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Abstract

Bioethics has become a subject of public debate, and the discussion has spread to a number of different, mainly deliberative, forums. Bioethical issues soon started to inﬂuence legislative debate and policies on health and new technologies. This entry reviews the evolution of the bioethics debate and its inﬂuence on politics and presents an overview of the future discussion.

Introduction

The terms “bioethics and politics,” “biopolitics,” and “bioethics governance” are used on different occasions when addressing different stages of understanding of the management and regulation of matters regarding progress and development of biomedicine and biotechnologies. The relationship between bioethics and politics arose principally from the increased discussion of bioethics in the public forum. Step by step, the original scope of bioethics, the reﬂection on the ethical issues raised by new technologies in health, science, and biomedicine in general, led to an increasing politicization of bioethical issues.

Can Bioethics Coexist With Politics?

The discussion on bioethics entered the public forum in the late 1970s with the impact of developments in biology and medicine and technological innovations. With these changes came the need to regulate the limits on their use and the conﬂicts they generated. Edmund Pellegrino (2006, p. 570) properly framed this issue: “when ethics does enter in the public square can it co-exist with politics, or is Machiavelli right that politics has no place for ethics? Can they interact without one capitulating to the other?” Pellegrino analyzes the relationship between ethics and politics, distinguishing two different kinds of politics: the ﬁrst one, “derived from both Plato and Aristotle, as a study of the nature and structure of a good society” and the second in the sense of “partisan politics, i.e., the participation of citizens, individually or collectively, in governance in order to inﬂuence society’s laws and policies.” In his opinion, although in the ﬁrst one ethics and politics do not conﬂict, partisan politics may be employed unethically as well as ethically, depending on whether the “cause is based in a sincere search for a good society.”

Moreover, it is argued that, with the interference of politics in the bioethics debate, the original nature and goals of bioethics have been diluted and are losing the ability “to generate moral guidance.” Bioethics discussion enters in the public arena and leads to the need to manage and regulate the problems raised by the progress of the biomedicine, biotechnologies, and scientiﬁc technologies in general. Do the rules applied to bioethics debate apply in the same way as the rules of policies and regulation?

Policies And Regulation

States must introduce public health strategies, and governments must opt for the most adequate framework when presenting their public health programs which will affect the lives of a whole population. For that purpose, it is also necessary to have an ethical framework that can identify the most important values to guide public policy in these matters. In light of this, it is appropriate to review the different models of the roles played by the states in their relationship with the individuals and other bodies that are governed by the state’s rules: from the libertarians’ perspective versus the collectivist point of view and, in between, the utilitarian and the social contract and liberal approaches.

The WHO’s (World Health Organization) concept of health, in its deﬁnition as “a state of complete physical, mental and social well-being and not merely the absence of disease or inﬁrmity,” does illustrate the fact that assessments of wellbeing can include value judgments. One of the interpretations (Nufﬁeld Council on Bioethics 2007) says that this means there may be disagreement about the justiﬁcation for speciﬁc policies. Furthermore, liberal states will typically see it as their responsibility to provide frameworks that reduce the risks its citizens pose to each other’s health but also to promote the health of those who cannot take full responsibility for themselves. The tension that may arise between the protection of personal autonomy and the promotion of welfare for all (which may sometimes be seen as intrusive) challenges the ethical debate as a helpful and necessary instrument to help policy makers to make appropriate decisions. One of the examples pointed out in the “Public Health: ethical issues” report (Nufﬁeld Council on Bioethics 2007) is consent and the relevance of individual consent when considering public health measures and the need, in some situations, to obtain approval from the population as a whole. In order to enlighten policy makers on their decisions, this Council proposed a model (“stewardship model”) that “outlines the ethical principles that should be considered” (Nufﬁeld Council on Bioethics 2007, p. 26).

Different strategies have been used over the years to establish a dialogue between bioethics professionals and policy makers. These have included consultative committees to provide ethical discussion and recommendations (ethics committees) or committees for legislative purposes (i.e., the Warnock Committee in the UK). The basic purpose is to provide a multidisciplinary and independent debate and to present recommendations for legislation on the developments in science, medicine, and, later, even in new technologies in general. Other forms of ethics committees, such as the USA Presidential Commission for the Study of Bioethical Issues (2009), have gone further in identifying and promoting policies and practices, advising the president directly on bioethical issues: “The Commission shall recommend any legal, regulatory or policy actions (.. .).”

In fact, different forms of participation, from consultation to deliberation, have entered the public forum and have placed the bioethics discussion between citizens and political decision-makers. Bioethics committees have, over the years, spread throughout the majority of democratic states, and other more sophisticated elaborate authorities have appeared at different levels of inﬂuence: regional, continental (e.g., EGE – European Group on Ethics in Science and New Technologies of the EU Commission), and international (UNESCO, Council of Europe).

It has been noted that the major efforts to reach a consensus on bioethics at an international level have also been made. Above all, an attempt has been made to achieve political consensus, where representatives of different countries try to reach a common language that may be adapted in each of them that is as ﬂexible and comprehensive as possible, so that it can be interpreted in each jurisdiction. Examples of this are the UNESCO Universal Declaration on Bioethics and Human Rights or the Council of Europe’s Convention on Human Rights and Biomedicine. Principles such as “human dignity” (which plays a central role in the majority of international and national declarations, opinions, and guidelines) may then vary according to the interpretation given to the principle in each country where it is applicable. In such cases, political agreement can be achieved only at the price of a certain vague and general approach.

Nevertheless, as stated by Rendtorff (2002, p. 236), bioethics principles such as autonomy, dignity, integrity, and vulnerability “are not only deduced from universal standards, they are also and primarily induced from the particular situations of application.” Many countries adopt such principles, which represent a signiﬁcant development of the international law, mainly in the EU. Those principles have been developed and extended at an international level, either in the declarations and conventions (UNESCO and Council of Europe), referred to above, but also in the EU, in the Charter of Human Rights. As considered by Rendtorff (2002, p. 240), the “legal regulation based on the basic ethical principles should be considered as a fourth generation of human rights or bio-rights that imply a universal protection of the human person with intrinsic value as an end-in-itself.”

Despite the signiﬁcant efforts for harmonization of European legislation, there are still gaps in some policies regarding, mainly, the beginning and ending of life. Such gaps have contributed to create the so-called “medical tourism”. They also evidence the great difﬁculties of harmonization of the principles and the aimed consensus at least in the European sphere. Most difﬁculties in harmonization have been found mainly regarding assisted reproduction (i.e., some countries allow the use of the techniques to single women or homosexual couples, whereas others remain very strict about such permission) and assisted suicide (European legislations differ radically, with countries that allow assisted suicide, i.e., the Netherlands, Belgium, and Switzerland, and the majority being opposed to it).

The risk of politicization of the bioethics debate is also raised when, for instance, ethics committees are used for political purposes, to legitimize political decisions or nondecisions. On this subject, Göran Hermerén (2009) analyzing the questions “is it always avoidable and is it always bad?” argues that in order to avoid a negative approach, trust, openness, transparency, and integrity are essential. On the other hand, it is sometimes very difﬁcult to establish a clear borderline between ethics and politics. For example, it is impossible to discuss the ethical aspects of energy in the EU without having regard to the Lisbon Treaty and the TFEU (Treaty on the Functioning of the EU), the SET-Plan, the Energy 20-20-20 Strategy, or the Energy Roadmap 2050.

As Art Caplan wrote, “bioethics maturation as a ﬁeld has brought recognition, and that it is time we admitted that with recognition comes power and with power comes politics” (Kahn 2006, p. 10). Citizen debates over the years on the ethical matters regarding beginning of life or the end of life decisions as well as regarding the progress of science and medicine (e.g., human stem cell research, assisted reproduction, euthanasia) place bioethics in the middle of the political arena and of legislative decisions.

Both due to the lack of uniform legal standards and the need to take appropriate decisions on life and death, bioethics took a privileged space in the public debate, and soon it was considered as essential in order to help legislators to interpret the grounds of the discussion, the moral dilemmas, and the different positions at stake. Having regard to the different (and many times radically opposing) moral positions in society, it has been necessary to promote national debates in order to reach a general consensus to allow governments and parliaments to take appropriate decisions on legislation.

Such debates are so relevant that nowadays candidates for President are often asked to present their views on certain hot topics, such as stem cell research, human cloning, or assisted suicide, and sometimes they also form part of political programs. Today, decisions such as the choices for innovative medicines (cancer, hepatitis, AIDS, rare diseases) must be taken into consideration by governments on the bases of the management of scarce resources. Such choices cannot be made without taking into account the ethical discussion on the subject.

Recently, ethics has also been used as a tool to justify the inversion of the rules in policies as a justiﬁcation for emergency interventions on exceptional occasions such as for the viral disease Ebola. It happened in 2014 with the outbreak of Ebola in West Africa, the high mortality rate and the need to stop the disease from spreading through entire populations. New drugs and vaccines that have been developed in the past decades were only tested on animals and not evaluated for safety and efﬁcacy in humans. The report of an advisory panel to the WHO (World Health Organization 2014, p. 7) on the ethical considerations for use of unregistered interventions for Ebola concluded that in such a particular context, “it is ethically acceptable to offer unproven interventions that have shown promising results in the laboratory and in animal models but have not yet been evaluated for safety and efﬁcacy in humans as potential treatment of prevention.” Pleading for the sharing of all scientiﬁc data generated from such uses, under such circumstances the “compassionate use” of unproven drugs and vaccines has also been accepted. In fact, in normal terms, the use of unproven drugs and vaccines and even their “compassionate use” has been treated as unacceptable without fulﬁlling all the criteria established worldwide for clinical research. Curiously, ethics have been the safe conduct needed to proceed with policies applied to exceptional emergency situations. Moral duty has been to a certain extent the justiﬁcation to break the “traditional” rules.

Access to scarce drugs by Ebola sufferers has been one of the other questions raised: who should have access to the drugs? The same question is now being raised more often with the appearance of new expensive drugs, such has the new treatment for hepatitis C that provides the cure in most of the cases but is very expensive, so governments have to select who will have access to it. How governments will manage the question of which innovative treatments are affordable is a matter that should be placed on the agenda of all candidates for governments. On the other hand, it is argued that such choices should not remain merely in the hands of politicians but, on the contrary, citizens should be empowered to participate in such decisions.

On other occasions, principles that ﬁrst appear to have ethical grounds, such as the precautionary principle (ﬁrst introduced as a result of the impact on the environment of the new technologies), have rapidly turned into a political principle introduced into legal texts and policies, although it does not correspond to precise rules of risk management. First formulated in environmental declarations, such as the Rio Declaration in 1992, the precautionary principle quickly came into force in legally binding treaties, with wider scope, such as the Maastricht Treaty (1992). It represents a major principle presented, for instance, in the French Constitution (2005) (in February 2005, the Parliament included in the Constitution the Charter of the Environment, thereby inserting the precautionary principle (Art. 5) at the highest level of the hierarchy of legal rules). The 2 February 2000

Communication from the Commission on the Precautionary Principle, from the EU Commission, noted that, “The precautionary principle is not deﬁned in the Treaty, which prescribes it only once – to protect the environment. But in practice, its scope is much wider, and speciﬁcally where preliminary objective scientiﬁc evaluation indicates that there are reasonable grounds for concern that the potentially dangerous effects on the environment, human, animal or plant health may be inconsistent with the high level of protection chosen for the Community” (Communication from the Commission on the precautionary principle) (2000). The application of an ethical principle that has been integrated into political speech and interpreted in order to forbid certain products produced by certain new technologies (e.g., GMO) has been enforced in such a way that some governments have been asked to equilibrate the precautionary principle so that it is not perceived as a brake on research and economic development.

Bioethics is also an excellent ﬁeld in which to analyze participatory movements and steps toward citizen’s involvement in contributing to or inﬂuencing political decisions, from consensus conferences to citizens’ conferences. The most difﬁcult step is actually knowing how to introduce this kind of involvement into legal and political systems and implement the steps necessary to enforce the practice.

Interaction seems to be a key word in the issue of implementing people’s views in democracy. “Such interaction,” adds Hermerén, “is a key strategy for creating, maintaining and improving trust. This is an essential element in the relation between many stakeholders: the committee itself, the political decision-makers, and the general public but also the scientiﬁc and legal communities” (Hérmeren 2009, p.170).

The implementation in society of different models of representation of civil society and the way representatives’ positions are empowered also raise the question of their legitimacy as society’s representatives. They are not always neutral, in a space were neutrality is very often not envisaged, and this gives space to a rather more transversal pluralism than political parties or instances offer to the public debate on bioethics. Should governments take in charge the legislative procedure by themselves without public consultation or the recommendations of a consultative body? Some describe at least three main challenges of legitimacy: pluralism (“which recognises that in many areas of bioethics the subject matter gives rise to differences of view” sometimes “bitterly contested”), liberalism (related with the question of “whether we should regulate the area in question at all”), and authority (meaning the “power of closure on issues to enable practical steps to be taken”).

Almost two decades have passed since Pellegrino (2000) wrote, in a pessimistic sense, about contemporary bioethics’ ability to generate moral guidance, stating that there is a tendency “toward the gradual abandonment of the idea of normative ethics and moral truth of any kind” and the tendency to emphasize procedures and public policy (Bishop and Jotterand 2006, quoting Pellegrino on page 206).

Conclusion

In just a few decades, bioethics has evolved from a multidisciplinary debate inside committees to a public debate, which then moved to the political arena and is enforced through legislation. The discussion of bioethics is now a fundamental tool to promote society’s decisions on complex and divisive issues on life and death and to implement new legislation on medicine, science, and new technology issues. This discussion empowers citizens but brings into political discourse matters that, as some argue, should be kept at their initial level of discussion.

It is true that, as Pellegrino (2006, p. 577) wrote, “maintaining cultural and moral diversity without granting hegemony to any single culture will complicate the task of bioethics substantially.” It is also true that the bioethics debate, despite trying to be a “device for responsible moral analysis,” appears sometimes to be “a weapon for ideological or political supremacy.” Politics have contributed to that deviation of the bioethics debate. But bringing diversity to the moral debate has always been within the scope of bioethics. We believe that the bioethics community will survive in a politicized debate.

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