New EU 'Medicine' Definition: Difficult Times for Natural Cures and Prevention
CategoriesThe European Union has published, as part of a directive amending its laws relating to medicinal products, a new definition for what is to be considered a medicine. While the stated aim is to include new types of medicine, such as gene therapy and radiopharmaceutical products, the emergence of what is called "borderline products" appears a major concern, confirming an earlier post on this site.
Directive 2004/27/EC of 31 March 2004 defines as medicinal (necessitating registration as a pharmaceutical drug) as:
(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or(b) Any substance or combination 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.’
According to proponents of nutrition based prevention and treatment, many products which today are on the open market as food supplements, herbal remedies or otherwise as products used in alternative medicine could be irredeemably lost in a jungle of regulations that none but large pharmaceutical manufacturers can afford to venture into.
Certainly the definition would cover any product that is in any way said to prevent disease - so much for that "level playing field" the internal market is supposed to be, not to mention the de facto destruction of any nutrition-based large scale preventive strategy for health.
Apart from what may be said (or rather may not be said) about health promoting qualities of any product, the directive would appear to cover nutritional or other ingredients intended to restore or correct physiological functions by some form of metabolic action, putting many of grandma's remedies as well as the majority of supplements and natural medicines in the immediate danger zone.
Confirmation of such fears seems to come from a clause in the directive itself, which reads:
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.Health authorities in Europe thus have the power to legally re-define almost any healthy product "a medicine" and require registration, meaning that the product will not be available unless a pharmaceutical company can be persuaded that it would be financially advantageous to manufacture and sell that product under pharmaceutical license and with all the attendant bueraucratic controls.
The fact that pharmaceutical companies have little interest in manufacturing and selling products which directly compete with their chemical medicines and have been suppressing those kinds of alternatives to their often toxic remedies for years, seems to be completely lost on European legislators.
Nutritional health products, also called food supplements, have their own EU directive which was published in July 2002. The directive on supplements severely restricts the kinds of substances that may be used as sources of vitamins and minerals and the EU bueraucracy is slated to set "maximum tolerable levels" of nutrients for these products. This restrictive legislation is being transposed into national law and will be in full force by 12 July 2005. The British implementation of the directive has recently been challenged in court by a pan-European alliance of users, practitioners, retailers and producers - the judge decided that the matter should be referred to the EU Court of Justice.
With restrictive Food Supplements legislation recently passed and with the ominous clause in the pharmaceutical products directive that reads "... In cases of doubt ... the provisions of this Directive shall apply", it is hard to imagine that someone is not preparing to eliminate the nasty competition that nutritional supplementation and natural medicines represent for the pharmaceutical way of life and health. After all, if we really started preventing illness in a serious way, there is no telling what would happen to pharmaceutical profits, is there?
See related articles:According to this article in 'Alive', ill feeling towards the EU could 'reach the point where it threatens the EU itself'. No wonder with the kind of legislation that is being introduced, quite apart from whether the legislators and the Commission believe they are acting in defense of consumer choice and safety...
Food Supplements in Europe - What is the Problem?
Prevention Prohibited - Homus Pharmaceuticus Reigns Supreme
European Commission Financing Own Consumer 'Opposition'
UK: Petition Against EU Supplements Ban
EU Commissioner Byrne: No Zero Risk Society
Risk Free Vitamins - How Safe is Safe Enough?
Supplements case to go to European Court
Pharmaceuticals no longer good investment, says Forbes
Drugs do not work - in most cases
Pharma profits do not equal health - Berkely Prof advocates alternative
posted by Sepp Hasslberger on Wednesday May 5 2004
updated on Saturday September 24 2005URL of this article:
http://www.newmediaexplorer.org/sepp/2004/05/05/new_eu_medicine_definition_difficult_times_for_natural_cures_and_prevention.htm