Health Supreme by Sepp Hasslberger

Networking For A Better Future - News and perspectives you may not find in the media

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December 20, 2003

EU to extend concept of medicine - eliminate "borderline products"

18 December 2003 - The European Union is in the process of revising legislation that regulates pharmaceutically manufactured medicinal products. This legislation was first passed in 1965 and is known to those who are familiar with food and medicines regulations simply as "65/65", that is, directive number 65 passed in the year 1965.

Some of the discussion, which is currently being held in the European Parliament in Strassbourg, centers around a proposed revision of the definition of a medicinal product, contained in the directive. The current definition has long been seen as too broad by the advocates of a natural approach to health. It subsumes under the concept of medicinal product anything which "may be administered to human beings with a view to ... restoring, correcting or modifying physiological functions".

You might agree that any natural nutritional product containing vitamins, minerals or a range of other natural ingredients, and certainly anything containing herbs, would do something to restore or modify physiological functions, and would therefore fall under this broad definition. It could thus be legally considered a medicine.

While this definition was clearly too broad for the proponents of natural, food-based alternatives to pharmaceutical medicines and there was a move for reform to limit the all-powerful medicine definition, the other side - health administrators and their friends in the pharmaceutical industry - have always thought that it is not really broad enough. They were looking for ways to eliminate what they call borderline products. Those are foods, supplements, herbal remedies, traditional remedies which are perceived to be competing with pharmaceutical medicines. They might prevent disease or eliminate it in an early stage - and that would clearly threaten to disrupt the most lucrative industry in the western world, the pharmaceutical industry.

The proposed revision of European pharmaceutical law is seeking to extend the definition of a medicine even further, by eliminating what small limitation is contained in the words "administered to" contained in the definition. In fact, if a product has to be "administered", that implies it must be prescribed by a medical doctor or dispensed in a health-system-type environment. The new proposed definition does away with that limit, adding that it would be sufficient for the product to be "used in" human beings. See the slight difference? No more doctor needed to prescribe it, a medicine can now be any normal product we might use!

Now to really sew things up good, the pharmaceutical interests which have mainline access to European Commission officials, even in the drafting stage of legislation, have introduced a new provision. The proposed new text would also state: "In cases of doubt, where a product falls within the definition of ‘medicinal product’, this Directive shall apply, even in cases where the product also falls within the scope of other Community legislation."

Translated into everyday language, this means: "We (the health authorities) want the right to remove any product from the market which, although it is not registered as a medicine, has any positive influence on health. After all, physiological functions of the human body are to be modified or restored only by registered medicines." Think about this. Anything, even a glass of water, which restores your physiological functions when you're thirsty, could legally be considered a medicine.

Of course no one would seriously propose that a glass of water must be bought in the pharmacy or prescribed by a doctor, but think about all those natural health products, the vitamins, the herbs, grandmother's remedies, they would be at risk, if they posed any kind of a threat to pharmaceutical medicine sales at all.

Thankfully, the law has not yet been passed. And thankfully, there are some dedicated people who work around the clock to make sure it won't get that far. But they need your support! The Alliance for Natural Health was in Strassbourg this week, talking to members of the European Parliament, alerting them to the dangers. There will be more discussions, and there is still time to act - not much, to be sure.

If you are the type of person with a legal mind, if you would like to see for yourself, what written words are meant to enshrine to be the law, you can download this legal opinion, which the ANH activists have shown to some of the members of the European Parliament. You can also contact your country's members of the European Parliament and let them know that you are concerned. That you do not appreciate the prospect of losing any possibility to prevent illness by natural means.

If you don't care about the legal details, at least visit the Alliance for Natural Health site and look around. You will discover that the pharmaceutical directive is not the only potentially disastrous legislation that is being cooked up in Brussels and Strassburg. A quite restrictive food supplements directive has already been passed and is becoming law in all the member states. Herbs are being discussed - they are known in those arcane halls as "traditional herbal medicinal products" and they will have their own legislation. Yes, you guessed it, they will all have to be registered as medicines and if that is too expensive or inaccessible because of too much red tape, that's tough - nothing can be done about it. After all, those nasty "borderline products" must be eliminated.

Do not worry, this is all well justified. You - the consumer - must be protected, at least that is what Commissioner Byrne said in a speech welcoming the food supplements directive. Never mind the excellent safety record of all natural remedies, indluding supplements and herbs in comparison with, let's say, pharmaceutical medicines, which have become one of the leading causes of death in the world.

If all goes well for our friends in the pharmaceutical industry, health will finally have its perfect monopoly, and it will be firmly in the hands of the pharmaceutical companies. I wonder how long it might take the anti-trust authorities to wake up to the scam and start dismantling the monopoly - or if indeed the monopoly will ever be recognized as what it is and will be dismantled. But no, what am I thinking, I am too far ahead! We are only constructing the monopoly just yet.

It is happening right now in Brussels and Strassbourg, in the European Parliament, the European Commission, and the European Council. Here is a report of the Alliance for Natural Health about the pharmaceutical law proposal and what is being done about it.

Will supplements be classified as medicines in Europe?

Pharmaceuticals legislation in Europe has the potential to classify any food, food supplement, cosmetic or medical device as a medicine!! Find out what ANH is doing about it!

Alliance for Natural Health

18 December 2003

The ANH identified on 11 December that a Compromise Package developed for the Pharmaceuticals Directive (amending Directive 2003/83/EC), in preparation for its second (and final) reading in the European Parliament could be particularly disastrous for the leading edge of the supplement industry.

This was because this Package, prepared in consultation with the European Commission, the Council of Ministers and Rapporteur for the directive, French MEP Francoise Grossetête (EPP group), would be put forward in place of Recommendations made by the the Committee on the Environment, Public Health and Consumer Policy, lead also by Ms Grossetête. These latter Recommendations included most of the key amendments that had succeeded at first reading of the amending directive, but had 'fallen away' in the subsequent Common Position.

Indeed, during the vote on 17 December, the key part of the Compromise Package affecting food supplements (including amendments 60, 63 and 65) was adopted as a whole.

Fortunately, steps were taken before the vote in an attempt to protect the 'medicalisation' of all supplements in Europe.

On 12 December, ANH consulted with its expert legal Counsel and commissioned a legal Opinion that confirmed the nature of the problem. This Opinion and ANH's Briefing Note on the subject were delivered on 16 December, both to the European Parliament and the European Commission in Strasbourg, by a delegation from ANH (including Executive Director Dr Robert Verkerk and Legal Director, David Hinde, as well as representatives from Sweden and France).

ANH's key concern is that the scope of the pharmaceuticals legislation is so broad that it completely subsumes legislation on foods, food supplements, cosmetics and medical devices, including the Food Supplements Directive itself. Furthermore, the Commission's attempt to rectify this anomaly would not firmly delineate medicinal from non-medicinal products in law. This is because the Commission indicated in a Recital (7) to the amending directive that medicine legislation should not be applied to products that were „...clearly..." foods, food supplements, cosmetics or medical devices.

The new directive would therefore allow any national authority - whenever it so chose - to consider any product that fulfilled the very broad definition of a medicinal product (including a food, food supplement, cosmetic or medical device) as a medicine and so force its manufacturer to comply with a full drugs licensing regime if it wished to go to market! Given that this regime is prohibitively expensive for most food supplement manufacturers, it would effectively amount to a ban on products - at the whim of the legislators!

Irish MEP Avril Doyle (EPP group) became the key focal point for these issues in the EU Parliament in Strasbourg and raised the issues in the plenary debate on the evening of 16 December. Extracts from her speech and questions as well as the responses from Commissioner Liikanen, are given after the ANH Briefing Note.

We eagerly look forward to a meeting of stakeholders, in which ANH will be represented, in order that the Commission's interpretation of the issue of delineation between medicinal and other products can be clarified. ANH, together with other interested parties, wishes to continue to influence the situation in such a way that a product which is clearly a food supplement cannot be arbitrarily classified as a medicine.


posted by Sepp Hasslberger on Saturday December 20 2003
updated on Friday December 17 2010

URL of this article:


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Readers' Comments

Great comprehensive article! I found it VERY interesting, I didn't know many things before...

Posted by: ambulance nurse on May 29, 2004 09:25 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 07:16 PM


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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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