News - New regulation found after the CAMbrella deliveries:
No new regulation found.
Notice! All text below is copied from the CAMbrella report - delivered Dec 31, 2012
In this summary, you will find:
- Direct links to the legislation of specific CAM therapies in Spain
- The legal and regulatory status of CAM and CAM practices in Spain
- The governmental supervision of CAM practices in Spain
- The reimbursement status of CAM practices and medicinal products in Spain
Go directly to legislation of specific CAM therapies in Spain:
Acupuncture – Anthroposophic medicine – Ayurveda – Chiropractic – Herbal medicine/Phytotherapy – Homeopathy – Massage – Naprapathy – Naturopathy – Neural therapy – Osteopathy – Traditional Chinese Medicine (TCM) - Other treatments
Spain is a member of the European Union since 1986 (11) and a member of the Council of Europe since 1977 (12).
The legal and regulatory status of CAM and CAM practices
Health care is provided by the Regional Governments in Spain, and national health regulations are consequently implemented by the regional governments (263).
CAM in general is not regulated in Spain (43, 106).
The Congress adopted 29 September 2009 a proposal forwarded by the Committee on Health and Consumer Affairs of the Spanish Parliament on a new act recognizing some CAM treatments (acupuncture, homeopathy and natural medicine) as a medical act (28,263). The law was planned to come into force in 2011 (263). CAM practices provided by medical doctors are regulated within the authorization system for health care services and centers (263).
WHO reported in 2005 that “Spain does not have a national policy, laws, regulations, a national programme, a national office … nor are there currently any plans to establish these” (59). According to the Royal Decree 3166/1966 only authorized health care professionals are allowed to perform medical acts. Licensed paramedics are allowed to perform medical acts only under the supervision of an allopathic physician (43).
The Royal Decree (RD) 1277/2003 (10 October) regulates the health care services and centers (public or private) (264). Within the integrated care units in healthcare facilities, the so called U.101 units “Terapias no convencionales”(unconventional therapies ) may be found (263).
The U.101 unit is a “health care unit where a medical doctor (MD) is responsible for making treatment through natural medicine, homeopathic medication or using techniques for peripheral stimulation with needles, or any other treatments that demonstrate efficacy and safety”(263). It needs no specific requirement other than those given in RD 1277/2003 (263).
The regional governments authorize the installation, operation, modification and closure when required of health care services, facilities and units located in its territory (263). Consequently, the centers for non-conventional therapies are considered as health centers (public or private) if the person performing the acupuncture, homeopathy or herbal medicine is a MD and are subject to prior approval by the regional regulations (263).
Most of the centers that provide CAM in Spain are not health centers according to the law, but “non-sanitary centers” or “parasanitary centers” where there is no need of a MD
providing therapies (263).
There is no specific regulation regarding the training and qualifications of CAM providers in Spain. To conduct their business activity in these areas, undergraduate providers (non-MDs) are classified in group 841 of activities related to paramedical professionals (naturopaths, acupuncturist and other paramedical professionals), professional activity described in RD 1175/1990, (28 September), “Agrupación 84.- Profesionales relacionados con Actividades Parasanitarias (PARAMEDIC activities) GRUPO 841. NATUROPATAS, ACUPUNTORES Y OTROS PROFESIONALES (263, 265). The Royal Decree 127/1984 regarding medical specialties does not include CAM (43).
The governmental supervision of CAM Practices
The Council of Medical Colleges has been delegated the authority of supervision of physicians (43). The state authorities are tolerant to CAM as a counseling service not intruding on the health care service. According to the Penal Code intrusions made by nonmedical providers are illegal (43).
The reimbursement status of CAM practices and medicinal products
CAM treatment is not reimbursed in the public insurance system. Under Article 94 of Law 26/1990 of 20 December 1990 there is no justification for homeopathic products to be funded through the State insurance system, INSALUD (44). Some insurance companies provide coverage for CAM (43, 44). Acupuncture treatment is covered by the national health insurance system in one region (106).
11. EUROPA. Gateway to the European Union; member countries. Brussels EUROPA
Communication department of the European Commission; 2011 [cited 2011 November 3]; Available from: http://europa.eu/about-eu/countries/index_en.htm.
12. Council of Europe. Council of Europe. Strasbourg: Council of Europe; 2011 [cited 2011
November 7]; Available from: http://www.coe.int/lportal/web/coe-portal.
28. ECH (European Committee for Homeopathy). ECH in European Countries. Brussels: ECH; 2011 [cited 2011 September 12]; Available from: http://www.homeopathyeurope.org/countries.
43. Ersdal G, CAM-CANCER consortium. 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. Tromsø: NAFKAM, University of Tromsø 2005 28 October Report No.: Report CAM 21.11.05-1.doc.
44. Legal Status of Traditional Medicine and Complementary/Alternative Medicine : A Worldwide Review [database on the Internet]. World Health Organization. 2001 [cited 9 March 2010]. Available from: http://whqlibdoc.who.int/hq/2001/WHO_EDM_TRM_2001.2.pdf, http://hinfo.humaninfo.ro/gsdl/whohss/1.00.0000/en/d/Jh2943e/.
106. CAMDOC Alliance ECH ECPM ICMART and IVAA. The regulatory status of Complementary and Alternative Medicine for medical doctors in Europe. Brussels 2010 January 2010. Report No.: 2010.
263. Koldo Santos Rey. Email: Regulation of CAM in Spain. Dos Hermanas 2011.
264. 19572 REAL DECRETO 1277/2003, de 10 de octubre, por el que se establecen las bases generales sobre autorización de centros, servicios y establecimientos sanitarios, (2003).
265. REAL DECRETO LEGISLATIVO 1.175/1990, DE 28 DE SEPTIEMBRE; “Agrupación 84.-Profesionales relacionados con Actividades Parasanitarias (PARAMEDIC activities) GRUPO 841. NATUROPATAS, ACUPUNTORES Y OTROS PROFESIONALES ARASANITARIOS”, (1990).