Administrative Law

CONTEXT: The European Union (EU) governs global health through its constituent laws, institutions, actors and policies. However, it is unclear whether or how these political factors interact to position the Union as a political determinant of global health. METHODS: A case study of the political factors (Rushton and Williams, 2012) influencing the adoption of the EU's Biotechnology Directive 98/44/EC and Orphan Medicines Regulation 141/2000. FINDINGS: The European Commission (EC) generally framed both of its proposals around economical and biomedical paradigms aligned with the needs of the EU's industry and patients, whereas the European Parliament (EP) contested some of these frames and proposed amendments supporting global access to medical products...

The objective of this paper is to explain the political factors determining the relatively weak performance of the Polish health care (HC) sector. This can be treated as a critical case due to several reasons: first, the Poles as patients belong to the most unsatisfied ones in the European Union (EU), second, Poland spends on its HC-related expenditures one of the lowest shares of the GDP among the OECD countries, third, the number of doctors per 1000 inhabitants remains at the lowest European level, and the life expectancy in Poland is one of the lowest in the EU and is decreasing...

CONTEXT: The COVID-19 pandemic has highlighted how the European Union (EU) impacts national health systems and people's health. In November 2020, the European Commission launched the European Health Union (EHU) to better coordinate and maximise EU Member States' abilities to deal with cross-border health threats. This paper scrutinises the early institutionalisation of the EHU and its implications for EU health policy as a political determinant of health (PDoH). METHODS: The study explores how EU health policy may be appreciated from a PDoH perspective...

The pandemic raises the question of the problematic social toll of austerity for health in the South of Europe. Has EU economic governance constrained health spending fuelling inequalities, in turn, shaping responses to the pandemic? EU economic governance is often dismissed as ineffective due to its poor track record of compliance. Yet, austerity is blamed for negative health outcomes. I show the EU fiscal rule is a determinant of health by impacting of fiscal policies of European countries. Firstly, the analysis of EU Member States 1995-2018 shows austerity policies impact health spending and health inequalities...

The extent to which healthcare reforms affect health remains understudied. Healthcare reforms result in policy outputs that determine provision of medical services, which have consequences for the health of the population. We scrutinize this relationship between health policy outputs and population health, using an original dataset of healthcare reforms passed in 36 European countries from 1989 to 2019. Focusing more specifically on legislative changes implying privatization of healthcare delivery and finance, we ask the following question: What is the relationship between reforms that privatize healthcare provision and population health in terms of health outcomes and inequalities? We answer this question by relying on fixed effects time-series cross-section models...

Front-of-pack labeling schemes are an effective but contested regulatory approach to nudge consumers towards healthy food choices. The Nutri-Score, being implemented by seven European countries, is one of the most elaborated and evidence-based examples. Therefore, the Nutri-Score has been deemed as the frontrunner within the EU Commission's attempt to harmonize front-of-pack labeling among EU member states under its Farm-to-Fork strategy (F2F) by the end of 2022. However, the endeavor is on the brink of failure due to massive resistance by Mediterranean member states and parts of the food industry capitalizing on patriotic narratives (e...

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BACKGROUND: Research in Social and Administrative Pharmacy has been expanding in the last decade. The recently published Granada Statements offer key recommendations to improve the quality of research in this field. OBJECTIVES: To identify the factors associated with the citations of articles in the field of social, administrative, clinical pharmacy and practice research. METHODS: This study was a retrospective, observational analysis of articles published in three leading journals...

Biosimilars are biologic agents the Food and Drug Administration (FDA) has deemed to have no clinical difference from their reference biologics. In dermatology,  biosimilars are approved for the treatment of psoriasis and hidradenitis suppurativa. Although dermatologists are high prescribers of biologics, they are more reluctant to prescribe biosimilars than other specialists. This survey-based study sought to characterize dermatologists’ current perspectives on biosimilars.  Methods: A 27-question survey was distributed via email to dermatologists between September and October of 2022...

Monitoring cannabis consumption holds great interest due to the increasing trend towards its legalization for both medicinal and recreational purposes, despite the potential risks and harms involved. Wastewater-based surveillance (WBS) offers a valuable tool for assessing shifts and patterns in drug consumption and to evaluate law enforcement strategies and harm reduction programs. However, WBS-derived cannabis use estimates have been linked to greater uncertainties compared to other drugs, in part due to the many different routes of administration and a substantial excretion of metabolites in faecal matter...

Vitamin A supplements are used by many people, and the number of newly registered dietary supplements is continuously increasing. The preparations fall under food law and are not subject to the strict controls of pharmaceuticals. Risk indications and maximum quantity recommendations, e.g., from the Bundesinstitut für Risikobewertung (BfR) and the U.S. Food and Drug Administration (FDA) are not binding, which means that overdoses and potentially serious health problems can easily occur. The hepatotoxicity and teratogenicity of vitamin A are well documented, and other negative effects of high doses of vitamin A are also being discussed...

The lack of in vivo studies on the delivery of doxorubicin within human skin, especially the absence of data on the doxorubicin diffusion coefficient, has made understanding its transdermal delivery kinetics challenging. In this study, as a first step, governing equations and finite element methods were employed to reproduce Franz diffusion cell experiment in human cadaver skin. The application of this experiment representative model with a fitting method resulted in approximate values for the diffusivity of doxorubicin across various skin layers...

Bacteriophage therapy is a promising approach to treating bacterial infections. Research and development of bacteriophage therapy is intensifying due to the increase in antibiotic resistance and the faltering development of new antibiotics. Bacteriophage therapy uses bacteriophages (phages), i.e., prokaryotic viruses, to specifically target and kill pathogenic bacteria. The legal handling of this type of therapy raises several questions. These include whether phage therapeutics belong to a specially regulated class of medicinal products, and which legal framework should be followed with regard to the various technical ways in which phage therapeutics can be manufactured and administered...

INTRODUCTION: Although medical marijuana usage continues to become more socially acceptable and is increasingly regarded as a legitimate treatment alternative for certain medical conditions such as cancer and epilepsy, stigma remains. METHODS: This study examined whether offering an educational session addressing several key aspects of medical marijuana (e.g., pharmacology, legality) to healthcare providers in a community hospital setting improved knowledge about and/or altered attitudes toward marijuana use...

The entry into force of the Organic Law on the Regulation of Euthanasia in June 2021 obliges clinicians to reconsider their professional work, in the face of a new service that expands the limits of what was considered correct until then. This new service affects the entire healthcare system, but especially primary care professionals. Beyond the procedural and moral aspects, it is necessary to rethink the assessment of the patient who expresses a wish to die. In this review, we start with the relatively recent definition of the wish to hasten death (WTHD), its causes, epidemiology and differential diagnosis...

BACKGROUND: Human papillomavirus (HPV) infection causes nearly all cervical cancer cases and is a cause of anogenital and oropharyngeal cancers. The incidence of HPV-associated cancers is inequitable, with an increased burden on marginalized groups in high-income countries. Understanding how immunization status varies by material and social deprivation, health system, and geospatial factors is valuable for prioritizing and planning HPV immunization interventions. OBJECTIVE: The objective of this study was to describe school-based HPV immunization rates by individual and geospatial determinants of health in Alberta, Canada...

BACKGROUND: Nuclear medicine uses radionuclides in medicine for diagnosis, staging, therapy, and monitoring the response to therapy. The application of radiopharmaceutical therapy for the treatment of certain diseases is well-established, and the field is expanding. Internal dosimetry is multifaceted and includes different workflows, as well as various calculations based on patient- specific dosimetry. AIM: The objective of this study was to introduce the technical issues which might occur during iodine-131 (¹³¹I) dosimetry performed in nuclear medicine departments...

BACKGROUND: Federal authorization of the use of Clinical Laboratory Improvement Amendments of 1988 (CLIA) waived point-of-care tests for SARS-CoV-2 by pharmacists during the pandemic resulted in a dramatic rise in the number of community pharmacies that became CLIA-waived test sites. Now as we exit the pandemic, the wide-ranging expansion of the scope of practice facilitated currently by the PREP Act is set to expire in fall 2024. As a result, American pharmacists' ability to offer CLIA-waived testing services will revert to a patchwork of state laws...

INTRODUCTION: This study investigated the occurrence of various animal welfare violations at German abattoirs by analyzing the results of an anonymous online survey and relevant German court decisions. METHODS: The survey targeted official veterinarians (OVs) and other individuals responsible for enforcing animal welfare laws and regulations at German abattoirs. Participants were asked to report the five most common animal welfare violations in their workplaces during the past 3 years (2019-2021), and whether 22 specific given violations had occurred or not (in the same timeframe)...

This article considers how distanciation, understood as the active production of different forms of distance as a method of control, is used to manage people racialised and criminalised as migrants within the UK's hostile environment. Analysing different policies introduced under the hostile environment agenda, as well as the more recent New Plan for Immigration, we argue distanciation is a key tactic that shapes these policies and their implementation as well as offers us insight into changing forms of governing migration...