Dimitra Panteli

Clinical guidelines in the European Union: Mapping the regulatory basis, development, quality control, implementation and evaluation across member states

INTRODUCTION Clinical guidelines are advocated to improve the quality of care, especially for chronic diseases. However, the regulatory basis of clinical guidelines, their development, quality control, implementation and use as well as evaluation within countries across the European Union is not systematically known. METHODS Using information collected from key informants in each country by means of a structured questionnaire, this mapping exercise illustrates the varied status of guideline production in European Union countries. RESULTS Most European Union countries have an established national, regional or local clinical guideline programme, and a substantial proportion have developed guidelines on the prevention and management of chronic diseases. Several countries have mechanisms in place to ensure the quality of scientific evidence used for the development of guidelines is high and that the process is consistent and transparent. Others are only now taking an interest in guideline development and are taking the first steps towards establishing ways of implementing them. The majority of countries have no legal basis for the development of guidelines and those that have well established systems mostly implement them on a voluntary basis. The process of guideline development varies in its degrees of decentralisation across countries with many different types of organisations taking on this responsibility. There is general acceptance of the value of the instrument developed by the AGREE collaboration for evaluating the methodological robustness of guidelines. However, the extent to which guidelines are implemented in Europe is unknown, as there is no systematic data collection and, in most countries, no structure to enable it. There are few examples of formal evaluations of the development, quality, implementation and use of guidelines. CONCLUSIONS Our findings call for renewed efforts to respond to the severe lack of standardized guideline terminology and accessibility as well as rigorous studies to evaluate the relationship between different ways to develop guidelines and their methodological quality, between their quality and the actual implementation and usage, and finally between implementation and health outcomes.

HEALTH TECHNOLOGY ASSESSMENT OF MEDICAL DEVICES IN EUROPE: PROCESSES, PRACTICES, AND METHODS.

OBJECTIVES To review and compare current Health Technology Assessment (HTA) activities for medical devices (MDs) across European HTA institutions. METHODS A comprehensive approach was adopted to identify institutions involved in HTA in European countries. We systematically searched institutional Web sites and other online sources by using a structured tool to extract information on the role and link to decision making, structure, scope, process, methodological approach, and available HTA reports for each included institution. RESULTS Information was obtained from eighty-four institutions, forty-seven of which were analyzed. Fifty-four methodological documents from twenty-three agencies in eighteen countries were identified. Only five agencies had separate documents for the assessment of MDs. A few agencies made separate provisions for the assessment of MDs in their general methods. The amount of publicly available HTA reports on MDs varied by device category and agency remit. CONCLUSIONS Despite growing consensus on their importance and international initiatives, such as the EUnetHTA Core Model®, specific tools for the assessment of MDs are rarely developed and implemented at the national level. Separate additional signposts incorporated in existing general methods guides may be sufficient for the evaluation of MDs.

Major challenges ahead for Hungarian healthcare

The health sector in Hungary is facing its most serious crisis since the fall of the communist regime. Péter Gaál and colleagues discuss the challenges and how to respond to them

From market access to patient access: overview of evidence-based approaches for the reimbursement and pricing of pharmaceuticals in 36 European countries.

BackgroundCoverage decisions determining the benefit baskets of health systems have been increasingly relying on evidence regarding patient benefit and costs. Relevant structures, methodologies, and processes have especially been established for pharmaceuticals but approaches differ. The objective of this work was thus to identify institutions in a broad range of European countries (n = 36) in charge of determining the value of pharmaceuticals for pricing and reimbursement purposes and to map their decision-making process; to examine the different approaches and consider national and supranational possibilities for best practice.MethodsInstitutions were identified through websites of international networks, ministries, and published literature. Details on institutional practices were supplemented with information from institution websites and linked online sources.ResultsThe type and extent of information available varied considerably across countries. Different types of public regulatory bodies are involved in pharmaceutical coverage decisions, assuming a range of responsibilities. As a rule, the assessment of scientific evidence is kept structurally separate from its appraisal. Recommendations on value are uniformly issued by specific committees within or commissioned by responsible institutions; these institutions often also act as decision-makers on reimbursement status and level or market price. While effectiveness and costs are important criteria in all countries, the latter are often considered on a case-by-case basis. In all countries, manufacturer applications, including relevant evidence, are used as one of the main sources of information for the assessment.ConclusionTransparency of evidence-based coverage decisions should be enhanced. International collaboration can facilitate knowledge exchange, improve efficiency of information production, and strengthen new or developing systems.

How do medical doctors in the European Union demonstrate that they continue to meet criteria for registration and licencing

This paper reviews procedures for ensuring that physicians in the European Union (EU) continue to meet criteria for registration and the implications of these procedures for cross-border movement of health professionals following implementation of the 2005/36/EC Directive on professional qualifications. A questionnaire was completed by key informants in 10 EU member states, supplemented by a review of peer-reviewed and grey literature and a review conducted by key experts in each country. The questionnaire covered three aspects: actors involved in processes for ensuring continued adherence to standards for registration and/or licencing (such as revalidation), including their roles and functions; the processes involved, including continuing professional development (CPD) and/or continuing medical education (CME); and contextual factors, particularly those impacting professional mobility. All countries included in the study view CPD/CME as one mechanism to demonstrate that doctors continue to meet key standards. Although regulatory bodies in a few countries have established explicit systems of ensuring continued competence, at least for some doctors (in Belgium, Germany, Hungary, the Netherlands, Slovenia and the UK), self-regulation is considered sufficient to ensure that physicians are up to date and fit to practice in others (Austria, Finland, Estonia and Spain). Formal systems vary greatly in their rationale, structure, and coverage. Whereas in Germany, Hungary and Slovenia, systems are exclusively focused on CPD/CME, the Netherlands also includes peer review and minimum activity thresholds. Belgium and the UK have developed more complex mechanisms, comprising a review of complaints or compliments on performance and (in the UK) colleague and patient questionnaires. Systems for ensuring that doctors continue to meet criteria for registration and licencing across the EU are complex and inconsistent. Participation in CPD/CME is only one aspect of maintaining professional competence but it is the only one common to all countries. Thus, there is a need to bring clarity to this confused landscape.

TAXONOMY OF MEDICAL DEVICES IN THE LOGIC OF HEALTH TECHNOLOGY ASSESSMENT

OBJECTIVES The suitability of general HTA methodology for medical devices is gaining interest as a topic of scientific discourse. Given the broad range of medical devices, there might be differences between groups of devices that impact both the necessity and the methods of their assessment. Our aim is to develop a taxonomy that provides researchers and policy makers with an orientation tool on how to approach the assessment of different types of medical devices. METHODS Several classifications for medical devices based on varying rationales for different regulatory and reporting purposes were analyzed in detail to develop a comprehensive taxonomic model. RESULTS The taxonomy is based on relevant aspects of existing classification schemes incorporating elements of risk and functionality. Its 9 × 6 matrix distinguishes between the diagnostic or therapeutic nature of devices and considers whether the medical device is directly used by patients, constitutes part of a specific procedure, or can be used for a variety of procedures. We considered the relevance of different device categories in regard to HTA to be considerably variable, ranging from high to low. CONCLUSIONS Existing medical device classifications cannot be used for HTA as they are based on different underlying logics. The developed taxonomy combines different device classification schemes used for different purposes. It aims at providing decision makers with a tool enabling them to consider device characteristics in detail across more than one dimension. The placement of device groups in the matrix can provide decision support on the necessity of conducting a full HTA.

Assessing the role of regulatory bodies in managing health professional issues and errors in Europe.

OBJECTIVE This paper explores how medical regulatory bodies in nine European countries manage professional issues involving quality and patient safety, to build on limited existing information on procedures for regulating medical professionals in Europe. DESIGN Twelve vignettes describing scenarios of concerns about standards of physicians were developed, covering clinical, criminal and administrative matters. Medical regulatory bodies in nine European countries were asked what action they would normally take in each situation. Their responses were related to their regulatory mandate. RESULTS Responses varied greatly across participating countries. Regulators are always involved where patients are at risk or where a criminal offence is committed within the clinical setting. Non-criminal medical issues were generally handled by the employer, if any, at their discretion. Countries varied in the use of punitive measures, the extent to which they took an interest in issues arising outside professional activities, and whether they dealt with issues themselves or referred cases to another regulatory authority or took no action at all. CONCLUSIONS There is little consistency across Europe on the regulation of medical professionals. There is considerable diversity in the range of topics that regulatory bodies oversee, with almost all covering health care quality and safety and others encompassing issues related to reputation, respect and trust. These inconsistencies have significant implications for professional mobility, patient safety and quality of care.

Deciding when physicians are unfit to practise: an analysis of responsibilities, policy and practice in 11 European Union member states

In 1974, the European Economic Community established mutual recognition of medical qualifications obtained in any of its member states. Subsequently, a series of directives has elaborated on the initial provisions, with the most recent enacted in 2013. However, greater movement of physicians across borders and some high-profile scandals have raised questions about how to prevent a physician sanctioned in one country from simply moving to another, without undermining the principle of free movement. A survey of key informants in 11 European Union (EU) member states was supplemented by a review of peer-reviewed and grey literature, with the results validated by independent reviewers. It examined processes, adjudicative and disciplinary measures that are in place to evaluate physicians about whom concerns arise, and related sanctions, along with other aspects of professional standards and regulation. Overall, responses varied greatly between participating countries, with respect to the institutions responsible for the regulation of medical professions, the investigation processes in place, and the terminology used in each member state. While the types of sanction (removal from the register of medical professionals and/or licence revocation, suspension, dismissal, reprimand, warnings, fines, as well as additional education and training) applied are similar, both the roles of the individuals involved and the level of public disclosure of information vary considerably. However, some key features, such as the involvement of professional peers in disciplinary panels and the involvement of courts in criminal cases, are similar in most member states studied. Given the variation in the regulatory context, individuals and processes involved that is illustrated by our findings, a common understanding of definitions of what constitutes competence to practise, its impairment and its potential impact on patient safety becomes particularly important. Public disclosure of disciplinary outcomes is already applied by some member states, but additional measures should be considered to protect medical professionals from undue consequences.

Informed consumer or unlucky visitor? A profile of German patients who received dental services abroad

OBJECTIVES A common characteristic of sending countries in cross-border dental care is that of high costs and/or high copayments for dental services. This study aims to provide an insight into the characteristics of German patients receiving planned and emergency (unplanned) dental care abroad and their satisfaction with received services. METHODS The Europabefragung is a postal survey carried out by Techniker Krankenkasse for patients who are treated in EU/EEA countries. This study uses data from the Europabefragung 2012. The survey was sent to 45 189 individuals; descriptive statistics for the subset of respondents who received emergency (unplanned) or planned dental treatment are presented. RESULTS There were 18 339 responses to the questionnaire, out of which 17 543 were deemed valid; 1416 respondents had received emergency (unplanned) (78%) or planned (22%) dental care and were included in the analysis. There were clear differences between unplanned and planned treatments regarding country and type of treatment as well as satisfaction with different aspects of treatment and the need for follow-up care. Overall, satisfaction with treatment was high for both groups; individuals who had received planned treatment were more satisfied on all aspects of care and reported a need for follow-up care less frequently. CONCLUSIONS While German patients who received both emergency (unplanned) and planned services abroad are mostly satisfied with their experience, some concerns arise with regard to continuity of care. Types of information provided to patients seeking care abroad and dissemination modalities should be carefully planned.

Gender in health technology assessment: pilot study on agency approaches.

OBJECTIVES Gender as a social construct is a recognized health determinant. Because best practice in reporting health technology assessment (HTA) clearly specifies the need to appraise a technologys social impact within the target population, the extent to which gender issues are taken into account in HTA production is of interest, not only in light of equitable practices but also for reasons of effectiveness. The aim of this study is to provide a first assessment of the degree of gender sensitivity shown by HTA agencies around the world today. METHODS The Web sites of sixty HTA agencies were analyzed. The consideration of gender aspects was specifically looked for in each agencys general mission statement, its priority setting process, and its methodological approach. Additionally, specific gender-oriented initiatives not belonging to any of the aforementioned categories were identified. RESULTS Of the sixty agencies, less than half mention a commitment to addressing the social implication of health technologies. Only fifteen institutions make information on their priority setting principles available on their Web sites and gender was an issue in two of those cases. Data on methodology were obtainable online from 18 agencies, two of which mentioned gender issues explicitly. Finally, gender-oriented initiatives were identified by thirteen agencies. CONCLUSIONS A gender-sensitive approach is apparently rarely adopted in current HTA production. Exceptional practices and relevant tools do exist and could serve as examples to be promoted by international collaborative networks.