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International audience ; The legal regulation of innovations in health, which offer great therapeutic and economic promises, but also pose considerable risks, is both complex and essential. European Union (EU) law has regulated these innovations notably through various legislations such as those on advanced therapy medicinal products or on human cells and tissues. Within the EU, there is a transversal and implicit European strategy on innovation in health. It is currently part of various other strategies that aim to strengthen economic competitiveness and improve health. This paper defends that the EU should explicitly adopt a European strategy on innovation in health: it discusses its interest and content. ; La réglementation des innovations en santé, qui soulèvent à la fois de nombreux espoirs thérapeutiques et économiques mais aussi des risques, est essentielle et complexe. Le droit de l'Union Européenne (UE) s'est intéressé à ces innovations notamment à travers diverses règlementations, telles celles relatives aux médicaments de thérapie innovante ou aux cellules et tissus humains. Au sein de l'UE, il existe une stratégie européenne d'innovation en santé transversale et implicite, actuellement intégrée à diverses autres stratégies qui ont pour objectif le renforcement de l'économie et l'amélioration de la santé. Cette contribution soutient que l'UE devrait explicitement adopter une telle stratégie : elle discute de son intérêt et de son contenu.

International audience ; The legal regulation of innovations in health, which offer great therapeutic and economic promises, but also pose considerable risks, is both complex and essential. European Union (EU) law has regulated these innovations notably through various legislations such as those on advanced therapy medicinal products or on human cells and tissues. Within the EU, there is a transversal and implicit European strategy on innovation in health. It is currently part of various other strategies that aim to strengthen economic competitiveness and improve health. This paper defends that the EU should explicitly adopt a European strategy on innovation in health: it discusses its interest and content. ; La réglementation des innovations en santé, qui soulèvent à la fois de nombreux espoirs thérapeutiques et économiques mais aussi des risques, est essentielle et complexe. Le droit de l'Union Européenne (UE) s'est intéressé à ces innovations notamment à travers diverses règlementations, telles celles relatives aux médicaments de thérapie innovante ou aux cellules et tissus humains. Au sein de l'UE, il existe une stratégie européenne d'innovation en santé transversale et implicite, actuellement intégrée à diverses autres stratégies qui ont pour objectif le renforcement de l'économie et l'amélioration de la santé. Cette contribution soutient que l'UE devrait explicitement adopter une telle stratégie : elle discute de son intérêt et de son contenu.

International audience ; The legal regulation of innovations in health, which offer great therapeutic and economic promises, but also pose considerable risks, is both complex and essential. European Union (EU) law has regulated these innovations notably through various legislations such as those on advanced therapy medicinal products or on human cells and tissues. Within the EU, there is a transversal and implicit European strategy on innovation in health. It is currently part of various other strategies that aim to strengthen economic competitiveness and improve health. This paper defends that the EU should explicitly adopt a European strategy on innovation in health: it discusses its interest and content. ; La réglementation des innovations en santé, qui soulèvent à la fois de nombreux espoirs thérapeutiques et économiques mais aussi des risques, est essentielle et complexe. Le droit de l'Union Européenne (UE) s'est intéressé à ces innovations notamment à travers diverses règlementations, telles celles relatives aux médicaments de thérapie innovante ou aux cellules et tissus humains. Au sein de l'UE, il existe une stratégie européenne d'innovation en santé transversale et implicite, actuellement intégrée à diverses autres stratégies qui ont pour objectif le renforcement de l'économie et l'amélioration de la santé. Cette contribution soutient que l'UE devrait explicitement adopter une telle stratégie : elle discute de son intérêt et de son contenu.

International audience ; The legal regulation of innovations in health, which offer great therapeutic and economic promises, but also pose considerable risks, is both complex and essential. European Union (EU) law has regulated these innovations notably through various legislations such as those on advanced therapy medicinal products or on human cells and tissues. Within the EU, there is a transversal and implicit European strategy on innovation in health. It is currently part of various other strategies that aim to strengthen economic competitiveness and improve health. This paper defends that the EU should explicitly adopt a European strategy on innovation in health: it discusses its interest and content. ; La réglementation des innovations en santé, qui soulèvent à la fois de nombreux espoirs thérapeutiques et économiques mais aussi des risques, est essentielle et complexe. Le droit de l'Union Européenne (UE) s'est intéressé à ces innovations notamment à travers diverses règlementations, telles celles relatives aux médicaments de thérapie innovante ou aux cellules et tissus humains. Au sein de l'UE, il existe une stratégie européenne d'innovation en santé transversale et implicite, actuellement intégrée à diverses autres stratégies qui ont pour objectif le renforcement de l'économie et l'amélioration de la santé. Cette contribution soutient que l'UE devrait explicitement adopter une telle stratégie : elle discute de son intérêt et de son contenu.

Cell-based regenerative therapies are presented as being able to cure the diseases of the twenty-first century, especially those coming from the degeneration of the aging human body. But their specific nature based on biological materials raises particular challenging issues on how regulation should frame biomedical innovation for society's benefit regarding public health. The European Union (EU) supports the development of cell-based regenerative therapies that are medicinal products with a specific regulation providing their wide access to the European market for European patients. However, once these medicinal products have obtained a European marketing authorisation, they are still far away from being fully accessible to European patients in all EU Member States. Whereas there is much written on the EU regulatory system for new biotechnologies, there is no systematic legal study comparing the insurance provisions in two EU countries. Focussing on the situation in the UK and France that are based on two different healthcare systems, this paper is based on a comparative methodological approach. It raises the question of regulatory reimbursement mechanisms that determine access to innovative treatments and their consequences for social protection systems in the general context of public health. After having compared the French and English regulations of cell-based regenerative therapy regarding pricing and reimbursement, this papers analyses how England and France are addressing two main challenges of cell-based regenerative therapy, to take into account their long-term benefit through their potential curative nature and their high upfront cost, towards their adoption within the English and French healthcare systems. It concludes that England and France have different general legal frameworks that are not specific to the reimbursement of cell-based regenerative therapy, although their two current and respective trends would bring more convergence between the two systems while addressing the main challenges for ...

International audience ; The field of regenerative medicine (RM) faces many challenges, including funding. Framing the analysis in terms of institutional politics, valuation studies and 'technologies of knowledge', the paper highlights growing debates about payment for RM in the UK, setting this alongside escalating policy debates about 'value'. We draw on interviews and publicly available material to identify the interacting and conflicting positions of institutional stakeholders. It is concluded that while there is some common ground between institutional stakeholders such as industry and health system gatekeepers, there is significant conflict about reward systems, technology assessment methodologies and payment scenarios; a range of mostly conditional payment schemes and non-mainstream routes are being experimented with. We argue that current developments highlight a fundamental conflict between a concern for the societal value of medical technologies in a resource-limited system and a concern for engineering new reward and payment models to accommodate RM innovations.

International audience ; The field of regenerative medicine (RM) faces many challenges, including funding. Framing the analysis in terms of institutional politics, valuation studies and 'technologies of knowledge', the paper highlights growing debates about payment for RM in the UK, setting this alongside escalating policy debates about 'value'. We draw on interviews and publicly available material to identify the interacting and conflicting positions of institutional stakeholders. It is concluded that while there is some common ground between institutional stakeholders such as industry and health system gatekeepers, there is significant conflict about reward systems, technology assessment methodologies and payment scenarios; a range of mostly conditional payment schemes and non-mainstream routes are being experimented with. We argue that current developments highlight a fundamental conflict between a concern for the societal value of medical technologies in a resource-limited system and a concern for engineering new reward and payment models to accommodate RM innovations.

International audience ; The field of regenerative medicine (RM) faces many challenges, including funding. Framing the analysis in terms of institutional politics, valuation studies and 'technologies of knowledge', the paper highlights growing debates about payment for RM in the UK, setting this alongside escalating policy debates about 'value'. We draw on interviews and publicly available material to identify the interacting and conflicting positions of institutional stakeholders. It is concluded that while there is some common ground between institutional stakeholders such as industry and health system gatekeepers, there is significant conflict about reward systems, technology assessment methodologies and payment scenarios; a range of mostly conditional payment schemes and non-mainstream routes are being experimented with. We argue that current developments highlight a fundamental conflict between a concern for the societal value of medical technologies in a resource-limited system and a concern for engineering new reward and payment models to accommodate RM innovations.

International audience ; The field of regenerative medicine (RM) faces many challenges, including funding. Framing the analysis in terms of institutional politics, valuation studies and 'technologies of knowledge', the paper highlights growing debates about payment for RM in the UK, setting this alongside escalating policy debates about 'value'. We draw on interviews and publicly available material to identify the interacting and conflicting positions of institutional stakeholders. It is concluded that while there is some common ground between institutional stakeholders such as industry and health system gatekeepers, there is significant conflict about reward systems, technology assessment methodologies and payment scenarios; a range of mostly conditional payment schemes and non-mainstream routes are being experimented with. We argue that current developments highlight a fundamental conflict between a concern for the societal value of medical technologies in a resource-limited system and a concern for engineering new reward and payment models to accommodate RM innovations.

International audience ; Structured Abstract 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.

International audience ; Structured Abstract 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.

International audience ; Structured Abstract 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.

International audience ; Structured Abstract 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.

Genome editing techniques have generated a growing interest following the discovery of the so-called CRISPR-Cas technique. It has raised a global uproar as regards its use in humans, especially after the 2018 announcement of a Chinese scientist who had used CRISPR to edit the genes of twin embryos. Indeed, one of the greatest concerns, although not the only one, has been the use of genome editing technologies to modify the human germline. In such scientific and technological context, the law plays a key role in framing what should be allowed or prohibited, and under which conditions, to find a balance between safe and accessible innovative treatments and respect of fundamental rights in accordance with the societal values and choices. Within the European Union, several institutions have considered the issues raised by human genome editing, and several legal texts participate in the establishment of the European regulatory framework applicable to human genome editing. Yet we argue in this article that the established regulatory landscape is fragmented in the sense of being divided, split, or segmented. Such fragmentation, which may have been inevitable for historical and technicolegal reasons, produces effects regarding the role of the current regulatory frameworks applicable to human genome editing. Focusing on the European Union and on the French levels of governance, we discuss how such fragmentation takes place through the identification of determinants of the human genome editing fragmented regulatory landscape. We argue that it should be seen as a process providing more contingent responses to human genome editing reflecting changing political and legal contexts.