Safeguarding patients

Every European country regulates by law the access to medical practise and the use of titles. Practitioners are authorised / licensed / given a protected title and the quality of the service is controlled by supervisory bodies. Some countries offer, in addition, a voluntary registration scheme for CAM providers.

Authorisation / licensing / protected title

Authorising or licensing (in some countries) practitioners within a certain profession allows governments to secure the quality of a given service. An authorisation is given when the practitioner can provide educational and other qualifications. Authorisation is granted in the health care service to practitioners, such as physicians, nurses, midwives, and dentists, giving them the right to use a specific title, in addition to accepting various privileges and responsibilities. The governments decide which professions are authorised / licensed. Some European countries authorise CAM practitioners as health personnel. Some countries’ statutory regulations recognise the use of a title but do not thereby automatically authorise the practitioner the status of health personnel.

Health acts and ethical rules of the practitioners’ own federations regulate the work of authorised / licensed personnel. The common objective is to contribute to safety of the patients and to a high quality of health service, as well as to maintain confidence in health personnel and services. The most important aspects of safeguarding the patients are requirements regarding responsible professional conduct, duty of confidentiality, obligatory documentation, ethical rules, regulations about insurance and rules concerning marketing.

Regulated personnel are supervised. The supervisory body controls the quality of the work administered by the personnel and monitors adherence to laws and regulations. The personnel may lose their authorisation if the law is violated. If the violation is serious, the supervisory body may ask the police to investigate the matter.

Voluntary registration

In some countries where anybody is allowed to treat ("semi-regulated system"), the government provides a voluntary registration scheme for CAM providers. The registration task may be accomplished by the authorities or by the federations. The intent of the regulation is to safeguard the patient and ensure the rights of consumers who seek "registered" CAM providers.

To be a "registered CAM provider" the provider must, in all countries, have a membership in a practitioners’ organisation approved by the government. Special characteristics are required for a federation to be approved. Typically the federations must have membership requirements concerning educational qualifications, ethical rules, claim of responsible professional conduct, of confidentiality, and documentation routines. Furthermore, the organisation must establish a commission for complaints. The ethical issues that "approved federations" regard as relevant for all CAM providers are competence, research, respect for autonomy and consent, special duties towards children, respect of confidentiality, maintenance of professional boundaries, professional etiquette, and presence of effective complaint mechanisms (ref 1).

The health authorities do not undertake supervision of the practise of registered CAM providers. If CAM providers are registered, violation of the rules of the federation may exclude the person from membership of the federation. The CAM provider will thereby lose his/her "registration". If CAM providers violate current legal rules, however, the authorities (often the health authorities) or patients can ask the police to investigate the matter. The only existing public supervision of the field is the marketing control by the Consumers’ Ombudsman. The safeguarding of consumers seeking "registered" CAM providers depends on the governments’ requirements when approving a federation.

Organisation of regulation

(ref 2)

There are three main models used to regulate the practise of medicine:

  1. Direct Government-administered regulation
  2. Government-sanctioned self-regulation
  3. Independent self-regulation

These three approaches differ in the depth of direct government involvement. These systems are, of course, often used in tandem with other acts, which may regulate certain aspects of the health service and medical practise.

Direct government-administered regulation

In most European countries the government authorises, registers and supervises the personnel. The authorities can withdraw the authorisation of health personnel if the law is violated. If the violation is serious, the authorities may also ask the police to investigate the matter. This implies that the government through the appropriate authorities decides to what extent the use of CAM by regulated personnel can be designated as "responsible professional conduct".

Government-sanctioned self-regulation

In some countries the law delegates the tasks of authorisation, registration and supervision of practitioners to the medical federations. If the rules are violated, the federation may withdraw the authorisation and may ask the police to investigate the matter. This implies that the medical federations decide to what extent the use of CAM by authorised personnel can be designated as "responsible professional conduct".

Independent self-regulation

Some federations of CAM providers are developing what they call "self-regulation". "Self-regulation" is a process in which federations of individual therapies develop their own statistics, educational programmes, code of ethics, research programmes and standards of competence (ref 3). In some countries, self-regulation is required for a federation to be approved by the government.

References

1. Stone J. Ethical issues in complementary and alternative medicines. Complementary Therapies in medicines 2000; 8, 207-213.

2. Referee for the chapter where nothing else is noted: Stone J, Matthews J. Complementary medicine and the Law. Oxford University Press 1996.

3. European Council for Classical Homeopathy. Report: The Recognition and Regulation of the Practise of Homeopathy in Europe, June 2004.