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Abstract

The ﬁrst international documents on medical ethics and bioethics were produced in the aftermath of the Second World War and, therefore, focused on biomedical research with human subjects. In the following decades different institutions dedicated to bioethics were created, some of them in the international realm, such as the Council for International Organizations of Medical Sciences, the Council of Europe, WHO, and UNESCO – these last three, having a larger scope, established specialized departments and/or programs on bioethics.

As the institutionalization process of bioethics unfolded, the number of international documents increased signiﬁcantly, the range of ﬁelds expanded from research to clinical practice and to public health policies, the diversity of the issues studied multiplied accordingly, and the ethical principles formulated grew in number and speciﬁcation.

This entry refers to the main institutions or bodies in the ﬁeld of bioethics and the most important international documents they produced, reﬂecting on their nature and strength, within a historic and thematic framework, establishing a line of evolution of bioethics.

Introduction

There are a growing number of international documents on medical ethics and bioethics. They started to be produced after the Second World War, and they still keep their original and common goal to establish a core of ethical principles aiming to standardize the rules of action in the widest scope possible.

The majority of these international documents are nonlegislative; they are of an ethical and deontological nature and not legally binding. Nevertheless, their inﬂuence at the regulatory and political levels is very signiﬁcant, also depending on the nature and political representativeness of the institution or body that issues the document, as well as on the level of consensus reached and the legal nature of the document itself.

The most inﬂuential international documents on bioethics will be highlighted which, together, have been establishing a common standard of action in the ﬁeld and at an international level.

From The Second World War Until Today: International Institutions And Documents

The ﬁrst international documents on medical ethics and bioethics were produced in the aftermath of the Second World War because of the atrocities committed by the Nazi doctors performing human experimentation for scientiﬁc and medical purposes. They were issued to prevent any other similar occurrences in the future.

Among these ﬁrst international documents, the most important is the Nuremberg Code, in 1947, and the Declaration of Helsinki/DoH by the Word Medical Association/WMA, in 1964. Both are committed to establish the ethical requirements for biomedical research involving human subjects.

The Nuremberg Code is a ten-point statement of the ﬁnal judgment of the Nazi doctor’s trial and has become part of international law, still prevailing at the basis of all documents concerning the ethics of research with human subjects. The Helsinki Declaration, ethical principles for medical research involving human subjects is also a cornerstone for research ethics. Its ﬁrst version from 1964 was extensively revised in 1975 following the project to combine and integrate the Nuremberg Code and the DoH in one single document. It is this version from 1975 of the DoH that constitutes the basis for the subsequent revisions, in a total of seven amendments and two notes of clariﬁcation added – 1975, 1983, 1989, 1996, 2000, 2002, 2004, 2008, and 2013 – some of them quite controversial, being the most recent adopted at the General Assembly in October 2013.

The World Medical Association/WMA, founded in 1947, has dedicated itself deeply to ethical issues since the very beginning. The Declaration of Geneva, an intended revision and update of the Oath of Hippocrates in the light of the crimes against humanity committed by the Nazi doctors, was adopted by the General Assembly of the WMA at Geneva in 1948 and amended in 1968, 1984, 1994, 2005, and 2006. The WMA is also responsible for other kind of international documents on medical ethics such as the International Code of Medical Ethics, in 1949, amended in 1968 and in 1983. Both documents are of a deontological nature.

The WMA was the ﬁrst institution to produce Declarations that go further than deontological guidance, causing impact on society as a whole. Besides the DoH, and among the most inﬂuential international documents, one should also refer to the Declaration of Lisbon on the Rights of the Patient, adopted in 1991, amended in 1995, and editorially revised in 2005. It presents itself as a recognition of the changes that the physician patient relationship has undergone, making it insufﬁcient to act according to the best interest of the patient regardless of the patient autonomy and a core of rights that physicians, and other healthcare professionals, have the responsibility to uphold.

In 1987, the WMA also issued a signiﬁcant number of other important documents during its General Assembly in Madrid: a Statement on Genetic Counseling and Genetic Engineering, a Statement on In-Vitro Fertilization and Embryo Transplantation, a Resolution on Euthanasia, the Declaration of Madrid on Professional Autonomy and Self-Regulation, and a Declaration on Human Organ Transplantation.

WMA widened the diversity of topics that worked on along the decades, namely, a Statement on Access to Health Care (1988), a Statement on Fetal Tissue Transplantation, a Statement on Animal Use in Biomedical Research, a Statement on Persistent Vegetative State (1989), a Declaration on Chemical and Biological Weapons (1990), a Declaration on the Human Genome Project (1992), a Statement on Ethical Aspects of Embryonic Reduction (1995), a Resolution on Cloning (1997), a Statement on the Ethics of Telemedicine (1999), a Statement on Human Organ Donation and Transplantation (2000), a Resolution on the Responsibility of Physicians in the Documentation and Denunciation of Acts of Torture or Cruel or Inhuman or Degrading Treatment (2003), a Statement on Genetics and Medicine (2005), a Statement on Forced and Coerced Sterilization, and ﬁnally a Statement on the Ethical Implications of Collective Action by Physicians (2012). These are all international documents, with a strong ethical appeal, that play an important role not only on the ﬁeld of bioethics worldwide but are also inﬂuential for other international organizations and national governments, establishing a pattern of conduct for physicians and healthcare professionals that becomes widely required by society.

Within this large period following the Second World War, there are still two more elements that must be brought to light: the creation of the World Health Organization/WHO, in 1948, and the joint initiative by WHO and UNESCO, in 1949, to create the Council for International Organizations of Medical Sciences/CIOMS, a nongovernmental, nonproﬁt organization.

WHO has always acknowledged health ethics as an integral part of its activities and produces regularly normative guidelines, especially in what concerns research ethics (standards of procedure for researchers, guidance for establishing ethics committees, to educate its members), and also recommendations or guidelines on speciﬁc issues such as HIV/AIDS (mother-to-child transmission of HIV, prevention and treatment of HIV, use of antiretroviral drugs for treating and preventing HIV infection (antiretroviral therapy for HIV infection in adults and adolescents), testing and counseling, and care for adolescents living with HIV) and on gender issues (researching, documenting, and monitoring sexual violence in emergencies, domestic violence against women), with a strong ethical perspective.

CIOMS together with WHO issued, in 1981, the Manila Declaration which points to some of the major difﬁculties in applying a so-called Western bioethics to other parts of the world, in particular with regard to the underdeveloped countries. One of the main issues relates to the informed consent, which can only be applied to all communities if it is adapted to each one according to their own culture and to the level of education of the people at stake.

CIOMS has been responsible for many other normative declarations dedicated to different issues following the most pressing problems raised by biomedical progress, such as the Declarations of Valencia on the Human Genome Project (1988) and on Ethics and the Human Genome Project (1990); the Declaration of Inuyama on Genetics, Ethics and Human Values: Human Genome Mapping, Genetic Screening and Therapy (1990), following an international workshop cooperation relative to the Human Genome Project, organized by UNESCO; Declaration of Moscow (1991) adopted at the “International Meeting on Bioethics and the Social Consequences of Biomedical Research” organized by UNESCO; a Declaration on Gene Patenting (1992), adopted by the International Council for Science/ICSU; the Declaration of Caxambu (1992) adopted at the North–South Meeting on the human genome organized by UNESCO; and the Declaration of Ixtapa: A Global Agenda for Bioethics (1994). They all show a particular sensitiveness of CIOMS toward speciﬁc problems of the developing world.

Nevertheless, none of the work authored by CIOMS is as important as the International Ethical Guidelines for Biomedical Research Involving Human Subjects, issued in 1982 and later revised in 1993 and in 2002, being until today one of the most inﬂuential documents in the ﬁeld.

These ﬁrst attempts to establish ethical principles for biomedical research, from the early years following the Second World War until the 1980s, are the best-known policy statements, and they are universally accepted, although not legally binding. They are considered to be soft law: they lack legally binding effect but have a potential impact in practice. These documents were inspired by international law and deontological codes and have ever since shaped bioethical reﬂection around the world, as well as national legislation and international policies, thus proven to be highly inﬂuential in determining decisions and legal documents at all levels of biomedical reﬂection and practice. They focus mainly on biomedical research in the follow-up of the rejection of the human experimentation that took place in Nazi Germany but also in other countries before and even after the Second World War according to several scandals that were disclosed, for example, in the United States during the 1960s and 1970s. The scandals about human experimentation pursued in the United States after the Nuremberg Code and violating its rules lead to the institution of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, in 1974, which would produce, in 1948, the well-known Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. The Belmont Report was the ﬁrst document in the world to systematize the ethical principles and guidelines for research involving human subjects: respect for persons, beneﬁcence, and justice. These are the core principles of research ethics involving human subjects that indelibly inﬂuenced all future statements on the ﬁeld.

Broadly, the international documents pursued two common goals: to make medical doctors and researchers in general more responsible in their practice but also in their duty to acknowledge the patients as well as the research subjects as persons, respecting them in their unconditional human dignity, assuring their individual best interest prior to the interest of science or society, and, on the other hand, to empower patients as well as the research subjects in order to make them more autonomous and more aware and active participants of the processes they become involved in.

After this period, a new era of international normative document production begins, characterized by the widening of the subject matter, as had already become evident in the series of declarations from WMA or from CIOMS in the 1980s and following, and also with the institution of a speciﬁc body responsible for the proposal of future documents on bioethics. Different international organizations decided to create what soon came to be a growing number of ethics committees, at the beginning assigned with a speciﬁc task (ad hoc) and later on with a permanent statute.

Reference is made, for example, to the Ad Hoc Committee of Experts on Bioethics/CAHBI, created in 1985 by the Council of Europe/CoE, and responsible for the intergovernmental activities of the CoE in the ﬁeld of bioethics. It became permanent in 1992 under the name Steering Committee on Bioethics/CDBI. The work of these committees led to the preparation of the Convention on Human Rights and Biomedicine (1997) and its four protocols.

The CoE also developed important resolutions on different topics such as xenotransplantation (2003), Protection of the Human Rights and Dignity of Persons with Mental Disorder (2004), and Research on Biological Materials of Human Origin (2006).

In the European Union, the Group of Advisers to the European Commission on the Ethical Implications of Biotechnology/GAEIB was created in 1991 to promote ethical discussions on the development of biotechnology. In 1997 it was restructured into the European Group on Ethics in Science and New Technologies/EGE, an independent, pluralist, and multidisciplinary body advising the European Commission on ethics in science and new technologies in connection with community legislation or policies. According to its nature, the EGE is strictly an advisory, and its opinions are not binding. Nevertheless, their opinions are of major importance for Europe as well as for the rest of the world as a trans disciplinary and pluralist position well-grounded on scientiﬁc knowledge and sound arguments. In the current mandate, the EGE has presented several relevant opinion documents in the speciﬁc ﬁeld of bioethics: Ethical Aspects of Patenting Inventions Involving Human Stem Cells (2002); Ethical Aspects of Clinical Research in Developing Countries (2003); Ethical Aspects of Umbilical Cord Blood Banking (2004); Ethical Aspects of ICT Implants in the Human Body (2005); Ethical Aspects of Nanomedicine (2007); and Ethics of Synthetic Biology (2009). The most recent opinion document is the Proposal for a Regulation of the European Parliament and the Council on Clinical Trials (2014).

Meanwhile this proposal has already been approved by the European Parliament and the European Council and should enter into force in 2016. This regulation substitutes the directive from 2001 on the approximation of the laws, regulations, and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for humans (2001) and will become law in all the member states and will surely come to inﬂuence the requirements for the conduct of clinical trials in other parts of the world.

In the European Union, many other directives and regulations proposed by the European Commission and approved by the European Parliament and the Council, with a high importance for bioethics, are now in place, such as Directive 98/44/ EC on the legal protection of biotechnological inventions; Directive 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells; and Directive 2010/63/EU revising Directive 86/609/EEC on the protection of animals used for scientiﬁc purposes. The European directives and regulations establish a harmonization of the legal framework for bioethics practice in the 28 member states and inﬂuence similar procedures in many other parts of the world.

UNESCO, the United Nations agency of the education, the sciences, culture, and communication, is the most representative institution in the whole world with regard to bioethics. It has been involved in the ﬁeld of bioethics since the 1970s but only later ofﬁcially created three ethics committees: the International Bioethics Committee/IBC, in 1993, a body of 36 independent experts that follow progress in the life sciences and its applications in order to ensure respect for human dignity and freedom, producing advices, recommendations, and reports on speciﬁc issues; the Intergovernmental Bioethics Committee/ IGBC, in 1998, comprised of 36 member state representatives who examine the advices and recommendations of the IBC; and the World Commission on the Ethics of Scientiﬁc Knowledge and Technology/COMEST, in 1998, an advisory body and forum of reﬂection constituted by 18 scholars appointed by the director general in their individual capacity, along with 11 members representing UNESCO’s international science programs and global science communities. Although COMEST is designated to work in several areas of the ethical challenges raised by new technologies, it has mainly dedicated to environmental ethics, through works pursued on ethical principles and responsibilities for climate change adaptation.

IBC and IGBC are jointly responsible for three important declarations: the Universal Declaration on Human Genome and Human Rights, in 1997, the International Declaration on Human Genetic Data, in 2003, and the Universal Declaration on Bioethics and Human Rights, in 2005. Once adopted by the General Conference of UNESCO, they were endorsed by the General Assembly of the United Nations. Other initiatives can also follow as it happened with the Declaración de Santo Domingo sobre Bioética y Derechos Humanos (Declaration of Santo Domingo on Bioethics and Human Rights) for Mexico and Latin America, which recommends the implementation of the UNESCO’s Universal Declaration on Bioethics.

To evaluate the impact of these different international documents, there are two approaches to be considered: an academic and scientiﬁc one that takes into account the number of quotations and the impact factor of the journals where they are quoted and a legal and political one, and surely the most important, that analyzes the number and importance of the legislative documents and the political decisions they shaped in the whole world, either at the national level or at the professional level.

International Documents And Their Different Ethical And Legal Status And Strength

International documents on medical ethics and bioethics are of a different nature and imply a different level of legal obligations, according to a variety of factors, such as the nature and scope of the body or institution that issues them, and to the level of agreement reached between parts, especially if they are composed by states or political representatives.

These international documents can then be legally binding, to various degrees, to the parties that adopt or ratify them, such as “conventions” and their “protocols,” “directives” and “regulations,” or nonbinding documents, such as “declarations” (some legally binding), “resolutions,” “recommendations,” and “opinions.”

A “convention” can be deﬁned as an international agreement, similar to a treaty, for the regulation of international affairs of common interest, between states or international organizations, being legally binding for those who agree to subscribe or adopt it. So far, there is only a single convention in the ﬁeld of bioethics – 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 Rights and Biomedicine of the CoE. It was open to signature in 1997 in Oviedo, Spain, and entered into force in 1999. In 2014, there were 29 member states of the CoE that had ratiﬁed the convention.

The provisions of the convention have been furthered and supplemented by several additional protocols. These are annexes appended to treaty or convention to deal with subsidiary matters in one particular ﬁeld or to render the treaty more clear. The Additional Protocols to the Convention on Human Rights and Biomedicine are Prohibition of Cloning Human Beings, adopted in 1998 and entered into force in 2001; Transplantation of Organs and Tissues of Human Origin, adopted in 2002 and entered into force in 2006; Biomedical Research, adopted in 2005 and entered into force in 2007; and Genetic Testing for Health Purposes, adopted in 2008 and opened for signature in 2008.

At the European level, directives and regulations have also legal force. A “directive” is an ofﬁcial pronouncement on a policy or procedure or an authoritative instruction establishing certain end results that must be achieved in every country where it applies, within a deadline. The European Union issues, as previously mentioned, great number of directives, some of them focusing on bioethical issues, and they can concern one or more member states, or all of them, as they most usually do. Once a directive is approved by the European institutions, national authorities are required to adapt their laws to its content, being free to decide how to do so in order to take account of differing national situations. On the other hand, a “regulation” is a legislative document which can have an international scope, as it does within the European Union, but does not allow any adaptation by the member states. Having a general application, it is binding in its entirety and directly applicable in the member states, imposing itself equally to all of them.

This is not the case for nonlegislative documents. A “declaration” is not a legislative document. Nevertheless, it is a potential alternative source for international law. The declarations proclaimed and adopted under previewed circumstances by the United Nations System can produce a legal effect in becoming sources of international rights and obligations. The UNESCO Declarations must be incorporated by contracting states into their national laws, regulations, or policies in order to take effect.

A legislative body can also express ofﬁcially its views on speciﬁc issues by presenting resolutions, recommendations, and opinions. A “resolution” is an ofﬁcial decision or the adoption of a motion on matters of public policy, limited to a speciﬁc issue or event. Without being a law, it can have the effect of one. Sometimes there is already a law on the subject and lawmakers just want to emphasize a particular point of view or a goal to achieve. Therefore, resolutions intend to be well timed and to have a temporary effect. A “recommendation” deliberately points out a course of action, aiming to prepare future legislation, and can be presented by a legislative or nonlegislative body, the same happening with opinions. An “opinion” is a judgment, an inference, or a conclusion on a speciﬁc issue which statute is solely advisory.

Not all these international documents have legal force, but they all have a variable and always have signiﬁcant ethical and political impact and are able to inﬂuence national legislation.

Building Up International Ethical Consensus

The reading of the most important international documents in the ﬁeld of bioethics and medical ethics, since the end of the Second World War until today, allows to highlight the fundamental consensual ethical principles and their evolution, as well as to summarize what is currently acknowledged as good research and clinical practice, and also the major ethical principles that should guide public health policies and international cooperation.

Research Ethics: Informed Consent And More

Biomedical research was indeed the ﬁrst domain of bioethical reﬂection and practice and also the ﬁrst one to be targeted by international documents. Informed consent was the very ﬁrst ethical principle to be conceptually and functionally deﬁned and the major one in the ﬁrst international documents, speciﬁcally the Nuremberg Code and the DoH.

The Nuremberg Code explicitly states that “voluntary consent of the human subject is absolutely essential” and that the person involved should have “legal capacity to give consent”; be “able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufﬁcient knowledge and comprehension of the elements of the subject matter involved” in order “to make an understanding and enlightened decision,” keeping the “liberty to bring the experiment to an end.”

In 1964, the DoH reinforces the requirement of informed consent, specially strengthening the need for a “careful assessment of predictable risks in comparison with foreseeable beneﬁts to the subject or to others,” ceasing “any investigation if the hazards are found to outweigh the potential beneﬁts.” In this path, comes the paramount statement: “Concern for the interests of the subject must always prevail over the interests of science and society.” This normative statement represents so to speak the normative bedrock of medical and health-related research ethics. The DoH also considered, for the ﬁrst time, the right procedure to obtain informed consent from legally incompetent persons. At the same time it also refers to therapeutic privilege (the physician can consider that, in some cases, it is better not to obtain informed consent), which will tend to disappear throughout time.

It is worthwhile to underline other ethical (basic) principles introduced in the DoH, since its very ﬁrst edition, namely: the principle of privacy (“to respect the privacy of the subject”) and the principle of scientiﬁc integrity (“publication of the results of his or her research, the physician is obliged to preserve the accuracy of the results. Reports of experimentation not in accordance with the principles laid down in this Declaration should not be accepted for publication”).

The Multiplication Of Ethical Principles And The Empowering Of Individuals And Groups

Beyond the abovementioned principles in these ﬁrst international documents on biomedical ethics, there is an important presupposition that stands out in a very clear and strong way: there are scientiﬁc requirements prior to all research involving human subjects and that should be maintained throughout it. The main idea, which is already present in the Nuremberg Code and in the ﬁrst version of the DoH and still prevails today, is that there is no good ethical practice apart from sound science, although not all good science is ethically acceptable.

The DoH, along its seven amendments, introduced some additional ethical principles, all gathering a wide consensus, namely: dignity, self-determination, and conﬁdentiality (and privacy), as well as requirements for “compensation and treatment for subjects who are harmed as a result of participating in research” and “appropriate arrangements for post-trial provisions.”

In what concerns informed consent, the ethical requirements are successively unfolding, mentioning also the need to ensure that “the potential subject has understood the information” and also that “when a potential research subject who is deemed incapable of giving informed consent is able to give assent to decisions about participation in research, the physician must seek that assent in addition to the consent of the legally authorized representative. The potential subject’s dissent should be respected.” Besides, it is also emphasized that the “research subjects should be given the option of being informed about the general outcome and results of the study,” together with the obligation of “research registration and publication and dissemination of results.” Another novelty is informed consent for the “collection, storage and/or reuse” of “human material or data […] contained in biobanks or similar repositories.”

A special section on “vulnerable groups and individuals” has also been included, which is in line with the speciﬁc reﬂection on vulnerability and the need to provide vulnerable groups and individuals with adequate protection. An earlier requirement, that of an ethical review from a research ethics committee, which recently started to be challenged (European Commission’s proposal for a regulation on medical trials) is very explicitly stated.

It is also worthwhile to mention the recent inclusion of respect for the welfare of animals used for research in the DoH.

The new issues that have been introduced along the several amendments of the DoH, together with the unfolding of those that are present since the ﬁrst version of the Declaration, draw a path of evolution in the medical ethics and bioethics reﬂection and practice: these cover a wider ﬁeld and variety of situations, becoming more rigorous in the ethical requirements, more strengthening at the level of obligation each step of the way, and also more empowering of persons.

The 1982 CIOMS’ International Ethical Guidelines for Biomedical Research Involving Human Subjects do not really introduce new bioethical issues. As it is well known, these guidelines were issued “to indicate how the ethical principles that should guide the conduct of biomedical research involving human subjects, as set forth in the DoH, could be effectively applied, particularly in developing countries, given their socioeconomic circumstances, laws and regulations, and executive and administrative arrangements.”

Nevertheless, in an effort to answer the new ethical challenges of clinical trials carried out in low-income countries, CIOMS became a pioneer in the evaluation of some speciﬁc situations – women in general and pregnant women in particular as research subjects or research in populations and communities with limited resources – and also on the ethical requirements addressed to all stakeholders involved such as obligations of sponsors and investigators on the procedure to obtain informed consent or ethical obligations of external sponsors to provide healthcare services. Concerning the latter, CIOMS guidelines intensify the path that started to be followed before either strengthening the principle of informed consent or widening the obligations toward the research subjects. In what concerns the recruitment of women and pregnant women for clinical trials as well as vulnerable groups or communities as research subjects, the CIOMS guidelines intensify the movement toward their inclusion in research whenever they might beneﬁt from the study participation and all scientiﬁc and ethical safeguards and requirements are in place.

A Legally Binding International Document: The Convention On Human Rights And Biomedicine And Its Protocols

In 1997, the Convention on Human Rights and Biomedicine adopted a wider perspective than the traditional one in international documents. Instead of narrowing the ethical considerations to research with human subjects or to clinical practice, as is the case in the former documents, it opens now to more ethical issues raised by the advancements of biomedicine and its application to mankind. This is also an opportunity to formulate new ethical principles that can be applied to the new situations arising from the progress of biotechnologies. Nevertheless the new bioethical issues considered throughout the draft process are not as many as it was expected. At the end, the decision of the CoE was to include only the themes that gather a wide consensus and could be expected to reach the approval of the majority if not of all the members of the CoE.

On what concerns the issues that were already part of the former international documents, there are some novelties, namely: a clear statement that the right to private life and to information includes “the wishes of individuals not to be so informed,” restoring a balanced position after the excess of the obligation to tell the truth about a clinical condition to respect autonomy which can also be respected by not informing the patient; at the same time, a prolongation of the exercise of autonomy through the acceptance of “previously expressed wishes relating to a medical intervention by a patient who is not, at the time of the intervention, in a state to express his or her wishes”; ﬂexibility on the requirement of informed consent, also after a period of strict demand, some exceptions begin to be accepted such as “when because of an emergency situation the appropriate consent cannot be obtained, any medically necessary intervention may be carried out immediately for the beneﬁt of the health of the individual concerned”; and exceptional ﬂexibility on the possibility to conduct research projects even when they do not have “the potential to produce results of direct beneﬁt to the health of the person concerned,” always under “the protective conditions prescribed by law.”

The Convention also introduces very speciﬁc issues, putting in place new bioethical principles. Chapter IV is dedicated to the human genome and demands for a nondiscrimination on grounds of genetic heritage, warning that any “intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modiﬁcation in the genome of any descendants” and prohibiting the use of techniques of medically assisted procreation “for the purpose of choosing a future child’s sex, except where serious hereditary sex-related disease is to be avoided.”

Chapter V concerns research and refers to research on embryos in vitro, which also come under protection, and the prohibition of the “creation of human embryos for research purposes.” The next chapter is on “organ and tissue removal from living donors for transplantation purposes,” and the following chapters focus on different themes related to organ transplantation, namely, on the prohibition of ﬁnancial gain and also the possibility to store removed body parts and to use them for a purpose other than that for which they were removed.

Some of these views on bioethics are not consensual worldwide. The principle of gratuity and non-marketability of the human body is broadly advocated in the West, but not in some other regions of the world. The restrictions to research on embryos and mostly the prohibition of creation of human embryos for research are one of the main reasons for the lack of ratiﬁcation from many member states of the CoE.

The protocols of the convention reﬂect mainly European views, broadly consensual but not necessarily shared worldwide: that on Cloning states that “any intervention seeking to create a human being genetically identical to another human being, whether living or dead, is prohibited,” a norm which has been prevailing in the world; that on Transplantation promotes organ and tissue donation, also from living donors, establishing the requirement of “a close personal relationship as deﬁned by law”; that on Biomedical Research presents a speciﬁc article dedicated to “research on persons deprived of liberty,” who have been mentioned in other international documents but not with the visibility they acquire in this context and exactly with the same treatment conceived to minors, pregnant and breastfeeding women, or legally incapacitated persons; that on genetic testing refers to several scientiﬁc and ethical requirements for genetic testing such as clinical utility, individualized supervision, and genetic counseling, as well as speciﬁc conditions for tests for the beneﬁt of family members, including persons not able to consent or are deceased.

The UNESCO Bioethical Trilogy

This level of speciﬁcation is also common to the two ﬁrst UNESCO Declarations, both also focusing on genetics, although they have a universal scope. The ﬁrst one, on the Human Genome and Human Rights, states that the human genome is a heritage of mankind and, therefore, cannot give rise to any ﬁnancial gains; the human genome binds together mankind and makes all human beings equal, regardless of their genetic characteristics, and without jeopardizing the uniqueness and diversity of each and all of us. This statement has been fundamental most specially on what concerns gene patents. The patenting of human genetic material represents a huge potential proﬁt for biotechnology industry but has always been highly controversial, facing a powerful public protest. The Declaration on the Human Genome and Human Rights should have ended the discussion. But, because it has no legal power and it refers only to the “human genome in its natural state,” it does not really prevent human gene patents, which are never presented “in its natural state” by biotechnology industry. Nevertheless, the declaration’s statement of the human genome as heritage of mankind remains essential to refrain more liberal patent policies.

It should also be underlined that this Declaration on the Human Genome and Human Rights goes a step further to protect human dignity of all individuals requiring that the “advances in biology, genetics and medicine, concerning the human genome” be available to all, thus stressing the requirement for international solidarity and cooperation. This is a very important statement that opens, in a decisively way, the scope of bioethics to international relations and to biopolitics.

The second UNESCO Declaration, on Human Genetic Data, adopts, as its grounding presupposition, the special status of human genetic data, highly sensitive due to the signiﬁcant impact it can have on individuals, families, and groups. Besides, the declaration presents important principles, some of them already common to the majority of ethical documents, but differently systematized in a way that will prevail later in the Declaration on Bioethics and Human Rights. These principles, restricted in this Declaration to human genetic data, are respect for the person’s identity, which should not be reduced to genetic characteristics; nondiscrimination and non-stigmatization; consent, withdrawal of consent, and the right to decide whether or not to be informed about research results; genetic counseling; collection of biological samples for forensic medicine or in civil, criminal, and other legal proceedings; access, privacy, and conﬁdentiality; and accuracy, reliability, quality, and security. Circulation and international cooperation as well as sharing of beneﬁts of human genetic data are two other important principles pointing to a line of evolution of bioethics that will continue to intensify and that could only be pursued by a worldwide institution as UNESCO. The third UNESCO Declaration will follow, indeed, the same path.

The Universal Declaration of Bioethics and Human Rights is the only international document that intends to put together the most fundamental bioethical principles to be applied to biomedical research, clinical practice, healthcare policies, and to international cooperation at the three mentioned levels. Besides, the sequence of the formulated principles draws also another line of evolution within bioethics: it starts to focus on principles that apply to individuals, and then to societies, to international relations and, ﬁnally, to worldwide matters such as environmental sustainability and protection of future generations, in a growing and widening manner. Moreover, due to the nature of the institution that drafted it, the Declaration of Bioethics has a worldwide scope. Therefore, the body of principles presented is the broadest of all the international documents on bioethics and the most consensual too. And they are: human dignity and human rights, beneﬁt and harm, autonomy and individual responsibility, consent, persons without the capacity to consent, respect for human vulnerability and personal integrity, privacy and conﬁdentiality, equality, justice and equity, nondiscrimination and non-stigmatization, respect for cultural diversity and pluralism, solidarity and cooperation, social responsibility and health, sharing of beneﬁts, protecting future generations, and protection of the environment, the biosphere, and biodiversity. The declaration’s core principles are broad and complete enough to gather the principles that made the history of bioethics as biomedical ethics, mainly in Western countries, and also new principles regarding cultural diversity, environment concerns, and the future generations, generally supported by all UNESCO state members. As novelty in bioethics, it also includes concerns about the social condition of the most disadvantaged in the world requiring the satisfaction of human basic needs in order to accomplish a reasonable level of healthcare conditions, and justice in the world, such as “access to adequate nutrition and water” and “reduction of poverty and illiteracy” (article 14). This comes out mainly from a contribution of South American countries that have a social perspective of bioethics. They are correct in stressing that there are elementary requirements for health in the absence of which all discussions on medical ethics are futile; on the other hand, when the scope of bioethics expands so much, there is the risk of losing its identity and invading other professional ﬁelds where it is not efﬁcient.

Regardless of the different views concerning this widening of the bioethics’ scope, the Declaration of Bioethics and Human Rights does gather the contribution of all continents and establishes a minimum consensus as a sound ground for further developments.

Although the idea of drafting this Declaration of Bioethics and the whole process up to the approval of the ﬁnal text were strongly criticized, especially by some bioethicists from Western countries, the rest of the world and mostly the developing and under developing countries welcomed this declaration. They view the ethical principles put forward as a means to pressure national authorities to respect human dignity at the level of biomedicine, namely, public health policies, and also a commitment of the international community toward those who are more in need, respecting them and caring for them specially within research projects, and sharing the beneﬁts of biotechnological advances with poor societies. The declaration is not a legal binding document but is a good commitment worldwide.

The three UNESCO Declarations together with the European Convention inaugurate what has been called the fourth generation of human rights: the ﬁrst being the civil and political rights; the second, the social, economic, and cultural rights; the third, the collective rights; and the last one, the biological rights, the right to an inherited biology, rights related to genetic engineering, or, more broadly said, rights related to the application of biology and medicine to human beings. This is the most relevant contribution of the international documents so far produced on bioethics, expressing the level of ethical consensus internationally acknowledged, which adds political strength to ethical deliberation, namely, when the document at stake has no legal force due to its nature.

Conclusion

Today, the international documents on bioethics cover a wide range of issues and propose a significant variety of ethical principles in a well succeeded effort to answer to the ever new ethical dilemmas raised by the evolution of biomedical sciences and biotechnological innovations. These answers are no longer individual or national, but collective, international and tend to become global, universal.

The ethical nature of the majority of these international documents on bioethics does not make their guidelines compulsory. Most of them are not legally binding. Nevertheless, the level of consensus reached implicates the parts involved and establishes a strong commitment among them. And that is why they are very inﬂuential at different levels, professional, local, regional, national, and international. Mainly at this latter level, the current international documents on bioethics question the level of development needed of biolaw and biopolitics in order to introduce legal obligation and political implementation into bioethical deliberation, without waiving ethical reﬂection.

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