The problem of drug shortages has been reported worldwide, gaining prominence in multiple domains and several countries in recent years. The aim of the study was to analyze, characterise and assess this problem in Belgium and France, while also adopting a wider perspective from the European Union. A qualitative methodological approach was employed, including semi-structured interviews with the representatives of respective national health authorities, pharmaceutical companies and wholesalers, as well as hospital and community pharmacists. The research was conducted in early 2014. Four themes, which were identified through the interviews, were addressed in the paper, i.e. a) defining drug shortages, b) their dynamics and perception, c) their determinants, d) the role of the European and national institutions in coping with the problem. Three groups of determinants of drug shortages were identified throughout this study: manufacturing problems, distribution and supply problems, and problems related to economic aspects. Currently, the Member States of the European Union are striving to resolve the problem very much on their own, although a far more focused and dedicated collaboration may well prove instrumental in coping with drug shortages throughout Europe more effectively. To the best of the authors’ knowledge, this is the first qualitative study to investigate the characteristics, key determinants, and the problem drivers of drug shortages, focusing on this particular group of countries, while also adopting the European Union’s perspective.

BackgroundGALI or Global Activity Limitation Indicator is a global survey instrument measuring participation restriction. GALI is the measure underlying the European indicator Healthy Life Years (HLY). Gali has a substantial policy use within the EU and its Member States. The objective of current paper is to bring together what is known from published manuscripts on the validity and the reliability of GALI.MethodsFollowing the PRISMA guidelines, two search strategies (PUBMED, Google Scholar) were combined to identify manuscripts published in English with publication date 2000 or beyond. Articles were classified as reliability studies, concurrent or predictive validity studies, in national or international populations.ResultsFour cross-sectional studies (of which 2 international) studied how GALI relates to other health measures (concurrent validity). A dose-response effect by GALI severity level on the association with the other health status measures was observed in the national studies. The 2 international studies (SHARE, EHIS) concluded that the odds of reporting participation restriction was higher in subjects with self-reported or observed functional limitations. In SHARE, the size of the Odds Ratio’s (ORs) in the different countries was homogeneous, while in EHIS the size of the ORs varied more strongly. For the predictive validity, subjects were followed over time (4 studies of which one international). GALI proved, both in national and international data, to be a consistent predictor of future health outcomes both in terms of mortality and health care expenditure. As predictors of mortality, the two distinct health concepts, self-rated health and GALI, acted independently and complementary of each other. The one reliability study identified reported a sufficient reliability of GALI.ConclusionGALI as inclusive one question instrument fits all conceptual characteristics specified for a global measure on participation restriction. In none of the studies, included in the review, there was evidence of a failing validity. The review shows that GALI has a good and sufficient concurrent and predictive validity, and reliability.

The European Union (EU) initiative on the Digital Transformation of Health and Care (Digicare) aims to provide the conditions necessary for building a secure, flexible, and decentralized digital health infrastructure. Creating a European Health Research and Innovation Cloud (HRIC) within this environment should enable data sharing and analysis for health research across the EU, in compliance with data protection legislation while preserving the full trust of the participants. Such a HRIC should learn from and build on existing data infrastructures, integrate best practices, and focus on the concrete needs of the community in terms of technologies, governance, management, regulation, and ethics requirements. Here, we describe the vision and expected benefits of digital data sharing in health research activities and present a roadmap that fosters the opportunities while answering the challenges of implementing a HRIC. For this, we put forward five specific recommendations and action points to ensure that a European HRIC: i) is built on established standards and guidelines, providing cloud technologies through an open and decentralized infrastructure; ii) is developed and certified to the highest standards of interoperability and data security that can be trusted by all stakeholders; iii) is supported by a robust ethical and legal framework that is compliant with the EU General Data Protection Regulation (GDPR); iv) establishes a proper environment for the training of new generations of data and medical scientists; and v) stimulates research and innovation in transnational collaborations through public and private initiatives and partnerships funded by the EU through Horizon 2020 and Horizon Europe.

BackgroundIn 2005, the European Union (EU) started to use a disability-free life expectancy, known as Healthy Life Years (HLY), to monitor progress in the strategic European policies such as the 2000 Lisbon strategy. HLY are based on the underlying measure: the Global Activity Limitation Indicator (GALI). Twelve years after its implementation, this study aims to assess its current use in EU Member States and the European Commission.MethodsIn March 2017, a questionnaire was sent to 28 Member states and the European Commission. The questionnaire inquired how the GALI and HLY are used to set policy targets, in which surveys the GALI has been introduced since 2005, how the GALI and HLY are presented, and what the capacity in each country is to investigate the GALI and HLY.ResultsThe survey was answered by 22 Member States and by the Commission. HLY are often used to set targets and develop strategies in health such as national health plans. Analysis of HLY has even led to policy change. In some countries, HLY have become the main indicator for health, gaining more importance than life expectancy. More recently, the GALI and HLY have also been used for policy targets outside the health sector such as in the area of pension and retirement age or in the context of sustainable development. Regarding surveys, the GALI is mostly obtained from the EU-SILC, SHARE and EHIS, but is also increasingly introduced in national surveys. National health reporting systems usually present HLY on their national statistics websites. Most countries have up to three specialists working on the GALI and HLY, which has been consistent through time. Others have increased their capacity over various institutions.ConclusionHLY is an indicator that is systematically used to monitor health developments in most EU countries. The SHARE, EU-SILC and EHIS are commonly used to assess HLY through the GALI. The results are then described in reports and presented on national statistics websites and used in different policy settings. Expertise to analyse the GALI and HLY is available in most countries.Electronic supplementary materialThe online version of this article (10.1186/s13690-018-0279-z) contains supplementary material, which is available to authorized users.