Embryo and Fetus: III. Stem Cell Research and therapy

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III. STEM CELL RESEARCH AND THERAPY

In this entry we review the ethical and legal issues that arise in the context of stem cell research and therapy. Stem cells have attracted both immense scientific interest and equal ethical and legal concern because of their capacity to "specialize" and become virtually any part of the organism into which they are introduced. Thus if introduced into the brain they become brain cells, if into the cardiovascular system they become cells of that type and so on. They also appear to be able to trigger cell regeneration and colonize damaged tissue effecting "repair" in situ. Thus if such cells are made compatible with the genome of a host using cloning techniques they could in principle repair and regenerate damaged tissue and halt or even cure many diseases. This holds out both great promise and causes great unease in equal measure. Here we examine both the scientific promise and the extent to which ethical and legal safeguards may be appropriate.

Ethical Issues

The ethical aspects of human stem cell research raise a wide variety of important and controversial issues. Many of these issues have to do with the different sources from which stem cells may be obtained. Stem cells are at present obtained from adults, umbilical cord blood, and fetal and embryonic tissue. Although there are widely differing views regarding the ethics of sourcing stem cells in these ways, there is general consensus that embryos are the best source of stem cells for therapeutic purposes—a consensus that may of course change as the science develops. If spare embryos or aborted fetuses may be used as sources for stem cells, there is a further question: Should embryos or fetuses be deliberately produced in order to be sources of stem cells, whether or not they are also intended to survive stem cell harvesting and grow into healthy adults?

The European Group on Ethics in Science and New Technologies, which advises the European Commission, has highlighted the women's rights issues involved in stem cell research. It is particularly worth bearing in mind that women, as the most proximate sources of embryonic and fetal material and hence also of cord blood, may be under special pressures and indeed risks if these are to be the sources of stem cells.

The issue of free and informed consent, both of donors and recipients, raises special problems. Because embryos and fetuses can hardly consent to their role in sourcing stem cells, the question of who may give consent for the use of fetal or embryonic material is important, particularly because the usual basis for parental consent is hardly appropriate. This basis involves a judgment about what is in the best interests of the individual, and because, in most cases, the individual in question will not survive, the test is irrelevant (Harris, 2002a). Competent risk–benefit assessment is vital, and particular attention needs to be paid to appropriate ethical standards in the conduct of research on human subjects. Other issues concern the anonymity of the donors, the security and safety of cell banks, and the confidentiality and privacy of the genetic information and the tissue the banks contain. Finally, there are issues of remuneration for those taking part and of the transport and security of human tissue and genetic material and information across borders both within the European Union (EU) and worldwide. While these issues are important, they are well understood in biomedical ethics, and with the exception of the issue of consent, they do not raise special issues in connection with stem cell research and therapy (U.K. Human Genetics Commission).

Before considering the ethics of such use in detail, it is important to first explore the possible therapeutic and research uses of stem cells and also the imperatives for research and therapy.

WHY EMBRYONIC STEM CELLS? Embryonic stem cells were first grown in culture in February 1998 by James A. Thomson of the University of Wisconsin. In November of that year Thomson and his colleagues announced in the journal Science that such human embryonic stem cells formed a wide variety of recognizable tissues when transplanted into mice. Roger A. Pedersen, writing in 1999, noted potential applications of these stem cells:

Research on embryonic stem cells will ultimately lead to techniques for generating cells that can be employed in therapies, not just for heart attacks, but for many conditions in which tissue is damaged.

If it were possible to control the differentiation of human embryonic stem cells in culture the resulting cells could potentially help repair damage caused by congestive heart failure, Parkinson's disease, diabetes, and other afflictions. They could prove especially valuable for treating conditions affecting the heart and the islets of the pancreas, which retain few or no stem cells in an adult and so cannot renew themselves naturally.

Stem cells, then, might eventually enable us to grow tailor-made human organs. Furthermore, using cloning technology of the type that produced Dolly the sheep, these organs could be made individually compatible with their designated recipients. In addition to tailor-made organs or parts of organs, such as heart valves, it may be possible to use embryonic stem cells to colonize damaged parts of the body, including the brain, and to promote the repair and regrowth of damaged tissue. These possibilities have long been theoretically understood, but it is only now with the isolation of human embryonic stem cells that their benefits are being seriously considered.

Stem cells for therapy. It is difficult to estimate how many people might benefit from the products of stem cell research should it be permitted and prove fruitful. Most sources agree that the most proximate use of human embryonic stem cell therapy would for Parkinson's disease, a common neurological disease that has a disastrous effect on the quality of life of those afflicted with it. In the United Kingdom around 120,000 individuals have Parkinson's, and the Parkinson's Disease Foundation estimates that the disease affects between 1 million and 1.5 million Americans. Another source speculates that "the true prevalence of idiopathic Parkinson's disease in London may be around 200 per 100,000" (Schrag, Ben-Shlomo, and Quinn). Untold human misery and suffering could be stemmed if Parkinson's disease became treatable. If treatments become available for congestive heart failure and diabetes, for example, and if, as many believe, tailor-made transplant organs will eventually be possible, then literally millions of people worldwide will be treated using stem cell therapy.

When a possible new therapy holds out promise of dramatic cures, caution is of course advised, if only to dampen false hopes of an early treatment. For the sake of all those awaiting therapy, however, it is equally important to pursue the research that might lead to therapy with all vigor. To fail to do so would be to deny people who might benefit the possibility of therapy.

Immortality

Finally we should note the possibility of therapies that would extend life, perhaps even to the point at which humans might become in some sense "immortal." This, albeit futuristic dimension of stem cell research raises important issues that are worth serious consideration. Many scientists now believe that death is not inevitable that that the process whereby cells seem to be programmed to age and die is a contingent "accident" of human development which can in principle and perhaps in fact be reversed and part of that reversal may flow from the regenerative power of stem cells. Immortality has been discussed at length elsewhere but we should, before turning to the ethics of stem cell research and therapy note one important possible consequence of life extending procedures.

Human Evolution and Species Protection

Human Embryonic Stem Cell research in general, but the immortalizing properties of such research in particular raises another acute question. If we become substantially longer lived and healthier, and certainly if we transformed ourselves from "mortals" into "immortals" we would have changed our fundamental nature. One of the common defining characteristics of a human being is our mortality. Indeed in English we are "mortals"—persons; not "immortals" or Gods, demi-gods or devils. Is there then any moral reason to stay as we are simply because it is "as we are"? Is there something sacrosanct about the human life form? Do we have moral reasons against further evolution whether it is "natural" Darwinian evolution, or evolution determined by conscious choice?

One choice that may confront us is as to whether or not to attempt treatments that might enhance human functioning, so-called "enhancement therapies." For example it may be that because of their regenerative capacities stem cells inserted into the brain to repair damage might in a normal brain have the effect of enhancing brain function. Again it would be difficult if the therapies are proved safe in the case of brain damaged patients to resist requests for their use as enhancement therapies. What after all could be unethical about improving brain function? We don't consider it unethical to choose schools on the basis of their (admittedly doubtful) claims to achieve this, why would a more efficient method seem problematic?

We should not of course attempt to change human nature for the worse and we must be very sure that in making any modifications we would in fact be changing it for the better, and that we can do so safely, without unwanted side-effects. However if we could change the genome of human beings, say by adding a new manufactured and synthetic gene sequence which would protect us from most major diseases and allow us to live on average twenty five per cent longer with a healthy life throughout our allotted time, many would want to benefit from this. In high-income countries human beings now do live on average twenty five per cent longer than they did 100 years ago and this is usually cited as an unmitigated advantage of "progress." The point is sometimes made that so long as humans continued to be able to procreate after any modifications, which changed our nature, we would still be, in the biological sense, members of the same species. But, the point is not whether we remain members of the same species in some narrow biological sense but whether we have changed our nature and perhaps with it our conception of normal species functioning.

THE ETHICS OF STEM CELL RESEARCH. Stem cell research is of ethical significance for three major reasons:

  1. It will for the foreseeable future involve the use and sacrifice of human embryos.
  2. Because of the regenerative properties of stem cells, stem cell therapy may always be more than therapeutic—it may involve the enhancement of human functioning and indeed the extension of the human lifespan.
  3. So-called therapeutic cloning, the use of cell nuclear replacement to make the stem cells clones of the genome of their intended recipient, involves the creation of cloned pluripotent (cells that have the power to become almost any part of the resulting organism—hence pluri-potent) and possibly totipotent cells (cells which have the power to become any part of the resulting organism including the whole organism), which some people find objectionable.

In other venues, John Harris has discussed in detail the ethics of genetic enhancement (Harris, 1992, 1998a) and the ethics of cloning (Harris, 1997, 1998b, 1999b). The focus of this entry, however, is on objections to the use of embryos and fetuses as sources of stem cells.

Because aborted fetuses and preimplantation embryos are currently the most promising sources of stem cells for research and therapeutic purposes, the recovery and use of stem cells for current practical purposes seems to turn crucially on the moral status of the embryo and the fetus. There have, however, been a number of developments that show promise for the recovery and use of adult stem cells. It was reported in 2002 that Catherine Verfaillie and her group at the University of Minnesota had successful isolated adult stem cells from bone marrow and that these seemed to have pluripotent properties (capable of development in many ways but not in all ways and not capable of becoming a new separate creature), like most human embryonic stem cells have. Simultaneously, Nature Online published a paper from Ron McKay at the U.S. National Institutes of Health showing the promise of embryo-derived cells in the treatment of Parkinson's disease.

Such findings indicate the importance of pursuing both lines of research in parallel. The dangers of abjuring embryo research in the hope that adult stem cells will be found to do the job adequately is highly dangerous and problematic for a number of reasons. First, it is not yet known whether adult cells will prove as good as embryonic cells for therapeutic purposes; there is simply much more accumulated data about and much more therapeutic promise for embryonic stem cells. Second, it might turn out that adult cells will be good for some therapeutic purposes and embryonic stem cells for others. Third, whereas scientists have already discovered that virtually any gene in embryonic stem cells can be modified or replaced, this has not yet been established to hold for adult stem cells. Finally, it would be an irresponsible gamble with human lives to back one source of cells rather than another and to make people wait and possibly die while what is still the less favored source of stem cells is further developed. This means that the ethics of embryonic stem cells is still a vital and pressing problem and cannot for the foreseeable future be bypassed by a concentration on adult stem cells.

RESOLVING THE ETHICS OF RECOVERING STEM CELLS FROM EMBRYOS. There are three more or less contentious ways of resolving the question of whether it is ethically permissible to use the embryo or the fetus as a source of material, including stem cells, for research and therapy. The three methods involve: (1) solving the vexing question of the moral status of the embryo; (2) invoking the principle of waste avoidance; and (3) showing that those who profess to accord full moral status to the embryo either cannot consistently do so or do not in fact believe (despite what they profess) that it has that status. Regarding the first of these, it is difficult to determine whether there will ever be sufficiently convincing arguments available for this question to be finally resolved in the sense of securing the agreement of all rational beings to a particular view of the matter (Harris, 1985, 1999a). Putting aside this contentious issue, then, the other two issues will be discussed below.

The principle of waste avoidance. This widely shared principle states that it is right to benefit people if we can, that it is wrong to harm them, and that faced with the opportunity to use resources for a beneficial purpose when the alternative is that those resources will be wasted, we have powerful moral reasons to avoid waste and do good instead.

That it is surely better to do something good than to do nothing good should be reemphasized. It is difficult to find arguments in support of the idea that it could be better (more ethical) to allow embryonic or fetal material to go to waste than to use it for some good purpose. It must, logically, be better to do something good than to do nothing good, just as it must be better to make good use of something than to allow it to be wasted.

It does not of course follow from this that it is ethical to create embryos specifically for the purposes of deriving stem cells from them. Nevertheless, in all circumstances in which "spare" embryos have been produced that cannot, or will not, be used for reproduction, because they have no chance of developing into normal adult human beings, it must be ethical to use such embryos as sources of stem cells or therapeutic material or for research purposes.

Does anyone really believe that embryos are moral persons? One way in which stem cell research and therapy using human embryos might be successfully defended is to draw a distinction between what people say and what they do, or rather to point out that there may be an inconsistency between the beliefs and values of people as revealed by their statements on the one hand and by the way they behave on the other. Although many people, including most so-called pro-life or right-to-life supporters, are prone to make encouraging noises about the moral importance of embryos, and even sometimes talk as if embryos have, and must be accorded, the same moral status as human adults, such people very seldom, if ever, behave as if they remotely believe any such thing. Taking for the moment as unproblematic the idea, made famous by the Greek philosopher Socrates (c. 470–399 b.c.e.), that "to know the good is to do the good," many pro-life advocates do not behave consistently with their professed beliefs about what is good. A few examples must suffice.

One would expect that those who give full moral status to the embryo, who regard it as a person, would both protect embryos with the same energy and conviction as they would their fellow adults and mourn an embryo's loss with equal solemnity and concern. This, however, they do not do. It is true that some extreme pro-life advocates in the United States have taken to murdering obstetricians who perform abortions, but those same individuals are almost always inconsistent in some or all of the following ways.

For every live birth, up to five embryos die in early miscarriages. Although this fact is widely known and represents massive carnage, pro-life groups have not been active in campaigning for medical research to stem the tide of this terrible slaughter. Equally well known is that, for the same reasons, the menstrual flow of sexually active women often contains embryos. Funeral rights are not usually routinely performed over sanitary towels, although they often contain embryos. In the case of spare embryos created by assisted reproductive technologies, there has not been the creation of a group of pro-life women offering their uteruses as homes for these surplus embryos. In his 1992 book, Wonderwoman and Superman, John Harris had to invent a fictitious quasi-religious order of women, "The Sisters of the Embryo," who would stand ready to offer a gestating uterus to receive unwanted embryos because (surprisingly given the large numbers of pro-life women available) there has never been such a movement. Indeed, anyone engaging in unprotected intercourse runs substantial risk of creating an embryo that must die, and yet few people think that this fact affords them a reason either to refrain from unprotected intercourse or to press for medical research to prevent this tragic waste of human life.

Finally, it is notorious that many pro-life supporters, including many Catholics, are prepared to permit abortions in exceptional circumstances, for example, to save the life of the mother or in the case of rape. In the former situation, however, the right course of action for those who believe the embryo has full moral status is to give equal chances to the embryo and the mother (perhaps by tossing a coin) in cases where one may survive but not both. In the case of rape, because the embryo is innocent of the crime and has therefore done nothing to compromise its moral status, the permitting of abortion by those who give full status to the embryo is simply incoherent (Richards).

These cases provide reasons for thinking that even if the views of those who believe the embryo to have the same moral status as normal adult human beings cannot be conclusively shown to be fallacious, it can at least be shown that these views are inconsistent with practice and that the "theory" is therefore not really believed by those who profess it or indeed that it is not actually compatible with the lives that human beings must, of necessity, lead.

Legal and Regulatory Issues

A draft United Nations (UN) convention to prohibit human reproductive cloning seeks to augment the advisory regulatory approach enshrined in the Universal Declaration on the Human Genome and Human Rights. The latter was developed by the United Nations Educational, Scientific and Cultural Organization (UNESCO), adopted unanimously by its 186 states on November 11, 1997, and adopted by the UN General Assembly on March 10, 1999 (via Resolution 53/152). Article 11 of the UNESCO Declaration states (in part): "Practices which are contrary to human dignity, such as reproductive cloning of human beings, shall not be permitted." The limitations of this provision were revealed in a report by the director-general of UNESCO. The report concluded that "this prohibition concerns the reproductive cloning of human beings and should not be interpreted as prohibiting other applications of cloning" (UNESCO, 1999, p. 13).

The Council of Europe's Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (1997; known as the Convention on Human Rights and Biomedicine), to which the United Kingdom is not a signatory, does provide some form of protection for the human embryo. Thus, Article 18(1) provides the following: "Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo," and Article 18(2) states, "The creation of human embryos for research purposes is prohibited." Under Article 36, countries—such as the United Kingdom—that have a preexisting law may make a reservation to the convention based on that existing law. Those countries that have no preexisting law on the embryo and that sign the convention will be hindered or prohibited from sanctioning embryo research, unless they formally withdraw from the convention, pass the new permissive law, and then re-sign (as has happened with Finland and Greece).

In the United Kingdom, the appending of the Human Rights Act of 1998, which brought U.K. domestic law closer to the provisions of the Convention on Human Rights and Biomedicine, has provoked some commentators to focus on the provisions of Article 2 as having potentially significant effect on domestic abortion law and hence the status of the embryo in law. Article 2 stipulates the following: "Everyone's right to life shall be protected by law." Whether this will afford any greater degree of recognition to the fetus, let alone to the embryo, is unlikely.

No European consensus exists on abortion, (or, as Table 1 shows, on embryo research), and the European Commission and the European Court of Human Rights have been reluctant to pronounce substantively on whether the protection in Article 2 of the convention extends to the fetus. In the light of these differing laws, a state will have what is called under European human rights legislation a wide "margin of appreciation" with regard to the convention on the issue of abortion, and hence, it is thought, on the status of the embryo (Decision Reports of the European Commission of Human Rights, Application 17004/90 H v Norway 73 DR 155 (1992) E Com HR.).

The European Court of Human Rights has yet to rule on whether the term everyone includes a fetus. In Open Door Counselling & Dublin Well Woman v. Ireland, the European Commission had recognized the possibility that Article 2 might in certain circumstances offer protection to a fetus, but they took the point no further.

THE UNITED KINGDOM POSITION. Important distinctions must be drawn in the law's treatment of human cloning. The first distinction is between reproductive cloning, which is designed to result in the birth of a live human being genetically identical to another, and therapeutic cloning, in which an embryo is cloned for research purposes and will not be permitted to develop into a fetus or a live birth. The second essential distinction is that between two different cloning techniques: The first of these (when applied to human cloning) involves replacing the nucleus of an embryonic cell with a nucleus taken from another human embryonic or adult cell, and it is known as cell nuclear replacement (CNR).

The HFE Act of 1990. The Human Fertilisation and Embryology Act of 1990 (HFE Act) contains a clear prohibition on the first technique. Section 3(3)(d) states that a license granted under the act "cannot authorise … replacing a nucleus of a cell of an embryo with a nucleus taken from a cell of any person, embryo or subsequent development of an embryo." CNR, on the other hand, is not expressly prohibited by the act, nor is "embryo splitting," a process that can occur naturally at a very early stage of embryonic development, forming identical twins, but which can also be done in vitro to produce identical, cloned embryos. The form of CNR whereby the nucleus of an oocyte is replaced with a nucleus from an adult cell was beyond the bounds of scientific credibility when the 1990 legislation was being debated and drafted.

The legal status of CNR in the United Kingdom is, therefore, unclear. The regulatory framework of the HFE Act rests on a definition in section 1(1)(a), in which an embryo is defined as "a live human embryo where fertilisation is complete." This definition's emphasis on the process of fertilization (an emphasis repeated throughout the act) raises the possibility that embryos created by CNR fall outside the scope of the act and that accordingly their creation and use is unregulated. In their 1998 report, Cloning Issues in Human Reproduction, the Human Genetics Advisory Commission (HGAC) and the Human Fertilisation and Embryology Authority (HFEA) argued for a purposive rather than a literal interpretation of the definition. Through such an approach, organisms created by CNR would fall within the statutory definition of embryo on the basis that Parliament clearly intended to regulate the creation and use of embryos outside the human body, and that excluding organisms created by

TABLE 1

Legislation on Reproductive/Therapeutic Cloning, Embryo Research, and Stem Cell Research, 2003
Country Reproductive Cloning Allowed Therapeutic Cloning (SCNT*) Allowed (General) Research on Embryos Allowed Stem Cell Research on Spare Embryos Allowed Legislative Source (s)
SOURCE: Compiled from various sources by Authors.
ArgentinaNoDecree No. 200 of March 1997: A Prohibition of Human Cloning Research
Australia (federal)NoNoYesYesResearch Involving Human Embryos Act of 2002; Prohibition of Human Cloning Act of 2002 (Embryos created before April 5, 2002, may be used for stem cell embryo research; Subject to license)
AustriaNoPossiblyNoNoReproductive Medicine Law of 1992 (Embryos may be created for (Cf. Import) reproductive purposes only)
BrazilYesYesLaw 8974/95, Normative Instruction by National Technical Committee of Biosecurity
CanadaNoNoYesYesCIHR Guidelines; Bill C-13, An Act Respecting Assisted Human Reproductive Technologies and Related Research (Surplus embryos only; Subject to license)
Costa RicaNoNoNoDecree no. 24029-S. A Regulation on Assisted Reproduction, February 3, 1995
DenmarkNoNoNo*NoAct no. 460 of June 10, 1997, on Assisted Procreation *as interpreted by the Danish Council of Ethics
FinlandYesMedical Research Act no. 488, April 9. 1999
FranceNoNoYesYesProjet de loi relatif á la bioéthique, tel qu'adopte par l'Assemblée nationale le 22 jan. 2002 (Subject to licence)
GermanyNoNoNoYesEmbryo Protection Law of 1990; Stem Cell Act of 2002 (Imported stem cell lines created before January 1, 2002; Subject to licence)
IcelandNoNoYesNoMinistry of Health and Social Security, Regulation No. 568/1997 on Artificial Fertilization
IrelandNoNoNoNoConstitution of Ireland, Article 40, para. 3
IsraelNoYesYesYesProhibition of Genetic Intervention Law (1999); (Five year moratorium); Bioethics Advisory Committee of the Israel Academy of Sciences and Humanities (Section 8—surplus embryos only)
JapanNoYesYesYesThe Law concerning Regulation Relating to Human Cloning Techniques and Other Similar Techniques (Article 3); The Guidelines for Derivation and Utilization of Human Embryonic Stem Cells (Surplus and created embryos; Subject to license)
NetherlandsNoYesYesYesAct Containing Rules Relating to the Use of Gametes and Embryos (Embryos Act), October 2001
NorwayNoNoNoNoNorwegian Law on Assisted Reproduction and Genetics, 1994
PeruNoNoNoNoGeneral Law No. 26842 of 9 July 1997 on Health
RussiaNoLaw of Reproductive Human Cloning, April 19, 2002
SpainYesYesLaw no 42/1988 of 28 December 1988 on the Donation and Use of Human Embryos and Fetuses or Their Cells, Tissues, or Organs
SwedenNoYesLaw 115 of March 14, 1991, Act Concerning Measures for the Purposes of Research or Treatment in connection with Fertilized Human Oocytes, as interpreted by the Swedish Research Council's Guidelines for Research—Ethical Review of Human Stem Cell Research, December 4, 2001; Swedish Council on Medical Ethics, Statement of Opinion on Embryonic Stem Cell Research, January 17, 2000
SwitzerlandNoNo?NoYes/No?Constitution fédérale de al Confédération suisse, 1999
United KingdomNoYesYesYesHuman Reproductive Cloning Act of 2001 (extends to Northern Ireland); Human Fertilisation and Embryology Act of 1990 (Subject to license)
United StatesYes**Yes**Yes****No federal law to date; no federal funds for embryo research nor for creation of stem cell lines after August 9, 2001

CNR from the definition in the HFE Act would frustrate this legislative intention.

It is important here to immediately observe three things:

  1. CNR is not specifically prohibited by the HFE Act.
  2. The same is true of embryo splitting.
  3. The HFEA gave careful consideration to embryo splitting as an additional possible form of infertility treatment in 1994, when its potential use at the two- or four-cell embryonic stage was discussed. After considering the social and ethical issues involved, the HFEA decided to ban embryo splitting as a possible fertility treatment. The HFEA, however, did not make a similar prohibition with respect to CNR research.

Is somatic CNR specifically covered by the wording of section 3(3)(d) of the HFE Act? And, as CNR does not involve fertilization, does section ("No person shall bring about the creation of an embryo … except in pursuance of a licence") 3(1) apply either? Is CNR regulated at all by the HFE Act? At least from a moral point of view, and taking what could be called a purposive or result-oriented approach, it may be possible to reconcile the CNR embryo with embryos created in vitro. From this, it would follow that there is no particular difficulty in accepting the view with which the HFEA works—that the creation of embryos through CNR is already brought within the scheme of the HFE Act by an extended interpretation of section 1.

Section 1(1)(a) reads in full: "In this Act, except where otherwise stated (a) embryo means a live human embryo where fertilisation is complete" (emphasis added). The emphasized words make it plain that the legislators could have provided otherwise for embryos created other than by in vitro fertilization to be included within the statute, but evidently they did not. To read the statute as providing for embryos created by CNR is to read it as providing that an embryo means a live human embryo where fertilization is complete, unless the context otherwise requires.

The Quintavalle case. In the early 2000s, a legal challenge by the Pro-Life Alliance, a U.K. lobbying group, tested the question of whether the HFE Act can be interpreted purposively to include organisms produced by CNR. In the High Court (Regina [on the Application of Quintavalle] v. Secretary of State for Health, 2001), the claimant submitted simply that an embryo that has not been produced by fertilization cannot be "an embryo where fertilization is complete" in terms of section 1(1)(a) of the HFE Act. The Secretary of State for Health argued for a purposive construction of this section, whereby the definition would be expanded to include embryos produced other than by fertilization. The judge decided that such a purposive approach would "involve an impermissible rewriting and extension of the definition" (Quintavalle, 2001, para. 62). In immediate response to this, the government introduced the Human Reproductive Cloning Act of 2001, under which it is an offense to place, in a woman, a human embryo that has been created by any method other than fertilization.

In the Court of Appeal (Regina [on the Application of Quintavalle] v. Secretary of State for Health, 2002), the Secretary of State continued to argue that section 1(1)(a) must be given a "strained" construction in order to give effect to the obvious intention of Parliament. The claimant disagreed that the intentions of Parliament with regard to CNR can be thought to have been clear when the technique was unheard of at the time the HFE Act was enacted. Furthermore, the claimant pointed out, had Parliament known of the CNR technique, they may well have decided to include it in the prohibition on cloning included in section 3(3)(d).

In upholding the appeal, the court placed particular emphasis on two considerations. First, it observed the dictum of Lord Wilberforce, in his dissenting judgment in the case of Royal College of Nursing of the United Kingdom v. Department of Health and Social Security (1981), that:

Where a new state of affairs, or a fresh set of facts bearing on policy, comes into existence, the courts have to consider whether they fall within the Parliamentary intention. They may be held to do so, if they fall within the same genus of facts as those to which the expressed policy has been formulated. (Royal College of Nursing, p. 822)

The court decided, regarding "genus of facts," that the fact that an embryo was created by fertilization had not been a factor of particular relevance to the desirability of regulation when the HFE Act was envisaged, and that, furthermore, the embryo created by CNR is "morphologically and functionally indistinguishable" (Quintavalle, 2002, p. 639) from the embryo created by fertilization. The relevant point was taken to be the capacity to develop into a human being, which is shared by both.

The second point the court emphasized related to the policy of the HFE Act. Rejecting the argument that Parliament's intention was undiscoverable and that CNR, if possible at the time, may have been prohibited under s3(3)(d), the court decided that the rationale behind that prohibition was

to prevent the production artificially of two or more genetically identical individuals. This policy would be put in jeopardy if the creation and use of embryos by cell nuclear replacement were unregulated. It would be furthered by making the production of embryos by cell nuclear replacement subject to the regulatory regime under the Act, for it is inconceivable that the licensing authority would permit such an embryo to be used for the purpose of reproduction. (Quintavalle, 2002, pp. 641–642)

In the final appeal to the House of Lords (Regina [on the Application of Quintavalle] v. Secretary of State for Health 2003), the decision of the Court of Appeal was unanimously sustained. In his leading judgment Lord Bingham upheld the Court of Appeal's endorsement of the dictum in Royal College of Nursing, saying that this "may now be treated as authoritative" (Quintavalle, 2003, para. 10). Indeed, following the House of Lords' judgment in Quintavalle, the passage in question can be regarded as enshrining a new rule of statutory interpretation.

The House of Lords' decision (and the Court of Appeal ruling that it upheld) is highly contestable, on several grounds. First, the clarity of the statutory language in section 1(1)(a) casts doubt on either court's freedom to use a purposive approach to interpreting it; moreover, the 2001 act prohibiting human reproductive cloning was in force when the appeal was considered, so the court's view that a purposive approach was necessary to prevent the production of genetically identical individuals is surprising. Second, embryos produced by the process prohibited in section 3(3)(d) would also be "morphologically and functionally indistinguishable," in the words of the Court of Appeal, from embryos produced by fertilization, just as are embryos produced by CNR, and yet Parliament adopted a different regulatory approach to their creation and use. This being so, the assumption that Parliament intended to treat all "morphologically and functionally indistinguishable" embryos alike seems mistaken. Finally, in its consideration of genus, the House of Lords seems to have replicated the Court of Appeal's erroneous conflation of the term's legal application (to facts) and its scientific sense.

The current research purposes specified in the HFE Act relate only to research that could be envisaged at that time. It is nevertheless difficult to argue that they were based on immutable moral criteria, and indeed the existence in the HFE Act of the power to broaden the research purposes in due course supports this view. Additional research purposes were in fact added by important new regulations that were enacted in 2001, as is discussed below. In all types of embryo research under consideration it has to be accepted that the embryo cannot itself receive any benefit. The embryo is used instrumentally—as a means to an end—and will be destroyed. This is, in any event, an inevitable outcome for all spare embryos whether donated for research under the currently allowed research purposes or no longer required for treatment. If the arguments of the Warnock Committee (established in 1982 by the U.K. government to report and advise on developments in human fertilization and embryology, in its report published in 1984), are accepted, the issue to be considered is one of balance: whether the research has the potential to lead to significant health benefits for others and whether the use of embryos at a very early stage of their development in such research is necessary to realize those benefits.

The post-Quintavalle situation. So far as CNR research within the United Kingdom is concerned, the legislation now draws a line at the point of implantation by prohibiting the placing in a woman of "a human embryo which has been created otherwise than by fertilisation." Until the Court of Appeal reversed the High Court decision, a decision confirmed by the House of Lords, it would not have been unlawful to do CNR work preparatory to implantation. After the reversal, however, research involving CNR embryos is lawful only when authorized by a license granted by the HFEA, and so long as the Human Reproductive Cloning Act remains in place it is inconceivable that the HFEA would license research directed at human reproductive cloning.

A license authorizing specific research under the HFE Act may be granted by the HFEA for a maximum period of three years. Any research license may be made subject to conditions imposed by HFEA and specified in the license, and any authority to bring about the creation of an embryo, keep or use an embryo, or mix human sperm with a hamster or other specified animal's egg may specify how those activities may be carried out. Each research protocol must be shown to relate, broadly, to one of the existing categories of research aim, and then again only if the authority is satisfied that the research is "necessary for the purposes of the research" (Schedule 2, para. 3[5]). These research aims are:

  • Promoting advances in the treatment of infertility
  • Increasing knowledge about the causes of congenital disease
  • Increasing knowledge about the causes of miscarriage
  • Developing more effective techniques of contraception
  • Developing methods for detecting the presence of gene or chromosome abnormalities in embryos before implantation
  • Increasing knowledge about the creation and development of embryos and enabling such knowledge to be applied

The Human Fertilisation and Embryology (Research Purposes) Regulations of 2001 extended these original purposes. These regulations provided for three further purposes for which research licenses may be authorized:

  • (a) increasing knowledge about the development of embryos;
  • (b) increasing knowledge about serious disease, or
  • (c) enabling any such knowledge to be applied in developing treatments for serious disease.

THE EUROPEAN DIMENSION. The Council of Europe's Convention on Human Rights and Biomedicine (1997), along with its Additional Protocol on the Prohibition of Cloning Human Beings (1998), which covers only reproductive human cloning, is an important document. Ten of the fifteen EU countries have now signed the convention, despite what some have seen as its (almost necessary) limitations.

The protocol makes what was implicit in the convention explicit by declaring that "[a]ny intervention seeking to create a human being genetically identical to another human being, whether living or dead, is prohibited" (Article 1[1]). Because "genetically identical" is defined as "sharing with another the same nuclear gene set" (Article 1[2]), somatic CNR is included within this prohibition. The term human being is not defined in the convention, and because human being is unlikely to be interpreted to include embryonic human life, some countries, in signing the convention and its protocol, have added their own interpretative statements. For example, the Netherlands, in doing so, stated that "[i]n relation to Article 1 of the Protocol, the Government of the Kingdom of the Netherlands declares that it interprets the term 'human beings' as referring exclusively to a human individual, i.e., a human being who has been born."

In its report titled "Ethical Aspects of Human Stem Cell Research and Use," however, the European Group on Ethics in Science and New Technologies advised that, at present, "the creation of embryos by somatic cell nuclear transfer ['therapeutic cloning'] for research on stem cell therapy would be premature" because there are alternative sources of human stem cells.

EXAMPLES OF OTHER JURISDICTIONS' LEGAL APPROACHES. In the United States, regulation of human cloning and embryo research has been undertaken or debated at both the national and state levels. At the federal level, there is a rigid separation between the public and private sectors. Little if any regulation applies to research involving the use of human embryos if it is funded by the private sector, although the U.S. Food and Drug Administration has asserted jurisdiction over reproductive cloning whenever safety issues are raised.

Federal attempts to regulate cloning have the support of President George W. Bush, who, on April 10, 2002, called on the U.S. Senate to endorse the Human Cloning Prohibition Act, which would ban all human cloning in the United States, including the cloning of embryos for research. This bill was nearly identical to the bipartisan legislation that passed the U.S. House of Representatives by more than a 100-vote margin in 2001.

This announcement supplemented the one issued on August 9, 2001, regarding stem cell research. In the latter, Bush resolved that federal funding of research using the more than sixty existing stem cell lines from genetically diverse populations around the world that have already been derived would be permitted, but that he would not sanction or encourage the destruction of additional human embryos. Henceforth, federal funds could be used only for research on existing stem cell lines that were derived: (1) with the informed consent of the donors; (2) from excess embryos created solely for reproductive purposes; and (3) without any financial inducements to the donors. In order to ensure that federal funds are used to support only stem cell research that is scientifically sound, legal, and ethical, the U.S. National Institutes of Health was charged with examining the derivation of all existing stem cell lines and creating a registry of those lines that satisfy these criteria. A further result was that federal funds cannot be used for: (1) the derivation or use of stem cell lines derived from newly destroyed embryos; (2) the creation of any human embryos for research purposes; or (3) the cloning of human embryos for any purpose.

In Canada, a similar approach was taken in February 2002. In Australia, the Research Involving Embryos and Prohibition of Human Cloning Act of 2002 was introduced into Federal Parliament in June 2002. There are three main elements to the bill: a ban on human cloning, a ban on certain other practices relating to reproductive technologies, and a system of regulatory oversight for the use of excess embryos created through assisted reproductive technologies that would otherwise have been destroyed. The legislation would establish a system of licensing, administered by the National Health and Medical Research Council.

john m. harris

derek morgan

mary ford

SEE ALSO: Abortion: Medical Perspectives; Cloning; Feminism; Fetal Research; Human Dignity; Infants; Infanticide;Maternal-Fetal Relationship; Moral Status; Reproductive Technologies: Ethical Issues; Research Policy: Risk and Vulnerable Groups; Research, Unethical;Transhumanism and Posthumanism; and other Embryo and Fetus subentries

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INTERNET RESOURCES

Decree no. 200 of March 1997: A Prohibition of Human Cloning Research. Available from <infoleg.mecon.gov.ar/txtnorma/42213.htm>.

Decree no. 24029-S. A Regulation on Assisted Reproduction, February 3, 1995. Available from <www.netsalud.sa.cr/ms/decretos/dec5.htm>.

Ministry of Health and Social Security, Regulation No. 568/1997 on Artificial Fertilization. Available from <htr.stjr.is/interpro/htr/htr.nsf/pages/lawsandregs0002>.

Parkinson's Disease Foundation. "Parkinson's Disease: An Overview." Available from <www.pdf.org/AboutPD/>.

Swedish Council on Medical Ethics. "Statement of Opinion on Embryonic Stem Cell Research, January 17, 2000." Available from <www.smer.gov.se>.

The Swedish Research Council's Guidelines for Research—Ethical Review of Human Stem Cell Research, December 4, 2001. Available from <www.vr.se/index.asp>.

United Kingdom Human Genetics Commission (HGC). 2002. Inside Information: Balancing Interests in the Use of Personal Genetic Data. Available from <www.hgc.gov.uk/insideinformation/>.

United Nations Educational, Scientific and Cultural Organization (UNESCO). 1997. "The Universal Declaration on the Human Genome and Human Rights." Available from <www.unesco.org/ibc/index.html>.

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Embryo and Fetus: III. Stem Cell Research and therapy

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