Embryo research, cloning, assisted conception, neonatal care, saviour siblings, organ transplants, drug trials – modern developments have transformed the field of medicine almost beyond recognition in recent decades and the law struggles to keep up. In this highly acclaimed and very accessible book Margaret Brazier and Emma Cave provide an incisive survey of the legal situation in areas as diverse as fertility treatment, patient consent, assisted dying, malpractice and medical privacy. The sixth edition of this book has been fully revised and updated to cover the latest cases, from assisted dying to informed consent; legislative reform of the NHS, professional regulation and redress; European regulations on data protection and clinical trials; and legislation and policy reforms on organ donation, assisted conception and mental capacity. Essential reading for healthcare professionals, lecturers, medical and law students, this book is of relevance to all whose perusal of the daily news causes wonder, hope and consternation at the advances and limitations of medicine, patients and the law.
The Human Fertilisation and Embryology Act 1990 (as amended) and the Human Fertilisation and Embryology Authority regulate reproductive technologies. Neither has escaped criticism. Tough questions surround issues of access to treatment. The law has struggled with the meaning of ‘father’ and ‘mother’. The first ‘test tube’ IVF baby was born in 1978. Since then, reproductive technologies have advanced considerably. Many generate moral controversy. Pre-implantation genetic diagnosis (PGD) involves screening embryos to avoid implanting embryos with a defective gene. The technology has led to the creation of ‘saviour siblings’ where parents whose child is afflicted by a potentially fatal genetic disorder can seek to have another baby whose stem cells, taken from her umbilical cord, could ‘cure’ her brother or sister. Surrogacy remains a difficult issue, particularly around the question of payment.
In this chapter, we examine the law governing doctors’ relationships with child patients. The courts are often asked to determine the fate of ill children when doctors and parents disagree about how best to care for the child. One recent example involved parents removing their five year old from hospital to seek treatment abroad. In another recent case a mother disappeared for days when the court ruled her son should receive aggressive treatment for his cancer. Very poorly babies born at the threshold of viability sometimes raise questions about the withholding or withdrawing of treatment. Older children can give consent if they are judged to have sufficient understanding to be considered ‘Gillick competent’, but they cannot necessarily refuse treatment that others consider to be in their best interests.
In the 2015 Supreme Court decision, Montgomery v Lanarkshire Health Board, Lady Hale said: ‘Gone are the days when it was thought that, on becoming pregnant, a woman lost, not only her capacity, but also her right to act as a genuinely autonomous human being.’ This chapter charts the development of reproductive autonomy and the legal response. We start by looking at patient rights to contraception before examining cases of therapeutic and non-therapeutic sterilisation. We consider the legal response to injury sustained before birth, the Congenital Disabilities (Civil Liability) Act 1976 and consider the validity of claims for wrongful birth and life. Moving on to birth, we ask how far the woman retains control of her labour.
The Thalidomide tragedy was one of a series of disasters that well illustrates the dangerous nature of drugs. The Consumer Protection Act 1987 imposed on all producers of goods strict liability for unsafe products. But claiming under the Act is far from straightforward. Alternatives, such as negligence, offer little by way of advantage. We illustrate the difficulties through a range of case examples including vaccines and contaminated blood.
This chapter focuses on the regulation of Healthcare Research. If medicine is to progress to combat cancer and continue the battle against diseases such as diabetes and multiple sclerosis, new drugs and procedures must be subject to trials. But patients must not be used as a means to an end. We consider the role of Research Ethics Committees in balancing the risks and burdens of research and set out the law relating to consent, children, those lacking capacity and emergency research. Compensation is considered and we consider the legal response to research misconduct.
This chapter considers the legal and moral status of the human embryo and foetus. It is an area that continues to attract controversy. Consensus is impossible to attain. We consider the terms of the Abortion Act 1967 and proposals for reform and examine the status of the embryo in embryo research. We also analyse the response of the European Court of Human Rights in Vo v France and A, B and C v Ireland and its impact on domestic law.
The patient wishing to claim clinical negligence faces a number of problems. How can a lawsuit be funded? Which health professional caused the injury? As a result of the Legal Aid, Sentencing and Punishment of Offenders Act 2012 (LASPO), legal aid has been withdrawn for most clinical negligence claims. A radically reformed system for conditional fee agreements (CFAs) became the primary source of funding for clinical negligence claims. But the NHS Litigation Authority (NHSLA) reports high levels of claims that the NHS struggles to bear. Resources are limited and money spent defending claims is money that cannot be spent on healthcare. Are we in the midst of a compensation culture? Are doctors becoming increasingly defensive? The civil litigation system struggles to balance justice to patients and affordability to the NHS.
Whilst death cannot be evaded, the precise moment of its onset is subject to debate. Biologically, death is a process and not an event. Historically, the key factors in the process used to determine whether death had occurred were the cessation of breathing and the cessation of heartbeat. Medical advances show this to be problematic. Consider elective cardiac arrest during open-heart surgery, for example, or cases of spontaneous cardiac arrest followed by successful resuscitation. The heart stops but the patient is not dead. Official endorsement of ‘brain stem death’ in the UK is now to be found in a comprehensive Code of Practice issued by the Academy of Medical Royal Colleges. The legal implications are examined in full.
Robert Francis QC’s Report of the Mid Staffordshire NHS Trust Public Inquiry 2013 (the Francis Report) criticised the Trust’s poor reaction to persistently appalling standards of care. Despite numerous reforms, the NHS complaints procedure has come under fire for many years. This chapter examines the history, reforms and future of the NHS complaints process within a wider system of patient redress. It analyses the two stage complaints process- local resolution and appeal to the Health Service Commissioner, better known as the NHS Ombudsman; examines the role of apologies; and considers the viability of an alternative to tort: no-fault compensation.