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.

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' field of activity nor the types of treatment or therapy which they may apply. These matters, in the absence of any other relevant legislation, therefore fall within the competence of the 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' 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 doctors Directive.

(4) OJ L 19, 24.1.1989.

(5) OJ L 209, 24.7.1992.