Reimbursement of cell- based regenerative therapy in the UK and France

Cell- based regenerative therapies are presented as being able to cure the diseases of the XXI 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. Focusing on the situation in the United Kingdom 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 up front 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 the reimbursement of these therapies. Nevertheless, despite their current differences neither the English nor the French national healthcare systems have yet approved the reimbursement of cell- based regenerative therapies. The paper highlights where both systems could be learning from each other experiences to favour the adoption of cell- based regenerative therapies through the adaptation of their reimbursement methodologies. It also emphasizes the gap between market access and patients’ access and, it calls for research and discussions through reflexive agencies such as Regenerative Medicine Expert Group in the UK

EU law and policy on new health technologies

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Règlementation de la recherche sur les cellules souches en France

Lay overview of regulation of stem cell research in France for EuroStemCell Websit

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

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

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

Étude normative comparée : diagnostic préimplantatoire -HLA

Remerciements Dr. Pilar Nicolas, Chair in Law and the Human Genome, Universidad del País Vasco / Euskal Herriko Uniberstitatea. Dr. Deborah Mascalzoni, EURAC research Center for Biomedicine, Bioethics – ELSI, Bolzano. Dr. Julie Cousineau, Avocate, LL.M., D.C.L, Centre de recherche, Centre hospitalier universitaire Sainte-Justine, Centre de recherche en éthique, Université de Montréal, Centre de recherche en droit public, Université de Montréal. Pr. Roger Browsnword, Professor in Law, founding..

Avant-propos : l’humain médicament

Remerciements : Cette étude a été soutenue par les projets Theracels(N° ANR-08-JCJC-0048-01), Canadian Institutes of Health Research 07-08-0420 Leibing/Tournay AMS 84639 et PICS CNRS Labstitution. L’objectif de ce dossier est d’examiner, puis de qualifier les formes de relations entre les régimes éthiques, juridiques et sociaux appliqués aux biotechnologies et l’irruption de nouveaux médicaments s’inscrivant dans la catégorie des biotechnologies. L’hypothèse développée dans ce numéro est que..

Entretien avec Sophie Samuel-Lucas, Pôle Thérapies innovantes et produits issus du corps humain à l’ANSM

L’Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) est en charge de l’évaluation et de la surveillance des produits de santé, y compris des produits de thérapies innovantes. Elle exerce également les missions d’inspection et de contrôle des établissements qui développent ces produits. Enfin, elle a mis en place une « cellule d’accompagnement de l’innovation ». Quel est l’apport du règlement européen sur les médicaments de thérapie innovante ? À titre principal, s’i..