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 Sweden
- The legal and regulatory status of CAM and CAM practices in Sweden
- The governmental supervision of CAM practices in Sweden
- The reimbursement status of CAM practices and medicinal products in Sweden
Go directly to legislation of specific CAM therapies in Sweden:
Acupuncture – Anthroposophic medicine – Ayurveda – Chiropractic – Herbal medicine/Phytotherapy – Homeopathy – Massage – Naprapathy – Naturopathy – Neural therapy – Osteopathy – Traditional Chinese Medicine (TCM) - Other treatments
Sweden has been a member of the European Union since 1995 (11), and a founding member of the Council of Europe since 5 May 1949 (12).
The legal and regulatory status of CAM and CAM practices
The health and medical services in Sweden are regulated by two main acts; Hälso-och sjukvårdslagen (1982:763) (The Health and Medical Service Act), that has been amended to Svensk förfatningssamling (SFS) 2010:1314 (267) and Patientsäkerhetslagen (2010:659) (The Patient Safety Act), as of January 1, 2011 (268).
These acts define which professionals are to be considered health professionals and what responsibilities they have. The Patient Safety Act (268) defines twenty-one professional titles as registered health care professionals, including Pharmacists, Occupational therapists, Dietitians, Chiropractors, Physicians, Naprapaths, Nurses, Physiotherapists, Psychologists.
In general, CAM professionals are not included in the definition of health professionals according to this act. The Patient Safety Act, chapter 6, §1 defines that registered health care professionals shall practise according to “science and tested experience” (268). In practice, this means that registered health care professionals are not allowed to use or recommend any CAM that is not evidence-based.
As Knox et al. (269) write “there is a small exception to this rule: registered health care providers may be permitted to practise CAM on the rare occasion when a patient request for it, no alternative conventional treatment options exist, and the treatment is given in conjunction with conventional care”. Also, the CAM treatment must be documented as safe (269). However, with the new Patient Safety Act (268) these conditions may have shifted towards a stronger focus on patient safety and patient preference. In a recent court case, the highest court acquitted a medical doctor who had prescribed homeopathic remedies to his patients. The basis for this decision were:
- The homeopathic remedies that were described had not been a threat to the patients’
- Patients themselves had asked for homeopathic treatment.
- Conventional treatment was given in parallel to the homeopathic remedies (270, 271).
This court case may be seen as establishing a precedent for other cases involving the prescription or practice of CAM services by registered health care professionals. CAM professionals are not governed by any explicit law or regulation other than their own professional rules of conduct. However, the Patient Safety Act, Chapter 5 (268), provides limitations for individuals other than registered health professionals (i.e. CAM professionals) to offer any services to patients for prevention, cure or symptom relief in association with the following conditions:
- Contagious diseases obliged to be reported.
- Cancer, other malignant tumors, diabetes, epilepsy or illness symptoms in association
with pregnancy and delivery.
- Examination or treatment of patients undergoing anaesthesia or hypnosis.
- Treatment using radiology.
- Without personal examination, give written advice or recommendations for
- Examination or treatment of children under the age of eight.
- Adjust contact lenses.
WHO reports in 2005 that “Sweden does not have national policy, laws, regulations or a national programme on TM/CAM, and there are no plans to establish them” (59). With the exception of herbal medicinal products, Naprapathy, Chiropractic and Anthroposophic care at the Vidar Clinic hospital, a hospital with special research and development status- no CAM practice is explicitly mentioned in the Swedish health care laws.
The governmental supervision of CAM Practices
The Public Health Care Services (including registered health care professionals) are supervised by “Socialstyrelsen” according to The Patient Safety Act, chapter 7, §1 (268).
The reimbursement status of CAM practices and medicinal products
CAM treatments provided by non-registered health care professional are not covered by the official Swedish health insurance system.
Herbal products registered as Herbal medicinal products except traditional herbal medicinal products are covered by the official reimbursement system like other medicinal products. Acupuncture is covered by national health insurance when practised by registered health care professionals, primarily for the treatment of pain and nausea (106).
When acupuncture is practised by non-registered health care professionals it is not covered by the national health insurance. Anthroposophic care given under the supervision of the Vidar Clinic (see description here) is covered by the national health insurance system (60, 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.
59. WHO. National policy on traditional medicine and regulation of herbal medicines: Report of a WHO global survey. Geneva: World Health Organization 2005 May 2005. Report No.
60. ECHAMP. Homeopathic and Anthroposophic Medicine: Facts and Figures. Second Edition ed: ECHAMP E.E.I.G: European Coalition on Homeopathic and Anthroposophic Medicinal Products E.E.I.G; 2007.
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.
267. Hälso- och sjukvårdslag (1982:763), (The Health and Medical Service Act (1982:763)): Amended up to SFS 2010:1314 Svensk Riksdag(1982).
268. Patientsäkerhetslag (2010:659) (The Patient Safety Act), Svensk Riksdag(2010).
269. Knox KE, Fonnebo V, Falkenberg T. Emerging complementary and alternative medicine policy initiatives and the need for dialogue. Journal of Alternative & Complementary Medicine. 2009;15(9):959-62.
270. The Local (Swedens news in English). ‘Doctors can recommend homeopathy’: court. Stockholm2011 [cited 2011 24 September]; Available from: www.thelocal.se/36332/20110924/.
271. Högsta förvaltningsdomstolens dom, Mål 66-349, 23/9 2011., (2011).