European Union Regulatory Framework Research Articles

The Sanctions Principles-Based Regulation: A Blueprint for a New Approach for the EU Sanctions Policy (Part I)

192 Despite the tremendous number of studies devoted to the effectiveness of economic sanctions, the unprecedented number of sanctions applied and the recent European Union (EU) reforms on sanctions, sanctions effectiveness should be still a matter of debate. More than a year after Russia’s full-scale invasion of Ukraine, but G7-led sanctions have not materially hindered Russia’s war effort. This study intends to address this problem by focusing on how to make the use and application of EU sanctions against Russia more effective. In doing so, I argue that the main impediments to EU sanctions effectiveness are systemic in nature and inherent to the EU sanctions policy framework. The piecemeal changes of the EU sanctions regulatory framework undertaken so far have not solved these systemic flaws that undermine the effectiveness of EU sanctions. A fundamental revision of the entire system of the EU sanctions policy framework is needed. This study proposes implementing a comprehensive principles-based framework for EU sanctions policy, where harmonisation and the risk-based approach are its foundations, to make sanctions more effective. The proposed sanctions principles-based framework is broader in its scope than is currently the case; it covers a broader set of principles. The proposed frame includes all the stages of the sanctions process, is addressed to a broader number of actors and its foundations are developed. I recommend that this sanctions principles-based framework should be mandatory for use. This is the first part of a two-part article. Part I of the article discusses the need for the revision of the regulatory approach to the EU sanctions policy to increase the effectiveness of sanctions. It includes the analysis of the EU sanctions as a foreign policy instrument and a comprehensive overview of the EU regulatory framework on sanctions as well as the analysis of imposition of the EU sanctions against Russia. Part I also discusses policy proposals for the effectiveness of the EU sanctions, such as harmonisation of the EU sanction policy and the application of a sanctions risk-based approach.

The Registration of Medical Device in FDA, EU and CDSCO: Overview

This comprehensive summary provides a detailed look into the regulatory processes for registering medical devices in three major jurisdictions: the US Food and Drug Administration (FDA), the European Union (EU), and India's Central Drugs Standard Control Organization (CDSCO). Each regulatory agency plays a crucial role in ensuring the safety, effectiveness, and quality standards of medical devices in their respective markets. The FDA, as the regulatory authority in the United States, has a stringent registration system in place to evaluate and approve medical devices before they can be marketed and sold. Manufacturers must adhere to specific procedures and programs to comply with FDA regulations, which are designed to safeguard patient health and promote innovation in the medical device industry. In the European Union, medical device registration is regulated by the EU's Medicinal Products for Human Use Directive, which sets forth stringent requirements for safety and quality standards. Manufacturers must undergo a thorough review process and obtain a CE Mark certification before their devices can be introduced to the European market. The EU's regulatory framework aims to harmonize standards across member states and ensure consistency in device registration procedures. In India, the CDSCO oversees the registration of medical devices and plays a key role in evaluating the safety and efficacy of products before they can be launched in the Indian market. Manufacturers must comply with CDSCO regulations and submit detailed documentation to demonstrate the safety and performance of their devices.

Cost and competitiveness of green hydrogen and the effects of the European Union regulatory framework

By passing the delegated acts supplementing the revised Renewable Energy Directive, the European Commission has recently set a regulatory benchmark for the classification of green hydrogen in the European Union. Controversial reactions to the restricted power purchase for electrolyser operation reflect the need for more clarity about the effects of the delegated acts on the cost and the renewable characteristics of green hydrogen. To resolve this controversy, we compare different power purchase scenarios, considering major uncertainty factors such as electricity prices and the availability of renewables in various European locations. We show that the permission for unrestricted electricity mix usage does not necessarily lead to an emission intensity increase, partially debilitating concerns by the European Commission, and could notably decrease green hydrogen production cost. Furthermore, our results indicate that the transitional regulations adopted to support a green hydrogen production ramp-up can result in similar cost reductions and ensure high renewable electricity usage.

A harmonisation approach to traditional Chinese medicine registration in Asian countries

The traditional Chinese medicine (TCM) industry is critical to not only for public health but also for economic growth. According to the European Union (EU) directives, under the EU framework for (traditional) herbal medicinal products, herbal medicines with long history of use can be registered in EU. However, there is a condition in this directive in which only those that have at least 10–15 years in the EU market are accepted for registration and/or marketing authorization. In author opinion, the condition of 10–15 years of use in EU countries set within the EU regulatory framework is with consideration of the genetic differences which can result in variation in adverse drug responses among different world populations. With this concept in mind, it is reasonable to project the principal of the EU directive to the Asian countries where TCM is originated. Countries like China, Singapore, Japan and South Korea that have well established drug registration framework are in best position in executing the best practice and facilitate harmonization of registration for TCM within the region. Furthermore, the registration process itself allows more safety and efficacy data to be collected systemically before and after product registration/marketing authorization. These are valuable information for future drug development. The therapeutic value of TCM is limitless, it has been left out in the EU regulatory framework, and the opportunity for it to be expanded and carried forward in modern medicines is shadowed by the limited number of TCM that are qualified to be registered under the EU regulatory framework. An early establishment of a harmonized risk-based registration process for TCM in Asian countries is important. This will strengthen the database to substantiate the history of safe use and further preserving and expanding the therapeutic values of TCM within and beyond the Asian region.

Development of Legal Regulation of the Use of Mobile Medical Technologies (mHealth) in the Law of International Integration Associations: European Union Experience

The paper examines the experience of legal regulation of the use of mobile medical technologies (MMT, mHealth) in the largest regional integration association — the European Union (EU). It is noted that digital healthcare is a multifaceted concept that includes various aspects of public health and the digital environment surrounding it. Digitalization of healthcare covers medical processes, including software to support the work of doctors (including telemedicine technologies), tools for managing a medical institution, remote interaction with patients and monitoring such interaction; big data analytics for drug development, clinical research management, patient population studies; additional patient-oriented tools and including applications related to the determination of physical condition and the course of treatment, as well as compliance with the medication regimen. The paper provides a detailed overview of the main EU documents in the relevant field, illustrates the impact of judicial practice on the development of regulation in the field of mobile medical technologies, and analyzes the mechanisms of selfregulation in this area using the example of specific court cases. It is emphasized that while self-regulation on the part of the applications store can set developers of mobile healthcare applications in the right direction by converting the provisions of Regulation 2016/679 (GDPR) into technical requirements for preliminary approval, compliance with privacy provisions is facilitated by increased awareness of both application users and developers, as well as brokers of medical data about the risks to the observance of fundamental human rights. from the side of mobile healthcare applications. In conclusion, the authors formulated the key problems and ways to improve EU regulatory framework in the field of mobile medical technologies, recommended the use of EU best practices in the development of MMT regulatory regulation in the Russian Federation and integration associations with its participation.

Construction Productivity Graph: a comprehensive methodology based on BIM and AI techniques to enhance productivity and safety on construction sites

The construction sector is characterised by distinctive issues, such as product uniqueness, the reluctance to introduce innovation, player fragmentation leading to a low productivity level and a related high level of risk intended due to the increased likelihood of damages and injuries, and the consequences on construction productivity. The common European Union regulatory framework provides strict regulations about on-site working activities, but there is still no standard for the environmental and social sustainability of construction sites. Productivity assumes a crucial role in reducing the environmental impact of construction and positively influences workers’ safety due to higher levels of organisation, reducing time, costs, resource consumption and wasted time. This paper presents a methodology developed by augmenting BIM systems capabilities using Agent-based simulation techniques to simulate and optimise on-site work. The augmented BIM model allows analysis of site conditions in terms of space utilisation and resource allocation, resulting in the ‘Construction Productivity Graph – CPG’. This graphic representation synthesises the results obtained, making it possible to visualise the work progression in different working areas with the resources employed, allowing for the management of productivity rates and the verification of work safety conditions.

The AI cycle of health inequity and digital ageism: mitigating biases through the EU regulatory framework on medical devices

Abstract The use of Artificial Intelligence (AI) medical devices is rapidly growing. Although AI may benefit the quality and safety of healthcare for older adults, it simultaneously introduces new ethical and legal issues. Many AI medical devices exhibit age-related biases. The first part of this paper explains how ‘digital ageism’ is produced throughout the entire lifecycle of medical AI and may lead to health inequity for older people: systemic, avoidable differences in the health status of different population groups. This paper takes digital ageism as a use case to show the potential inequitable effects of AI, conceptualized as the ‘AI cycle of health inequity’. The second part of this paper explores how the European Union (EU) regulatory framework addresses the issue of digital ageism. It argues that the negative effects of age-related bias in AI medical devices are insufficiently recognized within the regulatory framework of the EU Medical Devices Regulation and the new AI Act. It concludes that while the EU framework does address some of the key issues related to technical biases in AI medical devices by stipulating rules for performance and data quality, it does not account for contextual biases, therefore neglecting part of the AI cycle of health inequity.

Media Concentration Law: Gaps and Promises in the Digital Age

Power concentrations are increasing in today’s media landscape. Reasons for this include increasing structural and technological dependences on digital platform companies, as well as shifts in opinion power and control over news production, distribution, and consumption. Digital opinion power and platformised media markets have prompted the need for a re-evaluation of the current approach. This article critically revisits and analyses media concentration rules. To this end, I employ a normative conceptual framework that examines ”opinion power in the platform world” at three distinct levels (individual citizen, institutional newsroom, and media ecosystem). At each level, I identify the existing legal tools and gaps in controlling power and concentration in the digital age. Based on that, I offer a unifying theoretical framework for a “digital media concentration law,” along with core concepts and guiding principles. I highlight policy goals and fields that are outside the traditional scope yet are relevant for addressing issues relating to the digital age. Additionally, the emerging European Union regulatory framework—specifically the Digital Services Act, the Digital Markets Act, and the European Media Freedom Act—reflects an evolving approach regarding platforms and media concentration. On a final note, the analysis draws from the mapping and evaluation results of a Europe-wide study on media pluralism and diversity online, which examined (national) media concentration rules.

Food access and commercialization in integrated markets: a bridge linking private and public aspects

The purpose of this paper is to analyze what are the changes in the legal regulation on food in the European Union (EU) and in the Common Market of the South (MERCOSUR) that have occurred in recent times to account for the impact on the actions of legal and natural persons as consumers in integrated spaces. It starts from the premise that -currently- there are three purposes pursued by legislation issued both locally and regionally: food safety, quality and competitiveness. The regional legal framework must ensure that the rules applied to food allow a wide offer to ensure competition in the regional market, and at the same time that food is safe and of high quality so that consumers have the possibility of choosing freely. The jurisprudence of the Court of Justice of the EU (CJEU), exemplifies, through its interpretation - in selected cases - of the norms concerning the multiple facets - from the introduction and circulation (commercialization) of a food in the regional market- and allows reflection from the public (member states-third states) and private (operators and consumers) spheres on the importance of the rules. The main data collection technique used -in this work- is the analysis of documentation from the EU regulatory framework, both original and secondary law - in particular, Parliament and Council regulations, or directives - as well as the analysis of jurisprudence of the CJEU, through which secondary data is collected -mainly Decisions of the Common Market Council (CMC), Resolutions of the Common Market Group (GMC), Directives of the Common Market Trade Commission (CCM)-. In relation to the data analysis procedures, qualitative and comparative analyses are used.

Advocacy coalitions and policy change for decarbonisation of international maritime transport: The case of FuelEU maritime

The legislators of the European Union (EU) have agreed on the FuelEU Maritime regulation, so far, the world's most ambitious pathway to maritime decarbonisation. FuelEU Maritime establishes a common EU regulatory framework to stimulate an increased share of renewable and low-carbon fuels in the fuel mix of international maritime transport. This article analyses, through the lens of the Advocacy Coalition Framework, the policy process leading to the political agreement on the FuelEU Maritime regulation. Core beliefs of two different advocacy coalitions including the European Commission, the Council of Ministers, EU Member States, the European Parliament and different IGs are identified like Transport & Environment and the European Community Shipping Association, as are the paths to policy change. The agreement on the FuelEU Maritime regulation follows the Paris Agreement and the following international discussions on how to curb the climate impact from shipping, the presentation of the ‘European Green Deal’ with a European Climate Law and the presentation of a broad package of EU climate, energy and transport legislation. In addition, it is a result of problem-solving bargaining between the Council of Ministers and the European Parliament.

Devising policy strategies for the deployment of energy efficiency Pay-for-Performance programmes in the European Union

Triggering a massive wave of renovation in buildings and sustaining it over the long term requires a mix of policy instruments ranging from regulations, renovation incentives, and financial models. In this context, an innovative financing approach to consider is Pay-for-Performance (P4P) programmes, which use data-driven measurement and verification approaches and engage both energy and third-party service providers in energy efficiency projects. However, while in North America, several energy utilities have already piloted and launched energy efficiency P4P programmes, progress in the European Union (EU) still remains slow. In this article, we focus on how the existing EU regulatory and market framework could support the deployment of P4P programmes. To do so, we combine a Strengths, Weaknesses, Opportunities, and Threats framework with an Analytical Hierarchy Process method and a Threats, Opportunities, Weaknesses, and Strengths matrix for the analysis of different stakeholder perceptions and the formulation of policy strategies. Policy recommendations include, among others, establishing demanding energy performance standards, valuing energy efficiency as a resource, and promoting “metered savings” methodologies. Overall, our work serves as a reference point for policy developments and adjustments that could facilitate the design and deployment of performance-based energy efficiency programmes in the EU.

Article: The Distorting Effects of Imputation Systems on Tax Competition in the EU

The design of corporate income tax systems and thus the taxation of (cross-border) dividends are encompassed within the sovereignty of the Member States of the European Union (EU). However, these rules are restricted by the EU regulatory framework and the case law of the European Court of Justice (ECJ) which prohibit discrimination of foreign- against domestic-sourced dividends. Therefore, five EU Member States abolished their discriminatory imputation systems in favour of shareholder relief systems between 1999 and 2019 which had not only legal but also economic implications. In this simulation study, the authors assess how and to what extent the abolishment of discriminatory imputation systems in the EU Member States affected a country’s tax location attractiveness for capital investments and tax competition. The analysis is based on the cost of capital (CoC) and effective average tax rates (EATR) using the Devereux/Griffith methodology. Overall, under the discriminatory imputation systems, the authors find lower CoC and EATR for investments located in the shareholder’s residence country compared to foreign investment alternatives. The advantageousness is, on average, reversed after the switch to the shareholder relief systems and places additional tax competition pressure on the affected Member States. Corporate tax systems, Dividend taxation, Devereux/Griffith methodology, European Court of Justice, Internal market, Effective tax rates, Cost of capital JEL classification: H21, H24, H25, K34

EU regulation of gene-edited plants-A reform proposal.

This article presents a proposal on how the European Union's regulatory framework on genetically modified (GM) plants should be reformed in light of recent developments in genomic plant breeding techniques. The reform involves a three-tier system reflecting the genetic changes and resulting traits of GM plants. The article is intended to contribute to the ongoing debate over how best to regulate plant gene editing techniques in the EU.

European Union Regulatory Framework on Artificial Intelligence (SMEs)

Artificial Intelligence (AI) and its application has become a popular topic of discussion, especially within the last decade, with its being seen with both enthusiasm for the opportunities it rings, and fear of its potential. The current paper aims to investigate the European Union (EU) regulatory framework proposal on Artificial Intelligence, and its impact on small and medium size enterprises (SMEs). Within the paper, the regulatory goals and recommendations, conceptual view of AI, and global trends on its application are presented.

Regulatory policy and pharmaceutical innovation in the United Kingdom after Brexit: Initial insights.

Brexit was presented as an opportunity to promote innovation by breaking free from the European Union regulatory framework. Since the beginning of 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) has operated as the independent regulatory agency for the United Kingdom. The MHRA's regulatory activity in 2021 was analyzed and compared to that of other international regulatory bodies. The MHRA remained reliant on EU regulatory decision-making for novel medicines and there were significant regulatory delays for a small number of novel medicines in the UK, the reasons being so far unclear. In addition, the MHRA introduced innovation initiatives, which show early promise for quicker authorization of innovative medicines for cancer and other areas of unmet need. Longer-term observation and analysis is needed to show the full impact of post-Brexit pharmaceutical regulatory policy.

Use of new approach methodologies (NAMs) to meet regulatory requirements for the assessment of industrial chemicals and pesticides for effects on human health.

New approach methodologies (NAMs) are increasingly being used for regulatory decision making by agencies worldwide because of their potential to reliably and efficiently produce information that is fit for purpose while reducing animal use. This article summarizes the ability to use NAMs for the assessment of human health effects of industrial chemicals and pesticides within the United States, Canada, and European Union regulatory frameworks. While all regulations include some flexibility to allow for the use of NAMs, the implementation of this flexibility varies across product type and regulatory scheme. This article provides an overview of various agencies’ guidelines and strategic plans on the use of NAMs, and specific examples of the successful application of NAMs to meet regulatory requirements. It also summarizes intra- and inter-agency collaborations that strengthen scientific, regulatory, and public confidence in NAMs, thereby fostering their global use as reliable and relevant tools for toxicological evaluations. Ultimately, understanding the current regulatory landscape helps inform the scientific community on the steps needed to further advance timely uptake of approaches that best protect human health and the environment.

Public sector information in the European Union policy: The misbalance between economy and individuals

Algorithmic technologies and artificial intelligence are centred on data and generate new business models, known as the data-driven economy. In the European Union context, the development of such new business is accompanied by a regulatory and political framework. An important aspect of this regulatory framework regards the legal conditions that enable the data collection, availability, sharing, use and reuse. Within the larger context, this article analyses the development of the European Union regulatory framework governing the availability, sharing and reuse of public sector data, also referred to as Public Sector Information policy. Anchored in the analytical tools provided by Discursive Institutionalism and Critical Data Studies and after studying the evolution of this policy over 25 years, this article argues that economic considerations have been overwhelmingly decisive in the European Union Public Sector Information policy and much less attention has been paid to fundamental rights and democracy issues. It also shows how European Union Public Sector Information policy contributes to the data infrastructure, enabling a thriving data-driven economy. In doing so, this article argues that the possible problematic effects of this new data-driven economy are not only affordances of the technology itself but are also the result of political and regulatory choices. More globally, the article stresses the need for policymakers to inscribe each of the policies and regulations affecting the digital transformation in the framework of fundamental rights and democracy.

Genetically Modified Crops in Romania before and after the Accession of the European Union

Modern biotechnology entered the world science arena after 1972, and in less than 22 years the first genetically modified crop was placed on the market. The analysis of relevant biosafety portals and official and scientific documents was applied in this study to reveal positive and negative issues of the Romanian biosafety framework before and after the European Union (EU) accession. The success in cultivating highly productive GM soybean was rapidly embraced by Romania between 1999 and 2005. Before 2007, Romania was cited among the Mega Biotech Countries, with a cultivation of 87.500 ha. After the accession to the European Union, Romania stopped any GM crop cultivation. There was an immense effort to harmonize with the EU regulatory framework between 2005 and 2007. The monitoring system for GM crops has been in place since 2007. Public research on aspects of GMOs started before 1996 and continues to develop. The analysis of our results supports the idea that Romania is a perfect example of a country committed to embracing GM crop cultivation for 7 years, followed by almost complete phasing out of GM crop cultivation to comply with all requirements for EU accession in less than 1 year.

2020–2022: Pivotal Years for European Energy Infrastructure

The development of energy infrastructure is crucial for the fulfilment of multifaceted European Union (EU) policy objectives in the energy field. The EU’s support to projects is financial, technical, and political, and explicated through a series of legislative acts. This opinion aims to provide an overview of the main energy policy initiatives introduced in recent years (or soon to be introduced) and their impact on European energy infrastructure development. Examples include the revision of the Trans-European Networks for Energy, funding mechanisms to foster sustainable investments in renewable energies, and the EU taxonomy on sustainable activities. We also discuss possible future improvements of EU policy and regulatory frameworks on energy with the aim of supporting an efficient achievement of the European Green Deal objectives.

A Multi-Criteria Approach to Decision Making in Broadband Technology Selection

A new European Union regulatory framework for the telecom sector has been under a process of transposition to national laws by its member states that should have been completed by the end of 2020, notwithstanding some delays. A core purpose of the regulatory framework is to guarantee that most citizens will have access to very fast Internet connections, capable of 100 Mbps download link speed, regardless of where they live. According to this new framework, in areas where the market does not deliver, governments are to launch public tenders for the deployment, maintenance, and operations of network infrastructure as well as services, and public funds should be used to support the deployment of these broadband networks in less densely populated areas. Needless to say, public tenders of this nature are subject to different criteria when it comes to candidate evaluation. In this paper, we present a decision model for the selection of operators to deploy and maintain broadband networks in scarcely populated areas, taking into consideration infrastructure costs, the technical quality offered by the solutions, and the credibility of the candidates. We suggest an integrated multi-stakeholder multi-criteria approach and demonstrate how it can be used in this complex area and find that in the example provided, taking a relevant set of criteria into the analysis, optical fibre networks hold much higher chances to be used in these public tenders compared to networks based on the broadly favoured 5G technology.