(a)  The United States

20  The earliest known attempts to enshrine a patient’s bill of rights appears to have begun through a movement recognizing the need for collaborative efforts between medical professionals, patients, and their families/caregivers within the scope of healthcare. It is likely that this independent movement for patients’ rights began in the US (Annas), and thus it is necessary in incorporate the US jurisdiction into this entry. In 1973, the American Hospital Association drafted one of the first Patient Bill of Rights (revised 1992) in the country, followed by the Association of American Physicians and Surgeons in 1990 (modified 1995). To date, however, a so-called Patient Bill of Rights has never been successfully enacted as legislation at the federal level. Given that the US healthcare system has been described as a ‘monument to perverse incentives, unintended consequences and political inertia’ (Harford), and subjected to constant heavy criticism (Anderlini 2), this is not surprising.

21  The Patient Self-Determination Act 1990 (US) is the closest legislation recognizing patients’ rights in a specific form. It was prompted by the landmark ‘right to die’ case in the Supreme Court, Cruzan v Director, Missouri Department of Health (1990) (US). However, the Act does not apply to physicians, and is more particularly concerned with decision-making rights of patients who have been admitted into institutions of health care and their advanced health care directives. The main purpose of the Act was to alleviate and prevent cruel over-treatment of the elderly and disabled (rights of disabled persons) on medical aid, but its goals have not been realized, as there is inadequate facilitation of palliative and end-of-life discussions with patients (Kring 125).

22  When the US Congress considered a bill in 2001 which would, amongst other aims, seek to ensure that patients would have new rights to sue if they were denied medical care, this seemed to be a promising start to enacting the ‘Bipartisan Patient Protection Act’. However, it eventually failed.

23  It should also be noted that the US Constitution: 17 September 1787 (as Amended to 1992) (US) is silent on the issue of patients’ rights. With the exception of the legislative powers of the federal government stipulated in Article 1 Section 8 of the Constitution, all such other matters are for the state to regulate. However, the protection of individual liberties and freedom is enshrined in the Amendments to the Constitution (also known as its Bill of Rights). It is constitutional interpretation of the scope of the Bill of Rights which bestows upon patients the silent and implicit protection of the Constitution. At no material time is the phrase ‘patients’ rights’ expressly mentioned; but a widening of the scope of protections under the Bill of Rights means that the patients’ rights we are now familiar with found their origins in a piecemeal manner, through the sphere of ‘penumbral rights’ (Greely 262).

24  Penumbral rights, or the penumbra of rights, are ‘silent’ rights that are derived from the explicitly protected rights within the Bill of Rights. The ‘penumbra’ of rights gained significant contemporary interpretation in the case of Griswold v Connecticut (1965) (US), where Justice Douglas of the Supreme Court found that ‘the source of the federal constitution’s right to privacy has been fixed in the penumbras of the Bill of Rights’ (Greely 251). Because of the absence of a ‘concrete constitutional anchor’ (Greely 252) for this right, the opinion has been subject to controversy and critique.

25  In pre-Griswold jurisprudence, it has been highlighted that ‘penumbra’ was not simply plucked out of thin air (Henly 83). In fact, prior to the Griswold case, another Supreme Court decision may have provided an earlier reckoning on the interpretation of the penumbral rights. In Skinner v Oklahoma (1942) (US), the Supreme Court found that the state’s forced sterilization laws for repeat criminal offenders would violate the applicant’s ‘right to procreate’ (Lau Comparative Legal Frameworks for Pre-Implantation Embryonic Genetic Interventions 233). The ‘right to procreate’ is nowhere to be found in the Constitution of the United States of America. However, the Supreme Court’s interpretation of this ‘right’ hinged on the equal protection clause of the Fourteenth Amendment, with Justice Douglas (who delivered the opinion of the court) proclaiming that the offending legislation had the effect of depriving some individuals (and not others) of their fundamental right of procreation (Lau Comparative Legal Frameworks for Pre-Implantation Embryonic Genetic Interventions 40).

26  The judicial reasoning in Skinner v Oklahoma (1942) (US) has been criticized for lacking a ‘secure constitutional foundation’ (Stone et al 779). Nevertheless, it provided an interesting interpretation that paved the way for penumbral rights.

27  It was only after the Griswold case that the penumbra metaphor could be envisaged as part of the Bill of Rights. In Griswold, Justice Douglas made a distinction between specific rights and peripheral rights (Henly 96), making the claim that there are ‘zones of privacy’ in the First, Third, Fourth, and Fifth Amendments. In this manner, the right to privacy in the US was established, even when its Constitution remained silent as to such a right.

28  Considering the foregoing, it is possible that the Griswold judgment on penumbral rights has partially contributed to the trajectory of patients’ rights in the US, especially for the recognition of a right to privacy. Although commentators questioned the scope of this right to privacy and whether it would cover personal autonomy (Stone et al 852), the landmark Roe v Wade Case (US) (1972) (US) appeared to confirm this. The effect of Roe v Wade was to decriminalize abortion on the grounds of a woman’s constitutional right to privacy, including personal privacy that is ‘fundamental’ and ‘implicit in the concept of ordered liberty’ (Stone et al 855). Another landmark case that has impacted the operability of patients’ right to privacy in medical settings is Washington v Glucksberg (1997) (US), regarding assisted suicide (euthanasia), where the court held that an alleged ‘right’ to assisted suicide was not protected by the Due Process Clause (due process).

29  The courts in the US have also had a long history in the adjudication of legal cases relating to informed consent, a doctrine that is the cornerstone of all aspects of medical ethics and treatment. In the case of Schloendorff v Society of New York Hospital (1914) (US), Justice Cardozo stated: ‘Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits an assault for which he is liable in damages’. Although the facts in this led to the establishment of respondeat superior in US law, it is likely that Justice Cardozo’s legal reasoning has led to the further development and evolution of the doctrine, as being one that goes beyond mere consent. Other noteworthy cases regarding informed consent can be found in modern reports pertaining to the Tuskegee syphilis experiments which took place from 1932 to 1972, Canterbury v Spence (1972) (US), which has often been touted as the seminal case that formally recognized informed consent (as opposed to mere consent) in medical settings in the US, and Schreiber v Physicians Insurance Co of Wisconsin (1999) (US).

(b)  The United Kingdom

30  The inclusion of the UK into this entry is instrumental for three reasons: firstly, the UK’s constitution has been described as ‘unwritten’ in nature, although it may be more accurate to refer to it as being ‘uncodified’, comprising of both written and unwritten sources of laws (for example, cases, statutes, and conventions) (Lau Comparative Legal Frameworks for Pre-Implantation Embryonic Genetic Interventions 237; codified / uncodified constitutions). This contributes to a fascinating view of how the rights of patients have evolved in the UK. Secondly, the UK has been forerunner in new and emerging technologies in medicine, adopting, amongst others, a national strategy on regenerative medicine (Taking Stock of Regenerative Medicine in the United Kingdom by Department of Health [URN 11/1056]) and the establishment of its Human Fertilisation and Embryology Authority vis-à-vis the Human Fertilisation and Embryology Act in 1990 (now the revised Human Fertilisation and Embryology Act 2008) when at such a time this was regarded as a novel and future-forward approach. Thirdly, the UK is also notably the first country in the world to regulate mitochondrial DNA donation treatment (‘The Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015’).

31  The UK’s former entry into the European Union (‘EU’) vis-à-vis the European Communities Act of 1972 was seen as adding a new dimension to the UK constitutional system (Lau Comparative Legal Frameworks for Pre-Implantation Embryonic Genetic Interventions 238). Particularly relevant to this Europeanizing influence was the enactment of the Human Rights Act of 1998 which incorporated the European Convention for the Protection of Human Rights and Fundamental Freedoms (1950) into its national laws. However, even prior to this, the UK had demonstrated through its common law system its own foundations in the protection of individual rights and liberties. Whether the UK’s exit from the EU will impact the operability of the Human Rights Act remains to be seen.

32  The UK’s National Health Service (‘NHS’) has been subject to grave criticism in a manner similar to the US health system, with healthcare outcomes identified as its main weakness (Dayan et al 4). Similarly to the US and in the absence of a codified federal constitution by which to derive legitimacy, or Parliamentary legislation enacted to pronounce the same independently, patients’ rights in the UK have evolved through efforts of various patient organizations (Grosios, Gahan, and Burbidge 529), judicial pronouncements in legal cases and official government guidelines vis-à-vis the NHS.

33  In 1991, the UK government issued the Patients’ Charter for patients who used the NHS (Grosios and others 530), detailing the rights and responsibilities afforded to them. It has since been revised several times and borne heavy criticism. In 2009, it was replaced by the NHS Constitution for England (published 8 March 2012, last updated 14 October 2015). The NHS Constitution for England ‘sets out the rights to which patients, public and staff are entitled, and pledges which the NHS is committed to achieve’ (at 2). Amongst others, it pledges that the rights of patients shall be respected: the right of access to medical services (at 6), the right to respect, consent and confidentiality (at 8) and the right to informed choice (at 9). The formality of recognizing patients’ rights, culminating from the first formal Patients’ Charter in 1991, has evolved through a process of trial and error, change of governments, and the language of entitlement of rights (Mold 1287). In the meantime, Scotland passed the Patient Rights (Scotland) Act of 2011, expressly setting out the rights of patients in Sections 3 and 4, and the establishment of a Patient Advice and Support Service in Sections 17, 18, and 19.

34  The NHS Constitution, however, despite its title, is not a legally binding document. The apparent ‘legalistic’ nature of its title may also be misleading to the general public and result in poor impact (Tingle). Besides this, the NHS Constitution’s applicability is limited to England; Scotland, Wales, and Ireland are required to develop their own health policies and legislation. The force of the NHS Constitution, however, has been addressed vis-à-vis the Health and Social Care Act of 2012, which substantially revamps the NHS and requires them to ‘have regard to’ the NHS Constitution.

35  Besides the foregoing, however, this is not to say that there has been no recognition of patients’ rights whatsoever in the UK, even prior to the establishment of the NHS Constitution. Where key aspects of patients’ rights in the US found validation through the application of penumbral rights in its federal constitution, the UK’s common law system and the application of the doctrine of judicial precedent founded a rich trove of legal cases that have impacted on patients’ rights. Some of these cases include Sidaway v Board of Governors of the Bethlem Royal Hospital (1985) (UK) relying on the ‘Bolam test’ for legal consent in Bolam v Friern Hospital Management Committee (1957) (UK). The Bolam case was instrumental in establishing the criteria of legal consent. The Bolam test meant that a doctor, if acting in accordance with acceptable medical practices (by a responsible body of medical practitioners skilled in that art) would have ‘no obligation to provide patients with unsolicited information about risks if the mention of risks could have a detrimental effect on the patient’s mind and if it deterred the patient from undergoing treatment that the doctor believed was in her best interest’. However, this position was no longer sustainable, according to the UK Supreme Court in Montgomery v Lanarkshire Health Board (2015) (UK), emphasizing that doctors must show ‘they have gone through the whole spectrum of activities in supporting the patient accessing all the information and advice’ (International Alliance of Patients’ Organizations 2016).

36  It is also interesting to note that in the UK, the right to privacy, especially relating to the context of patients in a medical environment, or even in the manner that has been interpreted in the US, appears to be a relatively recent phenomenon. Prior to the 1990s, and the Human Rights Act 1998 (UK), the UK’s recognition of privacy was limited to a varied form of privacy in the doctrine of breach of confidence in English common law (Lau Comparative Legal Frameworks for Pre-Implantation Embryonic Genetic Interventions 242). After the Human Rights Act 1998 was passed, a number of cases such as Campbell v MGN Ltd (2004) (UK) and Douglas v Hello! Ltd (2005) (UK) extended the realm of privacy in accordance with Article 8 of the Convention for the Protection of Human Rights and Fundamental Freedoms (more commonly known as the European Convention on Human Rights (‘ECHR’)). In Regina v Secretary of State for Health (Respondent) ex Quintavalle (on behalf of Pro-Life Alliance) (2003) (UK), an opportunity to clarify a right to privacy was missed as the application to the court couched the issues regarding parental autonomy and a public authority’s jurisdiction to issue licenses for using reproductive technologies (Lau Comparative Legal Frameworks for Pre-Implantation Embryonic Genetic Interventions 244).

37  The scope of the right to privacy in the UK still remains rather undeveloped and limited, especially compared to the other core jurisdictions in this entry. The UK government has made it clear that it does not intend to enact specific privacy legislation and prefers to look to the courts to interpret any issues that may arise (Pennings). This has been evidenced vis-à-vis Evans v UK (2007) (ECtHR) and Dickson v UK (2007) (ECtHR), both concerning reproductive rights claimed within the scope of Article 8 of the ECHR.

(c)  Israel

38  As an emerging international leader in the medical sciences, and one of the handful of countries in the world that specifically legislated on patients’ rights in the 1990s period, the Israeli framework of healthcare and medical governance, as well as its significant advancements in medical and scientific developments in the natural sciences, serves as an illuminating comparator in this entry. Boasting universal health coverage for all citizens since 1995, with a progressively financed statutory health insurance system (Rosen and others xxii) and a broad spectrum of health benefits to its citizens, the Israeli position provides an interesting contrast to the US and the UK. The Israeli legal system is also a mixed one (Rivlin 781), with both civil law codifications influenced by Roman-German legal systems, and common law traditions vis-à-vis the role of judge-made laws (Barak (2002)). Although Israel, like the UK, does not have a written constitution, its constitutional regime lies in its Basic Laws, with various Basic Laws dealing with administration of the government. In 1992, a political compromise was reached to include human rights within the Basic Laws (Navot). In this regard, the Basic Law: Human Dignity and Liberty (1992) and Basic Law: Freedom of Occupation (1994) were enacted and formed part of Israel’s Bill of Rights (Basic Law: Human Dignity and Liberty: March 17, 1992 and Basic Law: Freedom of Occupation: March 9, 1994).

39  Israel’s unique constitutional regime is also characterized by its ‘creative judicial innovation’ (Rivlin 784). Most notably, in what has been described as Israel’s ‘constitutional revolution’ (Michelman 748), the Israeli Supreme Court in the Mizrahi Bank Case (Isr) (1995) held that Israel’s Basic Laws (particularly the basic laws on human rights) are equivalent to its formal constitution, and are ‘superior to ordinary laws’ (Navot), thereby allowing the court to have the power of judicial review over primary legislation enacted by the Knesset. In essence, the effect of this decision was similar to the Marbury v Madison Case (US) (1803). Although the doctrine of judicial review has had a long legal history, it was less prominent within the context of Israel until United Mizrahi Bank, and signalled the beginning of a more active judiciary (Michelman 745), led by former President of the Israeli Supreme Court, Justice Aharon Barak.

40  The Basic Law: Human Dignity and Liberty (1992) contains human rights protections for life (s 1 and 4), bodily freedom (s 1, 4, and 5), dignity (s 1 and 4), property (s 3), and privacy (s 7). Although there may be consternation that principles of equality and non-discrimination, as well as other civil and political freedoms such as freedom of speech, expression, association, and the like, are not expressed (Michelman 755) in the said Basic Law, it is more than likely that these omissions are deliberate, so as to allow such Basic Law to be built upon as a foundational basis for further rights protections, although the existing political realities also cannot be avoided (Hirschl 72).

41  On this basis, the expression and protection of patients’ rights in Israel vis-à-vis its Patient Rights Act 1996 is highly commendable and was enacted at that time to demonstrate that Israel was able to surpass the US in its own protection of patients’ rights (Gross 14). Section 13 of the Act, which specifically provides for informed consent of a patient to medical treatment, is likely heavily influenced by the Israeli Supreme Court decision of Hadassah Medical Organisation, Ein Kerem v Ophra Gilad (1995) (Isr), where Justice Barak stated (Weil 245):

42  The key components of the Patient Rights Act 1996 are contained in Chapters 3, 4, and 5, which protect, respectively, the patient’s right to medical treatment, the right of informed consent, and the right to confidentiality and receipt of medical records and information.

(d)  Europe

43  The European framework on the protection and enforcement of patients’ rights, and the protection of human rights generally, bears mention in this entry. Because patients’ rights, by virtue of individual recognition as human beings, are grounded in the human rights narrative, the European approaches have demonstrated over time the deep influence it holds through relevant legislation, directives, and conventions. Although the framework in which patients’ rights are championed exists at a regional level, and although some of the legal instruments do not specifically mention patients’ rights, the framework has a rich exposition of jurisprudence and legal cases, and deep-seated interest especially in biomedical issues.

44  In Europe, the Charter of Fundamental Rights of the European Union (2000) (‘EU Charter’) lays out the political, social, and economic rights afforded to citizens and residents of the EU, but only gained full legal effect when the Treaty of Lisbon entered into force in 2009 (Douglas-Scott 648). Article 3 of the EU Charter specifically focuses on right to the integrity of the person, and paragraph 2 highlights the importance of free and informed consent in the fields of medicine and biology. Paragraph 2 further prohibits eugenic practices, commercializing the human body and its parts, and reproductive cloning of human beings. These provisions do not expressly mention patients’ rights, but an implicit interpretation begs the reasoning that Article 3 is meant to encompass said rights, without specifically intending to limit these to patients only.

45  The Council of Europe’s Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine (1997), more commonly known as the Oviedo Convention, is one of the most comprehensive conventions that specifically focuses on human rights and biomedicine. Although its application is limited to the Council of Europe member states, and even though the patients’ rights movement began in the US, the Oviedo Convention is often regarded as one of the most articulate, complete, and contemporary instrument (Annas) to ‘promote the protection of human rights in the biomedical field at a transnational level’ (Andorno 133).

46  The focus of the Oviedo Convention on human rights and ethical and legal principles in medicine, as well as in new biomedical technologies and its implications on human beings, was and remains an important milestone in European legal jurisprudence (Seatzu 5). Although the Oviedo Convention does not use the words ‘patients’ rights’, the full spectrum of its contents speaks volumes. Particularly, Articles 1 to 3 place the primacy of the human being, dignity, and identity, at the centre of ‘respect for their integrity and other rights and fundamental freedoms with regard to the application of biology and medicine’. Articles 5 to 9 embody one of the most important rules in medical ethics: informed consent. And throughout the whole convention, the main principles in medical ethics (autonomy, confidentiality, beneficence/non-maleficence, and justice) are comprehensively covered (Lwoff).

47  There is also a plethora of cases brought before the European Court of Human Rights (‘ECtHR’) that deal with bioethical issues under the ECHR, as well as issues specific to the Oviedo Convention. This is not surprising since the ECHR and the Oviedo Convention share a close relationship. The ECtHR, through these specific biomedical issues submitted to it vis-à-vis the Oviedo Convention, has contributed to effective implementation of the convention’s provisions (Seatzu 8).

48  Part of a report from the ECtHR details the cases submitted to the court, with specific reliance on the provisions of the Oviedo Convention that relate to the rights of an individual in medical settings (Department of the Jurisconsult 2017). For example, in Glass v the United Kingdom (2004) (ECtHR), the applicants made the allegation that actions taken by doctors and the hospital authority regarding treatment of the first applicant had interfered with the right to respect for personal integrity, with the central issue being that of informed consent. Finding a violation of Article 8 of the ECHR, and in reaching its decision, the ECtHR also referred to Articles 5 to 9 of the Oviedo Convention with specific materiality on the doctrine of informed consent. In VC v Slovakia (2011) (ECtHR), Articles 1, 4, 5, and 8 of the Oviedo Convention were considered in the case of sterilization of a Roma woman without her full and informed consent. Costa and Pavan v Italy (2012) (ECtHR) concerned the applicants’ access to pre-implantation genetic diagnosis banned by the Italian government. In this, the ECtHR made reference to Article 12 of the Oviedo Convention, and paragraph 83 of its Explanatory Report, which outlined the position regarding predictive genetic testing.

49  Adjudicating over matters that ranged from informed consent to medical treatment, reproductive rights, assisted suicide, and retention of DNA or genetic information by governmental authority, the rich spectrum of legal cases at the ECtHR demonstrates the European commitment to patients’ rights.

(a)  Southeast Asia: Malaysia

50  The case of Malaysia in this entry purports to highlight a dualistic constitutional regime, a regime that adopts the British Westminster system of parliamentary government and democracy whilst simultaneously employing Shari’a law in adjudicating matters pertaining to Islam and Muslims in Malaysia (Lau Comparative Legal Frameworks for Pre-Implantation Embryonic Genetic Interventions 262; constitutions and Sharia provisions), with the result of juggling the applicability of patients’ rights within this dualistic domain. It is not surprising that in many instances of contemporary Malaysian life, the tussle between Malaysia’s civil laws and Shari’a law has been subject to ‘fragmented ‘‘domains of control’’ within social life in Malaysia’ (Baharuddin 4). So too would this affect the sphere of patients’ rights.

51  In the Constitution of Malaysia: 31 August 1957 (as Amended to December 27, 2007) (Malay), Articles 5 and 8 respectively protect the life and liberty of persons and guarantees equality before the law. Pursuant hereto, although there is no one specific, express legislation on patients’ rights, these rights are protected in a variety of laws relating to healthcare, but more specifically, the Private Health Care Facilities and Services Act 1998, and its Regulations. The protection of patients’ rights herein covers the provision of medical care by registered doctors, confidentiality of medical records and information, and consent. The Malaysian Medical Council, through its Patient’s Rights Charter (Malaysian Medical Association, Patients Charter) and Code of Ethics (Malaysian Medical Association Code of Ethics), also to a large degree upholds the importance of patients’ rights in the provision of healthcare.

52  The problems arise, however, because the imposition of responsibilities and protection of these patients’ rights do not appear to be similarly extended into the public sector. Not only is this inconsistent with Article 8 of the Constitution of Malaysia, some additional concerns may also arise in the context of Muslim patients. By way of example, in considering reproductive rights, Article 312 of the Malaysian Penal Code permits abortions ‘if the pregnancy poses a risk to the life of the pregnant woman’ (Tong et al 744). However, if the woman is Muslim, then Shari’a law may apply, in which case, access to abortions are more restrictive and dependent on the limited interpretation of fatwas in accordance with Muslim jurists (Husni et al 40), with a large body of Islamic jurisprudence deeming it a criminal offence under Shari’a law (Noor and others 47). There is, therefore, in reality, an incongruence in the application of patients’ rights in Malaysia.

(b)  Latin America: Brazil

53  Brazil’s inclusion into this entry presents a juxtaposed treatment of patients’ rights, which is worth examining. In addition, it is noteworthy to take into account the Latin American contribution to the universality of human rights discourse, which has now been declared ‘the forgotten crucible’ (Glendon 27). Brazil does not have specific legislation on patients’ rights, and individual liberties and freedoms are protected in the Constitution of the Federative Republic of Brazil: 5 October 1988 (as Amended to 2017) (Braz). Article 5 in particular states that all persons are equal and ‘ensured of inviolability of the right to life, to liberty, to equality, to security, and to property’. In Chapter II of the constitution, however, Article 196 proclaims that ‘health is a right of all … and shall be guaranteed by means of social and economic policies aimed at reducing the risk of illness’. Notably, these constitutional pronouncements have been iterated in Law 8.080/1990 (the Organic Law of Health) (1990) (Braz) and other legislation such as the Codigo de Etica Medica (Code of Medical Ethics) (2009) (Braz) (Behrens 256). These laws manifest the patients’ rights to informed consent and confidentiality.

54  The reality, however, is that Brazil’s health system is weak, and patients have difficulties in partaking the perceived social rights scheme put in place (Ghosh 68). Part of this has also been attributed to an ‘over-judicialization’ of health in the country (Ferraz 1651), leading to judicial interventions in health litigation by patients concerning access to medicines, surgical or diagnostic procedures beyond the public health sphere, or specialized medical procedures, equipment, or products (Biehl et al 37).

55  On the other end of the spectrum, despite the fact that these patients’ struggles are ongoing, a juxtaposed emerging ‘right’ that grew from the beauty industry would seem to suggest that in Brazil, patients’ rights may additionally include a ‘right’ to be beautiful (Edmonds 365). In the midst of its struggling health system, there are public hospitals in the country that are supported by federal or municipal budgets, offering plastica (plastic surgery) at no cost (Edmonds 364).

56  Following Brazil’s Ministry of Health Ordinance No 529/2013, concerning issues of patient safety, the Programa Nacional de Seguranca do Paciente (National Program on Patient Safety) put into place a system in hospitals to attempt to achieve a better quality of care for patients (Behrens 254). This is seen as the ‘gateway to ally the quest for quality with respect for the constitutional rights of the patient, still unknown and therefore, ill-treated in Brazil’ (Behrens 259).