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Preimplantation genetic diagnosis (PGD) is an assisted reproductive technology (ART) that offers great potential for preventing genetic disease, but also raises troubling ethical concerns. Because of these concerns, some countries regulate PGD in a variety of ways, ranging from a complete ban on PGD to open non-regulation. The United States does not regulate PGD, but several policy concerns suggest that it should adopt some form of regulation. This Note proposes that the United States should implement a regulatory scheme similar to that of the United Kingdom's mandatory licensing system. The regulation should strike a balance between the moral and ethical concerns arising from the various uses of PGD and the advancement of PGD technology for the treatment and prevention of genetic disease. The United States should seriously consider PGD regulation because, as stated by Norbert Gleicher, "the 'politics' of PGD deserve more consideration than they have been given in the past. If we don't start paying attention, somebody else will do it for us." (1) Many groups have scientific, economic, political, and ethical interests in PGD, and the United States should implement regulation that balances these competing interests.
The analysis and recommendations made in this Note are based on the premise that it is not ethically unacceptable in all circumstances to create excess embryos to perform PGD, even though some of those embryos may be destroyed or used for other research purposes. Therefore, the reader should interpret statements that a particular use of PGD is "noncontroversial" or "acceptable" as based on this premise.
II. BACKGROUND--THE TECHNOLOGY AND USES OF PGD
PGD is a type of genetic testing performed on embryos created using in vitro fertilization (IVF). (2) PGD can determine the existence or non-existence of particular genes, either desirable or undesirable. (3)
Medical practitioners most commonly use PGD to screen embryos for serious genetic disease. Available tests include those for cystic fibrosis, Tay-Sachs syndrome, and muscular dystrophy. (4) Parents who carry or may likely carry these genes can use IVF with PGD to select embryos that do not carry the genes; this greatly increases the chance of bearing a healthy child not afflicted by the disease. Using PGD to screen embryos for disease has been considered and debated by legal, ethical, and medical commentators, and has been generally accepted as a valid and ethically acceptable medical procedure. (5) However, PGD also has the potential to be used in other, possibly desirable but more ethically troubling ways. Parents could use PGD to select embryos based on the presence of non-disease-linked genes, or to select disease-free embryos with the intention of using their stem cells to save a living, disease-afflicted child. (6)
A. Screening for Non-disease-linked Genes
PGD screening for non-disease-linked genes may be done either for sex selection or for genetic "enhancement." Some genetic diseases are "sex-linked," meaning that they pass to the child in conjunction with the X chromosome. (7) On the one hand, using PGD for sex selection to prevent transmittal of these diseases, such as fragile-X syndrome and hemophilia, is generally regarded as noncontroversial. (8) On the other hand, PGD may also be used to perform sex selection for non-medical reasons. Sex selection has long been desired by many different societies and cultures for a variety of reasons, (9) and a number of clinics advertise and perform PGD for non-disease-linked sex selection. (10) Commentators have made ethical arguments both supporting and rejecting the use of PGD for non-disease-linked sex selection. (11) PGD for non-medical sex selection appeals especially to two groups: those who want a first-born child of a particular gender, and those who already have children and want a more "balanced" family of males and females. (12) The selection of a first-born child's gender may raise more ethical issues than gender selection for family balancing, assuming that one accepts that using PGD for non-medical sex selection may be ethical in some cases. (13)
Expanding uses of PGD may lead to testing and selecting embryos for genetic enhancement. (14) Many commentators have expressed concern about this possibility, (15) finding the use of PGD for enhancement either very troubling ethically or completely unacceptable. (16) PGD used for genetic enhancement would involve the screening of embryos for "desirable" genes, such as those linked to intelligence, musicality, or athleticism. (17) Currently, preimplantation tests for these types of genes are not available. (18) Also, this type of "enhancement" cannot surpass the genetics of the parents--PGD merely tests for the presence of certain genes, and does not alter an embryo's genome by inserting or deleting particular genes. (19) This distinguishes genetic "enhancement" through the use of PGD from genetic "engineering." (20) The amount of control exercised over the embryo draws the distinction between the two--genetic enhancement through PGD simply tests the embryos for particular genes, while genetic engineering involves manipulation of the embryo, such as the insertion or removal of particular genes. (21) While this difference may ease somewhat the ethical concerns about PGD, it may also accentuate slippery slope suspicions about human intervention in genetics. (22)
B. The Creation of Savior Siblings
PGD can be used in combination with Human Leukocyte Antigen (HLA) matching to select embryos that both are free of a particular disease-linked gene and are HLA-identical to an existing child that is afflicted by the gene-linked disease. (23) When the child is born, doctors use stem cells from the umbilical cord blood and the placenta to treat the afflicted sibling. (24)
A commonly discussed example of the use of PGD to create a savior child is the case of the Nash family. Jack and Lisa Nash had a daughter, Molly, who was afflicted with Fanconi anemia, a rare gene-linked disorder. (25) Fanconi anemia causes bone marrow failure, often at a very early age. (26) The Nashes used IVF along with PGD and HLA-matching to give birth to a son, Adam, who did not carry the anemia-linked gene and also shared Molly's HLA type. Stem cells from Adam's placenta and umbilical cord were used to treat six-year-old Molly, completely curing her of the anemia. (27) At first glance, using PGD with HLA matching seems ethically acceptable as a medical procedure because it can eliminate serious disease, (28) but it raises many additional ethical issues. (29)
For example, Adam's creation could be viewed as a means to the end of saving Molly's life (as it clearly is), thus violating the oft-cited principle that all persons should be considered ends in themselves, and not means to some other end. (30) Parents using this procedure generally respond to this argument by stating that they wanted another child anyway, and that the child's status as a savior would not change its role in the family. (31) An additional problem could have arisen if the initial stem-cell treatment did not cure Molly of the anemia; Adam may have been called upon later for bone marrow donation--a harmful, invasive procedure. (32) Requests for bone marrow harvesting and transplantation potentially could continue throughout a savior sibling's lifetime. (33)
Other concerns about PGD have been expressed, such as concerns about the safety of PGD for the embryos created. (34) The general consensus is that PGD does not adversely affect children born through its use, as these children express no greater rate of genetic abnormalities such as Down's syndrome than the general population. (35)
III. TYPES OF PGD REGULATION AND MODEL COUNTRIES
The varied international PGD regulatory systems generally can be classified into four broad regimes. This Section will discuss each regime: the complete constitutional or statutory ban, statutory mandatory licensing, regulation through professional organizations, and non-regulation. It will also include a discussion of representative countries employing the four types of regulation.
A. Statutory Ban
Some countries, including Germany and Switzerland, have imposed a complete statutory ban on PGD. (36) A complete ban can be justified by strong moral concerns about the status of the embryo. A ban on PGD protects concerns for excess embryos which may be stored or discarded after testing, rather than other concerns about genetic testing. (37) The policies supporting a statutory ban thus are not necessarily related to the ethical concerns specific to PGD; rather, they are related to the moral status of the embryo. An analysis of the appropriate regulation of PGD where creation of excess embryos for testing is accepted, therefore, is not well-informed by an examination of countries imposing a complete ban. Total prohibition of PGD is a viable and utilized regulatory option, however, and should therefore be recognized, even in a society that accepts the creation of excess embryos. For example, a complete ban on PGD could find support from the concern that not enough is known about the procedure and its potential implications to allow its use. (38)
1. The Statutory Ban on PGD in Germany
German law currently does not allow the performance of preimplantation testing. (39) The law affords a high level of protection to the embryo; thus, the ban is grounded on the premise that by conferring upon the embryo the right to life, performing PGD is unacceptable because it likely will result in the destruction of those embryos that carry disease-linked genes. (40)
The German Basic Law (the German Constitution) and Embryo Protection Law entitle the embryo to the right to life from the time of fusion between the sperm and the egg. (41) The relevant provisions of German Basic Law are Article 1, Article 2, and the second sentence of Article 3(3). (42) Article 1(1) states, "Human dignity is inviolable." (43) Article 2(2) states, "[e]veryone has the right to life and to physical integrity. The freedom of the person is inviolable." (44) These two provisions, in combination with the Embryo Protection Law, give embryos the right to protection of dignity and life. (45) The second sentence of Article 3(3) states, "[n]o one may be disadvantaged because of his handicap." (46) The effect of this provision is also to outlaw PGD, even for therapeutic, medical purposes. Generally, "therapeutic" PGD refers to the use of PGD to select those embryos that will result in disease-free children. (47) Read in the negative, this means that therapeutic PGD is used to reject those embryos that will result in disease-afflicted …