European Union Public Health Research Articles

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.

The EU Vaccines Strategy: A Missed Opportunity for EU Public Health?

Abstract The response to the COVID-19 crisis implied an unprecedented involvement of the European Union (EU) executive in public health matters. In June 2020, the Member States agreed upon a joint EU Vaccines Strategy, whereby the European Commission was enabled to negotiate, support and allocate vaccine doses on their behalf. Entailing political and redistributive choices, the Commission’s centralised procurement presents some innovative patterns when compared to traditional EU executive action. This paper will focus on the institutionalisation of such patterns within the legal framework of the Health Emergency Preparedness and Response Authority (HERA). Did EU administrative law offer appropriate tools for this process? Or did the EU merely formalise the procedural and organisational schemes set up during the crisis? Answers to these questions will contribute to a fuller understanding of the administrative dimension of the new European Health Union and shed light on some recent evolutions of the EU administrative system.

2.K. Round table: Everything you always wanted to know about (COVID-19 and) EU-health policy

ObjectiveThere is no European Union (EU) health system but there is an EU health policy and this health policy is rapidly changing due to the COVID-19 responses of the EU and Member States. The aim of this panel discussion is to analyze and put into context the rapid evolvement of EU health policy during the pandemic. This panel discussion will therefore focus on 1) EU public health policy 2) EU action for health 3) the EU Market shaping health 4) the fiscal governance 5) the institutions, processes and powers.BackgroundEU health policy has often been overlooked and was never on the political agenda. COVID-19 and the pandemic response, however, changed this dramatically. EU-health policy has become centre stage followed by bold investments and new regulatory initiatives. Obvious examples are the EU4Heatlth programme, the Recovery and Resilience fund, the new agency HERA, the new remit for the European Medicines Agency and the European Center for Disease Control. There are also new European Commission mechanisms with regards to the purchase of personal protective equipment, supplies, medicines including vaccines and medical technologies. But will the new EU health policy strengthen health systems of Member States or just focus on stronger emergency responses? Will the constitutional asymmetry between health and internal market be addressed? Will EU-health policy remain after the crisis a centre-piece of European Integration? This panel is based on the COVID-19 update of the EU-health policy handbook ‘Everything you always wanted to know about European Union health policies but were afraid to ask'InteractivityThere will be a high level of interactivity. After an introductory presentation, attendees can use the chat-box to choose specific topics from the aforementioned five themes. These topics will be presented in a table. The chair will then pass the questions and topics to the panelists.Speakers/Panelists Sarah Rozenblum University of Michigan, Ann Arbor, USA Holly Jarman University of Michigan, Ann Arbor, USA Nick Fahy University of Oxford, Oxford, UK Anniek de Ruijter University of Amsterdam, Amsterdam, Netherlands Eleanore Brooks University of Edinburgh, Edinburgh, UK Key messages The European Health Union will be one of the most important constitutional and policy outcomes of the pandemic.It is essential that the European Health Union is not only strengthening emergency planning and response but also accessibility, equity and resilience of health systems.

Healthy Stadia Programme: innovative approach to health promotion

Abstract Sports stadia play an important role in local communities, therefore they are seen as very suitable places for various health promotion programmes. Since 2005, the Healthy Stadia programme has become a new standard for establishing policies regarding health promotion in local communities and during big international tournaments. This programme is an example of an effective setting-based approach to health promotion. Being funded by the European Union Public Health Programme, it has gained popularity in many European countries and also in Canada and Australia. Key parts of the programme include policies on tobacco and alcohol control, healthy food options and physical activity promotion on stadium grounds. Healthy Stadia programme proved to be an effective tool for promoting healthy lifestyle at many sports stadia. The programme is constantly improving and developing new projects, like Football Fans in Training (FFIT) or European Fans in Training (EuroFIT). This article provides an introduction to the programme’s main parts as well as its origins and future projects. Poland is active member of the Healthy Stadia since 2007.

Complementary and Alternative Medicine Use and Initiatives in Europe

Complementary and Alternative Medicine Use and Initiatives in Europe

The EU's Competence Gap in Public Health and Non-Communicable Disease Policy

The European Union (EU) has had a Treaty competence in the field of public health since 1993, however the slow development of this competence has not kept up with the rate at which the EU's policy ambitions in public health have developed, especially in the field of non-communicable disease (NCD) prevention. This has led the EU to rely on alternative legal bases in order to realise these ambitions, leading to a ‘competence gap’ between the legal bases that authorise EU action on NCD prevention and the policies the EU would like to pursue. This paper will explore, in three stages, how this competence gap might be addressed. First, it will examine the arguments for and against giving the EU public health competences. Second, it will analyse the EU's specific public health competence in Article 168 of the Treaty on the Functioning of the European Union (TFEU) and the general internal market harmonisation competence in Article 114 TFEU, in order to explore the precise boundaries of each competence as legal bases for EU public health action. Third, it will explore the legal relationship between Articles 168 and 114 and explain why, despite a more powerful specific public health competence being a theoretically neat solution to the competence gap, the likelihood of the EU being given increased public health powers is low.

200th ENMC International Workshop “European Reference Networks: Recommendations and Criteria in the Neuromuscular field”, 18–20 October 2013, Naarden, the Netherlands

200th ENMC International Workshop “European Reference Networks: Recommendations and Criteria in the Neuromuscular field”, 18–20 October 2013, Naarden, the Netherlands

Twentieth anniversary of the European Union health mandate: taking stock of perceived achievements, failures and missed opportunities - a qualitative study.

BackgroundThe European Union (EU) health mandate was initially defined in the Maastricht Treaty in 1992. The twentieth anniversary of the Treaty offers a unique opportunity to take stock of EU health actions by giving an overview of influential public health related EU-level policy outputs and a summary of policy outputs or actions perceived as an achievement, a failure or a missed opportunity.MethodsSemi-structured expert interviews (N = 20) were conducted focusing on EU-level actions that were relevant for health. Respondents were asked to name EU policies or actions that they perceived as an achievement, a failure or a missed opportunity. A directed content analysis approach was used to identify expert perceptions on achievements, failures and missed opportunities in the interviews. Additionally, a nominal group technique was applied to identify influential and public health relevant EU-level policy outputs.ResultsThe ranking of influential policy outputs resulted in top positions of adjudications and legislations, agencies, European Commission (EC) programmes and strategies, official networks, cooperative structures and exchange efforts, the work on health determinants and uptake of scientific knowledge. The assessment of EU health policies as being an achievement, a failure or a missed opportunity was often characterized by diverging respondent views. Recurring topics that emerged were the Directorate General for Health and Consumers (DG SANCO), EU agencies, life style factors, internal market provisions as well as the EU Directive on patients’ rights in cross-border healthcare. Among these recurring topics, expert perceptions on the establishment of DG SANCO, EU public health agencies, and successes in tobacco control were dominated by aspects of achievements. The implementation status of the Health in All Policy approach was perceived as a missed opportunity.ConclusionsWhen comparing the emerging themes from the interviews conducted with the responsibilities defined in the EU health mandate, one can identify that these responsibilities were only partly fulfilled or acknowledged by the respondents. In general, the EU is a recognized public health player in Europe which over the past two decades, has begun to develop competencies in supporting, coordinating and supplementing member state health actions. However, the assurance of health protection in other European policies seems to require further development.

Impact of innovations in national public health markets in Europe

Social innovations can contribute to health and wellbeing. PHIRE (Public Health Innovation and Research in Europe) investigated the impacts at national level of innovation projects funded by the European Union Public Health Programme. Through the European Public Health Association, experts assessed the uptake of the eight public health projects, for 30 European countries. Their reports were assembled by country and, thereafter, national public health associations reviewed the reports. Following stakeholder workshops, or internal and external consultations, 11 national reports were produced which included discussion on the impacts of the public health innovations in national product markets. In 11 countries, there were reports on the eight innovations for 45 (51%) of the possible public health markets. The innovations contributed positively to policy, practice and research, across different levels and in different ways, in 35 (39%) market, while competing innovation activities were recorded in 10 (11%) markets. The workshops also discussed contributing factors and limitations in dissemination and timing for policy cycles. The impacts of European Union social innovations in public health markets can be identified through national discussions. Further attention should be given to understanding drivers and incentives for successful public health innovations.

PHIRE (Public Health Innovation and Research in Europe): methods, structures and evaluation

Public Health Innovation and Research in Europe (PHIRE), building on previous European collaborative projects, was developed to assess national uptake and impacts of European public health innovations, to describe national public health research programmes, strategies and structures and to develop participation of researchers through the organizational structures of the European Public Health Association (EUPHA). This article describes the methods used. PHIRE was led by EUPHA with seven partner organisations over 30 months. It was conceived to engage the organisation of EUPHA--working through its thematic Sections, and through its national public health associations--and assess innovation and research across 30 European countries. Public health research was defined broadly as health research at population and organisational level. There were seven Work Packages (three covering coordination and four for technical aspects) led by partners and coordinated through management meetings. Seven EUPHA Sections identified eight innovations within the projects funded by the Public Health Programme of the European Commission Directorate for Health and Consumers. Country informants, identified through EUPHA thematic Sections, reported on national uptake of the innovations in eight public health projects supported by the European Union Public Health Programme. Four PHIRE partners, each taking a regional sector of Europe, worked with the public health associations and other informants to describe public health research programmes, calls and systems. A classification was created for the national public health research programmes and calls in 2010. The internal and external evaluations were supportive. PHIRE described public health innovations and research across Europe through national experts. More work is needed to conceptualize and define public health 'innovations' and to develop theories and methods for the assessment of their uptake and impacts at country and cross-country levels. More attention to methods to describe and assess national public health research programmes, strategies and structures--contributing to development of the European Research Area.

Tracking uptake of innovations from the European Union Public Health Programme

The European Commission developed the Public Health Programme to enable cross-national innovation and transfer in fields of health information, health threats and health promotion. PHIRE (Public Health Innovation and Research in Europe), a collaboration of the European Public Health Association (EUPHA) with seven partners, addressed the uptake of these public health innovation projects at country level. EUPHA thematic sections lead on areas of public health practice and research and experts can choose to be section members. The section presidents of seven sections chose eight European public health projects, starting in the EU Public Health Programme in 2003-05, that provided new knowledge for practice and covered a majority of the EU countries. A web-based questionnaire recorded country informants' (CIs) perceptions of uptake, assessed as relevance and dissemination to a range of public and non-governmental organizations. 108 CIs individually described the eight innovations in an average of 14 (46%) of the 30 European countries. Three of the eight innovations were considered of high relevance by >60% of respondents and at least 70% of informants considered seven of the eight innovation projects as of high or moderate relevance. Dissemination was noted across governmental, professional and academic settings, with high impact on knowledge/awareness for at least 30% of CIs. Some projects had uptake within the policy cycle in particular countries and connected strongly with academics and professionals. Projects working at local level had less visibility nationally and some projects were unknown to national respondents. European Union funding for public health can contribute to cross-national knowledge transfer and uptake of innovations. More attention is needed to classify, characterize and identify public health innovations and to demonstrate their direct contribution to European health and well-being.

Glass half empty: the Eurozone and internal market overshadow the health effects of Maastricht

In the past 20 years, the European Union (EU) has become part of health policymaking to an extent that few commentators would have predicted. But the EU’s positive contributions as an advocate for public health have been overshadowed by the effects of its internal market regulation and centralized fiscal governance on the health of Europeans. Three things happened in Maastricht 20 years ago. European heads of state met to celebrate the completion of the internal market as prefigured in the Single Europe Act, agreed to create a common currency and added the first clear and positive words about health to the Treaties. This first mention of health was the harbinger of more effective promotion of health issues within EU policymaking.1 In time, however, the internal market and the single currency have had the biggest health consequences of the three.2 Putting aside some specific areas of EU competency created under the public health power, such as blood safety, the public health language in the treaties as they stand authorizes EU action, obliges the EU to take health into account and clarifies that it does not have a role in the organization and finance of health care services. Within this framework, most of EU public health policy is expenditure. This means it is limited. EU expenditures as a percentage of gross domestic product (GDP) are nowhere near as much as a member state health system spends, and health is a tiny share of EU expenditures (the EU member states’ average expenditure on health in 2012 was 9% of GDP, according to …

The European Centre for Disease Prevention and Control: Hub or Hollow Core?

The European Centre for Disease Prevention and Control (ECDC) is the small agency established by the European Union (EU) to act as a hub for disease control, drawing on networks across the continent to achieve what other political systems do with large agencies. Despite this important task, the agency is largely unstudied. This article examines the ECDC from different angles, focusing on whether it can become the center of the networks that monitor, control, and prevent contagious diseases in Europe. The essay first retraces the events that led up to the ECDC's creation, focusing on the combination of policy debates about EU actions, political initiatives, and crises such as SARS that led to its creation. It then presents an overview of ECDC activities. The article concludes by examining the ECDC's prospects in light of its ability to secure its future through multiple political connections and a reputation for unique and useful advice. Insofar as it can do that, it will be able to contribute to the development of the EU and European public health.

The Role of Networks in the European Union Public Health Experience

Improving our understanding of how the public health system should be organized is important, because the system's organizational structure makes a significant difference to the public's health. How the system is structured influences a practitioner's ability to respond and the system's capacity to adapt to changing circumstances. In view of the scarce resources society is willing to expend for public health, it is essential to have a structure in place that most appropriately and efficiently allocates those resources. The articles in this issue offer considerable insight from a European context, that deserves attention from US public health practitioners, advocates, and policy makers.

Crossing borders: A critical review of the role of the European Court of Justice in EU health policy

Over the last two decades, the European Union (EU) has steadily increased its involvement in the health policies of its member states, with considerable support from the European Court of Justice (ECJ). However, much of the literature examining the Court's role has focused upon the intersection between internal market law and the health services sector; the majority of studies have failed to examine the potential role for the Court in public health policy. Observers such as Greer have seen the development of healthcare as a clear case of neofunctional spillover, a view supported but qualified by Wasserfallen and others, who present a more detailed account of the mechanics of the process. Alternative analyses have focused upon the new modes of governance, soft law and other factors – this article reviews the current state of research in the field and the extent to which it should concern health policy actors and non-specialists in EU policy alike. It concludes that the Court has played and continues to play a crucial role in the development of EU public health policy, as well as in health services and broader social policy, where its influence has already been well documented.

European solidarity is changing the face of rare diseases

Almost 1 year ago, a BBC fi lm about a teenager called Louisa Ball briefl y captured the imagination of the British public. Called The Real Sleeping Beauty, the fi lm told the story of Louisa and her family as they dealt with the consequences of Louisa’s Kleine-Levin syndrome: a vanishingly rare neurological disorder that causes prolonged episodes of sleep, lasting, in most cases, between 1 and 3 weeks. By focusing on the eff ect that the disorder had on one family, the fi lm makers were able to capture the sense of frustration and isolation caused by a disease about which so little is known that it is impossible to estimate just how rare it is, and, for a short time at least, raise its profi le. But equally, the understandable temptation to focus on the extraordinary stories of individual patients with specifi c rare diseases can obscure a wider truth: that although individuals with any particular rare neurological diseases are—to state the obvious—rare, patients with rare neurological diseases are in fact numerous if they are taken together. And there can be strength in numbers. The European Union defi nes a rare disease as one that aff ects no more than fi ve people in 10 000, although most rare diseases have a prevalence closer to the one in 10 000 mark. However, put all of the estimated 5000–8000 distinct rare diseases together, and between 6% and 8% of the population will experience a rare disease during their lifetime. “If you

Implementation and outcome of thrombolysis with alteplase 3–4·5 h after an acute stroke: an updated analysis from SITS-ISTR

In September, 2008, the European Acute Stroke Study III (ECASS III) randomised trial and the Safe Implementation of Treatment in Stroke-International Stroke Thrombolysis Registry (SITS-ISTR) observational study reported the efficacy and safety of the extension of the time window for intravenous alteplase treatment from within 3 h to within 4.5 h after stroke onset. We aimed to assess the implementation of the wider time window, its effect on the admission-to-treatment time, and safety and functional outcome in patients recorded in SITS-ISTR. Patients treated according to the criteria of the European Summary of Product Characteristics, except for the time window, were included. Patients were grouped according to whether they were registered into SITS-ISTR before or after October, 2008. We measured admission-to-treatment time and rates of symptomatic intracerebral haemorrhage, mortality, and functional independence at 3 months. 23 942 patients were included in SITS-ISTR between December, 2002, and February, 2010, of whom 2376 were treated 3-4.5 h after symptom onset. The proportion of patients treated within 3-4.5 h by the end of 2009 was three times higher than in the first three quarters of 2008 (282 of 1293 [22%] vs 67 of 1023 [7%]). The median admission-to-treatment time was 65 min both for patients registered before and after October, 2008 (p=0.94). 352 (2%) of 21 204 patients treated within 3 h and 52 (2%) of 2317 treated within 3-4.5 h of stroke had symptomatic intracerebral haemorrhage at 3 months (adjusted odds ratio [OR] 1.44, 95% CI 1.05-1.97; p=0.02). 2287 (12%) of 18 583 patients who were treated within 3 h and 218 (12%) of 1817 who were treated within 3-4.5 h had died by the 3-month follow-up (adjusted OR 1.26, 95% CI 1.07-1.49; p=0.005); 10 531 (57%) of 18 317 patients treated within 3 h of stroke and 1075 (60%) of 1784 who were treated within 3-4.5 h were functionally independent at 3 months (adjusted OR 0.84, 95% CI 0.75-0.95; p=0.005). Since October, 2008, thrombolysis within 3-4.5 h after stroke has been implemented rapidly, with a simultaneous increase in the number of patients treated within 3 h; admission-to-treatment time has not increased. Safety and functional outcomes are less favourable after 3 h, but the wider time window now offers an opportunity for treatment of those patients who cannot be treated earlier. Thrombolysis should be initiated within 4.5 h after onset of ischaemic stroke, although every effort should be made to treat patients as early as possible after symptom onset. Boehringer Ingelheim, Ferrer, the European Union Public Health Executive Authority, and Medical Training and Research (ALF) from Stockholm County Council and Karolinska Institutet.

Differences in self-medication in the adult population in Spain according to country of origin

OBJECTIVES To explore the factors determining self-medication among the Spanish adult population, paying special attention to differences in pharmaceutical consumption patterns between the immigrant and autochthonous populations in Spain. METHODS Logistic regression models were used to evaluate the effect of several demographic, socioeconomic, lifestyle, and health-related variables on self-medication. Data were drawn from the adult sample of the 2006 Spanish National Health Survey, which included 29,478 individuals over 15 years old. RESULTS The results show that individuals at higher risk of self-medication were young, with a positive perception of health and no chronic diseases, frequent consumers of alcohol, widowers, holders of a private medical insurance policy not contracted through the civil servants' mutual funds, residents in the Autonomous Communities of Madrid or Valencia, and individuals born in Central or Eastern Europe. CONCLUSIONS Identifying the profile of self-medicated drug users in Spain may help health authorities to target high risk individuals in order to comply with European Union public health goals.

Diferencias en la automedicación en la población adulta española según el país de origen

Objectives To explore the factors determining self-medication among the Spanish adult population, paying special attention to differences in pharmaceutical consumption patterns between the immigrant and autochthonous populations in Spain. Methods Logistic regression models were used to evaluate the effect of several demographic, socioeconomic, lifestyle, and health-related variables on self-medication. Data were drawn from the adult sample of the 2006 Spanish National Health Survey, which included 29,478 individuals over 15 years old. Results The results show that individuals at higher risk of self-medication were young, with a positive perception of health and no chronic diseases, frequent consumers of alcohol, widowers, holders of a private medical insurance policy not contracted through the civil servants’ mutual funds, residents in the Autonomous Communities of Madrid or Valencia, and individuals born in Central or Eastern Europe. Conclusions Identifying the profile of self-medicated drug users in Spain may help health authorities to target high risk individuals in order to comply with European Union public health goals.

Thrombolysis with alteplase 3–4·5 h after acute ischaemic stroke (SITS-ISTR): an observational study

Intravenous alteplase is approved for use within 3 h of ischaemic stroke onset, although a meta-analysis of randomised controlled trials suggests treatment benefit up to 4.5 h. We compared outcome in patients treated between 3 h and 4.5 h versus those treated within 3 h, who were recorded in the in the Safe Implementation of Treatments in Stroke (SITS), a prospective internet-based audit of the International Stroke Thrombolysis Registry (ISTR). We compared 664 patients presenting with ischaemic stroke and given intravenous altepase (0.9 mg/kg total dose) between 3 h and 4.5 h with 11 865 patients treated within 3 h. All patients were otherwise compliant with European summary of product characteristics criteria and had been documented in the international stroke treatment registry between Dec 25, 2002, and Nov 15, 2007. Outcome measures were symptomatic intracerebral haemorrhage within 24 h (haemorrhage type 2 associated with National Institutes of Health Stroke Scale [NIHSS] > or = 4 points deterioration), and mortality and independence (modified Rankin scale of 0-2) at 3 months. In the 3-4.5-h cohort, treatment was started at a median of 55 min later after symptom onset (195 min [IQR 187-210] vs 140 min [115-165], p<0.0001), median age was 3 years younger (65 years [55-73] vs 68 years [58-74], p<0.0001), and stroke severity was lower (NIHSS score 11 [7-16] vs 12 [8-17], p<0.0001) than in the 3-h cohort. We recorded no significant differences between the 3-4.5-h cohort and the within 3-h cohort for any outcome measure--rate of symptomatic intracerebral haemorrhage: 2.2% (14 of 649) versus 1.6% (183 of 11 681) (odds ratio [OR] 1.18 [95% CI 0.89-1.55], p=0.24; adjusted OR 1.32 [1.00-1.75], p=0.052); mortality: 12.7% (70 of 551) versus 12.2% (1263 of 10 368) (OR 1.02 [0.90-1.17]; p=0.72; adjusted OR 1.15 [1.00-1.33]; p=0.053); and independence: 58.0% (314 of 541) versus 56.3% (5756 of 10231) (OR 1.04 [0.95-1.13], p=0.42; adjusted OR 0.93 [0.84-1.03], p=0.18). Alteplase remains safe when given at 3-4.5 h after ischaemic stroke, offering an opportunity for patients who cannot be treated within the standard 3-h timeframe. Boehringer-Ingelheim, European Union Public Health Executive Authority.