Implementation Of Legislation Research Articles

Anti-corruption disclosure: evidence from the natural experiment of the Non-Financial Reporting Directive

AbstractDrawing upon institutional theory, we investigate how companies react to coercive pressures which impose anti-corruption disclosure practices. We adopt the concept of change in the institutionalized field and investigate the impact of the natural experiment of the Non-Financial Reporting Directive (NFRD) implementation on a company’s choice for disclosing its anti-corruption policy. We examine the relationship between firm linkages with the external environment, proxied by board independence and ownership dispersion, and anti-corruption disclosure. We use a sample of 72 companies listed on the Warsaw Stock Exchange over the period of 2015–2019 that were subject to the NFRD legislation. The evidence from the Tobit model shows that the linkages with the external environment differentiate company reactions to the implementation of the mandatory reporting legislation. In particular, greater company linkages via interdependent directors and ownership dispersion increase the scope of the anti-corruption disclosure in the post-NFRD period. Our study offers policy implications suggesting that corporate scrutiny and exposure to external constituencies may improve implementation of legislation into company practice and enhance anti-corruption disclosure.

The implementation of national labour legislation in England after the Black Death, 1349–1400

AbstractThe responses of labour markets to global pandemics are attracting renewed interest, although the English labour laws in response to the Black Death of 1348/9 – capping wages, imposing annual contracts, and restricting mobility – have a long and established scholarship. The conventional wisdom is that the legislation represented an extension of existing local practices and created common cause among all categories of employer. Yet this view is hard to reconcile with the fact that, despite subsequent revisions, the legislation soon failed. These arguments are tested through original research into how the legislation was actually enforced in a variety of legal tribunals (manorial, borough, and royal). A clear distinction is maintained between public presentments and private litigation, and a robust methodology is pursued to record their absence as well as quantifying their presence. This casts new light on the novelty of the labour laws, the reasons for their failure, and their influence on contract law. The analysis exemplifies the potential for short‐term legal responses to infectious diseases to have unintended and unanticipated long‐term consequences.

EU social dialogue revitalisation: Between rhetoric, new rights, political commitments and historical caution

The Council Recommendation on strengthening social dialogue is a positive recognition of the key role of social dialogue in the EU's social market economy. At the same time, episodes of institutional disfavour of the social partners’ co-determination role and resistance to robust sectoral collective bargaining warrant a cautious assessment. This article looks at the current state of EU social dialogue, examining its primary dimensions: the involvement of social partners in policymaking and the scope of collective bargaining. It assesses the Council Recommendation, along with other measures adopted during the Von der Leyen presidency, to ascertain their collective contribution in realigning EU social dialogue with the principles of the EU Treaties. Overall, the analysis reveals a nuanced picture, with both positive and challenging aspects. While collective bargaining has been given a new (albeit partial) boost, the same cannot be said for the social partners’ participation in EU policymaking. Notably, the Council Recommendation reaffirmed the Court of Justice's decision in the EPSU case, solidifying the Commission's discretionary authority to decide on the legislative implementation of framework agreements, to the detriment of the social partners’ regulatory agency. Finally, the article proposes a blueprint for further advancing the EU's aspiration for social dialogue, seeking to reconciling it with the social objectives that, constitutionally, the Union aspires to achieve.

Temporary placement of a child in the family of an actual caregiver as a from of children`s placement

Ensuring the rights and well-being of the child is one of the main priorities of modern society. As Ukrainian and foreign legislation states that every child has the right to a family. However, due to different life circumstances, unfortunately, not every child has the opportunity to live in a family with their parents. That is why the question arises, how to ensure the realization of all the rights of a child who has lost his parents, or whose parents have given up their child. In this way, the institution of placement of a child was born. To date, Ukrainian legislation distinguishes such forms of placement of children as foster family, guardianship and care, adoption, family-type orphanage, placement in the family of relatives, acquaintances. All of these forms of placement have a clear procedure for placing a child in a family and a legal mechanism for regulating the rights and responsibilities of the person who took the child into their family, as well as the rights and responsibilities of the child. Each case of placement of children is unique and requires a specialized approach taking into account specific situations, circumstances and needs of the child. However, one form of placement should be singled out, such as placement of a child in the family of an actual caregiver. It is this form that has shown itself to be the most unexplored and at the same time convenient, first of all for a child. However, the problem of legislative implementation of temporary placement of a child by the actual guardian remains unsolved, since the existing legislation quite briefly describes the mechanism of such placement. This form of placement requires clear regulation from the side of the legislation, because the legal mechanism of placement of a child in the family of an actual tutor, the rights and obligations of the actual tutor and the pupil himself need to be researched. The article examines the advantages and disadvantages of such a temporary form of placement of a child as placement in the family of an actual tutor.

Counterterrorism laws and state repression in the aftermath of the 9/11 attacks

ABSTRACT The relationship between terrorism and human rights has attracted considerable research and policy attention. As countries grapple with formulating effective strategies to combat terrorist groups, governments have faced criticism for resorting to increased repression in the name of counterterrorism. One common response by states to terrorism has been the implementation of counterterrorism legislation, with numerous countries enacting such laws in the aftermath of the September 11 attacks to establish a legal framework for addressing the terrorist threat. In this paper, we delve into the impact of counterterrorism legislation on abuses by the state, with a specific focus on the use of torture and political imprisonment. We argue that the introduction of counterterrorism legislation has exposed more citizens to the threat of being detained and the risk of torture by state forces. We contend that this relationship is particularly pronounced in countries adopting new counterterrorism legislation after 9/11. To substantiate our argument, we utilise data on counterterrorism legislation and conduct empirical testing, uncovering some supportive evidence for the relationship between the introduction of counterterrorism legislation and the prevalence of torture and political imprisonment, especially in cases where new laws were introduced in the aftermath of the September 11 attacks.

Implementation of the Ecosystem Services Concept in the Environmental Legislation of Ukraine: Current State and Prospects

The article outlines the general principles of the concept of ecosystem services and examines the current state and prospects of its implementation in national environmental legislation. It is established that the need to introduce this concept has already been envisaged by a number of strategic programmatic documents, headed by the “Basic Principles (Strategy) of the State Environmental Policy of Ukraine for the Period up to 2030”, but this concept is still not reflected at the level of key environmental legal acts, in particular, the Law of Ukraine “On Environmental Protection” and resource-specific codes and laws which not only lack any mention of ecosystem services, but also hardly ever use the term “ecosystem” at all. It is proved that one of the ways to implement the concept of ecosystem services in Ukraine is to develop an appropriate legal framework, namely: The Law of Ukraine “On Ecosystem Services” and other related bylaws, which should be done in the near future. At the same time, it is substantiated that in addition to the adoption of new legislation in this area, it is extremely important to analyze the current environmental legislation through the prism of the ecosystem approach and make appropriate changes and additions to it, since only under such conditions can legislative gaps and conflicts be avoided and a coherent model for implementing the concept of ecosystem services be developed, which in the current realities of the armed aggression of the russian federation will help to assess and take into account all the damage caused to the environment of Ukraine.

Exploring the Mechanisms of Regional Environmental Collaborative Legislation in China: Policy Effectiveness, Practical Challenges, and Policy Suggestions

The legislation for regional environmental collaboration is of significant importance in enhancing the effectiveness of environmental protection. The existing literature focuses on the power struggle between central and local governments regarding environmental regulation within the realm of regional environmental governance, lacking an examination of the collaborative governance mechanisms and their effectiveness. Therefore, this study takes China’s regional environmental collaborative legislation as its research object. It employs a difference-in-differences model to test the effectiveness of regional environmental collaborative legislation concerning environmental governance and conducts a qualitative analysis to examine the current practical challenges facing regional environmental collaborative legislation. The quantitative analysis results indicate that regional environmental collaborative legislation can effectively suppress the emission of environmental pollutants. Specifically, the implementation of regional environmental collaborative legislation results in a 19.7% reduction in prefecture-level wastewater emissions and a 26.6% reduction in sulfur dioxide emissions. Qualitative analysis results show that regional environmental collaborative legislation currently faces challenges such as localism, difficulties in legislative authority allocation, and a lack of cooperation mechanisms. Therefore, this paper proposes to establish a collaboration platform, balance the interests of stakeholders, and improve the allocation mechanism of environmental regulatory powers in order to better optimize the regional environmental collaborative legislation and enhance the government’s environmental governance capacity.

Assessing the Gap between Environmental Legislation and Effective Implementation: A Study and Guidelines for Enhancing the Implementation Performance of Environmental Laws

This article explores the gap between environmental legal regulations and their actual implementation in the Kingdom of Saudi Arabia. A comprehensive research approach was used, linked to a survey conducted among a randomly selected sample of 592 individuals in Saudi Arabia. Through a comparative assessment, various factors contributing to this gap were identified, including administrative, regulatory, financial, and cultural aspects specific to the region. Practical recommendations are provided based on the evaluation of research findings, aiming to enhance the implementation of environmental laws. The goal is to strengthen environmental safety and promote sustainable development in Saudi Arabia. The outcomes of this study hold significant importance for policymakers, aiding in the reinforcement of law enforcement and the encouragement of sustainable practices adaptable to local contexts, while also contributing to global environmental initiatives.

School Meals for All: A Qualitative Study Exploring Lessons in Successful Advocacy and Policymaking in Maine and California

BackgroundThe COVID-19 pandemic focused national attention on food insecurity, equity, and the role of school meal programs in supporting children, families, and communities. In doing so, the pandemic created a rare policy window – an opportunity to advance a longstanding public health goal of guaranteed access to free school meals for all students. In July 2021, California and Maine became the first states to authorize school meal for all legislation (also known as universal free meals). ObjectiveThe aim of this study was to explore perspectives of policymakers, state agency officials, and advocates on the conditions and mechanisms that facilitated passage of school meal for all legislation in California and Maine. DesignA qualitative case study was conducted. ParticipantsBetween December 2021 and June 2022, semi-structured interviews were conducted with 30 policymakers, state agency officials, and advocates. AnalysisPerformed: Interviews were analyzed using principles of content analysis. Key themes are organized using Kingdon’s multiple streams framework for public policy. ResultsEleven key themes were identified. Lessons are drawn from the policy and advocacy strategies used to advance laws in California and Maine. For instance, paving the way with incremental policy change, tailoring messaging to diverse audiences, and organizing at the grassroots and grasstops levels were critical to success of advocacy efforts. ConclusionsPromising practices can guide efforts to expand access to school meals and advance other child nutrition policies in other states and nationally. Moving forward, lessons learned from implementation of universal free school meal legislation in California, Maine, and other early adopters should be documented and shared.

Foreign experience of legal regulation of criminal liability for violation of the procedure for transplantation of human anatomical materials established by law

The article examines the experience of individual countries in matters of legal regulation of criminal liability for violation of the procedure for transplantation of human anatomical materials in order to determine important legal assets of foreign legislation, which could be discussed for the purpose of further implementation in Ukrainian legislation. Within the framework of the article, we will analyze national and international legislation, namely, we will compare the content of Articles 143 and 144 of the Criminal Code of Ukraine with the content of the corresponding articles and provisions in the legislation of several countries from the perspective of the used terminology, interpretation of concepts, descriptions of crimes, measures of criminal liability, etc. The Constitution of Ukraine guarantees every person the right to life. However, experts increasingly raise questions about various violations of this right from the perspective of transplantation of human anatomical materials. Today, criminal offenses in relation to both donors and recipients become difficult to detect due to high self-interest and profitability, disguised nature, network systematicity, extensive illegal infrastructure and fast mechanisms for its recovery, group organization and strong connections with other criminal groups, use of deception, coercion, intimidation and other methods of forced donation, corruption in the field of donation, large-scale latent level of crimes related to transplantation. Detection of illegal transplantation is also burdened by their contradictory geography, when potential donors are recruited in the so-called "depressed" countries around the world, and anatomical materials are seized in countries that are highly developed in the field of transplantology, having loyal legislation to carry out such operations. In Ukraine, the detection of such crimes is also aggravated by the fact that people who are ready to illegally donate their organs for payment, travel to remove the organ outside the country and carry out their plans in other countries ("transplant tourism"). Due to the low level of information and enlightenment of the society in matters of transplantation, the detection of crimes in this area is also complicated by the so-called "victimhood" of people (both donors and recipients) – a set of personal traits that cause a high probability of becoming the object of a criminal attack (a tendency to become a victim of crime). These grounds contribute to a dynamic increase in the number of violations of the law-enforced procedure for the transplantation of human anatomical materials, which constitutes a high public danger. At the same time, the legal regulation of criminal liability for such violations still has certain differences. Therefore, the study of foreign experience in matters of transplantation, the comparison of the norms of articles in the Criminal Codes of different countries, and the analysis of concepts used in normative legal documents and their interpretations help to identify gaps in Ukrainian legislation, clarify the wording, expand the range of crimes and facilitate the qualification of their composition, adaptation of the Ukrainian legal system according to European standards.

Survival After Out-of-Hospital Cardiac Arrest Before and After Legislation for Bystander CPR

The lack of evidence-based implementation strategies is a major contributor to increasing mortality due to out-of-hospital cardiac arrest (OHCA) in developing countries with limited resources. To evaluate whether the implementation of legislation is associated with increased bystander cardiopulmonary resuscitation (CPR) and automated external defibrillator (AED) use and improved clinical outcomes for patients experiencing OHCA and to provide policy implications for low-income and middle-income settings. This observational cohort study analyzed a prospective city registry of patients with bystander-witnessed OHCA between January 1, 2010, and December 31, 2022. The Emergency Medical Aid Act was implemented in Shenzhen, China, on October 1, 2018. An interrupted time-series analysis was used to assess changes in outcomes before and after the law. Data analysis was performed from May to October 2023. The Emergency Medical Aid Act stipulated the use of AEDs and CPR training for the public and provided clear legal guidance for OHCA rescuing. The primary outcomes were rates of bystander-initiated CPR and use of AEDs. Secondary outcomes were rates of prehospital return of spontaneous circulation (ROSC), survival to arrival at the hospital, and survival at discharge. A total of 13 751 patients with OHCA (median [IQR] age, 59 [43-76] years; 10 011 men [72.83%]) were included, with 7858 OHCAs occurring during the prelegislation period (January 1, 2010, to September 30, 2018) and 5893 OHCAs occurring during the postlegislation period (October 1, 2018, to December 31, 2022). The rates of bystander-initiated CPR (320 patients [4.10%] vs 1103 patients [18.73%]) and AED use (214 patients [4.12%] vs 182 patients [5.29%]) increased significantly after legislation implementation vs rates before the legislation. Rates of prehospital ROSC (72 patients [0.92%] vs 425 patients [7.21%]), survival to arrival at the hospital (68 patients [0.87%] vs 321 patients [5.45%]), and survival at discharge (44 patients [0.56%] vs 165 patients [2.80%]) were significantly increased during the postlegislation period. Interrupted time-series models demonstrated a significant slope change in the rates of all outcomes. These findings suggest that implementation of the Emergency Medical Aid Act in China was associated with increased rates of CPR and public AED use and improved survival of patients with OHCA. The use of a systemwide approach to enact resuscitation initiatives and provide legal support may reduce the burden of OHCA in low-income and middle-income settings.

The Devil in the Details: Changes Under Stable Trends of Femicide in Italy During COVID-19 Lockdowns

In recent decades, the issue of violence against women has increasingly drawn the attention of international and national legislators and policymakers. The term “femicide” became widespread in the early 2000s and was incorporated into the criminal codes of several countries. The onset of the COVID-19 pandemic and the subsequent social distancing measures raised significant concerns about their impact on women’s safety. This study examines the effect of COVID-19 confinement measures on femicide trends in Italy, a country which adopted stringent COVID-19 confinement measures and, since 2019, implemented new legislation to counteract violence against women. Using two data sets—one from the Italian Ministry of Interior containing 1,382 cases of female homicides (2013–2022) and another from Italian NGOs detailing 1,253 femicides according to media coverage (2012–2022)—the study employs autoregressive integrated moving average (ARIMA) analysis to assess monthly trends alongside the stringency index for COVID-19 containment efforts. The findings reveal that, although overall femicide rates remained stable during lockdowns, there was a significant shift in victim–perpetrator relationships. Specifically, from March to May 2020, there was a decline in femicides by former partners, offset by an increase in those by cohabiting partners. These results underscore the complexity of femicide and the need for further research on various facets of violence against women. This includes the potential escalation of physical and psychological violence during lockdowns, influenced by forced proximity and substance abuse in domestic environments.

Delibazione e divorzio nella giurisprudenza della Cassazione: il difficile bilanciamento tra attuazione della normativa concordataria e tutela del coniuge più debole

Exequatur procedure and divorce in the jurisprudence of the Supreme Court: the difficult balance between implementation of the concordat legislation and protection of the weaker spouse ABSTRACT: The 1984 Agreement with the catholic church modified the rules for implementing canonical sentences of nullity of marriage in the Italian legal system, introducing several controls among wich the non-contradiction to Italian public order of such sentences has acquired increasing importance. In recent years, this requirement has been interpreted by the jurisprudence of the Supreme Court in a very restrictive manner in order to limit the recognition proceeding as much as possible, with the aim of avoiding the unfavorable economic consequences deriving from the nullity of the marriage for the spouse who would have been entitled to maintenance allowance in the event of divorce. The work focuses on the relationship between recognition of canonical nullity and divorce, analyzing the repeated interventions of the Court of Cassation to prevent that with the exequatur procedure the economic measures taken in the divorce judgment could be annulled. The protection of the weaker spouse was made even more complete by the recent ruling of the United Sections of the Supreme Court of 2021 that allowes the treatment of economic issues still pending, provided that the divorce decree between the parties was pronounced before the exequatur of the ecclesiastical sentence of marriage nullity. SOMMARIO: 1. Premessa - 2. I tratti salienti dell’attuale procedimento di delibazione - 3. La differente tutela del coniuge nel caso di nullità e di divorzio - 4. Il rapporto delibazione-divorzio tra tesi dottrinali e orientamenti giurisprudenziali dalla metà degli anni Ottanta alla fine degli anni Novanta - 5. Gli interventi della giurisprudenza di vertice su delibazione e divorzio a partire dal 2001 - 6. L’ulteriore passo in avanti della Cassazione: dopo il giudicato di divorzio è possibile la trattazione delle questioni economiche ancora pendenti anche se nelle more sia intervenuto l’exequatur della nullità canonica - 7. Conclusioni.

Linguistic Genocide of Minority and Mother Tongue Languages: Unravelling International Implications on Indian Laws Through a Critical Discourse

Language is an inherent and intrinsic form of human communication, and India is renowned for its extensive range of languages. Nevertheless, the languages that are spoken in India, which play a crucial role in fostering this diverse cultural landscape, have encountered obstacles stemming from the forces of globalisation and domestic prejudice over an extended period of time. This paper underscores the concerning phenomenon of language attrition throughout history, wherein numerous languages have become extinct, resulting in fragmented remnants of cultural heritage. The majority of extinct languages were of Indigenous origin, suggesting a discernible racial bias in their eradication. Many linguists see the current situation as linguistic genocide, the intentional destruction of languages to achieve cultural unity. This study assesses the laws and policies pertaining to minority languages in India and examines their compatibility with international standards. This paper examines the difficulties associated with the implementation of language preservation legislation and explores the potential consequences of linguistic genocide on cultural identity, social cohesion and human rights within the context of India.

Multidoor Approach in Law Enforcement against Environmental Crimes by Corporations

In case of natural resource and environmental management by corporations, violations over laws occur quite often, especially in respect of state administrative, criminal, and civil laws. To present, the real implementation of law enforcement for violating corporations is not all-out as it only works limited on the surface of the cases, not on the core of which. In other words, law enforcement is so partial due to its ignorance to any other possibilities of violations over other legal dimensions and how they should be enforced. As a matter of the fact, overlapping happens, which causes failure in achieving the legal goals, i.e., certainty, justice, and utility. This article, thus, is aimed to acquire new thoughts through optimization of the implementation of valid legislation combined with the practice of solid law enforcement by means of multidoor approach. The approach also involves normative-juridical method through statute and conceptual approaches, completed with case study in combined. Further, the research has seen that law enforcement against corporations for their violations over natural resources and environment is of vast urgency. It is because the violations are inevitably interwoven with three legal dimensions at once, i.e., state administrative, criminal, and civil laws. Next, there are no comprehensive regulations that regulate environmental crimes for corporations. Therefore, a multidoor approach is a powerful way of law enforcement that is suitable for applying to corporations.

National public health institutes in the Eastern Mediterranean Region: Insights from experts in the field

National public health institutes (NPHIs) are crucial to the effectiveness of public health systems, including delivering essential public health functions and generating evidence for national health policies, strategies and plans....

Миграционная политика и проблемы иностранной трудовой миграции в Российской Федерации (по материалам экспертного опроса)

This article presents basic results of an expert survey on the problems of foreign labor migration and the im-plementation of migration policy. As part of this study, among other things, the current state of Russian migra-tion legislation was discussed, the existing legal system of conditions and measures determined by national migration policy was assessed, and the problems of adaptation and integration processes of foreign labor mi-grants were considered. The results of the study made it possible to identify entrenched generalized problems of the current migration policy: insufficient flexibility and unacceptable implementation of migration legislation, imperfection of the existing system of visa-free entry and stay of foreign citizens. Also, during the expert survey, the difficulties faced by migrants were highlighted. The work emphasizes that the success of adaptation and integration processes largely depends on how open/closed the migrant community itself is, and how favorable conditions for adaptation and integration of migrants are created in the receiving social space. It is emphasized that the creation of conditions for effective adaptation and integration of newcomers on the territory of the Rus-sian Federation is among the priority tasks of the national migration policy. Conclusion dwells upon the fact that a competent migration policy is based on a balance between control and liberalization, depending on the goals and objectives to be achieved.

Features of regulatory support for social security of a modern state

The article aims to elucidate the features of regulatory support for the social security of a modern state, examining these through the criteria for appropriate regulatory support for the social security of modern Ukraine. The author identifies that effective legal and regulatory support for the social security of a modern state relies on a set of standards. The legal regulation of the social security of the state should primarily be conducted by entities vested with the requisite rule-making powers, and these powers must be exercised in accordance with the procedures stipulated by law. Rulemaking activities and the legal framework for the social security of the state must align with the principles of law, ensuring legal certainty in the provisions of regulatory legal acts pertaining to social security. Regulatory and legal support for the social security of the state, as an integral component of the legal framework, should adhere to the provisions outlined in the Constitution of Ukraine, current social standards, and consider the international legal obligations of the state, which also emanate from the European integration objectives of Ukraine. The regulatory support for the social security of a modern state must incorporate norms with direct applicability and establish an institutional foundation for the effective implementation of legislation on social security. The regulatory framework for the social security of the state must be coordinated, consistent, flexible, and adaptive, while also being subject to an assessment of its impact on the field of social security. Moreover, in the context of democratizing the socio-legal regime for ensuring the social security of modern Ukraine, the process of legal regulation of social security involves the active participation of interested entities, including civil society actors. The conclusion of the article succinctly summarizes the results of the study.

Evaluating environmental legislation on disaster resilience: Data insights from Nigeria and the USA

This review provides a succinct overview of the research conducted to evaluate the effectiveness of environmental legislation in enhancing disaster resilience, drawing insights from case studies in Nigeria and the United States. Environmental legislation plays a pivotal role in mitigating the impacts of natural disasters, yet its effectiveness in fostering resilience remains a subject of debate. This study employs a comparative analysis approach, examining the legislative frameworks and their implementation in two diverse contexts: Nigeria, representing a developing nation with significant environmental challenges, and the USA, a developed nation with robust regulatory mechanisms. Through comprehensive data collection and analysis, this research scrutinizes the extent to which environmental legislation contributes to disaster resilience in both countries. Key factors such as regulatory compliance, enforcement mechanisms, stakeholder engagement, and institutional capacity are evaluated to gauge the efficacy of the legislative frameworks. Findings reveal disparities in the implementation and effectiveness of environmental legislation between Nigeria and the USA. In Nigeria, despite the existence of relevant laws, challenges persist in enforcement due to institutional weaknesses, corruption, and inadequate resources. Consequently, communities remain vulnerable to recurrent disasters, exacerbating socio-economic disparities and environmental degradation. Conversely, the USA demonstrates a more structured approach to environmental legislation, with robust regulatory mechanisms, efficient enforcement, and proactive risk management strategies. This has led to greater resilience and adaptive capacity, evidenced by effective disaster preparedness, response, and recovery measures. However, despite these disparities, the study identifies common areas for improvement in both contexts. Strengthening institutional capacity, enhancing public awareness and participation, promoting sustainable practices, and fostering international cooperation emerge as crucial strategies to bolster disaster resilience through environmental legislation. This research underscores the significance of evaluating environmental legislation in enhancing disaster resilience, providing valuable insights for policymakers, practitioners, and stakeholders in Nigeria, the USA, and beyond. By addressing the identified challenges and leveraging best practices, nations can foster a more resilient future in the face of escalating environmental risks and uncertainties.

Trends in orphan medicinal products approvals in the European Union between 2010–2022

BackgroundOver the last twenty years of orphan drug regulation in Europe, the regulatory framework has increased its complexity, with different regulatory paths and tools engineered to facilitate the innovation and accelerate approvals. Recently, the proposal of the new Pharmaceutical Legislation for the European Union, which will replace at least three Regulations and one Directive, was released and its new framework is raising many questions. The aim of this study was to present a characterisation of the Orphan Medicinal Products (OMPs) authorised by the European Commission (EC), between 2010 and 2022, looking into eighteen variables, contributing to the ongoing discussion on the proposal and implementation of the new Pharmaceutical Legislation proposed.MethodsData of the OMPs identified and approved between 2010 and 2022 were extracted from the European Public Assessment Reports (EPARs) produced by the European Medicines Agency. Information regarding legal basis of the application, applicant, protocol assistance received, type of authorization, registration status, type of molecule, ATC code, therapeutic area, target age, disease prevalence, number of pivotal clinical trials supporting the application, clinical trial designs, respective efficacy endpoints and number of patients enrolled in the pivotal clinical trials were extracted. A descriptive statistical analysis was applied.ResultsWe identified 192 OMPs approved in the period between 2010 and 2022. 89% of the OMPs have legal basis of “full application”. 86% of the sponsors received protocol assistance whereas 64% of the MAA benefited from the accelerated assessment. 53% of the active substances are small molecules; about 1 in 5 molecules are repurposed. 40% of the OMPs have oncological therapeutic indications and 56% of the OMPs are intended to treat only adults. 71% of the products were approved based on a single pivotal trial.ConclusionsThis analysis of OMPs approved between 2010 and 2022 shows that a shift has occurred in the rare disease medicine development space. Through the period studied we observe an increase of non-small molecules approved, accelerated assessment received and non-standard MA’s granted.