WRITTEN QUESTION E-2572/00 by Florence Kuntz (UEN) to the Commission. Legislation applicable to homeopathy in the European Union.
Date: 2000-08-01
Institutions: European Parliament, Provisional data
Subjects: competence of the Member States, free movement of goods, homeopathic product, intra-EU trade, legal basis

20.3.2001

EN

Official Journal of the European Communities

C 89 E/209

Answer given by Mr Bolkestein on behalf of the Commission

(27 September 2000)

for establishing a Community patent (1). The
The Commission has recently agreed on a proposal
discussions in the Council and the Parliament on this proposal will certainly address the issue of the so-
called (cid:145)Bolar type(cid:146) exception to patent rights. The Commission will take note of the positions taken on this
issue in respect of the Community patent and will,
if necessary, then consider whether any further
initiatives should be taken in relation to the national patent systems in the Community.

(1) COM(2000) 412 final.

(2001/C 89 E/236)

WRITTEN QUESTION E-2572/00

by Florence Kuntz (UEN) to the Commission

(1 August 2000)

Subject: Legislation applicable to homeopathy in the European Union

Can the Commission provide information on the legislation currently applicable to homeopathy and
homeopathic medicines within the European Union and can it provide full references for the relevant texts
(directives, etc.)?

Can it say whether this legislation applies to all fifteen Community countries and, if that is not the case,
what reasons are given for exempting certain Member States from the application of legislation on
homeopathy?

Does it consider that the single market in the homeopathy sector is a reality and, if not, can it say what
initiatives it will take?

Can it say, in particular, what measures it will propose to ensure that the products listed on homeopathic
prescriptions can be obtained in all the countries of the European Union, in order to ensure that citizens of
the various countries can be certain, when travelling within the Community, that they will be able to
obtain homeopathic medicines and protect their health while enjoying free movement and travel?

Answer given by Mr Liikanen on behalf of the Commission

(28 September 2000)

Community legislation governing homeopathic medicines is contained in Council Directive 92/73/EEC of
22 September 1992 widening the scope of Directives 65/65/EEC and 75/319/EEC on the approximation
of provisions laid down by law, regulation or administrative action relating to medicinal products and
laying down additional provisions on homeopathic medicinal products (1).

The Member States were required to take the necessary measures to comply with the Directive no later
than 31 December 1993. This legislation therefore applies throughout the European Union.

The Directive, which provides for the possibility of a special, simplified registration procedure, also
stipulates, however, that the Member States may decide not to implement the procedure, on condition
that they inform the Commission accordingly. In this event, the Member States must allow the use on their
territory of medicines which have been registered in other Member States using the simplified procedure.

Similarly, the Directive allows a Member State to introduce or apply special rules on testing requirements,
in line with the principles and rules governing homeopathic medicines in that Member State.

C 89 E/210

Official Journal of the European Communities

EN

20.3.2001

Situations may arise in which certain homeopathic medicines are not marketed in all the Member States,
with the result that some patients are unable to obtain them, even with a duly completed medical
prescription. The same applies to all types of medicine.

It should be borne in mind that patients are free to travel with medicines intended for their personal use.

Regarding doctors, Council Directive 93/16/CEE of 5 April 1993 to facilitate the free movement of doctors
and the mutual recognition of their diplomas, certificates and other evidence of formal qualifications (2)
defines neither doctors(cid:146) field of activity nor the types of treatment or therapy which they may apply. These
in the absence of any other relevant legislation, therefore fall within the competence of the
matters,
Member States.

As regards health professionals other than doctors (3), where a person other than a doctor is allowed to
practise homeopathy in a Member State, Council Directives 89/48/EEC of 21 December 1988 on a general
system for the recognition of higher-education diplomas awarded on completion of professional education
and training of at least three years(cid:146) duration (4) and 92/51/EEC of 18 June 1992 on a second general
system for the recognition of professional education and training to supplement Directive 89/48/EEC (5),
do not harmonise the conditions of training or regulate access to or pursuit of the activities in question.
This matter therefore falls within the competence of the Member States.

(1) OJ L 297, 13.10.1992.
(2) OJ L 165, 7.7.1993.
(3) And other than general nurses, dental practitioners, midwives, veterinary surgeons and pharmacists, these being
professions covered by specific Directives whose contents are broadly similar to the content of the (cid:145)doctors(cid:146)
Directive.

(4) OJ L 19, 24.1.1989.
(5) OJ L 209, 24.7.1992.

(2001/C 89 E/237)

WRITTEN QUESTION P-2580/00

by Dorette Corbey (PSE) to the Commission

(25 July 2000)

Subject: Implementation of the Birds Directive

The European Parliament recently received 2,2 million signatures of citizens from all countries of Europe.
These citizens are extremely concerned about the persistence of hunting practices that do not respect the
conservation requirements of European legislation on the protection of wild birds.

Can the Commission provide an overview of the actual implementation of Article 7(4) of the Birds

1.
Directive (79/409/EC) (1)?

2.
Hunting during return migration is still practised in some Member States, notably France (February),
Finland (seaducks), Greece (February), and Austria (woodcock). What steps has the Commission taken to
rectify these breaches of Article 7(4) of the Birds Directive and what steps are being planned?

3.
Does the Commission share the view that the new hunting law in France (28 June 2000 and the
decrees) does not comply with the Birds Directive because of its authorisation of night hunting and
because of the insufficient opening and closing dates?

4.
In the United States, federal framework regulations ensure that hunting is prohibited from 20 January
until 1 October. Does the Commission share the view that a Europe-wide opening and closing date of the
hunting seasons, adapted to the latest and earliest species respectively, would serve legal certainty,
implementation and enforcement in Member States and candidate member states?

5.

Is the Commission prepared to provide a clear guideline to the Member States?

(1) OJ L 103, 25.4.1979, p. 1.