Legislative Challenges Research Articles

Understanding medicine access strategies for innovator medicines registered in South Africa

BackgroundSouth Africa is composed of a two-tier healthcare system. One tier is a private healthcare system that is funded through medical insurance, and comprised of people who can afford to make monthly payments towards their medical insurance. Second tier is a government-funded public healthcare system, which covers the majority of the population. This study explored the perceived barriers and current strategies being utilised by the pharmaceutical industry to increase access to innovator medicines.ObjectivesThe objectives of the study were to: (1) quantify and classify innovator medicines registered between 2010 and 2020 by the South African Health Products Regulatory Authority (SAHPRA); (2) identify barriers to accessing innovator medicines in South Africa through interviews with market access managers from innovator companies; and (3) explore the current market access strategies used by the pharmaceutical industry.DesignThis study employed a quantitative and qualitative methodology. Whereby the former involved the extraction of a list of innovator medicines from the regulator database, and the latter involved 9 semi structured interviews. Purposive sampling was conducted through pharmaceutical association member companies. The interviews included seven market access managers and two medicine managers from one of the payers in South Africa. Thematic analysis was used to interpret the data collected from the study.ResultsAccording to the regulator database during the review period, 238 innovator medicines were registered. Only 14.77% were available in the public sector in the form of tenders, whereas in the private sector (based on the products having a SEP), 76.92% were available. From the interviews six themes emerged: reimbursement of medicines, types of reimbursement, partnerships, technology, legislative challenges, and other factors (e.g., real-world evidence).ConclusionAccess to innovator medicines in South Africa is a challenge, as the price of these therapies is high. Therefore, various stakeholders in the health sector must collaborate to identify and implement solutions that are locally relevant. The government needs to proactively update policies that would allow for alternative reimbursement methods to be explored.

Challenges for Occupational Safety and Health Legislation in Climate Change Adaptation - Focusing on policies to prevent health hazards from heat waves -

Challenges for Occupational Safety and Health Legislation in Climate Change Adaptation - Focusing on policies to prevent health hazards from heat waves -

Legal Regulation of the Use of Physical Force by Police Officers Under Martial Law

The legal regulation of the use of physical force by police officers is a critical issue in the system of public safety, particularly under martial law. In modern times, as countries face growing national security threats, the problem of ensuring that police use force both legally and appropriately becomes increasingly important. Martial law, which involves extraordinary measures by the state to protect its sovereignty and citizens, often grants law enforcement agencies expanded powers. These powers are intended to facilitate a quicker response to threats that may endanger both public order and national security. However, such expanded powers raise legal and ethical concerns regarding the boundaries of acceptable force. In the context of martial law, there is an urgent need to formalize the legal frameworks that govern the use of physical force by police officers. This includes not only national legislation but also international agreements that set standards for law enforcement conduct during crises. The complexity of maintaining public safety during military operations requires specific guidelines to ensure that law enforcement agencies act within the bounds of the law, while still effectively protecting citizens. This article focuses on analyzing how martial law affects the legal regulation of the use of force by police officers, using Ukraine as a case study. It highlights the key legislative challenges that have emerged in Ukraine since the introduction of martial law, such as ambiguities in the scope of police authority and gaps in existing regulations. Additionally, it offers recommendations for addressing these issues, emphasizing the need for clear and precise legal standards that balance public safety and the protection of human rights, even in times of crisis.

Long-term trends in mental health disparities across sexual orientations in the UK: a longitudinal analysis (2010-2021).

In the context of increasing hate crimes, legislative challenges, and anti-LGBTQ + sentiment, we conducted the first study that comprehensively examined long-term mental health disparities across sexual orientations in the UK from 2010 to 2021. Prior studies predominantly relied on cross-sectional or limited longitudinal designs, thus failing to capture evolving trends over a decade and providing crucial insights into the dynamics of mental health challenges faced by sexual minorities, essential for devising targeted public health interventions and policies. Waves 2-12 of the UK Longitudinal Household Survey for adults (n = 52,591) were used. MCS-12 (Mental Health Component Scale of the Short-Form Health Survey) for mental functioning and GHQ (General Health Questionnaire) for psychological distress were included as the main outcomes, along with other measures of well-being. Mixed-effect longitudinal models were used to examine the trends of mental health disparities across sexual orientations. Relative to their heterosexual counterparts, psychological distress (GHQ) increased for gay men, lesbians, and women with "other" orientations. Bisexual women saw the steepest increase from 1.69 higher GHQ vs. their heterosexual counterparts in 2010 (95%CI: 0.81 to 2.57), up to 3.37 in 2021 (95%CI: 2.28 to 4.45). Similar trends were also shown in the other measures. The study highlights increases in mental health disparities between sexual minorities and heterosexuals. The escalating psychological distress among sexual minorities, particularly bisexual women, calls for an urgent, multi-faceted, and intersectoral response. This approach must address both symptoms and the social structures perpetuating these disparities across sexual orientations.

Legislative Challenges of Application of Restorative Justice Practices in The Criminal Courts of Iraq

Restorative justice does not only aim to impose harsher punishment on criminals and defend the victims’ justice, but rather it works in a balanced manner to distribute roles between the victim and the accused in order to restore the damage that befell the victim and those around him. It also works to hold the offender responsible for this according to the order of the Imam. Society. The Economic and Social Council in Vienna stipulated in 2002 that the criminal case should be transferred to restorative justice institutions before being considered by the criminal court. The question raised here are: What are the legal challenges that hinder the application of restorative justice in the Iraqi criminal courts? To answer this question, and through collecting opinions and decisions, it is noted that conciliation is the only form taken by the Iraqi criminal courts as an aspect of restorative justice. However, it faces many challenges that prevent the judge from expanding to cover a large number of crimes, the most important of which are the inflexibility of legal texts and the inflation in Punitive legislation and the failure of laws to keep pace with developments. Added to these challenges are existing laws that focus largely on custodial penalties and restrict the possibility of applying restorative justice. Also, social and cultural norms, such as tribal customs, play a role in out-of-court reconciliation, requiring updating laws to align with these norms and further strengthening the application of restorative justice within the Iraqi judicial system. In short, Iraqi laws are still insufficient to effectively implement restorative justice programs, and criminal mediation has not yet been provided for, despite its importance and actual practice by Iraqi society in resolving disputes.

Transparency and consent as the main principles of personal data protection in Ukraine

The rapid digitization of the modern world has led to an increase in the collection and processing of personal data. The principles of transparency and consent have become crucial for citizens to understand how their data is being used and to be able to give their voluntary consent to its processing. Ukraine is actively adapting its legislation to EU standards in the field of personal data protection. In particular, the General Data Protection Regulation (GDPR) affects approaches to data collection and processing. Examining transparency and consent in the context of these changes can help identify which aspects of the law need special attention. Citizens are becoming increasingly cautious about who they trust with their data. This article analyzes and evaluates the role and impact of the principles of transparency and consent on the effective mechanism of personal data protection in Ukraine, taking into account modern technological and legislative challenges. Studying these principles demonstrates their importance and relevance in today’s digital society. The principle of transparency determines the need for accessible and understandable information for data subjects regarding the processing of their data. Openness is a fundamental requirement for maintaining trust between organizations and citizens. Providing the ability to control and regulate their data allows data subjects to play a more active role in the processing and use of their personal data. The principle of consent, in turn, emphasizes the voluntary and informed nature of consent to data processing. The consent of the data subject determines the basis for the legal processing of personal data, ensuring harmony between the rights of citizens and the interests of organizations. As technology advances and legislation changes, transparency and consent become even more important aspects. They help build trust between organizations and citizens, ensure responsible use of personal data, and empower individuals to control their own information.

Mitochondria as therapeutic targets in assisted reproduction.

Mitochondria are essential organelles with specialized functions, which play crucial roles in energy production, calcium homeostasis, and programmed cell death. In oocytes, mitochondrial populations are inherited maternally and are vital for developmental competence. Dysfunction in mitochondrial quality control mechanisms can lead to reproductive failure. Due to their central role in oocyte and embryo development, mitochondria have been investigated as potential diagnostic and therapeutic targets in assisted reproduction. Pharmacological agents that target mitochondrial function and show promise in improving assisted reproduction outcomes include antioxidant coenzyme Q10 and mitoquinone, mammalian target of rapamycin signaling pathway inhibitor rapamycin, and nicotinamide mononucleotide. Mitochondrial replacement therapies (MRTs) offer solutions for infertility and mitochondrial disorders. Autologous germline mitochondrial energy transfer initially showed promise but failed to demonstrate significant benefits in clinical trials. Maternal spindle transfer (MST) and pronuclear transfer hold potential for preventing mitochondrial disease transmission and improving oocyte quality. Clinical trials of MST have shown promising outcomes, but larger studies are needed to confirm safety and efficacy. However, ethical and legislative challenges complicate the widespread implementation of MRTs.

Politics of International Labor Migration and the Survival of (Illegal) Brokers in Indonesia

Indonesian labor migration is a multifaceted process heavily influenced by private actors, particularly brokers who operate both within the bounds of legality as recruitment agencies and outside it as illicit recruiters. These brokers are frequently accused of exploiting Indonesian migrant workers, leading to government efforts to limit their roles. However, despite legislative efforts, such as the 2017 law aimed at restricting the roles of labor-recruiting companies and illegal brokers, these intermediaries persist. Drawing on the concept of brokerage and the Theory of Strategic Action Field, this article explains why brokers remain despite legislative challenges. This study also argues that state regulations inadvertently create structural holes, thereby providing brokers with opportunities to maintain their involvement in labor migration. Through 56 in-depth interviews with various actors—including current and former migrant workers, recruiters, recruitment agencies, civil society organizations (CSOs), and government officials—the study illuminates how the Indonesian government’s framing of "procedural migration” contains inherent loopholes. Brokers then exploited these gaps to legitimize their presence and assert control over workers’ destinies. These brokers adeptly adapt to regulatory changes and influence migration.

How can a balanced ecosystem of technology, collaboration and innovation build greener airports? The case study of Groningen Airport Eelde

This paper discusses Groningen Airport Eelde’s (GRQ) transition to sustainable aviation, emphasising its commitment to minimising environmental impact while enhancing regional connectivity. It details GRQ’s initiatives, collaborations and future plans, showcasing how the airport leverages its unique position to spearhead the adoption of sustainable technologies, particularly in hydrogen. Through collaboration, innovation and strategic partnerships, GRQ aims to lead the way towards a more sustainable aviation future. GRQ’s commitment to minimising environmental impacts aligns with community interests, maintaining local trust and government support. By 2030, GRQ aims for a fully emission-free ground operation. The airport has successfully implemented a 22MW airside solar park and is now pioneering a comprehensive hydrogen ecosystem, aiming to become Europe’s first Hydrogen Valley Airport. Despite challenges in funding and legislation, GRQ advises other airports to build consortia, connect with regional partners and prioritise sustainability.

Justice, Equity, Diversity, Inclusion, and Belonging (JEDI-B) in Transition to Practice Programs.

Justice, equity, diversity, inclusion, and belonging (JEDI-B) are essential for creating safe and productive professional environments. Clear definitions of JEDI-B terms are essential for collective understanding and organizational buy-in. Institutional and transition to practice program efforts should focus on the development of inclusive cultures, diverse curriculum, and data-driven evaluation of JEDI-B policies, processes, and practices. Engagement in bias recognition and the unlearning of those biases is also vital. Despite current legislative challenges, the integration of JEDI-B principles remains a vital component in enhancing health care experiences for patients and fostering inclusive workplaces. [J Contin Educ Nurs. 2024;55(6):273-275.].

The Policy Basis, Challenge and Response of Lifelong Education Legislation

The Policy Basis, Challenge and Response of Lifelong Education Legislation

Natural Extracts and Essential Oils as Ingredients in Cosmetics: Search for Potential Phytomarkers and Allergen Survey

The increasing use of natural ingredients such as essential oils (EOs) and natural extracts (NEs) in cosmetics is an analytical and legislative challenge due to their complex composition, which includes recognized allergenic compounds. In this work, 17 EOs and NEs have been characterized by gas chromatography coupled to mass spectrometry (GC-MS) of dilutions of the original samples. Additionally, solid phase microextraction (SPME) was applied for the analysis of volatile components. The results obtained allowed the identification of more than 90 compounds, including 20 allergens, in the analyzed samples and the study of potential phytomarkers of the addition of EOs and ENs in cosmetics.

We outside: Modeling equity‐centered, antiracist, community‐driven partnerships in resident education

AbstractBackgroundCommunity engagement is increasingly recognized as a necessity in addressing intractable racial and ethnic health disparities in the United States. However, institutions have not adequately trained resident physicians in developing symbiotic community partnerships that preserve community autonomy and identity without exploitation. Our goals were to highlight the experiences of expert academic emergency physicians in creating innovative, community‐driven, and anti‐racist solutions to achieving measurable equity in health outcomes and to introduce a novel framework entitled the Social Change Method to take a community‐embedded intervention from concept to creation.MethodsThe methodology was based on the development of a didactic session at the 2023 SAEM Annual Meeting. The three novel initiatives discussed were Emergency Medicine Remix (EMR); Trust, Research, Access, and Prevention (TRAP) Medicine; and The Health Equity Accelerator (HEA). A team of multi‐institutional experts convened to develop the session objectives through priority setting.ResultsOur expert panel discussed successes and challenges encountered while using evidence‐informed strategies to conduct their community‐based programming. Participant questions were centered on fostering sustainability, emphasizing the importance of carefully crafted interventions in the face of uncertain legislative challenges and strategies to empower others.ConclusionsEmergency medicine residency education should incorporate training on methods to leverage community partnerships to improve individual and community health outcomes. The Social Change Method can be used as a conceptual framework to generate easily re‐creatable and scalable partnerships that establish trust and forge relationships that honor identity and autonomy without exploiting community members.

CRITICAL ANALYSIS OF HEMP (CANNABIS SATIVA L.) USE: SCIENTIFIC, LEGISLATIVE AND SOCIO-ECONOMIC ASPECTS

Cannabis sativa L. culture has encountered various legislative challenges throughout history, and these have varied according to the social, political and economic context of each period. Historical stigma and prohibitions brought restrictions on cannabis, and anti-drug and prohibition policies adopted in the 20th century led to the prohibition of the cultivation of Cannabis sativa L. Its incorrect association with drugs of abuse and its classification as a narcotic substance complicated the legislation. Problems in differentiating between recreational and medical use have created confusion in law. Global inconsistency in cannabis rules and regulations has created difficulties in international trade and research cooperation. The recent evolution of legislation, marked by ambiguities and inconsistencies regarding the medical, industrial, and food use of cannabis, has raised questions and challenges. Production and marketing issues, such as strict regulations and licensing hurdles affect the cannabis industry in the Republic of Moldova too. These challenges are constantly changing, reflecting the diversity of perspectives and societal developments.

Systems Thinking Interplay Between Project Complexities, Stakeholder Engagement, and Social Dynamics Roles in Influencing Construction Project Outcomes

Construction projects are fraught with the challenges of cost overruns, schedule deviations, and not meeting expectations. Underlying these failures are factors related to complexity, stakeholder management, and external social dynamics. The literature review highlighted research gaps, leading to conceptualizing the research aim. The study explored the roles of project complexity, stakeholder engagement, and social dynamics in the UK construction project management sector. A survey research strategy combining qualitative interview questions was employed to extract data from project professionals across the UK. Convenience sampling resulted in a high response rate from seventy-three (73) participants across the UK. Four main themes emerged: project complexity and lessons learned; stakeholder engagement and social climate; project failures and conflicts; and project success. System thinking causal loop diagramming was applied in amalgamating implications drawn from the findings. The implications noted that challenges in governance, regulation, and legislation, coupled with stringent cost and schedule targets, added to project complexity, effective stakeholder engagement, clear communication, and understanding of social contexts were crucial for project success where complexities of stakeholders and social dynamics proved difficult.

Fabrication and Falsification of Scientific Research – a Challenge for Legislators or an Irrelevant Issue?

The article addresses the problem of fabrication and falsification of scientific research in the context of the role that lawmakers can play in combating this practice. Legisla­tors may establish organisational units specialising in combating scientific miscon­duct (also referred to as ‘research misconduct’), having the authority to, for instance, to conduct investigations or recommend penalties. A researcher who commits such misconduct may face not only disciplinary, but also civil, administrative or criminal liability. The article discusses the results of a survey asking 70 Polish academics about their opinion on the role of legislators in countering fabrication and falsifica­tion in research. The findings show, for example, that respondents mostly support disciplinary responsibility for such misconduct (81%), and also believe that legisla­tors should combat this practice using ‘soft’ measures, such as promoting codes of ethics in research (70%). Half of those surveyed wanted such behaviour crimina­lised. According to almost half of the respondents, the Polish legislator does not combat such misconduct effectively.

Athlete–Student–Influencer: How the Introduction of Name, Image, and Likeness in Intercollegiate Athletics Further Complicates Applications of Role Theory

The revered tradition of amateurism has transformed due to legal and legislative challenges initiated by the name, image, and likeness landscape. In contrast to the traditional National Collegiate Athletic Association model, college athletes have now gained the opportunity to benefit financially from their notoriety by adopting an influencer role. The purpose of this manuscript was to explore the conceptual and theoretical shifts resulting from the introduction of the influencer role, considering the existing literature on athlete–student role theory. By achieving harmony between the athlete, student, and influencer roles, athletes should produce the most significant gains in each area, including academic performance, athletic achievement, and monetary benefit. However, greater psychological and sociological consequences may emerge for athletes if the influencer role further complicates the conflict between their athlete and student roles.

Advances and challenges in animal source food inspection legislation for Brazilian small-scale and artisanal producers.

The strict sanitary inspection legislation of animal source food has been considered a trade barrier for smallholder farmers and small-scale producers in Brazil. In this sense, law flexibilization is suggested to facilitate national trade of these products. We conducted a social and sanitary analysis, presenting the current Brazilian conjuncture and difficulties for animal source food Brazilian inspection law flexibilization. By discussing inequalities, human rights issues, animal source food legislation, and international food safety standards, we evidenced critical barriers for legislative reform in Brazil. Among these barriers, the main ones are social inequalities; high zoonotic risk of animal source food products; the Brazilian political structure and its reflection on different inspection practices among country jurisdictions; and the lack of inspection services in most Brazilian municipalities. At the same time, we present positive updates in the normative framework, and point out game-changers to modify the actual safety and trade situations of Brazilian small-scale and artisanal animal source food products, including policies to strengthen state and municipal inspection services and harmonization initiatives based on international standards and national legislation. We also suggest policies to implement inspection services in municipalities, whether by municipal action or by a consortium, as well as policies to strengthen technical assistance and rural extension for small-scale and artisanal producers. These policies aim to reduce technical and sanitary education inequalities and build a fairer animal source food system.

CYBERCRIME LEGISLATION: A COMPARATIVE ANALYSIS OF LEGAL FRAMEWORKS, POLICY RESPONSES AND RECOMMENDATIONS

The World Economic Forum's Global Risk Report 2021 highlights cybercrime as a top global risk, necessitating robust legislation to address its evolving nature. The United States signed two cybersecurity bills into law in June 2022, aiming to enhance the federal cyber workforce and promote coordination on security issues. This paper exams a comparative cybercrime legislation across various jurisdictions, including the United States, reveals divergent approaches, with the United States adopting a decentralized model, while Germany and Singapore opt for centralized regimes. This paper highlights the need for comprehensive legal frameworks to combat cyber threats effectively, key trends and challenges in cybercrime legislation include the need for harsher sanctions, extraterritorial jurisdiction, and balancing legal principles in sentencing. Best practices and recommendations emphasize international collaboration, capacity building, public-private partnerships, technological solutions, and continuous legislative review. Future solutions emphasize the importance of rigorous monitoring and adaptable legal frameworks to address the evolving landscape of cyber threats. By understanding international laws and collaborations, policymakers can develop innovative policies to safeguard digital environments against cybercrime.

Enhancing the criminal justice response to human trafficking in South Africa: Legislation and case law in the spotlight

Human traffickers continually develop new tactics to trick and trap their victims, making human trafficking a complex and evolving crime that demands a robust criminal justice response. This response must be consistently refined to combat this pervasive crime effectively. In South Africa, the Prevention and Combating of Trafficking in Persons Act 7 of 2013 (Trafficking Act) came into force in 2015 to address the multifaceted crime. Now, after eight years, this article delves into the status of the counter-trafficking response, focusing on the efficacy of the anti-trafficking legislation and its implementation by the courts. It was found that, first, the Trafficking Act, as previously confirmed, complies with international minimum standards, and encompasses all forms of trafficking. Secondly, through the implementation and interpretation of this legislation, the courts have established jurisprudence on human trafficking, making a significant contribution to the criminal justice response. By reviewing case law spanning the period 2009 to 2023, this article aims to contribute novel insights to the existing body of knowledge, based on evidence tested in courts. Examining emerging case law, the article sheds light on various features of human trafficking within the criminal justice arena. It focuses specifically on the gravity and nature of human trafficking, penalties imposed by the courts, both domestic and cross-border trafficking, and new insights into various types of trafficking perpetrated within South Africa. Notably, court judgments increasingly offer binding and clarifying decisions. Case law has endorsed the only legally binding definition of human trafficking and provided interpretations of concepts in trafficking legislation. However, alongside the positive contributions of case law, the article also identifies legislative challenges. Consequently, recommendations are presented to enhance and fortify the criminal justice response to human trafficking in South Africa.