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The extent to which EU competition law applies in the healthcare context remains a contested question. The contemporaneous publication of the European Commission’s Evaluation of State Subsidy rules for health and social services of general economic interest (SGEI) in December 2022, and of the Court of Justice of the European Union’s April 2023 judgment in Casa Regina Apostolorum regarding state support to hospitals in Italy, underscore uncertainty and appear to indicate an impasse. These publications unfold against the backdrop of two tensions: between state and market, and between the EU and national levels. Hospitals illustrate these tensions well due to the expansion of competition mechanisms into the hospital sector (notably expanding private provider delivery of public hospital services, often supported by “patient choice” policies), and of hospitals remaining typically local or regional in character rather than supranational. This article provides a timely and original analysis of the Casa Regina Apostolorum judgment in light of Commission policy regarding SGEI and hospitals and how EU Member States engage with this. It offers insights into the potential legacy of Casa Regina Apostolorum, and indicates where future legal challenges may focus.
Since early 2022, routine testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) based on symptoms and exposure history has largely ceased in Canada. Consequently, seroprevalence studies, particularly longitudinal studies, have become critical for monitoring the rate of incident SARS-CoV-2 infections and the proportion of the population with evidence of immunity. EnCORE is a longitudinal SARS-CoV-2 seroprevalence study comprising five rounds of serology testing from October 2020 to June 2023, in a sample of 2- to 17-year-olds (at baseline), recruited from daycares and schools in four neighbourhoods of Montreal, Canada. We report on SARS-CoV-2 incidence and seroprevalence among the 509 participants in the fifth and final round of the study. Seroprevalence of antibodies from either infection or vaccination was 98% (95 per cent confidence interval [CI]: 97, 99). The infection-acquired seroprevalence was 78% (95% CI: 73–82), and the incidence rate was 113 per 100 person-years (95% CI: 94–132), compared to the seroprevalence of 58% and the incidence rate of 133 per 100 person-years, respectively, in the fourth round of testing (mid–late 2022). Of the 131 participants newly seropositive for infection in Round 4, only 18 were seronegative for infection in Round 5 (median follow-up: 326 days).
Exposure to maternal hyperglycemia in utero has been associated with adverse metabolic outcomes in offspring. However, few studies have investigated the relationship between maternal hyperglycemia and offspring cortisol levels. We assessed associations of gestational diabetes mellitus (GDM) with cortisol biomarkers in two longitudinal prebirth cohorts: Project Viva included 928 mother–child pairs and Gen3G included 313 mother–child pairs. In Project Viva, GDM was diagnosed in N = 48 (5.2%) women using a two-step procedure (50 g glucose challenge test, if abnormal followed by 100 g oral glucose tolerance test [OGTT]), and in N = 29 (9.3%) women participating in Gen3G using one-step 75 g OGTT. In Project Viva, we measured cord blood glucocorticoids and child hair cortisol levels during mid-childhood (mean (SD) age: 7.8 (0.8) years) and early adolescence (mean (SD) age: 13.2 (0.9) years). In Gen3G, we measured hair cortisol at 5.4 (0.3) years. We used multivariable linear regression to examine associations of GDM with offspring cortisol, adjusting for child age and sex, maternal prepregnancy body mass index, education, and socioeconomic status. We additionally adjusted for child race/ethnicity in the cord blood analyses. In both Project Viva and Gen3G, we observed null associations of GDM and maternal glucose markers in pregnancy with cortisol biomarkers in cord blood at birth (β = 16.6 nmol/L, 95% CI −60.7, 94.0 in Project Viva) and in hair samples during childhood (β = −0.56 pg/mg, 95% CI −1.16, 0.04 in Project Viva; β = 0.09 pg/mg, 95% CI −0.38, 0.57 in Gen3G). Our findings do not support the hypothesis that maternal hyperglycemia is related to hypothalamic–pituitary–adrenal axis activity.
We describe 10 patients with severe coronavirus disease 2019 (COVID-19) who received tocilizumab and dexamethasone. We correlated isolation duration with cycle thresholds (Ct) values of nucleic acid amplification tests, clinical state and viral cultures. Isolation duration exceeded 21 days for 7 patients due to positive viral cultures or Ct values <30.
To estimate the minimum prevalence of adult hereditary ataxias (HA) and spastic paraplegias (HSP) in Eastern Quebec and to evaluate the proportion of associated mutations in identified genes.
Methods:
We conducted a descriptive cross-sectional study of patients who met clinical criteria for the diagnosis of HA (n = 241) and HSP (n = 115) in the East of the Quebec province between January 2007 and July 2019. The primary outcome was the prevalence per 100,000 persons with a 95% confidence interval (CI). The secondary outcome was the frequency of mutations identified by targeted next-generation sequencing (NGS) approach. Minimum carrier frequency for identified variants was calculated based on allele frequency values and the Hardy–Weinberg (HW) equation.
Results:
The minimum prevalence of HA in Eastern Quebec was estimated at 6.47/100 000 [95% CI; 6.44–6.51]; divided into 3.73/100 000 for autosomal recessive (AR) ataxias and 2.67/100 000 for autosomal dominant (AD) ataxias. The minimum prevalence of HSP was 4.17/100 000 [95% CI; 4.14–4.2]; with 2.05/100 000 for AD-HSP and 2.12/100 000 for AR-HSP. In total, 52.4% of patients had a confirmed genetic diagnosis. AR cerebellar ataxia type 1 (2.67/100 000) and AD spastic paraplegia SPG4 (1.18/100 000) were the most prevalent disorders identified. Mutations were identified in 23 genes and molecular alterations in 7 trinucleotides repeats expansion; the most common mutations were c.15705–12 A > G in SYNE1 and c.1529C > T (p.A510V) in SPG7.
Conclusions:
We described the minimum prevalence of genetically defined adult HA and HSP in Eastern Quebec. This study provides a framework for international comparisons and service planning.
Calls for a European Health Union apparently challenge long-standing beliefs that national healthcare system organisation is a Member State competence. Interaction between Member State and European Union (EU) levels therefore fundamentally requires reflection in the design, overall structure and legal basis of any European Health Union. Article 168(7) Treaty on the Functioning of the European Union (TFEU) provides the current version of the seemingly limited EU competence with regards to national healthcare system organisation and has received surprisingly little attention thus far. On the one hand, within the wider EU health competence ‘web’, Article 168(7) TFEU constrains EU adoption of measures incentivising Member States to use particular treatments or to increase intensive care units in response to COVID-19. On the other hand, Article 168(7) TFEU is challenged by the perceived influence of Country-Specific Recommendations issued in the context of the European Semester on national health policies. This opinion piece provides an original assessment of Article 168(7) TFEU to argue that Treaty change to redress the balance between EU and Member State competence regarding national healthcare systems may be uncalled for given both the flexibility afforded by the provision and the complexity and diversity of Member State healthcare systems.
The relevance of the European Union (EU) for health has been widely recognised within the health community for some time, and is increasingly apparent to European policy-makers and publics. Despite being an area of policy that national governments would prefer to keep exclusive control of, and though in the past it has rarely been at the top of the agenda, many elements of health have been gradually ‘Europeanised’. This special issue marks the culmination of a British Academy-funded project – EU Health Law and Policy: Shaping a Future Research Agenda – which sought to build on the growing web of expertise in this field and reflect upon the future of health as an EU competence, at a time when it appeared to be under threat.
Identifying profiles of people with mental and substance use disorders who use emergency departments may help guide the development of interventions more appropriate to their particular characteristics and needs.
Aims
To develop a typology for the frequency of visits to the emergency department for mental health reasons based on the Andersen model.
Method
Questionnaires were completed by patients who attended an emergency department (n = 320), recruited in Quebec (Canada), and administrative data were obtained related to sociodemographic/socioeconomic characteristics, mental health diagnoses including alcohol and drug use, and emergency department and mental health service utilization. A cluster analysis was performed, identifying needs, predisposing and enabling factors that differentiated subclasses of participants according to frequency of emergency department visits for mental health reasons.
Results
Four classes were identified. Class 1 comprised individuals with moderate emergency department use and low use of other health services; mostly young, economically disadvantaged males with substance use disorders. Class 2 comprised individuals with high emergency department and specialized health service use, with multiple mental and substance use disorders. Class 3 comprised middle-aged, economically advantaged females with common mental disorders, who made moderate use of emergency departments but consulted general practitioners. Class 4 comprised older individuals with multiple chronic physical illnesses co-occurring with mental disorders, who made moderate use of the emergency department, but mainly consulted general practitioners.
Conclusions
The study found heterogeneity in emergency department use for mental health reasons, as each of the four classes represented distinct needs, predisposing and enabling factors. As such, interventions should be tailored to different classes of patients who use emergency departments, based on their characteristics.
Part of the controversy surrounding competition and health care stems from the complexity connected with delineating the applicability of competition law – encompassing both the provisions governing anticompetitive agreements and abuse of dominance and the state-aid rules. Cases determined at the European Union (EU) level within the past 30 years have developed a broad framework, and notable trends have emerged – for example, a distinction between health care providers and managing bodies (purchasers). The former have been subject to an ‘abstract’ test and the latter to a more sophisticated ‘concrete’ test. In this paper, we chart the development of the EU courts’ approach to developing the ‘undertaking’ concept in health care and examine the current EU competition law framework with a view to identifying future directions. van de Gronden has recently identified a ‘three-prong’ test of exemption from competition law in connection with the recent CEPPB case: firstly, where the supply of services is predominantly dependent upon public financing; secondly, the public funding aims to achieve a public interest goal and thirdly, the activities concerned are closely related to this public interest goal. We examine this test in a health care context, drawing on our findings regarding Dutch competition reforms.
Preliminary evidence has suggested that high-fat diets (HFD) enriched with SFA, but not MUFA, promote hyperinsulinaemia and pancreatic hypertrophy with insulin resistance. The objective of this study was to determine whether the substitution of dietary MUFA within a HFD could attenuate the progression of pancreatic islet dysfunction seen with prolonged SFA-HFD. For 32 weeks, C57BL/6J mice were fed either: (1) low-fat diet, (2) SFA-HFD or (3) SFA-HFD for 16 weeks, then switched to MUFA-HFD for 16 weeks (SFA-to-MUFA-HFD). Fasting insulin was assessed throughout the study; islets were isolated following the intervention. Substituting SFA with MUFA-HFD prevented the progression of hyperinsulinaemia observed in SFA-HFD mice (P < 0·001). Glucose-stimulated insulin secretion from isolated islets was reduced by SFA-HFD, yet not fully affected by SFA-to-MUFA-HFD. Markers of β-cell identity (Ins2, Nkx6.1, Ngn3, Rfx6, Pdx1 and Pax6) were reduced, and islet inflammation was increased (IL-1β, 3·0-fold, P = 0·007; CD68, 2·9-fold, P = 0·001; Il-6, 1·1-fold, P = 0·437) in SFA-HFD – effects not seen with SFA-to-MUFA-HFD. Switching to MUFA-HFD can partly attenuate the progression of SFA-HFD-induced hyperinsulinaemia, pancreatic inflammation and impairments in β-cell function. While further work is required from a mechanistic perspective, dietary fat may mediate its effect in an IL-1β–AMP-activated protein kinase α1-dependent fashion. Future work should assess the potential translation of the modulation of metabolic inflammation in man.
Telestroke is an effective way to improve care and health outcomes for stroke patients. This study evaluates the cost-effectiveness of a French telestroke network.
Methods
A decision analysis model was built using population-based data. We compared short-term clinical outcomes and costs for the management of acute ischemic stroke patients before and after the implementation of a telestroke network from the point of view of the national health insurance system. Three effectiveness endpoints were used: hospital death, death at 3 months, and severe disability 3 months after stroke (assessed with the modified Rankin scale). Most clinical and economic parameters were estimated from the medical files of 742 retrospectively included patients. Sensitivity analyses were performed.
Results
The analyses revealed that the telestroke strategy was more effective and slightly more costly than the reference strategy (25 disability cases avoided per 1,000 at 3 months, 6.7 avoided hospital deaths, and 13 avoided deaths at 3 months for an extra cost of EUR 97, EUR 138, and EUR 154, respectively). The results remained robust in the sensitivity analyses.
Conclusions
In France, telestroke is an effective strategy for improving patient outcomes and, despite the extra cost, it has a legitimate place in the national health care system.
This paper presents the results of the work of the new field initiative launched by the British Museum at the Darband-i Rania pass in the Kurdistan Region of Iraq. The pass is located at the northeastern corner of Lake Dokan, where, though now subsumed into the lake, the Lower Zab flows from the Peshdar into the Rania Plain. It is a strategic location on a major route from Mesopotamia into Iran, and control of both the road and the river must always have been important. The aim of the work, which commenced in autumn of 2016, is to explore a cluster of sites that commanded the pass, with a particular focus on the first millennium b.c. Excavation is being carried out principally at two sites: Qalatga Darband, a large fortified site at the western end of the pass, and Usu Aska, a fort inside the pass itself. The occupations of these two sites are predominantly Parthian and Assyrian respectively. Smaller operations have also been carried out at Murad Rasu, a multi-period site situated on a headland across the waters on the southern shore of Lake Dokan. The results have included the discovery at Qalatga Darband of a monumental complex built of stone and roofed with terracotta roof tiles containing the smashed remains of Hellenistic statuary. Other features indicative of Hellenistic material culture are Mediterranean-type oil-presses and Corinthian column bases and capitals. At Usu Aska remains are being uncovered of an Assyrian fortification of massive proportions.
The recent discovery of a Late/Final Pre-Pottery Neolithic B burial of an adult and two children associated with fox bones at the site of Motza, Israel, demonstrates the broader socio-cultural perspective, and possibly continued animistic world views, of Neolithic foragers at the onset of the agricultural revolution.
Patient choice in the context of National Health Service (NHS) reforms in England can refer to the law and policy underpinning patient movement between the NHS and private healthcare sector (in existence since the introduction of the NHS in 1948), as well as recent competition reforms of the Health and Social Care Act 2012, the National Health Service (Procurement, Patient Choice and Competition) (No 2) Regulations 2013 and the 2014 Private Healthcare Market Investigation by the Competition and Markets Authority (CMA). This paper highlights the existence of two discrete, yet related frameworks: the ‘NHS patient – private patient’ framework based on Department of Health, NHS England and latterly Clinical Commissioning Group policy, and the ‘NHS patient choice’ framework, derived from New Labour choice and competition policies and subsequently enshrined by the 2012 Act reforms. The juxtaposition of these frameworks underscores the symbiotic relationship between the NHS and private healthcare, which raises questions about the fitness for purpose of current policy. It also helps explain why the competition reforms are difficult to implement, and suggests that the knitting together of patient choice and competition may unravel following the 2012 Act reforms and CMA private healthcare market development.
This book brings a unique, comparative approach to competition policy in healthcare. By examining an insurance-based and a taxation-funded healthcare system, insights emerge into the applicability and application of general competition law and healthcare-specific competition rules at EU and Member State level. The developing interactions between healthcare regulators and competition authorities, and issues arising from hospital mergers with regard to general and healthcare-specific merger control both receive in-depth analysis.Insights into competition reforms in the Dutch and English healthcare systems show that the term “healthcare” is problematic: there are important distinctions between public and private healthcare, and between healthcare providers and healthcare purchasers. Even a focus on “healthcare providers” has limitations given the myriad services which comprise healthcare delivery. Competition reforms in healthcare attract controversy if seen exclusively as an end in themselves. This book argues that a nuanced approach is needed: competition in healthcare needs to be tempered, and even focused, by national and EU commitments to solidarity. Following Brexit, scholars and policy makers will maintain interest in comparative and EU law research. This book will thus be essential reading for anyone wishing to understand the mutual implications of EU competition law and policy for developing national healthcare reforms.Dr Mary Guy is a Lecturer in Law at Lancaster Law School and is directing the law component of a British Academy/Leverhulme Trust–funded interdisciplinary project on ‘EU Health Policy and Law – Shaping a Future Research Agenda’ in 2018-2020. She is a member of the European Association of Health Law, the Society of Legal Scholars, the Socio-Legal Studies Association, the British Association of Comparative Law, and the Chartered Institute of Linguists Educational Trust.
The development of competition in the Dutch and English healthcare systems has been accompanied by the establishment of sectoral regulators for healthcare: the Nederlandse Zorgautoriteit (Dutch Healthcare Authority (NZa)) by the Wet marktordening gezondheidszorg (Dutch Healthcare (Market Regulation) Act 2006 (Wmg)) and NHS Improvement by the Health and Social Care Act 2012 (HSCA 2012), respectively. Both the Wmg and the HSCA 2012 make provision for the NZa and NHS Improvement to work with, respectively, the Autoriteit Consument en Markt (Authority for Consumers and Markets (ACM)) and the Competition and Markets Authority (CMA) in the context of implementing competition policy. It is to be noted that, in discussing the evolution of this relationship in the context of the English reforms, it is necessary to be aware of the change in name from Monitor to NHS Improvement. Thus, developments in the course of the enactment of the HSCA 2012 and immediately subsequent to this will refer to Monitor and the NHS Trust Development Authority (NHS TDA) to reflect the agencies in operation during that period, whilst more general references – for example to the legal framework which is still in force – specify NHS Improvement, which has been operational since April 2016 (and incorporates the functions of both of these agencies).
The primary focus of this chapter is the particular relationship between the competition authority and sectoral regulator regarding the application of competition law. This relationship has been outlined by the Wmg and HSCA 2012, but how it can, or should, operate in practical terms is less obvious. Certainly it is less clear-cut than the relationship between the two agencies in respect of merger control, where tensions may arise primarily from the two agencies reaching different conclusions – from different tests – about whether a merger should be approved.
Another factor which makes this relationship worthy of consideration is the benefit of national comparisons in view of the relative novelty of sectoral (economic) regulation in healthcare – the NZa being established in 2006 and Monitor's (now NHS Improvement's) designation as 'sectoral’ (as opposed to ‘economic’) regulator dating from 2012 – amid wider change within competition policy: both the ACM and CMA are relatively new agencies, having been established in 2013 and 2014, respectively.