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!
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 2010URL of this article:
http://www.newmediaexplorer.org/sepp/2003/12/20/eu_to_extend_concept_of_medicine_eliminate_borderline_products.htm
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