WRITTEN QUESTION P-1188/00 by Giuseppe Nisticò (PPE-DE) to the Commission. Medicinal herbs and plants.
Date: 2000-04-10
Institutions: European Parliament, Provisional data
Subjects: European social policy, drug surveillance, market approval, medical plant

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(2001/C 53 E/124)

WRITTEN QUESTION E-1186/00

by Cristiana Muscardini (UEN) to the Commission

(12 April 2000)

Subject: Scarcity of melatonin on the market

There have been numerous reports (cid:129) in press articles and readers(cid:146) letters (cid:129) of the difficulty of finding
pure melatonin in European Union countries, and there is even talk of a possible sales boycott.

Can the Commission state:

(cid:129) whether it has prohibited the sale of this substance, or published any information concerning its

adverse effects on human health?

(cid:129) what are its views on the subject?

(cid:129) can the Commission state, finally, whether it is possible that the current situation was created by

commercial interests as a means of pushing up prices?

Answer given by Mr Liikanen on behalf of the Commission

(16 May 2000)

The Commission has not made any general pronouncement on melatonin. Like the Member States,
however, it considers that, given its function and presentation, this substance meets the definition of a
medicinal product and may not therefore be marketed without authorisation.

As melatonin was in fact being placed on the market without authorisation, most of the Member States
wanted to draw consumers(cid:146) attention to the risk of using a product which had not been evaluated.
Accordingly, they took measures which have in some cases resulted in the substance being withdrawn
from the national market, and in others in appropriate information being given out.

(2001/C 53 E/125)

WRITTEN QUESTION P-1188/00

by Giuseppe Nistic(cid:242) (PPE-DE) to the Commission

(10 April 2000)

Subject: Medicinal herbs and plants

Because of the widespread distribution and abuse of medicinal herbs, without proper controls over either
the marketing or prescribing of these products, this highly sensitive sector needs to be regulated as a
matter of urgency, bearing in mind the possible effects on human health.

International scientific literature on the subject has revealed, as widely reported in the media recently in
both the United States and Europe, that some of these medicinal herbs, when used without medical
supervision, are responsible for thousands of cases of fatal poisoning, as well as causing a series of
unwanted or toxic side-effects in the form of allergies or affecting the cardiovascular system, the kidneys,
the central nervous system and other systems or organs.

Unfortunately, as a result of subtle and deceitful propaganda by the industries and operators concerned,
the belief has taken root that herbs, being natural products, are useful and harmless and produce no toxic
effects.

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The uncontrolled use of medicinal herbs is dangerous for the following reasons:

(cid:129) the concentrations and/or doses of the active principles present in herbs freely sold by herbalists are
not properly standardised, with the result that it is never possible to be sure what dose has been taken;

(cid:129) it is not known whether pollutants such as herbicides, pesticides or heavy metals may be present;

(cid:129) little is yet known about interactions between herbs and other drugs or foodstuffs or caused by the
administering of several herbs at the same time, with the result that the taking of some medicinal
herbs may produce unforeseeable toxic effects;

(cid:129) there is a danger that the use of medicinal herbs thought to be effective and innocuous by uninformed
patients may lead to their abandoning conventional treatments such as antineoplastic drugs with
serious consequences for their health.

Consumer protection is needed in the following areas:

(cid:129) consumers must be informed of the active principles and possible pollutants present in the medicinal

herbs they are taking;

(cid:129) consumers must be aware of the exact dose they are taking;

(cid:129) consumers must be informed of interactions between herbs and other drugs or foodstuffs;

(cid:129) consumers must be informed of risks deriving from the toxicity of the active principles and possible

pollutants.

In the light of the above considerations, what steps does the Commission plan to take to protect public
health? Will it review the rules governing the marketing of medicinal herbs in the light of the documented
scientific findings? Will it ask the EMEA to assess the information available on individual plants and herbs
and provide the guidelines needed for the proper dispensing of these products, which are currently
administered with hardly any controls?

Answer given by Mr Liikanen on behalf of the Commission

(10 May 2000)

According to Article 1 of Council Directive 65/65/EEC of 26 January 1965 on the approximation of
provisions laid down by law, regulation or administrative action relating to proprietary medicinal
products (1), (cid:145)any substance or combination of substances presented for treating or preventing disease in
human beings or animals shall be regarded as medicinal product(cid:146). Likewise, (cid:145)any substance or combination
of substances which may be administered to human beings or animals with a view to making a medicinal
diagnosis or to restoring, correcting or modifying physiological functions in human beings or animals(cid:146), has
to be considered a medicinal product. The decision whether a given product falls under the definition of
medicinal product and therefore needs to be authorised as medicinal product must be taken by the
national authorities on a case by case approach, taking into account both the ingredients and the
presentation of a concrete product.

Community pharmaceutical
legislation makes no difference between (cid:145)herbal(cid:146) or (cid:145)non-herbal(cid:146) medicinal
products. Therefore, in the absence of any specific legislation on (cid:145)herbal medicinal products(cid:146), medicinal
products containing medicinal herbs and plants have to be assessed and authorised like any other
medicinal product.

Community legislation acknowledges, however, the fact that long term experience with well established
substances may offer help in the assessment of safety and efficacy of a given product. According to
Article 4 paragraph 8 lit.a (ii) of Directive 65/65/EEC an applicant for a marketing authorisation for a
medicinal product shall not be required to provide the results of pharmacological and toxicological tests or
the results of clinical trials if he can demonstrate (cid:145)by detailed references to published scientific literature
presented in accordance with the second paragraph of Article 1 of Directive 75/318/EEC that
the
constituent or constituents of the medicinal product have a well established medicinal use, with recognized
efficacy and an acceptable level of safety(cid:146). Commission Directive 1999/83/EC of 8 September 1999

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amending the Annex to Council Directive 75/318/EEC on the approximation of the laws of the Member
States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the
testing of medicinal products (2) has specified in detail the practical application of this provision and may
be of particular help for the authorisation of well established herbal medicinal products.

is up to regulatory authorities in Member States to apply the above principles of Community
It
pharmaceutical legislation and to take concrete decisions on authorisations and restrictions (e.g. medical
prescription) for specific herbal products. The Commission is not considering a change to that approach.

The practical application of the above rules falls primarily in the competence of Member States. The
attention of the Honourable Member is, however, drawn to the activities of the working party on herbal
medicinal products at the European agency for the evaluation of medicinal products (EMEA) in London,
which has been created with the aim of fostering gradual harmonisation of the safety and efficacy
evaluation of herbal medicinal products in the Community. Reports on the activities of this working
group can be accessed through the EMEA(cid:146)s website:
http://www.eudra.org/emea.html.

(1) OJ 22, 9.2.1965.
(2) OJ L 243, 15.9.1999.

(2001/C 53 E/126)

WRITTEN QUESTION P-1191/00

by Timothy Kirkhope (PPE-DE) to the Commission

(10 April 2000)

Subject:

(cid:145)The beer tie(cid:146)

Nearly 700 cases have been brought against the Inntrepreneur Pub Company regarding the validity of the
obligations imposed upon their tenants of public houses to buy beer from a supplier nominated by them
(cid:145)(the beer tie)(cid:146). Many tenants believe that this beer tie infringes the EC rule of competition under Article 81
(ex Article 85) of the EC Treaty of Rome.

One case, Crehan v Courage, was referred to the European Court of Justice by the Court of Appeal in the
United Kingdom but two others have been refused leave to appeal by the House of Lords.

Can the Commission confirm whether there are provisions in Article 234 (ex Article 177) of the EC Treaty
of Rome whereby a question that is raised before a national court against whose decision there is no
judicial remedy under national law can be brought before the European Court of Justice?

Answer given by Mr Prodi on behalf of the Commission

(23 May 2000)

The Commission must point out at the outset that Article 234 (ex Article 177) of the EC Treaty confers
jurisdiction on the Court of justice to give preliminary rulings on the interpretation of Community law and
on the validity of acts of the institutions of the Community. The second subparagraph of Article 234
makes it clear that only the courts or tribunals of a Member State may request the Court of justice to give
such rulings. Thus, the parties to the domestic proceedings may not themselves address questions to the
Court of justice, as the question submitted by the Honourable Member would seem to imply, but must
convince the domestic court of the need to refer a question to the Court of justice. When the domestic
court is a court of last resort, against whose decision there is no remedy, that court must, according to
Article 234 third subparagraph, bring the matter before the Court of justice.

It follows from the scheme and wording of Article 234 that only a domestic court which is still seised of a
dispute can refer a question to the Court of justice. When the domestic court is no longer seised of a
dispute, such as when the case settles or when a court of last resort has given a final ruling, the Court of
justice cannot assume competence to give a ruling on the matter and the parties cannot refer a question
to it.