European Legislation Research Articles

A feminist legal analysis of non-consensual sexualized deepfakes: contextualizing its impact as AI-generated image-based violence under EU law

ABSTRACT This article focuses on the legal contextualization of the generation of fake audiovisual sexual content based on replacing and shuffling facial or voice data using artificial intelligence (AI) technology without the previous consent, commonly known as ‘non-consensual sexualized deepfakes'. The legal analysis will be limited to examination of the impact of non-consensual sexualized deepfakes on the gender equality spectrum and gender-based violence context. For this reason, the analysis will be built upon the European AI Act – the applied legal framework when AI software is used – the European Directive on combating violence against women and domestic violence (GBV Directive) – which criminalizes the generation of sexualized deepfakes – and the Digital Service Act (DSA) – the legislative framework regulating online platforms, where mostly sexualized deepfakes are distributed. To better understand how sexualized deepfakes are generated, we will examine their generation and detection techniques through a short overview from a technical lens. The methodology used is built on the feminist critical approach – based on the ‘King Kong’ theory and abolitionist feminism – to the doctrinal analysis of the relevant European legislation. After having captured the harms of deepfake technology, legal solutions will be provided through this cross-disciplinary perspective.

Overcoming the Friction between the “Right to be Forgotten” and Blockchain Technology through a New Approach

Objective: this paper explores the challenges arising from the conflict between blockchain technology and the “right to be forgotten” as provided by the European data protection framework.Methods: in the First Section, the author provides a brief description of the evolution of blockchain technology and the most pressing issues between traditional blockchain models and UE’s legislations. Among the latter, the author analyzes the specific issue concerning the clash between the traditional blockchains (both private and public models), typically immutable, and the individual’s right to cancellation or modification of own personal data. This section emphasizes the importance of personal data protection, which has always been one of the main tasks for supranational legislators. The legal regulation of data protection and the relevant judicial practice of the European Court of Human Rights is analyzed. The author raises the problem of expressing the free self-determination of an individual in the form of controlling their personal data on the Internet. The Second Section of this contribution is dedicated to the study of probable ways to solve the existing incompatibility and to make the distributed ledger system compatible with the European data protection legislation. An emphasis is made on the model provided by “Traent” company, which ensures the right to data cancellation or modification. The capability of this model to solve the said contradiction is analyzed.Results: the study delves into the peculiar features of the new model to understand how it strategically utilizes the advantages of public and private blockchains guaranteeing not only the validity and authenticity of the chain where the transaction was performed, but, most importantly, the modification and granular cancellation of client’s personal data. This innovative solution offers a potential path forward for navigating the complex intersection of data privacy and blockchain innovation in the European context.Scientific novelty: Traent has implemented a “hybrid” model blockchain that, incorporating both public and private components, to achieve an effective compliance with the European Union regulations, especially those concerning data protection and privacy.Practical significance: the obtained conclusions and proposals can be taken into consideration in improving the compliance of blockchain technologies with the European Union General Data Protection Regulation.

Pharmaceutical care for patients with coronary heart disease: transformation of pharmaceutical practice

The implementation of the National Recovery Plan of Ukraine in the field of “Health Care”, namely the restoration of the pharmaceutical sector, improving the population’s access to medicines and their proper use, taking into account the regulatory and legal field harmonized with European legislation, in the context of providing the qualified pharmaceutical care and pharmaceutical services requires application of modern approaches based on evidence-based medicine and implementation in pharmaceutical practice. Patients with cardiovascular diseases, who are provided with medication under the Reimbursement Program and prescriptions from doctors, must be accompanied by pharmaceutical care based on evidence-based medicine to ensure proper use of drugs and rational pharmacotherapy. The aim of the study was to investigate Ukrainian information and scientific databases, scientometric databases, i. e.: Embase, Web of Science, PubMed, and Cochrane Library to identify, generalize, and systematize scientific sources of medical and pharmaceutical data on providing patient-oriented pharmaceutical care to patients with coronary heart disease and predict the future vector of research on the specified topic. Results. The analysis of the main strategies of providing pharmaceutical care to patients with cardiovascular diseases, in particular, coronary heart disease in pharmaceutical practice was carried out; the most researched clusters of providing pharmaceutical care were identified; modern trends and tendencies in the provision of pharmaceutical care to patients with coronary heart disease were summarized. Conclusions. The development of providing qualified pharmaceutical care to patients with cardiovascular diseases is based on the principles of patient-oriented pharmacy and evidence-based medicine, which requires the design and implementation into the pharmaceutical practice of a sustainable conceptual model of providing patient-oriented pharmaceutical care by clinical pharmacists and pharmacists of pharmacy institutions with the expansion of the main roles, respectively the standards of Good Pharmacy Practice.

Detection of Bombyx mori as a Protein Source in Feedingstuffs by Real-Time PCR with a Single-Copy Gene Target

The silkworm, Bombyx mori, is reared on a large scale, mainly for silk production. The waste from this silk production, like pupae, is underused. As an edible insect, B. mori is a good source of protein in human food and animal feed. In recent years, European legislation on the use of insects has evolved and a multitude of European companies have initiated the rearing of insects specifically for food and feed applications. Regarding animal feed, Commission Regulations (EU) 2021/1372 and 2021/1925 authorize eight insect species, including silkworm, as processed animal proteins for use in fish, pig, and poultry feed. The incorporation of edible insects into the human diet falls within Regulation (EU) No. 2015/2283 concerning novel foods. Implementation of authentication methods is imperative to ensure the conformity of the products. In the present study, we propose a specific real-time PCR method for the detection of silkworm (B. mori). The developed PCR test amplifies a 98 bp fragment of the cadherin gene. This gene is present in a single-copy per haploid genome, as demonstrated by experimental evidence. The qualitative method was successfully evaluated on the performance criteria of specificity, sensitivity, efficiency, robustness, and transferability. The applicability of the test was assessed on samples of B. mori from industry. Light microscopy and DNA metabarcoding approaches were used as a complement to genomic analysis as a means of providing authentication of the samples.

Interactions between regulatory realms: new administrative law and credit rating agencies in a globalized society

This article examines European legislation and academic literature concerning the regulation of Credit Rating Agencies (CRAs) during times of crisis, focusing on the perspective of administrative law in global governance. To this end, it proposes a perspective that considers a communicative process to minimise negative consequences for society within the context of CRA regulatory activity. Existing regulations, reports from European, American, and international authorities, as well as relevant literature, are reviewed to understand how regulatory challenges are addressed in the era of globalization.

Policy Note: Special Taxes for Special Times? A Critical Analysis of Fiscal Crisis Responses with an Earmarking Feature in the Context of EU Law

Do special times require special taxes? The answer may not be the same from a legal, political, or economic perspective. One type of answer that legislators in Europe – both on the national and the supranational level – have given to the crises that make our times special are fiscal measures targeting extraordinary profits, revenues, or even assets while reserving the collected revenue for specific purposes. This article discusses the arguments for and against such earmarked crisis response measures in the context of their implications in the framework of EU law. It argues that specific earmarks may be attractive for reasons of political psychology such as health expenditure or inflation relief for households and firms. However, they may have unintended legal consequences by putting the respective measure into the scope of other legal regimes such as social security or banking regulation. The article contributes to the current debate about appropriate fiscal measures in times of crisis by pointing to examples of such direct and indirect interactions with primary or secondary EU law based on earmarking.

APPLICATION OF EUROPEAN CORPORATE GOVERNANCE PRINCIPLES IN THE PLANNING ACTIVITIES OF POST-WAR UKRAINE'S MULTI-LEVEL CONSUMER CO-OPERATION SYSTEM

The Association Agreement between Ukraine and the EU requires Ukraine to consider the adoption of a European model of corporate governance. The EU has a wealth of experience in the effective management of consumer co-operation, which can inform the development of best practices for Ukraine. The subject of the study is the adaptation and substantiation of the current specifics of the application of European principles of corporate governance in the process of planning the activities of a multi-level system of consumer co-operation in Ukraine. This study employs a range of general scientific methods, including modelling, economic analysis, forecasting, a system approach and synthesis. These methods have been used to develop generalisations and conclusions related to the object of research as a whole, namely the multi-level and multi-sectoral system of consumer co-operation in Ukraine. The objective of this study is to justify the implementation of European principles, mechanisms and tools of corporate governance, based on a comprehensive analysis, with the aim of optimising the planning processes and the development of a multi-level system of consumer co-operation in Ukraine. The fundamental characteristics of co-operative systems have been elucidated, and the principal distinctions between them and corporations have been identified. The functions of the corporate governance system are examined and a conclusion is reached regarding their alignment with the responsibilities and principles of consumer co-operation. The factors that contributed to the success of the development of the consumer co-operation trade sphere in the Soviet period are identified. This study considers the information base for planning the retail turnover of consumer co-operatives in the context of a planned economy. It identifies the main shortcomings and weaknesses of this approach. The principal indicators of activity for consumer co-operatives in Ukraine are examined in the context of their statutory mission. In light of the application of the substitution method, potential indicators of trade turnover for consumer co-operatives, contingent upon collaboration up to the level of 1990, are modelled. It can be concluded that the system of consumer co-operation has not yet fully adapted to the new economic conditions, new legislation and processes of increasing competition in the market, despite the transition to a market economy. In light of the aforementioned circumstances, it is imperative to implement European principles of corporate governance and contemporary international principles governing the advancement of the co-operative movement within the framework of consumer co-operation. The principles of corporate governance, developed by such international organisations as the Organisation for Economic Co-operation and Development, the European Confederation of Shareholder Associations, and the European Bank for Reconstruction and Development, have been subjected to detailed analysis. The evolution of the corporate governance system has been delineated with respect to the consumer co-operation. This trend coincides with the imperative necessity for the consumer co-operation of Ukraine to reform its planned system, which represents a key component of its commitment to more effective management. The necessity for additional harmonisation of Ukrainian co-operative legislation with European legislation has been established. The composition of the information base for the development of indicators of the plan of retail turnover of the consumer society in the modern context is justified. The article's primary conclusions are that the negative trends and the quantitative and qualitative indicators of consumer co-operatives in Ukraine can be halted and improved through the implementation and advancement of institutional co-operative advantages, which are codified by legislation and validated by both domestic and European experience. Consequently, members of consumer societies and potential shareholders must be regarded as a central object and subject of planning, regulation, operational activities and the development of consumer co-operatives. In the context of the implementation of the decentralisation policy in Ukraine, in order to optimise the relations between co-operative enterprises and organisations at the horizontal and vertical levels, it is necessary to plan the development of the co-operative system as a component of regional development. The use of IT technologies will allow automating all operational processes, using the full range of planning forms and methods, and at the same time preserving the scientifically sound principles of consumer co-operation development as a system with the possibility of medium- and long-term planning.

Ten-Year Antimicrobial Resistance Trend in Uropathogenic Escherichia coli (UPEC) Isolated from Dogs and Cats Admitted to a Veterinary Teaching Hospital in Italy

Urinary tract infections (UTIs) are a common occurrence in cats and dogs. Surveillance of antibiotic resistance trends helps in the prudent selection of suitable antimicrobial agents. However, there are limited available data on this matter in Italy. This retrospective study aimed to investigate the trends of antimicrobial resistance in uropathogenic Escherichia coli (UPEC) isolated from cats and dogs over ten years (January 2014 to October 2023). Three hundred thirty-nine UPEC strains were isolated from urine samples submitted to the Veterinary Teaching Hospital of Torino (Italy). Antimicrobial susceptibility testing was conducted for up to 11 classes of antibacterials, categorized into four categories (A, B, C, and D) following the European Medicine Agency guidelines for prudent antimicrobial use in animals. The results reveal a higher resistance towards compounds in categories C and D, while fewer isolates were resistant to antibacterials in categories B and A. Resistance has steadily increased from 2014 to 2019. Starting from 2020, a decline in resistance is evident in all four categories. The reduction is more pronounced for the categories subject to the greatest restrictions under European and national legislation. The change in resistance trend is in line with findings from other European countries and food-production animals in Italy.

Neurorights: Time to Discuss Rights to Mental Privacy and Integrity

The aim of this paper is to describe how artificial intelligence, algorithms, and deep learning can influence fundamental rights such as privacy and integrity. The authors consider the current protection of these rights the international level with a focus on Russian and European legislation. The authors also discuss whether AI poses a new threat to the protection of fundamental rights, and whether new laws should be established to deal with those violations. The study involves qualitative research methods, aimed at understanding people’s beliefs, experience, attitudes, behaviour, their interactions with social media and AI, as well as the analysis of sources of international and domestic law. The results have implications for new well-being interventions which look at the relationship between the internet and AI and their influence on individual privacy and mental integrity. The authors attempt to evaluate whether the right to privacy requires any special protection in the age of artificial intelligence, and if so, what do we mean by rights to mental privacy and integrity?

Formation of national varietal resources: status and prospects

Purpose. To study the current state and structure of national plant variety resources, analyse the dynamics of their formation, identify new challenges and threats to national interests and food security of the state. Methods. The research used general scientific methods including hypothesis, observation, search with elements of extrapolation from the source database, analysis, comparative evaluation and synthesis to draw conclusions. Results. The physical and geographical location of Ukraine in the centre of Europe determines the export­import segment of resources of varieties and hybrids, which depends on international trends and trends in the food market. In recent years, our country has lost its leading position in the market of varietal plant resources. At the beginning of the third quarter of 2024, the share of varieties of Ukrainian applicants in the State Re­gister of Plant Varieties Suitable for Distribution in Ukraine was lower than that of foreign varieties, slightly exceeding 44% (corn – 45.3%, sunflower – 32.9%, vegetables – 23.3%, rapeseed – 19.1%, beetroot – 19.2%). Currently, the priority of domestic breeding is maintained for the following groups: cereals – 52.3%, fodder – 64.2%, medicinal – 88.7%. According to experts, in the coming years three quarters of the varieties of plants grown in our country will be of foreign origin. This situation is of great concern not only because of the increased dependence on imports, but also because of the real prospect of the decline of domestic breeding and the emergence of risks in the field of plant variety rights protection. The reasons for this state of national varietal resources and trends in the development of the seed industry of the main strategic varieties were analysed, taking into account the production of seeds of both foreign and domestic breeding, the market share of which was determined during the research. The volumes and the main producers of conditioned seeds in Ukraine were determined. Conclusions. The state of plant variety resources was analysed, trends and main problems arising in the process of their formation were identified. The main directions of development and implementation of the norms of the European national legislation in the field of protection of rights to plant varieties and seed production were determined.

Implementing the Circular Economy in the European Union and Spain: Links to the Low-Carbon Transition

This paper reviews and analyzes the process of the implementation of the circular economy in the European Union (EU) and Spain, and its links to the low-carbon transition. The EU implementation of the circular economy went through several stages. Since the adoption of the first action plan in 1993, the links between the circular economy and carbon transition goals have become intertwined. Recently, the EU approved the framework of new monitoring measures and indicators for the circular economy. The adopted actions have involved the adaptation of European legislation at the national level. Spain has participated in this process since 2017, when the Circular Economy Pact was signed. The subsequent approval of the Spanish Strategy for a Circular Economy in 2020 was developed, considering a close relationship between decarbonization and the circular economy. Lately, the circular economy implementation has been strengthened with the strategic project for economic recovery and transformation, linked to the recovery of COVID-19, and the roadmap for the sustainable management of mineral raw materials, with both documents including actions directly related to transforming the energy system. Data show that Spain has made significant improvements in the circular economy transition. However, Spain’s vulnerability to externalities is greater than that of the EU as a whole.

Launching a European Employee Stock Ownership Plan (European ESOP)

PurposeWith a third of business successions failing, the EU is still confronted with a haemorrhage of around 150,000 enterprises and 600,000 jobs every year. Although 30 years of research have confirmed the positive effects of employee share ownership (ESO) for European enterprises and its important function for business succession, best practice, such as the US ESOP, is thinly spread across the EU. Nevertheless, Member States (MS) have developed a broad variety of ESO schemes involving intermediary entities to acquire and administer employee shares in the employer firm in particular for the transfer of businesses to employees. However, for small and medium enterprise (SME) owners the main barrier is still a lack of clearcut and transparent options to sell their enterprise to their employees and corresponding incentives to do so. In this light, this paper proposes a European approach, that is, a European Employee Stock Ownership Plan (European ESOP).Design/methodology/approachA “Common European ESOP Regime”, as a first step towards a “Common European Regime on EFP” would complement existing national laws aiming primarily at their harmonisation. As the name suggests, this would be a second contract law regime parallel to national legislation on ESO. Its objective is to eliminate obstacles to the single market that mainly, though not exclusively, stem from heterogeneous regulatory density. The existing obstacles are due to the multifarious development of national laws governing employee financial participation (EFP) in the MS. The “Common European ESOP Regime” would offer employers and employees a choice between two alternative EFP regimes one originating in national legislation, the other in European legislation. The choice between these two alternatives would be entirely optional, as in the case of the European Company Statute.FindingsThe European ESOP is modelled on the US ESOP and EU best practices. It embraces six European types of legal vehicles, i.e. the employee ownership trust (EOT), the French employee ownership mutual fund (FCPE), the Austrian civil law foundation, the Spanish Sociedad Laboral, the cooperative and the closely held limited liability company.Originality/valueThe “Common European ESOP regime” would neither replace nor override national legislation but would serve as a cross-border alternative to national laws, to be used at the discretion of the parties involved. Regarding its contents, it would contain best practice rules derived from each of the ESOP vehicles discussed to reflect the entire life cycle of SMEs (starting up, consolidation and succession).

РЕКЛАМНО-КОМУНІКАЦІЙНА ІНДУСТРІЯ УКРАЇНИ: ВПЛИВ ФАКТОРІВ МАКРОСЕРЕДОВИЩА

The article examines changes in the structure of the advertising market and its synergy with Digital. It was established that the structure of the advertising market, as of 2023, consists of four directions: media advertising, marketing services, digital advertising and PR market. In turn, media advertising includes: TV advertising (direct advertising, sponsorship); digital TV; advertising in the press (national, including sponsorship, regional, specialized); radio advertising (national, regional, sponsorship); OOH Media (outdoor advertising, transport advertising, DOOH, Indoor advertising); advertising in cinemas; Digital (Internet) Media advertising. Marketing services include: Trade marketing (Merchandising, Trade promo, Personnel motivation and control programs); Loyalty marketing (Mailing, DB management, Contact Center); Consumer marketing; Event Marketing and Sponsorship. Digital advertising includes: banner advertising, ads in social networks, rich media; digital video, incl. Youtube; search (paid publication in search engines), including part of GDN; influencer marketing and other digital. Quantitative indicators of the advertising market were studied and significant growth of Digital advertising in 2013-2022 was revealed. The influence of macroeconomic factors, in particular, digital technologies, the COVID-19 pandemic, the Russian-Ukrainian war on advertising and communication activities is analyzed. The study showed that the COVID-19 pandemic contributed to the development and increase of market volumes, and the war led to a significant decrease in the quantitative indicators of the media advertising, marketing services and PR market. The digital market also declined, but only to the indicators of the pandemic period. It was established that the technological factor had a significant impact on the advertising market, not only by changing traditional platforms, but also by additional opportunities in the field of production of advertising materials and creativity. The changes in the legislation of Ukraine introducing the norms of the European legislation into the national legislation through the implementation of certain provisions of the EU legislation in the field of audiovisual advertising are indicated.

Fit for 2030? Possible scenarios of road transport demand, energy consumption and greenhouse gas emissions for Italy

Decarbonizing the transportation sector is one of the key challenges to reduce greenhouse gas (GHG) emissions and meet EU Green deal 2030 targets. Road transport decarbonization requires a holistic approach encompassing various strategies and interventions aimed at fostering the sustainable transition of this sector. This challenge is crucial given that road is responsible for over 90% of the overall transport GHG emissions.Within this framework, this study aims, for the Italian case, to: a) estimate the national passenger and freight road travel demand with respect to three different time periods: 2005 (reference year for EU “fit for 55” target); 2019 (last consolidated pre-covid year); 2022 (base-line year); b) define possible road transport scenarios to 2030 following the Avoid-Shift-Improve (ASI) approach; c) estimate the GHG and energy consumption inventory related to national road transport for the 2005, 2019; 2022 and 2030 scenarios. Due to the current “deep uncertainty” regarding key economic and social variables in this period, two forecasting scenarios – named “moderate decarbo” and “high decarbo” – were designed and based on different and somewhat opposite hypotheses on exogenous variables (e.g., GDP) and penetration rates of measures and policies promoting sustainable transportation (e.g., subsidies for electric vehicles) already in place. Although the current European legislation refers only to Tank-to-Wheel (TtW) objectives, this study included also the Well-to-Wheel (WtW) evaluation, which is more accurate in assessing the GHG impact of different policies, energy carriers, and technologies. As for the past, results suggest that GHG reductions over the period 2005–2022 are mostly due to crises and stagnation of the Italian economy. “Moderate decarbo” forecasts for 2030 lead to a 12% reduction of TtW (and 15% for WtW) GHG emissions compared to 2005 levels, with ASI policies compensating for the assumed economic growth. In any case these values are far from the EU “Fit for 55” goal setting a 43.7% reduction of TtW emissions. Even under very favourable hypotheses (“high decarbo” scenario), GHG emissions might be reduced by only 28% for TtW and 33% for WtW, still well below EU objectives. Furthermore, passengers and freight show very different behaviour, with the latter contributing to emissions more than proportionally, and “shift-to-rail” policies, although very useful in some market segments, contribute moderately at the overall national level. The main conclusion of this study is that the pathway towards road transport decarbonization in Italy (and possibly in other EU Countries) is very uncertain, and the ambitious 2030 target is unlikely to be met with currently planned policies alone. The transportation system needs to be constantly monitored, and new policies have to be implemented to reach higher emissions reduction goals.

THE REPORT ON SUSTAINABLE DEVELOPMENT AND INVESTMENTS IN THE AGRICULTURAL SECTOR: THE ENVIRONMENTAL CAPITAL PERSPECTIVE

Introduction. Ukrainian agribusiness works in challenging conditions today, and the international community greatly supports it. The decision to grant Ukraine the status of a candidate for EU accession, adopted by the European Council in June 2022, and initiatives such as the provision of financial assistance under the Ukraine Facility program (June 2023) opened up new opportunities for the agricultural sector of Ukraine. The realization of these opportunities depends not only on Ukraine's ability to carry out reforms in the direction of European integration but also on the readiness of business entities to overcome the consequences of hostilities through recovery and reconstruction. Purpose. The article aims to provide scientific justification for the standardized forms of the Report on Sustainable Development and Investments (ESGI-report) in the agricultural sector of the economy for the preparation and publication of environmental capital indicators. Methods. The methods of induction and deduction, analysis, and synthesis formed the basis for developing environmental indicators for the ESGI report. The abstract-logical method became the basis for the study of the norms of European legislation and the leading systems for measuring sustainable development. The analogy method made it possible to propose indicative (reference) indicators for measuring sustainable development at the micro level. Results. The article systematizes the estimated and verifiable indicators of ecological capital. The first group includes risks and opportunities connected with climate change, the transition to sustainable technologies, and martial law. The second group comprises indicators that can be accurately measured with the help of calculators and technical means. They are related to the use of natural resources and the impact on the environment. To prepare the ESGI report, it is proposed that all materials posted on the Sustainable Reporting Platform (SR platform) be used: reporting forms, survey questionnaires, video recordings, as well as materials of webinars, presentations, and articles. The SR platform was developed within the framework of the MSCA4Ukraine program funded by the European Union. Conclusion. Attracting foreign investments for the post-war reconstruction of Ukraine's agribusiness is impossible without preparing and disclosing non-financial information about environmental capital at the micro level. One of the tools for disclosing such information is the ESGI report, which is posted on the SR platform. It is advisable to publish environmental indicators in standardized reporting forms to ensure their comparability with the data of other enterprises. At the same time, to assess the level of sustainable development, it is necessary to apply scientifically based reference values, which are based on best practices, statistical data and the company's own experience.

The changing food allergen landscape in Europe calls for harmonised food allergen monitoring: Position paper

With the changing food allergen landscape in Europe, there is an increasing need for the monitoring of (non-)prepacked food products to improve the protection of consumers with food allergies. Although food allergy is a condition affecting up to 10 % of the consumers worldwide, a European harmonised approach for the management of precautionary allergen labelling, allergen reference doses, analytical methods or food product monitoring is not in place. This leads to limited food choices for consumers with food allergies but can also result in the occurrence of serious allergic incidents. The current state of non-harmonised and unregulated food allergen monitoring in Europe means risks and considerable costs for the individual consumer, but also for society in general. In this position paper, we argue for the introduction of harmonised guidelines for food allergen monitoring on the European level based on a discussion of the wide-ranging implications their lacking entails. We believe that there is a pressing need to update the European legislation on food allergens, including the introduction of harmonised monitoring programmes, which will lead to improved overall food safety, and better protection and options for consumers with food allergies.

The ability of UWWTP to remove NSAIDs: Impact on water quality in the Odra River Czech Republic concerning incoming European legislation

Increased consumption of pharmaceuticals has resulted in their detection in wastewater. If wastewater treatment plants (WWTPs) fail to eliminate these substances adequately, they can seep into the environment, posing potential risks. As non-steroidal anti-inflammatory drugs (NSAIDs) belong to the pharmaceuticals most frequently examined in wastewater, this study aimed to monitor wastewater from the municipal wastewater treatment plant in Ostrava (UWWTP) over the course of a year, specifically assessing how the presence of these substances in discharged wastewater could contaminate the Odra River. To further understand the impact of NSAIDs, we evaluated the effectiveness of UWWTP technology in removing the following selected drugs: diclofenac (DCF), ibuprofen (IBU), naproxen (NAP) and ketoprofen (KET) - as well as their main metabolites: 4′-hydroxydiclofenac (hydroxyDCF), carboxyibuprofen (carboxyIBU), desmethylnaproxen (desmethylNAP), and ketoprofen glucuronide (glucuronideKET).Wastewater samples were collected at both the inflow and outflow of the urban wastewater treatment plant (UWWTP) Ostrava from October 2022 to September 2023. The analysis was performed using liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS). The concentrations of the monitored substances at the UWWTP inflow varied significantly, ranging from 79 ng/L to 112,125 ng/L, with the highest levels detected for ibuprofen (IBU), diclofenac (DCF), and their metabolites. The UWWTP demonstrated impressive treatment efficiency for IBU, exceeding 98%, while for DCF, it ranged between 56% and 87%. Building on these findings, a monitoring campaign was initiated along the Odra River to evaluate the concentrations of IBU and DCF - substances that had not been measured before. Water samples were taken from various locations along the Odra River from October to November 2023 and analyzed using the same methodology as the wastewater samples. The results indicate that, in line with the proposed environmental quality standards (EQS), IBU and DCF do not pose a significant contamination risk to the Odra River.

An Overview of Possible Beneficial Effects of Black Seeds (Nigella Sativa) on the Management of "Disease X".

A mystery pathogen that has not yet infected the entire world's population is predicted to be the cause of Disease X, which will be contagious. According to WHO scientists, 50 million people are expected to die from Disease X, which would be 20 times deadlier than coronavirus disease 2019 (COVID-19). Many international initiatives are currently in motion to get ready for future pandemics. These include updating the International Health Regulation and the European Legislation, establishing the Health Emergency Preparedness and Response Authority (HERA), establishing international hubs, taking on the international challenge of developing a vaccine for Disease X within 100 days of recognition of emerging Pathogen X, and updating the prepared-ness plan of National Institute of Allergy and Infectious Diseases. Our current review's main objective is to determine whether black seeds (Nigella sativa) can manage Disease X. It has been established by several studies that black seeds (N. sativa) have antiviral, antibacterial, antimicro-bial, immunomodulatory, anti-inflammatory, and antioxidant properties, which would be useful in the management of Disease X. Black seeds (N. sativa) may be utilized in conjunction with supportive care and symptomatic therapy to manage Disease X in early phases. Future random-ized controlled clinical trials would further evaluate the safety and effectiveness of black seeds (N. sativa) in patients with Disease X.

The impact of EU public procurement regulations on tenders in Spain: a study with adalimumab.

Pharmaceutical spending accounts for a significant portion of public healthcare budgets. To manage these costs, EU countries implement various cost-containment policies, including competitive tendering for pharmaceuticals. This study examines the impact of EU public procurement regulations on medication procurement practices. A search for all published tenders of adalimumab in Spain from 2018 to 2024 in the Spanish Public Sector Procurement Database, a period that coincides with the implementation of European legislation and the emergence of adalimumab biosimilars. All available documentation for each tender was reviewed, including the tender offer, technical specifications, specific administrative clauses, appointments of evaluation commissions, supporting memorandum, and evaluation reports. Our findings reveal substantial price reductions following the introduction of adalimumab biosimilars, yet highlight significant variability in tender criteria and practices across different regions. Despite adherence to EU directives, the inconsistent application of economic and non-economic factors and an erratic criteria concerning price undermine the intended balance of quality and cost, complicating procurement processes and potentially affecting the availability of a given treatment for patients.

Evaluation of the biodegradability of hazardous industrial solid waste: Study of key parameters.

The biological stability of solid waste is one of the main problems related to the environmental impact of landfills and their long-term emission potential. Current European legislation (European Landfill Directive, EC/99/31) introduced the need to reduce biodegradable organic compounds deposited in landfills; however, it set neither official parameters nor methods to define the stability of such a waste. In Spain, biodegradability is generally evaluated using the biological oxygen demand/chemical oxygen demand (BOD5/COD) ratio, measuring it on the leachate, thus not considering the non-soluble fraction and therefore creating false negatives. To solve this problem, the biodegradability of hazardous industrial waste has been determined by measuring its respirometric activity (AT4). Our results show that the measure of the AT4 is independent of the enrichment with a microbial inoculum, and a sample size no higher than 20g could be a reasonable value for a sensitive biodegradability determination. The highest respirometric index is obtained in waste with pH values between 6.5 and 10.5. Furthermore, respirometric biodegradability values are independent of traditional parameters of organic matter characterization such as BOD5/COD ratio, volatile content, and total and dissolved organic carbon. Consequently, the AT4 parameter provides new information on the composition and stability of organic matter in hazardous industrial waste. Its incorporation into pre-disposal waste characterization protocols allows to identify waste that exceeds recommended biodegradability thresholds. This approach ensures that only waste meeting specified biodegradability standards is deposited, avoiding landfill emissions and related environmental impacts, and thereby improving the overall effectiveness and sustainability of waste management practices.