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Edited by Thierry Vansweevelt and Nicola Glover-Thomas

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Thierry Vansweevelt and Nicola Glover-Thomas

This introductory chapter highlights the changing landscape in relation to the question of informed consent and the consequential impact of this on the legal frameworks in place in many parts of the world. Informational disclosure and informed consent are the focus of book one of the book series. This is a key foundational concept in health law and for many countries acts as the initial gateway to medical intervention. At the heart of contemporary medical ethics is the notion of self-determination and choice. How the concept of information disclosure and informed consent is understood and executed in different parts of the world varies widely; yet the concept of informed concept maintains some common characteristics that are shared and recognized around the world. The importance of informed consent is growing, both nationally and internationally – particularly as more patients become aware of their rights and seek to reinforce them. The countries in this book have been chosen to provide an insight across continents, representing a mix of jurisdictions: Australia, Canada (except Quebec), the United Kingdom, the United States, Belgium, France, China, the Nordic countries, South Africa, Germany and Russia.

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Ian Freckelton QC

In Australia, medical treatment cannot be provided without consent except in a number of narrow circumstances. However, Australian law has wrestled since the 1980s with what communications must take place to enable a patient’s consent to be sufficiently assisted by information; what conditions sufficiently impair capacity; and what the consequences should be when inadequate or misleading information is given to a patient. While Australia’s common law does not have a doctrine of ‘informed consent’, substantively and in popular legal parlance, the concept is alive and well. Consideration is given to the departure from the ‘Bolam test’ taken by the Australian appellate courts since the 1980s, and the likely direction of Australian jurisprudence and clinical practice. Scrutiny is also given to the definitions of ‘informed consent’ and ‘material risk’, and the status of informed consent is reviewed in mental health legislation, guardianship law and end-of-life decision making. While the direction of travel since the early 1990s has been a move away from health practitioner paternalism towards better-informed collaborative decision making by patients with assistance from their health practitioners, concerns remain that informed consent processes are too often formalistic, with patients being routinely ‘consented’. In Australia, as elsewhere, the challenge remains to operationalize the formal legal obligations in relation to the provision of information likely to be important to patients so that they are authentically at the centre of decision making about their own health.

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Miriam Pinkesz, Gabriel Marrocco, Yann Joly and Ma’n H. Zawati

Canadian medical law orbits in a constellation of diverse legal influences spanning the course of the country’s legislative historical development. The provision of healthcare in Canada is characteristically decentralized, with 13 individual models of provincial and territorial healthcare policies that share overarching standards defined by federal statute. This chapter examines the laws of consent to medical treatment in Canada as well as related physician obligations, such as duties of disclosure and associated exceptions, medical liability and emerging challenges to informed consent. In this chapter, we present a comparative overview of the dominant legal scheme in both the common and civil law in Canada, approaching such review through the lens of developments in informatics as well as medical research and clinical practice. Our objective is to underscore how the laws of informed consent are shaped by the dynamic and ever-expanding medical field, and how this requires constant scrutiny guided by legal deference to scientific, medical, ethical, and administrative experts on technical matters.

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Nicola Glover-Thomas

This chapter considers the current legal position of informed consent in the UK. Recognizing and protecting the rights of individuals to be self-determining has now garnered support in all aspects of healthcare provision and its regulation. While medical paternalism has lost ground, the support of individual autonomy and the informed consent mandate may be tempered by external factors in practice, such as resource allocation, questions over mental capacity, age or a patient’s desire to have knowledge (or not) about his or her medical status. At the micro level, there is greater judicial willingness to adopt a broader interpretation of capacity in a number of areas; while at a macro level, the UK’s ratification of the Convention on the Rights of Persons with Disabilities has presented the potential to further change the legal landscape around mental incapacity, which could directly impact on informed consent. Since the Supreme Court’s landmark decision in Montgomery v Lanarkshire Health Board [2015], clinicians also face a heightened level of information disclosure required of them. With patients now having a right to be fully apprised of all material risks relating to all treatment options, and the level of information sharing now being a decision for patients rather than clinicians, all healthcare workers face a much more stringent disclosure threshold.

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Robin Fretwell Wilson

This chapter breaks down the genesis, standards, critiques and questions of ‘informed consent’ in both medical and research contexts in the United States. The notion that patients may direct their care is complex, moulded by legal tests that sometimes frustrate private enforcement through litigation. Often, patients do little more than sign a paper consent form, never having the face-to-face conversation that the form should memorialize. Complicating the possibility of reform, not all patients are alike. Some patients want to be the decision maker; others a passive participant; others still a trusted partner in making medical decisions together with their physician.

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Thierry Vansweevelt

This chapter deals with the law on informed consent in Belgium and France, which share a common origin – the Napoleonic Code – but still have different interpretations. The similarities between the two are obvious: both countries require informed consent, which is in principle oral consent. However, for some specific medical interventions, and to protect patients and avoid impulsive decisions, the law requires the patient’s written consent and a specific waiting period. For minors, no legal age is stipulated: minors can exercise their right to informed consent when they are capable of a reasonable evaluation of their interests, taking into account their age and maturity. But the law in both countries differs on certain points. The French Court of Cassation has chosen a more patient-friendly interpretation – the physician must prove that he or she received the patient’s informed consent; whereas in Belgium, it is the patient who must prove the physician’s negligence. Another difference is that in Belgium, the patient must prove the causal connection between negligence and damage; while in France, the mere violation of the informed consent rule causes a new kind of damage.

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Vera Lúcia Raposo

China is still in the process of developing a coherent framework of health law, but some norms on informed consent are already in place. The most relevant difference when compared with Western regimes is the fact that in China, relatives are granted the same right to decide as patients and sometimes even play a dominant role. Chinese Confucianism and the relevance it places on the family over the individual largely explain this. Moreover, increasing difficulties in financing healthcare and deteriorating doctor-patient relationships have further empowered the family in healthcare decision making. However, the principle of ‘one country, two systems’ has led to the emergence of curious legal models in Greater China. For example, the Special Administrative Region of Macao follows a predominantly Western legal model, which recognizes the patient’s right to self-determination in the field of healthcare delivery, making it a crime to medically intervene without the patient’s informed consent.

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Mette Hartlev

The Nordic countries are known as welfare states and as strong promoters of human rights. This is reflected in the protection of patients’ rights in separate legislative acts or chapters in all Nordic countries. The right to self-determination has a prominent position, but the character and justiciability of patients’ rights vary from country to country. For example, there are differences in the legal schemes for children and vulnerable adults, and also as regards coercive somatic treatment and self-determination in reproductive issues. Patients’ right to self-determination must be balanced against the interests of other persons, such as genetic relations. As welfare states, the Nordic countries also strive to achieve a balance between individual rights and the collective interests of society. This balance has become increasingly important in the era of personalized medicine, when new ways of reconciling individual autonomy and solidarity may be needed.

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Sylvester C. Chima

The right to informed consent is constitutionally protected in South Africa through the rights to bodily integrity and freedom and security of the person, as enshrined in Sections 10 and 12 of the Constitution of South Africa, 1996. The requirements for informed consent in practice were later codified in the National Health Act 2003, which stipulates that all healthcare professionals must obtain informed consent from healthcare users prior to involvement in treatment or research. Nevertheless, recent studies have indicated that there are some barriers to implementation of informed consent in clinical practice. These include language, time and workload constraints on healthcare workers, as well as poor education, poverty and other cross-cultural issues prevalent among African populations. This chapter analyses the constitutional, legal and ethical requirements for informed consent in South Africa, and examines relevant case law and other cross-cultural factors impacting on the practice of informed consent in South Africa.