would be made if the donor had to assume the costs connected with the procedure to obtain the eggs.  Because a lack of donated unfertilized eggs would effectively prohibit or impede research on nuclear transfers, it must be presumed that the legislature did not intend to prohibit reimbursement for the medical procedure costs necessary to obtain unfertilized eggs or any adverse events.  "It is not our practice to construe a statute in a way to thwart its purpose…or in a way that fails to attain a rational and sensible result that bears directly on the purpose the legislature sought to achieve.'…Colonial Penn Ins. Co. v. Byrant, 245 Conn. 71 714 A.2d 1209 (1988)."  State v. Reynolds, 264 Conn. 1, 32 (2003). 

 

Reimbursement of the costs of the procedure necessary to procure the eggs for research purposes does not provide a benefit to the donor.  It simply protects the donor from suffering a financial loss as a result of the donation.  Such reimbursement would not, therefore, appear to be a "payment" prohibited under Section 19a-32d (c)(3).  Although subsection (c)(3) does not specifically address this issue, other provisions of the General Statutes make clear that reimbursement for the costs of the procedure to obtain unfertilized eggs is not a prohibited "payment."   The presumption is that "laws are enacted in view of existing relevant statutes … and that statutes are to be interpreted with regard to other relevant statutes because the legislature is presumed to have created a consistent body of law."  Hatt v. Burlington Coat Factory, 263 Conn. 279, 819 A.2d 260 (2003) (internal quotation marks omitted).

 

 Conn. Gen. Stat. 19a-32g calls for the establishment of a Stem Cell Peer Review Committee to review all applications submitted by eligible institutions for grants–in–aid awarded from the State Stem Cell Research Fund pursuant to Conn. Gen. Stat. 19a-32e, with respect to the ethical and scientific merit of each application.  Pursuant to section 19a-32g(d), the Peer Review Committee is charged with establishing guidelines for the rating and scoring of such applications.  Section 19a-32g(e) states:

 

All members of the committee shall become and remain fully cognizant of the National Academies4 Guidelines for Human Embryonic Stem Cell Research, as from time to time amended, and the committee may make recommendations to the Stem Cell Research Advisory Committee and the Commissioner of Public Health concerning the adoption of said guidelines, in whole or in part, in the form of regulations adopted pursuant to chapter 54 of the general statutes.

 

These Guidelines cover all derivations of hES cell lines and all research using hES cells derived from :  1. Blastocysts made for reproductive purposes and later obtained from in vitro fertilization (IVF) clinics, 2. Blastocysts made specifically for research using IVF, and 3. Somatic cell nuclear transfer (NT) into oocytes.  These Guidelines indicate that to ensure voluntary informed consent of all donors, there should be no financial incentives in the solicitation or donation of blastocysts, gametes or somatic cells for research purposes.  The Guidelines recommend that to facilitate autonomous choice, decisions related to the creation of embryos for infertility treatment should be free of the influence of investigators who propose to derive or use hES cells in research.  To that end, the Guidelines propose as follows:

 

3.4a.  No payments, cash or in kind, may be provided for donating blastocysts in excess of clinical need for research purposes.  People who elect to donate stored blastocysts for research should not be reimbursed for the costs of storage prior to the decision to donate.

 

3.4b.  Women who undergo hormonal induction to generate oocytes specifically for research purposes (such as for NT) should be reimbursed only for direct expenses incurred as a result of the procedure, as determined by an IRB.5  No payments, cash or in kind, should be provided for donating oocytes for research purposes.  Similarly, no payments should be made for donations of sperm for research purposes or of somatic cells for use in NT.6

 

3.8. Researchers may not ask members of the infertility treatment team to generate more oocytes than necessary for the optimal chance of reproductive success.  An infertility clinic or other third party responsible for obtaining consent or collecting materials should not be able to pay for or be paid for the material obtained (except for specifically defined cost-based reimbursements and payments for professional services).7

 

In addition, the National Academies stated that “[i]n the United States – where insurance coverage varies and often does not cover research-related costs – the donor must be informed of whether and how much compensation is available if she is injured as a result of research.  In general compensation is not assured.”  Id. at p. 87. 

 

In short, the National Academies' guidelines emphasize the critical requirement of voluntary donation, including the explicit prohibition of monetary inducement or promise of therapeutic benefit.  The guidelines, however, also explicitly recognize that reimbursement for expenses incurred for the procedure to obtain unfertilized eggs or any adverse event does not constitute a "payment" to the donor of the unfertilized eggs.

 

We conclude, therefore, that reading together Conn. Gen. Stat. 19a-32d through 19a-32g, reimbursement for the costs of the procedure to obtain unfertilized eggs or any adverse events resulting from the procedure, does not constitute a payment prohibited by statute for the donation of such eggs.

 

The answers to your questions are as follows:

 

1. Payment for eggs and sperm (gametes) or embryos procured for the purpose of in vitro fertilization is not prohibited by Conn. Gen. Stat. 19a-32d and does not preclude the subsequent donation of such unused gametes or blastocysts remaining unused after infertility treatment;

 

2. Coverage of the costs of infertility treatment by medical insurance is not a “payment” that would prevent donations made of eggs, sperm, human embryos or embryonic stem cells unused after infertility treatment;

 

3. Offsetting the direct cost of procedures or adverse events relative to the procurement of eggs directly for use in stem cell research is not a "payment" for the donation of the eggs to stem cell research prohibited under section 19a-32d.

 

Further, as the Guidelines may be adopted, in whole or in part, in the form or regulations, you may wish to take note of the following recommendations of the National Academies:

 

1. No payments, cash or in kind, shall be provided for donating blastocysts, in excess of clinical need, for research purposes;

 

          2. Individuals who elect to donate stored blastocysts for research shall not be reimbursed for the cost of storage prior to the decision to donate;

 

          3. Women who undergo hormonal induction to generate oocytes specifically for research purposes may be reimbursed only for direct expenses incurred as a result of the procedure as determined by an Institutional Review Board, e.g., reasonable payment for the removal, processing, disposal, preservation, quality control, storage, transportation or implantation, but not time, lost wages or other compensation;

         

4. Otherwise, no payments, cash or in kind should be provided for donating oocytes for research purposes.  Similarly, no payments should be made for donations of sperm for research purposes or of somatic cells for use in nuclear transfer.

 

I trust the foregoing responds to your concerns.

Very truly yours,


RICHARD BLUMENTHAL



1  Human embryonic stem cells (hES cells) currently can be derived from three sources:  blastocysts remaining after infertility treatment and donated for research, blastocysts produced from donated gametes (oocytes and sperm), and the products of nuclear transfer. 

 

“‘Embryonic stem cells’ means cells created through the joining of a human egg and sperm or through nuclear transfer that are sufficiently undifferentiated such that they cannot be identified as components of any specialized cell type.”  19a-32d(a)(4).

 

“Blastocyst” means a preimplantation embryo of 50-250 cells.

 

“Oocyte” means a female egg or egg cell.

 

“‘Nuclear transfer’ means the replacement of the nucleus of a human egg with a nucleus from another human cell.”  19a-32d(a)(5).  Nuclear transfer requires that women donate fresh eggs for research because, unlike embryos, oocytes cannot be frozen for later use.

 

2 The proponents of Public Act 05-149 opined that there are 450,000 unused embryos remaining after infertility treatment and that “it is virtually impossible to experiment or retrieve an embryo any other way than after infertility treatments.”  Id. at 143 (Statement of Rep. Cafero).

 

3  In hearings before the Public Health Committee, in response to the question whether there was anything in the Bill that makes a practice legal that was not legal before, it was stated:  “The only thing that this bill is changing in terms of legality is that we’re stating firmly that reproductive cloning of a human being is banned but we’re not creating any initial allowances.”  S.B. 934 (Public Health Committee, January 31, 2005), p. 31 (Statement of Dr. Krause).

 

4  The National Academies is an independent organization chartered by Congress to advise the government on scientific, engineering, and health matters.  The academies include the National Academy of Sciences, the National Academy of Engineering, The Institute of Medicine, and the National Research Council.

 

5 The IRB or Institutional Review Board is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated.  The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction as specified by both federal human subject's regulations and local institutional policy.  45 C.F.R.§ 46.101 et seq.

 

6 This recommendation is based, in part, on the recognition that payments to oocyte donors raise concerns that might undermine public confidence in the responsible management of hES cell research.  Following the recommendation will ensure consistency between procurement practices here and in other countries that have major hES cell research programs, thus facilitating international collaborations and the sharing of hES cell lines across national borders.  It also ensures consistency with the limitations enacted in California in Proposition 71, facilitating collaboration between California investigators and those in the rest of the country.

Guidelines at p. 87.

 

7  The Guidelines recognize that “[s]uch restrictions or payment to those who obtain the embryos discourage the production during routine infertility procedures of excess oocytes that might later be used for research purposes.”  Id. at p. 11, 90-91.


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