Health Supreme by Sepp Hasslberger

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May 05, 2004

New EU 'Medicine' Definition: Difficult Times for Natural Cures and Prevention

The 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?

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 Tuesday December 21 2010

URL of this article:
http://www.newmediaexplorer.org/sepp/2004/05/05/new_eu_medicine_definition_difficult_times_for_natural_cures_and_prevention.htm

 

 

 

 


Readers' Comments


Here is a comment received by e-mail through Frans in Belgium:

Dear Health List Friends,

Here is the reply from the EU Commission Direct contact provided as a new procedure to engage the Commission on any subject.

First, I welcome any improvement in the communication process between European Citizens and their very opaque process of imposing health altering substances (foodstuff or otherwise) on all of us.

I only regret that said direct communication is quite impersonal and would have liked to know a person to talk to and what position such contact may be in the Commission's general hierarchy and the person's audience or consulting power in the specific Commission we may talk to. In our case the the Health and Food Safety Commission headed by David Byrne, Irish Commissioner.

Clicking on the link provided below, it is welcome to see we have been directed to the correct informations, legislations, directives and due processes of the same through the EU Parliament. It takes a little willingness to search further and extrapolate, of course. But after all, what doesn't?

I wish you a good reading because it is very interesting indeed.

In the case of aspartame which was our initial subject, go to this link on that page : SCADPlus : Legislation on authorised sweetners: europa.eu.int/scadplus/leg/en/lvb/l21069.htm
(link no longer active)

I didn't go through all the Directives yet, but have a good feel of what is going on from that page alone.

First, on n° 4) IMPLEMENTING MEASURES : Labelling,
it is said in texto :  "It also stipulates that warnings should appear on the labels of foodstuffs containing aspartame or polyols."
This is supposed to have been voted by the EU Parliament in 2003.
Did any of our EU citizens on the list ever see any warning about aspartame on any label, anywhere? I sure didn't!
And we surely need more info on these 'polyols'!
The same holds true for the 'acesulfame K' and 'cyclamates'
You wizzards out there, we welcome your input.

Also: "Scientific Committee on Food" is assessing for the Commission what is and what isn't a health risk and to what degree. It is interesting to note who are the Committee members and who is the Committee Chairman in relation to the pharmaceutical industry. If I recall correctly the chairman is also a senior officer of one of the major chemical/pharma companies!

It is specifically in those obvious unbevlievable conflits of interests (corruption in my book!) that lies the angular stone on which the whole pyramid of special interests affects the entire administrative and political processes in the EU. Taken individually each person of said process may appear to be a very good impartial, honest asset for the process; but collectively the special interests people, positioned and corrupting the inside of technical and professional supporting bodies to the administrative process and the outside pressures of the same special interests lobbies on the political process and MPs, are operating the graveyard of the so-called democratic process.

By the same token, we can appreciate how everything is neatly tied together : "Commission Directive 95/31/EC of 5 July laying down specific criteria of purity concerning sweeteners for use in foodstuffs. In order to adapt these criteria to technical progress and the specifications and analytical techniques concerning sweeteners laid down in the Codex alimentarius drawn up by the Joint FAO-WHO Expert Committee on Food Additives, Directive 95/31/EC has been amended by the following acts: ......"

By the way, we are supposed to vote for European elections the next June 15, but I have yet to see or hear any debate about the positions and quality of my national candidates as well as their views on thes major Health policies. I mean, is there ANYTHING more important? Hyppocrate himself already said : " We are what we eat" !

Have you in your country?

Finally, everybody is cheering and excited about that "new" European constitution? But what that will do is, for all practical purposes, to chisel the above shenanigans in the granite of the graveyard of democracy. Thanks to the policies promoted since many years of the Windsor's Lucist Trust on the (dangerous) State and corporate worlds promiscuity and "cooperation". Privatisation of everything is also their motto.

This comes to no less than the actual take over of all democratic processes by the banking elite. Hence the elitist policies applied specifically in genocidal Health policies.

Law suits are nice ideas, but who do you think Courts belong to?

To paraphrase the Great Mahatma Gandhi speaking on democracy, I say :
" Consumer's Health Protection is a great idea whose time has come. "

Posted by: Sepp on May 7, 2004 01:07 PM

 


Here is a comment received by e-mail through Frans in Belgium:

Dear Health List Friends,

Here is the reply from the EU Commission Direct contact provided as a new procedure to engage the Commission on any subject.

First, I welcome any improvement in the communication process between European Citizens and their very opaque process of imposing health altering substances (foodstuff or otherwise) on all of us.

I only regret that said direct communication is quite impersonal and would have liked to know a person to talk to and what position such contact may be in the Commission's general hierarchy and the person's audience or consulting power in the specific Commission we may talk to. In our case the the Health and Food Safety Commission headed by David Byrne, Irish Commissioner.

Clicking on the link provided below, it is welcome to see we have been directed to the correct informations, legislations, directives and due processes of the same through the EU Parliament. It takes a little willingness to search further and extrapolate, of course. But after all, what doesn't?

I wish you a good reading because it is very interesting indeed.

In the case of aspartame which was our initial subject, go to this link on that page : SCADPlus : Legislation on authorised sweetners:
europa.eu.int/scadplus/leg/en/lvb/l21069.htm
(link no longer active)

I didn't go through all the Directives yet, but have a good feel of what is going on from that page alone.

First, on n° 4) IMPLEMENTING MEASURES : Labelling,
it is said in texto :  "It also stipulates that warnings should appear on the labels of foodstuffs containing aspartame or polyols."
This is supposed to have been voted by the EU Parliament in 2003.
Did any of our EU citizens on the list ever see any warning about aspartame on any label, anywhere? I sure didn't!
And we surely need more info on these 'polyols'!
The same holds true for the 'acesulfame K' and 'cyclamates'
You wizzards out there, we welcome your input.

Also: "Scientific Committee on Food" is assessing for the Commission what is and what isn't a health risk and to what degree. It is interesting to note who are the Committee members and who is the Committee Chairman in relation to the pharmaceutical industry. If I recall correctly the chairman is also a senior officer of one of the major chemical/pharma companies!

It is specifically in those obvious unbevlievable conflits of interests (corruption in my book!) that lies the angular stone on which the whole pyramid of special interests affects the entire administrative and political processes in the EU. Taken individually each person of said process may appear to be a very good impartial, honest asset for the process; but collectively the special interests people, positioned and corrupting the inside of technical and professional supporting bodies to the administrative process and the outside pressures of the same special interests lobbies on the political process and MPs, are operating the graveyard of the so-called democratic process.

By the same token, we can appreciate how everything is neatly tied together : "Commission Directive 95/31/EC of 5 July laying down specific criteria of purity concerning sweeteners for use in foodstuffs. In order to adapt these criteria to technical progress and the specifications and analytical techniques concerning sweeteners laid down in the Codex alimentarius drawn up by the Joint FAO-WHO Expert Committee on Food Additives, Directive 95/31/EC has been amended by the following acts: ......"

By the way, we are supposed to vote for European elections the next June 15, but I have yet to see or hear any debate about the positions and quality of my national candidates as well as their views on thes major Health policies. I mean, is there ANYTHING more important? Hyppocrate himself already said : " We are what we eat" !

Have you in your country?

Finally, everybody is cheering and excited about that "new" European constitution? But what that will do is, for all practical purposes, to chisel the above shenanigans in the granite of the graveyard of democracy. Thanks to the policies promoted since many years of the Windsor's Lucist Trust on the (dangerous) State and corporate worlds promiscuity and "cooperation". Privatisation of everything is also their motto.

This comes to no less than the actual take over of all democratic processes by the banking elite. Hence the elitist policies applied specifically in genocidal Health policies.

Law suits are nice ideas, but who do you think Courts belong to?

To paraphrase the Great Mahatma Gandhi speaking on democracy, I say :
" Consumer's Health Protection is a great idea whose time has come. "

Posted by: Sepp on May 7, 2004 03:09 PM

 


Here is a summary of salient points from a recent opinion of Advocate General Geelhoed of the European Court of Justice, in a series of cases originating in Germany, where the German court of appeals has asked the EU court for its view on several questions. The original problem that led to the cases was the classification by German health authorities of several products as medicines:

- a lactobacillus product composed of six forms of friendly bacteria
- a vitamin C product of 1000 mg
- OPC 85, oligomeric procyanidins, a bioflavanol extract
- Acid free C - 1000 mg of vitamin C buffered by 110 mg of calcium
- E 400, capsules with 268 mg of vitamin E

The opinion goes into the legal question of how to separate food products from medicines and shows clearly the great difficulty that an extremely wide and ambiguous EU medicine definition brings in determining coherently what is a food and what instead should be registered as a medicine.

Here are some of the salient points:

In classifying products as medicines, member states are bound by the definition of a medicinal product in directive 2001/83. Decisions by national authorities are subject to review only by the national courts. In their decisions, the courts have to apply community precedent, which interprets those definitions in more detail.

An overly extensive interpretation of the definition of a medicinal product would have, according to Geelhoed, three negative effects: Firstly, the term medicinal product tends to get watered down, if products are subsumed under it which by formulation and effects should not be so classified. Secondly, it can lead to a situation where community rules for specific categories of foods (such as novel food ingredients and supplements) lose their intended purpose. Thirdly, a creeping expansion of the field of application of the medicines directive has negative effects on the free movement of goods.

While small differences in interpretation of the medicinal directive across Europe are not excluded, a member state must be able to justify classifying a product as a medicine which elsewhere in the community is classified as a food, by objective scientific data.

National food laws have to afford a high standard of health protection and must be based on scientific risk assessment and, where needed, follow the precautionary principle. It will therefore be more and more difficult for member states to cite article 30 of the of the EU treaty for reasons of protecting health. They will have to prove that products, which elsewhere in the common market have been accepted as foods following high standards of protection, are posing unacceptable risks for health. The proof has to be convincing.

If they can prove the existence of real dangers or serious risks for health, the limiting measures they wish to take must still, according to the (EU) court's jurisprudence, be in accordance with the principle of proportionality. That means the measures must be effective, they must not go beyond what is strictly necessary to achieve the intended protection, and must be in relation to the goal in the sense that the protection cannot be achieved by other measures that would be less of a hindrance to the free movement of goods. This has been re-confirmed in recent jurisprudence.

In the case of foods and food ingredients that are subject to specific community rules, member states are therefore no longer free to take immediate restrictive measures in the presence of assumed dangers, with reference to article 30 of the EU treaty. They will therefore have to first follow the consultation procedures with other member states and the Commission as specified in community legislation.

Community food law is evolving and is characterized by a situation of national health authorities working side by side. Growing commerce brings with it a dual dependence - on the one side growing and increasingly complex chains of trade are vulnerable to one-sided obstacles and limitations, on the other hand, they make for a fast expansion of possible dangers and health risks. This forces national authorites to co-operate both horizontally among themselves, and vertically with the community institutions.

Due to the potentially serious consequences of differences in interpretation and application of rules and because of the vulnerability complicated legal systems face from imprecise application, national authorities of a member state have to be aware beforehand of the consequences of a different classification of products imported into their areas. Their duty of care implies that, before taking restrictive measures, they have to make use of the procedures community law offers to avoid trade limiting differences in interpretation and application of the law. This is especially the case when a product is seen as a medicine in one member state, while elsewhere it is considered a food product, because application of medicine law leads to much farther reaching limitations.

... as a basic rule, products are considered safe if they are in accordance with the particular regulations of the member states where they are put on the market (article 14, paragraph 9, first phrase of regulation number 178/2002 - novel foods).

(... as part of a discussion of fortified foods): A correct application of the precautionary principle requires, according to the jurisprudence of the EU court, firstly the determination of possible negative health consequences of the addition of nutrients to foods, and secondly a comprehensive evaluation of the health risk on the basis of the most reliable scientific data available, and the latest international science. If it turns out to be impossible to demonstrate with certainty the existence and the extension of the alleged risk, because the results of scientific studies are insufficient, inconclusive or inexact, and there is a continued likelihood of factual danger for public health if the risk should turn out to be real, then the precautionary principle justifies the taking of restrictive measures.

The term "upper safe level" does not play a role in determining the borderline between what is a food and what is a medicine. This is so because on the one hand, a number of foods which obviously are not medicines may necessitate determination of an upper safe level in connection with the daily dose of consumption suggested by the producer, and on the other hand, products that are far below an upper safe level can be used to restore, correct or influence human physiological functions and are thus classified as medicines. The term "upper safe level" has to be understood, regardless of product category - food or medicine - as a functional term. It is a measure which allows the consumer to obtain information needed for a responsible use of the product.

Posted by: Sepp on March 23, 2005 07:15 PM

 


Governments around the world are privatizing their responsibilities with the effect of transferring those responsibilities to Trans National Corporations Voters increasingly have the choice of parties who's Ministers of Parliament represent their interests in sold off asserts that are owned by the corporate sector. TNC are not democratic organizations. Government legislation is increasingly reflecting the interest TNC over those who elected them.
Voter's ability to make meaningful decisions relating to their most personal and historical right to choose what they eat or drink is being superseded or suspended by laws that reflect the best financial interests of TNC.
On loosing the perennial right to choose the foods herbs, and or medication I take who am I? Once my basic health needs are legislated to reflect the interests of the corporate sector then who am I and who owns me? Once my basic choices are made by TNC then by default I become and assert of the corporate sector.
"In the absence of the most basic ability to make chooses one becomes a slave�?

Terry Brennan


Posted by: Terry Brennan on October 15, 2005 01:48 PM

 















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The Individual Is Supreme And Finds Its Way Through Intuition

 

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These articles are brought to you strictly for educational and informational purposes. Be sure to consult your health practitioner of choice before utilizing any of the information to cure or mitigate disease. Any copyrighted material cited is used strictly in a non commercial way and in accordance with the "fair use" doctrine.

 

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