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International law is an independent system of law existing outside the legal order of particular states. It deﬁnes the legal responsibilities of states in their conduct with each other and their treatment of individuals within state boundaries. Its domain encompasses a wide range of international concerns among which are human rights. Given the close relationship between human rights and bioethics, international law and bioethics coincide almost with international human rights law although not entirely. After a brief introduction to international law and the main sources of international law, this contribution analyzes the international human rights framework regarding bioethics. Firstly, the general international human rights framework and its relevance to bioethics are presented: at the universal (global) level, the Universal Declaration of Human Rights and two United Nations Covenants on Human Rights; as an example of a regional instrument, the European Convention on Human Rights and Fundamental Freedoms; and then follows the speciﬁc international human rights framework regarding bioethics – internationally the UNESCO Universal Declaration on Bioethics and Human Rights and regionally the so far only legally binding and enforceable international law instrument in this domain, the European Convention on Human Rights and Biomedicine (Oviedo Convention).
Bioethics increasingly has become relevant not only in a national but also in an international context. The range of bioethical issues no longer primarily or exclusively considered at the national but also at the international level is vast, including issues in diverse areas as reproduction, organ transplantation, and experimentation with human subjects. The UNESCO’s International Bioethics Committee (hereinafter IBC) Report on the Possibility of Elaborating a Universal Instrument on Bioethics (hereinafter IBC Report) notes that “a growing number of scientiﬁc practices have extended beyond national borders” (2003, p. 4). These practices and experiences point to the need for people of all nationalities and their governments to look beyond their borders in understanding the bioethical issues that are being generated and providing solutions that are fair to all and compatible with the plurality of values and interests of the international community. Not only has bioethics become more relevant in an international context; it also has become to be addressed within legal contexts, in the ﬁrst place and foremost at the national level. But over the last decade, bioethical issues have more and more come to be addressed within international legal instruments that belong to the discipline of international law.
What is international law? What are the sources of international law? What is the relation between international law, human rights, and bioethics? These questions are dealt with in this paragraph. International law is an independent system of law existing outside the legal orders of particular states. The development of international law is one of the primary goals of the United Nations. The Charter of the United Nations (1945), in its preamble, sets the objective “to establish conditions under which justice and respect for the obligations arising from treaties and other sources of international law can be maintained.” International law deﬁnes the legal responsibilities of states in their conduct with each other and their treatment of individuals within state boundaries. Its domain encompasses a wide range of issues of international concern such as human rights, disarmament, international crime, refugees, migration, problems of nationality, the treatment of prisoners, the use of force, and the conduct of war, among others. It also regulates the global commons, such as the environment, sustainable development, international waters, outer space, global communications, and world trade. The sources of international law are listed under Article 38.1 of the Statute of the International Court of Justice (1945) (hereinafter ICJ): (a) treaties, (b) international customs, and (c) general principles are stated as the three primary sources. A rule must derive from one of these three sources in order to be considered international law. Article 38 of the ICJ Statute suggests an implicit hierarchy of sources. However, there is no concrete evidence to support such strict hierarchy.
A treaty is an agreement under international law entered into by actors in international law, namely, sovereign states and international organizations. A treaty may also be known as a covenant or convention, among other terms.
Customary international law is deﬁned as a general practice of law under Article 38.1 ICJ Statute. States follow such a practice out of a sense of legal obligation. This is called “consistent state practice,” which means that the rules or principles must be accepted by the states as legally binding in order to be considered as rules of international law. Thus, the mere fact that a custom is widely followed does not make it a rule of international law. States also must view it as obligatory to follow the custom, and they must not believe that they are free to depart from it whenever they choose or to observe it only as a matter of courtesy or moral obligation. This requirement is referred to as opinio juris. Both concepts, consistent state practice and opinion iuris, are far from being clear in terms of what amounts to either.
General principles of law recognized by civilized nations are also a source of international law. This may be considered as a compromise between those who viewed such principles as derived from natural law and others who focused descriptively on domestic legal systems (Faunce 2005, p. 174).
The inclusion into Article 38 ICJ Statute of such sources as general principles of law already indicates that international law cannot be reduced to treaties or international customary law. In addition, scholars over the last decades have noted that categories of the sources of international law embedded in the ICJ Statute sometimes are no longer adequate in describing international legal reality. Alternative forms of international lawmaking are prospering in areas where states have not yet had the time or the willingness to formulate a formal and binding agreement on a subject. These alternative forms of international law are often referred to as being “soft law.”
It has already been noted that international law encompasses a wide range of issues among which are human rights. This is important given the close relationship between human rights and bioethics. This relationship is a complex one: on the one hand, as the IBC Report (2003, p. 1) notes, “modern bioethics is indisputably founded on the pedestal of the values enshrined in the Universal Declaration of Human Rights (1948)”; on the other hand, the same report remarks that “bioethics (…) today plays a predominant role in ensuring respect for human dignity and the protection of human rights and fundamental freedoms” (2003, p. 2). When the IBC was in the process of drafting a Universal Bioethics Declaration, Faunce raised the intriguing question: “Will international human rights subsume medical ethics?” (2005). This is not the right place to deal with this in detail, but the question illustrates the complex relation between human rights and bioethics. In a response to Faunce, Ashcroft (2010) concluded that “whatever the theoretical difﬁculties, human rights and bioethics need each other to ﬂourish” (Ashcroft 2010, p. 643).
The relation between human rights and bioethics is so intimate that international law regarding bioethics is often reduced to international human rights law. Although this is understandable, it is not entirely correct. Also other issues of international law that do not deal directly with human rights issues may be relevant for bioethics. One example is international humanitarian law which is the branch of international law which seeks to limit the effects of armed conﬂict by protecting persons who are not or no longer participating in hostilities and by restricting and regulating the means and methods of warfare available to combatants. Another example is international trade law to which belongs the Agreement on Trade Related to Intellectual Property Rights (hereinafter TRIPS Agreement) (1994). The provisions of this agreement dealing with patents are of particular relevance to bioethics. The TRIPS Agreement expressly grants member states of the World Trade Organization the right to exclude inventions from patentability under strict conditions. Some of these possible exclusions have bioethical relevance. For instance, according to its Article 27.1 (3), “diagnostic, therapeutic and surgical methods for the treatment of humans and animals” can be excluded from patenting. Nevertheless, in the following section, international law will be understood as international human rights law.
The International Human Rights Law Framework And Bioethics
In this section, international human rights law and bioethics will be presented from two different angles: a general and a speciﬁc one. In both cases, the different sources of international law and the alternative instruments (soft law), if existing at all, will be discussed.
The General International Human Rights Framework And Bioethics
One encompassing and universal “International Treaty on the Fundamental Rights and Freedoms” does not exist. However, scholars often refer to the so-called tripartite “International Bill of Human Rights.” This bill includes the Universal Declaration of Human Rights (hereinafter UDHR) (1948), the International Covenant on Civil and Political Rights (hereinafter ICCPR) (1966), and the International Covenant on Economic, Social and Cultural Rights (hereinafter ICESCR) (1966). These three instruments have in common that they have been adopted by the United Nations. The UDHR which was adopted in 1948 by the United Nations General Assembly set forth the inalienable rights and fundamental freedoms of each and every human being. Particularly overlapping with bioethical standards are provisions requiring respect for human dignity and equality (Articles 1 and 2) as well as the human right to life (Article 3). Other provisions resemble components of bioethics in prohibiting torture or cruel and inhuman or degrading treatment or punishment (Article 5) and requiring nondiscrimination (Article 7), freedom from arbitrary interference with privacy (Article 12), and progressive realization of the human right to a standard of living adequate for health and medical care (Article 25). In the same category is the human right to share in scientiﬁc advancement and its beneﬁts (Article 27) (Faunce 2005, p. 174). The UDHR is not a Treaty or Covenant but a Declaration (a resolution of the General Assembly) and as such is not legally binding. However, the human rights standards in the UDHR have been most inﬂuential on current legal approaches to the area of bioethics and generally bioethical thought (Clados 2012, p. 62). Even more, it seems that the overwhelmingly majority of scholars and states agree that at least some parts of the UDHR constitute customary international law and thus are a source of international law (Clados 2012, p. 97). Nonlegal principles and standards in the area of bioethics, to the extent that they replicate these parts in the UDHR, thus could be argued to be customary international law. For example, the right to life (Article 3 UDHR) is generally accepted to constitute a norm of customary international law.
Seeking the recognition of human rights within legally binding instruments, the UN later adopted two International Covenants (Treaties): the ICCPR and the ICESCR. The ICCPR and the ICESCR are legally binding treaties and as such undoubtedly create binding obligations on states. They dispose however of different enforcement mechanisms.
Unlike the universal level, at regional level, there exist Treaties protecting the fundamental rights and freedoms in general. Examples are the American Convention on Human Rights (1969) and the African Charter on Human and Peoples’ Rights (1981). The oldest and probably most inﬂuential one is the Council of Europe’s Convention for the Protection of Human Rights and Fundamental Freedoms (ECHR) (1950). It has been particularly inﬂuential in framing human rights discourse across Europe. The ECHR is a traditional statement of civil and political rights. Many member states of the Council of Europe have signed protocols enabling individual citizens to bring cases before the European Court of Human Rights. Over the years, a considerable number of actions have been brought before this court that are relevant to bioethics. For instance, the right to life (Article 2 ECHR) has been used in claims concerning the status of the fetus and abortion, the resource allocation in health-care systems, and the “right to die.” Article 8 on the right to privacy has been used in claims concerning reproductive rights (McHale 2010, p. 286). Also Ashcroft remarks that the ECHR jurisprudence “is rather extensive in the bioethical ﬁeld” but also “that the Convention is not a speciﬁcally “bioethical” instrument and (…) the European Court has tended to make rather extensive use of its interpretative powers not to prescribe bioethical rules to states parties’ because the Court leans rather heavily on the “margin of appreciation” doctrine where an issue is considered to be a moral issue” (Ashcroft 2010, p. 655).
The Specific International Human Rights Framework And Bioethics
Historically, the ﬁrst international standard to be mentioned here is the so-called Nuremberg Code (1947), which resulted from the trials of Nazi physicians at the end of the Second World War. A military tribunal at Nuremberg opened criminal proceedings against 23 Nazi medical professionals for war crimes and crimes against humanity. The judges developed a set of ten principles setting out fundamental ethical standards based on “principles of the law of nations as they result from the usages established among civilized peoples, from the law of humanity, and from the dictates of pubic conscience.” These standards have later come to be known as the Nuremberg Code (Clados 2012, p. 59). For the ﬁrst time in history, bioethics was approached by a formal and internationally highly visible forum that “codiﬁed” principles of bioethics within an ofﬁcial, widely recognized, and internationally applicable document.
Reﬂecting the absence of a universal general Treaty on human rights, there is no universal human rights Treaty that speciﬁcally deals with bioethics. In 2001, the IBC decided to set up an ad hoc Working Group to discuss the possibility of drafting such a universal instrument on bioethics. In June 2003, the IBC published its “Report on the Possibility of Elaborating a Universal Instrument on Bioethics” prepared by the Working Group. This report examined the feasibility of an international instrument on bioethics within the context of existing international legal instruments relating to the subject. Without being exhaustive or prescriptive, it also examined some issues in bioethics that could be addressed in such an international instrument to illustrate how the elaboration of such an instrument could contribute and support international efforts being made to provide ethical guidelines in matters related to recent scientiﬁc developments. The Working Group considered it preferable, in the initial stage, to settle on a (nonbinding) Declaration and not an international binding Treaty, given that the aim of an international instrument on bioethics should be by its nature broad and should receive the broadest acceptance possible by public authorities, the scientiﬁc community, and the general public. The Working Group referred to the tradition of international instruments on human rights that Treaties are preceded by Declarations which contain guidelines and an invitation to states to follow them, for instance, the ICCPR and the ICESCR.
On the 19th of December 2005, the 33th session of the General Conference of UNESCO adopted the Universal Declaration on Bioethics and Human Rights (UDBHR) (2005). After the Universal Declaration on the Human Genome and Human Rights (1997), followed by the Universal Declaration on Human Genetic Data (2003), the UDBHR is the third international instrument related to bioethics adopted by UNESCO. It is also the most encompassing one until now. One of the most distinctive features of the Declaration is its title because it combines bioethics and human rights, probably the ﬁrst time in an international law instrument.
The UDBHR contains 28 Articles, divided into ﬁve sections. Articles 1 and 2 contain the “General Provisions”: Article 1 describes the scope of the Declaration while the already cited Article 2 proclaims its eight aims. The backbone of the Declaration is made up by the “Principles,” spread over the Articles 3–17. They range from topics that belong to the more classic human rights such as human dignity and human rights (Article 3); beneﬁt and harm (Article 4); autonomy (Article 5); consent (Article 6); persons without the capacity to consent (Article 7); respect for human vulnerability and personal integrity (Article 8); privacy and conﬁdentiality (Article 9); equality, justice, and equity (Article 10); and nondiscrimination and non-stigmatization (Article 11) to themes that belong more to the social-economic domain such as respect for cultural diversity and pluralism (Article 12), solidarity and cooperation (Article 13), social responsibility and health (Article 14), sharing of beneﬁts (Article 15), protecting future generations (Article 16), and the protection of the environment, the biosphere, and biodiversity (Article 17). The next section, “Application of the Principles,” deals with matters such as decision-making and addressing bioethical issues (Article 18), ethics committees (Article 19), risk assessment and management (Article 20), and transnational practices (Article 21). The fourth section is devoted to the “Promotion of the Declaration” through appropriate measures to be taken by the states (Article 22); bioethics education, training, and information (Article 23); international cooperation (Article 24); and follow-up actions by UNESCO (Article 25). The last three Articles are grouped under the heading “Final Provisions.”
The UDBHR is a Declaration, not a Treaty and as such is not legally binding. It seems highly doubtful according to Clados (2012, p. 99) whether provisions that are enshrined in the UDBHR constitute norms of customary international law by themselves. Given the obvious lack of consistent and harmonic state practice with regard to many issues of bioethical relevance, it is difﬁcult to sustain an argument in favor of a customary international law regarding any of these issues. Therefore, it seems that so far at least customary international law does not offer much with regard to issues of bioethical relevance.
For the time being, the UDBHR that has been elaborated between states and because of its legal nonbindingness and legal non-enforceability constitutes soft law. The same holds for the two other UNESCO Declarations mentioned above and the UN Declaration on cloning. According to Clados, “it is evident that the ﬁeld of bioethics makes a good example of an area where soft law standards offer an attractive choice” (2012, p. 42). Firstly, she states, because the ﬁeld of bioethics has only rather recently come to the attention of international lawmaker. Secondly, given the rapidly changing ﬁeld of bioethics, the ﬂexibility of soft law may offer a more attractive governance option than many hard law standards.
The ﬁrst and until now only international Treaty on bioethical issues is the European Convention on Human Rights and Biomedicine (hereinafter the Oviedo Convention) (1997) which was drawn up within the framework of the Council of Europe. The Oviedo Convention was adopted by the Committee of Ministers of the Council of Europe on 19 November 1996 and opened for signature in Oviedo, Spain, on 4 April 1997. After the ﬁfth ratiﬁcation, that of Spain, the Convention entered into force on 1 December 1999. As of this moment, 29 (of 47) member states of the Council of Europe have ratiﬁed the Convention. The Convention consists of a preamble and 28 Articles, organized into 14 chapters. The general norms are contained in Chapter I, which consists of Articles 1–4; chapters II to VII set up substantive provisions relating to speciﬁc bioethical issues such as medical research with human beings and removal and transplantation of organs, while chapters VIII to XIV include the procedural norms. The Oviedo Convention is completed by (as of now four) additional protocols: on the prohibition of cloning human beings (1998), on transplantation of organs and tissues of human origin (2002), on biomedical research (2005), and on genetic testing for health purposes (2008).
The Convention aims to establish a common European minimum level of protection concerning the application of biology and medicine. It is remarkable that the Convention does not use the term “bioethics” in its title nor in its provisions although in the ﬁrst drafts, the notion was included in its title. Eventually, the term was deleted because “bioethics” was considered being not clear enough and might lead to confusion.
The Oviedo Convention so far is the only legally binding and enforceable international text in the area of bioethics. The Convention and its protocols represent, as Ashcroft has noted, “the broadest coverage and most comprehensive attempt to place bioethical matters on a formal human rights convention footing” (2010, pp. 656–657). Although it is a “European” Convention, it has the potential to become a “universal” one. Apart from the member states of the Council of Europe, the following states, which took part in its preparation, may sign it: Australia, Canada, the Holy See, Japan, and the United States of America (Article 33). Moreover, the Committee of Ministers of the Council of Europe may, after consultation of the Parties, invite any nonmember state of the Council of Europe to accede to this Convention (Article 34). Until now, no such invitation has been directed to any nonmember state while none of the nonmember states which took part in its preparation have signed the Convention.
During its drafting process and the beginning of the twenty-ﬁrst century, the Convention received much positive and sometimes enthusiast reactions. For instance, two American scholars wrote that “the Convention represents a milestone in international bioethics and protection of human rights that will probably be referred to with increasing frequency” (Dommel and Alexander 1997, p. 259). However, it seems that more recently this positive reception has watered down. First and foremost, a number of member states including countries such as Germany and the United Kingdom have not even signed, let alone ratiﬁed the Convention. Clados rightly concludes that this considerably weakens the Convention’s potential impact and standing (2012, p. 78). As a consequence, it cannot be argued that the Convention embodies “a true European, let alone global consensus on questions of bioethical interest.” Clados also rightly points to the all by all limited scope of issues of bioethical interest in the Convention. Another point of criticism is that the Oviedo Convention lacks an enforcement procedure before the European Court of Human Rights, unlike the ECHR. In case a citizen claims that a provision of the Oviedo Convention has been breached, he has to frame his complaint as an infringement of one or another right protected by the ECHR. For instance, an infringement of Article 5 of the Oviedo Convention (informed consent) has to be construed as an infringement of Article 8 of the ECHR (protection of private life). Looking at the Oviedo Convention in that way, it merely interprets the ECHR without really adding new rights.
Other important sources of international law regarding bioethics in Europe are the Recommendations of the Committee of Ministers of the Council of Europe to the member states (e.g., Recommendation No. R (83) 2 Concerning the Legal Protection of Persons Suffering from Mental Disorders Placed as Involuntary Patients (1983); Recommendation No. R (83) 25 Concerning Common European Public Health Policy to Fight the Acquired Immunodeﬁciency Syndrome (AIDS) (1987); Recommendation No. R (89) 4 on Collection of Epidemiological Data on Primary Health Care (1989)). These Recommendations are not legally binding and are to be considered as a source of soft international law.
The past 60 years, in the ﬁeld of international law and bioethics, relevant authorities have come a long way from a complete lack of any legal framework to the rather extensive legal framework we are operating under today. A considerable amount of normative work has been done, as far as international relations permit, on the one hand to create clear and binding regulations regarding certain areas of both public and private life in relation to certain speciﬁc bioethical issues and on the other hand to stipulate nonbinding, nonetheless comprising certain legal obligations, declarations that refer to more universal issues. It can be concluded that the international community has recognized certain universal principles regarding bioethical issues that form a basis for, among others, national and regional legislation and scientiﬁc research and development in the bioethical ﬁeld.
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