Special treatment? Flexibilities in the politics of regenerative medicine’s gatekeeping regimes in the UK

Emerging flexibilities are apparent in gatekeeping regimes applicable to regenerative medicine products, raising issues about the extent to which and forms in which such flexibilities might promote emerging products as a sector warranting special treatment, in the context of recent policy developments in the UK and wider European Union. Concepts of ‘gatekeeping’, ‘gatekeeping regimes’ and ‘gateways’ can point to the ways in which regulatory institutions, health technology assessment organisations, and national planners and purchasers of health services together define and control entry to the medical product marketplace and the adoption of products into the public healthcare system. Flexibilities in existing regimes and new gateways are a way of maintaining ‘connection’ between gatekeeping regimes and technoscientific innovation in order to steer innovation pathways. The gateways concept has affinity with that of Callon’s ‘obligatory passage points’. A wide set of recent policy documents show that the measures promoted exhibit a range of alternative gateways that are being constructed around central, legal, restrictive gatekeeping regimes. However, it would be easy to over-estimate the significance of these developments as relaxations that would favour innovative producers and their products on a large scale with wide public health impacts. The concepts of gatekeeping regimes and gateways enable understanding of hybrid developments of exceptions and exemptions to dominant regimes which bridge across the arenas of market regulation, health technology assessment and healthcare system planning. These arenas are being drawn closer together as a means of politically managing stakeholders’ aims in the UK, EU and other innovating biomedical health systems globally

Opening the gateways to market and adoption of regenerative medicine? The UK case in context

Regenerative medicine is a site for opposing forces of gatekeeping and innovation. This applies both to regulation of market entry and to clinical adoption. Key gateways include the EU’s Advanced Therapy Medicinal Products Regulation, technology assessment body NICE and commissioning/service contractor National Health Service England. The paper maps recent gatekeeping flexibilities, describing the range of gateways to market and healthcare adoption seen as alternatives to mainstream routes. The initiatives range from exemptions in pharmaceutical and ATMP regulations, through ‘adaptive pathways’ and ‘risk-based’ approaches, to special designation for promising innovation, value-based assessment and commissioner developments. Future developments are considered in the UK’s ‘accelerated access review’. Caution is urged in assessing the impact of these gateway flexibilities and their market and public health implications

Law's performativities: shaping the emergence of regenerative medicine though European Union legislation

The paper undertakes a textual and documentary analysis of the Advanced Therapy Medicinal Products Regulation, which was passed into law in the European Union (EU) in 2007. This law is significant for the development of regenerative medicine in the EU and globally. Regulatory texts such as this one provide significant material for addressing key concerns in recent theorising about innovative technologies in socio-legal studies, innovation studies, and science and technology studies. These concerns include expectations about future technologies and economic sectorbuilding. By revisiting philosopher J.L. Austin’s well-known work on How to Do Things with Words, this paper deploys his concepts of performative utterances to inform its analysis. Pursuing Austin’s and later commentators’ analysis of performatives in language use, and drawing on Lindsay Prior’s application of actor-network theory to documents, the analysis shows two different types of performativity at work in and through the document. These are termed ‘generative’ and ‘enactive’ performativity. The ‘enactive’ type includes ‘legislative’ and ‘social’ forms. In addition, a more conventional content analysis reveals a range of actions, both legislative and discursive, in the regulatory document. The analysis shows a tension between standardisation and imprecision in the conceptual detailing of the document. Legislative texts produced through established politicolegal conventions are a special class of document that should be accorded a more prominent place in understanding the role of political governance processes in shaping emergent technoscientific fields and sectors

3D bioprinting regulations: a UK/EU perspective

This section introduces the challenges 3D bioprinting poses to the existing legal regime across bioethics, safety, regenerative medicine, and tissue engineering. We briefly review the 3D bioprinting technology and look into the relevant regulatory instruments for the pre-printing, printing, and post-printing stages. Special attention is paid to the applications of the EU Advanced Therapy Medicinal Products (ATMP) Regulation and the new Medical Device Regulation (MDR)

State strategies of governance in biomedical innovation: aligning conceptual approaches for understanding 'Rising Powers' in the global context

<p>Abstract</p> <p>Background</p> <p>'Innovation' has become a policy focus in its own right in many states as they compete to position themselves in the emerging knowledge economies. Innovation in biomedicine is a global enterprise in which 'Rising Power' states figure prominently, and which undoubtedly will re-shape health systems and health economies globally. Scientific and technological innovation processes and policies raise difficult issues in the domains of science/technology, civil society, and the economic and healthcare marketplace. The production of knowledge in these fields is complex, uncertain, inter-disciplinary and inter-institutional, and subject to a continuing political struggle for advantage. As part of this struggle, a wide variety of issues - regulation, intellectual property, ethics, scientific boundaries, healthcare market formation - are raised and policy agendas negotiated.</p> <p>Methods</p> <p>A range of social science disciplines and approaches have conceptualised such innovation processes. Against a background of concepts such as the competition state and the developmental state, and national innovation systems, we give an overview of a range of approaches that have potential for advancing understanding of governance of global life science and biomedical innovation, with special reference to the 'Rising Powers', in order to examine convergences and divergences between them. Conceptual approaches that we focus on include those drawn from political science/political economy, sociology of technology; Innovation Studies and Science & Technology Studies. The paper is part of a project supported by the UK ESRC's Rising Powers programme.</p> <p>Results</p> <p>We show convergences and complementarities between the approaches discussed, and argue that the role of the national state itself has become relatively neglected in much of the relevant theorising.</p> <p>Conclusions</p> <p>We conclude that an approach is required that enables innovation and governance to be seen as 'co-producing' each other in a multi-level, global ecology of innovation, taking account of the particular, differing characteristics of different emerging scientific fields and technologies. We suggest key points to take account of in order in the future to move toward a satisfactory integrative conceptual framework, capable of better understanding the processes of the emergence, state steerage and transnational governance of innovative biomedical sectors in the Rising Powers and global context.</p

Does the French Bioethics Law create a 'moral exception' to the use of human cells for health ?:A legal and organisational issue

This article focuses on the legal and organisational regulation of human cells in the United Kingdom and France. French Bioethics Law regulates human cells for health according to European Union law where it is enforceable. But products unregulated by EU law and based on human cells are never considered as medicinal products, given the strict implementation of the principle of “nonpatrimonialité” of the human body and its elements. By comparison, in the UK such products can be qualified as medicinal products. Moreover, the setting up of the UK stem cell bank gives rise to the development of policies which expand the stem cell as a legal object. The paper discusses how these societies’ ethical and legal commitments underlie organisational practices in order to analyse the relationship between the existence (or not) of a national stem cell bank and the broader regulation of human cells.Este artículo se centra en la regulación legal y organizativa sobre células humanas en el Reino Unido y Francia. La ley de bioética francesa regula las células humanas para la salud de acuerdo con la legislación de la Unión Europea, donde ésta tiene vigencia. Sin embargo, los productos no regulados por la legislación de la UE que hacen referencia a las células humanas no son considerados como medicamentos sujetos a la estricta aplicación del principio de "no patrimonialidad" del cuerpo humano y sus elementos. En comparación, estos productos en el Reino Unido pueden ser calificados como productos medicinales. Por otra parte, la creación del banco de células madre en el Reino Unido da lugar al desarrollo de políticas de elaboración que se expande a las célulasmadre en el campo de los objetos jurídicos. Este artículo muestra cómo los compromisos éticos y legales que estas sociedades han adoptado subyacen a las prácticas organizativas de estos países. Su propósito es analizar la relación entre la existencia (o no) de un banco nacional de células madre y la regulación más amplia del uso de células humanas

The emerging landscape of reimbursement of regenerative medicine products in the UK: publications, policies and politics

Aims This paper aims to map the trends and analyse key institutional dynamics that are constituting the policies for reimbursement of Regenerative Medicine (RM), especially in the UK. Materials & Methods Two quantitative publications studies using Google Scholar and a qualitative study based on a larger study of 43 semi- structured interviews. Results Reimbursement has been a growing topic of publications specific to RM and independent from orphan drugs. Risk- sharing schemes receive attention amongst others for dealing with RM reimbursement. Trade organisations have been especially involved on RM reimbursement issues and have proposed solutions. Conclusion The policy and institutional landscape of reimbursement studies in RM is a highly variegated and conflictual one and in its infancy

In the sociomedical laboratory of citizen health: exploring science, technology, governance and engagement in prostate cancer detection in the UK

Evidential science and governance are closely linked in contemporary societies, nowhere more than in the domain of health policy. Healthcare technology is everywhere scrutinised and innovating, raising questions of the relationship between the modernising state and citizens’ engagement in healthcare knowledge and practice. Prostate cancer is acknowledged as a major public health problem internationally, and has been widely represented in the mass media. Unusually, it is a high‐profile disease affecting only men. International, national and local policies for the appropriate healthcare response vary and are contested. This paper presents a preliminary consideration of the role of an evolving healthcare technology, the prostate‐specific antigen (PSA) blood test in the construction of this ‘public health’ problem; it identifies controversy between clinical practice and policy discourse on the disease – influenced by the methodologies of healthcare science; and it considers the part played by the science of prostate cancer detection in the shaping of the healthcare sciences. The significance of the engagement of men in sociomedical spaces of scientific uncertainty and healthcare risk is discussed. The paper draws upon science and technology studies (STS) approaches and concepts of public policy analysis. Materials used include medical and epidemiological research and commentary; surveys of the use and interpretation of the PSA test and treatment options by doctors; materials emerging from healthcare science (the health technology assessment and ‘health service research’ movements); and healthcare policy documents. This exploratory paper discusses what was formerly regarded as ‘early‐stage’ prostate cancer in the sense of localised disease confined to the prostate, and also is focused on the ‘early’ phase of healthcare science and governance engagement with this issue, which continues to evolve

The Legal Landscape for Advanced Therapies: Material and Institutional Implementation of European Union Rules in France and the United Kingdom

In 2007, the European Union adopted a lex specialis, Regulation (EC) No. 1394/2007 on advanced therapy medicinal products (ATMPs), a new legal category of medical product in regenerative medicine. The regulation applies to ATMPs prepared industrially or manufactured by a method involving an industrial process. It also provides a hospital exemption, which means that medicinal products not regulated by EU law do not benefit from a harmonized regime across the European Union but have to respect national laws. This article describes the recent EU laws, and contrasts two national regimes, asking how France and the United Kingdom regulate ATMPs which do and do not fall under the scope of Regulation (EC) No. 1394/2007. What are the different legal categories and their enforceable regimes, and how does the evolution of these highly complex regimes interact with the material world of regenerative medicine and the regulatory bodies and socioeconomic actors participating in it