Information on Access and Benefit Sharing regarding the Utilisation of Genetic Resources under the European Union Legal Regulation

Valentina Colcellianalyses how, in the European legal system, Access and Benefit-sharing information are exchanged and this could help the implementation of the Nagoya Protocol and its goals, whether data flow could be controlled and whether legal consequences for infringement of rules on information exchange and storage could be more well-defined and reinforced. The flow of information available in the Access and Benefit-sharing Clearing-house platform seems to favour users more than providers, stakeholders and consumers; it also appears to kindly invite the users to respect the Access and Benefit-Sharing system. Providers, stakeholders and consumers, as well as the States, have the possibility to discover the illegal utilisation of genetic resources only accidentally, after products have been placed on the market. However, Art. 7(1) of Regulation (EU) n. 511/2014 makes it clear that the due diligence declaration needs to be requested by the Member States, or by the European Commission if money is provided by EU funds and the EU Offices or by the public administrations of Member States in case of request for market approval or placing products on the market. Nevertheless, the agencies in charge of Access and Benefit-Sharing control are not responsible for market approval. However, a rather quite good control of the flow of information is possible in the EU legal system, if all involved public administrations or agencies check the Access and Benefit-Sharing due diligence fulfilment

Circulation of personal data and non-personal data within the European Research Area for research and health purposes

The availability and circulation of data, information, knowledge and materials are essential in all fields of research, but they are particularly important in a period in which it is necessary to tackle a global phenomenon like the COVID- 19 pandemic. Awareness of the importance of the circulation of information derived from data, the European Commission has been elaborating a strategy for the circula- tion and sharing of personal and non-personal data. The European strategy needs the data to circulate and be shared in the economic, academic, and social environments. To achieve those objectives, EU documents use the metaphor of building a ‘European Data Area’, that is to say, legal, economic, and cultural frameworks governed at the continental and national levels, such as European Research Area (‘ERA’, see Article 179 TFEU) and the proposed European Health Data Space (‘EHDS’). An analysis of the current legislation seems to indicate several legal constraints on the circulation of data (information, knowledge and material), able to affect the building of an effective European Data Area. These limitations aim at protecting individual rights, such as privacy or other interests. However, such limitations to the circulation of data may affect other relevant rights and interests such as freedom of research and health. For this reason, this paper intends to show what are the legal means to find the points of equilibrium between the different viewpoints and allow the sustainable function of the European Data Area. Because proper global governance of health data and materials is required, the paper tries to the analysis of the main EU instruments which at this moment are able to regulate it, in order to implement an effective system for the exchange of data, in the meantime that the scientific community is waiting for the European Data Protection Board (EDPB) guidance on the processing health data for research purposes, still pending

The SURPRISE demonstrator: a super-resolved compressive instrument in the visible and medium infrared for Earth Observation

While Earth Observation (EO) data has become ever more vital to understanding the planet and addressing societal challenges, applications are still limited by revisit time and spatial resolution. Though low Earth orbit missions can achieve resolutions better than 100 m, their revisit time typically stands at several days, limiting capacity to monitor dynamic events. Geostationary (GEO) missions instead typically provide data on an hour-basis but with spatial resolution limited to 1 km, which is insufficient to understand local phenomena. In this paper, we present the SURPRISE project - recently funded in the frame of the H2020 programme – that gathers the expertise from eight partners across Europe to implement a demonstrator of a super-spectral EO payload - working in the visible (VIS) - Near Infrared (NIR) and in the Medium InfraRed (MIR) and conceived to operate from GEO platform -with enhanced performance in terms of at-ground spatial resolution, and featuring innovative on-board data processing and encryption functionalities. This goal will be achieved by using Compressive Sensing (CS) technology implemented via Spatial Light Modulators (SLM). SLM-based CS technology will be used to devise a super-resolution configuration that will be exploited to increase the at-ground spatial resolution of the payload, without increasing the number of detector’s sensing elements at the image plane. The CS approach will offer further advantages for handling large amounts of data, as is the case of superspectral payloads with wide spectral and spatial coverage. It will enable fast on-board processing of acquired data for information extraction, as well as native data encryption on top of native compression. SURPRISE develops two disruptive technologies: Compressive Sensing (CS) and Spatial Light Modulator (SLM). CS optimises data acquisition (e.g. reduced storage and transmission bandwidth requirements) and enables novel onboard processing and encryption functionalities. SLM here implements the CS paradigm and achieves a super-resolution architecture. SLM technology, at the core of the CS architecture, is addressed by: reworking and testing off-the-shelf parts in relevant environment; developing roadmap for a European SLM, micromirror array-type, with electronics suitable for space qualification. By introducing for the first time the concept of a payload with medium spatial resolution (few hundreds of meters) and near continuous revisit (hourly), SURPRISE can lead to a EO major breakthrough and complement existing operational services. CS will address the challenge of large data collection, whilst onboard processing will improve timeliness, shortening time needed to extract information from images and possibly generate alarms. Impact is relevant to industrial competitiveness, with potential for market penetration of the demonstrator and its components

Competence Centre ICDI per Open Science, FAIR, ed EOSC - Mission, Strategia e piano d'azione

This document presents the mission and strategy of the Italian Competence Centre on Open Science, FAIR, and EOSC. The Competence Centre is an initiative born within the Italian Computing and Data Infrastructure (ICDI), a forum created by representatives of major Italian Research Infrastructures and e-Infrastructures, with the aim of promoting sinergies at the national level, and optimising the Italian participation to European and global challenges in this field, including the European Open Science Cloud (EOSC), the European Data Infrastructure (EDI) and HPC. This working paper depicts the mission and objectives of the ICDI Competence Centre, a network of experts with various skills and competences that are supporting the national stakeholders on topics related to Open Science, FAIR principles application and participation to the EOSC. The different actors and roles are described in the document as well as the activities and services offered, and the added value each stakeholder can find the in Competence Centre. The tools and services provided, in particular the concept for the portal, though which the Centre will connect to the national landscape and users, are also presented

Research activity and the principle of solidarity in the EU legal framework for biodiversity

The paper aims to analyse how Reg. EU n. 511/2014 links the principle of solidarity to one of the most visible areas of intersection between EU law and ethical choice, particularly in the field of research activity: the implementation of the Nagoya Protocol in the EU legal framework. A broad range of users and suppliers in the Union, including academic, university and non-commercial researchers and companies from different sectors of industry, use genetic resources for research, development and commercialisation purposes. Some also use traditional knowledge associated with genetic resources [see point 3 Reg (EU) 2014/511]. Thus, all research activities involving germplasm, genetic resources, and traditional knowledge related to genetic resources are currently subject to Article 15, point 6, of the Convention on Biodiversity, and they also must observe the fundamental principle (established by Article 19 of the Convention and EU legal sources) of benefiting the countries involved in the research and development actions. The mutually agreed terms and the contracts mandated by art. 3 reg. EU n. 511/2014 are correlated with distributive justice and the principle of solidarity, which underpin the entire EU legal system

Status de ciudadanos como status fundametal de la persona en el ordenamiento jurídico de la Unión Europea

La presente intervención querría indagar como en el ordenamiento jurídico de la Unión Europea se esté delineando (o de cualquier manera se haya ya elaborado) un concepto de status personal con características autónomas o de cualquier modo ulteriores respecto a los diferentes ordenamientos internos de los Estados miembros(1). El legislador de la Unión Europea promulga actos legislativos ordenándolos según el tipo de sujetos destinatarios, individuando conjuntos de acontecimientos económicos en los que se pueda agrupar la disciplina de cada actividad(2).Por lo tanto, se analizará porque en el ordenamiento jurídico de la Unión Europea se puede afirmar que con el derecho de circular libremente al interior de la Unión circula también el estatus de la persona. O sea circulan todas las precondiciones que son supuestas por la normativa UE por su misma operatividad y por la realización de los fines del sistema(3)

Precutionary Principle Liability in Food Chain : A Step Forward in the Emerging European Tort Law

Fil: Colcelli, Valentina. University of Perugia. Faculty of Law. Department of juridical studies "A. Giuliani". Perugia, ItalyFil: Colcelli, Valentina. Ministero dell'università e della ricerca (MUR). Consiglio Nazionale delle Ricerche (CNR). Roma, ItaliaLa cátedra Jean Monnet es una cátedra universitaria otorgada por la Comisión Europea en el marco de su plan de acción. Tienen como objetivo reforzar la docencia y la investigación sobre la integración europea en las universidades, tanto de los Estados miembros como de terceros países. Su nombre hace honor a quien fuera un político francés que, como asesor de Robert Schuman, contribuyó decisivamente a poner los cimientos de las entonces Comunidades Europeas. -- La primera etapa de esta publicación concluyó en el año 2018, comenzó una segunda época en el año 2019 con el nombre Revista "Integración Regional y Derechos Humanos". -- Sección Ensayos

Elementos para una cultura europea de desarrollo de herramientas de inteligencia artificial: el libro blanco sobre la inteligencia artificial y las directrices éticas para una IA fiable

El objetivo del trabajo es abordar el problema ético/jurídico del desarrollo de las tecnologías que utiliza la inteligencia artificial, utilizando la vía metodológica trazada por la Unión Europea en sus Directrices éticas para una IA fiable. Así, el artículo se centra en la descripción de algunos elementos que caracterizan la estrategia elegida por la Unión Europea para abordar la cuestión de la relación entre los aspectos ético-jurídicos y la tecnología relacionada con el desarrollo de la inteligencia artificial. Seguidamente, expone un ejemplo práctico de la sinergia entre desarrolladores de aplicaciones tecnológicas y juristas, que se ha llevado a cabo en un instituto del Consejo Nacional de Investigación de Italia

NAVIGATOR: an Italian regional imaging biobank to promote precision medicine for oncologic patients.

NAVIGATOR is an Italian regional project boosting precision medicine in oncology with the aim of making it more predictive, preventive, and personalised by advancing translational research based on quantitative imaging and integrative omics analyses. The project's goal is to develop an open imaging biobank for the collection and preservation of a large amount of standardised imaging multimodal datasets, including computed tomography, magnetic resonance imaging, and positron emission tomography data, together with the corresponding patient-related and omics-related relevant information extracted from regional healthcare services using an adapted privacy-preserving model. The project is based on an open-source imaging biobank and an open-science oriented virtual research environment (VRE). Available integrative omics and multi-imaging data of three use cases (prostate cancer, rectal cancer, and gastric cancer) will be collected. All data confined in NAVIGATOR (i.e., standard and novel imaging biomarkers, non-imaging data, health agency data) will be used to create a digital patient model, to support the reliable prediction of the disease phenotype and risk stratification. The VRE that relies on a well-established infrastructure, called D4Science.org, will further provide a multiset infrastructure for processing the integrative omics data, extracting specific radiomic signatures, and for identification and testing of novel imaging biomarkers through big data analytics and artificial intelligence