European Health Legislation, Codex And The Sustainability Of Health Care

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Health

Legislation

Brussels has been busy "adjusting" EU food and medicine laws for several years now, bringing increasingly onerous controls for natural products - notably herbs and food supplements. Some observers have criticized these moves as designed to give an unfair advantage to "conventional", pharma-based medicine and will cut across preventive health strategies. Prevention is high on the agenda, but official strategies are largely limited to avoiding and killing off germs. Nutritional intervention, giving people more strength to fight off illness, is not only ignored but is expected to suffer under the new rules.

The new regulations which will go into effect over the next months and years are set to give big business, especially in the pharma and food sectors, notable advantages over the smaller players in the health sector. Yet the public trend is opposite. We see double-digit growth in supplements, herbs and natural health care, while pharmaceutical producers are being blamed for much of the health-care malaise and excessive health care costs lamented by governments.

Dr. Robert Verkerk of the Alliance for Natural Health gives an overview of the various pieces of EU legislation and their expected effects. He also explains how the EU directives tie in to an analogous world wide effort to "regulate" nutritional health intervention by Codex Alimentarius, the UN's food code.

Thanks to Louise Mclean of Zeus Infoservice for forwarding this excellent interview which finally explains the rather complex subject on international health legislation in understandable terms...

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INTERVIEW WITH DR. ROBERT VERKERK

Executive Director of the
ALLIANCE FOR NATURAL HEALTH

by Louise Mclean

The EU Food Supplements Directive became law in the European Union in June 2002 and was later transposed into UK law in July 2003. If unopposed, up to 5000 products could disappear from independent health food shops across the UK after 1st August 2005.

The Alliance for Natural Health brought its case to the High Court of Justice in London in January 2004 in an attempt to get this highly restrictive Directive overturned. The hearing was successful and Mr. Justice Richards referred the case on to the European Court. 

The ANH's landmark challenge to the EU Food Supplements Directive was subsequently heard in Luxembourg on 25th January 2005, with the Advocate-General giving his Opinion on 5th April. A final ruling will be made in June 2005.

Louise Mclean talked to Dr. Robert Verkerk, Executive Director of the Alliance for Natural Health, about the EU FSD and other legislation that will seriously impact on natural healthcare.

When did you first realise there would be a threat to natural healthcare through these EU directives?

While I was still working with Imperial College I had a very strong interest in the natural health area from a personal point of view. I had signed up on the Rath Foundation petition thinking that was all I needed to do.

Then a large vitamin company asked for my views on the EU Food Supplements Directive because they had been informed by the UK Health Food Manufacturers Association that it would not be a major problem. This was around January 2002, just as the Directive was coming into its second reading at the European Parliament.

This company had looked at the Directive and seen the so-called Positive List of allowed vitamins and minerals and decided that there was potentially a significant problem because of ingredients used in their products. The list contained vitamins and minerals that would be allowed to be sold in Europe after 1st August 2005. 

A huge range of natural food supplements and organic forms of vitamins and minerals had been omitted from the list which contained mainly inorganic forms.

I went to the European website, downloaded the Directive and discovered there was a dossier provision for getting nutrients onto the Positive List if submitted before 31st July 2005.

I then looked at the technical requirements for these dossiers and went to a contract laboratory to find out what it would cost to put a dossier together for a single ingredient and got a quotation back for £800,000! That was based on the fact that there was no pre-existing information on the ingredient, though the cost would be significantly less if there was some available data. 

Although there was a campaign in existence through the Rath Foundation and La Leva, the Italian consumer association, I felt we needed to bring together all the groups working in this area under a unified umbrella to work in a positive manner in the European Parliament and try to affect the vote at second reading. 

As it happened, I had spent many years campaigning on environmental issues while living in Australia for 12 years. I had led campaigns against agrochemical companies and also internationally through South East Asia.

I believed we needed to employ a public affairs specialist company in Brussels, a PR company in the UK and work around the clock for 2 weeks to see if we could start to shift MEP opinion that was generally pro the Directive. Within about 24 hours the campaign was born. I asked for some time out from my job at Imperial College to take a three month sabbatical to fight this battle.

If vitamins and minerals aren't on the so-called Positive List, will they be banned?

Yes, unless companies can produce a dossier for each ingredient, but the type of vitamins and minerals that are on the Positive list ignore many food form nutrients. I could immediately see that natural mixed carotenoids were not there, nor the natural forms of vitamin E, folic acid or selenium. Neither were the most digestible, absorbable and safest forms of ascorbic acid (Vitamin C) or magnesium. 

It was very odd that the safest, most bioavailable nutrients were missing from the list. In fact it turned out that 75% of all vitamins and mineral forms were not there! 

People have been greatly heartened by the Opinion released on 5th April, of Advocate General Geelhoed of the European Court. He stated that the Food Supplements Directive infringes the principle of proportionality because basic principles of Community law, such as the requirements of legal protection, of legal certainty and of sound administration have not properly been taken into account and that it is therefore invalid under EU law.

It should be stressed that the Advocate General's pronouncement is not a ruling. That will come from the ECJ judges later - probably around June. But typically, in the vast majority of cases, the Court Judgment follows the recommendations of the Advocate General.

If the Advocate General's recommendations are adopted, in effect, the ban on vitamin and mineral forms not included on the EU's Positive list, due to come into effect on 1 August 2005, will be declared illegal. In essence, the positive list of allowable nutrient forms will be deemed to be too narrow, too restrictive, and based on flawed science.

If the Advocate General's recommendations are endorsed by the ECJ judges, it will represent the culmination of three years' dogged determination, dedication and hard work on the part of ANH and its many supporters around the world. Advocate General Geelhoed is the most senior Advocate General at the ECJ and his considered reasoning vindicates ANH's legal analysis and position.

With rapidly declining vitamin and mineral content in fruit vegetables and other foods, and continuing increases in degenerative diseases such as heart disease and cancer in the West, this has always been a very big issue worth fighting for. Fundamentally, an amended Directive would help to slow down the agenda of the Codex Alimentarius Commission to export worldwide an onerous, EU-style regime for food supplements.

Is it true that by 2007 the EU FSD will apply to limit access to essential fatty acids, amino acids, enzymes and probiotics, as well as other nutrient groups?

Unless our case is successful, we believe that proposed restrictions on other nutrient forms could be even more catastrophic than the restrictions on vitamins and minerals. It is one of the absolutely fundamental reasons why it's so important to support the work of ANH because we are now the single biggest route in terms of creating a positive influence because of the case we submitted to the European Court.

The EU FSD was passed into law without much media coverage. The wider public weren't really aware of its existence.

No the public weren't really informed. This Directive had been 10 years on the drawing board with the major trade associations having input on it. The general view in the industry was that the second reading amendments were the best compromise that could be reached after some ten years of discussion. We felt the Directive itself had advantages because it was a safe harbour for food supplements outside the medicines regime but the big killer was the Positive List. 

We need positive media, supporting the use of natural health ingredients because public opinion plays a role in this. If there are hundreds of negative media articles being manufactured to put a negative spin on nutritional supplements, that doesn't help us. 

We know very well that many of these negative stories are the results of either flawed or misrepresented studies that were conducted some time ago and which reappear in meta-analyses. If you look closely, you will often find that the authors themselves recognise serious limitations but the media machines pick up these negative findings and create headline news that vitamins kill based on a completely flawed interpretation of science.

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