Áreas de seguridad

Patients, practitioners (authorized/licensed as well as those without an authorization/ licence) and researchers would all benefit if there was a higher degree of harmonization of legislation and regulation of CAM in Europe. The four freedoms form the political platform of the EU/EEA area. These freedoms can only be fully practised if the citizens can enjoy a predictable and safe system of health care. Conventional medicine across Europe is predictable enough through the various directives passed over recent years. CAM has, however, not been given a similar degree of attention despite its widespread use.

There are in principle two options that can be chosen to achieve a higher degree of harmonization: legislation and regulation at the EU/EEA level or voluntary harmonization. We do not foresee EU/EEA level legislation/regulation in the foreseeable future since the EU repeatedly has upheld its position of leaving this to the individual country.

Voluntary harmonization is, however, possible within current legislation. Directive 2005/36/EC outlines how countries can enable mutual professional recognition for categories of professionals (5). The successful mutual recognition of physiotherapists across Europe shows how this can be done. Physiotherapists represent a profession in conventional medicine that is not regulated as one of the “Sectorial professions” giving automatic recognition on the basis of harmonization of minimum training requirements. Physiotherapy has therefore been harmonized according to the “General system” of mutual recognition of professional qualifications, and could serve as a potential template for development of harmonized regulation of CAM professions in Europe. Physiotherapy is recognized as a conventional regulated health profession in 38 of the 39 countries we have described, and 29 of 31 EU/EEA members have registered the profession in the EU regulated professions database (Figure 6.5.1). Physiotherapy professionals can thus with few obstacles move from one European country to another, and patients are ensured that, across Europe, they will encounter professionals with similar background and experience.

Chiropractic, massage, osteopathy, naprapathy could be similarly regulated and entered into the common EU regulated professions database. This would establish a situation similar to physiotherapy to which they are fairly closely related. Several countries in the eastern region of Europe have entered their massage therapist profession into the database, and have thereby established a “common market” for this profession in the region. This demonstrates that this approach is viable also in the CAM area.

We think a pan-European professional initiative could influence national health authorities to register the relevant profession in the EU regulated professions database. If this is done, EU-level regulation will turn out to be unnecessary.

Figure 6.5.1 Physiotherapy map

Table 6.5.1 Physiotherapy regulations - countries

Regulated profession and EU registered (29)

Regulated profession Not EU registered (9)

Regulated treatment Not regulated profession (0)

No regulation (1)

29 countries Albania Macedonia

Bosnia & Herzegovina

Croatia Estonia Israel Montenegro Romania Serbia Turkey

7

Conclusions

The EU treaties have repeatedly established that health policies are a national responsibility for the member states, and this is clearly reflected in the current situation with regard to CAM legislation and regulation. Despite several EU Directives, Regulations and Resolutions that influence how member states organize their national health policy and services, no two countries described in this report have a common approach to legislation and regulation in this area. The diversity applies to whether the field is regulated at all, what treatments are considered to be CAM, whether CAM treatments should be only practiced by practitioners with education/training in the discipline, whether license to practise should be limited to authorized/licensed health personnel and even whether medical doctors need a several-year specialization to be allowed to practice CAM. There appears to be no predictable pattern with regard to geography, political history, population size or cultural diversity. This diversity will clearly influence patients, practitioners and researchers crossing European borders (encouraged by the recent Cross-border Health Directive).

When patients cross European borders in search of CAM treatment, they may encounter substantial differences in the professional background of apparently identical CAM providers. They may also face a completely different reimbursement system, and if the treatment they undergo results in unwanted adverse or side effects they will be differently safeguarded depending on which state they are in. Every aspect of the current situation can thus be a threat to patient safety. In post-modern Europe where patient choice in health care is seen as a core value, this confusing European market makes any informed treatment- seeking very challenging.

There is room for a substantial variety of CAM practise in Europe. This ranges from an extreme in some countries where anyone can practise CAM without any CAM education or training to the other extreme where only medical doctors with a specialization in the relevant CAM discipline are allowed to practise. This situation raises serious concerns with regard to the predictability, quality and safety of health care delivery to European citizens. When CAM professions in some countries are tightly regulated while the same professional categories in other countries are totally unregulated, an establishment of collegial common ground is very challenging.

Research on efficacy and effectiveness of CAM is also severely hampered by the conglomerate of European regulation. Practices and practitioners are not comparable across national boundaries, and any observational or experimental study will therefore be generalisable only within a narrow national or cultural context.

There are in principle two options that can be chosen to achieve a higher degree of harmonization: legislation and regulation at the EU/EEA level or voluntary harmonization. We do not foresee EU/EEA level legislation/regulation in the foreseeable future since the EU repeatedly has upheld its position of leaving this to the individual country. Voluntary

harmonization is, however, possible within current legislation. The successful mutual recognition of physiotherapists across Europe shows how this can be done, and could be a potential template for development of harmonized regulation also of CAM professions in Europe.

8

Countries