Freedom of Expression and Enquiry, Study notes of Human Rights

Download Freedom of Expression and Enquiry and more Study notes Human Rights in PDF only on Docsity! James Hamilton Mackey Lecture, Trinity College at 19.00 on 18 November 2009 1 Freedom of Expression and Enquiry Introduction My intention in this paper is to examine the concept of freedom of enquiry, with particular reference to scientific and medical research and to examine the extent to which it is given effect as a legal concept both within international human rights law and in Irish law. I intend to compare it with freedom of expression, to which it is related, a right which has given rise to far more litigation and analysis, and to explore some similarities and differences between the two concepts. The right to impart or receive information is rendered useless if one is not entitled to discover that information in the first place. It could, therefore, be argued that the right to freedom of scientific research or enquiry is an aspect of freedom of expression.1 I will then go on to consider whether there is adequate protection given to the right to carry out scientific research through constitutional law and international human rights instruments. I will then discuss the abuses which can arise through the misuse of scientific research particularly in relation to the issue of consent of human subjects. Following this, I refer to areas which have been problematical in relation to scientific research, the protection of the human genome, human cloning and the use of human embryos in stem cell research. Finally, I raise the question whether there is a need for regulation in the area of biomedicine. I have tried to aim this paper at the listener who may not have a specialist knowledge in legal concepts so I apologize in advance to those to whom the concepts involved will be familiar. As I am a lawyer and not a scientist, insofar as I have to refer to scientific matters I apologize also for my very imperfect grasp of complexities which I think I can appreciate if not always understand. When Legal Rights Collide What happens when two legal rights come into collision with one another? It is important to recall that very few rights can be regarded as absolute and not capable of being derogated from. One of the few which does fall into this category is the right not to be subjected to torture, though even with regard to this right one well-known American scholar, Alan Dershowitz, has suggested that torture should be permitted in circumstances where it could be used to obtain information which could save lives.2 So far his views have not generally met with favour among lawyers. Nevertheless as noted most rights are not absolute, even the right to life is not unqualified, and legal systems generally permit life to be taken by a person acting in necessary and proportionate self- defence. Limitations on freedom of expression Many legal systems give the right to freedom of expression extensive protection and recognize only very precise circumstances in which it can be limited. For example, in the European Convention on Human Rights freedom of expression is given a very high value which can only be restricted for the reasons which are specified in Article 10(2). James Hamilton Mackey Lecture, Trinity College at 19.00 on 18 November 2009 2 Any restrictions on the right must be clearly provided for in law. The reasons which may justify a restriction are, firstly, for national security, territorial integrity or public safety, secondly, for the prevention of disorder or crime, thirdly, for the protection of health or morals, fourthly, for the protection of the reputation or rights of others, fifthly, for preventing the disclosure of information received in confidence, and finally, for maintaining the authority and impartiality of the judiciary. The restriction in question must be both necessary and proportionate to the aim to be achieved. Necessity is a very strict test: it will only be met if there is no other means to achieve the purpose which is sought. The European Court of Human Rights has found that freedom of expression constitutes one of the essential foundations of a democratic society, one of the basic conditions for its progress and the development of every person.3 It has consistently held that speech which shocks, offends and disturbs is protected.4 The Court has, for example, upheld the right of political parties to campaign for fundamental changes to the legal and constitutional structures of a state, provided that this is done through legal and democratic means, and provided also that the change sought is itself compatible with fundamental democratic principles.5 In the United States of America freedom of speech has been afforded a particularly strong position in constitutional law. There, the courts have gone so far as to uphold the burning of the national flag as an act of free speech which is constitutionally protected.6 In the Constitution of Ireland, by contrast, the right to freedom of expression is much more qualified. Article 40.6.1˚ of the Constitution of Ireland provides as follows: “The State guarantees liberty for the exercise of the following rights, subject to public order and morality:- i. The right of the citizens to express freely their convictions and opinions. The education of public opinion being, however, a matter of such grave import to the common good, the State shall endeavour to ensure that organs of public opinion, such as the radio, the press, the cinema, while preserving their rightful liberty of expression, including criticism of Government policy, shall not be used to undermine public order or morality or the authority of the State. . The publication or utterance of blasphemous, seditious, or indecent matter is an offence which shall be punishable in accordance with law.” As a result of the restriction on the freedom of expression in the interests of public order, morality or State security, the constitutional protection of freedom of expression in the Constitution of Ireland is much weaker than that afforded by either the European Convention system or the United States Constitution. James Hamilton Mackey Lecture, Trinity College at 19.00 on 18 November 2009 5 Constitutional and Human Rights Protection for the Freedom of Scientific Research Freedom of expression is universally protected in express terms in constitutions, bills of rights and general international human rights instruments. By contrast, this is by no means the case in relation to the freedom to carry out scientific research. There is, for example, no express protection for freedom of research or enquiry or for academic freedom in the Constitution of Ireland. Nor is such a right expressly guaranteed in the European Convention on Human Rights, although arguably it might be derived by implication from the right to freedom of expression in Article 10. The earliest example of a guarantee of the right to scientific enquiry appears to be that contained in Article 27 of the Universal Declaration of Human Rights of 1948 which provides that: 1. Everyone has the right freely to participate in the cultural life of the community, to enjoy the arts and to share scientific advancement and its benefits. 2. Everyone has the right to the protection of the moral and material interests resulting from any scientific, literary or artistic production of which he is the author. Note, however, that while the Universal Declaration guarantees the right to share in the benefits of scientific advancement no mention is made of the right to carry out scientific investigation or enquiry. When the United Nations elaborated the principles of the Universal Declaration in two United Nations Covenants, the right to scientific research was placed in the International Covenant on Economic, Social and Cultural Rights rather than the justiciable International Covenant on Civil and Political Rights. Article 15 of the Economic, Social and Cultural Rights Covenant effectively repeats the language of Article 27 of the Universal Declaration and in addition provides (at paragraph 3) that “the States Parties to the present Covenant undertake to respect the freedom indispensable for scientific research and creative activity.” The principal difference between the two Covenants is that the Economic, Social and Cultural Rights Covenant provides a weaker guarantee in that the rights it guarantees are to be achieved progressively whereas the Civil and Political Rights Covenant commits the parties to it to respect the rights it guarantees. Furthermore, where states have adopted the Optional Protocol to the Covenant, any breach of a right under the Covenant can be the subject of a complaint to the Human Rights Committee, which can deliver an opinion against the state concerned. With regard to constitutional protection for the freedom of scientific research and enquiry, Ireland is not alone in not providing such protection. Most European countries whose constitutions date from before 1948 (and some which are later) similarly have no such provision. These include Belgium, Denmark, France, Germany, the Netherlands, Norway, and Sweden. In the case of Sweden this is so despite the fact that the Swedish constitution (which dates originally from the early nineteenth century) contains very elaborate provisions in relation to freedom of expression and the freedom of the press. However, constitutions adopted more recently do tend to contain a provision James Hamilton Mackey Lecture, Trinity College at 19.00 on 18 November 2009 6 guaranteeing rights to scientific research as well as artistic endeavour. The Italian constitution, adopted in 1948, provides that “the arts and sciences as well as their teaching are free”.14 Article 20 of the Constitution of Spain adopted in 1978, guarantees the right to literary, artistic, scientific and technical production and creation as well as the right to academic freedom. The same article also protects freedom of expression and communication. Almost all of the constitutions adopted in the emerging democracies of central and eastern Europe after the collapse of communism guaranteed the freedom of artistic creation and scientific research, as well as the right to benefit from the achievement of scientific progress. Many of them also guarantee the autonomy of universities and institutions of higher education. The Charter of Fundamental Rights of the European Union has followed the tendency of recently drafted national constitutions. Article 13 of the Charter provides as follows: “The arts and scientific research shall be free of constraint. Academic freedom shall be respected.” The Lisbon Treaty has incorportated the Charter.15 It follows that rights under the Charter will now be interpreted and applied by the European Court of Justice in the same way as other Community law rights. However, the Charter is addressed to the Union rather than its Member States. Abuses of Scientific Research There have been many occasions in the past when shocking abuses of human rights were carried out in the name of scientific or medical research. The worst examples are well known and include the atrocities carried out by Dr. Mengele and others in the concentration camps in Nazi Germany under the guise of medical experimentation and the “experiments” carried out in the USSR in Stalin’s time by Prof. Ilya Ivanovich with the intention of interbreeding humans and chimpanzees. Such abuses of human rights were by no means confined to totalitarian states, as the infamous example of the ”Tuskegee Study of Untreated Syphilis in the Negro Male” demonstrates. This study concerned 616 African American males, who were given blood tests in 1932. Four hundred and twelve of those were diagnosed with syphilis. The test subjects were not told they had syphilis and were not treated for it despite the fact that after 1943 penicillin was available as a cure. The purpose of the research was to study the long term effects of untreated syphilis. The research was discontinued only in 1972 after a journalist reported on it. Meanwhile many medical experts had been aware of the study and had raised no objection.16 What all these examples of human rights abuses have in common is that they were carried out on the subjects of the experimentation without their consent. In the wake of the Nazi experiments and the subsequent “doctors’ trial” at Nuremberg attempts were made to formulate ethical principles under which research involving humans might be carried out. The first attempt was in the Nuremberg Code in 1947 which was derived from the judgment in the doctors’ trial17. It emphasized the requirement for voluntary consent of the human subject of research and the weighing of the expected benefits of research against the risks to participants. The Declaration of James Hamilton Mackey Lecture, Trinity College at 19.00 on 18 November 2009 7 Helsinki of the World Medical Association adopted in 1964 set out ethical principles in relation to human experimentation and is regarded as the ethical cornerstone of biomedical research in human subjects. After the Tuskegee case came to light in 1972 the US Congress created a National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research which published ethical principles generally known as the “Belmont Report” in 1979. Three general principles were identified: respect for persons and particularly those with diminished autonomy, the principle of doing no intentional harm while maximizing benefits and minimizing risks, and the fair distribution within society of risks and benefits (for example, not carrying out research among those who will not benefit). Consent to Medical Research The International Covenant on Civil and Political Rights contains an important provision relating to scientific research. That is the provision in Article 7 which prohibits the carrying out of scientific or medical experimentation on human beings without their consent. This again is a provision which is commonly found in recent national constitutions. Article 3 of the Charter of Fundamental Rights of the European Union provides, among other things, that in the field of medicine and biology the free and informed consent of subjects must be obtained.18 The question of consent to medical experimentation is also dealt with in two international human rights instruments that aim to protect people against the misuse of medical and biological advances: the UNESCO Universal Declaration on Bioethics and Human Rights adopted in 2005 and the Council of Europe Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the application of Biology and Medicine adopted in 1997 (the Oviedo Convention). The UNESCO Declaration provides a universal framework of principles and procedures to guide States in the formulation of their legislation, policies or other instruments in the field of bioethics.19 It sets out a number of general principles to be observed. Human dignity, human rights and fundamental freedoms are to be fully respected. The interests and welfare of the individual are to have priority over the sole interest of science or society.20 The fundamental provision in relation to consent is that any preventive, diagnostic and therapeutic medical intervention is only to be carried out with the prior, free and informed consent of the person concerned, based on adequate information. Where persons do not have the capacity to consent, authorization should be obtained in accordance with the best interests of that person.21 Research should only be carried out for the direct health benefit of the person who cannot consent and if there is no research alternative of comparable effectiveness with research participants who are able to consent. Research which does not have potential direct health benefits should only be undertaken by way of exception, with the utmost restraint, exposing the person only to a minimal risk and minimal burden. The Declaration also provides that benefits resulting from scientific research should be shared with society as a whole and with the international community, in particular with developing countries.22 The Oviedo Convention contains similar principles to the UNESCO Declaration. The Convention is an important instrument on human rights and biomedicine. Many of the Member States of the Council of Europe have ratified the Convention though Ireland is James Hamilton Mackey Lecture, Trinity College at 19.00 on 18 November 2009 10 well as the recognition of their inherent dignity and diversity. It is described in a symbolic sense as the heritage of humanity.34 The Declaration proclaims everyone’s right to respect for their dignity and their rights regardless of their genetic characteristics. Human dignity makes it imperative not to reduce individuals to their genetic characteristics and to respect their uniqueness and diversity.35 The Declaration includes principles on prior-informed consent, confidentiality of data, reparation, protection of public health, benefit-sharing and international cooperation. Cloning Reproductive cloning means the creation of an organism that is a genetic copy of another existing organism. Scientists have successfully cloned a number of animals and these include cats, dogs, cows, horses, deer, pigs, rabbits, sheep, mice and rats. The technique has been described as “highly inefficient” as there is less than a one per cent chance of obtaining a live birth.36 Also unpredicted problems have arisen in all of the mammals cloned so far leading to a high rate of foetal abnormalities and prenatal death and to health problems of those animals born alive. Article 3 of the Charter of Fundamental Rights of the European Union prohibits the reproductive cloning of human beings. The Charter is, however, addressed to the Union rather than its Member States. The UNESCO Declaration on the Human Genome and Human Rights provides in Article 11 that “practices which are contrary to human dignity such as reproductive cloning of human beings shall not be permitted”. The Council of Europe has adopted an additional protocol to the Oviedo Convention prohibiting the cloning of human beings. The Protocol, adopted in 1998, notes that the cloning of human beings may become a technical possibility, but considers that the instrumentalization of human beings through the deliberate creation of genetically identical human beings is contrary to human dignity and thus constitutes a misuse of biology and medicine and also refers to the serious difficulties of a medical, psychological and social nature that the deliberate cloning of human beings could imply for all the individuals involved. For these reasons, the Convention prohibits any intervention which seeks to create a human being genetically identical to another human being, whether living or dead.37 Adherence to the protocol is open only to parties to the Oviedo Convention.38 Domestic Irish law has yet to prohibit reproductive cloning. Stem Cell Research and the use of Human Embryos Undoubtedly the most difficult ethical and legal problems at the moment in the field of scientific research relate to the use of human embryos. At this stage, it will be clear that I am not a scientist or a medical person, and I neither could nor do I intend to attempt to describe all of the amazing developments which have been taking place in this field in recent years. I would, however, recommend anyone who is interested in the area to read the Irish Council for Biothethics Opinion on Ethical, Scientific and Legal Issues concerning Stem Cell Research (2008) which can be found on the Council’s website: http://www.bioethics.ie/uploads/docs/lowStemCellReport.pdf. Briefly, the Report explains that stem cells are immature cells from which all specialized cell types can be derived. There are two basic types, adult stem cells and James Hamilton Mackey Lecture, Trinity College at 19.00 on 18 November 2009 11 embryonic stem cells. Adult stem cells are found in various sites in the body such as bone marrow, the brain, blood, the eye, the liver. Generally speaking adult stem cells have a relatively limited capacity to turn into more specialized cells. For example, the adult stem cells found in blood can transform into the various different blood cells but not into, for example, skin cells. Embryonic stem cells are the cells which are found in the developing embryo at a very early stage of development and have a capacity to develop into any of the different cell types that make up the human body. They begin to specialize as the embryo develops into a foetus. Stem cells can be isolated and used to generate lines of stem cells in the test tube. Stem cells have potentially huge implications for medicine. Potentially they can be used to replace and repair diseased cells in the human body and are therefore of potential value in all illnesses and disorders characterized by diseased or damaged cells. The ethical and legal questions relating to stem cells arise in relation to embryonic stem cells. There is no particular ethical objection in principle to the use of adult stem cells. The characteristics of embryonic and adult stem cells differ. Embryonic stem cells are not only more versatile in their potential development but are capable of multiplying much more rapidly than is the case with adult stem cells. On the other hand, the risks attached to rejection in the case of transplanting cells would be less for adult stem cells. A diseased person’s own stem cells could be used to create stem cell lines and thereby avoid the risk of rejection. The technology in this area is advancing very rapidly and there is, for example, a possibility that adult stem cells may have the potential of being “dedifferentiated” – in other words turned into stem cells which are capable of being developed into a greater variety of cell types than is the case with the differentiated adult stem cells produced in the human body. The Irish Council for Bioethics Report points out that there is an emerging consensus among stem cell researchers that a continuum of stem cell types exists, with foetal stem cells, for example, lying somewhere in between embryonic and adult stem cells in terms of their ability to transform into a variety of specialized cell types.39 The Report points out that at present it is very difficult to predict which type of stem cell might be most successful in treating various diseases and conditions and concludes that “many scientific bodies converge on the view that research using all types of stem cells, including human embryonic stem cells, represents the optimal strategy for the advance of stem cell research and the delivery of therapies”.40 The ethical and legal questions in relation to the use of embryonic stem cells arise, of course, from the question of what moral value we ascribe to an embryo. The embryos which are used in stem cell research are the surplus frozen embryos which arise as a byproduct of assisted human reproduction. If not used in stem cell research they would either be frozen indefinitely or destroyed. There are those who believe that full moral value should attach to life from the moment when the sperm fertilizes the ovum and that the resulting organism, starting with two cells and dividing into four, eight and so on, has already the moral quality of a human being. Persons who hold this view believe that any act which is carried out and results James Hamilton Mackey Lecture, Trinity College at 19.00 on 18 November 2009 12 in the destruction of the embryo and its ability to progress on the path towards birth is morally unacceptable. On the other hand, others do not ascribe such a moral value to an 8 or 16 cell embryo resulting from in vitro fertilisation and consisting entirely of undifferentiated stem cells, and which does not have a nervous system or any ability to perceive anything or feel pain, even though if implanted in the womb it would have the potential to develop into a foetus and eventually be born as a human body. The legal issue in Ireland, of course, arises because of the constitutional protection given to the “unborn” as a result of the Eighth Amendment to the Constitution made in 1983. Unfortunately, there is no definition within the Constitution of an “unborn”, nor, despite judicial pronouncements, has the Oireachtas attempted to define it by legislation. Even if it were permissible to examine the question by reference to what was stated at the time of the referendum by proponents of the amendment – a process which is probably not admissible from a legal point of view – one would still find quite a variety of opinion. There is no doubt that many of those who promoted the amendment were strongly of the opinion that life begins at the moment of conception and that what they wished to protect was that life from that very moment. At the same time, there were those who denied that an effect of the constitutional amendment would be to render unlawful such practices as the use of the morning after pill which if they were correct must mean that “unborn” is not referable to pre-implantation embryos. Be that as it may, the legal position in Ireland remains unclear. In the recent decision of MR v TR & the Attorney General,41 the High Court declined to hold that the word “unborn” in Article 40.3.3 includes embryos outside the womb or in vitro. The case concerned a dispute between an estranged husband and wife over the status of three frozen embryos which were created by in vitro fertilization. Mr. Justice McGovern stated as follows: “It is not for the courts to decide whether the word “unborn” should include embryos in vitro. This is a matter for the Oireachtas, or for the people, in the event that a Constitutional Amendment is put before them. In 2000 the Government established a Commission on Assisted Human Reproduction to make recommendations in the area of in vitro fertilization practices.42 … In March, 2005 the Commission published its report in which it made forty recommendations, most of which were unanimous. … A majority of the Commission recommended that “the embryo formed by IVF should not attract legal protection until placed in the human body, at which stage it should attract the same level of protection as the embryo formed in vivo”. It is a matter for the Oireachtas as to whether they implement the recommendations of the Commission. In the meantime the Courts are being asked to deal with a complex dispute involving social issues which should be governed by a regulatory regime established by an Act of the Oireachtas." I understand that this case is currently under appeal and the decision of the Supreme Court on the point will be awaited with great interest. The Irish Council on Bioethics in a strongly worded conclusion to its 2008 Report stated as follows: James Hamilton Mackey Lecture, Trinity College at 19.00 on 18 November 2009 15 22 Article 15 23 Article 16 24 Article 17 25 170 Seanad Debates Col. 1528 26 http://www.dohc.ie/publications/cahr.html 27 EC (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 – 2009 which transposed the European Communities Clinical Trials Directive 2001/20/EC into Irish law. The 2004 Regulations have been amended by EC (Clinical Trials on Medicinal Products for Human Use) (Amendment) Regulations 2004; the EC (Clinical Trials on Medicinal Products for Human Use) (Amendment No. 2) Regulations 2006; and the EC (Clinical Trials on Medicinal Products for Human Use) (Amendment) Regulations 2009. 28 Section 2(4) of the Control of Clinical Trials Act 1987 as inserted by section 22 of the Irish Medicines Board (Miscellaneous Provisions) Act 2006 states that: “(4) The provisions of this Act shall not apply in respect of any clinical trial that is subject to control under the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004” 29 Part 2 of Schedule 1 of the Regulations as inserted by the EC (Clinical Trials on Medicinal Products for Human Use) (Amendment No. 2) Regulations 2006 30 The EC Regulations initially applied only to medicinal products which were defined as: “(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or (b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.” (Article 1(1) of Directive 2004/27/EC) Since the amending regulation, EC (Clinical Trials on Medicinal Products for Human Use) (Amendment) Regulation 2009, the Regulations apply to “tissue engineered products” in the same manner as the Regulations apply to medicinal products for gene therapy and somatic cell therapy. A “tissue engineered product” means a product that: “— contains or consists of engineered cells or tissues, and — is presented as having properties for, or is used in or administered to human beings with a view to regenerating, repairing or replacing a human tissue. A tissue engineered product may contain cells or tissues of human or animal origin, or both. The cells or tissues may be viable or non-viable. It may also contain additional substances, such as cellular products, bio-molecules, biomaterials, chemical substances, scaffolds or matrices. Products containing or consisting exclusively of non-viable human or animal cells and/or tissues, which do not contain any viable cells or tissues and which do not act principally by pharmacological, immunological or metabolic action, shall be excluded from this definition.” (Article 1(b) of Regulation (EC) No 1394/2007) 31 See UNESCO Declaration, Articles 9, 10 and 11. See also Article 5 of the UNESCO Declaration on Human Genetic Data (16 October 2003). Article 12 of the Oviedo Convention provides that predictive genetic tests may be used only for health purposes or scientific research. 32 Article 13 33 Article 14 34 Article 1 35 Article 2 36 The Report of the Irish Council on Bioethics at p.20 37 Article 1 38 Article 4 39 The Report of the Irish Council on Bioethics at p.15 James Hamilton Mackey Lecture, Trinity College at 19.00 on 18 November 2009 16 40 Ibid p. 16 41 Unreported, High Court, 15th November 2006 42 The judgment referred to the fact that “The members of the Commission included a wide range of experts in the fields of reproductive medicine embryology genetics law and other relevant areas which can be ascertained from the description of the members of the Commission published at the commencement of their report. The Commission also invited a number of additional experts with complementary expertise in specific areas including Philosophers, Sociologists, a Director of Ecumenical Studies and a Roman Catholic Theologian.” 43 The Report of the Irish Council on Bioethics at p. 67 44 The position of the Irish Government in relation to this matter is discussed at pages 66 and 67 of the Irish Council on Bioethics Report.