European Regulatory Framework Research Articles

The Passing-On of Price Overcharges in European Competition Damages Actions: A Matter of Causation and an Issue of Policy

This paper analyses the functioning of the passing-on of price overcharges in damages actions for breaches of EU competition law and aims to give a critical appraisal of the present regulatory framework in Europe. In particular, this paper maintains that the European Directive 2014/104, in order to facilitate the claims of damages caused by the infringement of European competition rules and to provide full compensation for those damages, has adopted a complex set of rules placing the burden of proof on the party that has, assumedly, the best access to evidence on the relevant issue. Moreover, it is noted that these rules give a strict definition of the overcharge harm and of its diffusion through the market chain. In this connection, it is argued that the objectives of the Directive are partly compromised by the fact that this restrictive approach fails to take into consideration a number of other subjects who may potentially be damaged by the passing-on of the overcharge harm.Secondly, this paper maintains that the set of rules laid down by the Directive 2014/104 creates a system of presumptions, which, contrary to its intended purpose, is likely to discourage damages actions. Finally, this paper argues that actions by indirect purchasers based on the passing-on of the overcharge will still need to heavily rely on domestic civil law rules in particular on local principles of causation and evidence.

Mikrobiološka bezbednost kozmetičkih proizvoda i potencijalni rizici za potrošače

The European regulatory framework in the field of cosmetic products requires of manufacturers to provide an assessment of microbial limits tests and results of preservation challenge test, as well as microbiological stability data which should be documented in the cosmetic product safety report. During the development of a cosmetic product, it is necessary to consider the risk of microbiological contamination in the selection of starting cosmetic ingredients and packaging, manufacturing process, alongside with conditions of storage and use. The deviation of the microbiological quality of the cosmetic product from the manufacturer's specification presents a risk for consumers, especially if it is used around the eyes, on mucous membranes in general, on damaged skin or it is intented for use in specific groups of consumers (children under the age of 3, elderly people and immunocompromised persons).

Pravno uređenje kupnje dionica ciljnog društva zaduživanjem (LBO transakcije)

U radu se obrađuju transakcije kod kojih se stjecanje dionica financira zaduživanjem ciljnog društva (LBO transakcije), ukazujući na otvorena pitanja u njihovoj primjeni. Autori se posebno osvrću na primjenu propisa o povezanim društvima te na provođenje statusne promjene pripajanja kod LBO transakcija. Budući da je praksa pokazala da se LBO transakcije često koriste u postupcima preuzimanja, autori u zasebnom poglavlju obrađuju korištenje ovih transkacija u tim postupcima. U radu se analizira europski regulatorni okvir uređenja LBO transakcija te se iznose i uspoređuju rješenja hrvatskoga, slovenskog i talijanskog prava. Uspoređujući rješenja istraženih pravnih poredaka uočeno je da su sva tri istražena pravna poretka različito uredila ove transakcije. Dok su Hrvatska i Italija uredile LBO transakcije na način kako ih uređuje Druga direktiva u pravu društava, slovenski je zakonodavac znatno pooštrio uvjete za korištenje ovih transakcija, odnosno de facto onemogućio njihovo korištenje. Temeljem rezultata provedenoga istraživanja, autori zaključno daju prijedloge rješenja de lege ferenda.

A European banking business models analysis: the investment services case

PurposeBusiness Model Analysis is acquiring increasing visibility in the European banking regulatory framework, following the European Banking Authority guidelines on common procedures and methodologies for the supervisory review and evaluation process (SREP), developed to assess business and strategic risks (EBA, 2014, 2015a, 2015b, 2015c). Starting from a selected literature review, in the paper, the authors analyse business models set up by financial intermediaries, bank and non-banks, for the distribution of investment services, first by comparing European niche players with European banking global players, and second, comparing European niche players among themselves to understand the evolution of business models for the distribution of investment services at European level. The research is supported by the Baffi–Carefin Research Centre at the Bocconi University (Italy), in collaboration with ANASF, the Italian Association of Financial Advisors (Italy).Design/methodology/approachThe authors consider a sample of European financial players from 2009 to 2014. The authors’ focus is on France, Germany, Italy, The Netherlands, Spain and the UK; overall the authors’ handmade data set is based on 162 annual reports. The authors follow two main questions: Do the niche players, as they are focused on the distribution of investment services, have an upper limit to profitability, compared to the global players, as risk-takers in many financial areas? How is the business model of niche players changing, facing increasing competition and regulatory pressures?FindingsAnswering the first research question, the highest net profitability is found in the niche players group; the global players, as risk-takers, achieve lower remuneration, in contrast with the risk premium theory. The results were assessed over a limited period, however, deemed in line with the company’s strategic planning horizon. Answering the second research question, the authors focus on the case of niche players, using a cluster analysis. The authors identify three different business models: most dynamic niche players, which combine investment services, insurance and welfare services, achieving the highest margins and stability; players mainly focused on asset management, whose key vulnerability is the degree of open architecture, especially in light of future MiFID 2 implementation; and players mainly focused on the creation of well-structured on-line platforms, which offer also brokerage services, thereby reducing their marginality and potentially increasing their business risk.Research limitations/implicationsDespite the limited time series, the authors’ research gives some inputs for those interested in deepening the business model analysis focus on the distribution of investment services and the business and strategic risk assessment, both for the global banks and the niche players (banks and non-banks).Practical implicationsThe authors’ results could be of some interest during the strategic assessment of global banks and niche players, both adopting an internal perspective or an external one, as regulator.Social implicationsBy giving some specific insights into the assessment and comparison of business and strategic risks among global and niche players, the authors’ research provides the basis for further research in the field of the distribution of investment services.Originality/valueThe originality mainly regards the business model risk perspective and the focus of the authors’ analysis: the distribution of investment services. This sector, unlike the asset management, does not have an easily recognisable group of comparables at European level, all the European countries analysed have very different business models. This research avails of an original database, that is unique to Europe.

Impact Assessment of Pollutant Emissions in the Atmosphere from a Power Plant over a Complex Terrain and under Unsteady Winds

The development of a natural gas-fired tri-generation power plant (520 MW Combined Cycle Gas Turbines + 58 MW Tri-generation) in the Republic of San Marino, a small independent country in Northern Italy, is under assessment. This work investigates the impact of atmospheric emissions of NOx by the plant, under the Italian and European regulatory framework. The impact assessment was performed by the means of the Aria Industry package, including the 3D Lagrangian stochastic particle dispersion model SPRAY, the diagnostic meteorological model SWIFT, and the turbulence model SURFPRO (Aria Technologies, France, and Arianet, Italy). The Republic of San Marino is almost completely mountainous, 10 km west of the Adriatic Sea and affected by land-sea breeze circulation. SPRAY is suitable for simulations under non-homogenous and non-stationary conditions, over a complex topography. The emission scenario included both a worst-case meteorological condition and three 10-day periods representative of typical atmospheric conditions for 2014. The simulated NOx concentrations were compared with the regulatory air quality limits. Notwithstanding the high emission rate, the simulation showed a spatially confined environmental impact, with only a single NOx peak at ground where the plume hits the hillside of the Mount Titano (749 m a.s.l.), 5 km west of the future power plant.

Advanced therapies push regulatory boundaries: Novel therapeutic approaches require more regulatory flexibility and transparency.

The regulation of new medical applications has always been lagging behind the science that enabled these therapies in the first place, but emerging therapeutic approaches are pushing the boundaries harder than ever. Although fundamental principles around safety, efficacy and quality are cast in stone, new interpretations and greater flexibility are required for the clinical use of advanced medicines and treatments without introducing unacceptable risks. There are also ethical considerations that, although not new, are amplified by the potential of emerging therapies to address previously untreatable conditions. All major regulatory bodies, such as the US Food and Drug Administration (FDA) and the European Medical Agency (EMA), have for some years been aware of the challenges posed in particular by Advanced Therapy Medicinal Products (ATMPs). These roughly include three categories: gene therapy medicinal products (GTMPs), somatic cell therapy medicinal products (SCTMPs) and tissue‐engineered products (TEPs), many of which have emerged from the “omics” revolution and stem cell research. > All major regulatory bodies […] have for some years been aware of the challenges posed in particular by Advanced Therapy Medicinal Products ### Advanced Therapy Medicinal Products Both GTMPs and SCTMPs involve ex vivo manipulation of cells, but with a crucial difference in terms of manufacture and function. GTMPs deliver recombinant DNA to specific target cells in the body, whereas SCTMPs are whole cells or tissues genetically manipulated to change their biological characteristics or functions for preventing, diagnosing or treating disease. These cells can be autologous, coming from the patient, allogeneic from another human being or xenogeneic from animals. One recent example of GMTP is recombinant viral vaccines against cancer engineered from an immunogenic virus particle to express tumour antigens, cytokines or both [1]. SCTMPs were the first AMPs to be tested clinically in 1997 for corneal epithelial stem cell transplantation. Since then, the technique has been …

Guidelines for Bacteriophage Product Certification.

Following decades in the wilderness, bacteriophage therapy is now appearing as a credible antimicrobial strategy. However, this reemerging therapy does not rekindle without raising sensitive regulatory concerns. Indeed, whereas the European regulatory framework has been basically implemented to tackle ready-to-use pharmaceuticals produced on a large scale, bacteriophage therapy relies on a dynamic approach requiring a regulation on personalized medicine, nonexistent at present. Because of this, no guideline are currently available for addressing the scientific and regulatory issues specifically related to phage therapy medicinal products (PTMP).Pending to the implementation of an appropriate regulatory framework and to the development of ensuing guidelines, several avenues which might lead to PTMP regulatory compliance are explored here. Insights might come from the multi-strain dossier approach set up for particular animal vaccines, from the homologous group concept developed for the allergen products or from the licensing process for veterinary autogenous vaccines. Depending on national legislations, customized preparations prescribed as magistral formulas or to be used on a named-patient basis are possible regulatory approaches to be considered. However, these schemes are not optimal and should thus be regarded as transitional.

Strengths, weaknesses and future challenges of biosimilars’ development. An opinion on how to improve the knowledge and use of biosimilars in clinical practice

Biosimilars started receiving the marketing authorization by European Medicine Agency since 2006.The development of biosimilars follows a well-defined step-wise approach, the so-called comparability exercise, which aims to compare non-clinical (mainly quality features and biological activity) and clinical (efficacy and safety profiles) features of new biosimilars with their respective reference products. Despite the undeniable advantages of such procedure, some concerns (such as the absence of switching studies or the evaluation of efficacy and safety in all therapeutic indications) still exist about its. In particular, the European regulatory framework on biosimilars approval does not include the conduction of switching studies demonstrating the interchangeability to be carried out before marketing authorization. This is one of the main aspects that negatively affects healthcare professionals’ clinical decisions on switch.In order to achieve a better knowledge on safety and efficacy of biosimilar drugs, real world data should be collected and post-marketing efficacy and safety clinical studies (including those evaluating specific endpoints, therapeutic regimens and patients population), should be planned. also the conduction of well-designed switching studies is highly advisable, especially in the case of biosimilar drugs used in oncology settings. Lastly, considering the critical role of antidrug antibodies on efficacy/safety profile of biologic drugs, studies based on therapeutic drug monitoring would be useful in order to achieve treatment optimization.Implementing the above strategies could be helpful to fill the gap in knowledge observed in the present European biosimilar regulatory framework.

Regulatory and Scientific Advancements in Gene Therapy: State-of-the-Art of Clinical Applications and of the Supporting European Regulatory Framework.

Advanced therapy medicinal products (ATMPs) have a massive potential to address existing unmet medical needs. Specifically, gene therapy medicinal products (GTMPs) may potentially provide cure for several genetic diseases. In Europe, the ATMP regulation was fully implemented in 2009 and, at this point, the Committee for Advanced Therapies was created as a dedicated group of specialists to evaluate medicinal products requiring specific expertise in this area. To date, there are three authorized GTMPs, and the first one was approved in 2012. Broad research has been conducted in this field over the last few decades and different clinical applications are being investigated worldwide, using different strategies that range from direct gene replacement or addition to more complex pathways such as specific gene editing or RNA targeting. Important safety risks, limited efficacy, manufacturing hurdles, or ethical conflicts may represent challenges in the success of a candidate GTMP. During the development process, it is fundamental to take such aspects into account and establish overcoming strategies. This article reviews the current European legal framework of ATMPs, provides an overview of the clinical applications for approved and investigational GTMPs, and discusses critical challenges in the development of GTMPs.

The regulatory status of gene-edited agricultural products in the EU and beyond.

Governments all over the world are struggling with the regulatory status of gene-edited organisms. Are they regulated? Should they be regulated? In the present paper, the main focus is on the regulatory status of gene-edited organisms within the European regulatory framework. A stepwise analysis is performed that comes to the conclusion that gene-edited agricultural products that carry edits that can also occur naturally by mating and/or natural recombination are not a genetically modified organism. On the question whether they should be regulated, it is argued that it is difficult to require regulatory oversight that would go beyond what we now require for conventional products that can carry the same types of alterations. A regulatory approach is pleaded for that abides to fundamental principles of law making, and which allows for gene editing to develop responsibly.

Incentives for Investment in Fast Broadband: How Much Can Be Expected from the Proposed European Code?

In September 2016, the European Commission presented legislative proposals to replace the European Regulatory Framework for Electronic Communications (RFEC) with a new European Electronic Communications Code. Among the many stated objectives was to stimulate more rapid investment in fast and ultra-fast broadband. One can argue that the RFEC was put in place in 2002, at a time when networks were not yet liberalised or privatised, and when investment needs of existing copper networks were fairly consistent and predictable. As a consequence, the RFEC put great emphasis on achieving competition, relatively little on achieving investment. This reflects to some extent a preference for optimisation of static efficiency over dynamic efficiency, which was perhaps in order given that the former is far easier to analyse than the latter. In this paper, we review the regulatory instruments that provided in the European Code, and consider based on the economic literature, publicly available statistics, and our own analysis the degree to which the Action Lines in the proposed European Code are likely (individually or collectively) to contribute to increased investment in fast broadband in practice. Our assessment is that the proposed enhancements to broadband policy in the proposed European Code are broadly in the right direction, and collectively are likely to offer network operators a more profitable and predictable business case for investment in high speed broadband. Notwithstanding our observations that the case for FTTP/FTTP can often be significantly overblown, we would still say that this is a welcome or overdue change. The risks implied by insufficient specification of these provisions in the European Code, and the lack of clarity as regards technological neutrality, are however significant. We would hope that these provisions can be sharpened in the course of the legislative process.

Органічне сільське господарство в Україні

The organic sector is growing steadily throughout the world. At the same time, in Ukraine this growth is constrained by improper legislative environment, lack of state financial support, low domestic effective demand and inadequate development of the relevant infrastructure. Ukrainian organic sector has inviting development prospects. First of all, this applies to crop production: sunflower seeds, soybeans and cereals, high protein crops, processed fruits and berries, walnuts, medicinal herbs, aromatic plants, and honey. Comparative evaluation of the Ukrainian and European regulatory and legal frameworks in the regulation of organic sector allows to conclude on a general convergence of the above documents. The most problematic issue remains the state support for the development of organic production. In this context, the primary task consists in practical implementation of the still only declared strategy of the priority development of organic production in Ukraine. For this purpose it is necessary: to form an appropriate regulatory and legal framework and effective certification system; to provide financial support of agro-producers during the conversion period; to stimulate relevant scientific and research developments and provide informational, advisory and educational services to the operators in organic sector, together with supporting the cooperative movement there; to develop the infrastructure of the organic market; and to organize collection and processing of the on organic operators in the context of the EU indicators.

Regulation of Business-Clients Relationships through ‘Organisational Law’

AbstractIn the European regulatory framework, private law principles, and primarily party autonomy, may be interpreted as legal tools oriented beyond the interests of the single individuals involved in commercial transactions, and rather connected to the superior objectives of the Internal Market, and of the European Economic Constitution. Looking from this perspective at the regulation of Business-Client relationships, while it is clear that the strong interrelation of autonomy/heteronomy elements in commercial transactions calls for a methodological approach capable of providing an integrated view of regulation and private law, it also emerges that, up to now, similar attempts have been developed mainly within contract theory. The aim of this article is to test whether the regulatory perspective of European private law allows the regulation of Business-Client relationships through standards and rules not directly taken from contract law, but rather originating in other, formally different, legal branches. More specifically, attention in centred on corporate law, intended as that part of commercial law which defines the internal structure of the firm. Focus is thus put on organisational rules which are relevant within an incorporated business: the analysis starts from national rules, anchored to the traditional partition between civil law and commercial law; then it traces their rationale within the European framework, looking for hermeneutical insights capable of providing a more unified interpretation of those rules when framed back at a national level, as standards of regulatory private law.

Time for a New EU Regulatory Framework for GM Crops?

In recent years, the EU legislation on genetically modified (GM) crops has come under severe criticism. Among the arguments are that the present legislation is inconsistent, disproportionate, obsolete from a scientific point of view, and vague in terms of its scope. In this paper, the EU GM legislation (mainly the “Release Directive”, 2001/18/EC) is analysed based on five proposed criteria: legal certainty, non-discrimination, proportionality, scientific adaptability, and inclusion of non-safety considerations. It is argued that the European regulatory framework does not at present satisfy the criteria of legal certainty, non-discrimination, and scientific adaptability. Two ways of reforming the present legislation toward greater accommodation of the values expressed through the proposed criteria are briefly introduced and discussed.

Implementation of a safe-by-design approach in the development of new open pilot lines for the manufacture of carbon nanotube-based nano-enabled products

The project PLATFORM (H2020, GA 646307) aims to develop three new pilot lines (PPLs) for the manufacture of carbon nanotube-based nano-enabled products (buckypapers, treated prepregs, doped veils), for the European aeronautics and automotive industries (a Technology Readiness Level 6 - TRL6 - is expected at the end of the project). The Machinery Directive 2006/42/EC (MD) - transposed into the respective national legislations - is the European regulatory framework for the design and construction of new machinery, as the future PPLs. PPLs are not required to comply with the provisions of the MD until they are put into service - expected in 2020, after project completion - but then, the MD will be fully applicable. In this regulatory context, the project PLATFORM is aligning the design of the PPLs according to the MD requirements, in order to facilitate the CE marking in 2020 (TRL9) and avoid potential economic costs associated with future re-adaptations or modifications needed to ensure compliance with the MD. This paper discusses the methodological approach followed by the project PLATFORM to integrate all the nanosafety aspects in the design of the PPLs, in order to achieve safe designs in conformity with the relevant Essential Health and Safety Requirements (EHSRs) of the MD. Since machinery must be designed and constructed taking into account the results of the risk assessment (RA), this paper describes the systematic and iterative approach for RA and risk reduction followed to eliminate hazards as far practicable and to adequately reduce risks by the implementation of protective measures. This process has been guided by the harmonized standards EN ISO 12100 and EN ISO 14123, taking the relevant phases of life cycle, expected uses and operation modes of the PPLs into account. A specific tool to guide the safe design of the PPLs and facilitate the RA process has also been produced by the project (PLATFORM – SbD toolkit).

European regulatory framework for person carrier robots

The aim of this paper is to establish the grounds for a future regulatory framework for Person Carrier Robots, which includes legal and ethical aspects. Current industrial standards focus on physical human–robot interaction, i.e. on the prevention of harm. Current robot technology nonetheless challenges other aspects in the legal domain. The main issues comprise privacy, data protection, liability, autonomy, dignity, and ethics. The paper first discusses the need to take into account other interdisciplinary aspects of robot technology to offer complete legal coverage to citizens. As the European Union starts using impact assessment methodology for completing new technologies regulations, a new methodology based on it to approach the insertion of personal care robots will be discussed. Then, after framing the discussion with a use case, analysis of the involved legal challenges will be conducted. Some concrete scenarios will contribute to easing the explanatory analysis.

European regulations for the introduction of novel radiopharmaceuticals in the clinical setting.

The development of novel radiopharmaceuticals is very rapid and highly innovative both for diagnostic and therapeutic applications. The translation into the clinic, however, is hampered by the high regulatory demands in Europe. This article describes the main rules, guidelines and guidance documents in the European Union in relation to the pharmaceutical regulatory framework. Until today a great number of radiopharmaceuticals are introduced clinically using specific national pathways outside the clinical trial regulation and examples are provided. In this context, the European Pharmacopoeia with a legal status plays an important role in defining quality standards. For clinical trials the application system and regulatory framework in Europe is currently considerably changing. Whereas the current clinical trial directive requires a lengthy and complicated national application process, the new regulation 536/2014 will introduce a streamlined and unified European application process. This new regulation also takes into account the specific properties of radioactive investigational medicinal products and has introduced exceptions for good manufacturing practices (GMP) and labelling for radiopharmaceuticals. Besides the main regulatory texts, several guidelines have been published, e.g. related to toxicity testing or first in man studies. In relation to radiopharmaceuticals professional organization, in particular the EANM, have published a number of documents in relation to GMP, documentation and toxicity studies, that support professionals in the application process. All these documents are summarized and discussed.

Environmental risk assessment of pesticides: state of the art and prospective improvement from science.

Pesticide risk assessment in the European regulatory framework is mandatory performed for active substances (pesticides) and the plant protection products they are constituents of. The aim is to guarantee that safe use can be achieved for the intended use of the product. This paper provides a feedback on the regulatory environmental risk assessment performed for pesticide registration at the EU and member state levels. The different steps of pesticide registration are addressed considering both exposure and hazard. In this paper, we focus on the environmental fate and behaviour in surface water together with the aquatic ecotoxicity of the substances to illustrate pesticide regulatory risk assessment performed for aquatic organisms. Current methodologies are presented along with highlights on potential improvements. For instance, as regards exposure aspects, moving from field based to landscape risk assessments is promising. Regarding ecotoxicology, ecological models may be valuable tools when applied to chemical risk assessment. In addition, interest and further developments to better take into account mitigation measures in risk assessment and management are also presented.

Peer-to-Peer Lending: Opportunities and Risks

AbstractWeb-based financial intermediation on a peer-to-peer (P2P) basis will eventually prevail as an economically superior form of organisation compared to the traditional banking business model. P2P lending is the most popular type of crowdfunding, whereby an internet platform collects small amounts of funds from individuals in a crowd to finance collectively a larger loan to individuals or businesses. Unlike a commercial bank, the platform does not take risks through its own contractual positions. Whereas banks accumulate risks by taking positions on their balance sheet, platforms decentralise the risks by spreading them to their users. The emergence of financial platform businesses challenges legislators and regulators in several respects: the “easy way” of modifying existing finance and banking laws is inadequate; the internal organisation and knowledge of staff is not well suited to regulating crowdfunding; and capital mediation by crowdfunding platforms requires a different regulatory approach than banking. Finally, there is no doubt that P2P lending platforms will in the long run need a dedicated, single European regulatory framework.

Free Movement and Competition in the European Market for Pharmaceuticals

Very few industries are as profoundly influenced by regulation as the pharmaceutical industry. All aspects of the life-cycle of new drugs are regulated, from patent application, to marketing approval, commercial exploitation, patent expiration and competition with generics. The nature of demand for drugs, the identity of drugs brought to market, and the nature of competition in the drug market over time are all shaped by regulation. Throughout much of the world, administrative regulation, rather than competition policy, dominates efforts to afford consumers and governments adequate access to affordable drugs.As a result, the nature of competition in this market is sui generis. A significant number of infringements to competition law in this sphere across the world are concerned with practices that seek to take advantage of or manipulate the regulatory framework, including misuses of the patent system (e.g. ever-greening or patent clustering), spreading misleading information or inducing product switching, among others. A proper understanding of how competition law works in this area requires a solid knowledge of the structure of the market and its regulation. In the European context, any such analysis must also take into account free movement law, which provides a regulatory underpinning for integrated European markets in pharmaceutical products while also acting as a parallel tool to competition law in promoting and deepening market integration.This chapter will provide an overview of free movement cases on pharmaceuticals, with a view to frame such case law within the European regulatory framework and to identify its impact on competition law enforcement. It is structured as follows: a first section will provide an overview of the structure of the European market for pharmaceuticals, including the basic European regulatory framework; a second section will review the case law on free movement and pharmaceuticals; and a last section will detail how the basic pharmaceutical regulatory framework, free movement law and competition law interact to determine the shape of European pharmaceutical markets.