A4-0378/98

Resolution on the Commission report to the European Parliament and the Council on the application of Directives 92/73/EEC and 92/74/EEC on homeopathic medicinal products (COM(97)0362 - C4-0484/97)

The European Parliament,

- having regard to the Commission report, COM(97)0362 - C4-0484/97,

- having regard to the Treaty establishing the European Community, and in particular Article 100a thereof,

- having regard to Directive 92/73/EEC 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,

- having regard to Directive 92/74/EEC widening the scope of Directive 81/851/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to veterinary medicinal products and laying down additional provisions on homeopathic veterinary medicinal products,

- having regard to the decision of the Court of Justice of 12 February 1998 in case C-144/97 ((ECR, p. I-0613.)),

- having regard to its opinion at first reading of 13 June 1991 ((OJ C 183, 15.7.1991, p. 318.)) and its decision at second reading of 8 July 1992 ((OJ C 241, 21.9.1992, p. 93.)) on the proposal for a Directive 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,

- having regard to its resolution of 29 May 1997 on the status of non-conventional medicine ((OJ C 182, 16.6.1997, p. 67.)),

- having regard to the report of the Committee on the Environment, Public Health and Consumer Protection and the opinions of the Committee on Agriculture and Rural Development, the Committee on Economic and Monetary Affairs and Industrial Policy, the Committee on Research, Technological Development and Energy and the Committee on Legal Affairs and Citizens' Rights (A4-0378/98),

A. whereas between one fifth and one quarter of the citizens of the European Union make use of homeopathic medicinal products and whereas such products account for one percent of the turnover of the Union's pharmaceuticals industry,

B. whereas the differences between the Member States concerning the authorization or recognition of homeopathic medicinal products distort competition and the market,

C. whereas the accessibility and reliability of homeopathic medicinal products need to be guaranteed and whereas users need to be assured of information,

D. whereas transposition of Articles 2, 3, 4, 5, 10 and 11 of Directives 92/73/EEC and 92/74/EEC has resulted in a number of problems but no insuperable complaints or objections,

E. whereas transposition of Articles 1 and 8 and of Article 9 of Directive 92/73/EEC has resulted in problems in the registration or authorisation of homeopathic anthroposophic medicinal products,

F. whereas in a number of Member States homeopathic anthroposophic medicinal products are of considerable importance and whereas they appear in an official pharmacopoeia,

G. whereas Article 6(2) of both Directives provides for the possibility of refraining from establishing a 'special, simplified registration procedure for homeopathic medicinal products', but whereas the Member States have made no use of this provision which, accordingly, is redundant,

H. whereas transposition of Article 6(3) of Directive 92/73/EEC concerning advertising for homeopathic medicinal products and Article 9(1) of the two Directives concerning the authorization and labelling of homeopathic medicinal products other than those covered by a special, simplified registration procedure has not given rise to any particular problems,

Recognition

I. whereas Article 6(1) of the two Directives specifies that Member States 'shall take due account of registrations and authorizations granted by another Member State'; whereas this provision is so unclear de jure that transposition differs substantially from one Member State to another and is de facto too open-ended to act as an effective bar to distortions of competition; whereas a more uniform provision would result in fewer problems of interpretation and whereas only a binding provision will ensure the free movement of the products in question,

J. whereas separate assessment of every homeopathic medicinal product in each Member State is a considerable waste of time and money and is the cause of barriers to trade because assessment criteria and margins differ; whereas such assessment must be carried out in accordance with criteria involving full guarantees of the quality and harmlessness of the product,

Special, simplified registration procedure (SSRP)

K. whereas a number of Member States, in transposing Article 7(1) of the two Directives, have changed the provision in question or included other provisions such that there is a risk of unfair competitive advantages arising,

L. whereas, in accordance with the wording of Directives 92/73/CEE and 92/74/CEE, homeopathic medicinal products are only eligible for the SSRP if the degree of dilution per preparation does not exceed one part per 10 000 of the mother tincture or more than 1/100th of the smallest dose used in allopathy with regard to active principles in medicinal products requiring a doctor's prescription; whereas a number of Member States depart from this obligation; whereas this limiting of the degrees of dilution in which homeopathic active principles may be included in homeopathic medicinal products is entirely arbitrary, taking no account of factors linked to pharmaceutical form, means of administration and the formula of these products; moreover, the result of such a limit would be to withdraw from the market homeopathic medicines which have been on the market for decades, having given proof of their harmlessness, and whereas this would be very detrimental to a number of homeopathic laboratories,

M. whereas Directive 92/73/EEC restricts the SSRP to homeopathic medicinal products for oral or external use, although this does not follow from any generally accepted health and safety rules based on scientific research; whereas a number of Member States ignore this and allow other forms of use, too; whereas the safety of the form of dosage is guaranteed, not only by its inclusion in an official pharmacopoeia, but also through application of the rules of Good Manufacturing Practice,

N. whereas, notwithstanding Regulation (EEC) No 2377/90 laying down a Community procedure for determining residue limits of veterinary medicinal products in foodstuffs of animal origin, Directive 92/74/EEC reserves the SSRP for homeopathic medicinal products for pet animals or exotic species not intended for human consumption,

Labelling

O. whereas the obligatory use of the scientific name on labels and, possibly, in the package insert does not make for clarity; whereas this is the cause of confusion and errors; whereas clarity and ease of identification are an important aid for patients and consumers,

P. whereas the dosage provides the patient or consumer with information about the nature and purpose of a specific medicinal products,

Q. whereas the compulsory mention of 'homeopathic medicinal product without approved therapeutic indication' on the label and, where appropriate, in the package insert is applied by the Member States in different ways; whereas specifying therapeutic indications which may or may not be approved is no part of the registration procedure; whereas this phrase has pejorative overtones which have a clearly discriminatory effect,

R. whereas homeopathic medicinal products intended for humans must contain on the label and, where appropriate, in the package insert a warning to consult a doctor should symptoms persist 'during the use of the medicinal product'; whereas this warning is evidence of a lack of understanding of how medicinal products work and of the course of treatment or recovery; but whereas late intervention during long-term treatment should be avoided,

Special rules

S. whereas it is at Member States' discretion, with regard to the testing of homeopathic medicinal products for which the SSRP is not applicable, to lay down special rules for the pharmacological, toxicological and clinical tests; whereas some Member States have done so but others have not; whereas this makes it possible to take account of differences between countries and medical cultures, but whereas this also leads to distortions of competition,

Special rules

1. Notes that, according to Article 10 (3) of Directives 92/73/EEC and 92/74/EEC, the Commission should have reported not later than 31 December 1995 to Parliament and the Council concerning the transposition and application of the Directives by the Member States; deplores the delay incurred, whatever the reasons for this delay;

2. Calls on the Commission, pursuant to the report on homeopathic medicinal products and on the basis of the suggestions made by the European Parliament, to submit a proposal to amend Directive 92/73/EEC and a proposal to amend Directive 92/74/EEC;

3. Calls on the Commission to modify Article 1 of Directive 92/73/EEC in such a way that homeopathic anthroposophic medicinal products described in an official pharmacopoeia are given the same status as homeopathic medicinal products;

Recognition

4. Calls on the Commission to investigate whether, and to what extent, a system of mutual recognition of homeopathic medicinal products can be set up on the basis of binding principles and appropriate standards;

5. Calls on the Commission to lay down rules for the composition of registration requests applicable by all Member States and carrying full guarantees of quality and harmlessness;

6. Calls on the Commission to look into the desirability and feasibility of a system of recognition of homeopathic medicinal products by a Community body of persons with expertise in this field;

7. Pending the setting up of such a system of coordination or harmonization, calls for Article 6(1) of the existing Directives to be modified in such a way as to create an unmistakable obligation on the part of Member States actually to recognise registrations carried out, or authorizations granted, by other Member States, and to define exactly under which specific conditions national registration should be mutually recognised or endorsed by other Member States;

8. Calls on the Commission to ensure safeguards for a system of coordination or harmonization whereby the quality of registration procedures is monitored;

9. Is of the opinion that the application of the mutual recognition principle should be made dependent on the application, including appropriate control mechanisms, of Good Manufacturing Practice (GAMP) and Good Laboratory Practice (GAP) and on provisions which would ensure that no Member State would be forced to lower its standards relating to problematic residues or contamination of the substances used;

10. Is of the opinion that common safety criteria should be defined at EU level and that the Member State in which a homeopathic product is first registered has to evaluate and document compliance with such criteria;

Special, simplified registration procedure (SSRP)

11. Calls on the Commission to investigate whether homeopathic medicinal products administered by means of injection, plaster, spray, drops, suppository or by any other route other than orally or for external use with no risk to the health or safety of the user can be considered for the SSRP and, if so, to make the rules more flexible;

12. Calls on the Commission to investigate ways and means of producing a valid Community list of degrees of dilution determined for the mother tincture and, in the absence of such a list, to revise and, if possible, to increase the existing degrees of dilution;

13. Calls for homeopathic medicinal products for veterinary use to be given access to the SSRP regardless of the species of animal which the product is intended to cure;

Labelling

14. Calls for the lifting of the ban on fantasy names, in particular for combination preparations, on condition that this does not lead to a therapeutic indication being introduced or suggested;

15. Calls for an obligatory indication of the dose on the label and, where appropriate, in the package insert;

16. Calls for an end to the obligation to use the statement 'homeopathic medicinal product without approved therapeutic indications', and calls on the Commission to examine whether the obligation to use the statement 'application in accordance with clinical homeopathic pharmacology (pharmacological picture)' affords a viable alternative;

17. Calls for the obligatory warning, on specific homeopathic medicinal products intended for humans, advising the user to consult a doctor if the symptoms persist 'during the use of the medicinal product' to be modified, and calls on the Commission to propose doing away with the words 'during the use of the medicinal product';

Special rules

18. Calls on the Commission to submit a proposal, with the full participation of experts in homeopathic medicines, obliging Member States to draw up special rules for the pharmacological, toxicological and clinical tests for the testing of homeopathic medicinal products which are not eligible for the SSRP;

19. Calls on the Commission to submit to the European Parliament and the Council a report, no later than three years after the entry into force of the Directive amended in this way, on the progress achieved in regard to completion of the market and the free movement of homeopathic medicinal products;

20. Calls on the Commission to report without delay on the studies and surveys conducted on research into the effectiveness of homeopathic and other alternative treatments within the framework of the Community R& D programme for Biomedicine (budget heading B6-7142);

21. Considers that, as part of the biomedicine section of the Fifth R& D Framework Programme, research activities in the field of alternative medicine should be promoted on the basis of the report called for in the previous paragraph, with particular attention being paid to individualised and holistic approaches, the preventive role and particular features of alternative medical disciplines. These activities should include programmes for basic research into homeopathy, to be carried out by bio-medical institutions, designed in particular to explain the process of homeopathic potentisation and prove the efficacy of homeopathic high-level potencies. They should also include programmes to promote international pooling of the experience of experts in homeopathy;22. Instructs its President to forward this resolution to the Commission, the Council and the Member States.