Work package 2:
Legal status and regulations
Leading beneficiary: University of Tromsø (NAFKAM) (75)
The objectives of WP2 were twofold: firstly to review and describe for each member or associated state the legal status of CAM, the regulatory status, governmental supervision and reimbursement status of CAM practices, and the reimbursement status and regulation of CAM medicinal products; and secondly to review the status of and potential obstacles for EU wide regulation of CAM practices and medicinal products.
Description of work:
The status quo of each country was taken as at the start date of the project. WP2 took as its base the report ‘How are European patients safeguarded when using complementary and alternative medicine (CAM)? Jurisdiction, supervision and reimbursement status in the EEA area (EU and EFTA) and Switzerland’76 (NAFKAM 2005). The group developed a new report on the regulatory status of CAM medicinal products, while the report on EU wide regulation and potential obstacles to such regulation was built partly on the NAFKAM report and partly on other published work in the area.
The NAFKAM report on the legal, regulatory, supervisory and reimbursement status of CAM practices was revised and expanded. The WP contacted health ministries using a structured questionnaire, supplementing the primary data with publicly available written documentation. A sample of five countries was selected for personal visits and interviews with the bureaucrats responsible for this area of jurisdiction, to find areas that need deeper investigation, and local experts double checked draft reports for each country. The report on the status with regard to the regulation of CAM medicinal products was developed following the same methodology.
The work was summarised in a report on the status of and potential obstacles for EU wide regulation of CAM practices and medicinal products. The current and previous regulatory system was described based on the current and previous EU rules and regulations in the area.
The regulatory environment determines how a provider can be educated, certified and offer services. The organisation and regulation of health care is a national responsibility within the European Union. There is no common approach to the regulation of CAM practice in Europe. This results in a considerable variety in regional, national, European and international legal regulations, which make any comparison of CAM practice and provision in any respect almost impossible. Medicinal products are regulated at the Union level. Herbal and homeopathic products are uniformly regulated with regard to market authorization throughout Europe (Wiesener S et al. Legal status and regulation of Complementary and Alternative Medicine in Europe. Forsch Komplementmed 2012;19(suppl 2):29-36). (77)
As regards legislation of CAM, 19 of the 39 countries have a general legislation, of which eleven have a specific CAM law and eight have sections on CAM included in their health laws (such as ‘Law on health care’ or ’Law on health professionals’). In addition to general CAM legislation, some countries have regulations on specific CAM treatments. Several EU directives and other legal and informal documents have an indirect influence on how patients, practitioners and researchers can relate to CAM in Europe. However, the heterogeneity of the legal status and regulations for CAM in Europe creates the following obstacles:
for patients: when patients cross borders in search of CAM treatment, they may encounter substantial differences in the professional background of apparently identical CAM providers, who in addition tend to work under completely different reimbursement systems. This situation influences CAM patients’ rights, access and potential safety, and constitutes a challenge to a harmonized national and European follow-up of the new patients’ rights according to the cross-border health care Directive 2011/24/EU.
for practitioners: when practitioners cross borders they will encounter a substantial variety of CAM practice in Europe. While CAM professions in some countries are tightly regulated, the same professional categories in other countries are totally unregulated, meaning that it is almost impossible to establish professional common ground.
for researchers: when researchers cross borders they will experience that practices and practitioners are not comparable across national boundaries, and any observational or experimental study can therefore be generalised only within a narrow national or cultural context.
It is crucial to mention that the European Union has decided that the organization and regulation of health care is a national responsibility, while medicinal products are regulated at the Union level. The situation with regard to CAM regulation can be summarized in three points:
A) There is no common approach to the regulation of CAM practice in Europe. All 39 countries that were studied do it their own way.
B) Market authorization of herbal and homeopathic products is regulated similarly in each country in accordance with EU Directives.
C) Several EU directives and other legal and informal documents have an indirect influence on how patients, practitioners and researchers can relate to CAM in Europe. Although diversity in health care regulation and legislation enables a wider choice of options with regard to CAM aspects of health care, the same diversity seriously hampers any efforts to establish EU-wide predictable conditions for both treatment and research.