Protecting Patients And Society In An Era Of Private Equity Provider Ownership: Challenges And Opportunities For Policy.

Private equity (PE) acquisitions in health care delivery nearly tripled from 2010 to 2020. Despite concerns around clinical and economic implications, policy responses have remained limited. We discuss the US policy landscape around PE ownership, using policies in the European Union for comparison. We present four domains in which policy can be strengthened. First, to improve oversight of acquisitions, policy makers should lower reporting thresholds, review sequential acquisitions that together affect market power, automate reviews with potential denials based on market concentration effects, consider new regulatory mechanisms such as attorney general veto, and increase funding for this work. Second, policy makers should increase the longer-run transparency of PE ownership, including the health care prices garnered by acquired entities. Third, policy makers should protect patients and providers by establishing minimum staffing ratios, spending floors for direct patient care, and limits on layoffs and the sale of real estate after acquisition (forms of "asset stripping"). Finally, policy makers should mitigate risky financial behavior by limiting the amount or proportion of debt used to finance PE acquisitions in health care.

A joint penalized spline smoothing model for the number of positive and negative COVID-19 tests.

One of the key tools to understand and reduce the spread of the SARS-CoV-2 virus is testing. The total number of tests, the number of positive tests, the number of negative tests, and the positivity rate are interconnected indicators and vary with time. To better understand the relationship between these indicators, against the background of an evolving pandemic, the association between the number of positive tests and the number of negative tests is studied using a joint modeling approach. All countries in the European Union, Switzerland, the United Kingdom, and Norway are included in the analysis. We propose a joint penalized spline model in which the penalized spline is reparameterized as a linear mixed model. The model allows for flexible trajectories by smoothing the country-specific deviations from the overall penalized spline and accounts for heteroscedasticity by allowing the autocorrelation parameters and residual variances to vary among countries. The association between the number of positive tests and the number of negative tests is derived from the joint distribution for the random intercepts and slopes. The correlation between the random intercepts and the correlation between the random slopes were both positive. This suggests that, when countries increase their testing capacity, both the number of positive tests and negative tests will increase. A significant correlation was found between the random intercepts, but the correlation between the random slopes was not significant due to a wide credible interval.

Active afforestation of drained peatlands is not a viable option under the EU Nature Restoration Law.

The EU Nature Restoration Law (NRL) is critical for the restoration of degraded ecosystems and active afforestation of degraded peatlands has been suggested as a restoration measure under the NRL. Here, we discuss the current state of scientific evidence on the climate mitigation effects of peatlands under forestry. Afforestation of drained peatlands without restoring their hydrology does not fully restore ecosystem functions. Evidence on long-term climate benefits is lacking and it is unclear whether CO2 sequestration of forest on drained peatland can offset the carbon loss from the peat over the long-term. While afforestation may offer short-term gains in certain cases, it compromises the sustainability of peatland carbon storage. Thus, active afforestation of drained peatlands is not a viable option for climate mitigation under the EU Nature Restoration Law and might even impede future rewetting/restoration efforts. Instead, restoring hydrological conditions through rewetting is crucial for effective peatland restoration.

Public health relevance of medicines developed under paediatric legislation in Europe and the USA: a systematic mapping study.

BACKGROUND: Legislation in the European Union (EU) and the USA promoting the development of paediatric medicines has contributed to new treatments for children. This study explores how such legislation responds to paediatric health needs in different country settings and globally, and whether it should be considered for wider implementation. METHODS: We searched EU and US regulatory databases for medicines with approved indications resulting from completed paediatric development between 2007 and 2018. Of 195 medicines identified, 187 could be systematically mapped to the burden of the target disease for six study countries (Australia, Brazil, Canada, Kenya, Russia, South Africa) and globally, using disability-adjusted life years (DALYs). All medicines were also screened for inclusion on the WHO Model List of Essential Medicines (EML) and the EML for children under 13 years (EMLc). RESULTS: The studied medicines were disproportionately focused on non-communicable diseases, which represented 68% of medicines and 21% of global paediatric DALYs. On the other hand, we found 28% of medicines for communicable, maternal, neonatal and nutritional disorders, representing 73% of global paediatric DALYs. Neonatal disorders and malaria were mapped with two medicines, tuberculosis and neglected tropical diseases with none. The gap between medicines and paediatric DALYs was greater in countries with lower income. Still, 34% of medicines are included in the EMLc and 48% in the EML. CONCLUSIONS: Paediatric policies in the EU and the USA are only partially responsive to paediatric health needs. To be considered for wider implementation, paediatric incentives and obligations should be more targeted towards paediatric health needs. International harmonisation of legislation and alignment with global research priorities could further strengthen its impact on child health and support ongoing efforts to improve access to medicines. Furthermore, efforts should be made to ensure global access to authorised paediatric medicines.

[Care assistants at the international level: a narrative review]. / Gli operatori di supporto a livello internazionale: una revisione narrativa.

. Care assistants at the international level: a narrative review. INTRODUCTION: At the international level, the role of care assistants, their competencies and scope of their professional practice has been debated for many years. Periodically updating the state of the art regarding the different training pathways, expected competencies, and responsibilities of care assistants at the international level is crucial for monitoring the evolution of these professional profiles. OBJECTIVE: To map the available classifications of care assistants at the international level, by describing (a) where these figures receive training, with which pathways, and for which competencies, and (b) where they can work and with what level of professional autonomy/interdependence with respect to other healthcare professions. METHOD: A narrative review of the literature was conducted by examining documents produced by the World Health Organization and the European Union; and that of three reference countries, the United Kingdom, Canada, and the United States of America. RESULTS: Fourteen documents were selected. Numerous care assistant profiles are described in available classifications, totaling 32 different profiles; these individuals may receive training in upper secondary school or colleges to perform a range of competencies. They may be supervised in their practice not only by nurses. In some countries, compulsory registration is required. DISCUSSION: The results show an important heterogeneity in care assistant figures internationally.

Predicting the responses of European grassland communities to climate and land cover change.

European grasslands are among the most species-rich ecosystems on small spatial scales. However, human-induced activities like land use and climate change pose significant threats to this diversity. To explore how climate and land cover change will affect biodiversity and community composition in grassland ecosystems, we conducted joint species distribution models (SDMs) on the extensive vegetation-plot database sPlotOpen to project distributions of 1178 grassland species across Europe under current conditions and three future scenarios. We further compared model accuracy and computational efficiency between joint SDMs (JSDMs) and stacked SDMs, especially for rare species. Our results show that: (i) grassland communities in the mountain ranges are expected to suffer high rates of species loss, while those in western, northern and eastern Europe will experience substantial turnover; (ii) scaling anomalies were observed in the predicted species richness, reflecting regional differences in the dominant drivers of assembly processes; (iii) JSDMs did not outperform stacked SDMs in predictive power but demonstrated superior efficiency in model fitting and predicting; and (iv) incorporating co-occurrence datasets improved the model performance in predicting the distribution of rare species. This article is part of the theme issue 'Ecological novelty and planetary stewardship: biodiversity dynamics in a transforming biosphere'.

Mental health and work: a European perspective.

Among the many social determinants of health and mental health, employment and work are getting momentum in the European political agenda. On 30-31 January 2024, a 'High-level Conference on Mental Health and Work' was held in Brussels on the initiative of the rotating Belgian Presidency of the European Union. It addressed the issue developing two different perspectives: (1) preventing the onset of poor mental health conditions or of physical and mental disorders linked to working conditions (primary prevention); (2) create an inclusive labour market that welcomes and supports all disadvantaged categories who are at high risk of exclusion (secondary and tertiary prevention). In the latter perspective, the Authors were involved in a session focused on 'returning to work' for people with mental disorders and other psychosocial disadvantages, with particular reference to Individual Placement and Support as a priority intervention already implemented in various European nations. The themes of the Brussels Conference will be further developed during the next European Union legislature, with the aim of approving in 4-5 years a binding directive for member states on Mental Health and Work, as it is considered a crucial issue for economic growth, social cohesion and overall stability of the European way of life.

Inconsistencies in the EU regulatory risk assessment of PFAS call for readjustment.

Recognition of per- and polyfluoroalkyl substances (PFAS) as widespread environmental pollutants and a consequent risk to human health, has recently made the European Union (EU) adopt several regulatory measures for their management. The coherence of these measures is challenged by the diversity and the ubiquitous occurrence of PFAS, which also complicates the EU's endeavor to advance justified, harmonized, and transparent approaches in the regulatory assessment of chemical risks. Our study critically reviews the European approach for the risk assessment of PFAS, by applying a comparative analysis of the current and pending regulatory thresholds issued for these chemicals in water bodies, drinking water, and certain foodstuffs. Our study shows that the level of health protection embedded in the studied thresholds may differ by three orders of magnitude, even in similar exposure settings. This is likely to confuse the common understanding of the toxicity and health risks of PFAS and undermine reasonable decision-making and the equal treatment of different stakeholders. We also indicate that currently, no consensus exists on the appropriate level of required health protection regarding PFAS and that the recently adopted tolerable intake value in the EU is too cautious. Based on our analysis, we propose some simple solutions on how the studied regulations and their implicit PFAS thresholds or their application could be improved. We further conclude that instead of setting EU-wide PFAS thresholds for all the environmental compartments, providing the member states with the flexibility to consider case-specific factors, such as regional background concentrations or food consumption rates, in their national regulatory procedures would likely result in more sustainable management of environmental PFAS without compromising the scientific foundation of risk assessment, the legitimacy of the EU policy framework and public health.

European Technical Democracy? How Consumer Associations Did-or Did Not-Shape the 1980s Automotive Environmental Standards.

Did the 1980s automotive standards reflect the European Economic Community's move toward a "technical democracy" or a broader democratic deficit? In the early 1980s, Europe's automotive sector faced multiple challenges: the European Commission's desire to harmonize technical standards and achieve greater European integration, intense competition between manufacturers, and environmental issues like acid rain. Debates on reducing air pollution focused on unleaded petrol and catalytic converters. Two associations representing civil society in Brussels responded to the increase in environmental concerns with a 1982 joint campaign. Despite a rich historiography on pollutant emission standards, highlighting the strategies of governments and companies, no study has dealt with the role nongovernmental organizations played. Based on public and private archives, particularly those of the European Bureau of Consumers' Unions, this article argues the new regulations did not result from the EU's consultation with civil society organizations like consumer groups but rather with the automotive industry.

Coordination of COVID-19 platform trials in Europe.

To ensure optimal coordination of the EU-funded COVID-19 platform trials, a double coordination mechanism was established. It included the Trial Coordination Board (TCB) to promote the dialogue between investigators and relevant public health stakeholders and the Joint Access Advisory Mechanism (JAAM) to streamline access of new intervention arms to the platform trials. Both the TCB and the JAAM emerged as efficient instruments to promote cooperation and optimise the use of resources within EU-funded adaptive platform trials. In addition, an adaptive platform trial toolbox was developed to collect information and literature on challenges and solutions identified to date. The recently funded 'Coordination MEchanism for Cohorts and Trials' (CoMeCT) project will endeavour to make this model sustainable, with a further expansion to other emerging infectious diseases, as part of the governance of the current and future platform trials for pandemic preparedness. This example could serve as a model for platform trial coordination in other disease areas.

Navigating the Science System: Research Integrity and Academic Survival Strategies.

Research Integrity (RI) is high on the agenda of both institutions and science policy. The European Union as well as national ministries of science have launched ambitious initiatives to combat misconduct and breaches of research integrity. Often, such initiatives entail attempts to regulate scientific behavior through guidelines that institutions and academic communities can use to more easily identify and deal with cases of misconduct. Rather than framing misconduct as a result of an information deficit, we instead conceptualize Questionable Research Practices (QRPs) as attempts by researchers to reconcile epistemic and social forms of uncertainty in knowledge production. Drawing on previous literature, we define epistemic uncertainty as the inherent intellectual unpredictability of scientific inquiry, while social uncertainty arises from the human-made conditions for scientific work. Our core argument-developed on the basis of 30 focus group interviews with researchers across different fields and European countries-is that breaches of research integrity can be understood as attempts to loosen overly tight coupling between the two forms of uncertainty. Our analytical approach is not meant to relativize or excuse misconduct, but rather to offer a more fine-grained perspective on what exactly it is that researchers want to accomplish by engaging in it. Based on the analysis, we conclude by proposing some concrete ways in which institutions and academic communities could try to reconcile epistemic and social uncertainties on a more collective level, thereby reducing incentives for researchers to engage in misconduct.

Over 80% of the European Union's Common Agricultural Policy supports emissions-intensive animal products.

The European Union's Common Agricultural Policy strongly influences the European Union's food system via agricultural subsidies. Linking global physical input-output datasets with public subsidy data reveals that current allocation favours animal-based foods, which uses 82% of the European Union's agricultural subsidies (38% directly and 44% for animal feed). Subsidy intensity (€ kg-1) for animal-based foods approximately doubles after feed inclusion. The same animal-based foods are associated with 84% of embodied greenhouse gas emissions of EU food production while supplying 35% of EU calories and 65% of proteins.

EMA commentary on the guideline on quality, nonclinical and clinical aspects of medicinal products containing genetically modified cells.

Great advances have been made in the knowledge of development and regulatory approval of medicinal product containing genetically modified cells. Although a guideline has been available in the EU since 2012, the current updated version provides a useful guide to developers and professionals involved in the regulatory process of these medicines. This article presents the main issues communicated in that guidance, the regulators' insights and a commentary from the academic developers' point of view.

Risk assessment of feed components of botanical origin - Approaches taken in the European Union.

In view of a continuous trend in replacing synthetic feed additives and especially flavouring compounds by botanical preparations, different aspects of the safety evaluations of plants and plant-derived preparations and components in feed are discussed. This includes risk assessment approaches developed by the European Food Safety Authority (EFSA) for phytotoxins regarding unintentional exposure of target animals and of consumers to animal derived food via carry-over from feed. Relevant regulatory frameworks for feed additives and feed contaminants in the European Union are summarised and the essentials of existing guidelines used in the safety evaluation of botanicals and their preparations and components in feed are outlined. The examples presented illustrate how the safety of the botanicals, their preparations and components present in feed is assessed. An outlook on possible future developments in risk assessment by applying new in vitro and in silico methodologies is given.

A comparative ethical analysis of the Egyptian clinical research law.

BACKGROUND: In this study, we examined the ethical implications of Egypt's new clinical trial law, employing the ethical framework proposed by Emanuel et al. and comparing it to various national and supranational laws. This analysis is crucial as Egypt, considered a high-growth pharmaceutical market, has become an attractive location for clinical trials, offering insights into the ethical implementation of bioethical regulations in a large population country with a robust healthcare infrastructure and predominantly treatment-naïve patients. METHODS: We conducted a comparative analysis of Egyptian law with regulations from Sweden and France, including the EU Clinical Trials Regulation, considering ethical human subject research criteria, and used a directed approach to qualitative content analysis to examine the laws and regulations. This study involved extensive peer scrutiny, frequent debriefing sessions, and collaboration with legal experts with relevant international legal expertise to ensure rigorous analysis and interpretation of the laws. RESULTS: On the rating of the seven different principles (social and scientific values, scientific validity, fair selection of participants, risk-benefit ratio, independent review, informed consent and respect for participants) Egypt, France, and EU regulations had comparable scores. Specific principles (Social Value, Scientific Value, and Fair selection of participants) were challenging to directly identify due to certain regulations embodying 'implicit' principles more than explicitly stated ones. CONCLUSION: The analysis underscores Egypt's alignment with internationally recognized ethical principles, as outlined by Emanuel et al., through its comparison with French, Swedish, and EU regulations, emphasizing the critical need for Egypt to continuously refine its ethical regulations to safeguard participant protection and research integrity. Key issues identified include the necessity to clarify and standardize the concept of social value in research, alongside concerns regarding the expertise and impartiality of ethical review boards, pointing towards a broader agenda for enhancing research ethics in Egypt and beyond.