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Legal status and regulation of CAM in Europe – An Overview

(An overview of CAM-related EU resolutions according to CAMbrella’s final report – selected passages from the 3rd part of WP2) (193)

“Part III - CAM regulations in EU/EFTA/EEA

(…)

5. EU Resolutions, Information and Questions of importance for CAM

In this chapter we list EU Resolutions, Information and Questions of interest for CAM. Thereafter we describe the content of the documents with a CAM perspective.

  • The status of “non-conventional medicine”. Resolution A4-0075/97194 (194) (11)
    The European Parliament Resolution on how non-conventional medicine should be included more formally as a special field in the European legislation.
     
  • Common values and principles in health systems, 2006/C 146/01 I (Information) Council 22.6.2006 C 146/1 (195) (12).
    The Council of the European Union conclusions on Common values and principles in the European Health Systems.
     
  • Women’s health. 2006/C 146/02 I (Information) Council 22 June 2006 C 146/2 (196) (13).
    The Council of the European Union conclusions on women’s health.
     
  • Question from The Greek Association of Homeopathic Medicine, 2001 (197) (14).
    A question forwarded to the Commission about recognition of doctors practicing homeopathy.
     
  • Question about Naturopathy from Christina Muscardi, 17 June, 2002198 (198) (15).
    A question forwarded to the Commission regarding the recognition of naturopathy.
     

5.1 Resolution on the status of non-conventional medicine. OJ C 182, 16/06/1997 P. 0067(199) (11)

The European Parliament in this Resolution indirectly calls on the Commission to formulate European legislation in the area of non-conventional forms of medicine. They outlined specific areas that should be emphasized and linked to the legislation. Areas of importance were connections to conventional medicine, regulation and training of health professionals, medicinal products and European citizens’ rights and consumer protection.

“Non-conventional medicine” was previously used as the EU term for “alternative medicine”, “natural medicine” and “complementary medicine”. In the EU FP7 R&D Framework programme 2007-2013 and the current EU Health Framework programme 2008-2013 the term used is “complementary and alternative medicine”. (Remark: in the CAMbrella reports the notion is mostly “complementary and alternative Medicine (CAM)).

The Resolution underlined that the suggested activities on non-conventional medicine should focus on legislation and research on:

  • Quality and safety of non-conventional medicinal products; including homeopathic medicinal products and food supplements
  • The effectiveness and regulation of other therapeutic methods than conventional therapies, “in particular chiropractic, homeopathy, anthroposophic medicine, Chinese traditional medicine (including acupuncture), shiatsu, naturopathy, osteopathy, phytotherapy, etc.”
  • Making a clear distinction between alternative and complementary nonconventional medicine disciplines.
  • Developing harmonized forms of legislation and recognition of non-conventional medicine at the European level and within the member states.

With regard to health professionals (doctors mentioned specifically) the Resolution emphasizes the right to provide the treatment that they think will be the best for their patients. The Resolution outlines that the Treaties’ rights on free movement of persons and freedom of establishment in the member states should not be limited by heterogeneous regulation of non-conventional medicinal therapies and providers.

The Resolution underlined the patients’ rights to choose treatment, to be protected against unqualified individuals, to be guaranteed maximum safety and have access to accurate information.

The development of the legislation in this field in the European Union is described below. See particularly the EU legislation on the right to move and reside freely – Directive 2004/38/EC (200) (8) and The Cross-border Healthcare Directive. /2011 (201) (“The Patient Rights Directive”) (9).

The Resolution established that non-conventional medicine disciplines should be clearly identified and defined. Consequently the legislation in the European bodies and in the member states’ national legislation should be developed so they would become more homogeneous. To outline the development on this issue the national regulation of some of the main treatments mentioned above is described in the CAMbrella WP2 report part I “Legal, regulatory, supervisory and reimbursement status for each member state and the associated states”.

The Resolution stated that training criteria for non-conventional medical providers should be harmonized, and training of conventional health professionals should include an introduction to non-conventional disciplines. Mutual recognition of qualifications of health personnel in Europe has been developed through Directive 2005/36/EC (202) Professional Qualifications (7), but does not make any specific reference to CAM disciplines.

The Resolution emphasises research on effectiveness and safety of non-conventional medicine therapies and medicinal products. Directives of importance are Directive 2001/83/EC203 (16) relating to medicinal products for human use, Directive 2004/24/EC (204) (17) as regards traditional herbal medicinal products205 and Directive 2002/46/EC on food supplements206 (18). Development of the European legislation on medicinal products and food supplements is described in the CAMbrella WP2 Report part II on CAM medicinal products.

Note that this Resolution is merely an indication of where the parliament would like the EU to move in the future. The Lisbon treaty still stands: “. Union action shall respect the responsibilities of the Member States for the definition of their health policy and for the organization and delivery of health services and medical care”.

(…)

6. The Council of Europe

The Council of Europe is not included in the European Union legislative system. However, they have passed one CAM Resolution in 1999 as a follow-up of the European Parliament Resolution on the status of non-conventional medicine from 1997(11).

A European Approach to non-conventional medicines. Resolution 1206 (1999) (19)

The Council of Europe is “an international organization in Strasbourg which comprises 47 countries of Europe. It was set up to promote democracy and protect human rights and the rule of law in Europe”(20). Except for Israel, all the countries included in the WP2 CAMbrella reports are members of the Council of Europe.

The Parliamentary Assembly outlines in the Resolution 1206(1999) 8 points on how nonconventional medicines should be met with a common approach in Europe. At the same time as they confirm the importance of preserving national legislation, they encourage the recognition of non-conventional medicines and the patients’ freedom of choice in European health care. The Resolution supports the European Parliament Resolution A4-0075/97 (207) The status of “non-conventional medicine”(11) (see below) which emphasizes the importance of research programmes especially on safety and effectiveness of CAM medicines.

The importance of professional training is discussed in the Resolution, both for doctors and for other practitioners of non-conventional medicines. University courses and official recognition are pointed out as important efforts to strengthen this field.”

References (208)

(1) Weidenhammer W, Lewith G, Falkenberg T, Fønnebø V, Johannessen H, Reiter B, et al. EU FP7 Project ‘CAMbrella’ to Build European Research Network for Complementary and Alternative Medicine. Forschende Komplementärmedizin/Research in Complementary Medicine. 2011;18(2):69-76.

(2) Treaty of Lisbon amending the Treaty on European Union and the Treaty establishing the European Community, signed at Lisbon, 13 December 2007, entered into force December 1, 2009, (2007).

(3) EFTA. The European Economic Area (EEA) Fact sheet. Geneva: EFTA; 2007.

(4) DIRECTIVE 2004/38/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 April 2004 on the right of citizens of the Union and their family members to move and reside freely within the territory of the Member States, (2004).

(5) REGULATION (EC) No 883/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 April 2004 on the coordination of social security systems (Text with relevance for the EEA and for Switzerland), (2004).

(6) DIRECTIVE 2006/123/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 12 December 2006 on services in the internal market, (2006).

(7) DIRECTIVE 2005/36/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 7 September 2005 on the recognition of professional qualifications (Text with EEA relevance), (2005).

(8) DIRECTIVE 2005/36/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 7 September 2005 on the recognition of professional qualifications (Text with EEA relevance) (OJ L 255, 30.9.2005, p. 22) Amended up to March 2011, (2005).

(9) DIRECTIVE 2011/24/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 March 2011, on the application of patients' rights in cross-border healthcare (OJ l 88, 4.4.2011, p.45), (2011).

(10) The European Commission. Regulated professions database. Brussels: EUROPA; 2011 [cited 2012 February 10, ]; Available from:
http://ec.europa.eu/internal_market/qualifications/regprof/index.cfm?fuseaction=regProf.index.

(11) The European Parliament. Resolution on the status of non-conventional medicine. Brussels: The European Union, 1997 OJ C 182, 16/06/1997 P. 0067. 

(12) Council Conclusions on Common values and principles in European Union Health Systems (2006/C 146/01), (2006).

(13) Council conclusions on women's health (2006/C 146/02), (2006).

(14) The European Parliament and The Commission of the European Union, Alavanos A. Parliamentary Question; Subject: Recognition of homeopathy in Greece. E-2297/01 Brussels: The European Union; 2001.

(15) The European Parliament and the Commission of the European Union, Muscardini C. WRITTEN QUESTION by Cristiana Muscardini (UEN) to the Commission; Subject: Recognition of naturopathy. E-1734/02. Brussels: The European Union; 2002.

(16) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, (2001).

(17) Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use, (2004).

(18) The European Parliament and of the European Council. Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (Text with EEA relevance). OJ L 183, 1272002, p 512002.

(19) Council of Europe. Resolution 1206 (1999) An European approach to non-conventional medicines; November 4, 1999. In: Official Gazette of the Council of Europe, editor. Resolution. Strasbourg: Council of Europe 1999.

(20) Council of Europe. Council of Europe in Brief. Strasbourg: Council of Europe; 2011 [cited 2011 June 23 ]; Available from: http://www.coe.int/aboutCoe/index.asp?page=nepasconfondre&l=en.

(21) Maddalena S. Alternative medicines: on the way towards integration?; A comparative legal analysis in Western countries. Bern: University of Neuchâtel School of Law and Economics, Peter Lang Pub, Inc; 2005. 648 p.

(22) Commission Regulation (EEC) NO 1251/70 of 29 June 1970 on the right of workers to remain in the territory of a member state after having being employed in that state, (1970).

(23) Council Regulation (EC) No 539/2001 of 15 March 2001 listing the third countries whose nationals must be in possession of visas when crossing the external borders and those whose nationals are exempt from that requirement, (2001).

(24) European Parliament resolution of 15 November 2007 on application of Directive 2004/38/EC on the right of EU citizens and their family members to move and reside freely within the territory of the Member States, (2007).

(25) DECISION OF THE EEA JOINT COMMITTEE No 158/2007 of 7 December 2007 amending Annex V (Free movement of workers) and Annex VIII (Right of establishment) to the EEA Agreement, (2007).

(26) GREEN PAPER On the European Workforce for Health, (2008).

(27) The European Commission. Guidelines on free movement and residence rights of EU citizens and their families. Brussels: The European Union; 2009; Available from: http://europa.eu/rapid/pressReleasesAction.do?reference=MEMO/09/311&format=HTML&aged=0&language=EN&guiLanguage=en