• CAM-summaries
• CAM systematic reviews
• CAM and the law
  • Introduction
    • Preface
    • Report summary
    • Use of CAM
    • Why regulate?
    • Recommendations by WHO and EU
    • Relation to earlier publications
    • Methods and materials
  • Legal overview
  • Regulation of medical practise
  • Regulation of herbal products
  • Legal regulation
• Prevalence of CAM use

Recommendations by WHO and EU

The WHO Traditional Medicines Strategy 2002-2005 outlines the role and activities in traditional medicines / complementary and alternative medicine (TM/CAM) (ref 1). The strategy incorporates four objectives, two of which focus on safety:

1. Policy – Integrate TM/CAM with national health care systems, as appropriate, by developing and implementing national TM/CAM policies and programmes.
2. Safety, efficacy and quality – Promote the safety, efficacy and quality of TM/CAM by expanding the knowledge-base on TM/CAM, and by providing guidance on regulatory and quality assurance standards.

The European Union (EU) treaty came into force on November 1 1993. The treaty was intended to open a large market zone without borders, enabling the free movement of persons, goods, services, and capital. The treaty’s regulation of movement of persons and goods affects in particular health service and medications. WHO gives the following description in the "Legal status of TM/CAM: A worldwide review":

• Although the free movement of persons within the European Union is the cornerstone of the Treaty of Rome, the diversity of national policies severely limits its applicability to practitioners of CAM. Case 61/89 of the European Court of Justice involved an acupuncturist without allopathic medical qualifications practising in France. The courts decision confirmed the right of individual countries to make their own legislation on whether or not to reserve the practice of medicine to allopathic doctors.
• Nonetheless, in April 1994, European Deputy Paul Lannoye presented a proposal on the status of CAM to the European Parliament Committee on the Environment, Public Health, and Consumers Protection. He asked for provisions for CAM within social security systems, the incorporation of CAM into the European Pharmacopoeia, an end to prosecutions of non-allopathic practitioners in the countries where the practise of medicine is the exclusive domain of allopathic providers, and a pan-European system of recognition and regulation of CAM practitioners along the lines of the British Osteopath and Chiropractor Acts. He also requested a research budget of 10 million Euros per year for five years. At the last moment the European Parliament cancelled the vote on the proposal (ref 2).

In May 1997 The European Parliament adopted a resolution on the status of non-conventional medicine (ref 3). The resolution called the Commission to:

1. Launch a process of recognising non-conventional medicine.
2. Carry out a thorough study into safety, effectiveness, area of application and the complementary or alternative nature of all non-conventional medicines with a view to their eventual legal recognition….
3. Draw up a comparative study of the various national legal models to which non-conventional medical practitioners are subject….
4. In formulating European legislation … make clear distinction between non-conventional medicines that are "complementary" in nature and those which are "alternative" medicines in the sense that they replace conventional medicine…

A resolution of the European Parliament, however, is not a binding act, but a declaration of policy. Nonetheless, the adoption of the resolution has led several countries to consider revising legislation (ref 4).

Concerning CAM providers and CAM therapies, an EU resolution in 1999 stated:

• "In the health field, it is important to preserve the diversity of national legislation and practise that is one of Europe’s assets: people’s attachment to their own systems and tradition must not be called into question. Nevertheless, the Assembly believes that a common European approach to non-conventional medicine based on the principle of patients’ freedom of choice in health care should not be ruled out."
• "The Assembly believes that the best guarantee for patients lies in a properly trained profession, which is aware of its limitations, has a system of ethics and self-regulation and is also subject to outside control." (ref 5)

This resolution and case 61/89 of the European Court of Justice gave the members of the European Union the opportunity to regulate CAM therapies and providers according to health legislation and CAM tradition in their own countries.

The EU parliament has, since 1994, adopted several directives regulating the trade of herbal products. Two directives concerning homeopathy came into force on January 1994: one applicable for homeopathic products for humans and one applicable for homeopathic veterinary products. The directive on traditional herbal medical products will be in force from 1 November 2005 (2004/24/EC), and the directive on food supplements was set in force from 1 August 2005 (Vitamins & Minerals, 2002/46/EC). These directives will be adopted in the legislation of the European countries and will thus harmonize the regulation of herbal products and food supplements.

References

1. WHO, Traditional Medicine Strategy 2002-2005 (document WHO/EDM/TRM/2002.1). Geneva: World Health Organization, 2002.

2. Legal Status of Traditional Medicine and Complementary/Alternative Medicine: A Worldwide Review, (document WHO/EDM/TRM/2001.2). Geneva: World Health Organization, 2001: s 188.

3. European Parliament, Resolution A4 1997/0075.

4. Legal Status of Traditional Medicine and Complementary/Alternative Medicine: A Worldwide Review, (document WHO/EDM/TRM/2001.2). Geneva: World Health Organization, 2001.

5. European Parliament Resolution 1999/1206