La frágil rigidez de la ley italiana de reproducción asistida contra la rígida flexibilidad del modelo español: contenido vs. procedimiento

La investigación con células madre se conecta con la regulación de las técnicas de reproducción asistida por lo que se refiere a la obtención de líneas de células embrionarias derivantes de embriones sobrantes. El objeto de este trabajo consiste en analizar crítica y comparativamente el contenido de las legislaciones española e italiana en materia de reproducción asistida, respecto al destino de los embriones sobrantes. La obtención y la derivación de células embrionarias constituye por un lado elemento esencial por el desarrollo científico en ámbito biomédico, por otro lado pone unas cuestiones jurídicas que tienen que ser consideradas por el legislador en general. Las leyes objeto de análisis representan distintos modelos de regulación, de los cuales serán analizados el nivel de efectividad y racionalidad jurídica, atendiendo demostrar la paradoja por la cual una (proceduralmente rígida) flexibilidad puede revelarse más eficaz que una generalizada (pero frágil) prohibición

L a f r á g i l r i g i d e z d e l a l e y i t a l i a n a d e r e p r o d u c c i ó n a s i s t i d a c o n t r a l a r í g i d a f l e x i b i l i dad del modelo e s pañ o l : c o n t e n i d o v s . p r o c e d i m i e nt o

Research with stem cell is linked with the assisted reproduction techniques regulation with regard to obtaining stem cells line derived from embryos. The paper aims to analyse –in a comparative perspective– the Italian (Law 40/2004) and the Spanish (Law 14/2006) regulation of the assisted reproduction, with regard to the admitted utilization of the “non-transferred” embryos. The stem cells derivation from the embryos represents both a fundamental means for scientific development in the biomedical field and a ethically and legally critical issue which has to be regulated by the law. The regulations represent different regulative systems, which will be analysed in terms of effectiveness and legal reasonableness, in order to show a legal paradox: A legislative system based on a (procedurally strict) flexibility is more efficient than a system based on an absolute (even if fragile) body of prohibitions

L a f r á g i l r i g i d e z d e l a l e y i t a l i a n a d e r e p r o d u c c i ó n a s i s t i d a c o n t r a l a r í g i d a f l e x i b i l i dad del modelo e s pañ o l : c o n t e n i d o v s . p r o c e d i m i e nt o

Research with stem cell is linked with the assisted reproductiontechniques regulation with regard to obtaining stemcells line derived from embryos. The paper aims to analyse–in a comparative perspective– the Italian (Law 40/2004)and the Spanish (Law 14/2006) regulation of the assistedreproduction, with regard to the admitted utilization of the“non-transferred” embryos. The stem cells derivation fromthe embryos represents both a fundamental means for scientificdevelopment in the biomedical field and a ethicallyand legally critical issue which has to be regulated by thelaw. The regulations represent different regulative systems,which will be analysed in terms of effectiveness and legalreasonableness, in order to show a legal paradox: A legislativesystem based on a (procedurally strict) flexibility ismore efficient than a system based on an absolute (even iffragile) body of prohibitions.La investigación con células madre se conecta con la regulaciónde las técnicas de reproducción asistida por lo quese refiere a la obtención de líneas de células embrionariasderivantes de embriones sobrantes. El objeto de este trabajoconsiste en analizar crítica y comparativamente elcontenido de las legislaciones española e italiana en materiade reproducción asistida, respecto al destino de los embrionessobrantes. La obtención y la derivación de célulasembrionarias constituye por un lado elemento esencial porel desarrollo científico en ámbito biomédico, por otro ladopone unas cuestiones jurídicas que tienen que ser consideradaspor el legislador en general. Las leyes objeto de análisisrepresentan distintos modelos de regulación, de loscuales serán analizados el nivel de efectividad y racionalidadjurídica, atendiendo demostrar la paradoja por la cualuna (proceduralmente rígida) flexibilidad puede revelarsemás eficaz que una generalizada (pero frágil) prohibición

Legislator Facing the Science: Remarks from a Comparative Approach

El presente artículo se propone desarrollar el tema de la regulación de la actividad médica y de investigación científica por parte de los legisladores nacionales, en el marco de un panorama normativo en donde la influencia de las fuentes internacionales resulta ser un elemento relevante que los legisladores deben considerar a la hora de intervenir en este ámbitoThis paper deals with the sometimes problematic regulation at national level of medical and scientific issues and defends the necessity for national legislator of taking into consideration the sources of international and comparative law at thisregard

The Italian Way for Research Biobanks After GDPR: Hybrid Normative Solutions to Balance the Protection of Individuals and Freedom of Research

AbstractThe Italian context of biobanking is made up of a vast number of collections, in some cases well-organised and connected in virtuous networks and in others not identifiable as structured biobanks. From a comparative perspective, Italy can be regarded as a hybrid model, positioned between countries with full and detailed legislation concerning biobanks and those that rely only on guidelines published by national ethics committees or professional societies that have no binding legal value. In countries like Italy where the need for specific regulation is more urgent, the entry into force of the GDPR could have offered a chance to fill the gap in the legislation with regard to biobanking for medical scientific research purposes. This overview highlights the improvements made and the obstacles that persist

Grazing affects metabolic pattern of individual cow milk

Effective traceability tools able to characterize milk from pasture are important to safeguard low-input farming systems, niche dairy products, and local traditions. The aims of the present study were to investigate the ability of proton nuclear magnetic resonance (1H NMR) spectroscopy to discriminate between milk produced from cows before and after the beginning of the grazing season, and to assess the effects of grazing on milk metabolites. The research trial involved a single alpine holding with 72 lactating cows. Individual milks were repeatedly sampled from the same animals before (i.e., d −3 and −1) and after (i.e., d 2, 3, 7, 10, and 14) the onset of the grazing period. One-dimensional 1H NMR spectra of milk extracts were collected through a Bruker spectrometer. Random forest discriminant analysis was applied to 1H NMR spectra to predict the period of collection for each sample. Data concerning the relative abundance of milk metabolites were analyzed through a linear mixed model, which included the fixed effects of period of sampling, cow breed, stage of lactation, and parity, and the random effect of cow nested within breed. The random forest model exhibited great accuracy (93.1%) in discriminating between samples collected on d −3, −1, 2, and 3 and those collected on d 7, 10, and 14. Univariate analysis performed on the 40 detected metabolites highlighted that milk samples from pasture had lower levels of 14 compounds (with fumarate being the most depressed metabolite) and greater levels of 15 compounds (with methanol and hippurate being the most elevated metabolites). Results indicate that milk 1H NMR spectra are promising to identify milk produced in different conditions. Also, our study highlights that grazing is associated with significant changes of milk metabolic profile, suggesting the potential use of several metabolites as indicators of farm management

An EU comparative analysis of the regulation of clinical trials supervisory bodies in the aftermath of Regulation 536/2014

The new EU regulation on clinical trials is intended to promote a greater level of harmonization of European Union rules in this area. However, it does not elaborate a common normative framework regarding the functioning of research ethics committees, leaving this responsibility to the Member States. This article offers a comparative analysis of the resulting regulatory situation. It demonstrates that this scenario is defined by considerable variability in the regulation of ethics monitoring between the EU Member States. We argue that this disparity should not necessarily be a negative factor for the optimization of the trial supervision regime in the EU. Moreover, we consider that it may be a stimulus for the achievement of excellence in the performance of this monitoring task. On the other hand, we also highlight risks for the rights of participants if an adequate monitoring framework is not ensured. Under these circumstances, we observe how the EU faces a dilemma. On the one hand, it may promote a rigid uniformity between the regulation of ethics committees between Member States, but this might diminish the quality of their performance. On the other hand, it may opt for maintaining the current situation, but this might increase differences in the performance of the ethics committees between Member States, including the number trials performed by country. A third option would be to allow the competitive framework to remain for a set period of time, in order to learn from the best practices reached in individual Member States before finally harmonizing national legislative provisions on this basis.This work was supported by Eusko Jaurlaritza [grant number Ayudas a grupos de investigación IT-1066-16]; H2020 Science with and for Society [grant number GRANT AGREEMENT NUMBER — 788039 — PANELFIT]