This paper presents some of the main aspects of the Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border ...healthcare, commonly known as the Patients’ Rights Directive, and as well treats the problematic exclusion of the long-term services from its scope. This Directive represents the latest EU initiative in regard to the European Health Care and the Single Market, but it is observed that the exclusion made by the Member States might lead to conclusions that the PRD is biased against the chronically ill and patients seeking long-term care, especially in an ageing Europe background that emerges in nowadays society.
Rad predstavlja neke od glavnih aspekata Direktive 2011/24/EU koju su Europski parlament i Vijeće donijeli 9. ožujka 2011. Direktiva se odnosi na primjenu prava pacijenata u prekograničnoj zdravstvenoj skrbi, uobičajeno poznatoj kao Direktiva o pravima pacijenata, i tretira problematično isključivanje dugoročnih usluga iz svog djelokruga. Ova Direktiva predstavlja najnoviju inicijativu Europske unije u odnosu na europsku zdravstvenu skrb i jedinstveno tržište, ali se primjećuje da bi isključivanje od strane država članica moglo dovesti do zaključaka da je Direktiva pristrana prema kronično bolesnim pacijentima i pacijentima kojima je potrebna dugoročna skrb, osobito u europskoj pozadini sve starije populacije koja se pojavljuje u današnjem društvu.
Objectives: The aim of this study was to present the first four collaborative health technology assessment (HTA) processes on health technologies of different types and life cycles targeted toward ...diverse HTA users and facilitators, as well as the barriers of these collaborations. Methods: Retrospective analysis, through four case studies, was performed on the first four collaboration experiences of agencies participating in the EUnetHTA Joint Action project (2010–12), comprising different types and life cycles of health technologies for a diverse target audience, and different types of collaboration. The methods used to initiate collaboration, partner contributions, the assessment methodology, report structure, time frame, and factors acting as possible barriers to and facilitators of this collaboration were described. Results: Two ways were used to initiate collaboration in the first four collaborative HTA processes: active brokering of information, so-called “calls for collaboration,” and individual contact between agencies after identifying a topic common to two agencies in the Planned and Ongoing Projects database. Several success factors are recognized: predefined project management, high degree of commitment to the project; adherence to timelines; high relevance of technology; a common understanding of the methods applied and advanced experience in HTA; finally, acceptance of English-written reports by decision makers in non–English-speaking countries. Barriers like late identification of collaborative partners, nonacceptance of English language and different methodology of assessment should be overcome. Conclusions: Timely and efficient, different collaborative HTA processes on relative efficacy/effectiveness and safety on different types and life cycles of health technologies, targeted toward diverse HTA users in Europe are possible. There are still barriers to overcome.
Abstract 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.
Problem: The Smart Open Services for European Patients (epSOS) the exchange of electronic Patient Summaries and ePrescriptions between selected member states of the European Union (EU). This project ...basically solved the ‘communication’ or message transfer problem. However, it encountered a serious ‘delivery’ problem: the safe dispensation of a medicinal product noted in a prescription from a given country by a retail pharmacist in another country. The reason for this was that the specified medicine could in many instances not univocally be identified – the same name may identify a product with a different active ingredient, or the product with identical composition may carry a different name in the other country. If the prescribed medicine had not been authorised for marketing in the other country, information on its attributes may not be available. This rendered dispensation by the pharmacist impossible, even where substitution would, in principle, be allowed and possible.Objectives: This paper reports on the goal, activities and achievements of the openMedicine project towards development of a digital solution and its implementation to meet this identification and the resulting delivery challenge. European-wide and cross-Atlantic endeavours to enhance pharmacovigilance by being able to match adverse event reports filed under different drug names which provide, however, for the same active ingredient(s) were developed upon. And the need for and benefits of being able to trace for clinical purposes, e.g. the longer-term treatment with the same active ingredient, even when the name of the prescribed medicine changed several times, were explored.Methodological approach: The openMedicine project was funded by the European Commission (EC) on behalf of member states to analyse this European-wide problem. Work benefitted from the epSOS project and work by the European Medicines Agency (EMA), the USA Federal Drug Agency (FDA), and standard development organisations (SDOs). Reviews of white and grey literature, reports, regulatory documents, standards and other documents were undertaken. An online survey of 160 experts in all EU member states contributed empirical evidence. Work gained from discussions within an Expert Council representing core players and stakeholders in Europe and North America, and regional workshops across the EU and at the FDA. They also contributed towards validation of results.Results: The fragmentation of national markets for medicinal products lies at the root of the identification problem. About 600,000 different products are marketed across the Union, but even in a large country like Germany only ca. 50,000 are readily available. The great flexibility of marketing authorisation holders to provide different names for the same or equivalent products in different countries adds to this identification challenge, and naming issues related to legacy products complicate it further. – Options to identify medicinal products in a prescription are analysed, like noting a package code, the brand name of the product, the specification of an active substance only, or of a subset of similar products, from which the pharmacist has to choose. The EU-wide adoption of the International Standards Organisation’s (ISO) Identification of Medicinal Products (IDMP) suite of standards, as already under way by EMA and FDA for pharmacovigilance purposes, is proposed. Through globally agreed coding of packages, medicinal as well as pharmaceutical products, substances, dose forms, and other identifying attributes as needed, the identification as well as partly the ‘delivery’ problem can be solved. This will require linking to a central data base maintained by EMA, and the synchronisation of national as well as commercial medicinal and pharmaceutical product data bases with it. The full solution of the delivery problem will, however, also depend on the introduction – in countries where this is not yet allowed – and the relaxation respectively harmonisation of national substitution rules. Of course, if no equivalent product is available, delivery will fail – or require import from another country. Conclusions: Implementing digital infrastructures facilitating the univocal identification of medicinal products in regulatory and clinical contexts will generate long-term benefits for patient safety, pharmacovigilance, and positive socio-economic impacts for all key players. Harmonising the identification of medicines in regulatory processes as well as clinical documents is well on its way, but a European approach towards common processes for validation of contents, error mitigation, of linking from central hubs to national and regional levels, updates and mappings to other systems will require intensified cooperation of all stakeholders in years to come.
In this commentary, we establish a relationship between medical sociology and the study of medical tourism and cross-border healthcare by introducing Ronald Andersen's behavioral model of healthcare ...use, and linking this model to the recent empirical study of Kovacs et al. on patients travelling to Hungary for orthopedic treatment. Finally, we plead for more measurement in the field of patient mobility.
The case-law of the Court of Justice (ECJ) on patient mobility was recently challenged by a ruling that a patient could go to Germany for treatment when facilities in Romanian hospitals were ...inadequate. Given the reported impact of austerity measures in the field of health care this raises the question; what is the impact of the ECJ’s ruling on how Member States can manage expenditure and limit outflows of patients and how should such measures be legally evaluated? The objective of this article is to analyse potential impact on health systems in the context of increasing pressure on public financing for health. While the ECJ mainly referred to the requirement of treatment in due time, we also analyse possible austerity reductions of the basket of care against the background of EU law (i.e., ECJ case-law, patient mobility directive, Charter of Fundamental rights and social security regulation).
Abstract
This contribution comments on Directive 2011/24, providing a legal framework for cross border healthcare 13 years after the famous Kohll and Decker case law. The Directive contains ...provisions concerning the reimbursement of costs, the responsibilities of the Member States and their mutual cooperation in healthcare. Analysing the (potential) impact of the Directive 2011/24 on EU healthcare systems, patients and healthcare providers, it becomes clear that the impact of the Directives reaches far beyond patient mobility. The Directive creates patients' rights, pays attention to the quality and safety of healthcare services and creates an excessive structure of cooperation in the field of healthcare. The European Union seems ready to use its economies of scale to improve healthcare for all European patients.
To better enable cross-border healthcare delivery, particularly the exchange of ePrescriptions, this global undertaking advances the unique identification of medicinal products (MPs) and patient ...safety in cross-border settings. Major stakeholders harmonise their respective efforts to deliver • common data models for prescribed MPs • a common vocabulary for unambiguous definition, description, and identification of MPs • rules to harmonise practices of therapeutic and economic substitution • a global roadmap for post-project actions and implementations Based on earlier activities of standard development organisations (SDOs), use case scenarios are developed, where the identification of an MP is an issue, including pharmacological and pharmacokinetic attributes, clinical indications, and risks to be considered. Next, the univocal identification of MPs is addressed, for standard pre-packed ones as well as for special cases like MPs with multi-components, biologics, or special packaging. Impacts will be considerable for global healthcare services and systems as well as - through simplifying and speeding up the registration of new products and afterwards pharmacovigilance - for national and international regulatory agencies, the MPs industry, and, in particular, patients.
Trazer uma reflexão sobre a importância e o potencial impacto da migração pendular na busca por serviços de saúde e, em específico, sobre as peculiaridades dessa mobilidade na região de fronteira. O ...trabalho descreve o contexto em que a mobilidade pendular se insere na modificação do espaço urbano do século XX, apresenta alguns aspectos legais sobre o tema na área da saúde, ilustrando a partir da realidade da tríplice fronteira Brasil-Argentina-Paraguai, enquanto importante local de migração pendular para uso dos serviços de saúde. São apresentadas hipóteses para possíveis impactos da mobilidade pendular, desfechos em saúde, assim como medidas para aferir a mobilidade pendular, tais como o efeito da distância a ser percorrida da residência ao serviço de saúde, o local de residência (país diferente, com condições de desenvolvimento diferentes) e os aspectos organizacionais da atenção à saúde, como a incerteza relativa ao atendimento em função da mobilidade internacional. Conclui-se que essa forma de mobilidade é muito comum na busca por atenção à saúde, e não apenas, como versa a abordagem tradicional, para trabalho e estudo, e que faz-se de grande importância o estudo de seu impacto na saúde das pessoas e a sua inclusão nos debates sobre a atenção à saúde através da fronteira.
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