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.

The state of health in the European Union (EU-27) in 2019: a systematic analysis for the Global Burden of Disease study 2019.

BACKGROUND: The European Union (EU) faces many health-related challenges. Burden of diseases information and the resulting trends over time are essential for health planning. This paper reports estimates of disease burden in the EU and individual 27 EU countries in 2019, and compares them with those in 2010. METHODS: We used the Global Burden of Disease 2019 study estimates and 95% uncertainty intervals for the whole EU and each country to evaluate age-standardised death, years of life lost (YLLs), years lived with disability (YLDs) and disability-adjusted life years (DALYs) rates for Level 2 causes, as well as life expectancy and healthy life expectancy (HALE). RESULTS: In 2019, the age-standardised death and DALY rates in the EU were 465.8 deaths and 20,251.0 DALYs per 100,000 inhabitants, respectively. Between 2010 and 2019, there were significant decreases in age-standardised death and YLL rates across EU countries. However, YLD rates remained mainly unchanged. The largest decreases in age-standardised DALY rates were observed for "HIV/AIDS and sexually transmitted diseases" and "transport injuries" (each -19%). "Diabetes and kidney diseases" showed a significant increase for age-standardised DALY rates across the EU (3.5%). In addition, "mental disorders" showed an increasing age-standardised YLL rate (14.5%). CONCLUSIONS: There was a clear trend towards improvement in the overall health status of the EU but with differences between countries. EU health policymakers need to address the burden of diseases, paying specific attention to causes such as mental disorders. There are many opportunities for mutual learning among otherwise similar countries with different patterns of disease.

PCM4EU and PRIME-ROSE: Collaboration for implementation of precision cancer medicine in Europe.

BACKGROUND: In the two European Union (EU)-funded projects, PCM4EU (Personalized Cancer Medicine for all EU citizens) and PRIME-ROSE (Precision Cancer Medicine Repurposing System Using Pragmatic Clinical Trials), we aim to facilitate implementation of precision cancer medicine (PCM) in Europe by leveraging the experience from ongoing national initiatives that have already been particularly successful. PATIENTS AND METHODS: PCM4EU and PRIME-ROSE gather 17 and 24 partners, respectively, from 19 European countries. The projects are based on a network of Drug Rediscovery Protocol (DRUP)-like clinical trials that are currently ongoing or soon to start in 11 different countries, and with more trials expected to be established soon. The main aims of both the projects are to improve implementation pathways from molecular diagnostics to treatment, and reimbursement of diagnostics and tumour-tailored therapies to provide examples of best practices for PCM in Europe. RESULTS: PCM4EU and PRIME-ROSE were launched in January and July 2023, respectively. Educational materials, including a podcast series, are already available from the PCM4EU website (http://www.pcm4eu.eu). The first reports, including an overview of requirements for the reimbursement systems in participating countries and a guide on patient involvement, are expected to be published in 2024. CONCLUSION: European collaboration can facilitate the implementation of PCM and thereby provide affordable and equitable access to precision diagnostics and matched therapies for more patients. ble from the PCM4EU website (http://www.pcm4eu.eu). The first reports, including an overview of requirements for the reimbursement systems in participating countries and a guide on patient involvement, are expected to be published in 2024. CONCLUSION: European collaboration can facilitate the implementation of PCM and thereby provide affordable and equitable access to precision diagnostics and matched therapies for more patients.

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.

The role of the (in)accessibility of social media data for infodemic management: a public health perspective on the situation in the European Union in March 2024.

Public health institutions rely on the access to social media data to better understand the dynamics and impact of infodemics - an overabundance of information during a disease outbreak, potentially including mis-and disinformation. The scope of the COVID-19 infodemic has led to growing concern in the public health community. The spread of harmful information or information voids may negatively impact public health. In this context, social media are of particular relevance as an integral part of our society, where much information is consumed. In this perspective paper, we discuss the current state of (in)accessibility of social media data of the main platforms in the European Union. The European Union's relatively new Digital Services Act introduces the obligation for platforms to provide data access to a wide range of researchers, likely including researchers at public health institutions without formal academic affiliation. We examined eight platforms (Facebook, Instagram, LinkedIn, Pinterest, Snapchat, TikTok, X, YouTube) affected by the new legislation in regard to data accessibility. We found that all platforms apart from TikTok offer data access through the Digital Services Act. Potentially, this presents a fundamentally new situation for research, as before the Digital Services Act, few platforms granted data access or only to very selective groups of researchers. The access regime under the Digital Services Act is, however, still evolving. Specifics such as the application procedure for researcher access are still being worked out and results can be expected in spring 2024. The impact of the Digital Services Act on research will therefore only become fully apparent in the future.

Health care expenses impact on the disability-adjusted life years in non-communicable diseases in the European Union.

Background: Non-communicable diseases are a global health problem. The metric Disability-Adjusted Life Years was developed to measure its impact on health systems. This metric makes it possible to understand a disease's burden, towards defining healthcare policies. This research analysed the effect of healthcare expenditures in the evolution of disability-adjusted life years for non-communicable diseases in the European Union between 2000 and 2019. Methods: Data were collected for all 27 European Union countries from Global Burden of Disease 2019, Global Health Expenditure, and EUROSTAT databases. Econometric panel data models were used to assess the impact of healthcare expenses on the disability-adjusted life years. Only models with a coefficient of determination equal to or higher than 10% were analysed. Results: There was a decrease in the non-communicable diseases with the highest disability-adjusted life years: cardiovascular diseases (-2,952 years/105 inhabitants) and neoplasms (-618 years/105 inhabitants). Health expenditure significantly decreased disability-adjusted life years for all analysed diseases (p < 0.01) unless for musculoskeletal disorders. Private health expenditure did not show a significant effect on neurological and musculoskeletal disorders (p > 0.05) whereas public health expenditure did not significantly influence skin and subcutaneous diseases (p > 0.05). Conclusion: Health expenditure have proved to be effective in the reduction of several diseases. However, some categories such as musculoskeletal and mental disorders must be a priority for health policies in the future since, despite their low mortality, they can present high morbidity and disability.

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.

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'.

[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.

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.

Designing a circular cities declaration for Japan building on the European Union's case study.

Japan is progressing towards its circular economy (CE) goals as many of its cities have adopted circular city (CC) policies and programs, although further progress is constrained as a result of the lack of a common framework. A novel framework was proposed with the "European circular cities declaration" (ECCD) (2020), consisting of a list of 10 principles committing to integrate circularity into the city's design, development, and management. As a foremost finding, and building on the authors' previous studies of Japan's CE and CC, this work shaped a circular cities declaration (CCD) for Japan following a triple-axis methodology; It (1) evaluates the ECCD as a baseline, (2) adapts it to Japan's unique socio-economic landscape, and (3) considers the three pillars of sustainable development, offering practical guidance for governments facing similar challenges. This environmental management tool goes beyond the EU one providing a model of hybrid governance and monitoring and evaluation mechanism. The resulting declaration is intended for the government to facilitate a transition from insulated CE policies to holistic CC ones, but also for businesses, academia, and communities; Thus, it may aid in endorsing a cities' common framework and shared vision to harness the potential of CC to address environmental issues, foster innovation and collaboration toward a resilient future in Japan.

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.

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.

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.