Alliance for Natural Health

PRESS RELEASE: 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 (see text below) 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 below.

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.

Alliance for Natural Health

Briefing Note

Pharmaceuticals Review (Directive 2001/83/EC)

A proposal for a Directive updating the Pharmaceuticals Directive (Directive 2001/83/EC) (“PD”)(1) will receive its Second Reading on 17 December 2003. The Alliance for Natural Health (“ANH”) broadly welcomes the vast majority of the proposed provisions, which are required as a result of advances in science and generally to overhaul the PD, some of whose provisions have become outdated.

The Problem

However, ANH is very concerned that the Compromise Package fails to resolve the very serious problem that, unless amended, the PD will make many products covered by other sectoral legislation (such as food, food supplements, cosmetics and medical devices) subject to the PD, which will take precedence over them.

At the root of the problem lie two key factors:

• the very wide definition of the term “medicinal product” in Article 1(2), which overlaps with the definition of other products in different sectors

• the proposed primacy of the PD over all other legislation so that where a product fits the definition of a “medicinal product” it is the PD which is applicable to the exclusion of any other regulatory regime which otherwise would also apply (i.e. the ‘trump card' provision).

The idea behind the trump card provision is in principle a sound one, shared by ANH, of ensuring that there are no loopholes and that no unregulated medicinal products are placed on the market.

However unless modified, these two factors will create tremendous borderline problems.

Food supplements provide a good illustration. In June 2002, a Directive to regulate the formulation and marketing of food supplements (the Food Supplements Directive or “FSD”) was adopted. (2) It had the aim “to ensure a high level of protection for consumers and facilitate their choice” and made provision so that “the products that will be put on to the market must be safe and bear adequate and appropriate labelling.”(3)

But unless modified the PD will subsume into its ambit the vast majority of food supplements as defined by the FSD. The functional limb of the PD's proposed medicinal product definition will cover:

“[a]ny substance … which may be used … with a view to … restoring, correcting or modifying physiological functions” (4)

Food supplements however are according to the FSD defined as:

“…substances with a nutritional or physiological effect.” (5)

Moreover, as any substance with a “nutritional” effect as a matter of science, also has a “physiological” effect; all food supplements are automatically caught by the current proposed definition of “medicinal product”.

The consequence of this would be to emasculate the FSD regime in its entirety. First, because the FSD expressly states (emphasis added):

“This Directive shall not apply to medicinal products as defined by Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.” (6)

Thus a substance which, even though it comes within the definition of a food supplement under the FSD, is at the same time caught by the definition of “medicinal product” in the PD is automatically excluded under Article 2(a) of the FSD.

Secondly, even if there were no such automatic exclusion in the FSD, the trump card provision of the PD would override the applicability of the FSD in any event.

The Existing Compromise Package Solution

ANH does not believe that the Community legislator could have intended this result. Whilst there are good reasons for giving the PD a wide ambit so as to ensure that there are no unregulated medicinal products, it cannot be the objective of the PD to regulate a broad range of products which are already subject to other specialist Community law regimes, particularly tailored to their specific characteristics. Both the Commission's Amended Proposal (7) and the Council's Common Position (8) in fact acknowledge this and their solution is the proposed change to Recital 7 which contains the following sentence:

“Where a product comes clearly under the definition of other product categories, in particular food, food supplements, medical devices, biocides or cosmetics, this Directive should not apply.” (9)

This solution has been taken up by The Rapporteur as part of the Compromise Package with the Council.

However, as a matter of Community law, a mere declaration of intent in a recital cannot on its own have the desired effect if it is not reflected in the operative part of the Directive.

ANH has obtained a legal opinion from specialist European Law counsel (9) which demonstrates that this is the case because:

· A recital cannot be relied upon to circumvent the effect of substantive legislative provisions, such as the definition of “medicinal product” in combination with Article 1(2) of the FSD and the proposed Article 2(2) with which it is in conflict.

· A recital will only be used to interpret a substantive provision where this is reasonably capable of more than one meaning. However the interpretation of “medicinal product” and Article 2(2) is unambiguous.

· The proposed Recital 7, being merely a recital in the proposed amending directive, rather than one of the amendments listed in Article1 of the proposal, will not actually become part of the text of the amended PD.

· A recital in a Directive (the PD) could not normally affect the interpretation of a provision contained in a different Directive (Article 1 of the FSD).

Thus the Recital 7 solution proposed does not solve the problem.

Proposed New Compromise Solution

In order to avoid emasculation of the FSD and other specialist regulatory regimes, it is necessary to include wording along the lines of the currently proposed Recital 7 in the substantive provisions of the proposed Directive.

ANH therefore urges support for:

1. an amendment which places the agreed Compromise wording of Recital 7 within the definition of “medicinal product”:

“(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 save that where a product comes clearly under the definition of other product categories, in particular food, food supplements, medical devices, biocides or cosmetics, it shall not be considered a medicinal product.”

and,

2. the other amendments of the agreed Compromise Package.

ANH believes that this amendment wording is wholly consistent with the Common Position and thus supported in principle by both the Commission and the Council. It is a wording which ensures that food supplements are regulated as such under the FSD rather than as medicinal products, which they are not. The same applies to the other product categories, which are more adequately regulated under their own specialist legislative regimes.

References

(1) Directive 2001/83/EC on the Community code relating to medicinal products for human use.

(2) Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements.

(3) FSD (Directive 2002/46/EC) Recital 5.

(4) Common Position Article 1(1)(b) amending Article 1(2)(b) of the PD.

(5) FSD (Directive 2002/46/EC) Article 2(a).

(6) FSD (Directive 2002/46/EC) Article 1(2).

(7) Amended Proposal (COM(2003) 163 final) Amendment 18, page 11.

(8) Common Position VI.4.

(9) Common Position Recital 7.

Contacts

For any further comments or a copy of the legal opinion received by the Alliance for Natural Health, please contact:

David Hinde Solicitor Legal Director direct tel. +44 7958 548 186

Dr Robert Verkerk Executive Director direct tel. +44 771 484 7225

UK office tel. +44 1252 371 275

Pharmaceuticals Directive (amending Directive 2001/83/EC)Extracts from the plenary debate 16 December 2003

Speeches

Liikanen, Commission.

Concerning recommendations for second reading from Mrs Müller and Mrs Grossetête, the Commission can accept entirely the global compromise package as proposed by the Council and accepted by the two rapporteurs. As to Mrs Müller's request, once the legislation is adopted my services will organise a hearing with a view to adequately implement Article 2(2), where all stakeholders will be given the possibility to have input.

Avril Doyle (PPE-DE). Mr President, I thank Mrs Grossetête and Mrs Müller for their personal commitment.

There is a lot of good in the package before us but, if we are honest, there are a lot of problems as well. We have tried to do too much, too fast, with the threat of conciliation and enlargement used as the big stick to knock us into line. I object. In the months and years ahead we will pay the price, not least to the lawyers who unfortunately will have a field day.

Commissioner Liikanen, you mentioned that one of the objectives included the need to prepare for enlargement. I say to you that a race to conclude this package before enlargement is not the same thing.

On the Human Medicines Directive, concerns have been raised that, with the wide definition of medicinal products and the supremacy clause, it is possible that food and food supplements, cosmetics and medical devices could all be classified as drugs. The Commission's and the Council's solution to this problem is to insert wording in Recital 7 - Amendment 60 - to

the effect that: 'Where a product comes clearly under the definition of other product categories ... this directive should not apply', thereby distinguishing between medicinal products and other products.

The problem with this solution is that recital 7 will not have any legally binding effect. Indeed this recital will not actually go into the Pharmaceuticals Directive itself. I have seen an expert legal opinion which advises that, unless modified, the Pharmaceuticals Directive will completely subsume the Food Supplements Directive. I have two specific questions on this, which I would like you to answer, Commissioner.

Why did the Commission and the Council not propose that the recital 7 wording should go into the operative article of the directive to ensure that it has legal effect? What assurance can the Commission give that even if recital 7 wording is not put into an operative part of the directive, it will still be effective in addressing the problem of borderline or frontier products?

Q & A

Doyle (PPE-DE). Mr President, mine is as much a point of order as the last two were. I asked two specific questions on the Human Medicines Directive, particularly on the definition of a medicinal product, and Recital 7 on the legality of it. Maybe those two specific questions could be answered by the Commissioner. They are important.

Liikanen, Commission. On the issue raised by Mrs Doyle concerning Recital 7: it is an explanation of the clause provided for in Article 2(2); the provision contains only the legal wording of the clause. I said, in part, when I replied to Mrs Grossetête, that my services will discuss with all interested parties the proper application of this issue.