A critical analysis of the Recommendation CM/Rec(2016)6 of the Committee of Ministers to member States on research on biological materials of human origin on the basis of the comments made by the experts participating in its public consultation process

On 11 May 2016, the Council of Europe adopted the Recommendation CM/Rec(2016)6 of the Committee of Ministers to Member States on research on biological materials of human origin. This new legal tool is meant to play a key role in the harmonization of the regulation of the topic addressed in the Council of Europe geographical scope, and even beyond. This paper develops a critical analysis of the new Recommendation on the basis of the comments made by academics, representatives of the biotechnology industry, members of the ethics committees, professional and patient associations, national agencies, etc. in a public consultation organized to refine the preliminary draft of the document. It offers a detailed account of its main clauses while comparing them with the suggestions made by the participants in the consultation, highlighting the main disagreements that remained in its final version. In this way, it contributes to the most recent stage of development, both by performing a valuable analysis of the document and by including a critical comment on the utility of the public consultation made during the process

El 11 de mayo de 2016, el Consejo de Europa aprobó la Recomendación CM/Rec(2016)6 del Comité de Ministros a los Estados Miembros sobre investigación con materiales biológicos de origen humano. Este nuevo instrumento jurídico está destinado a desempeñar un papel clave en la armonización de la regulación del tema abordado en el ámbito geográfico del Consejo de Europa, e incluso más allá. En este documento se desarrolla un análisis crítico de la nueva Recomendación sobre la base de las observaciones formuladas por académicos, representantes de la industria biotecnológica, miembros de los comités de ética, asociaciones profesionales y de pacientes, agencias nacionales, etc. en la consulta preliminar sobre el documento realizada por el Consejo. Ofrece una descripción detallada de sus prin.cipales cláusulas, comparándolas con las sugerencias de los participantes en la consulta y destacando los principales desacuerdos que quedaron en su versión final. De esta manera, contribuye al estado de la cuestión a través de una doble vía, tanto realizando un valioso análisis del documento como incluyendo un comentario crítico sobre la utilidad de la consulta pública realizada durante el proceso

The Italian regulation on Assisted Reproductive Technologies facing the European Court of Human Rights: the case of Costa and Pavan v. Italy

En este artículo se describe el marco legal vigente en Técnicas de Reproducción Asistida (TRA) de acuerdo con la normativa italiana, teniendo en cuenta la reciente jurisprudencia consecuencia de la aplicación de la Ley 40 de 2004 sobre TRA. Especial atención se dedica al caso Costa y Pavan c. Italia, recientemente pronunciado por la Décima Sesión del Tribunal Europeo de Derechos Humanos (TEDH). En ese pronunciamiento, el Tribunal Europeo declaró la incompatibilidad de la prohibición para el diagnóstico genético preimplantacional introducida por la citada ley italiana sobre TRA. El caso es analizado desde una doble perspectiva. Por un lado, se estudio a la luz de la jurisprudencia del Tribunal Europeo de Derechos Humanos, con el fin de deducir los aspectos sistemáticos de la continuidad o discontinuidad entre el primero y el segundo. Por otro lado, el caso es tratado a la luz de su impacto concreto y potencial en el enfoque jurídico de Italia respecto de la regulación de las TRA, teniendo en cuenta especialmente la influencia directa e indirecta del caso: por ejemplo, su posible utilización por los jueces italianos cuando son llamados a poner en práctica la Ley 40 (AU)

This article will describe the current legal framework on Assisted Reproduction Technology (ART) regulation in Italy, taking into account recent case-law derived from the implementation of the Law 40 of 200e4 on ART. Special attention will be devoted to the case of Costa and Pavan v. Italy, recently decided by the Tenth Session of the European Court of Human Rights (ECtHR). In that decision, the European Court declared the incompatibility of the ban to pre-implantation genetic diagnosis introduced by the abovementioned Italian law on ART. The case will be analysed from a dual perspective. On the one hand, it will be considered in the light of the ECtHR case-law, in order to derive systematic aspects of continuity or discontinuity between the former and the latter2. On the other hand, the case will be considered in the light of its concrete and prospective impact on the Italian legal approach to ART regulation, considering especially the direct and indirect influence of the case: e.g., its possible utilization by Italian judges when they are called upon to implement Law 40 (AU)

The Italian regulation on Assisted Reproductive Technologies facing the European Court of Human Rights: the case of Costa and Pavan v. Italy.

This article will describe the current legal framework on Assisted Reproduction Technology (ART) regulation in Italy, taking into account recent case-law derived from the implementation of the Law 40 of 2004 on ART. Special attention will be devoted to the case of Costa and Pavan v. Italy, recently decided by the Tenth Session of the European Court of Human Rights (ECtHR). In that decision, the European Court declared the incompatibility of the ban to pre-implantation genetic diagnosis introduced by the abovementioned Italian law on ART. The case will be analysed from a dual perspective. On the one hand, it will be considered in the light of the ECtHR case-law, in order to derive systematic aspects of continuity or discontinuity between the former and the latter2. On the other hand, the case will be considered in the light of its concrete and prospective impact on the Italian legal approach to ART regulation, considering especially the direct and indirect influence of the case: e.g., its possible utilisation by Italian judges when they are called upon to implement Law 40.

The issue of constitutional law legitimacy on “human assisted reproduction” between reasonableness of the choices and effectiveness of the protection of all involved subjects

El presente artículo analiza, tomando en consideración la jurisprudencia de la Corte Costituzionale italiana en materia de reproducción humana asistida, el recurso de inconstitucionalidad en contra de la Ley 40 de febrero 2004 en materia de reproducción humana asistida en la parte en la cual prohíbe el análisis genético preimplantacional, por ser esta prohibición en contra del derecho a la salud de la madre (art. 32 Constitución italiana) y del principio de igualdad (art. 3 Constitución italiana) y del principio de inconstitucionalidad es la posibilidad de una interpretación conforme a la Constitución, siendo esta una ocasión para investigar la teoría del derecho vigente y de su relación con la interpretación “adeguatrice” de la ley y del texto constitucional

This article analyzes the constitutionality petition to the constitutional Court against Law 40 of 2001 on “human assisted reproduction”, where it prohibits the “preimplantatory genetical diagnosis”, because it could be against the mother´s right to health (art. 32 Italian Constitution) and the egalitarian protection clause (art. 3 Italian Constitution). In the constitutionally petition the ordinary judge proposes an interpretation in accordance with Constitution of the contested disposition (art 13 of Law 40 of 2004) and this could be the possibility to teste the “living law” theory and its relation with the “adequate interpretation” of the law and the Constitution

The issue of constitutional law legitimacy on "human assisted reproduction" between reasonableness of the choices and effectiveness of the protection of all involved subjects.

This artiche analyzes the constitutionality petition to the constitutional Court against Law 40 of 2004 on "human assisted reproduction", where it prohibits the "preimplantatory genetical diagnosis", because it could be against the mother's right to health (art. 32 Italian Constitution) and the egalitarian protection clause (art. 3 Italian Constitution). In the constitutionally petition the ordinary judge proposes an interpretation in accordance with Constitution of the contested disposition (art. 13 of Law 40 of 2004) and this could be the possibility to teste the "living law" theory and its relation with the "adequate interpretation" of the law and the Constitution.