CGS : International Policy Failures: Cloning and Stem-cell Research

In late 2003, two international bodies were unable to resolve disagreements that involved bioethical issues. First, the United Nations General Assembly failed to pass a treaty on reproductive cloning because of insistence by some countries that the treaty include a ban on cloning for research. In view of the importance of enacting prohibition of reproductive cloning, the two issues should be separated and each argued on its own merits. Relevant objections to separation of the two issues can be refuted. Second, the European Union (EU) failed to agree on conditions for funding stem-cell research because of the diversity of views and policies of the countries of the EU. Because a stalemate was reached, funding decisions in the next programme cycle will be made on an ad hoc basis. Scientists will not have information they need to plan research programmes, suggesting that clear guidelines, even if restrictive, are preferable to vague unpublicised criteria.

In late 2003, the United Nations (UN) General Assembly once again failed to pass a treaty on human cloning; the European Union (EU) reached a stalemate on funding for stem-cell research; and the US Congress abandoned its efforts to pass cloning legislation. Formulation of public policy at the international level becomes very difficult when little consensus exists on the moral and ethical issues involved. Within Europe, for example, the UK, Belgium, and Sweden have fairly permissive legislation on stem-cell research, whereas countries such as Germany and Italy are highly restrictive.1 Even within a country such as the USA, a pluralism of belief systems can make consensus impossible to attain.

In development of public policy on embryonic stem-cell research, an international body or individual state must recognise that many people hold strong views on the moral status of the human embryo. Since a human blastocyst must be destroyed to obtain stem cells, people who believe that the blastocyst is a human being will regard the process as killing. If those who hold this view form a critical mass, public policy probably will not support embryonic stem-cell research. In some political contexts a compromise can be reached: to permit stem-cell extraction only from surplus embryos developed as part of fertility treatment and destined to be destroyed, or to allow research only with embryos or stem-cell lines already in existence at a particular date.

Issues in public policy on cloning overlap somewhat with general stem-cell matters but have additional dimensions. Prohibition of cloning for reproductive reasons is directed at prevention of the birth of children who are genetic copies of already existing individuals. Legislation on cloning for research, however, deals mainly with development of stem-cell lines through somatic cell nuclear transfer (SCNT), thus raising issues about a specific type of stem-cell research.

This article will examine the UN's failure to pass a treaty on cloning and the EU's inability to agree on policies for funding of stem-cell research. In some cases, actions taken by individual countries might provide exemplars for processes at the international level. In other cases, lessons learned at the international level could be instructive for countries that find themselves at an impasse.

Currently, the international community agrees that human cloning for reproductive reasons should not be attempted. The rationale cites safety considerations in view of the many difficulties and defects reported in the cloning of animals.2 This argument, which lends support to at least a temporary ban on reproductive cloning, is almost universally accepted by both scientists and ethicists.

A different justification for prohibition of reproductive cloning states that to attempt to produce a genetic copy of an existing human being is simply morally wrong. This rationale might cite the denial of unique identity to the cloned child and the expectations that would probably be placed on him or her, thus limiting the child's future possibilities. If a cloned child was created to replace a deceased child or adult then the expectation would be not only unfair to the cloned child but also be based on the incorrect assumption that an identical person will result.3

Moral objections to reproductive cloning are more debatable than are those about safety. Some people argue that if cloning were shown to be safe then it might be legally permissible under guarantees of reproductive freedom. Others maintain that cloning might be ethically acceptable under certain conditions--for example, if it were the only way for couples with fertility difficulties or a genetic disorder to have a healthy genetically related child.

Whatever controversy exists about a permanent ban on reproductive cloning, safety arguments entail that human cloning should not be attempted at this time. Public policy affirming this conclusion has an important role, even if a few dissenting scientists insist on moving ahead. Public prohibition asserts public disapproval and ensures that those who violate the ban will be held in disrepute rather than admired.

Why are the UN and the US Congress unable to pass a ban on reproductive cloning? Because this type of cloning is linked to another procedure--development of stem-cell lines through SCNT, sometimes called cloning for research or therapeutic cloning. Although the two processes are related, they are also distinct in their goals and their research methods. When they are regarded as a unit for reasons of legislation two policies are possible: prohibit both reproductive cloning and cloning for research; or ban reproductive cloning and establish conditions under which cloning research is permitted. For individuals who support cloning for research, the first option is unacceptable; for most people who oppose such research, the second option is unacceptable because of its tacit approval of research cloning. Since the world is deeply divided along these lines, legislation might not be possible.

A third option, however, entails not linking the two cloning practices. Since there is essentially universal agreement that reproductive cloning should be prohibited, the link must be broken to avoid a continuing impasse. In view of the importance of reining in rogue scientists, who currently can move from one country to another to find hospitality for their work, and of setting to rest the unrealistic hopes of potential parents who are encouraged by these pseudoscientists, an international ban is needed.

A law or treaty that bans reproductive cloning and is silent on cloning for research is a compromise that both the UN General Assembly and the US Congress will have to make. Examples of such legislation are available in individual countries. The UK passed the Human Reproductive Cloning Act in 2001 to prohibit cloning for reproductive reasons (panel) and then dealt separately with cloning for research.4 In 2001, the UK Parliament extended the authority of the Human Fertilisation and Embryology Authority (HFEA) to allow stem-cell research with embryos produced either through in-vitro fertilisation (IVF) or SCNT (figure 1).5 After court challenges about whether an SCNT blastocyst was truly an embryo under the language of the law creating the HFEA, a final decision in the House of Lords affirmed that it was. The HFEA thus had authority to grant licences for stem-cell research with SCNT blastocysts.6

By separation of the issue of reproductive cloning from cloning for research, the UK was able to prohibit the former while allowing the latter under regulation and licensing. Models also exist in which a country has banned reproductive cloning and remained silent about cloning for research, neither ruling out nor explicitly approving it. Israel, for example, has barred reproductive cloning since 1999 in legislation that makes no reference to cloning for research.7 The silence of this law about research cloning has generally been understood to be permissive.8

Some examples of legislation that separate reproductive cloning from cloning for research prudently draw the line at the point of embryo transfer. In the UK the law states that "a person who places in a woman a human embryo which has been created otherwise than by fertilisation is guilty of an offence".4 Setting the legal limit at the point of transfer eliminates one of the more striking objections to allowing research cloning while ruling out reproductive cloning: the objection that if a cloned embryo were transferred to a uterus and implanted, then the law would require it to be aborted to prevent the birth of a cloned child. Prudent legislation ought to prohibit the transfer itself.

Two objections to separation of the issues of reproductive cloning and cloning for research deserve extended consideration. The first is related to the previous assertion about abortion but applies to the preimplantation embryo. The objection claims that allowing cloning for development of embryos for research while prohibiting reproductive cloning requires that SCNT embryos created for research must later be destroyed. If one believes that preimplantation embryos are human beings or have similar moral status then one cannot accept a legal mandate that they be destroyed.

Two responses to this objection are possible. First, an appropriate law would not mandate that these embryos should be destroyed, rather that they should not be transferred for implantation. To transfer embryos a proactive decision has to be made. What the law would require is that this decision not be taken. If embryos were not transferred then they would simply stop developing, since extended development in the laboratory culture dish is impossible.

The second response invokes a longstanding ethical principle in embryo research. When a preimplantation embryo is used in investigations then it may not be transferred for implantation unless the procedures are aimed at facilitation of pregnancy or provide a direct benefit for that embryo. If the research carries a risk of harm to the embryo (beyond the usual risks of assisted reproduction) then the embryo may not be transferred.9 Thus, even apart from prohibition of reproductive cloning, to seek further development of an SCNT embryo used in research would be unethical and the only alternative is to allow it to perish naturally.

The second objection to separation of reproductive cloning from cloning for research argues that the two practices are inextricably linked. Cloning for stem-cell development will improve cloning techniques and will inevitably facilitate reproductive cloning.

In responding to this objection one must note that it makes two distinct claims, both of which are empirical. The first claim is that cloning research will improve cloning techniques. Most probably this claim is correct. However, research in animal cloning (figure 2) has made the greatest contribution to date in improvement of cloning techniques and is likely to do so in the foreseeable future. Yet little pressure exists to prohibit animal cloning research, even research on reproductive cloning.

The more important empirical claim is that increased knowledge about cloning techniques will probably, or even inevitably, lead to human reproductive cloning. History is no guide for testing this claim since it provides examples when dire predictions about biomedical advances were fulfilled and when they were not. The best way to prevent human reproductive cloning from happening is to enact strong national and international bans on attempts to transfer a human SCNT embryo to a human uterus or other body for further development.

A ban on the transfer of an SCNT embryo for further development not only outlaws human reproductive cloning but also rules out such transfer for development of an SCNT embryo to the late-embryo or fetal stage to extract differentiated fetal tissue for research or treatment. Currently, transfer of an IVF embryo for such reasons would be judged unethical. It not only violates a generally accepted ban on preservation of embryos beyond 14 days' development for research but also, in the most plausible case of transfer to a human uterus, intends to establish a pregnancy and then abort it to obtain fetal tissue. Besides ethical objections, many countries have laws that prohibit this practice--eg, the Fetal Tissue Transplantation Act in the USA.10,11

Not only should legislation prohibiting the transfer of SCNT embryos to a uterus or other body be enacted but also the banning of implantation to procure tissue for research or treatment should be extended to all embryos, including those created through IVF. In its report on reproduction and responsibility, the US President's Council on Bioethics lends support to such a ban.12

An additional objection to laws or treaties that ban reproductive cloning but are silent on cloning for research maintains that such policies give tacit approval to research cloning. This objection would apply to a wide range of public policies--eg, those that prohibit embryo research beyond 14 days' development might seem to give tacit approval to investigations at earlier stages (figure 3).

Public policy on morally charged issues is feasible only when a high level of consensus exists within the relevant community.13 Currently, there is agreement that reproductive cloning should be banned and that embryo research beyond 14 days' development is ethically unacceptable. Consensus on cloning for research and on embryo studies before 14 days does not exist internationally nor within many countries, thus making legislation either impossible or unwise.

Opponents of a particular practice frequently realise that they cannot achieve total prohibition of that practice and thus they accept compromises. The abortion debate in the USA, as in many other countries, provides vivid examples. Abortion opponents in this country sought a ban of so-called partial-birth abortion, which was enacted in 2003.14 A policy that is silent on other types of abortion does not express approval of other abortions; neither does a restriction on work with 15-day embryos imply approval of research with earlier-stage embryos; nor does a ban on reproductive cloning imply approval of cloning for research.15

After the issue of reproductive cloning has been resolved, separate laws or treaties about cloning for research can be debated, including ethical concerns about the recruitment of egg donors. When a consensus exists either way--prohibiting or supporting research cloning--then the corresponding public policy can be enacted.

When the law is silent on a specific practice, individuals can assume the procedure is permitted but not necessarily supported at the policy level. However, when public policy provides funding for particular types of research then it seems to be approving that work. Citizens who object to their taxes paying for research that they judge immoral may legitimately raise concerns.

In the USA, laws at the federal level are generally silent about embryo, stem-cell, and cloning research. When federal funding is provided, however, regulations apply that severely restrict such work. In most countries this distinction is not made and laws or regulations apply to all research whether publicly or privately funded. But when a community of non-homogeneous states, such as the EU, undertakes promotion of scientific and biomedical research through funding then the EU has to distinguish what is explicitly permissible in (some) member states from what it as a whole is willing to fund.

The EU articulates a position of respect and tolerance towards the diverse legal and ethical views of its member states. Its documents express respect for pluralism while at the same time identifying common values or principles that are perceived to be generally acceptable.16 For example, in the Convention on Human Rights and Biomedicine, Article 18 states: "Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo."17 This general principle allows a wide range of interpretations as to adequate protection.

When the EU is faced with decisions about funding research these varied interpretations can clash. In December, 2003, an 18-month process for development of guidelines on funding stem-cell research within the Sixth Framework Programme collapsed. A 1-year moratorium in 2003 had allowed funding only for research on embryonic stem cells that had been derived before the end of 2002. During 2003 the European Parliament and Council of Ministers were to develop rules about whether additional stem-cell lines could be derived, studied, or both with EU funding. In November, 2003, the European Parliament approved permissive regulations, endorsing stem-cell research and eliminating any cutoff dates. However, the research ministers of the European Council had the final say and on Dec 3, 2003, they failed to reach agreement. Thus, the European Commission will have to make decisions about funding of stem-cell proposals on a case-by-case basis.18,19

A representative of the Irish government, which held the EU presidency for the first 6 months of 2004, described the Council's failure to reach a compromise as "the worst case scenario". However, Research Commissioner Philip Busquin noted that stem-cell proposals could still be submitted and would be reviewed by regulatory committees representing member states. He predicted that some less controversial projects involving embryonic stem cells would be approved.20 For member states that oppose any such research, the type of work that would be judged less controversial is unclear.

Some observers believe that limitations on EU funding are not important. In the first round of applications for funding under the Sixth Framework Programme, only 126 of more than 12 000 proposals focused on stem cells and only one of those dealt with human embryonic stem cells.19 Researchers, however, argue that to plan research and develop proposals is difficult when uncertainty exists about what the rules are. But even when the rules are clear, as in the USA, severe restrictions on the funding of stem-cell research might have curtailed interest in the field. The number of applications for federal funding under the current guidelines is small, and Elias Zerhouni, Director of the National Institutes of Health, has lamented the scarcity of research scientists with expertise in stem-cell research.21

When a country or group of countries makes a decision on the funding of research it is identifying activities that it wishes to encourage. Individual countries and the EU have decided to fund biomedical investigations to promote advances in science and medicine that might save lives and contribute to quality of life. The basic work that is needed for scientific progress is generally not of interest to private corporations or investors since prospects for a return on investment are theoretical and long-term. Public funding might be the only relevant means of supporting programmes of basic research.

The area of human embryonic stem-cell research is in its infancy. In most cases, years of basic work will probably be needed before differentiated cell types derived from stem-cell lines could be considered for human clinical trials. But if the research succeeds the results could provide breakthroughs in treatment of diseases such as diabetes, Parkinson's disease, and cancer. Stem-cell research is an example of the type of work that merits public funding and might require it to succeed. On the other hand, embryonic stem-cell research is an exemplar of morally controversial work. Whereas all biomedical research in people engages ethical issues such as proper informed consent and the balance of risks and benefits, embryonic stem-cell research has at its heart a moral issue on which people of many nations are deeply divided--the status of the early human embryo.

It is appropriate for the US government and the EU to distinguish "between permitting or tolerating an activity . . . and actively promoting it through governmental funding".22 Many reasons exist why a public body might decide not to fund a particular activity, and in view of the fact that public resources are not boundless, it can fund only some of the projects that are proposed. Yet decisions not to fund stem-cell research, or some categories of stem-cell work, are ordinarily based on deeper considerations than simply prioritising the allocation of limited resources. These decisions become a matter of principle based on the moral objections of (some of) the citizens of a country or certain member states of the EU.

A country or group of countries can legitimately not fund certain controversial types of scientific or biomedical research. But a decision is preferable to a stalemate. Scientists who do not know what types of research proposals can be considered for funding are likely to shy away from a particular area of investigation. In this respect, the US rules, while restrictive, might have some advantages over the EU's lack of agreement on rules. If clear rules exist about what can and cannot be publicly funded then scientists can plan and seek private funding if necessary. The EU needs to break its stalemate and agree on funding policies, if not within the Sixth Framework Programme then at least by the time of the next programme cycle.

CT is a member of the ethics advisory board of Advanced Cell Technology, a for-profit company in Worcester, MA, USA, engaged in stem-cell research.

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