Legislation

The Human Medicinal Products Directive
This is the key Directive (2004/27/EC), sometimes referred to as the ‘Pharmaceuticals Directive’, controlling the use and sale of pharmaceutical products across the EU. It was first enacted in 1965 and has been amended on several occasions, most recently in 2004. This most recent amendment is in the process of being transposed into regulations in the 25 EU Member States. There are two fundamental problems with this Directive as it relates to natural products, and these have already caused some governments in the European Union to consider high dose vitamin C, glucosamine, the amino acid 5HTP and ethylated Omega-3 fish oils as drugs.

Problem 1: the definition
First of all, it contains an extremely broad definition of a drug or “medicinal product” (Article 1), so that absolutely any product, even a food or food supplement, which has a physiological effect on the body, can be classified as a drug by regulators. The second (function) limb of the definition states that any substance or combinations of substances “which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis” should be classified as a medicinal product.

This definition is so broad it technically includes all therapeutic substances, as well as all foods, water, coffee and more or less everything that is consumed by or applied to humans. In an attempt to reduce legal uncertainty, the Directive purportedly provides exclusion for “food, food supplements, medical devices, biocides or cosmetics”, but since this exclusion is contained in a Recital rather than an Article, it has little legal weight, especially as this Recital applies to the amending Directive rather than the base Directive of 1965.

Problem 2: the scope
The Directive has the ability to ‘trump’ other Directives via its Article 2(2), which states, “In cases of doubt, where, taking into account all its characteristics, a product may fall within the definition of a 'medicinal product' and within the definition of a product covered by other Community legislation the provisions of this Directive shall apply.” Therefore, there is a real risk that leading-edge, practitioner-type food supplements may be classified as medicines, to be controlled by this Directive rather than the Food Supplements Directive. The full drugs regime provided by this Directive is so costly that it would be prohibitive for most food supplement manufacturers.

Apart from regulating conventional pharmaceutical products, the Directive also regulates homoeopathic products and traditional herbal medicinal products allowing specific dispensations over a normal drugs regime for each category.

What can be done?

• Lobbying to ensure that Member States’ interpretations are such that they exclude all foods and food supplements in all cases
• Lobbying to ensure that Member States consider most plant products as food supplements rather than as “medicinal products” or “traditional herbal medicinal products”
• Possible legal challenge to safeguard the future availability of functional foods and food supplements

Also See http://www.winhs.org/campaign/index.htm for more details on what YOU can do to help!

Our special thanks goes to the Alliance for Natural Health (ANH).