• CAM-summaries
• CAM systematic reviews
• CAM and the law
  • Introduction
  • Legal overview
  • Regulation of medical practise
  • Regulation of herbal products
    • Safeguarding patients
  • Legal regulation
• Prevalence of CAM use

Safeguarding patients

(ref 1)

During the past few decades, public interest in CAM has increased considerably in the industrialized countries. Medical plants and herbal medicines make up an essential part of this increase, and international trade with herbal medicines and other kinds of traditional preparations is growing. Although leading to new treatment possibilities, the commercial trade of these products represents a considerable challenge for governments to ensure safety, efficacy and quality for the users.

Herbal products are regulated as medicine or as food (food supplements and cosmetics). Claims of effect can only be made if the product is regulated as medicine. Countries classify medicinal plants or herbs, or products derived from them, differently with regard to being food or medicine, and have various approaches to licensing, dispensing, manufacturing, and trading to ensure that their safety, efficacy and quality standards have been adopted. The legal situation regarding herbal preparations has, until recently, varied considerably from country to country.

Policy of the World Health Organization

The World Health Organization stated the policy of traditional medicine in 1991 as follows: "WHO collaborated with its Member States in the review of national policies, legislation and decisions on the nature and extent on the use of traditional medicine in their health systems".

The major objectives of the Traditional Medicine Programme in WHO were to facilitate the integration of traditional medicine into national health care systems, to promote the rational use of traditional medicine through the development of technical guidelines and international standards in the field of herbal medicine and acupuncture, and to act as a clearing house for the dissemination of information on various forms of traditional medicine. "Guidelines for the Assessment of Herbal Medicines" were adopted by WHO in Ottawa in 1991. These guidelines define basic criteria for the evaluation of safety, efficacy and quality of herbal medicines to assist national regulatory authorities, scientific organizations, and manufactures.

The World Health Assembly adopted in May 2003 resolution WHA56.31 on traditional medicine. The resolution requested WHO to support Member States by providing internationally acceptable guidelines and technical standards and also evidence-based information to assist Member States in formulating policy and regulations to control the safety, efficacy and quality of traditional medicines (ref 2).

WHO has made a major effort in the area of herbal medicine.

Directives of the European Union

The EU has developed a comprehensive network to facilitate the free movement of goods. According to Directives 1965/65/EEC and 1975/318/EEC, pharmaceutical products require pre-marketing approval before gaining access to the market. Requirements for the documentation of quality, safety, and efficacy, and the dossier and expert reports are laid down in Directive 1991/507/EEC.

In order to achieve free movement of medicines within the common market of the European Union and a centralized system of marketing authorisation (e.g. for new chemical entities) with the possibility of application at a national level, a system of mutual recognition of marketing authorisation decisions have been installed (Directive 1993/39/EC). This "decentralized procedure" provides as a general rule that an assessment by one national authority should be sufficient for subsequent registration in other Member States. The Directive 1993/39/EC has been binding since 1995.

The EU parliament has, since 1994, adopted several directives regulating the trade of herbal products. Two European directives on homeopathy came into force on 1 January 1994, one applicable for homeopathic products for humans and one applicable for homeopathic veterinary products. The purpose of the directives is to ensure a common European market for these products. The provisions regulate manufacturing, inspection, marketing and labelling. An important rule is the establishment of a simplified registration procedure applying to medicines containing less than one part per 10 000 of the undiluted tincture or less than 1/100th of the smallest dose used in established medicine.

The European Union passed a new directive in 2004 regarding traditional herbal medicinal products (2004/24/EU). The aim of this directive is to guarantee a high level of health protection for European patients by giving them access to medicines of their choice, provided all the necessary safeguards are met. This will also ensure a single market for traditional herbal medicines by introducing similar rules and procedures, thereby encouraging cross-border trade for these products. The new legislation introduces a simplified system for registration of traditional herbal medicinal products in the European Union Member States. According to the directive, herbal preparations are to meet the same quality requirements as all registered medicinal products ("officially approved medicine"). However, to avoid unnecessary testing, the legislation states that clinical trials will not be necessary when sufficient knowledge already exists about a particular product. Medicines may be given a marketing authorisation without proof of efficacy, provided they

1. are safe,
2. have been in traditional medical use throughout a period of at least 30 years preceding the date of application. At least 15 of the 30 years must relate to the European Union,
3. are produced to expensive standards that are more appropriate to pharmaceutical drugs than to naturally occurring substances.

The directive requires all Member States to comply by 30 October 2005. CAM users in many European countries are worried that with this regulation, some herbal medicines will not be available after 1 November 2005.

In 2002 the European Union passed a directive concerning food supplements (Vitamins & Minerals 2002/46 EC). According to this directive the Member States shall ensure that food supplements may be marketed within the community only if they comply with the rules laid down by the directive. The directive has two annexes that list the vitamins and minerals that may be used in the manufacturing of food supplements. Nutrients that are not on the “Positive list�? cannot be used. The directive allowed for a derogation period so that nutrients not listed in the annexes could continue to be used through July 2005 but prohibit the trade of products that do not comply with the directive from 1 August 2005 at the latest. Many of the vitamins and minerals used by CAM providers in some countries are not on the “Positive list�? and cannot be marketed after 1 August 2005.

These directives have to be adopted in the legislation of the European countries and will thus harmonize the regulation of herbal products and food supplements.

References

1. Referee for the chapter where nothing else is noted: Regulatory Situation of Herbal Medicines: A Worldwide Review (document WHO/TRM/98.1). Geneva: World Health Organisation 1998.

2. National policy on traditional medicine and regulation of herbal medicines: Report of a WHO global survey. Geneva: World Health Organisation, May 2005: side 6.