Competent Authorities Research Articles

Differences in Patient Access to Newly Approved Antibacterial Drugs in EU/EEA Countries

The introduction of antibiotics in the beginning of the 20th century was one of the most important scientific breakthroughs in history. However, in recent decades, the growing threat of antimicrobial resistance (AMR) has shown the limitations of the current research and development programs for new antimicrobial drugs. In the last decade, 20 antibiotics, 7 β-lactam/β-lactamase inhibitor (BL/BLI) combinations and 4 non-traditional antibacterial drugs have been launched worldwide. Methods: This study aimed to assess the time to patient access for new antibacterial drugs in countries in the European Union and the European Economic Area (EU/EEA). Time differences in marketing authorization from the U.S. Food and Drug Agency (FDA) and the European Medicines Agency (EMA) were also described, as well as the availability of each drug in the countries in the EU/EEA according to the national competent authorities. Results: Substantial differences between countries were observed, with no or only one new drug available in some countries. Conclusions: Improving pricing and reimbursement timelines and fostering collaboration between national health authorities and market authorization holders can enhance timely and equitable patient access to new antibacterial treatments in Europe. Equitable and sustainable access to antibacterial drugs is a cornerstone in the battle against AMR.

Planning of the investigation of criminal offenses in the sphere of economic activities committed involving law enforcement officials: The Ukrainian perspective

The article is devoted to formulation of theoretical principles and practical recommendations regarding organization and planning of the investigation of criminal offenses in the field of economic activity, which are committed with the participation (assistance) of law enforcement officers. The methodology for the article is chosen taking into account the purpose and tasks, object and subject matter of the study. The research results were obtained with the help of the following methods: dialectical; formal and logical; formal and legal; comparative and legal; historical and legal, complex analysis; analysis and synthesis; axiomatic; system and structural method. The obtained results of the study indicated that organization and planning of the investigation of criminal acts under consideration is a purposeful activity of the authorized bodies, which is carried out under the guidance of the investigator, detective of the pre-trial investigation body. These activities require systematic, comprehensive approach and must take into account a wide range of circumstances that can affect the process and results of the investigation: the nature of the criminal offense, access to the necessary financial, human and technical resources; the competence of the investigator, the detective; terms and deadlines for investigation and presenting materials to the court, establishing effective cooperation between competent authorities. The study highlights the peculiarities of the organization and planning of the investigation of criminal offenses in economic activities, when law enforcement officers are involved, and suggests directions for improving the effectiveness of their implementation.

Legal entity of the Catholic Church as a participant in Land and Mortgage Register proceedings in Polish law – selected issues

This article evaluates the legal norms related to real estate trading by legal entities of the Catholic Church in the context of land and mortgage register proceedings. First, the issue of the legal entity of the relevant church legal entities is presented. Next, the principles of the representation of church legal entities by the competent authorities is analysed. This is important both for the capacity to undertake a substantive legal action, the subject of which is real estate, and for examining the effectiveness of procedural steps taken in the course of land and mortgage register proceedings. The last part is devoted to real estate trading with the participation of church legal entities in the context of the principles resulting from the regulations of land and mortgage register proceedings. The research leads to the conclusion that for land and mortgage register proceedings, it is of fundamental importance to assess the effectiveness of a legal act in the context of the specific requirements of canon law, examples of which are Canons 1281 § 1 of the Code of Canon Law with regard to acts exceeding the limits and manner of ordinary management, and Canons 1292 § 1–2 of this Code making the validity of alienation dependent on the consent or authorisation of the competent entity. The absence of the consent or authorisation required by the provisions of canon law should lead to dismissal of the application for entry, which can possibly be remedied by a subsequent confirmation of the legal act performed by applying the instruments of civil law, as exemplified by Articles 39 and 63 of the Civil Code. In addition, the implementation of the principle of the autonomy of the Catholic Church is expressed in leaving to the church authority regulation of the appointment of the competent bodies of church legal persons; the land and mortgage register court cannot question the effectiveness of the appointment of these bodies, the assessment of which is left to the Catholic Church and its organisational units.

Modification of the existing maximum residue levels for propamocarb in radishes (roots and small leaves)

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the Federal Public Service (FPS) Health, Food chain Safety and Environment submitted a request to the competent national authority in Belgium (evaluating Member State, EMS) to modify the existing maximum residue levels (MRLs) for the active substance propamocarb in radishes for the residues occurring in radish roots and in small radish leaves (proposed to be classified under the subgroup of Roman rocket/rucola). The data submitted in support of the request were found to be sufficient to derive MRL proposals for radishes and small radish leaves. Adequate analytical methods for enforcement are available to control the residues of propamocarb on the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of propamocarb according to the reported agricultural practice is unlikely to present a risk to consumer health. The chronic consumer risk assessment shall be regarded as indicative since affected by uncertainty related to the data gaps identified in the MRL review.

Peer review of the pesticide risk assessment of the active substance fenoxaprop-P-ethyl.

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Austria and co-rapporteur Member State Finland for the pesticide active substance fenoxaprop-P-ethyl are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of fenoxaprop-P-ethyl as a post-emergence herbicide in wheat, durum wheat, rye, triticale and barley to control annual monocotyledonous weeds. The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Use of sea wave containment techniques

This work makes a comparison between different wave control methods applied in coastal cities, using a small-scale experimental model. The coastal zone of Brazil extends over a considerable area and covers a significant portion of the national territory. It is common to find a variety of constructions on the seashore, from large buildings to small kiosks, many of which are irregular, as they do not follow the proper authorizations from the competent authorities, resulting in environmental, social and economic problems. The coastal environment is dynamic, subject to constant changes in its configuration, since the waves transport and deposit sand, even in small quantities. However, human activity has accelerated this process, although it is natural. Therefore, some methods have been developed to mitigate it.

Judicial control cause and causation in the United Arab Emirates

Judicial control in administrative law has become a necessity in administrations. Given the significant role it plays in confronting illegal activities and preserving property, money and the security of individuals in society. This research aims to introduce judicial in the United Arab Emirates and discuss the relationship between cause and causation.The descriptive analytical approach was used to study the research problem.the research conclude that cause and causation the most important element that enables the judiciary control the legality of the administration’s decisions. It is of great importance safeguards to protect individuals from abuse of administration by informing the person concerned of the reasons for making the decision, since the administration, in exercising its powers, must respect the set of legal rules established for it in the State.the research recommend that the competent authorities to make causation an essential part of the cause and a failure to render administrative decisions null and void in order to ensure transparency and to affirm the rule of law, with the exception of acts of supreme sovereignty, in order to preserve the supreme interest of the State.

Human-swine interface: is the hepatitis E virus a real risk for humans?

Abstract Background Hepatitis E virus (HEV) is the agent of hepatitis E, an emerging public-health infection with an increasing incidence in Europe. Due to the apparent lack of species barriers, HEV is considered a zoonotic agent, with swine as the main reservoir. This study investigated HEV prevalence in humans and domestic pigs in Northern Italy, a highly anthropic area with the highest pig farm density, to gain insights into the risk of HEV transmission from swine to humans. Methods A total of 508 blood samples were collected from blood donors (341 males and 167 females; from 18 to 66 years old) and from 1619 pigs in 40 different farms. Serological analyses were performed with ELISA to detect anti-HEV antibodies. In addition, 120 faecal pool samples collected from the pig farms with the highest seroprevalence and 69 salami produced in the same area were analysed to detect viral genome by Real-time PCR. Results In humans, HEV seroprevalence was 4.9% (CI95% 0.03-0.07); positive donors were mainly males, with seroprevalence increasing up to 12% (CI95% 0.09-0.15) in the 46-55 age group. Seroprevalence in swine was 53.00% (CI95% 0.50-0.55), with HEV detected in only 1% (CI95% 0.001-0.045) faeces. All food samples tested negative. Conclusions Even if the seroprevalence in pigs highlighted that HEV was actively circulating in the farms, the low seroprevalence in humans, the scarce HEV detection in swine faeces, and the absence in food products suggested that HEV transmission via faecal-oral or foodborne routes is unlikely, probably due to the implementation of severe biosecurity measures and high standards of hygiene in swine farms, and the continuous assessment of the critical points in the pig supply chain (from farm to fork). The serological surveillance of humans and the monitoring of farmed animals are needed to support the competent authorities in timely managing public health issues, improving human health and veterinary safety from a One Health perspective. Key messages • In the human-swine interface is important to monitor HEV presence. • The One Health approach is essential to control zoonotic diseases.

Prohibition of public employees from practicing commercial activities in the legislation of the United Arab Emirates and the French Republic: A comparative study

Practicing commercial activities as a public employee is a major negative phenomenon that affects the public interest, institutions, and employers, and affects economic development. Both the economy and society as a whole have significant effects on countries throughout all sectors. The study aimed to identify legislation restricting commercial activity by public sector workers in the United Arab Emirates and France. This research was based on the comparative descriptive approach between UAE legislation and French comparative legislation in the field of prohibiting public servants from engaging in business activities. The research concluded with a variety of findings, the most notable of which is the fact that the UAE legislature was flexible in dealing with this issue, making it simpler for employees to conduct businesses by reducing the load of life troubles on public employees. The study recommended the Establishing procedures, systems and rules for reporting to the competent authorities by public employees about acts of practicing commercial activities, when these acts come to their knowledge during the performance of their duties.

Features of theoretical approaches to the category "abuse of law" in the countries of the Anglo-American legal family

The article examines the peculiarities of theoretical approaches to understanding the category of «abuse of law» in the countries of the Anglo-American legal family, primarily in Great Britain and the United States. In particular, by using a set of philosophical and worldview, general scientific, special scientific methods (primarily, comparative legal, historical legal, normative, functional) and principles of scientific knowledge: the evolution of theoretical ideas about the abuse of law, their consolidation in legislation and practical implementation in individual states of the Anglo-American legal family; the peculiarities of the legal terminology used in the legislation and judicial practice of Great Britain and the USA to determine the abuse of the right are revealed; the characteristic features and general trends of the theoretical understanding and legislative consolidation of the category of «abuse of law» in the specified states have been established. It is argued that the principle of good faith is inherent in the entire legal system of Great Britain as a whole and is reflected in its individual provisions, and the duty to establish the facts about the presence or absence of abuse of the law corresponds to judicial or other competent authorities. It has been established that the doctrine of good faith is important in US judicial practice, but there is no description of the criteria of good faith in US law, their definition is left to the discretion of the court. It is proved that both English and American legislators do not provide a clear definition of the term ‘abuse of law’ in the provisions of legislation. The content of this concept is defined and disclosed in judicial practice and legal doctrine, which are closely interrelated and are based on the assessment of such actions from the standpoint of reasonableness, good faith and fairness. Depending on the branch of law and the legal system of the state, abuse of law is most often understood as damage or loss. Damage is the destruction or diminution of material goods. Losses are understood as real losses and lost profits. It is concluded that despite the fact that the problem of abuse has not been comprehensively resolved, in practice the judicial system of the United Kingdom and the United States is quite effective in combating manifestations of abuse of law.

International and European standards of regulation of the institute of whistleblowers

The article is devoted to clarifying the peculiarities of the international and European standards of regulation of the institute of whistleblowers. It was found that whistleblowers play an important role in detecting violations that can cause significant damage to society, accordingly, international and European standards protect not only the right of every person to disclose information of public interest, but also the rights of persons who report such information ( whistleblowers). It has been established that the concept of «whistleblower» is most widely interpreted by Directive 2019/1937 of the EU and the Council of the EU on the protection of persons who report violations of Union legislation. It was determined that the standards for the protection of the rights of whistleblowers, but only in the field of corruption, are contained in the UN Convention against Corruption, the Criminal Convention on the Fight against Corruption, the Civil Convention on the Fight against Corruption, among them, in particular, the duty of the states that have joined them to determine the competent authority(ies) for reporting whistleblowers and the ability to provide them with the protection they need. At the same time, attention is focused on the fact that EU Directive 2019/1937, in contrast to the mentioned acts, more broadly defines the standards for the protection of whistleblower rights, in particular: it extends its effect simultaneously to the private and public sectors, provides for the protection of not only persons who report violations, but also of persons who contributed to such a report, relatives, colleagues of whistleblowers, etc., as well as persons who suffered from false reports of whistleblowers, which minimizes abuse of the latter’s status (protection). The essential role of the ECtHR’s practice in establishing standards for the regulation of the whistleblower institute is emphasized. It was found out that the ECtHR determines the very concept of «exposure» as one of the manifestations of freedom of expression, which is guaranteed by Article 10 of the Convention on the Protection of Human Rights and Fundamental Freedoms and provides for adequate protection for whistleblowers from arbitrary interference in the exercise of this freedom and retaliation for the consequences of its exercise . Analysis of the practice of the ECtHR shows that the court is gradually expanding the standards of protection of whistleblowers, emphasizing their role in exposing violations in various areas and protecting public interests.

Adhesión del régimen de vigilancia y control fiscal a los principios de gestión y gerencia pública en el marco constitucional colombiano

This article examines the evolution of the fiscal oversight and control regime in Colombia from the perspective of public management and administration. Through a qualitative analysis of doctrine, legislation, and jurisprudence, the study seeks to understand how this system has evolved, particularly following the 1991 constitutional reform. The research reveals significant progress in implementing a more proactive and preventive fiscal control framework, focused on efficiency, economy, and equity. However, persistent challenges remain, such as effective resource management and the prevention of corruption. The methodology employed combines an exhaustive review of academic literature with an analysis of key documents, such as judicial rulings. The findings highlight the importance of strengthening the autonomy of territorial comptroller offices and promoting greater coordination among oversight entities to effectively combat corruption. In conclusion, this study underscores the close relationship between fiscal oversight and public administration, emphasizing the need for efficient and responsible public management to ensure the proper use of state resources. It concludes that while important advances have been made, challenges remain that require constant attention from the competent authorities.

Admissibility of ILA Principles on Intellectual Property and Private International Law in Vietnam

Abstract Private law on intellectual property (IP) has achieved significant international harmonization, but international jurisdiction is subject to national regulations. As a result, enforcement of IP rights is carried out on a country-by-country basis. This approach leads to multiple concurrent legal proceedings, increasing the risk of conflicting judgments and escalating litigation costs. These costs create a disparity between multinational corporations and small and medium-sized enterprises. As a potential model for future international agreements on intellectual property and private international law, the International Law Association (ILA) Committee on ‘Intellectual Property and Private International Law’ seeks to address cross-border IP disputes. This paper will explore whether the ILA principles can be utilized as models for legislators, judges, arbitrators and other competent authorities in Vietnam, a legal system characterized by a lack of case law on the topic.

How Do Flemish Laying Hen Farmers and Private Bird Keepers Comply with and Think about Measures to Control Avian Influenza?

Competent authorities of many countries, including Belgium, impose control measures (preventing wild bird access to feeders and water facilities, indoor confinement of captive birds, or fencing off outdoor ranges with nets) on professional and non-professional keepers of birds to prevent the spread of avian influenza (AI). Flemish laying hen farmers (FAR, n = 33) and private keepers of captive birds (PRI, n = 263) were surveyed about their opinion on and compliance with AI measures legally imposed during the most recent high-risk period before this survey in 2021. Participants answered questions on a 5-point Likert scale (1 = the worst, 3 = neutral, and 5 = the best). FAR indicated better compliance with the AI measures than PRI, except for net confinement. FAR indicated that they and other poultry farmers complied better with AI measures than PRI. Additionally, PRI indicated that they better complied than other PRI keepers. FAR regarded the AI measures as more effective than PRI. To prevent the spread of AI more effectively, national authorities could focus on information campaigns explaining to private bird keepers the need for the various control measures that they impose. If these campaigns fail, local authorities may need stricter enforcement or alternative ways to increase compliance.

Institutionalization Of Children And Their Overall Development

The ideal environment for children's physical, psychological, and emotional development is within a family. All children should live in supportive, protective, and caring settings that enables them to achieve their full potential. Those with inadequate or no parental care are especially at risk of missing out on such nurturing environments. Many children in India lack a stable home and family. These include abandoned, surrendered, and orphaned children, as well as destitute children with families. These children are particularly vulnerable in terms of their right to survival, development, and protection. The State is accountable for protecting the rights pertaining to these children and ensuring appropriate alternative care through its competent authorities, such as nongovernmental organizations and civil society organizations. The Government also enacted the Juvenile Justice (Care and Protection of Children) Act 2015, which serves as the major legislative framework for child protection in India, ensuring the security, protection, education, welfare, and development of children in need. The paper attempts to explore the institutionalization of children, the shortcomings of such a process, and the felt needs of the children. It focuses on the concerns of institutionalization and the overall development of children, access to their rights, welfare provisions, and relevant legislations. It also looks at adoption as an alternative to institutionalization. The paper thus examines child care institutions from the perspective of the child and argues that institutional care should be the last resort. It also discusses contemporary social work and advocates for alternative care, along with comprehensive welfare measures to guarantee the protection and overall development of children in need

The 2023 National Proficiency Test for molecular detection of shrimp infectious myonecrosis virus (IMNV) in China

Infectious myonecrosis virus (IMNV), an emerging virus that can cause severe viral disease in penaeid shrimp, was first confirmed to have spread to China in 2020. In order to standardize diagnostic procedures and reliable detection capability, and to evaluate the performances of aquatic clinical diagnostic laboratories, the competent authority has launched a proficiency test (PT) scheme for the molecular detection of IMNV in China from the year of 2023. In the ring test of IMNV-PT 2023, five tissue samples containing different concentrations of IMNV were provided as a panel of test samples. A total of 68 laboratories participated in the PT test of qualitative and quantitative analysis of the five samples using standard molecular assays. The results showed that 92.65 % (63/68) of the participants correctly reported all samples in the panel using Real-time reverse transcription PCR and 62 participants achieved satisfactory results, one participant using conventional PCR and four participants had not completed the test. Out of the 62 participants in the z-scores analysis, 88.71 % (55/62) achieved acceptable ZB-scores, with two outlier laboratories and five laboratories being questionable. Additionally, 98.39 % (61/62) achieved ZW-scores, with only one laboratory being questionable. Furthermore, the national PT conducted in the present study proved to be an effective tool for evaluating laboratory performance in IMNV molecular testing. This assessment can aid in improving the capabilities of IMNV molecular testing of the participating laboratories, and also provided technical supporting to enhance the national response to IMN outbreaks.

Identifying bottlenecks in the medical equipment procurement process of central equipment procurement agency of government of India (GOI) and suggesting remedial measures

BackgroundProcurement of equipments is a time-consuming process with an invariably long lead time due to a long procurement procedure. Long lead time may sometimes result in the procurement of an old equipment and may affect the modernization drive of any healthcare organization. Especially in Govt hospitals, it is noted with concern that there is a long lead time in equipment procurement. MethodsThe study was conducted on procurement processes of 4 different hospitals of Public and Private Health sector. The study compared the timelines in different stages of the procurement process i.e. Acceptance of Necessity (AON) to Tender stage, Tender to Technical bid opening (TBO) stage, TBO to Final Bid opening (FBO) stage and FBO to Supply Order (SO) stage. ResultsThis study on the medical equipment procurement process of the Central Govt organisation highlights significant delays, particularly between TBO to FBO stage, compared to much shorter durations in state health services and private hospital. Time taken by Central Govt organisation is more as compared to other healthcare organisations and the findings are statistically significant with p value less than 0.05. ConclusionThe study identifies major bottlenecks, including technical evaluation and retendering due to non-compliance with technical requirements, and suggests that detailed technical specifications, vendor compliance matrix and pre bid meetings, can mitigate these issues. The study also recommends regular training for personnel involved in procurement, enhancing inherent financial powers of competent financial authorities (CFA) and speedy process of files by integrated financial advisors (IFA).

Modification of the existing maximum residue levels for picloram in animal commodities and honey

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Corteva Agriscience International Sàrl submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) in certain animal commodities (fat and liver) and honey. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for honey. Adequate analytical methods for enforcement are available to control the residues according to the residue definition for enforcement proposed as ‘picloram, free and conjugated, expressed as picloram’ in honey at the validated limit of quantification (LOQ) of 0.01 mg/kg. For the commodities of animal origin, although the submitted data were found to be sufficient, EFSA concluded that no change of the existing MRLs was necessary. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues expected in honey, resulting from the existing uses of picloram on melliferous crops, is unlikely to present a risk to consumer health.

Modification of the existing maximum residue level for flonicamid in honey.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in Finland to modify the existing maximum residue level (MRL) for the active substance flonicamid in honey. The data submitted in support of the request were not found appropriate to derive an MRL proposal for honey. The assessment was complemented by an analysis of the monitoring data available from the EU monitoring programmes (conducted during 2009-2023). The results from the monitoring data analysis suggest that the current MRL is still sufficient to account for the residue uptake in honey resulting from plant protection products uses of flonicamid on melliferious crops. Adequate analytical methods for enforcement are available to control the residues of flonicamid in honey according to the residue definition as the sum of flonicamid, TFNA and TFNG, expressed as flonicamid at the validated limit of quantification (LOQ) of 0.01 mg/kg for each compound. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues in honey at a level of 0.05 mg/kg according to the monitoring data is unlikely to present a risk to consumer health.

Modification of the existing maximum residue levels for dichlorprop-P in cereal grains.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Nufarm Crop Products UK Ltd. submitted a request to the competent national authority in Italy to modify the existing maximum residue levels (MRLs) for the active substance dichlorprop-P in barley, oat, rye and wheat grain. The data submitted in support of the request were found to be sufficient to derive MRL proposals for these cereal grains. Adequate analytical methods for enforcement are available to control the residues of dichlorprop-P in the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg and in animal matrices at the validated LOQ of 0.01 mg/kg. Based on the risk assessment results, the European Food Safety Authority (EFSA) concluded that the short-term and long-term intake of residues resulting from the use of dichlorprop-P-2-ethylhexyl (dichlorprop-P 2-EHE) according to the reported agricultural practices is unlikely to present a risk to consumer health.