The rapidly evolving biosciences increasingly rely on the analysis, manipulation and reproduction of the human body. In the health setting, novel biotechnologies offer new methods/avenues for the investigation of wellbeing and the treatment of illness, but they do not just expand the clinician’s toolbox, they increase the very scope of her work. By offering new (and formerly invisible) measures for health, they have created new categories of illhealth (ie: expanding the ways in which humans can be classified as abnormal, unhealthy, or diseased). In doing so, they contain huge marginalising potential. And they are evolving at a pace that the law cannot match. Given this, important questions arise such as: What institutions are acting in this field and what is guiding them? How is health-related research being encouraged and regulated? How does the human subject figure in the bioeconomy? What values are we claiming and vindicating under existing regulatory regimes? What values ought we be emphasising bearing in mind social needs and individual rights? The body of work that forms this submission represents five years of socio-legal research and evolving thought on the topic of how values inform the law and are operationalised through the law and legal institutions. While the publications relied on are diverse, they all pursue small facets of this value inquiry. The first theme addressed – international values and actors – is composed of three papers which explore broad internationally shared values claimed in legal instruments such as the Universal Declaration on the Human Genome and Human Rights and the Universal Declaration on Bioethics and Human Rights, and institutions such as UNESCO and the EPO. A range of values emerge from these. Papers under the second theme – human participation in health research – explore how we access and use the human body in the modern biosociety/bioeconomy, and how we might better encourage subject participation in, and equitable benefit from, the biomedical research setting. Focusing on population biobanking, it assesses who has rights in the body and what those rights are, and how the existing environment interacts with our claimed values. Papers under the third theme – encouraging stem cell research in Argentina – explore governance instruments and their significance for realising claimed or desired values. These papers are informed by original empirical work conducted in Argentina over a 24-month period during which the Argentine government grappled with the realities of the new biosociety and the (perceived) need to facilitate bioscience research and medical treatment using human tissue. While these papers represent only part of the scholarship deriving from this project, they deploy new evidence on the existing environment and the way forward in that jurisdiction. As argued in the Critical Review, these publications form a broadly coherent and farranging body of interdisciplinary work which persistently questions the link between law and values and how we govern modern bioscience. While there are necessarily descriptive elements, the whole is critically analytical and normatively suggestive. In addition to summarising the aims, objectives, methodology, results and conclusions of these works, and indicating how they form a coherent body of work, the Critical Review goes further. Drawing on evolving thinking and recent scholarship, it argues for a regime less reliant on instruments and more reliant on expert institutions informed by, and charged with protecting, socio-moral values informed by the human rights paradigm.

The aim of this study was to evaluate seven GCC regulatory authorities and pharmaceutical companies active in the region in order to identify the strengths and weakness of the current GCC centralised procedure. The GCC regulatory authorities and the pharmaceutical companies who had registered their products through the GCC centralized registration procedure and the national registration systems were recruited into the study and asked to complete the questionnaires specifically designed for this study. The regulatory review process in Oman was evaluated to identify areas for improvement in the system. Information on the total application numbers and approval dates were obtained directly from the Oman Ministry of Health archives. Another study was conducted to evaluate the regulatory review process and approval times of the remaining six GCC countries (Bahrain, Kuwait, Qatar, Saudi Arabia, UAE and Yemen) and the GCC central registration, with respect to review time for new and existing substances, to identify the strengths and weaknesses of the process and to propose strategies that could help the policy maker in the GCC to enhance the review process. The results of the Omani regulatory system showed no significant increase (p>0.05) in the total number of registered pharmaceutical products from 2006 to 2010. The approval time in Oman showed that there was a significant increase in approval times for pharmaceutical products from 2006 to 2010 (p<0.001). The findings show that although there was an increase in the approval time for all pharmaceutical company products, the median approval time for the five year period was 117 days. This was within the time limit (4 months) fixed by the health authority for the overall registration time. The comparative study of the GCC States showed a downward trend in the median approval time for most of the GCC States, during 2008 to 2010. However, the approval time for all approved products in the GCC States during this period varied from 60 days in Qatar and Oman (2009 and 2010) to 609 days in Saudi Arabia (2008). The main reasons for the decrease in approval time in the Gulf States were due to the positive effect of the Gulf Central Registration, the rise in the number of reviewers in some GCC drug authorities, and the parallel procedure used in the regulatory approval review process. The study of the regulatory review process of the GCC central registration showed that a total of 413 products (96 NASs and 317 EASs) were approved during the period 2006-2010 with an overall significant increase in the EASs (p<0.001). The approval times increased from 107 calendar days in 2006 to 265 in 2010 (p<0.001). The lowest approval time was for EASs submitted by the Gulf companies (134 days) and the longest for NASs submitted by international companies (346 days) (p<0.001). VI Both the regulatory authorities and the pharmaceutical companies agreed that the centralised procedure is an effective system for authorising medicinal products in all seven GCC countries in one procedure and is the way forward in the future but there is room for improvement in the procedure and the follow ups. They also agreed that clear guidelines, transparency of procedures, effective interactions between authorities and companies, increase in the number of the committee meetings per year, use of electronic on-line submissions will improve approval time for registration of new medicines, enhance the quality of review practice and encourage the pharmaceutical companies to use the GCC central registration system. This research has enabled development of a new model of the GCC central registration procedure to be proposed for the GCC Health Authorities which could improve patient access to medicines in the GCC states.

This thesis seeks to contribute to the debate about the role of the criminal law in holding health professionals and health institutions to account for malpractice. The research attempts a critical comparison of the role of the criminal law and the criminal process in healthcare malpractice in France, a civil law jurisdiction, and England, a common law jurisdiction. In France, the criminal process is more readily invoked to address failings and malpractice in healthcare. The aim of this research is to see how the comparison of the two jurisdictions sheds light on the now much debated question of how the criminal process should relate to healthcare malpractice. The purpose of the comparative examination of law and process is twofold: (1) to highlight what might be seen as failings within each legal system and identify lessons that might be learned from each other and (2) to locate these differences in an analysis of how (if at all) the criminal process can best engage with healthcare malpractice. The much publicised HIV-contaminated blood episode in France and England is studied as an illustration of a case of systemic healthcare failure and the use of the criminal process in France. It is used to illustrate and explore more fully the questions above and shed light on the overall aim of the thesis, which is to assess what the role of the criminal law should be in the context of healthcare malpractice. The research reveals that particular features of the general substantive criminal law and criminal process go a long way toward explaining differences in the criminalisation of healthcare malpractice as between France and England. The criminalisation of ‘simple’ direct negligence which may result in death or injury in France provides the possibility to criminalise healthcare malpractice more readily than in England, where only gross negligence resulting in death is generally criminalised in the healthcare malpractice context. Features of the French inquisitorial criminal process (notably juges d’instruction and parties civiles) play a central role in providing a greater platform for the criminalisation of healthcare malpractice in France, whereas features of the English adversarial system (in particular the role of the Crown Prosecution Service and the jury) tend to minimise the possibility for a wider criminalisation of healthcare malpractice in England. However, I do not argue that England should follow France in adopting more extensive use of the criminal process in the context of healthcare malpractice. Key lessons drawn from the present study are that the criminal process is not usually an appropriate means to respond to many instances of healthcare malpractice. This is not to say that the criminal process has no role to play where the conduct of the professional has shown no regard for the safety of patients. Features of French criminal law and criminal procedure might be useful to counteract healthcare malpractice using alternative non-criminal proceedings. For instance, it will be argued that the model of thorough investigations conducted by juges d’instruction in the French criminal process could be better achieved outside the criminal law to provide transparency in the healthcare context. The study will point out the limitations of the criminal process in preserving health and safety and will thus highlight the importance of alternatives to the criminal process such as prevention in the healthcare setting and support to victims of healthcare malpractice.

The Mental Capacity Act (2005) (MCA) is part of the legislative framework of the NHS. Small scale studies in a range of health settings have shown that the understanding and use of the MCA (2005) varies considerably in different services and across staff of differing occupations and grades. The experiences of individual staff in using the MCA has received little attention. This grounded theory study aimed to explain how staff working with people with a learning disability (PWLD) make sense of and use the MCA, whilst also exploring the factors that influence applying the MCA in clinical practice. This study involved 11 healthcare staff from a specialist learning disability service that had used the MCA in the six months prior to their participation in the research. Staff interviews provided narratives about how they had used the MCA. A theoretical framework was developed from the analysis which underpinned three core conceptual categories. The first core category was that of ‘professional risk’ in which staff have awareness of a series of risks that pertain to themselves or the service user that could have negative professional or legal consequences. The second core category described ‘emotional risk’, which affected both the staff and service user. Staff appeared to experience those risks as feelings in the form of anxiety or concern. Both ‘professional risk’ and ‘emotional risk’ bring about ‘strategies’ which mediate the risk; allowing staff to justify and document their position, creating what feels like safe practice for both the staff and service user. Factors which facilitate the use of the Act are concerned not only with these risks but the significance of the decision that the service user has to make. The findings suggest that there is much uncertainty in the process of using the Act, some of which is due to the subjective nature of evidence gathering. The study suggests that peer support offers a range of factors important to education and development of experience in using the Act, along with helping staff cope with the outcome of decision making. The findings have clinical implications for those involved in managing difficult assessments and decision making, including how to gain an appropriate balance between risk and human rights against a backdrop of adversity that can be present for people with a learning disability. Further implications clinically and for future research, along with limitations of the study are also discussed.

Geographers have investigated agri-foods, commodity chains, 'alternative' food networks, 'local' production, and multicultural cuisine. However, the relationship between food, place, boundaries, environmental determinism, and authenticity remains under-researched. This thesis seeks to redress this deficiency with a detailed study of the construction of the Protected Food Names (PFN) scheme in the UK. PFNs are a type of Intellectual Property (IP) and form the European component of the international Geographical Indications (GI) system. These place-based foods and drinks originate from defined and bounded areas and are produced in supposedly traditional ways. Their manufacturers consider them unreplicable outside the protected zone. This qualitative investigation of three PFNs – Melton Mowbray Pork Pies, Stilton Cheese, and Grimsby Traditional Smoked Fish – critiques the ways in which ideas of place, boundaries, and authenticity are invoked by producers. The thesis interrogates how manufacturers understand place and its boundedness, employ supposedly 'objective' historical evidence, and apply the ambiguous notion of authenticity to stabilise and sustain local practices. The study also examines the strategies deployed to generate consumer interest in an era where uniqueness is an important marker of value. This work thus introduces a different conceptual angle to accounts of the PFN structure which primarily privilege legal or economistic assessments. It aims instead to deconstruct the geographical concepts on which the PFN edifice is based. The ultimate aim is to draw attention to the vagaries inherent in the increasingly hegemonic GI model. This research connects with geographical debates about the construction of place and boundaries, the social production of authenticity, the role of selective historical 'facts' in the development of narratives about place, and the 'selling' of location and its products. It therefore provides a lens through which the foundations and everyday operation of the GI system can be profitably analysed.

This thesis examines the development of medical liability in Germany during its intense formative period from 1800-1945. The focus is on how the fault requirement in civil law was conceptualised and applied to liability for errors in the diagnosis and treatment of a patient. By focusing on the development of the law, and how it related and responded to changes in the nature of medicine, medical practitioners and healthcare over this period, this thesis uncovers a rich interaction between the legal and medical narratives of fault. In doing so, it offers an account of legal development where the law and lawyers were deeply embedded in, and influenced by, that broader social context. It identifies a gradual shift towards asserting courts’ independence from the medical narrative alongside greater willingness to question accepted practice, particularly in light of medical advances. The thesis says nothing directly about the closely related topic of liability for failure to secure the patient’s consent. We begin by mapping medicine and medical practice during this period. We then consider the evolution of ‘internal’ regulatory mechanisms and conceptions of error, in particular discussion over how to define a ‘Kunstfehler’ during the nineteenth century. We then unpack how the legal relationship between practitioner and patient was framed in nineteenth century Germany in criminal law, contract law and the law of delict before analysing the attendant standards of care and their application. Finally, we examine the changes wrought by the Bürgerliches Gesetzbuch and the growth of medical liability and technology in the first half of the twentieth century. The thesis offers a heavily contextualised study of legal development in a core area of private law and concludes that the pattern of development here was driven by acceptance of, and eventually reaction against, a concept of fault rooted in the medical discourse.

This thesis sets out to examine the place of patient choice in English health care, primarily within the National Health Service and in relationship to English law with regard to (a) informed consents and information and risk disclosure, and (b) confidentiality and privacy in relation to the access to and management of patient information. The analysis in underpinned with a limited review of the associations between choice and respect for individual autonomy. Health policy rhetoric has been laden with references to pro-patient choice in recent years and yet this research re-affirms that in law (still) it is the negative patient choice that carries weight in matters of consent to treatment. There is (still) no place for real demand. Similarly, in individual medical information access and management there is no sanction for demand, even negative patient choice is bounded. In both aspects of health care the ‘choices’ are (rightly) limited and can hardly constitute choice as the consumer-patient might see it. What the three papers contribute is the recognition that restrictions in patient choice are necessary; to be supported and for some individuals should be even more fettered than that of the general public in the interest of that general public. The papers examine the language of choice and find it lacking in transparency, with the reality dissociated from patient engagement, information dissemination and shared decision making; so compromising trust. If the health care system is to genuinely respect the individual autonomy of the capable adult and not utilise choice language as covert method of policy implementation, the language of what is on offer and why, the reasons for information acquisition and use and why, needs to be part of the patient-practitioner discussion as well as clarified in policy.

It has been suggested by some commentators that the ‘real’ damage (as opposed to that pleaded) in the cases of Rees v Darlington Memorial Hospital NHS Trust [2004] 1 AC 309 and Chester v Afshar [2005] 1 AC 134 was the claimant’s lost autonomy. Arguments have consequently been put forward that lost autonomy either already is or should be recognised as a new form of actionable damage in medical negligence cases. Given the value placed on respecting patient autonomy in medical law and bioethics, it might be thought that such a development should be welcomed. But if lost autonomy is accepted as a new form of damage in negligence, it will not be confined to the two scenarios that were present in those cases and it may be inconsistent with other established negligence principles. This thesis considers whether lost autonomy ought to be recognised as a new form of damage in negligence and concludes that it should not. A close textual analysis of Rees and Chester is undertaken in order to determine whether a ‘lost autonomy’ analysis actually provides the best explanation of those two cases. I then look at how the concepts of autonomy and harm should be understood to determine whether, ethically speaking, to interfere with someone’s autonomy is to cause them harm. The final part of the thesis considers important doctrinal tort law considerations that have been overlooked in the medical law literature. I argue that the nature of autonomy means that it cannot coherently be considered actionable damage within the tort of negligence and that recognising a duty of care to avoid interfering with people’s autonomy would be inconsistent with the restrictive approach the courts take to recovery for psychiatric injury and economic loss. My ultimate conclusion is that the benefits of allowing such claims do not outweigh the undermining of established principles that would ensue if lost autonomy were recognised as a form of actionable damage in negligence.

The 24-hour day/night cycle naturally helps to maintain balance and stability within a nocturnal ecosystem. While the rhythms of the natural light-dark cycle of day and night are able maintain a stable balance with ecological and human-made activities in relation to the nature of lighting and darkness, light pollution still significantly reduces average human well-being, impacts on the visibility of faint night sky objects during the night with the naked eye and telescope, and damages the night environment. It can be defined as “every form of artificial light in the wrong place at the wrong time which creates a sky glow, glare, nuisance, and other relevant causes of environmental degradation including some properties of artificial light which emit non-environmentally friendly or inappropriate light.” Light pollution can reduce human health, interfere with the nocturnal and/or dark-sky environment, reduce transportation safety and waste lighting energy consumption. Therefore, hard laws and soft laws from international and national jurisdictions established a duty on local authorities to manage outdoor lights and control all key elements of light pollution so as to ensure that people are not exposed to risks to the night environment. These also include environmental risks arising from a sky glow when measuring the non-environmentally atmospheric smog that hangs over urban areas at night where the level of exterior lighting from outdoor light sources is relatively high. However, English law does not contain stage processes and responsibilities for local authorities to deal with all aspects of outdoor light pollution. It also does not contain powers concerning the use of certain measurable degrees of non-environmentally friendly light metric, together with powers for the Government to approve a single framework for the minimisation of sky glow in public atmospheric areas at night. The main purpose of this study is to use comparative law studies to better understand the strengths and weaknesses of light pollution laws in different jurisdictions where adopted legislation has been designed to limit light pollution from outdoor light fixtures and design, and to improve national or local light pollution regulatory frameworks by providing better outdoor lighting practices through making valuable contributions to a comparison of international, European, national and local light pollution laws and to the improvement of regulatory measures in English legal system. It also proposes to do so by illustrating key differences between England and other jurisdictions and examining a set of necessary or proportional regulatory standards to combat light pollution. This research’s review of the jurisdictions and the legal systems available for both light pollution control and sustainable lighting practices has highlighted the recent evidence of such influence of hard and soft law on legislation in selected countries. When comparative law on different jurisdictions is discussed, the influence of a comparative approach in each national or municipal light pollution law is, at most, one of finding inspiration in the procedure of establishing a number of necessary steps to reforming the English law of light pollution control in favour of a better solution. Taking legal action to reduce the effects of non-environmentally friendly or unnecessary lights at night provides an excellent opportunity to deliver further benefits to both environmental lighting practices and energy efficiency. This research also highlights the key legal aspects concerning light pollution and outlines the ways in which regulators and policy makers can make the most of the interconnections between regulatory measures to address key elements of outdoor light pollution, such as sky glow, glare and intrusive light. It is intended to outline a wider vision for how English law can prevent all key elements of light pollution. This research also comparatively examines why England should be committed to ensuring that the English regulatory measures compare favourably with the global and regional light pollution control standards in the highest performing jurisdictions, and establishes stringent legal requirements for light pollution control which measure up to the highest standards set internationally. In the final Chapter we present useful recommendations which highlight instances in which England should be able to promote the application of necessary principles and stage processes through comparative effectiveness for outdoor lighting practices by applying international, regional and national criteria for different forms of outdoor lighting practices.

This thesis seeks to examine how healthcare decisions are made for children, with a particular focus on situations where medical interventions that (1) are not intended to advance the medical welfare of the individual child (eg bone marrow donation and research without therapeutic intent involving young children), or (2) are contrary to the expressed will of the child (e.g. the imposition of life-saving treatment on adolescents who have refused it), are authorised by parents or the state. The authorisation of these procedures is contentious because they breach the child’s bodily integrity while either (a) lacking a clear therapeutic purpose with regard to that child, or (b) being imposed even though refused by a possibly competent adolescent. Their controversial nature has lead to attempts to justify these procedures, generally by the application of ideal-type adult-child relationship theories. The four papers at the core of this thesis examine these legitimising propositions, but demonstrate that they are insufficiently robust to legitimise the acts in question. Instead, this thesis raises questions about inequality; about why it is deemed acceptable to take the tissue of the vulnerable incompetent but not the capable adult; or why it is appropriate to impose different tests of mental capacity on the adolescent and the adult, or of competence on the ‘criminal’ child and ‘innocent’ teenager. It is proposed that the reason that inequitable treatment can occur is because adults sit in a position of power and authority relative to children. The common themes in all four papers are thus the issues of power, inequality and fairness. There is also a focus on the use of language, and it is argued that terms are used in academic debate about children’s healthcare issues that lead to a lack of clarity and transparency in discussions about the imposition of unchosen healthcare burdens on vulnerable populations. If we hold that children are morally relevant beings deserving of respect then debates about matters that concern them should take place using language that avoids obfuscation and the cloaking of adult interests.