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The Directive on the application of patients´ rights in cross-border healthcare was adopted by the Council of the European Union and the European Parliament on March 9th, 2011. In the context of the adoption deadline on October 25th, 2013, as well as considering the national positioning towards the Directive and the interpretational leeway, it is interesting to see how and to what extent national legislators transpose the Directives´ implications. This paper will focus on the process of transposition, specifically domestic public consultations. The analysis is a two-level comparison: on the one hand, it presents an intrastate study of the various stakeholders involved in the discourse during the transposition process, whereby a country-specific picture of diverse proposals, opinions and challenges can be drawn. On the other hand, the paper marks an inter-country comparison, offering a sample of European adaptational patterns. The healthcare systems of the analysed countries Germany, Poland and Austria are characterised by a Statutory Health Insurance (SHI) system, nevertheless they differ concerning systemic specifics of healthcare, their voting behaviours towards the Directive and initial situations regarding transposable provisions. The study of domestic discourses from an actor-centred perspective concludes on the most critical points of the Directive, which reflect on prior authorisation, reimbursement, information provision and National Contact Points, and on transposition patterns in the member states. Hypotheses on the goodness of fit, the scope of patients´ rights and difficult interpretational areas of the Directive were tested and partly verified. The intrastate study and cross-national comparison revealed considerable differences among a small sample of EU-states, with only some analogies regarding stakeholder and governmental behaviour. The contrast is visible in the number and type of stakeholders, timing of public consultations, the emphasis set in the discourse, frequency of discussed articles and accurateness of implementation. This results not only from the difficult and debated area of health policy, but also from country-specific characteristics. Overall, the analysis indicates how important the process of transposition, as part of EU law-making, is for the correctness and success of European policies. An emphasis on the implementation phase is required to closely understand, analyse and improve the functioning of the Acquis Communautaire. Die Richtlinie über die Ausübung der Patientenrechte in der grenzüberschreitenden Gesundheitsversorgung wurde vom Rat der Europäischen Union sowie dem Europäischen Parlament am 9. März 2011 verabschiedet. Im Kontext der Umsetzungsfrist am 25. Oktober 2013 sowie unter Berücksichtigung nationaler Positionen gegenüber der Richtlinie und dem zu Verfügung stehenden Interpretationsspielraum, gilt es zu erforschen, inwieweit die nationalen Gesetzgeber die Implikationen der Richtlinie umsetzen. Diese Arbeit beschäftigt sich mit dem Transpositionsprozess der Patientenrichtlinie 2011/24/EU, insbesondere mit den nationalen Konsultationen während der Umsetzungsphase. Die Analyse besteht aus einem zwei-Ebenen Vergleich: einerseits präsentiert sie eine innerstaatliche Studie über diverse, in den Transpositionsprozess involvierte Stakeholder, wodurch eine länderspezifische Skizze bezüglich verschiedener Umsetzungsvorschläge, Meinungen sowie Herausforderungen gezeichnet wird. Andererseits stellt die Studie einen zwischenstaatlichen Vergleich dar, durch welchen Europäische Transpositions- und Implementierungsmuster verdeutlicht werden. Die drei ausgewählten Staaten Deutschland, Polen und Österreich sind jeweils durch das Gesundheitssystem der Gesetzlichen Krankenversicherung gekennzeichnet, nichtsdestotrotz unterscheiden sie sich im Hinblick auf die systemischen Ausprägungen, ihr Abstimmungsverhalten zur Richtlinie im Rat der Europäischen Union sowie ihre Ausgangsposition der Transposition. Die Analyse der nationalen Diskurse aus einer Akteur-zentrierten Perspektive mündet in einer Zusammenstellung der kritischsten Aspekte der Richtlinie, welche die Vorabgenehmigung, Kostenerstattung, Informationsbeschaffung und die Nationalen Kontaktstellen beinhaltet. Gleichzeitig fasst die Studie die Transpositionsmuster der Mitgliedstaaten zusammen. Die Hypothesen zu "Goodness of fit", zur Reichweite der Patientenrechte sowie zu interpretativen Problemfeldern der Richtlinie wurden getestet und teilweise verifiziert. Sowohl der inner- wie auch zwischenstaatliche Vergleich zeigt die enormen Differenzen einer relativ geringen Staatenprobe auf, mit lediglich wenigen Analogien in Bezug auf die Stakeholder und das Verhalten der staatlichen Entscheidungsträger. Der Kontrast zeigt sich insbesondere hinsichtlich der Anzahl und des Typs der Akteure, der zeitlichen Koordinierung der öffentlichen Konsultationen, des Diskursschwerpunkts, der Häufigkeit der diskutierten Umsetzungsartikel sowie der Transpositionsgenauigkeit. Die hervorstechenden Differenzen sind nicht nur Ausdruck eines sensiblen und umstrittenen Politikfelds, sondern resultieren aus den staatenspezifischen Eigenschaften. Insgesamt zeigt die Analyse auf, wie wichtig der Transpositionsprozess als Teil der EU-Gesetzgebung für die Korrektheit und den Erfolg Europäischer Politik ist. Die Fokussierung auf die Implementierungsphase ist notwendig, um die Funktionsfähigkeit des Acquis Communautaire genau zu verstehen, analysieren und zu verbessern.
In this report, we present the methodology and results for the 'Study on Enhancing implementation of the Cross-Border Healthcare Directive 2011/24/EU to ensure patient rights in the EU'. The purpose of this study was to support the Commission's work to deepen analysis of the problem that it continues to be difficult for a number of patients to access healthcare in another Member State and many remained shortcomings in the practical application of the Directive, by: (1) identifying options and solutions for improving the consistency and transparency in the application of the Directive; (2) gathering, mapping and analysing information from the 27 Member States as well as EEA EFTA countries on specific areas of the Directive's practical implementation; and (3) developing an intervention logic and critical review of existing monitoring indicators for future evaluation of the Directive. In the light of these objectives different research methods were applied including, a literature review, interviews and written inquiries with NCP's, online questionnaires with patient organisations, healthcare insurers and healthcare providers, and workshops with NCP's and patient organisations. The core findings of this study are: The way Prior Authorisation procedures are implemented differs greatly across Member States and EEA EFTA countries. Guiding Principles were developed to provide recommendations to streamline and simplify Prior Authorisation procedures; Certain administrative procedures and requirements across Member States and EEA EFTA countries may be regarded as creating potentially unjustified obstacles for patients seeking cross-border healthcare under the Directive; The 2019-toolbox can still be helpful to further enhance the implementation of the Directive. Most Member States indicated that the Toolbox is implemented by their NCP. Patient organisations, healthcare insurers and healthcare providers do not appear to be familiar with the Toolbox; A limited number of Member States implement consultation arrangements between NCPs and relevant national stakeholders such as healthcare insurers, providers and patient organisations. To facilitate future monitoring and evaluation of the Directive, a shortlist of indicators has been developed and associated stakeholder views were provided.
The European Commission Directorate-General for Health and Food Safety (DG SANTE) has commissioned ECORYS Nederland B.V., Technopolis and Spark Legal Network to conduct a study to enhance the implementation of the Cross-Border Healthcare Directive 2011/24/EU to ensure patient rights in the EU. One of the aims of the study is to develop Guiding Principles that will serve as a recommendation for streamlining and simplifying prior-authorisation (PA) systems across Member States (MS). For that purpose, data was collected and analysed to answer the following two research questions: 1. How is prior-authorisation applied in the Member States and EEA EFTA countries? 2. What are the underlying reasons for the different prior-authorisation approaches in the Member States and EEA EFTA countries? This report presents the answers to these research questions and served as background information for the virtual workshops organised on 11 and 12 March 2021. The aim of these workshops was to validate and discuss the presented results, as well as to have an exploratory interactive discussion on how to streamline and simplify PA across MS. After the workshop was conducted, a separate workshop report was shared with the participants. The current analytical paper was updated with the most important insights and reflections that were discussed during the workshop.
The present study supports the European Commission in its ex-post evaluation of the Directive 2011/24/EU on the application of patients' rights in cross-border healthcare to take stock on its achievements and shortcomings ten years after its adoption. Relying on an extensive review of the literarure, a public consultation and targeted consultation activities, the study has found mixed results in the implementation of the Directive in terms of its provisions on patients' rights and cooperation between Member States in rare and low prevalence diseases and the establishment of the European Reference Networks (ERN), virtual networks involving healthcare providers across Europe. The Directive is a valuable legal instrument that has brought certainty and a clear legal framework for EU citizens to exercise their rights to cross-border healthcare and the free movement of services. It responds to current needs of patients and provides EU added value. However, in spite of removing some obstacles, some important barriers to cross-border care persist, such as a general lack of awareness of patients of their rights and entitlements, issues regarding information provision by Member States, as well as problems with the national implementation of some of its provisions that have led to complicated administrative procedures. While increasing patients flow across border is not an objective, these have been low under the Directive. This has meant that the impact of the Directive has been minor for national health systems, but also has limited the benefits for patients in general. In terms of cooperation in rare diseases and the ERNs, the study shows promising results in terms of of their relevance to address current and future patient needs as well as their effectiveness in meeting their objectives, their coherence with the wider EU policy and activities in the field of rare diseases and their clear EU added value. However, there are some issues affecting the effectivess of the networks, the most important being the weak integration of the networks in national health systems and the absence of reimbursement mechanisms for the time spent by healthcare professionals in virtual consultations.
In this report, we present the methodology and results for the 'Study on Enhancing implementation of the Cross-Border Healthcare Directive 2011/24/EU to ensure patient rights in the EU'. The purpose of this study was to support the Commission's work to deepen analysis of the problem that it continues to be difficult for a number of patients to access healthcare in another Member State and many remained shortcomings in the practical application of the Directive, by: (1) identifying options and solutions for improving the consistency and transparency in the application of the Directive; (2) gathering, mapping and analysing information from the 27 Member States as well as EEA EFTA countries on specific areas of the Directive's practical implementation; and (3) developing an intervention logic and critical review of existing monitoring indicators for future evaluation of the Directive. In the light of these objectives different research methods were applied including, a literature review, interviews and written inquiries with NCP's, online questionnaires with patient organisations, healthcare insurers and healthcare providers, and workshops with NCP's and patient organisations. The core findings of this study are: The way Prior Authorisation procedures are implemented differs greatly across Member States and EEA EFTA countries. Guiding Principles were developed to provide recommendations to streamline and simplify Prior Authorisation procedures; Certain administrative procedures and requirements across Member States and EEA EFTA countries may be regarded as creating potentially unjustified obstacles for patients seeking cross-border healthcare under the Directive; The 2019-toolbox can still be helpful to further enhance the implementation of the Directive. Most Member States indicated that the Toolbox is implemented by their NCP. Patient organisations, healthcare insurers and healthcare providers do not appear to be familiar with the Toolbox; A limited number of Member States implement consultation arrangements between NCPs and relevant national stakeholders such as healthcare insurers, providers and patient organisations. To facilitate future monitoring and evaluation of the Directive, a shortlist of indicators has been developed and associated stakeholder views were provided.
The EU Directive (2011/24/EU) on the application of patients' rights in cross-border healthcare came into force in April 2011 and was due to be transposed by Member States into national law by October 2013. The Directive clarifies the rights of patients to seek reimbursement for healthcare received in another Member State. The EU Directive has also considered European cooperation in healthcare and importantly the establishment of the European Reference Networks for rare and low prevalence complex diseases. In preparation for the forthcoming evaluation of the Directive after almost 10 years since adoption, the European Commission has commissioned a study to enhance the implementation of Directive. Since evaluation framework of EU policies, programmes and legislation rely on an "intervention logic" and such a logic model was not developed at the time of impact assessment accompanying the proposal for the Directive in 2008, this had to be developed as part of the current preparatory study. In addition, the development of qualitative and quantitative indicators linked to the intervention logic of the Directive was requested so that to facilitate the evaluation of the Directive. It is important to emphasise that developing an intervention logic retrospectively must draw a clear line and distinguish between how the Directive was expected to work at the outset and how in practice it did work. This baseline framework will provide the future evaluator of the Directive a tool to identify not only intended but also unintended (positive and possibly negative) effects of the Directive.
Directive 2011/24/EU on the application of patients' rights in cross-border healthcare, states that Member States (MSs) shall ensure that National Contact Points (NCPs) consult with patient organisations, healthcare providers and healthcare insurers. In light of the 2018 study on cross-border healthcare and enhancing information provision to patients, it was observed that in general NCPs consider their cooperation with other stakeholders as 'very good'. Up to now it has not been assessed however, what these collaborations actually contain and whether any (formal) consultation arrangements exist between the NCPs and stakeholders. In the same study, a toolbox for the NCPs was developed to help them improve their communication to patients, in terms of clear and accessible information on all aspects related to cross-border healthcare. The aim of the current mapping exercise, was to provide insight into consultation arrangements between NCPs and patient organisations, healthcare insurers, and healthcare providers, as well as information on how the 2019 Toolbox is perceived by MSs. For that purpose we conducted: 1) written inquiries with NCPs; and 2) online questionnaires with patient organisations, healthcare insurers, and healthcare providers.