«Document hosted at WRONGFUL SELECTION: ASSISTED REPRODUCTIVE ...»
One approach would be to extend federal regulation of assisted reproduction, including the use of PGD. The federal government regulates IVF clinics in part through the Centers for Disease Control, which is directed to collect information regarding the procedures utilized at IVF clinics,148 and through the Federal Trade Commission, which has the general authority to investigate false and misleading advertising.149 But more substantial authority rests with the Food and Drug Administration (FDA), which in 1998 announced its intention to regulate IVF clinics through its authority over tissue and cellular-based products.150 There is little question that the FDA can regulate techniques that might inadvertently harm the implanted embryo or the mother, but there is not as much authority for the proposition that the FDA could regulate techniques like human Lars Noah, Assisted Reproductive Technologies and the Pitfalls of Unregulated Biomedical Innovation, 55 FLA. L. REV. 603, 649 (2003) (citing 42 U.S.C. §§ 263a-1(a), 263a-2(a)(1), 263a-3(a), 263a-5 (2000)).
Id. (citations omitted).
cloning, which implicate reproductive choices rather than techniques.151 Such regulation would probably be insupportable absent clearer statutory guidance.
Another novel proposal calls for the creation of a separate regulatory agency whose purpose would be to monitor IVF clinics and approve applications for new PGD techniques and methods, an approach that has been adopted in the United Kingdom.152 A federal statute that would provide for the creation of an organization that has the authority to inspect clinics, grant licenses for types of treatments, and regulate what procedures may and may not be utilized would have considerably less statutory and regulatory ambiguity than an agency that is attempting to expand outside of the normal scope of its authority.153 Also, absent a statutory proclamation, a court may find that the government has not asserted a compelling enough interest in the regulation of PGD and ART.154
As noted earlier, a minority of states has enacted statutes that seek to regulate IVF clinics, and none of those states have passed legislation that proscribes or limits the use of PGD for non-therapeutic purposes. Approaches range from prohibiting PGD for research purposes to prohibiting PGD unless it is “beneficial or risk-free to the embryo.”155 Louisiana, in another issue related to IVF, has passed legislation that requires the recognition of embryos as a juridical person.156 But beyond those limited statutes, the use
Noah, supra note 148, at 651-52.
Groman, supra note 48, at 2773.
Sarah A. Weber, Dismantling the Dictated Moral Code: Modifying Louisiana’s In Vitro Fertilization Statutes To Protect Patients’ Procreative Liberty, 51 LOY. L. REV. 549, 550 (2005). Although the Louisiana statute purports only to grant embryos such status in relation to the matter of their cryopreservation, it is hard to see how granting such status would not have some effect on the matter of embryos, PGD, and intentional diminishment. See LA. REV. STAT. ANN. §§ 9:123, 129, 130 (2006).
of PGD is unregulated by the states, and it is perfectly legal for IVF clinics to aid parents who seek to produce disabled children.
One approach is simply to ban the use of PGD altogether, giving parents no option to screen for inheritable diseases or conditions either positive or negative. This is the approach that is adopted more or less in Germany, where popular public opinion is still largely against the use of PGD for any purpose.157 Another approach is to ban the use of PGD to intentionally create disabled children; this approach is used in the United Kingdom and does not permit the use of PGD except to prevent genetic disorders from being passed on.158 However, both of these options tread most directly on the procreative liberty that is constitutionally protected in the United States.159 A flat ban on PGD, even to screen against inheritable disorders, would face the most difficulty passing constitutional muster, but any restriction of the use of PGD will face constitutional challenge from those who believe it infringes a nearly unlimited procreative right.160 The U.S. Constitution does not permit states to impose their moral beliefs on the personal lives of their citizens.161 Consequently, a state cannot simply decree that PGD is illegal because it contradicts the legislature’s collective moral values. Because the use of PGD touches on a fundamental liberty, there are limitations on how a state may act to regulate it. A state may not attempt to limit abortion rights or undermine the holdings in Roe and Casey, nor can the state curtail personal autonomy and bodily integrity.162 Vacco, supra note 68, at 1205-06 (citations omitted).
Id. at 1201 (stating that England’s Human Fertilization and Embryology Act of 1990 “created the Human Fertilisation and Embryology Authority (‘HFEA’), which licenses and regulates the use of PGD and generally regulates clinics offering assisted reproductive procedures.... [C]linics cannot perform any other tests or treat individuals for new disorders without approval” (internal citations omitted)).
Roe v. Wade, 410 U.S. 113, 152-53 (1973).
Stankovic, supra note 37, at 12-19.
Lawrence v. Texas, 539 U.S. 558, 585 (2003).
Stankovic, supra note 37, at 14-15; see Lawrence, 539 U.S. at 567, 574, 578.
Instead, legislation must be focused on the state’s compelling interest in the preservation and protection of potential life,163 and the state must demonstrate that the use of PGD to select for disability risks the commodification of human life and causes harm to children who are produced via the procedure as a result.164 Although critics of regulation argue that any effort to proscribe PGD infringes upon the procreative right, other commentators disagree. Dr. Laura Shanner argues that there are fundamental differences in the right to procreate, the right to an abortion, the right to contraception, and the right to avoid forced sterilization.165 She distinguishes negative rights, the right to act free of any government forbearance, from positive rights, the right to some form of entitlement or assistance.166 She distinguishes PGD and other assisted-reproductive techniques, which require assistance from the IVF clinic to bring about pregnancy and can be characterized as a positive right, from abortion, which necessitates assistance from a clinic or doctor but also implicates a negative right the woman has in avoiding the burden of being required to bear a fetus to term.167 In this analysis, abortion is the expression of a negative right that cannot be interfered with by Stankovic, supra note 37, at 15.
Id. (“These harms could include but are not limited to: destruction of embryos, commodification of human life, gender- and disability-based discrimination, and easing the way to non-medical enhancement.” (citing Robertson, Genetic Selection of Offspring Characteristics, supra note 98, at 429)).
Laura A. Shanner, The Right To Procreate: When Rights Claims Have Gone Wrong, 40 McGill L.J.
823, 823 (1995). “Dr. Shanner is an Associate Professor in the School of Public Health Sciences with a joint appointment to the John Dossetor Health Ethics Centre, University of Alberta, [Canada]. She obtained her Ph.D. in Philosophy-Bioethics from Georgetown University, following training in pre-clinical sciences.” University of Alberta, John Dossetor Health Ethics Centre, Laura Shanner, http://www.ualberta.ca/BIOETHICS/Profiles-1/Profiles-1_files/page0005.htm (last visited Jan. 16, 2009).
Shanner, supra 165, at 839-40.
Id. at 841; see Webster v. Reprod. Health Servs., 492 U.S. 490, 510 (1989) (noting the Court’s
application of this dichotomy in the abortion context and finding that while the state may not proscribe the right of a woman to an abortion at the pre-viability stage, neither is the state required to provide women with access to an abortion); Harris v. McRae, 448 U.S. 297, 316 (1980) (noting the Court’s explanation that the negative right to obtain an abortion does not implicate a positive right to the financial resources to afford an abortion).
the state before viability, whereas assisted reproduction is a positive right that invites acquiescence by the state. As Dr. Shanner explains, As is the case with women seeking abortions, the persons or couples seeking infertility treatment are asking medical and social institutions to help them achieve what they cannot accomplish on their own. Unlike the abortion case, however, there is no concomitant negative claim akin to that of the pregnant woman's desire to restore her bodily integrity by choosing not to share her body with a fetus. The goal is actually the opposite: to initiate the sharing of a woman’s body with the fetus. The patients in the infertility clinic are thus clearly not asking for forbearance; they are asking for help.168 It is, of course, impossible to know if the U.S. Supreme Court, in interpreting any provision that seeks to proscribe the use of PGD for certain purposes, would interpret its own holdings in such a manner (and in fact, one federal district court has not);169 but, there is some precedent for believing that the Court would be reluctant to extend the right to procreate to specific forms of procreation, especially when the form involves the deliberate creation of a disabled child.170 Similarly, it can be argued that PGD can be regulated because it bears more on the type of child that parents would like to have, not on whether or not they may have a child at all.171 Under this view, parents who are trying to conceive from PGD and other methods of assisted reproduction are trying to invoke more than their right to have a child; they are trying to control the traits and characteristics of their future child, a matter that affects the health and well-being of that child and, as such, is more likely to come under state purview.172 Shanner, supra note 165, at 842.
Lifchez v. Hartigan, 735 F. Supp. 1361, 1376 (N.D. Ill. 1990); Groman, supra note 48, at 2773.
Note, Human Cloning and Substantive Due Process, 111 HARV. L. REV. 2348, 2354 (1998).
Vacco, supra note 68, at 1220 (“The right to ‘bear and beget a child’ does not invoke a right to a ‘beautiful or talented child.’”) (citations omitted).
Id. at 1221.
Whatever the approach, it would be necessary for the state to demonstrate a substantial and compelling interest in the well-being of the children being produced utilizing PGD.173 The state’s interest in how children are reared (as opposed to whether or not they are born at all) supports an interest in the use of PGD sufficient to justify stricter regulation,174 and the “[p]ursuit of the perfect baby through nontherapeutic genetic enhancement[s]” does not trump this claim175 (and by implication, neither does the pursuit of the “imperfect” baby through PGD or genetic diminishment). In addition, courts have recognized the state’s legitimate interest in the child’s best interests in the context of frozen embryos, supporting the idea that state interest in protecting human life does not begin only at the point of viability but extends also to the manner and method of procreation.176 One commentator has argued that the state also has an interest, though perhaps a less compelling one, in the doctor-patient relationship that exists between the prospective parents and the doctors seeking to assist them in procreation.177 In this view, the state regulating PGD relieves the physician of making a determination in each instance of the appropriateness of the prospective parents’ desires.178 Physicians would assist couples making difficult choices who use PGD for therapeutic purposes, but the state would make the determination that non-therapeutic uses are insupportable.179 Stankovic, supra note 37, at 12.
Vacco, supra note 68, at 1221; Ziker, supra note 43, at 8 (“Avoiding severe [genetic] diseases constitute a compelling objective for reprogenetics [(PGD)].”).
Ziker, supra note 43, at 8.
Stankovic, supra note 37, at 19.
Another view, put forth by Professor Alvaré, argues that parental duties to their future children run concomitant with the procreative right.180 She points out several instances in which the Court has endorsed the notion that parental rights flow from the fulfilling of parental duties, and she believes that this would also extend to constitutional rights.181 In her view, because access to PGD is “unrelated to the exercise of any parental duties,” the state may legitimately proscribe it.182 It may also be possible to regulate PGD in a way that does not require a specific ban on a particular use of the procedure. Professor Patrik S. Florencio advocates for a more general limitation on parents’ access to the genetic information.183 This approach is premised on objectives and interests referenced above, such as a desire to avoid harm to the future child, the state’s interest in the best interests of a future child, and respect for the future child’s autonomy.184 The denial of access to genetic information would be facilitated by leaving the decision as to whether the parents’ desired use of the information is in the child’s best interests185 or by legislating for what purposes the information can be collected and to what use it can be put.186
Methods of regulation that are non-coercive and do not involve the power of the state may also be utilized if laws are ineffective or fail to survive constitutional challenges.187 One of these methods is the use of self-imposed regulation by professional Alvaré, supra note 65, at 44.