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 statistical and dynamic modeling of the first part of the 2013-2014 Euromaidan protests in Ukraine: The Revolution of Dignity and preceding times.

Ukraine's tug-of-war between Russia and the West has had significant and lasting consequences for the country. In 2013, Viktor Yanukovych, the Ukrainian president aligned with Russia, opted against signing an association agreement with the European Union. This agreement aimed to facilitate trade and travel between the EU and Ukraine. This decision sparked widespread protests that coalesced in Kyiv's Maidan Square, eventually becoming known as the Euromaidan protests. In this study, we analyze the protest data from 2013, sourced from Ukraine's Center for Social and Labor Research. Despite the dataset's limitations and occasional inconsistencies, we demonstrate the extraction of valuable insights and the construction of a descriptive model from such data. Our investigation reveals a pre-existing state of self-excitation within the system even before the onset of the Euromaidan protests. This self-excitation intensified during the Euromaidan protests. A statistical analysis indicates that the government's utilization of force correlates with increased future protests, exacerbating rather than quelling the protest movement. Furthermore, we introduce the implementation of Hawkes process models to comprehend the spatiotemporal dynamics of the protest activity. Our findings highlight that, while protest activities spread across the entire country, the driving force behind the dynamics of these protests was the level of activity in Kyiv. Furthermore, in contrast to prior research that emphasized geographical proximity as a key predictor of event propagation, our study illustrates that the political alignment among oblasts, which are the distinct municipalities comprising Ukraine, had a more profound impact than mere geographic distance. This underscores the significance of social and cultural factors in molding the trajectory of political movements.

CENTRALIZATION AND CORRUPTION IN HEALTH PROCUREMENT OF THE SOUTHERN EUROPEAN UNION COUNTRIES.

Healthcare procurement management in public hospitals has been a major concern for the countries of the Southern Europe, both due to their perennial problems in the field of corruption and the impact of increasing migration flows on the Mediterranean routes to the European Union. This study attempts to analyze the healthcare procurement systems of the Southern EU countries (EU MED or MED-9) based on the degree of centralization and perceived corruption and examine the applied procurement policies and their results in terms of efficiency, transparency, and competition. The MED-9 group consists of Cyprus, Croatia, France, Greece, Italy, Malta, Portugal, Slovenia, and Spain. The study employed an analytical research design and was conducted in two phases. In the first phase, data regarding the model of health system and the type of healthcare procurement of MED-9 countries based on the degree of centralization were collected using a comprehensive documentation review. In the second phase, seven different corruption perception indices in the public procurement and healthcare sector were collected, recorded, processed and compared to validate findings from the first phase and gain additional insights and feed-back regarding the relationship between centralized procurement and corruption. The study revealed significant differences in the healthcare procurement systems among the MED-9 countries, confirming that they vary due to their different organizational structure and socioeconomic choices. Our findings showed that there is a relationship between the degree of centralization and perceived corruption. Although Southern EU countries display relatively high levels of general corruption, some of them have significantly lower levels of perceived corruption in the specific areas of the healthcare system and public procurement. The study concludes that corruption is likely to decrease when purchasing processes are centralized. Healthcare procurement centralization through a central purchasing body can be an effective and powerful tool for cost reduction and fighting corruption in the public health sector.

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.

Strengthening the European Semester to Achieve Economies of Wellbeing.

The environmental crisis, growing levels of social inequalities and rising levels of noncommunicable diseases are all symptoms of economic systems that are failing to generate wellbeing. There is increasing support for the notion that addressing these crises requires shifting the focus from economic growth to a broader range of measures that reflect wellbeing, through more comprehensive, consistent and integrated policy approaches to deliver this. In 2019, the EU Finnish Council Presidency Council Conclusions called amongst other things for the development of a new long-term, post-2020 strategy to provide the framework for horizontal assessment and cross-sectoral collaboration, in particular through the European Semester process. This article contextualises this call and explores its follow-up. It draws from key policy documents to explore what Economies of Wellbeing are, why and how the concept has emerged and how they can be put in place. It then explores to what extent this concept is being applied at the EU level, by tracking changes in some of the EU's key policies and strategies over the past 10 years and in the Semester process, as a mechanism to implement them. It concludes that while progress towards more comprehensive, consistent and integrated policy approaches has been made in the context of the Annual Sustainable Growth Strategy, underpinning the Semester processes, it is limited by the continuing emphasis on economic, over other policy, areas. It also argues that the process needs to be broadened even further, to include other dimensions of wellbeing, which intersect with the economy and impact wellbeing. To strengthen the European Semester process to achieve Economies of Wellbeing, it should be put at the service of an even more consistent and comprehensive EU Strategy that enables policy sectors to deliver wellbeing objectives in a more integrated and coordinated manner. This paper ends with recommendations for action.

The transition towards community-based mental health care in the European Union: Current realities and prospects.

The shift of mental health care from mental institutions to community-based services has been implemented differentially throughout the EU. However, because a comprehensive overview of the current mental health provision in member states is lacking, it is challenging to compare services across nations. This study investigates the extent of implementation of community-based mental health services within the EU using data collected from the WHO Mental Health Atlas. Results show that, although great cross-country variation exists in the implementation of community-based services, mental hospitals remain the prominent model of care in most countries. A few countries endorsed a balanced care model, with the co-occurrence of community services and mental hospitals. However, missing data, low quality of data and different service definitions hamper the possibility of a thorough analysis of the status on deinstitutionalization. Although policies on the closing and downsizing of mental institutions have been endorsed by the EU, the strong presence of mental hospitals slows down the shift towards community-based mental health care. This study highlights the need for an international consensus on definitions and a harmonization of indicators on mental health services. Together with the commitment of member states to improve the quality of data reporting, leadership must emerge to ensure quality monitoring of mental health-related data, which will help advance research, policies and practices.

The role of environmental tax on the environmental quality in EU counties: evidence from panel vector autoregression approach.

This study intends to analyze the influence of environmental taxes on pollution in EU-27 nations. Furthermore, energy from renewable sources consumption and urbanization are employed to clarify CO2 emissions in this study that tests the EKC hypothesis. According to the findings, an increase in environmental taxes reduces CO2 emissions by 0.14%. Also, the data supported the validity of the EKC concept. The findings of the causality test demonstrated that there is a bidirectional causal link between CO2 emissions and environmental taxes. These results reflect that environmental tax revenues contribute to sustainability as an effective policy tool in EU countries. Policies regarding environmental tax enforcement come to the fore in terms of both keeping the balance in economic activities and serving sustainability.

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.

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: 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.

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.

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.

Science Shops as key intermediary structures to respond to the current health research agenda bias: Evidence from the InSPIRES project.

INTRODUCTION: To increase the likelihood of research responding to societal needs, intermediary structures such as Science Shops are being created. Science Shops respond to research needs identified and prioritized through participatory processes involving civil society. However, these are not mainstream structures, and most research needs addressed by the scientific community are not defined by a diversity of stakeholders (including citizens) but are mostly prioritized by researchers and funders. Literature shows this often leads to bias between the research topics investigated and the research needs of other relevant stakeholders. This study analyses how 14 Science Shops contribute to decreasing bias in health research agenda setting. METHODOLOGY: We compare the research priorities identified through participatory processes by the Science Shops, which participated in the European Union-funded project InSPIRES (2017-2021), to the available research addressed in the literature (identified in Web of Science), which we use as a proxy for current research priorities. RESULTS: Science Shop projects contributed to decreasing the existing bias in health research agenda setting: (1) between drug and nondrug treatments and (2) between clinical trials of treatments for illnesses affecting high-income versus middle- and low-income countries, which leads to a lack of local strategies for high disease burdens in nonhigh-income regions. CONCLUSION: This study provides the first evidence of Science Shops' effectiveness in addressing current biases in health research agenda setting. We conclude they could play a key role in shaping local, national and international research policies.

Effectiveness of XBB.1.5 Monovalent COVID-19 Vaccines During a Period of XBB.1.5 Dominance in EU/EEA Countries, October to November 2023: A VEBIS-EHR Network Study.

Using a common protocol across seven countries in the European Union/European Economic Area, we estimated XBB.1.5 monovalent vaccine effectiveness (VE) against COVID-19 hospitalisation and death in booster-eligible ≥ 65-year-olds, during October-November 2023. We linked electronic records to construct retrospective cohorts and used Cox models to estimate adjusted hazard ratios and derive VE. VE for COVID-19 hospitalisation and death was, respectively, 67% (95%CI: 58-74) and 67% (95%CI: 42-81) in 65- to 79-year-olds and 66% (95%CI: 57-73) and 72% (95%CI: 51-85) in ≥ 80-year-olds. Results indicate that periodic vaccination of individuals ≥ 65 years has an ongoing benefit and support current vaccination strategies in the EU/EEA.