"Then I went to a hospital abroad": acknowledging implications of stakeholders' differing risk understandings related to use of complementary and alternative medicine in European health care contexts.

BACKGROUND: Complementary and alternative medicine (CAM) is a rather novel issue within public healthcare and health policy-making. CAM use in Europe is widespread, patient-initiated, and patient-evaluated, and the regulation across countries has been evaluated as disharmonized. CAM users are left in an uncertain position, and patient safety may be threatened. How "risk" is understood by individuals in health policy-making and clinical encounters involving the use of CAM has not yet been much debated. The aim of this article is to explore and discuss the existence and possible consequences of differing risk understandings among stakeholders maneuvering in the complex landscape of CAM practice and CAM regulation contextualized by European public healthcare systems. METHODS: Qualitative data were derived from two studies on CAM in European healthcare contexts. Findings from the EU project CAMbrella on legislation and regulation of CAM were mixed with data from an interview study exploring risk understandings, communication, and decision-making among Scandinavian CAM users and their doctors. In a secondary content analysis, we constructed the case Sara as a typology to demonstrate important findings with regard to risk understandings and patient safety involving European citizens' use of CAM in differing contexts. RESULTS: By combining and comparing individual and structural perspectives on risk and CAM use, we revealed underexplored gaps in risk understandings among individuals involved in European CAM regulation and legislation, and between CAM users and their medical doctors. This may cause health risks and uncertainties associated with CAM use and regulation. It may also negatively influence doctor-CAM user communication and CAM users' trust in and use of public healthcare. CONCLUSION: Acknowledging implications of stakeholders' differing risk understandings related to CAM use and regulation may positively influence patient safety in European healthcare. Definitions of the concept of risk should include the factors uncertainty and subjectivity to grasp the full picture of possible risks associated with the use of CAM. To transform the findings of this study into practical settings, we introduce sets of questions relevant to operationalize the important question "What is risk?" in health policy-making, clinical encounters and risk research involving European patients' use of CAM.

Which risk understandings can be derived from the current disharmonized regulation of complementary and alternative medicine in Europe?

BACKGROUND: Many European citizens are seeking complementary and alternative medicine (CAM). These treatments are regulated very differently in the EU/EFTA countries. This may demonstrate differences in how risk associated with the use of CAM is perceived. Since most CAM treatments are practiced fairly similarly across Europe, differing risk understandings may influence patient safety for European CAM users. The overall aim of this article is thus to contribute to an overview and awareness of possible differing risk understandings in the field of CAM at a policymaking/structural level in Europe. METHODS: The study is a re-analysis of data collected in the CAMbrella EU FP7 document and interview study on the regulation of CAM in 39 European countries. The 12 CAM modalities included in the CAMbrella study were ranked with regard to assumed risk potential depending on the number of countries limiting its practice to regulated professions. The 39 countries were ranked according to how many of the included CAM modalities they limit to be practiced by regulated professions. RESULTS: Twelve of 39 countries generally understand the included CAM treatments to represent "high risk", 20 countries "low risk", while the remaining 7 countries understand CAM treatments as carrying "very little or no risk". The CAM modalities seen as carrying a risk high enough to warrant professional regulation in the highest number of countries are chiropractic, acupuncture, massage, homeopathy and osteopathy. The countries understanding most of the CAM modalities in the study as potentially high-risk treatments are with two exceptions (Portugal and Belgium) all concentrated in the southeastern region of Europe. CONCLUSION: The variation in regulation of CAM may represent a substantial lack of common risk understandings between health policymakers in Europe. We think the discrepancies in regulation are to a considerable degree also based on factors unrelated to patient risk. We argue that it is important for patient safety that policy makers across Europe address this confusing situation. This could be done by applying the WHO patient safety definitions and EU's policy to facilitate access to "safe and high-quality healthcare", and regulate CAM accordingly.

Legal status and regulation of complementary and alternative medicine in Europe.

OBJECTIVE: The study aims to review the legal and regulatory status of complementary and alternative medicine (CAM) in the 27 European Union (EU) member states and 12 associated states, and at the EU/European Economic Association (EEA) level. METHODS: Contact was established with national Ministries of Health, Law or Education, members of national and European CAM associations, and CAMbrella partners. A literature search was performed in governmental and scientific/non-scientific websites as well as the EUROPA and EUR-lex websites/ databases to identify documents describing national CAM regulation and official EU law documents. RESULTS: The 39 nations have all structured legislation and regulation differently: 17 have a general CAM legislation, 11 of these have a specific CAM law, and 6 have sections on CAM included in their general healthcare laws. Some countries only regulate specific CAM treatments. CAM medicinal products are subject to the same market authorization procedures as other medicinal products with the possible exception of documentation of efficacy. The directives, regulations and resolutions in the EU that may influence the professional practice of CAM will also affect the conditions under which patients are receiving CAM treatment(s) in Europe. CONCLUSION: There is an extraordinary diversity with regard to the regulation of CAM practice, but not CAM medicinal products. This will influence patients, practitioners and researchers when crossing European borders. Voluntary harmonization is possible within current legislation. Individual states within culturally similar regions should harmonize their CAM legislation and regulation. This can probably safeguard against inadequately justified over- or underregulation at the national level.

International development of traditional medicine / complementary and alternative medicine research--what can Europe learn?

BACKGROUND: The aim of this study was to analyse global research and development (R&D) strategies for traditional medicine (TM) and complementary and alternative medicine (CAM) across the world to learn from previous and on-going activities. METHODS: 52 representatives within CAMbrella nominated 43 key international stakeholders (individuals and organisations) and 15 of these were prioritised. Information from policy documents including mission statements, R&D strategies and R&D activities were collected in combination with personal interviews. Data were analysed using the principles of content analysis. RESULTS: Key stakeholders vary greatly in terms of capacity, mission and funding source (private/public). They ranged from only providing research funding to having a comprehensive R&D and communication agenda. A common shift in R&D strategy was noted; whereas 10 years ago research focused mainly on exploring efficacy and mechanisms, today the majority of stakeholders emphasise the importance of a broad spectrum of research, including methodologies exploring context, safety and comparative effectiveness. CONCLUSION: The scarce public investment in this field in Europe stands in stark contrast to the large investments found in Australia, Asia and North America. There is an emerging global trend supporting a broad research repertoire, including qualitative and comparative effectiveness research. This trend should be considered by the EU given the experience and the substantial research funding committed by the included stakeholders. To facilitate international collaborative efforts and minimise the risk of investment failure, we recommend the formation of a centralised EU CAM research centre fostering a broad CAM R&D agenda with the responsibility for implementing the relevant findings of CAMbrella.