French Regulations Research Articles

The Concept of Development: From Dependency Theory to Diversity of Capitalisms

This article will analyze the three most significant theoretical standpoints that have attempted to study Latin America’s development: the dependency theory, the neo-institutionalist school, and the Varieties of Capitalism perspective. In order to differentiate diverse forms of development in the continent, the final part develops the argument. It proposes a view based on the dependency theory and the French regulation school.

Effectiveness evaluation of an organisational intervention, targeting pregnancy and addiction care professionals, among women who have just given birth in maternity wards and smoked tobacco during pregnancy (5A-QUIT-N): study protocol for a stepped-wedge cluster randomised trial

IntroductionIn 2021, among French women who smoked when they knew they were pregnant, 59% still smoked at the end of pregnancy. Support for pregnant women to stop smoking must include...

Transfer Pricing End-of-Year Adjustments in France

Though there are no specific provisions on year-end adjustments in French law and regulations, the application of the general transfer rules and a rather well-established practice are reasons to allow, and even recommend, to perform such adjustments where TNMM methods are applied. This article indicates how to properly perform and document such adjustments.

Impact sound insulation performance measurements on CLT floors – Effect of excitation source type: Tapping machine and rubber ball

Laboratory and field measurements of the impact sound acoustic performance of a CLT wood-based floors have been performed. French national regulation requires the use of the standardized tapping machine for impact sound performance measurements. Since the early 2000s, rubber ball impact source has been standardized in some Asian countries to measure and evaluate the low frequency impact sound performance of floors; this excitation source is now part of international standards concerning building acoustic measurement in laboratories and in-situ. Indeed, the impact sound level associated to this soft impact source is supposed to provide a better correlation with annoyance from jumping and/or running children in buildings. The paper reviews the measurements performed using the standard tapping machine and the rubber ball as impact source, on CLT based floors in a laboratory, as well as those on the CLT based experimental building. Impact sound improvements are presented and discussed. The necessity of measuring with both impact sources, rather than only with the tapping machine is examined.

Auditory changes in awake guinea pigs exposed to overcompressed music

Exposure to loud sound during leisure time is identified as a significant risk factor for hearing by health authorities worldwide. The current standard that defines unsafe exposure rests on the equal-energy hypothesis, according to which the maximum recommended exposure is a tradeoff between level and daily exposure duration, a satisfactory recipe except for strongly non-Gaussian intense sounds such as gunshots. Nowadays, sound broadcast by music and videoconference streaming services makes extensive use of numerical dynamic range compression. By filling in millisecond-long valleys in the signal to prevent competing noise from masking, it pulls sound-level statistics away from a Gaussian distribution, the framework where the equal-energy hypothesis emerged.Auditory effects of a single 4 hour exposure to the same music were compared in two samples of guinea pigs exposed either to its original or overcompressed version played at the same average level of 102 dBA allowed by French regulations. Apart from a temporary shift of otoacoustic emissions at the lowest two frequencies 2 and 3 kHz, music exposure had no detectable cochlear effect, as monitored at 1, 2 and 7 days post-exposure. Conversely, middle-ear muscle strength behaved differentially as the group exposed to original music had fully recovered one day after exposure whereas the group exposed to overcompressed music remained stuck to about 50% of baseline even after 7 days. Subsamples were then re-exposed to the same music as the first time and sacrificed for density measurements of inner-hair-cell synapses. No difference in synaptic density was found compared to unexposed controls with either type of music.The present results show that the same music piece, harmless when played in its original version, induces a protracted deficit of one auditory neural pathway when overcompressed at the same level. The induced disorder does not seem to involve inner-hair cell synapses.

Welfare within planetary limits: deep transformation requires holistic approaches

In January 2023, Anders Rhiger Hansen visited Lund University to talk to Max Koch about sustainable welfare, human needs, social inequality and a little bit about Bourdieu. The message from Max was clear: politicians need to drop the idea of green growth and instead define a safe and just operating space to determine what can be done within this space. His sociological approach combines Marxian and Bourdieusean traditions, and he recommends that the Consumption and Society community investigates consumption in combination with processes of production, for example by engaging with critical political economy approaches such as the French regulation school or the Frankfurt School. According to Koch, the survival of the planet requires holistic approaches that would transform society and its exchanges with nature, based on principles of degrowth and on a scale that we have not yet seen.

PRESOLRE: study protocol for a primary school-based, cluster randomised controlled trial of three sun exposure risk prevention strategies on Reunion Island

IntroductionReunion Island, a French overseas department, is located in the southern hemisphere, close to the Capricorn tropic. This island has a multicultural and multiethnic population of 860 000 inhabitants, a...

A comparative ethical analysis of the Egyptian clinical research law

BackgroundIn this study, we examined the ethical implications of Egypt’s new clinical trial law, employing the ethical framework proposed by Emanuel et al. and comparing it to various national and supranational laws. This analysis is crucial as Egypt, considered a high-growth pharmaceutical market, has become an attractive location for clinical trials, offering insights into the ethical implementation of bioethical regulations in a large population country with a robust healthcare infrastructure and predominantly treatment-naïve patients.MethodsWe conducted a comparative analysis of Egyptian law with regulations from Sweden and France, including the EU Clinical Trials Regulation, considering ethical human subject research criteria, and used a directed approach to qualitative content analysis to examine the laws and regulations. This study involved extensive peer scrutiny, frequent debriefing sessions, and collaboration with legal experts with relevant international legal expertise to ensure rigorous analysis and interpretation of the laws.ResultsOn the rating of the seven different principles (social and scientific values, scientific validity, fair selection of participants, risk-benefit ratio, independent review, informed consent and respect for participants) Egypt, France, and EU regulations had comparable scores. Specific principles (Social Value, Scientific Value, and Fair selection of participants) were challenging to directly identify due to certain regulations embodying 'implicit' principles more than explicitly stated ones.ConclusionThe analysis underscores Egypt's alignment with internationally recognized ethical principles, as outlined by Emanuel et al., through its comparison with French, Swedish, and EU regulations, emphasizing the critical need for Egypt to continuously refine its ethical regulations to safeguard participant protection and research integrity. Key issues identified include the necessity to clarify and standardize the concept of social value in research, alongside concerns regarding the expertise and impartiality of ethical review boards, pointing towards a broader agenda for enhancing research ethics in Egypt and beyond.

Social Protection, Informality, and Social Reproduction: A Schematic Analytical Framework for Latin America

The lack of social protection coverage for informal workers is an enduring problem in Latin American countries, to which governments have responded by expanding different forms of social assistance. This solution has been insufficient, however, and it is also criticized for deepening the fragmentation of social protection systems. In this article, I adopt an alternative view to analyze such matters, based on the Theory of Social Reproduction and a schematic representation of National Systems of Social Protection from the French Regulation school. I adapt the schematic representation to portray a typology of systems of social reproduction with informality, which makes up an analytical framework to understand the interaction between informality and social protection. Based on it, I argue that social protection fragmentation and the pervasiveness of informality are both stabilizing social responses in the context of an increased commodification of social reproduction in Latin America. Therefore, these problems should be better addressed through institutional and structural transformations towards decommodification that push capital to internalize the costs of social reproduction.

Management of dredged marine sediments in Southern France: main keys to large-scale beneficial re-use.

Fifty million cubic meters of marine sediments are dredged each year in France in order to maintain harbor activities and sustain the economy of littoral territories. Because of anthropogenic activities in and around harbors, sediments can contain significant amounts of chemical and organic pollutants whose behavior during dredging must be addressed in order to avoid releasing risks for humans and the environment. French regulations come to govern the management of dredged sediments, considering them "safe" and possible to be dumped at sea or "contaminated" and needed to be treated on land as waste. In recent years, new constraints have been pushed toward the management of land. This management is, however, challenging as few channels are proposed to reuse marine sediments, and elimination appears to be economically and environmentally unsustainable. This study provides an overview of the technical and regulatory aspects related to dredged marine sediment management in France and aims to identify and discuss the limits of their valorization. Dredged sediments are mainly composed of particles with heterogeneous grain size, some being known for many applications such as building materials and growing media. However, several reasons have been put forward to explain why these particles are not reused when extracted from dredged sediments. Several technical, socio-economic, and regulatory obstacles explain the low demand for dredged sediments. This demand can be stimulated by government incentives and a good regulatory framework. National regulations could help streamline their reuse by removing their "waste" status and creating a regulated market for dredged sediment.

Artificial Intelligence in the French Law of 2024

The use of artificial intelligence in France is growing and intensifying in many areas, particularly in the field of justice. French President Macron has made it one of his government’s priorities to build on these assets and make France a world leader in AI. In parallel, the French government has deployed some efforts towards anticipating the regulatory challenges related to AI, the “National Strategy for Artificial Intelligence” launched as part of «France 2030» . As an illustration of the developments in artificial intelligence and its specific regulation, the French parliament passed a law to ensure the proper conduct of the 2024 Olympic and Paralympic Games (Law N° 2023-380 of 19.05.2023). The law permits the use of the experimental “augmented video-protection” technology, which uses cameras equipped with AI systems to detect and report specific events in real time. French regulations begin already now in the area of justice and must continue in the fields of AI liability and intellectual property. AI is a source of fears, particularly for the respect of human rights, and requires a very elaborate legal and ethical environment that is flexible enough to avoid slowing down the development of AI. The AI Liability EU Directive complements the Artificial Intelligence Act by introducing a new liability regime that ensures legal certainty, enhances consumer trust in AI, and assists consumers’ liability claims for damage caused by AI-enabled products and services. But the new European AI Act does not resolve all issues that therefore need to be addressed nationally.

Exavir : mise en place et évaluation de l’acquisition de compétences en pharmacologie expérimentale par des étudiants en pharmacie

With the evolution of European and French regulations on animal experimentation in higher education, taking greater account of animal welfare, the University of Angers has developed a virtual animal experimentation software named Exavir. Used for practical work (PW) in physiology, pharmacology and toxicology in the Health, Sciences, and engineering curricula, Exavir can be used to simulate various experiments for teaching purposes, in vivo or ex vivo. Thanks to an original approach integrating serious games with different scenarios, students gain autonomy and become directly involved in their learning. In addition, Exavir's collaborative and participative development approach fosters inter-university partnerships and the emergence of innovative teaching methods. A hybrid pilot study carried out on a sample of 22 students in the Pharmacy Department of the Faculty of Health showed that Exavir improved students' acquisition of teaching skills in both physiology and pharmacology, compared with practical work only based on animal organs. These encouraging results demonstrate for the first time the pedagogical advantages of Exavir and confirm the interest in developing such a platform. In this context, it appears that Exavir also opens up the possibility of adapting the practical work offered within universities, and thus responding to the changing ethical issues of the coming decades.

Defining Best Available Technique Performances for Urban Wastewater Plants: A French Application

The treatment of wastewater (WW) and the resulting sludge in urban WW treatment plants (UWWTPs) is accompanied by a significant consumption of resources as well as the concomitant emission of pollutants into the environment. One of the objectives of the NEXT (next generation of wastewater treatment plants) project is to identify sufficiently long-term optimization opportunities for processes to be selected as best available techniques (BATs) within the meaning of the industrial emissions directive (IED). The methodological framework used in this article is based on multi-criteria statistical tools, processing data from industrial plants to classify the sites studied and identify the reference plants in order to propose BAT references and associated emission levels that are reachable. Two public databases available on the internet were used, and 1,010 plants served as samples. The application and results demonstrated the applicability of the methodology and validated the mathematical approach used, as the thresholds comply with current French and European regulations. In the framework of the analysis conducted, five techniques (membrane bioreactor, bacterial bed, sand filter, and high-load or medium-load activated sludge) were identified as BAT according to the range of regulatory classification requirements for WW treatment plants (WWTPs). In addition, an example of reference values that may constitute a possible basis for the regulatory thresholds has been proposed. In parallel, a few discussion points were identified, including the choice of the metric for the reference values, the lack of data for the sludge line limiting identification of the BATs to the water line alone, the approximate characterization in the databases of certain parameters, as well as the problem of technique coupling due to the identification of one main technique.

Enhancing Sustainability in Power Electronics through Regulations and Standards: A Literature Review

Considering sustainability in Power Electronics (PE) is a relatively recent topic of interest. However, the existing regulatory and normative frameworks supposed to guide designers and industries in this direction have not been combined in an exhaustive way. This article aims to bridge the gap by conducting a literature review of the regulative and normative constraints for sustainability in PE. This study primarily addresses the framework at the European level, with a focus on French regulations and standards. In this study, a total of 63 relevant documents are collected and analyzed. A framework representing the overview of existing legislation and facultative guidelines for PE ecodesign is established. A collaborative online tool is developed to enable access to the inventory by PE stakeholders. The analysis of the framework outlines the limitations and challenges needing to be addressed, including the absence of constraints on environmental performance, the inadequacy of material efficiency standards for PE products, and the unclear methodology for ecodesign implementation. This work, undertaken at the European level with a detailed examination of the French context, is intended to serve as an inspiring analysis for other countries and for PE designers who are considering the regulatory framework of a European representative country.

NUWARD SMR safety approach and licensing objectives for international deployment

Drawing on the deep experience and understanding of the principles of nuclear safety, as well as many years of nuclear power plant design and operation, the EDF led NUWARD SMR Project is developing a design for a Small Modular Reactor (SMR) of 340 MWe composed of two 170 MWe independent units, that will supplement the offering of high-output nuclear reactors, especially in response to specific needs such as replacement of fossil-fuelled power plants. NUWARD SMR is a mix of proven and innovative design features that will make it more commercially competitive, while integrating safety features that comply with the highest international standards. Following the principles of redundancy and diversity and rigorous application of Defence in Depth (DID), with an international view on nuclear safety licensing, the Project also incorporates new safety approaches into its design development.The NUWARD SMR Project has been in development for a number of years, it entered conceptual design formally in mid-2019 and entered Basic Design in 2023. The objective of the concept design phase was to confirm the project technological choices and to define the first design configuration of the NUWARD SMR product, to document it, in order to launch pre-licensing with the French Safety Authority (ASN) and to define its estimated cost and its subsequent development and construction schedules. As a delivery milestone the Safety Options file (called the Dossier d’Options de Sûreté (DOS)) has been submitted to ASN in July 2023 for their opinion.An integral part of the NUWARD SMR Project, is not only to deliver a design suitable for France and to satisfy French regulation, but to develop a product suitable and indeed desirable, for the international market, with a first focus in Europe. In order to achieve its objectives and realise its market potential, the NUWARD SMR Project needs to define and realise its safety approach within an international environment and that is the key subject of this paper. The following paper:• Summarises the foundation principles and technological background which underpin the design;•Contextualises the key design features with regard to the international safety regulatory framework with particular emphasis on innovative passive safety aspects;•Illustrates the Project activities in preparation for first licensing in France, and also a wider international view via the ASN led Joint Early Review of the NUWARD SMR design, including Finnish and Czech Republic regulators, recently joined by the Swedish, Polish and Dutch regulators;•Articulates the collaborative approach to design development from involvement with the Project partners (the Commissariat à l’énergie atomique et aux énergies alternatives (CEA), Naval Group, TechnicAtome, Framatome and Tractebel) to the establishment of the International NUWARD Advisory Board (INAB), to gain greater international insight and advice;•Concludes with the focus on next steps into detailed design development, standardisation of the design and its simplification to enhance its commercial competitiveness in a context of further harmonisation of the nuclear safety and licensing requirements and aspirations.

Radwaste analysis and package optimization with the F4E-radwaste tool and application to the ITER IVVS

A methodology to evaluate the neutron activation, categorize as radwaste, generate radiological checklists, and optimize the packaging for disposal of activated components according to French regulations is presented. The methodology obtains results like specific activity, dose rates and radwaste relevant parameters in a fine 3D mesh superimposed over the geometry of interest and can handle the typically complex models common in the nuclear fusion analyses like those of the ITER project. State-of-the-art radiation transport and activation codes are used along with a purposefully developed Python tool (F4E-radwaste), which performs the post-processing of the large amount of data generated and includes a graphical user interface. The 3D nature of the results allows the organization of packages of activated materials in a way that minimizes the amount of mass classified with higher radwaste levels and is subject to more stringent regulations and expensive disposals. An application case study of the methodology is presented for the In-Vessel Viewing System (IVVS) ITER system. The IVVS is especially suited as an example for this type of analysis as its elongated shape pointing towards the plasma results in a significant gradient of neutron flux and activation levels, and therefore radwaste categories. It is demonstrated how the methodology enables the reduction of the total higher radwaste level mass by optimizing the packaging of the IVVS radwaste.

공공조달계약의 체결과 이해충돌 상황

The Act on the Prevention of Conflict of Interest prohibits public officials from pursuing private interests in connection with the performance of their duties. The Act aims to ensure fair performance of duties, and to secure the public's trust in public administration. It was enacted and went into effect on May 19, 2022. It is not easy to find precedents in comparative law for regulations regarding conflict of interest situations. In particular, defining and determining the scope of conflict of interest involves evaluation and judgment on very comprehensive issues, such as procurement contracts. Conflicts of interest in public procurement are an area in which violations of public official duties, criminal punishment, administrative sanctions, civil suits for damages, and issues of contract validity can be complexly connected, and a systematic review of legal principles related laws and regulations.
 In France, regulations on conflict of interest were established relatively late, but judgements established a specific precedent for conflict of interest in the area of procurement contracts. Administrative court's strong will to comply with the principle of open and fair competition was revealed in that it confirmed that if a conflict of interest is recognized through judgement, it can lead to termination of concluded contract. French law cases can give a reference in relation to case analysis and precedent issues regarding the situations of conflict of interest. This paper examine French regulations on conflicts of interest focusing on public procurement contracts, and discuss the resolution of legal disputes regarding compliance with the obligation to open and fair competition in the process of concluding public procurement contracts.

État de l'activité de rythmologie interventionnelle en France et conséquences des réformes des seuils sur les autorisations d'activité

BackgroundInterventional rhythmology activity (electrophysiology and pacing) has progressed in France during the last decade. The objective of this article is to assess the distribution of this activity depending on the type of centre (public, university or non-university, private). As the French government issued a new regulation regarding rhythmology activity in 2022, the impact of this regulation on activity distribution has been evaluated. MethodologyAll French data activity can be evaluated after accessing to a national database called PMSI [Programme de Médicalisation des Systèmes d'Information]. Based on data collected in year 2021, the level of activity of the different centres, and the impact of the new criteria of the French regulation regarding rhythmology activity have been analysed. ResultsAbout 200,000 arrhythmias interventions have been done in France in 2021 in 382 centres. According to the new criteria of the French regulation, 66% responded to level A (diagnostic electrophysiology, single- and dual-chamber pacing), 68% for level B (A+ right atrial ablation, implantable automatic defibrillator, cardiac resynchronisation therapy) and 70% for level C (B + left atrial and ventricular ablation). 1/4 of the centres do not meet criteria for level A activity, and 1/5 of them for levels B and C ConclusionsThis work showed that immediat and systematic application of new threshold could be threatening for 1/4 of A center and 1/5 of B or C center. The priority will be to reinforce existing centres before allowing new centres to perform arrhythmias management activity in France.

Aspects sociologiques des transidentités

The surgery of trans people is not apprehended by most of plastic surgeons as a simple surgery for the purpose of morphological transformation. At the same time, the French trans population does not benefit from adequate surgical coverage. Over the past few years, French regulations have simplified the process of reassignment surgeries. In addition, we have witnessed a fairly rapid increase in requests for transition surgery with accelerated and sometimes atypical courses. In recent years, a number of specialists have warned the medical community about the risks of slippage due to a lack of psychological monitoring of certain people beginning a transition process. Quite recently, hybrid transition paths have also appeared which, from a surgical point of view, are no longer limited to ensuring that a native assigned female patient can take on the most masculine appearance possible or the reverse. In this manuscript, we expose the biological, historical and societal place of transidentity and then address the reasons for the warnings of a certain category of the medical population while reassuring the surgical community on the benefits of reassignment surgeries in a controlled context. We end by proposing a few ways to improve the care course of trans people applicable in France.

Mobile blood depots in ground ambulances in compliance with French legislation: A feasibility study.

Prehospital transfusion is a way of improving the management of hemorrhagic shock. In France, prehospital transfusion is struggling to develop, both because of logistical difficulties and particularly restrictive legislation. To comply with this, we propose to store the blood products (BPs) in ground ambulances with refrigerated boxes allowing remote continuous monitoring of storage conditions, called "NelumBox" (Tec4med Lifescience GmbH). To open them, the ambulance's team needs a code that is only given by the Transfusion Center if the request meets all required regulatory criteria. We conducted a prospective simulation-based feasibility study using dummy BPs. Two ambulances were equipped. Simulations were triggered unexpectedly, including during on-call hours. The ability to quickly access the BPs was the main judgment criterion. The quality of hemovigilance during these simulations was also examined. Twenty-two simulations were performed. The ambulance's team was able to access the BPs in 100% of cases. The average waiting time for receiving the unlocking code was 5 min 27 s (SD = 2 min 12 s, MAX = 12 min 00 s). The transfusion traceability was compliant with regulations in 100% of cases. The transfusion center was able to remotely monitor BPs storage conditions for the entire duration of their stockage in the NelumBox. The present procedure is efficient, repeatable, and fast. It guarantees a strict transfusion safety without slowdown a severe trauma management, while complying with French regulations.