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This chapter determines the defining features of the relationships between EU law and new health technologies. It begins by mapping out the key elements of EU regulation of new health technologies. The map covers the regulatory environment from the initial basic research up until the point at which a new health technology reaches the market and/or a patient receives treatment under a health care system. It then presents the results of the analysis of the contents of the map, with respect to the central research questions — what are the roles of risk, ethics, rights, and markets as framing devices for the EU's regulation of new health technologies? The chapter shows that markets are key to the EU approach to the regulation of new health technologies. Risk — in the sense of patient or consumer safety — is a very strong element of the frame, but in general it is not a ‘stand alone’ element of the frame — virtually all the elements of EU regulation of new health technologies that frame through risk do so with the importance of markets underlying that frame, and risk as a frame supports the market. Rights and ethics map back to markets in much the same way that risk does, and they do operate more as legitimating devices or even as ‘false fronts’ — but their role is greater than originally envisaged.

This chapter reflects on the relationships between European law and new health technologies. In so doing, it asks a further question: To what extent does the current investigation define a new field of scholarship — European law of new health technologies? It begins by reflecting on the core concepts: first, ‘new health technologies’ and thereafter ‘European law’. It then turns to the defining features of European law approaches to new health technologies, and considers whether there is a European law of new health technologies. It suggests that if there is a European law of new health technologies, it is typified by a certain ‘European-ness’ in terms of four features: markets, risk, human rights, and ethics. Each of these is discussed in turn. The chapter concludes with suggested directions for future research.

This chapter first sets out the book's principal objective, which is to analyzes European law and its relationships with new health technologies. The collective research agenda focuses on the following inter-related questions: What — if any — are the defining features of European law approaches to new health technologies? What is the significance of European law to such technologies? To what extent, and if so, how is European law on new health technologies legitimated? In particular, what are — and what should be — the roles of markets, risk, human rights, and ethics in European law approaches to new health technologies? An overview of the five parts of the book is also presented.

This chapter emphasizes two aspects for discussions of health technologies: their contribution to the improvement of personal and public health and their growing importance in the cost determination of all public health systems. It argues that the development of European legislation should guarantee the safety and efficacy of these health technologies as well as facilitate innovation and rapid access to the market for their use as a health resource. There is also a need to establish mechanisms that permit access to both clinical assessments that identify a benefit-risk ratio and the evaluation of incremental cost effectiveness, so as to understand the impact on health and the economy at the time of their authorisation.

This chapter examines the ways in which, in an era of costly, high-tech biomedical apparatuses and treatments, a simple book has acted — and continues to act — as an innovative health technology: the Diagnostic and Statistical Manual of Mental Disorders (DSM). Popularly known as ‘the bible’ of psychiatry, the DSM is the official list of psychopathologies recognized by the American Psychiatric Association (APA). The chapter first discusses the social dimensions of innovative health technologies broadly, before detailing the development and reception of the seminal third edition of the DSM — the DSM-III — which was released by the APA in 1980. In focussing on a less obviously sensational technology, it highlights the social, legal, and ethical issues that might otherwise go unnoticed by lawyers and other regulators. In so doing, it implicitly seeks to recontextualize innovation, and indeed regulation more broadly.

The chapter argues that, more than playing catch up with and being determined by technoscientific innovation, law also plays a leading role in the regulation of new technologies by shaping and directing the conditions of possibility for their development and market availability. The chapter charts some of the main ways in which EU internal market law retains its regulatory capacity and efficacy through techniques of negative and positive integration. These techniques centralize the harms or hazards relating to product safety as ‘the’ risks posed by new technologies. Designing regulation and limiting ‘risk’ (through it) marginalizes and obscures other kinds of harms or hazards to which it might pertain. The current regulatory design also depoliticizes, naturalizes, and quells contestation around the approach taken and obscures other potential framings of regulation, such as by human rights and bioethics.

This chapter considers the effects of the ‘medical’ and ‘morality’ exclusions in patent law on new health technologies. It begins by outlining the legal framework for patents in Europe and describing the main relevant instruments and institutions (the TRIPS Agreement; the European Patent Organization and European Patent Convention; and EU law). It then explains the rules concerning the two important exclusions in European patent law with respect to new health technologies: the morality and medical exclusions. Finally, it considers the implications of these rules for the development of new health technologies in four fields: stem cell therapy; gene-based diagnostics and therapy; nanomedicine; and human performance enhancement.

This chapter examines the EU's regulation of therapeutic nanoproducts. The first section discusses the potential benefits and risks of therapeutic nanoproducts. The second section explores regulatory problems that are induced by the challenges of nanotherapeutic development. The third section deals with governance activities that have been employed in the EU to control therapeutic nanoproducts. The fourth section analyzes the governance approach that has emerged to guide therapeutic nanoproducts. The analysis of governance responses to regulatory problems of therapeutic nanoproducts leads to the following tentative lessons: uncertain risks and benefits call for a preparatory and collaborative mode of regulation; effective preparation of regulatory adaptation requires ongoing extension and integration of regulatory networks; prudent regulators focus primarily on a case-by-case approach using the benefit-risk balance principle; and adaptation of regulation should be embedded in changes of the research, policy, and industrial environment.

An ‘orphan drug’ technology may be defined as one which is developed for treating a rare medical condition. This chapter analyzes how the policy problem presented by orphan drug technologies has been addressed by EU law. The EU legal framework is designed to ensure that new health technologies to treat rare diseases are made more widely available. However, a major obstacle remains for those who wish to obtain these technologies. EU law does not guarantee that a particular individual or physician will gain access such a treatment, because a Member State (MS) may choose to deny or restrict provision within its own national health system. The high cost of such technologies (or at least, a perception of their high cost) is the most important, albeit not the sole, factor explaining the existence of such limitations. This in turn raises difficult questions as to the extent to which obligations of a normative type might compel an MS to permit access, given that only finite resources are available to fund a health system. It is argued that certain steps might be taken, both at the EU and MS level, to minimize the obstacles to access, but that ultimately elicitation of citizen preferences will be crucial to legitimation of the highly challenging ethical choices which inevitably shape policy on provision of treatment for rare diseases.

This chapter examines the role and interpretation of ‘newness’ in EU regulatory and policy debates. It begins by looking at the debate on nanotechnologies. It shows that while the contours of ‘newness’ may be ill-defined and elastic, they are nonetheless considered to be important determinants of regulatory responses. It explores the regulatory environment in which a new technology finds itself, and then examines the different contexts in which debates about newness come to the surface. It returns to the findings that, even though newness is made up of innumerable shades of grey, there is a tendency in the EU policy debate to focus almost exclusively on expert calculations of risk. The chapter argues that under the current approach to nanotechnologies, the propensity of regulators to default to existing regulations in managing new technologies stems from certain assumptions about the content, nature, and workings of those regulatory provisions. Since those assumptions develop from long-standing regulatory frameworks and make up part of a deep-seated ‘regulatory heritage’, they are too often accepted without full and appropriate scrutiny.

This chapter examines the impact of new health technologies on EU product liability law, with particular reference to risks, markets, and rights. It reveals a lack of uniformity at the Member State level in relation to victims' rights to claim compensation as a result of suffering harm through the use of certain products that are regulated under specific product liability regimes, such as pharmaceuticals and human tissue products. Notwithstanding such lack of uniformity, however, it is shown that the market for new health technologies has not been affected. In addition, reference is made to how risk has been interpreted in the context of the relationship between product safety and product liability legislation.

This chapter explores the relationship between risk and legitimacy in the context of the EU regulation of health technologies. It focuses on EU-wide risk regulation regimes that have been established in relation to organs and blood, pursuant to Article 168(4)(a) TFEU. It argues that effective risk governance of health technologies, such as blood and organs, involves moving beyond narrowly defined standard setting for quality and safety, towards a broader approach that views risk as a socio-cultural construct shaped by public perception and a range of ethico-social concerns. If risk regulation involving health technologies is to operate as an effective technique of legitimation at the EU level, then this should be assessed based on the following criteria: how risk is defined in the regulatory regime and its match with risk- and ethics-based concerns of relevant constituencies; whether the stated aims and objectives of the regulatory regime have been met following implementation; and what opportunities are available for facilitating transparency and evaluation about the functioning of the regime.

Science and technology studies (STS) is a relatively young academic field that has developed from the 1970s onwards. Today it encompasses a range of scholarly perspectives and, as a result, a range of methods and organizing ideas — including both Sheila Jasanoff's empirical comparative work around concepts such as co-production, sociotechnical imaginaries, and bioconstitutionalism, and Bruno Latour's actor-network theory. This chapter analyzes STS as a human rights method. It takes two new-health-technology cases from the European Court of Human Rights, and sets about reading them in two different ways — in one particular law way, and in the style of STS. It argues that reading cases with STS was surprisingly enabling. Critics argue that human rights lawyers spend too much time on rights as law, that they have cabined rights in a ‘juridical cage’. Other critics argue that both lawyer and non-lawyer alike spend too much time on rights; that even those who oppose rights engage in rights talk by seeking to draw boundaries between what is and what is not a legally-protected right. Reading the two cases with STS brings a fresh perspective to rights-as-law talk along with freedom from the standard-fare of law and limits.

Advances in tissue engineering techniques have resulted in the potential for groundbreaking new health technologies for human use. A particularly promising field of tissue engineering is that of substantially altering human donor heart valves to increase the transplant's lifetime and recipient tolerance. Early reports indicate that the decellularized homograft valve (DHV) offers a number of advantages over conventional treatments. This chapter outlines the EU's initial regulatory impetus in the context of the DHV. It considers implementations of relevant EU instruments into domestic law in order to examine the degree of current disparity. It argues that while the primary aim of EU instruments is ensuring safety and quality, regulating for these common standards across the Union is also a facet of facilitating the common market. A side effect in this case seems to be a high level of health protection (potentially by removing the DHV from the market altogether) but a low degree of congruence in marketing authorization terms, which opens up the possibility of actors gravitating towards the jurisdiction with the most permissive regulatory set in the EU. This counteracts attempts at establishing a level playing field within the Union and impacts negatively the mobility of the services or the products (simply put, just because a DHV might be available in one Member State does not mean that it can simply also be made available in another without restriction).

This chapter discusses the development of a normative framework for European governance of biomedicine, and the institutionalization of a human rights approach. It begins with a brief description of how bioethics has been used within the EU institutions. It suggests that bioethics has not become deeply embedded in policy-making, and that there is not (or at any rate not yet) an emergent ‘European bioethics’. The discussion then turns to the debates over the relationship between human rights and bioethics, which arose in the context of the development and proclamation of UNESCO's Universal Declaration on Bioethics and Human Rights 2005 (UDBHR). The UDBHR provides a useful case study for thinking about the limits of bioethics — and human rights — which may be instructive in the developing European context.

This chapter analyzes the regulation of xenotechnologies in Europe, focusing on the implications of this process for humans and other animals. It argues that, although processes of purification and effacement can be discerned in the work undertaken by the Council of Europe, xenotechnologies emerge as vastly more ‘hybrid’ here than they do within the EU's medicinal products legislation. In the regulatory work conducted by the Council of Europe, humans and animals are recognized as entities with entwined interests that are placed at mutual risk through the hybrid corporeality facilitated by xenotechnological innovation. Although a degree of purification does take place, resulting in the Council's positioning of humans and animals as separate entities with unequal claims to the protection of the law, the implications of xenotechnologies for animal bodies and lives are fully acknowledged.

Assisted reproduction technology (ART) is a term referring to any technique or medical intervention that enables individuals to procreate, where such procreation would be unlikely to occur otherwise. The UK has some of the most liberal ART regulations in Europe, but increasing numbers of patients seek treatment using donor gametes across the borders of European Union. The main reason that drives UK patients abroad is the donor shortage. This chapter begins with a brief background to the donor conception regulations in the UK. It then presents the views of the UK patients who received fertility treatment abroad using donated gametes or embryos. It concludes that current UK policy seems to undermine the sustainability of gamete donation while failing to promote communication within families. The UK needs to work towards an inclusive, fully informed debate on balancing the right to know one's genetic identity against a range of other rights and interests.

This chapter by the former deputy chair of the UK's Human Fertilisation and Embryology Authority (HFEA), provides a brief personal overview of some of the challenges faced by the HFEA in recent years. One of the most obvious difficulties, from the regulator's point of view, is that science moves quickly, whereas amending primary legislation is a laborious process, which happens relatively infrequently. In the UK, the Human Fertilisation and Embryology Act 1990 has been amended by Parliament twice since it came into force over thirty years ago. While it has stood the test of time remarkably well, there have been occasions when, first, its wording has led to a lack of clarity over whether a new technique fits within the statutory scheme, and, secondly, when what it means to say that the use of embryos is ‘necessary’ has had to be reevaluated in the light of scientific developments.