European Legislative Framework Research Articles

Bioethics research under European and national regulations

The timeliness of the subject is due to the interest shown in knowledge of the European and national legislative framework in bioethical research. The European and national legislative framework for bioethical research is clarified in this Article, and the biophysical issues are classified into domestic legislation. It also assesses certain rules and legal regulations contained in the Treaties drawn up by the European institutions, which aim at establishing and operating best the Community institutions on bioethics and which are useful for the national legislative framework.

Training professionals to improve media accessibility

COVID-19 has affected all areas of our lives, and cinema, as part of culture, is no exception. New and existing technologies applied to audiovisual products are changing the way in which we provide and access culture.Nobody challenges the importance of having accessible audiovisual content. This is the aim of the recently approved European Directives following the ratification of the UN Convention on the Rights of Persons with Disabilities (UNCRPD). The new European legislative framework must guarantee the full and democratic participation of all citizens in the new information society. It is crucial to ensure access to technology and content for all citizens.The objective of this article is to present the new professional profiles in the accessibility field that have been developed in the last decades through Erasmus+ projects initiatives. First, the current European legislative framework on accessibility will be outlined. Then, the main accessibility services available in the media field will be explained. Next, the professional profiles in accessibility will be presented together with the emerging new profiles and Erasmus+ projects. Finally, the conclusions will outline the existing needs and improvements in the education and training of new professionals in media accessibility.

Monitoring environmental and climate goals for European agriculture: User perspectives on the optimization of the Copernicus evolution offer

A vicious cycle exists between agricultural production and climate change, where agriculture is both a driver and a victim of the changing climate. While new and ambitious environmental and climate change-oriented goals are being introduced in Europe, the monitoring of these objectives is often jeopardized by a lack of technological means and a reliance on heavy administrative procedures. In particular, remote sensing technologies have the potential to significantly improve the monitoring of such goals but the characteristics of such missions should take into consideration the needs of users to guarantee return on investments and effective policy implementation. This study aims at identifying gaps in the current offer of Copernicus products for the monitoring of the agricultural sector through the elicitation of stakeholder requirements. The methodology is applied to the case study of Italy while the approach is scalable at European level. The elicitation process associates user needs to the European and national legislative framework to create a policy-oriented demand of Copernicus Earth Observation services. Results show the limitations faced by environmental managers in relation to the use of Remote Sensing technologies and the shortcomings associated with a purely technology driven approach to the development of satellite missions. Through the introduction of this flexible and user centred approach instead, this paper provides a clear overview of agro-environmental user requirements and represents the basis for the definition of an integrated agricultural service.

A Weight of Evidence (WOE) Approach to Assess Environmental Hazard of Marine Sediments from Adriatic Offshore Platform Area

European legislative framework supports a multidisciplinary strategy of environmental monitoring because the environment is a complex system of abiotic and biotic interactions, and it should not be studied and protected by looking at one single aspect. The resulting heterogeneous data request to be carefully processed, and the application of Weight of Evidence (WOE) approaches is, thereby, an integrated validated tool. In this perspective, the present study aims to: (i). apply a specific model (Sediqualsoft) based on the WOE approach for processing multidisciplinary data related to four Lines Of Scientific Evidence (LOEs: chemical analyses, ecotoxicological bioassays, bioaccumulation tests and biomarkers) regarding sediments from an area of the Adriatic Sea; (ii). evaluate the usefulness of this specific integrated approach to estimate the potential environmental hazard due to the presence of gas production platforms respect to the traditional approach of sediment chemical characterization. This latter recognized a more contaminated area within 100 m of the platforms in which the Sediqualsoft model showed the presence of a chemical hazard, ranging from moderate to severe, and identified the contaminants (e.g., some metals, benzo(a)pyrene and acenaphthene) most responsible for it. A significant hazard also appeared in some of the sampled stations by analyzing the LOEs dedicated to the biological responses. The choice of different reference values (regulatory limits, threshold values or concentrations measured in the control area) influenced only the chemical hazard but not the overall integration with other LOEs, showing a moderate hazard for the majority of stations. Here, the concentrations measured in a control area are firstly proposed as possible reference values in Sediqualsoft model applications; this could be of particular relevance when Sediment Quality Guidelines are not available for all the measured substances. Moreover, the limitations of a conventional pass-to-fail approach or worst-case scenario were overcoming interpreting whole chemical and ecotoxicological results. All data analyzed and discussed confirm Sediqualsoft as a suitable tool for processing environmental data, including those first processed here on a monitoring scenario of gas platforms that discharge Produced Water into the sea.

Biogas from Anaerobic Digestion as an Energy Vector: Current Upgrading Development

The present work reviews the role of biogas as advanced biofuel in the renewable energy system, summarizing the main raw materials used for biogas production and the most common technologies for biogas upgrading and delving into emerging biological methanation processes. In addition, it provides a description of current European legislative framework and the potential biomethane business models as well as the main biogas production issues to be addressed to fully deploy these upgrading technologies. Biomethane could be competitive due to negative or zero waste feedstock prices, and competitive to fossil fuels in the transport sector and power generation if upgrading technologies become cheaper and environmentally sustainable.

Small Renewable Energy Community: The Role of Energy and Environmental Indicators for Power Grid

The Clean Energy for all Europeans Package pushes for the diffusion of renewable energy communities, introducing their definition in the European legislative framework. Following this interest, this paper analyses the energy and environmental performance of a renewable energy community composed of two office buildings located in Naples (Italy). Each building has a rooftop photovoltaic plant and one office presents an electric vehicle. The heating and cooling demands of both offices are satisfied by two reversible air to water heat pumps. The offices are connected through an electric microgrid and they are in parallel with a power grid. Buildings and plants are modelled and simulated by means of TRNSYS 17 simulation software. The first analysis has concerned the comparison of the results achieved in renewable energy community configuration and from individual buildings in terms of quantity of electricity imported, exported from/to power grid and consumed on-site. The share of self-consumed photovoltaic electricity rises up to 79% when energy sharing is allowed. The second analysis has been carried out to evaluate the energy and environmental performance of a renewable energy community by means of fixed and hourly varying values for power grid efficiency and emission factors for electricity. The use of time-dependent indicators has led to a lower community primary energy demand and carbon dioxide emissions of 18% and 12%, respectively, in comparison with the scenario in which the fixed parameters have been adopted.

User Needs Analysis for the Definition of Operational Coastal Services

According to the global growth of the “Blue economy”, coastal zones are under pressure from both land and marine side economic activities. The fragmentation of sectorial interests and legislation along the coasts has led to the need for bridging knowledge (data/information and methods/tools) and governance (decision-makers at every level) in order to ensure sustainable economic development and social and ecosystem resilience. This poses the need for an interaction process that associates user needs to the European and national legislative framework to create a policy-oriented demand of Copernicus Earth Observation services in coastal areas. Such goals need a strong and effective system to monitor compliance and to assess the progress of the legislation. This study aims at identifying potential gaps in the current Copernicus product offer for the monitoring of the coastal sector through the elicitation of stakeholder requirements. The methodology is applied to the Italian landscape of users, but it is scalable at European level. The results provide a clear overview of the coastal user requirements, highlighting the common need of integrated information for the management, and represents the basis for defining the coastal services.

COVID-19, Fake News, and Vaccines: Should Regulation Be Implemented?

We analysed issues concerning the establishment of compulsory vaccination against COVID-19, as well as the role of misinformation as a disincentive—especially when published by health professionals—and citizen acceptance of measures in this regard. Data from different surveys revealed a high degree of hesitation rather than outright opposition to vaccines. The most frequent complaint related to the COVID-19 vaccination was the fear of side effects. Within the Spanish and European legislative framework, both compulsory vaccination and government regulation of FN (Fake News) appear to be feasible options, counting on sufficient legal support, which could be reinforced by additional amendment. However, following current trends of good governance, policymakers must have public legitimation. Rather than compulsory COVID-19 vaccination, an approach based on education and truthful information, persuading the population of the benefits of a vaccine on a voluntary basis, is recommended. Disagreements between health professionals are positive, but they should be resolved following good practice and the procedures of the code of ethics. Furthermore, citizens do not support the involvement of government authorities in the direct control of news. Collaboration with the media and other organizations should be used instead.

Legal regulation of the transmission of health-related data: Balance of public interests and individual rights in the context of cross-border health care

The article provides a comparative analysis of the regulatory and legal regulation for the processing of a special category of personal health data in the European Union and in the Russian Federation in regard to the digitalization of national health systems. Special attention is paid to the legal framework for the transmission of health information at the cross-border level. It is established that within the framework of European and Russian legislation at this stage, in the context of the formation of digital medicine, there is a comparability in the definition of legal mechanisms for the protection of medical data. It is also noted that in the issue of the transfer of personal health data to third countries, both the Russian Federation and the European Union choose the path of strict restrictive regulation and the introduction of a closed list of grounds for overcoming the ban on cross-border transfer. The reasons for this approach to issues of supranational interaction in healthcare are analyzed, as well as the potential risks of inertia of national legislators in this issue. Based on the analysis, the authors propose a number of amendments and additions to the national legislation on personal data, aimed at simplifying the interaction between jurisdictions on the transfer of confidential medical information. The authors suggest an international agreement on the exchange of medical data in digital format, which potentially should include not only the Russian Federation and the EU states, but also other countries, including Eurasian Economic Union member states, China, and countries of the American continent. The proposed concept is intended to create an opportunity for the formation of a supranational information system in the field of healthcare, which allows for the effective exchange of medical data, taking into account the sovereign interests of the countries participating in the agreement.

СПІВРОБІТНИЦТВО ДЕРЖАВ У СФЕРІ БОРОТЬБИ З КІБЕРЗЛОЧИННІСТЮ ТА ПІДХОДИ ДО ВИРІШЕННЯ ПРОБЛЕМИ КІБЕРТЕРОРИЗМУ

Currently, society is evolving into information one, which, on the one hand, simplifies the interaction between participants in public relations, and on the other hand, increases the risk of human rights violations, when using information and communication technologies. Changing the structure and scope of information transfer requires both the subjects of social relations, which have a personal interest in ensuring the highest possible level of security of transmitted data, and the state as a whole as a guarantor of the stability of the legal field of public relations. It is obvious that national security largely depends on information security, and in the course of technical progress, this dependence is only growing. Information, acting as an economic and social guarantee of stability of existence and development of society and the state, is the object of close attention and influence of the state. The introduction of e-document management and the creation of interconnected information resources have made information vulnerable to outside interference.The choice is made by the individual user of information-and-communication technologies, by civil society as a whole (for example, by opposing or supporting certain state policies inthe information sphere) and by public authorities, as they decide on lawmaking and implementation of relevant norms. Each state is constantly balancing between the principles of respect for human and civil rights and freedoms, integration into the international community, the need to ensure economic growth and national security. However, no domestic policy should outweigh the need for international cooperation in the fight against crime, which should be based on the principles of openness, mutual assistance, development of new forms of cooperation. It seems that international cooperation in the fight against cybercrime should be carried out with the participation of all countries.The legal basis of the regime of preservation of information in internationallaw includes the following components: basic principles of human rights protection; the procedure for cross-border circulation of information; protection of confidential information; the status of international bodies implementing a unified legal policy in the field of information protection and its implementation. It seems that international cooperation in the fight against cybercrime must be carried out with the participation of all countries. At the same time, based on a generalized analysis of the legal framework of international, European and national legislation of the EU countries, a certain approach to the implementation of international cooperation in combating cybercrime is proposed: improving the legal framework for international cooperation, harmonized implementation of developed legal norms into national legislation, improving approaches to information exchange.

Mechanisms for Innovative-Driven Solutions in European Smart Cities

Innovative procurement is an important tool for smart cities to improve the effectiveness and efficiency of public services, especially in sectors such as smart living (for example, health conditions), smart mobility, or smart environment (with emphasis on waste and water management). The European Union (EU) public procurement legislative framework encourages the deployment of innovation by several means (including, inter alia, the introduction of competitive procedures promoting innovation, use of award criteria based on factors other than price, and the life-cycle approach) and sets the scene for a more strategic procurement for EU smart cities. Despite the proven benefits of innovative procurement, public authorities, driven mainly by their preference to follow traditional tender procedures under solely budgetary considerations, have hesitated to introduce innovation. The case study of Greece is examined, and it is concluded that despite the adopted policy measures that are conducive for mainstreaming innovation procurement, innovation procurement in Greece is at an early development stage. One of the reasons that hinder the application of innovation-oriented procedures by public purchasers is their insufficient knowledge of the available legal framework. The broad objective of this article is to outline the main innovation-friendly tools, as set out in the applicable European public procurement legislative framework that smart cities should adopt in order to make strategic use of innovative procurement.

A multifunctional assessment of integrated and ecological farming in olive agroecosystems in southwestern Spain using the Analytic Hierarchy Process

Olive agroecosystems have for several decades undergone management changes aimed to meet the demands of new agricultural policy trends and of consumers and society. While the main role of olive groves is the production of olives and oil, its multifunctional performance is supported through the European and regional legislative framework, promoting the recognition of non-productive ecosystem services provided by agriculture to society. The objective of this work is to compare two types of olive grove management (integrated and ecological) under the multifunctionality of agriculture (MFA) approach, in Estepa (Andalusia, Spain). To this end, environmental, economic and social indicators were considered. Subsequently, the multifunctional behaviour of olive groves under different management schemes was evaluated using the multicriteria Analytic Hierarchy Process (AHP) methodology. Ecological farming presented greater valuation in the satisfaction of social demands, with better weightings in all the indicators evaluated, except for farm income and Lepidoptera richness. Thus, the implementation of practices related to ecological management leads to a greater multifunctionality of olive groves. It is thus fundamental that multi-scale policies consider the value of the environmental externalities of this type of management, favouring its implementation to contribute positively to the multifunctionality and sustainability of olive groves in Andalusia.

РАЗВИТИЕ ГЕНДЕРНОЙ ПОЛИТИКИ ЕВРОПЕЙСКОГО СОЮЗА ПОСЛЕ 2010 ГОДА

Introduction: one of the most relevant and at the same time debatable issues in the modern world is that of gender equality of men and women that implies the legal principle and the person’s legal status in relations with the state void of any discrimination by gender. Gender equality therefore reflects political and social changes in society. Aims: to analyze the institutional and regulatory aspect of the EU gender policy formation and to identify the main trends in the development of the European gender balance policy after 2010. Methods: gender approach provides for the analysis of the political component in the EU society and outlining such basic concepts as “gender policy”, “gender equality” and “gender egalitarianism”. Based on these basic concepts, it becomes possible to analyze the political participation of men and women, to compare their roles and opportunities under the framework of European legislation. Results: the study of the EU gender policy development indicates the presence of political initiatives within the European legislation framework aimed at achieving gender equality and gender egalitarianism. It is concluded that the EU gender policy is a complex set of various measures, political initiatives and institutions, ultimately leading to women gaining equal political rights to participate in governance. However, the statistical reports analyzed do not make it possible to assess the expected effectiveness of the adopted strategies due to the existing economic and migration crises. Conclusions: the EU is halfway towards achieving gender equality. At present, a comprehensive mechanism has been launched to ensure gender balance, which includes both various institutes dealing with this issue, as well as constitutional and legal mechanisms embodied in strategies, conventions, treaties and various other legal initiatives aimed at ensuring continuous work to overcome gender discrimination in European society.

Основні напрями впровадження міжнародних стандартів оцінки ринкової вартості майна, майнових прав та активів комерційних банків в Україні

In the article, on the basis of generalization of the international experience of valuation of the market value of property, property rights and assets of commercial banks, the proposals for harmonization of national valuation standards with the international ones are formed. The structural features of international and European standards of assessment are considered. It is emphasized that the European Valuation Standards (EVS 2016) contain elements of the European legislative framework that are related to the financial valuation of property, which allows for various types of financial valuation of tangible and intangible assets. It is found that the difference between these standards is their large structural detail and focus on examining the specific specifics of specific areas of evaluation work. The peculiarities of application as a base of valuation of the market value in the valuation of assets of commercial banks containing property rights are considered. The introduction of the Technical Document of the Automated Assessment Model to substantiate the practical implementation of the Unified Database of Assessment Reports of the State Automated Information and Telecommunication System provided by the legislation of Ukraine is substantiated; of the Technical Document of fair value determination according to the International Financial Reporting Standards is substantiated. Researched estimation of the market value of mortgage property in the case of mortgage lending by banks, which require improvement of professional national standards, are considered. The extension of existing national property and property valuation standards is justified by an approach to value appraisal using optional pricing models. The peculiarities of application of Black-Scholes dynamic model for estimation of market value of a commercial bank are considered. Because, in this sector, assets and liabilities are close in value because of the peculiarities of doing business, mainly at the expense of attracted funds.

Orphan drug designation in Europe-Procedural guidance and challenges

The European legislative framework on orphan medicinal products was implemented to stimulate the development of medicinal products against rare diseases and to ensure the patient’s adequate access to qualitative and specific treatment methods. Between 2000 and 2018 3210 orphan drug designation applications were submitted in Europe of which 2121 orphan designations have been issued by the European Commission. (1) Though the definitions for orphan medicinal products and the regulatory procedures are well defined, a high degree of regulatory knowledge is needed and strategic decisions on the development program must be considered at a very early stage of development: in fact, only 164 of the 2121 designated orphan development products have resulted in authorised orphan medicinal products since the orphan legislation was implemented.
 In this article, the requirements and procedures for the orphan designation application and maintenance at the time of marketing authorisation application are discussed in the context of the European Regulation.

The Effects of Nickel on the Structure and Functioning of a Freshwater Plankton Community Under High Dissolved Organic Carbon Conditions: A Microcosm Experiment.

In the present study, we aimed to test the protectiveness of the bioavailability-normalization procedure, with its associated hazardous concentrations for x% of the species (HCx), that is currently implemented to derive environmental threshold concentrations for nickel (Ni) in European environmental legislative frameworks. We exposed a natural plankton-dominated community to 3 constant Ni concentrations, that is, a control with no Ni added (background Ni of 1.2-4 µg/L) and the bioavailability-normalized HC5 and HC50 of 24 and 97 µg dissolved Ni/L, respectively, during a 56-d microcosm experiment under high dissolved organic carbon (DOC) conditions (DOC of 14 mg/L at test initiation). The effects of the bioavailability-normalized HC5 and HC50 values were evaluated at the levels of community structure (community composition and plankton group abundances), community functioning (measured as indirect physicochemical proxies for overnight respiration and carbon fluxes), and individual species abundances. The bioavailability-normalized HC50 treatment had clear effects (defined as effects occurring on at least 2 consecutive sampling days) on both the structure and functioning of the investigated aquatic community. Through its effect on community functioning (i.e., reduced pH and DOC), Ni also influenced its own bioavailability. Clear direct effects of Ni were observed for only 3 species (the Cyanobacteria Oscillatoria sp. 1 and the rotifers Asplanchna/Testidunela sp. and Trichocerca group similis). Most other effects occurring in the plankton community in the HC50 treatment were indirect and likely driven by the direct effect of Ni on the Cyanobacteria Oscillatoria sp. 1, which was the dominant phytoplankton species in the control microcosms. In contrast, the bioavailability-normalized HC5 did not induce clear effects on community structure and functioning endpoints: these were only affected on individual sampling days. Clear (direct) effects were observed for only 2 plankton species (the rotifer Trichocerca group similis and the Cyanobacteria Oscillatoria sp. 1), but their abundances recovered to control levels at the end of the study. In addition, a few species (1 phytoplankton and 3 zooplankton species) were affected in the HC5 treatment only on the last sampling day. It is uncertain whether these species would have shown clear effects over a longer exposure duration. Thus, our study shows that the bioavailability-normalized HC5 of Ni at high DOC induced clear effects on a few individual species. However, the overall conclusion is that the bioavailability-normalized HC5 of Ni as derived through the procedure that is currently implemented in European legislative frameworks protects against clear effects on community structure and function. Environ Toxicol Chem 2019;38:1923-1939. © 2019 SETAC.

The ‘enabling’ master’s degree in architecture, an opportunity for experiential learning

Schools of architecture have recently converted the former Final Degree Project into a one-year ‘enabling’ master’s degree. This is a collateral effect of adapting Spanish university studies to the European legislative framework. Faced with this challenge, the Escola Tècnica Superior d’Arquitectura del Vallès (ETSAV) proposed the implementation of a teaching model that would allow students to learn based on the experience of interaction with ‘the people’ and construction experimentation. On a methodological level, the article reviews the theoretical basis related to this model based on the condition of an open process, physical experimentation and social return. It also makes a critical approach of the three first years of the master’s degree to identify and review the teaching tools implemented, the subjects being researched and the contradictions that emerge. It concludes by evaluating the results obtained and identifying the need to balance learning between psychosocial competences and construction and technological competences, representing the main challenge and potential complexity of the service-learning projects conducted by the ETSAV’s ‘enabling’ master’s degree.

The Legal Framework for Academic Professional Development for Radiographers in Higher Education

Technology has changed the world of radiography, setting the request for development and promotion of radiography occupation. This article focuses on key factors of education for radiologic technologist / radiographer. The important role of EFRS in promoting and developing advanced educational standards and qualifications for radiographers is elaborated. Harmonization and development of radiographer’s profession following technological development considers cooperation among educational institutions, employers and professional bodies, within the framework of European and national legislation. Society should provide the conditions for further education. Obtaining a master's and / or doctoral degree, and integration in teaching and research activities, helps transform radiographers into leadership roles within their departments.

Official controls regarding artisanal ice cream shops: public health policies and consumer protection in the Italian and European legislative frameworks.

Ice cream is a widely enjoyed food that is especially popular during summer. To ensure it is safe and ready-to-eat for consumers, legislation imposes a series of obligations for food business operators, and for competent authorities that have to carry out official controls, including official sampling. This article reviews the general and specific requirements applicable to the premises where ice cream is produced, concerning aspects related to health notification obligations and to implementing and maintaining procedures based on the principles of the Hazard Analysis and Critical Control Point system. The review extends to results stemming from the most recent official control activities conducted in Italy, and to future perspectives on control methods that will have to be compliant with the provisions of the new EU Regulation 625/2017 applicable from 2019.

Protectionist vs liberalised maritime cabotage policies: a review

Purpose The development of the current European economic area maritime cabotage market occurred when, at a policy level, the European Union forced the opening of its member-states cabotage markets to Community shipowners and extended this openness, in 1997, to the european free trade area countries. A two-tier cabotage market emerged, where a European economic area legislative framework co-exists with the legislative acts of each member-state. With such a unique background, this paper aims to investigate both the European economic area member-states and the rest of the world cabotage regimes and identify a list of reasons and policy measures used to implement cabotage policies. Design/methodology/approach By means of a desk research methodological approach, this paper analyses, from a geographical perspective, different countries’ cabotage policies and classifies them, and identifies in a systematically way a set of reasons and policy instruments that support each of chosen policies approach. Findings The outcome indicates that only a few countries promote free liberalised cabotage services and that most countries favour protectionist cabotage policies, whose governments can control the number of foreign vessels participating in these trades. Cabotage regimes have been categorised and the reasons behind both policies and respective policy instruments have been identified. Originality/value Quite often, researchers only focus on the cabotage policies of the European economic area countries, the USA, Australia, Japan and South Korea. This paper value rests on its ability to incorporate cabotage policies from other African, Asian and Latin American countries and to update existing information on the subject. Overall, this paper paves the way to broaden the cabotage knowledge.