European Union Regulatory Framework Research Articles

Dynamic Regulatory Assessment: evolving the European Regulatory Framework for the Benefit of Patients and Public Health—an EFPIA View

The European Union regulatory framework supports development, review, authorization, and maintenance of medicines to benefit public health; however, many elements are 2 decades old and undergoing review. Scrutiny was triggered by the coronavirus disease 2019 pandemic, the need to support future innovative medicines, the digital transformation of data exchange, and the need to address efficiency and capacity limitations. There are also ongoing evolutions in regulatory science for medicines (eg, cell and gene therapies), medical device combinations, and software, as well as the need to fully leverage contemporary information technology (IT). Important initiatives to address these challenges include the European Medicines Agency (EMA) Regulatory Science Strategy,1 the EU Regulatory Network Strategy,2 and the Big Data Steering Group,3 alongside European Commission-led initiatives such as the Pharmaceutical Strategy.4 Dynamic regulatory assessment (DRA) is a concept that seeks to integrate these various elements to re-imagine regulatory review interactions across the product life cycle. DRA calls for iterative regulatory dialogue, data submission, and evidence assessment, enabled by contemporary IT. DRA will facilitate iterative interaction and data assessment as it accumulates over a product's life cycle, bringing significant efficiencies for all product types. The DRA concept primarily evolved through dialogue within working groups of the European Federation of Pharmaceutical Industries and Associations. This article describes the long-term vision of the European Federation of Pharmaceutical Industries and Associations and outlines important strategic elements of progress, including: aligning on a multi-stakeholder vision for DRA in the European Union and across regions; leveraging learnings from ongoing initiatives; and advancing IT, governance, and standards considerations. Ultimately, DRA should consider outcomes that deliver optimal benefits for patients in the European Union and worldwide.

Improving Risk Assessment for Transporting Dangerous Goods through European Road Tunnels: A Delphi Study

Managing the transportation of dangerous goods (DG) through road tunnels is of great importance since it is associated with a serious risk of accidents. The consequences of an accident involving DG, especially in the closed tunnel environment, might be more significant and even more catastrophic compared to the same accident occurring on an open road. This article presents the Greek experience regarding the application of quantitative risk assessment (QRA) methods for the transportation of DG through Greek road tunnels. The modified Delphi method, with the participation of nine experts, is employed to investigate the obstacles to successfully conforming with the mandatory European Union regulatory framework that applies to transport operations within the Trans-European road network. Recommendations are made to improve the applied QRA approach, to facilitate the cooperation between tunnel managers and emergency services, to communicate lessons learned and to enhance the training of risk assessors.

The ethics of facial recognition technologies, surveillance, and accountability in an age of artificial intelligence: a comparative analysis of US, EU, and UK regulatory frameworks

The rapid development of facial recognition technologies (FRT) has led to complex ethical choices in terms of balancing individual privacy rights versus delivering societal safety. Within this space, increasingly commonplace use of these technologies by law enforcement agencies has presented a particular lens for probing this complex landscape, its application, and the acceptable extent of citizen surveillance. This analysis focuses on the regulatory contexts and recent case law in the United States (USA), United Kingdom (UK), and European Union (EU) in terms of the use and misuse of FRT by law enforcement agencies. In the case of the USA, it is one of the main global regions in which the technology is being rapidly evolved, and yet, it has a patchwork of legislation with less emphasis on data protection and privacy. Within the context of the EU and the UK, there has been a critical focus on the development of accountability requirements particularly when considered in the context of the EU’s General Data Protection Regulation (GDPR) and the legal focus on Privacy by Design (PbD). However, globally, there is no standardised human rights framework and regulatory requirements that can be easily applied to FRT rollout. This article contains a discursive discussion considering the complexity of the ethical and regulatory dimensions at play in these spaces including considering data protection and human rights frameworks. It concludes that data protection impact assessments (DPIA) and human rights impact assessments together with greater transparency, regulation, audit and explanation of FRT use, and application in individual contexts would improve FRT deployments. In addition, it sets out ten critical questions which it suggests need to be answered for the successful development and deployment of FRT and AI more broadly. It is suggested that these should be answered by lawmakers, policy makers, AI developers, and adopters.

The Ethics of Facial Recognition Technologies, Surveillance and Accountability in an Age of Artificial Intelligence: A Comparative Analysis of USA, EU and UK Regulatory Frameworks

The rapid development of facial recognition technologies (FRT) has led to complex ethical choices in terms of balancing individual privacy rights versus delivering societal safety. Within this space, increasingly commonplace use of these technologies by law enforcement agencies has presented a particular lens for probing this complex landscape, its application and the acceptable extent of citizen surveillance. This analysis focuses on the regulatory contexts and recent case law in the United States (USA), United Kingdom (UK) and European Union (EU) in terms of the use and misuse of FRT by law enforcement agencies. In the case of the USA, it is one of the main global regions in which the technology is being rapidly evolved, and yet it has a patchwork of legislation with less emphasis on data protection and privacy. Within the context of the EU and the UK, there has been a critical focus on the development of accountability requirements particularly when considered in the context of the EU’s General Data Protection Regulation (GDPR) and the legal focus on Privacy by Design (PbD). However, globally there is no standardised human rights framework and regulatory requirements that can be easily applied to FRT roll out. This article contains a discursive discussion considering the complexity of the ethical and regulatory dimensions at play in these spaces including considering data protection and human rights frameworks. It concludes that data protection impact assessments (DPIA) and human rights impact assessments together with greater transparency, regulation, audit and explanation of FRT use and application in individual contexts would improve FRT deployments. In addition, it sets out ten critical questions which it suggests need to be answered for the successful development and deployment of FRT and AI more broadly. It is suggested that these should be answered by lawmakers, policy makers, AI developers and adopters.

LEGAL BASIS OF THE EUROPEAN UNION INFLUENCE ON THE VIRTUAL ASSETS MARKET

The article analyses the legal basis of the European Union (EU) influence on the virtual assets market. It was found that the current EU legislation on the virtual assets is still full of legal gaps and does not ensure proper market regulation because of the early stage of its development. The absence of a unanimous position regarding the virtual assets market regulation forces the EU Member States to apply their own, sometimes contradictory, approaches to market regulation. It disaffirms the basic principles of the European Singe Market functioning, in particular the free movement of goods and services. It was found that according to the current EU legislation, virtual assets may be qualified as payment tokens, investment tokens and utility tokens. Payment tokens may be considered as electronic money or funds. They are covered by the Directive (EU) 2009/110 and the Directive (EU) 2015/2366. For the purposes of anti-money laundering, virtual assets may also be classified as virtual currencies under the Directive (EU) 2018/843. Investment tokens may be qualified as transferable securities or other financial instruments and will therefore fall within the scope of the Directive (EU) 2014/65. Utility tokens are not covered by EU legislation for now. Instead of merely addressing issues and challenges of virtual assets, the European Commission took a broader approach to the future development of the virtual assets market in the EU, and adopted on 24.09.2020 a new Digital Finance Package. At the core of the mentioned Digital Finance Package are the legislative proposals for an EU regulatory framework on virtual assets. This includes the proposal for a Regulation on Markets in Crypto-assets (MiCA) which is designed to provide a comprehensive bespoke regulatory framework for virtual assets in the EU. It was substantiated that MiCA is an ambitious EU legislative project that responds to an urgent policy need. However, further substantial revision of its detailed provisions will be necessary to provide a comprehensive regulatory framework of the EU influence on the virtual assets market.

Cobalt–Chromium Dental Alloys: Metal Exposures, Toxicological Risks, CMR Classification, and EU Regulatory Framework

During the 20th century, metal alloys have assumed an important role as restorative materials. Among existing examples, cobalt–chromium (Co–Cr) alloys increasingly began to be used in medicine and especially in dentistry. Their success is mainly due to their mechanical properties such as stiffness, strength and corrosion resistance, thus allowing a high biocompatibility. There are quite meaningful data on the corrosion and toxicity of Co–Cr alloys for their use in restorative materials such as dental prostheses. Toxicological studies following Co and Cr exposures in the oral cavity are more difficult to conduct because there are many different situations leading to the release of metal ions and wear particles. Furthermore, the links between exposure and the appearance of local or systemic toxicity are not automatic. Since 2017, the European Union (EU) regulatory framework for Co–Cr alloys has been undergoing profound changes. A new EU Medical Devices Regulation (MDR) (2017/745) will be applied in May 2021 with the need to consider that Co metal is a new carcinogenic, mutagenic and toxic to reproduction (CMR) substance. On 18 February 2020, the 14th Adaptation to Technical Progress (ATP14) to the Classification, Labelling and Packaging (CLP) regulation was published, including the harmonised classification for Co metal as a CMR 1B substance. In this context, the use of Co might be forbidden if the medical devices are invasive and as soon as they include more than 0.1% (m/m) Co. This review provides a specific overview on Co–Cr dental alloys in terms of metal ions and wear particles release, toxicological risks, and the actual and new EU regulatory framework.

Safe use of chemicals and risk communication among dentists and dental students in Greece.

Use of chemicals, most often classified for intrinsic hazards, is rather common among dentists. To date, no data have been recorded in the European Union (EU) on dentists' awareness regarding the safe use of chemicals. In the EU regulatory framework, two Regulations with wide applications, namely Regulations (EC) 1907/2006 (REACH) and 1272/2008 (CLP), have been introduced to protect human health and the environment and clearly communicate hazards posed by chemicals to workers and consumers. The aim of this study was to assess the extent of comprehension of hazard communication of chemicals among Greek dentists. For this, a closed-ended, anonymous and validated questionnaire was initially distributed to a total of 300 Greek dentists, both professionals and university students, over a period of 4 months. The collected data from 240 final responders were subjected to statistical analysis (frequencies, percentages, chi-square (χ2) and significance (p < 0.05)). The vast majority (90%) of the interviewed dentists are not aware of the CLP. Main sources of information regarding chemical hazard and safe use was the supplier through direct communication (90%), while some dentists also consulted the product labels (39%) and the material safety data sheets (54%). Regarding hazard communication, the perceived information from the pictograms is confusing to the vast majority of the dentists (86%), especially for systemic hazards (carcinogenicity and/or reproductive toxicity). In addition, 88% of the professional dentists have not noticed any changes in the labelling of chemical products, which also shows the low input of labels to hazard communication. On the other hand, 90% of the responders always utilize personal protective equipment (PPE), although it is not clear whether this PPE is adequate. In conclusion, rising awareness campaigns are needed, in collaboration with universities and dental care professional associations, to inform dentists about the safe use of chemicals not only to ensure protection of their own health but also to contribute to environmental sustainability.

An extension of exemptions: systemic shifts in European Union law and policies

Rules on services of general interest allow exceptions to the internal market law of the European Union. Do these exceptions really remain within the limits of free competition? Nowadays, this question seems not to be independent from the risk of direct political considerations influencing the market of public services. This tendency may result in national legislative or administrative measures that may run counter to the spirit of the original objectives of European Union integration. European Union substantive and procedural law does not seem to raise unavoidable obstacles to such efforts. In the context of the European Union regulatory framework for services of general interest, our research focuses on the results of an analysis of a database of European Union court cases that highlights the challenges and threats of recent national instruments of public sector organization to the operation of the European Union internal market and competition rules.

Disharmonization in the Regulation of Transgenic Plants in Europe

Disharmonization in the Regulation of Transgenic Plants in Europe

Orphan Medicines for Pediatric Use: A Focus on the European Union

PurposeEuropean policy makers have provided a number of incentives for the development of medicines for orphan diseases as early as 1999 through the Orphan Regulation and created obligations for medicines developers to investigate their products in children through the Paediatric Regulation adopted in 2006. This article describes the challenges that developers of orphan medicines are facing with pediatric indications, discusses the interplay between the Orphan Regulation and the Paediatric Regulation, and provides some recommendations on how to optimize drug development under the current European Union regulatory framework. MethodsThis article discusses the European Union's Orphan Regulation, Paediatric Regulation, and the implications of the intersection of the regulations on the development of orphan medicines for pediatric use. FindingsAlthough these regulations have been successful in meeting their objectives separately, different regulatory frameworks entail separate governance, multiple assessments, varying approaches and priorities to unmet medical needs, and joined-up regulatory process coordination. Better integration of regulatory pathways would therefore be helpful in stimulating more global drug development of pediatric orphan medicines, including optimizing the interaction between both regulations, using innovative drug development approaches while considering alternatives to randomized clinical trials, better identification and prioritization of unmet medical needs in pediatrics, and ensuring the alignment of regulatory processes. ImplicationsRare diseases are categorized as “orphan diseases” because their occurrence in a small number of patients means that, regardless of the apparent high unmet medical need, there is limited public and market interest to justify the high development risk and significant investment to develop new treatments. However, unexplored potential within the area, as well as a conducive regulatory environment, can further support the development of medicines to treat rare diseases, including for children.

The EU regulatory framework on genetically modified organisms (GMOs).

The European Union (EU) legislation on genetically modified organisms (GMOs) aims to ensure a high level of protection for human, animal and environmental health and a well-functioning EU internal market. The framework regulates the release of GMOs into the environment and their use as, or in, food and feed. It has three main pillars: pre-market authorisation based on a prior risk assessment, traceability and labelling. Within this legal framework, the EU has authorised the placing on the market of 118 GMOs so far. These have been obtained through long-standing techniques of genetic modification, namely transgenesis. Following the adoption of the GMO legislation, new techniques of genetic modification, including new mutagenesis techniques, have been developed, which have raised questions regarding the applicability of the GMO legislation and attracted a lot of attention from stakeholders and the general public. This article provides an overview of EU GMO legislation and implementation of the EU Court of Justice ruling on organisms obtained by mutagenesis techniques, issued in July 2018. It also updates on the recent initiatives by the European Commission and EU Member States on new developments in biotechnology. The manuscript is based on the author's contribution at the OECD Conference on Genome Editing, Applications in Agriculture, Implications for Health, Environment and Regulation held in Paris on 28-29 June 2018. It is complemented with updated information.

Path dependencies versus efficiencies in regulation: Evidence from “old” and “new” broadband markets in the EU

This paper examines the determinants of sector-specific regulation imposed on broadband markets related both to efficiency objectives of regulators and to those of narrowly defined interest groups. We test hypotheses derived from the normative and positive theoretical literature employing recent panel data on 27 European Union member states taking into account endogeneity of the underlying regulation and market structure variables. Our empirical specification employs three different estimators based on instrumental variables in order to identify causal effects. We find evidence supporting both regulators pursuing normative objectives and inefficiencies related to regulatory path dependence, bureaucracy goals and an inadequate consideration of competition from mobile broadband networks. Our results call for adjustments in the institutional design of the decision-making process under the current European Union regulatory framework.

LAND CONSOLIDATION – A TOOL FOR SUSTAINABLE RURAL DEVELOPMENT

Discussions of the future European rural development policy started in September 2016. Participants at the Cork 2.0 European Conference on Rural Development have declared that an innovative, integrated and inclusive rural and agricultural policy in the European Union (EU) should be guided on ten policy orientations. Rural Europe is home to more than half of the EU population and covers more than three quarters of the territory. Rural areas are also important in the preservation of Europe’s natural and cultural landscapes and heritage. EU support for investment in rural areas should focus on generating added value for society. Land management has a key role in the interface between citizens and the environment. Policies must incentivise the delivery of environmental public goods, including the preservation of Europe's natural and cultural heritage. Increased pressure on natural resources must be met by coordinated cross-sectorial policy responses. These should ensure the sustainable management of natural resources such as water, soil, and biodiversity, being the very means of agricultural and forestry production. There is a need to develop and mainstream innovative, science-based solutions that allow for producing more with less while ensuring that natural resources are at the disposal of future generations. Effective formats of knowledge exchange and advice should be developed and support provided for the adoption of well-designed land management schemes. For achieving the above-mentioned objectives, in the EU regulatory framework is envisaged a possibility for direct and indirect support for land consolidation, as a tool for sustainable rural development.

Global status of the regulation of genome editing technologies.

Abstract Innovations affect societies in various ways. For example, the latest innovations in cell phones and electronics are readily adopted without hesitation. However, many innovations regarding the breeding of plants, the production of food crops and the processing of food products, can be met with fear and trepidation by some societies. Europe, the foundation of the Industrial Revolution, has developed strong adversity to agricultural innovations that involve innovative genome editing methods in general and to genetically modified (GM) crops in particular. While much of the industrial world models their regulatory frameworks for plant agriculture on the science-based risk assessment framework developed through the efforts of the Organisation for Economic Cooperation and Development, the European Union's regulatory framework for GM crops is based on the precautionary principle, approving but a single GM crop variety for production in the twenty-first century. As any field of science and technology advances, so has the breeding of GM crops. GM crop varieties were developed through the insertion of a gene or genes from a different species, such as the insertion of the trait for insect resistance in plants that originally came from a soil bacterium. Crop varieties are now being developed through a group of targeted, site-directed mutation technologies, known as genome editing, where some of this group of technologies results in no foreign genes being transferred into new varieties. While technologically viewed as a significant advancement in the development of new plant varieties, some jurisdictions have chosen to regulate genome editing as equivalent to GM crops, thereby establishing a de facto ban on the application of the technology. Yet other jurisdictions have chosen to embrace the technology, announcing that some applications of genome editing will face no regulatory oversight. This paper provides a global overview of the various regulatory frameworks for genome editing.

Path Dependencies versus Efficiencies in Regulation: Evidence from 'Old' and 'New' Broadband Markets in the EU

This paper examines the determinants of sector-specific regulation imposed on broadband markets related both to efficiency objectives of regulators and to those of narrowly defined interest groups. We test hypotheses derived from the normative and positive theoretical literature employing recent panel data on 27 European Union member states taking into account endogeneity of the underlying regulation and market structure variables. Our empirical specification employs three different estimators based on instrumental variables in order to identify causal effects. We find evidence supporting both regulators pursuing normative objectives and inefficiencies related to regulatory path dependence, bureaucracy goals and an inadequate consideration of competition from mobile broadband networks. Our results call for adjustments in the institutional design of the decision making process under the current European Union regulatory framework.

Чинники та ризики створення стратегічних нафтогазових резервів національної економіки

У статті розглянуто поняття та передумови побудови стратегічних нафтогазових резервів національної економіки. Проведений огляд нормативної бази Євросоюзу щодо формування стратегічних нафтогазових резервів. Виділені чинники створення стратегічних нафтогазових резервів та здійснена їхня систематизація за зазначеними критеріями. Розглянуті та узагальнені ризики, які впливають на стабільність постачання енергетичних ресурсів на внутрішній ринок України. Сформовано пропозиції щодо управління такими ризиками на засадах використання стандарту ISO 31000.

Towards an EU Regulatory Framework for Climate-Smart Agriculture: The Example of Soil Carbon Sequestration

AbstractThis article assesses current and proposed European Union (EU) climate and environmental law, and the legal instruments associated with the Common Agricultural Policy (CAP), to see whether soil carbon sequestration is sufficiently promoted as a promising example of ‘climate-smart agriculture’. The assessment shows that current and proposed policies and instruments are inadequate to stimulate large-scale adoption of soil carbon projects across Europe. Given the identified structural flaws, it is likely that this is true for all climate-smart agricultural practices. An alternative approach needs to be developed. Under EU climate policy, agriculture should be included in the EU Emissions Trading System (ETS) by allowing regulated industries to buy offsets from the agricultural sector, following the examples set by Australia and others. The second element of a new approach is aimed at the CAP, which needs to be far more focused on the specific requirements of climate change mitigation and adaptation. Yet, such stronger focus does not take away the need to explore new income streams for farmers from offsets under the ETS, as the CAP will never have sufficient funds for the deep and full transition of Europe’s agriculture sector that is needed.

Path Dependencies versus Efficiencies in Regulation: Evidence from 'Old' and 'New' Broadband Markets in the EU

This paper examines the determinants of sector-specific regulation imposed on broadband markets related both to efficiency objectives of regulators and to those of narrowly defined interest groups. We test hypotheses derived from the normative and positive theoretical literature employing recent panel data on 27 European Union member states taking into account endogeneity of the underlying regulation and market structure variables. Our empirical specification employs three different estimators based on instrumental variables in order to identify causal effects. We find evidence supporting both regulators pursuing normative objectives and inefficiencies related to regulatory path dependence, bureaucracy goals and an inadequate consideration of competition from mobile broadband networks. Our results call for adjustments in the institutional design of the decision making process under the current European Union regulatory framework.

The unintended consequences of EU law and policy on air pollution

Air pollution still represents a major environmental hazard in urban areas in the European Union (EU). This article argues that the EU's regulatory framework in this policy area for the past decade contributed to a series of unintended consequences. The increasing influence of climate change objectives on the air pollution agenda led to a shift in the regulatory approach to emissions from vehicles by focusing solely on the overriding interest of reducing carbon dioxide emissions and developing individual policies to that effect. This resulted in a disconnect between regulatory approaches to urban air quality and vehicle emissions standards with the effect of producing unintended consequences of unlawful levels of air pollution, in particular nitrogen oxides and particulate matter emissions as well as unintended consequences for the car industry and consumers. The article applies Merton's framework of unintended consequences, which provides a useful explanatory model of the EU's multi‐level governance process in the complex area of environmental law.

Financial Consumers and Applicable Provisions a European and Italian Perspective

In Europe, general legislation requires protection of the economic interests of consumers. This includes, for instance, the consumer protection from financial services, misleading advertising and unfair contract terms. However, only after the global financial crisis, the European Union (EU) has become aware of the lack of transparency, poor handling of conflicts of interest, over-indebtedness, and low awareness of risks of the consumers in dealing with financial services. This paper aims to investigate the financial knowledge and overconfidence in Europe, and to provide an overview of consumer protection policy in EU. Here, it will be analyzed the EU regulatory framework, whose aim is to ensure the stability of the financial markets and to establish specific and common rules for banks and investments companies among the Member States. Furthermore, it deals with protections of financial consumers in the Italian legislation and within a European context. It concludes providing the Italian financial system as best example of crisis management and resolution, by providing out-of-court settlements, collective redress and crisis management procedures, with the aims to establish a systemic stability and financial consumers’ confidence in the bank system.