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* Challenges of Emerging Technologies: Cloning and Inheritable Genetic Modification

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By Rosario Isasi, Centre de recherche en droit public, Université de Montréal, Canada

THIS DOCUMENT APPLIES TO THESE EVENTS:

Plenary #5: Challenges of Emerging Technologies: Reproductive Cloning and Inheritable Genetic Modification


Gender and Justice in the Gene Age:

A Feminist Meeting on New Reproductive and Genetic Technologies

New York City, May 6-7 2004.

CHALLENGES OF EMERGING TECHNOLOGIES : CLONING AND INHERITABLE GENETIC MODIFICATION

Rosario Isasi, JD, MPH – CRDP, Université de Montréal

Emerging genetic/reproductive technologies have the potential to transform society, science and the environment, economic structures and even the human species.

The socio-ethical restrictions placed on biotechnological progress for medical social, political and economic interests are weakening, and the consequences of this could be serious if not properly addressed. As we have heard from previous speakers, the challenge is to balance responsible regulation and reproductive freedoms, scientific progress and protection of human health and safety.

These challenges have ethical as well as legal implications. For instance, the conceptual problem of distinguishing between prevention, therapeutic interventions and eugenics could become (or is already) a matter of political legislation. There is therefore a relationship between values/ethics and policy/legislation, which necessitates, when considering a specific policy, posing the question: “Does this policy live up to that minimum of humanity which society wishes to preserve?” .

An area of particular concern when addressing the challenges posed by emerging genetic technologies is the lack of a coherent regulatory framework in many societies, as well as the absence of a meaningful public debate. Certainly, consistent responsible regulation is essential to ensure that research on these new technologies is not only scientifically sound but also conducted under an imperative ethical framework. Science should not proceed in an ethical and social vacuum.

Conversely, the problem juridification (this is the danger of the uncritical and unreflective appeal to law) is also an area of concern. This happened recently in Italy when, after decades of enjoying a laissez-faire model, the Assisted Reproductive Technology law was passed shifting the model to one of the most prohibitive regulatory regimes in place in the world. According to that law, reproductive and research cloning is prohibited as is IGM and the creation of human-animal chimeras.

Furthermore, the fertilization and transfer of more than three embryos into the uterus is prohibited. Even more, the implantation of those three IVF-created embryos is mandatory, while any genetic testing/diagnosis is prohibited. Women cannot refuse or change their minds about the implantation of those embryos once they have being created, and the ART law imposes criminal sanctions for its violation.

It is clear that in this law the focus is on the embryo and not the women (what has been called embryocentrism).

NATIONAL POLICIES

A recent survey shows us that, worldwide, where legislation has been enacted, it is typically to prohibit reproductive cloning (23% of the world, of which half are developing countries), in smaller scale to prohibit germline genetic manipulation (14% of the countries, only 1/3 of them from the South) and embryo or cloning research (16%). Nevertheless, there is far less convergence on issues such as the permissibility of pre-implantation genetic diagnosis (PGD), prenatal diagnosis (PND) and other emerging reproductive and genetic technologies.

In other countries, however, there are only guidelines or recommendations from national bioethics committees. At best, these indicate trends as their incorporation into legal texts is far from certain.

And of course, in many countries the politics of abortion permeate much of the relevant discourse and policy-making activity. For example, discussions about the moral status of the human embryo are present in virtually every policy document.

In some cases, the constitutional framework of a jurisdiction limits the regulatory option available to legislators; this is the case in Ireland and most Latin American countries where the “right to life” is enshrined in their national constitutions. This right not only has been interpreted as prohibiting abortion, embryo manipulation or research, and some cloning procedures but also has been widely regarded as implicitly prohibiting PGD and even in-vitro fertilization (IVF) (Costa Rica). In these cases, moral status of the human embryo supercedes women’s health.

Legislation is part of the world of competing ideas markedly influenced by cultural differences. Each national jurisdiction has sought to fashion a scheme of regulation – or has chosen not to regulate – in a way that is acceptable to its own culture and community.

The diversity of approaches in regulating species-altering procedures is not necessarily problematic; in the case of cloning, for example, there are various restriction mechanisms that are not mutually exclusive. But some countries have attempted to ban human cloning, inadvertently using language that creates ambiguities, or have enacted prohibitions limited to embryo research (i.e. Austria, Finland, Ireland) and cloning through the Dolly technique of somatic cell nuclear transfer (SCNT) may not be viewed as embryo research .

Other countries have approached species-altering procedures with caution, instituting moratoria in order to consider the wide range of effects of these technologies (Russia); however, some of these moratoria are set to expire soon.

Internationally, the bans on germline (i.e. inheritable) genetic interventions are general enough to cover a wide range of technologies. These laws reflect a profound understanding of the need to avoid the social pressures to engineer a “better” human race, as occurred in the Nazi era. German law understandably forbids germline interventions.

In some cases, potentially relevant laws were adopted more than two decades ago to deal with a different set of technologies and concerns; it is unclear whether their expansive prohibitions will be applied to the newer technologies of reproductive cloning and inheritable genetic modification. Moreover, many of the existing declarations and laws do not include sanctions or provide for regulatory oversight .

INTERNATIONAL INSTRUMENTS

International instruments provide guidance and core principles that potentially apply to all biomedical innovations regardless of the scientific advances made. They play an essential role, therefore, even if they must be complemented by more specific provisions at the national level .

At the international level two organizations - UNESCO and the United Nations – have played key leadership roles in the area of new human genetic technologies. Two others– the World Health Organization and the UN High Commission on Human Rights – have given these issues some attention.

In 1997 UNESCO unanimously adopted the Universal Declaration on the Human Genome and Human Rights, the first global instrument addressing the legal and ethical human rights implications of human genetic technologies. The Declaration reaffirms, in Article 1, the fundamental principles enshrined in the International Bill of Human Rights which states, “the human genome underlies the fundamental unity of all members of the human family, as well as the recognition of their inherent dignity and diversity […] it is the heritage of humanity.”

In 2002 the United Nations began discussions on an international convention banning human reproductive cloning. However, many nations are unwilling to support bans on reproductive cloning in the absence of bans on research cloning, and at least several key countries, including the United Kingdom and China, are unwilling to agree to such bans. The United Nations requires an effective consensus before it proceeds with treaty negotiations, so at the present time further movement towards a legally binding instrument appears unlikely.

REGIONAL POLICIES

The most encouraging policy initiative taken to date to address the dangers of species altering procedures is the Council of Europe's 1997 Convention on Human Rights and Dignity with Regard to Biomedicine. The European Convention highlights “the need to respect the human being both as an individual and as a member of the human species.”

Other regional bodies, including the African Union, have adopted statements calling for prohibitions or regulations concerning new human genetic technologies. Regional bodies such as the African Union, the Organization of American States, and others need to play leadership roles in helping formulate responsible human genetic technology policies covering countries as part of their regions.

CONCLUSION

Formal legislation is not the only regulatory response available and, if legislation is to be effective, it must be supported by less formal mechanisms, such as cultural norms, values and professional support .

In countries where the relevant species-altering technologies is likely to be developed and applied to meet demand, no regulation is not an option. Regulatory oversight needs to attract public support to be effective, and it must be the product of adequate consideration of all morally relevant interests and variables by those legitimately empowered to do so. In those countries where the government has failed to act – such as the US where there has been little federal regulatory intervention and only piecemeal state responses to species altering technologies - private arrangements regulated only by voluntary agreements and self-regulatory initiatives are the only controls. Both have well-documented weakness , .

As noted by Wellman,

“(…) a society can safely leave important and potentially dangerous interventions without legal regulation only if there is a sufficient degree of moral consensus so that individuals can be expected to act morally without the regulation or more informal regulation can be trusted to be morally enlightened. Unfortunately, legal regulation may be necessary in areas of human conduct where liberty is often abused and important moral values are in jeopardy.

How we deal with the challenges posed by the new human genetic technologies, touches on our self-understanding not only as moral persons but also as members of the species . The stakes are high. If we believe in the fundamental values of liberty, equality, solidarity and justice, in other words, if we are committed to upholding universal human rights, we need to act globally and act now.