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This research paper begins with a deﬁnition of biolaw and explains the passage from bioethics to biolaw.
In the ﬁrst part, the paper investigates the relationship between moral pluralism and biolaw, outlining the models and theories stemming from the theoretical debate, which precedes and lays the foundations for bio legislation and bio jurisprudence. The different models of biolaw, the libertarian, the liberal, and the utilitarian model, are critically described, placing a particular emphasis on their neutral common perspective within the context of ethical pluralism. The personalist model of biolaw based on the recognition of human dignity in the human rights perspective is presented as opposed to the neutral perspective.
The second part of the paper focuses on tracing the historical evolution of biolaw at the national and international levels. At the national level, emerging trends show prevalence in different legal systems, of either rights to freedom, to social convenience, or to the dignity of the human person, based upon the development of different biolegal models related to the single topics, within the context of moral pluralism, resulting in regulatory heterogeneity. At the international level, different regulation paths have been considered, with a view to achieving a global regulatory harmonization: codes of conduct drawn up by international organizations are mainly devoted to human experimentation; the sources of international biolaw, within the framework of governmental, nongovernmental, and regional international organizations (UNESCO, WHO), set forth general issues in the context of the relationship between bioethics and human rights or speciﬁc topics.
“Biolaw” is a neologism which, even though more recent than the expression bioethics, has spread rapidly. The origin of the use of the term is not certain; however, it is evident how this expression tends to appear more and more alongside the expression bioethics, if not substituting it. Bioethics cannot avoid the reference to biolaw: this is mainly due to the ever-growing need in present-day society for juridical regulations on biomedical activity, resulting from scientiﬁc and technological progress. Just as the term bioethics does not coincide with its etymological meaning “ethics of life,” so the expression biolaw is not equivalent to “law of life.” Law, like ethics, has always been concerned with life.
The speciﬁcity of biolaw is to be found in the elaboration of rules to regulate human behavior at a social level in the context of progress in scientiﬁc knowledge and technological applications in biology and medicine. Bioethics and biolaw do not overlap, even though they deal with analogous questions at a normative level. Bioethics reﬂects, rationally, on what is good and what is evil, aiming at promoting the fulﬁllment of each person. Biolaw deals with bioethical problems with a narrower goal, the one of ensuring human relationships in a peaceful society. Biolaw, therefore, born as an offshoot of bioethics, is becoming an autonomous discipline to a greater extent.
In the context of today’s society, there is an urgent need for biojuridical rules. Scientiﬁc discoveries and technological applications opened up new possibilities, enabling novel interventions and manipulations with human and nonhuman life. In legal terms, it is essential to clearly identify the rights and duties at the individual and social levels.
The legal systems existing in different countries worldwide do not always provide for rules explicitly governing the new technologies, with regard to life. In some cases new bioethical problems are implicitly regulated by legal systems: i.e., rules that were not originally drawn up to address bioethical issues might be interpreted in a broader sense, either obtained by extensive or analogical reasoning and applied to recent concerns. In other cases, law is called upon to lay down new rules to be able to tackle arising problems, in order to prevent and settle emerging disputes: e.g., the regulation of access and methods of use related to reproductive technologies, the regulation of euthanasia, medically assisted suicide and treatment refusal, etc.
Yet, despite the clearly emerging requirement for legal systems to set out new rules in the ﬁeld of bioethics, as a result of emerging social needs, the juridical systematic elaboration on a doctrinal, legislative, and jurisprudential level is delayed. Within the civil law legal systems based on the legislation enacted by Parliament, which is composed of representatives elected by the people, the legislature either does not make new laws with regard to timely social matters or lags behind in their development. In such countries, judges must often intervene to resolve conﬂicts also when laws are lacking. In countries with a common law legal system, the intervention of courts is more ﬂexible in relation to single cases. However, there are emerging needs for more homogeneous and uniform regulatory adjustments in the social context.
This delayed intervention of biolaw in society leads to a situation of “juridical emptiness,” allowing for the so-called far west in collective practice (Menikoff 2001). The lack of clear and speciﬁc rules can lead individuals to believe that anything is possible, with signiﬁcant social implications. This is the case, for example, of countries where reproductive technologies are not regulated. All technologies are applied, without any limitation whatsoever, homologous and heterologous artiﬁcial fertilization procedures or surrogate motherhood, without a clear deﬁnition of the rights of both born and unborn children, the parents, the donor, the physician, and society.
As part of the biojuridical reﬂection, questions have been raised about what caused this delay in biolaw. In spite of the need to regulate the use of new technologies within society, why is biolaw still falling behind with regard to juridical elaboration?
One reason for the delay in biolaw can be identiﬁed in the asynchrony or momentum gap between the rapidity and dynamism of the biomedical techno-scientiﬁc progress and the slowness of biolaw. In the political debate, the production of laws, the jurisprudential interpretation and the elaboration of doctrines require extensive time for their discussion, formulation, and implementation. The different speed of techno-science with respect to biolaw is structural and often results in the difﬁculty of the law in intervening in bioethical issues.
The law is unable to keep up with the fast pace of progress. There are two possible risks. The ﬁrst risk is obsolescence insofar as the law addresses matters, the regulation of which is either old or outdated, as technologies have changed in the meantime or require further clariﬁcation. Biolaw tends to arrive too late when the problem is no longer felt, substantially transformed or perceived differently. The second risk is the hurried interventionism, when the law, in consideration of problems giving rise to particular social alarm, swiftly intervenes leaving no time for an adequate analysis of the scientiﬁc aspects, often anticipating science while it is still evolving, as well as balancing social issues. The slowness of biolaw also stems from the interdisciplinary epistemological status of bioethics, requiring the continuous scientiﬁc updating and the constant debate among experts of different disciplines, with heterogeneous languages and methodologies. The need sometimes arises to identify new juridical categories to deﬁne and classify new phenomena, just as the need to rethink the traditional legal concepts and categories, which are inadequate with respect to the new reality. Another reason for the delay of biolaw is to be found in prudence or precaution, in the fear that certain techno-scientiﬁc intervention on life may cause unforeseeable and irreversible effects.
The main reason of the delay of biolaw is the phenomenon of moral pluralism, that is the plurality of ethics, of biojuridical theories, as ways of understanding the relationship between bioethics and biolaw and the function of the law in bioethics.
The theoretical models of biolaw will be, therefore, examined, i.e., the libertarian, liberal, utilitarian, and personalist models, leading to different types of regulation, under the legislation and pertaining to the various countries. National differences shape a heterogeneous landscape which entailed, at the international level, spaces for discussion, constituting and elaborating documents with the purpose of devising shared principles and elements to harmonize biolaw.
A Preliminary Philosophical Reflection: Which Kind Of Law In Biolaw?
A general question that has always summed up the core aspect of bioethics and biolaw arises from progress: all that is techno-scientiﬁcally possible is also ethically permissible and legally legitimate?
Contemporary moral philosophical thought is strongly marked by pluralism: moral positions differ as far as the choice of principles and values is concerned. There is no absolute unanimity in morality: different moral trends justify different principles and values that should be the boundary line between what is right and what is wrong in techno-scientiﬁc practice. Since moral values in society are many and sometimes irreconcilable, therefore different, it is difﬁcult to develop rules that can be convergent, as they must apply to all citizens who may have different views of good and evil.
The debate on biolaw revealed several lines of thought and different models regarding the understanding of the relationship between ethics and law. The different thinking patterns of biolegal theories endeavor to answer the question: which kind of law in biolaw?
The most extreme model is the libertarian model which, in the name of the afﬁrmation of individual freedom, considers the absence of law preferable in bioethical questions. According to this perspective, it is considered more appropriate to exclude the public intervention of law, perceived as an instrument of oppression and unduly interference with the subjective self-determination. This is a model of thought which asks for a “space free from law,” supposing that all that is neither prescribed nor forbidden by laws is allowed. The need for the libertarians is the guarantee of freedom in the choices concerning life and death and health and sickness: each individual, in this perspective, should act according to his/her “private” moral conscience, without any external coercive imposition. This is the movement of thought known as “HIL,” or “highly inappropriate legislation,” which considers that legislation in bioethics, in whatever way it may be formulated, can only be highly inadequate. Its inadequacy lies in the oppression of individual freedom.
On this basis, the libertarian model considers it appropriate not to legislate in bioethics. There is a preference for regulations of deontological codes, that is, codes of professional practice such as medical codes, or the decisions of ethical committees, as “soft laws” indirect and ﬂexible rules and regulations, making responsibility coincide with the self-control of a community or the selfdiscipline of single researchers. This model proposes the removal of public law in bioethics, with the consequent privatization of choices, reducing the biojuridical intervention to a minimum and extending the individual autonomous decision to a maximum (Engelhardt 1996, 2006).
The liberal model of biolaw asks for the intervention of the law in bioethics with the function of guaranteeing freedom, understood as individual self-determination. According to this theory moral rights pertain to the sphere of autonomy of the bioethical choices with respect to which the law must not interfere. Biolaw should protect the external and formal conditions allowing freedom to be concretely manifested and should abolish the impediments, procuring the means for the translation into behavior. According to this model, biolaw should strengthen subjective freedom, broadening it with the multiplication of the possibilities of choice. See, for example, a law permitting the access to all reproductive technologies or medical ways to end life. In this sense biolaw recognizes ethical pluralism, seeking to elaborate “neutral” rules without taking sides in favor or against any moral perspective, so that each single person is free to express his/her individual option, with the only limit to avoid damages to others.
This model is in favor of the so-called minimal legislation, a legislation that limits itself to procedural rules to negotiate controversies or ﬂexible intervention of case law – that is, the intervention of the judges. Only if there is a justiﬁed fear of possible risks and damages of certain choices to society, the liberal biolaw introduces temporary rules to deal with social emergencies, which may be reviewed and eliminated if not necessary (Charlesworth 2009).
The utilitarian model in biolaw searches for the maximization of beneﬁts and minimization of costs for the greatest number of individuals. It is the model of the collective utilitarianism. The aim of this model is to elaborate laws that guarantee the best pragmatic result possible in relation to social efﬁcacy and productivity increasing the quality of life and well-being and decreasing the sufferance. The utilitarian bioethics of the “quality of life” inﬂuences also biolaw, subordinating the value of life to the presence of quality, measurable in aggregative terms of welfare. Utility in biolaw coincides with welfare or the best optimal balance, in comparative terms, of beneﬁts over costs, of satisfactions over frustrations, and of preferences /interests in terms of pleasure/joy over damage in terms of pain/suffering (Singer 1993; Macklin 2003).
Through the description and analysis of these different models of biolaw, the neutral approach comes out, which – in the different theories with different arguments – has a common conceptual origin: the assumption of the impossibility to know a common universal objective truth in ethics. In this perspective bioethical pluralism is understood not only as a fact but also as something good to maintain, as expression of differences in society.
According to the mentioned perspectives – libertarian, liberal, utilitarian – albeit with different arguments, it is stressed that only individuals claiming rights are entitled to them, within a condition of social convenience. Only individuals who can be free or beneﬁt from a certain level of quality of life may claim rights: in other words, healthy adults capable of understanding and taking action. Other individuals are entitled to secondary rights, which are provisional and changeable according to circumstances, social concerns, whether of opportunity or prudence, and benevolence or sympathy: embryos, fetuses, infants, young children, terminally ill patients, mentally disabled people, or those suffering brain damage become objects of the law (Palazzani 2009; Silvers 1999).
According to this line of thought, the rights of scientists to conduct scientiﬁc experimentation, positive reproductive rights to have a child with technologies, and the right to eugenic selection to have a healthy child prevailing over the rights of the unborn outweigh other rights. The right to decide how and when to die or the right to use technologies in order to meet individual desires prevails.
The personalist model, which focuses on the recognition of the human being as a person or legal entity, is opposed to the neutral perspective. According to the personalist model, biolaw cannot and should not be neutral, that is, without ethics, in the context of ethical pluralism. Reference to human dignity is the “minimum” ethical recognition that can be shared by all human beings on a plane of practical rationality, independently of the theoretical ethical position assumed at “maximum” level.
It is not a question of making a choice between the ethics in the context of the plurality characterizing the present debate. Such a choice would inevitably determine the privilege of one set of ethics and the delegitimization of another. The law is called upon to account for the internal meaning of the law itself, as an instrument for the defense of the intrinsic and objective dignity of each human being, considered as person. In this perspective the concept of person is identiﬁed with the human condition: every human being, even at the beginning or at the end of life, healthy or ill, minor, adult, or old, is a person and should be treated as a person and human, in each developmental stage, and must not be exploitable for scientiﬁc or experimental purposes. Each human being must always be recognized as an end and never just a means (Barilan 2012; Andorno 2009).
This perspective brings back biolaw to the structural and speciﬁc meaning of law, stressing the danger of a law that radically alienates itself from ethics, the danger of using the law against human beings and not for human beings. In law it is important to recover that awareness, which has progressively matured and which has consolidated after the atrocious historical experiences of totalitarianism: the awareness that the law cannot become a mere instrument of the will of the strongest whether individual or collective and cannot be limited to the recording of social practices and individual revendications (Andorno 2009, 2013).
It is the doctrine of human rights grounded in the principle of equality, namely, recognizing that each human being, for the fact of being human, cannot become the object of discrimination, but must be treated as a subject having an intrinsic dignity irrespective of other extrinsic considerations, related to political, religious, or cultural background, to sexual or chronological difference, and also related to the stage of psychophysical development reached or the capabilities and abilities they express, such as autonomy or the perception of a certain quality of life.
The principle of equality is rooted in human’s being, independently of his appearance and action. Dignity is a natural fact to be recognized and not a qualiﬁcation to be given or awarded. The biojurist is called upon to defend, by means of the law, the dignity of the human being as a right that cannot be disposed of, prohibiting any form of exploitation of the human body and violation of human life. This perspective is founded on the awareness that human life is deserving, since man is the only natural subject capable of identifying himself and of recognizing others relationally.
Such a critical effort is particularly complex in bioethics, where the recognition of rights at the borders of life is at stake, with the rapid progress of biomedical science and technology. Biolaw is called upon to point out human juridical subjectivity, showing the need for all human beings identiﬁed in biologically human organisms to have equal juridical protection. The point that needs a special reﬂection is the recognition of the dignity of those who – due to accidental or provisional reasons, such as age, phase of development, or conditions of illness, temporary or stable – are not able to carry out certain abilities or do so weakly, thus becoming particularly vulnerable and fragile when faced with the pressures of the progress made in biotechnology. In other words, it is a question of using and updating the human rights doctrine in bioethics, highlighting the biojuridical need for the protection of the biological body of the human being with respect to the new possibilities of manipulation and experimentation in techno-science.
Faced with ethical pluralism, the task of biolaw is not that of ﬁghting pluralism or of dogmatically imposing an ethical vision, but rather of ﬁnding, in the context of the plurality of values, the common elements in the recognition of the defense and promotion of human dignity. Bioethics represents a real challenge for the human rights doctrine, an opportunity for propulsive development toward the future. It is in bioethics that the need emerges to express and explicitly enumerate human’s concerns in relation to scientiﬁc and technological progress, even in the awareness that the path can never be considered concluded and will need continuous reﬂections and dialectic debates. The important thing is to at least establish the insurmountable limits concerning the dangerous attempt to subjugate techno-science to arbitrary individual or political will or to the contingent novelty of extemporaneous social needs (Beyleveld and Brownsword 2002).
The Evolution Of Biolaw In The National Context And In The Regional Context
It is not possible to provide an in-depth analysis with regard to the development of biolaw in single states and different continents. Some trends and general interpretations may be identiﬁed.
One can certainly point out that the evolution of biolaw within single countries is affected by the social-political context, the existing legal system, and the prevailing biolegal model shaped by the theoretical debate.
It is appropriate to make a preliminary distinction between countries based on legal systems of common law and civil law. The AngloSaxon, North-American, and Australian model of common law, where case law overrides legislation, as the judge is involved in the regulation of disputes, suggests the presence of a prominent trend in favor of the protection of individual freedom and social utility. In civil law models, where legislation overrides case law, a delay is mainly perceived in biolaw, while foreseeing different paths: sometimes in the direction of the defense of freedom with a prevalence of the liberal and utilitarian model, other times in the direction of the defense of human dignity entailing a prevalence of the personalist model.
If one considers, for example, the European national biolegal paths, it is noted that, concerning the beginning-of-life issues with regard to reproductive technologies, there is a prevailing liberal utilitarian model in the UK and Spain with a greater openness toward access to the new technologies and a weaker defense of the unborn child, giving rise to the so-called positive reproductive rights. In Germany, Austria, Italy, and France, there is instead a higher prevalence of the personalist model or, at least, the search for a balance between the rights of those seeking access to technology and the rights of the embryo and the unborn child.
When considering end-of-life issues, there is a dominance of the liberal and utilitarian model in Holland, Belgium, and Luxembourg, which have passed laws in favor of active euthanasia with consent, in the name of self-determination, regarding the choice of dying, as well as Switzerland where assisted suicide is not punishable by law. The personalist approach is prevailing in other countries that have not yet legislated or are currently legislating against euthanasia, for the accompaniment of the dying through palliative care, which is meant to ease and relieve pain and suffering, alongside striving to improve life and its quality.
Taking into account recent developments in the common law countries, particularly the USA, Canada, and Australia, although with consider able heterogeneity, the judgments of the High Court tend to give a prominent role to the libertarian and utilitarian model that places strong emphasis on individual self-determination and the rate of proﬁt of society, both in the beginning of-life and end-of-life issues. A similar fragmentation can be found in other continents, at the single-state level.
The fragmentation characterizing the combination of legislation and case law when comparing single states is the underlying cause of the phenomenon of “bioethical tourism,” resulting in procreative tourism or death tourism, i.e., the displacement of individuals claiming rights being prohibited in their country to go to the country that allows the implementation of those rights. This phenomenon increases conditions of injustice, namely, the different treatment of similar conditions, giving priority to those who are able to pay this transfer to fulﬁll their desires.
Just in order to overcome fragmentation and biojuridical pluralism with a view to harmonizing diverse laws, regulations have been enacted by existing organizations or bodies, at the level of regional international biolaw, or bodies were established aiming to the elaboration of common standards, with the purpose of either guiding the standard revision process or drawing up novel rules on bioethics.
In Europe, working groups and committees were set up with this aim. The European Group on Ethics in Science and New Technologies at the European Commission is composed of experts and draws up opinions meant for all EU states on topics of European and international relevance, raised by techno-science developments. The Committee on Bioethics (DH-BIO) at the Council of Europe, composed of delegates representing the many countries of the Council, holds regular exchanges of views and debates aimed at proposing the drafting of recommendations and resolutions to be presented to the states, with a view to ﬁnalizing a biolegal hormonization. Opinions, recommendations, and resolutions are not binding acts, but guidelines. Binding acts, such as regulations and directives, are also issued by the European Parliament.
Many EU regulations, if implemented and ratiﬁed by single national legal systems, become legally binding upon the states, requiring an adaptation or adjustment, supplement, and/or completion of the regulations under consideration.
Among the documents that are gaining importance in Europe but also outside Europe, we should mention the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Right and Biomedicine of the Council of Europe (Oviedo 1997). It is a document which – referring to Additional Protocols on cloning, transplantation of organs and tissues, biomedical research, and genetic testing for health purposes to deal with more speciﬁc aspects – stresses the primacy of human beings and guarantees everyone respect for their physical integrity which should prevail over the interests of society or science. Although concerning the protection of early human life, ambiguity arises to some extent by referring to different domestic laws. The following rights are, however, clear: the right to an equal access to health care and the right not to experience any form of discrimination on grounds of his or her genetic heritage. Moreover, the use of techniques of medically assisted procreation is not allowed for eugenic reasons; the selection of a future child’s sex is prohibited, except where serious hereditary sex-related disease is to be avoided; the use of predictive genetic tests is also restricted to health purposes, such as preventive, diagnostic or therapeutic, and subject to consent. A speciﬁc protection of persons unable to consent is guaranteed; it is deemed appropriate to take into account wishes previously expressed by the patient.
Even the Charter of Fundamental Rights of the European Union (Nice 2000) places speciﬁc attention on a number of bioethical questions. It particularly recalls the value of human dignity, the right to life, and the integrity of the person to an informed consent regarding human experimentation, prohibiting eugenic practices and making the human body and its parts as such a source of ﬁnancial gain, as well as the reproductive cloning of human beings. Moreover, under the principle of equality, it reiterates the duty to consider diversity based on culture and gender and speciﬁcally to protect children, the elderly, and persons with disabilities by extending the duty to protection to the environment in accordance with the principle of sustainable development.
Also at the institutional level, case law falls within European biolaw, including the judgments of European Court of Human Rights and the Court of Justice of the European Union. In this context, individuals, national legislation, and European laws are called upon to refer to basic fundamental human rights placed at a higher level.
In Africa there is the Union of several African countries (COPAB), which is attempting to centralize the debate, in order to progressively include the discussion on bioethics within the single states, aimed at making progress in terms of regulation. The debate is also focused on how to conceive medicine by comparing the so-called “traditional” medicine with “conventional” medicine, with particular attention paid to information and education, along with the issue of human experimentation carried out and funded by multicenter pharmaceutical companies of technologically advanced Western countries.
The Asian Bioethics Association was established in Asia, with the aim of harmonizing the bioethical and biolegal debate, that is part of a signiﬁcantly different cultural, social, and religious background compared to Western countries.
Even in America, where there is considerable diversity in the debate throughout the Northern, Central, and Southern regions, regional organizations of American States were established, in order to create platforms for dialogue, with a view to achieving a harmonization, careful to avoid subordinating a set of trends to other ones, alongside enhancing speciﬁc cultural issues.
In Australia, the debate is linked to existing stances in the Anglo-Saxon and North-American countries.
It is important to note that almost all countries have either established or are in the process of setting up a National Bioethics Committee. It is an institutional body with diverse characteristics in different countries that aims to promote an internal debate on particularly sensitive bioethical issues, with the purpose of elaborating opinions to be submitted to parliament, judges, and society’s governmental bodies, in order to formulate rules and inform society by raising critical awareness of the questions emerging from techno-science advances.
Several consultation initiatives have been launched involving National Committees, such as the International Dialogue organized by the European Commission, which takes place once a year in Brussels and the Global Summit organized by the WHO, being held every 2 years. The European Commission also supports the Forum of National Ethics Councils (NEC Forum), taking place once a year in the countries holding the rotating presidency of the Council of the European Union. The importance of the European Conference of National Ethics Committees (COMETH) should also be recalled.
The Evolution Of Biolaw In The International Context
The awareness of the harmonization of laws at the international level is gradually maturing, as opposed to libertarian and utilitarian individualistic orientations but also to regionalisms and localisms.
The need for internationalization comes, in fact, from the emergence of structurally transnational problems, as they are not delimited within a region (e.g., pandemics, human genome mapping, international trials, environmental issues). The awareness that solutions of bioethical issues raised within a nation often have immediate or future, direct, or indirect implications, which go beyond the speciﬁc historical and social conditions from which they have emerged to embrace the entire planet, appears ever increasingly. There is a need for a macro-bioethics, broadened in space, between cultures, countries, and continents and, in time, between distant and future generations.
Within the international biolaw evolution, we must distinguish between the professional codes of ethics as sources of soft law, that is, a ﬂexible regulation and subject to revision addressed to physicians and health professionals and the universal and global international law sources and regional sources paths.
As for the professional ethics international documents, we can say that they have originated with the 1947 Nuremberg Code, developed within the Nuremberg trial held at the International Military Tribunal with the task of judging crimes against humanity. Within the “trial against physicians,” the Code has been drawn up by a US military court asked to rule on doctors and administrators accused of having conducted trials on human beings in Nazi concentration camps. This code states, for the ﬁrst time, the principle of the need, for informed consent in human experimentation, of the scientiﬁc nature of trials, and of noninduction of pain.
Other international biolaw professional ethics sources are the Declaration of Geneva of the World Medical Association, adopted by the Second General Assembly in 1948, revised in 1968, 1983, 1994, and most recently in 2005–2006, drawn up on the basis of a revision of the Hippocratic oath in view of the humanization of medicine and thematization of the duties of the physician; World Medical Association International Code of Medical Ethics, adopted in London in 1949 and amended in 1968, 1983, and 2006, deﬁning the physician’s duties toward patients and colleagues; the Declaration of Helsinki of the World Medical Association “Ethical Principles for Medical Research Involving Human Subjects,” 1964 and amended in 1975, 1983, 1989, 1996, 2000, 2002, and 2013, which deﬁnes the basic principles for all medical research and medical care; the Belmont Report on “Ethical Principles and Guidelines for the Protection of Human Subjects of Research,” adopted in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which deﬁnes the ethical principles of respect for persons and risk/beneﬁt proportionality in the beneﬁcence and justice context; the International Ethical Guidelines for Biomedical Research Involving Human Subjects of the Council for International Organization of Medical Sciences (CIOMS), adopted in conjunction with the World Health Organization in 1982 which speciﬁcally deﬁnes certain elements of research conducted with humans, also with minors; the World Health Organization Guidelines for Good Clinical Practice for Trials on Pharmaceutical Products, adopted in 1995, which today is still the reference point for ethical assessment of clinical research on humans, with speciﬁc reference to the trial protocol, protection of persons, investigators and sponsors responsibility, and data protection; and the Guidelines for Good Clinical Practice International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use drawn up in 1995 and subsequently adopted by the European Union, the USA, and Japan.
As for international law sources in bioethics, we should consider the documents that have been developed by international organizations. The complexity of bioethical issues transcends the boundaries of individual countries and continents and has urged the international community’s reﬂection (van Beers et al. 2014). The existing international organizations have set up internal committees aimed at the discussion of speciﬁc issues and the preparation of documents. The pronouncements of the international organizations on certain issues have anticipated or even replaced the pronouncements of individual states that often, due to delays of internal politics and ethical pluralism, postpone or do not even get involved in internal regulation. Therefore, within the international debate, meeting places and discussions have been started, aimed at identifying minimum shared ethical elements that can serve as a reference guide for individual countries that do not have a regulation or are developing one and as an outline for the international community.
Since 1948, with the Universal Declaration of Human Rights, the United Nations Organization (UN) has adopted a number of acts in the human rights ﬁeld, implicitly or explicitly related to bioethics. Among them, one can mention the resolutions of the General Assembly devoted to human rights faced with scientiﬁc and technological progress (Human Rights and Bioethics, 2001 and 2003), genetics (Genetic privacy and nondiscrimination in 2004, 2007, 2008), and human cloning (2005).
This trend was consolidated at the international level within the United Nations Organization for Education, Science, and Culture (UNESCO), through the establishment of two committees: the International Bioethics Committee in 1993, aimed at drafting documents on general and speciﬁc topics, and the Intergovernmental Bioethics Committee, a political body representing the different governments and which plays a monitoring and analysis role. Issued documents include Universal Declaration on the Human Genome and Human Rights (1997); International Declaration on Human Genetic Data (2003); and Universal Declaration on Bioethics and Human Rights (2005).
This last document is particularly important as a universal legal instrument, as it sets the minimum principles considered universally essential for bioethics. The statement came from the theoretical effort to ﬁnd common ground through international consultation. The principles set out express the recognition of the duty to respect human dignity and human rights in a pluralistic and multicultural setting, given the new possibilities opened up by techno-science in the biomedical ﬁeld. The recognized principles are autonomy and responsibility, equity of access and justice, informed consent and conﬁdentiality, respect for the integrity and vulnerability of the human person, solidarity and international cooperation, and responsibility toward the environment and future generations.
The documents of the department of bioethics of the World Health Organization (WHO), on the issues of cloning, reproduction, transplants, and genetics and the discussions and opinions of the World Commission on the Ethics of Scientiﬁc Knowledge and Technology (COMEST) on many applied ethics issues also contribute in the direction of the development of a global bioethics.
The need for a regulation of bioethical issues arising from scientiﬁc and technological progress is becoming ever more necessary and urgent. Biolaw is called upon to process legislation and solve case law conﬂicts at the national level. Moral pluralism characterizing the bioethical debate has framed different models that have guided countries in different and sometimes opposing directions with regard to regulation. At the international, regional, and universal levels, there are many institutional bodies operating to ensure an international dialogue aimed at the harmonization of rules and the construction of a global biolaw consistent with thematizing fundamental human rights faced with scientiﬁc and technological development (ten Have and Gordijn 2014).
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