A4-0075/97

Resolution on the status of non-conventional medicine

The European Parliament,

- having regard to the motion for a resolution by the following Members: Pimenta, Dell'Alba, Diez de Rivera Icaza, Crowley, Ewing, González Alvarez and Lord Plumb on 'complementary medicine' (or non-traditional medicine) (B4-0024/94),

- having regard to its opinion of 13 June 1991 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 ((OJ C 183, 15.7.1991, p. 318.)),

- having regard to Council Directive 92/73/EEC ((OJ L 297, 13.10.1992, p. 8.)) 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 budget heading B6-8332 of the 1994 EC budget, to heading B6- 7142, penultimate paragraph, of the 1995 EC Budget and to paragraphs 4 and 5 of heading B6-7142 of the 1996 EC Budget, which provide for ECU 1 m for 'research on the effectiveness of other therapeutic methods such as chiropractic, osteopathy, acupuncture, naturopathy, Chinese medicine, anthroposophic medicine, phytotherapy, etc.',

- having regard to the report by the Committee on the Environment, Public Health and Consumer Protection and the opinion of the Committee on Legal Affairs and Citizens' Rights (A4-0075/97),

A. whereas a number of people in the Member States are making use of certain non-conventional medicines and therapies and it would be unrealistic to ignore this de facto state of affairs,

B. whereas the view, shared by a number of doctors, is increasingly widely held that different methods of treatment and different approaches to health and illness are not mutually exclusive, but can on the contrary be used to complement one another,

C. whereas it is important to ensure that patients have the broadest possible choice of therapy, guaranteeing them the maximum level of safety and the most accurate information possible on the safety, quality, effectiveness and possible risks of so-called non-conventional medicines, and that they are protected against unqualified individuals,

D. whereas the whole corpus of medical systems and therapeutic disciplines covered by the term 'non-conventional medicine' is either not recognized as valid, or only partially so; whereas a given medical or surgical treatment applied instead of another may be described as 'alternative', and a treatment used to supplement another treatment may be described as 'complementary'; whereas it would be wrong to speak about 'alternative' or 'complementary' disciplines insofar as the fact of a medical discipline's being alternative or complementary can only be determined from the specific context within which it is being used; whereas an alternative medical discipline may also be a complementary one; whereas, in this resolution, the term 'non-conventional medicine' covers the notions of 'alternative medicine', 'natural medicine' and 'complementary medicine' as used indiscriminately in certain Member States to designate medical disciplines other than conventional medicine,

E. whereas, in order to protect the health of his own patients to the full, a doctor may use all resources and knowledge in any field of medicine in accordance with his own judgment and conscience,

F. whereas there is a broad range of non-conventional medical disciplines, and some of them enjoy some form of legal recognition in certain Member States and/or possess an organizational structure at European level (common basic training, deontological code, etc.) in particular chiropractic, homeopathy, anthroposophical medicine, Chinese traditional medicine (including acupuncture), shiatsu, naturopathy, osteopathy, phytotherapy, etc.; whereas, however, only a certain number of them meet all the following criteria: a form of legal recognition in certain Member States, an organizational structure at European level and self-regulatory mechanisms,

G. having regard to the EC Treaty and specifically Title III, Articles 52 to 66 thereof, on the free movement of persons and freedom of establishment; whereas these freedoms are undermined by the heterogeneous prevailing situation with regard to the status and recognition of all the non-conventional medical disciplines within the European Union; whereas the freedom to exercise their profession which certain health practitioners currently enjoy in their countries should under no circumstances be limited by modifying the status or the degree of recognition enjoyed by these disciplines at European level, nor by limiting the freedom of choice of therapy enjoyed by patients with regard to non-conventional medical treatment; having regard to the provisions of the Treaty in respect of the Member States and, more specifically, those laid down in Article 57(1), (2) and (3),

H. whereas there are already clear signs of developments, whether in the form of national legislation in certain Member States liberalizing the practice of non-conventional medicine while reserving certain specific activities for authorized practitioners (the 'Beroepen in de Individuele Gezondheidszorg' law adopted on 9 November 1993 by the Netherlands Senate), or specific regulations (UK law on osteopaths in 1993 and on chiropractic in 1994, legislation on chiropractic in Denmark in 1991, Sweden in 1989 and in Finland), or by making the training official (chiropractic in the UK and the Nordic countries), or the introduction of medicines into the pharmacopoeia (anthroposophical medicine in Germany),

I. whereas European legislation concerning the status and the practice of non- conventional medicine would provide patients with guarantees; whereas each type of medicine should be able to organize the profession at European level (deontological code, professional registers, and training criteria and levels),

J. whereas it is necessary clearly to identify each of the non-conventional medical disciplines; whereas to this end, clinical trials, evaluation of results of treatment, basic research (operating mechanisms of action) and other scientific studies or academic research should evaluate the effectiveness of the therapies applied; whereas this evaluation must be carried out according to the customary methodologies used for all human therapy, in other words, those based on current scientific knowledge, in particular the specifics of biological and statistical sciences,

K. whereas the regulation and coordination of training criteria imposed on the practitioners of non-conventional medical disciplines would constitute an essential guarantee for citizens; whereas it is essential, in the interests of both patients and practitioners, that qualifications be harmonized at a high level and that in all cases it is compulsory for practitioners to obtain a state diploma meeting the specific requirements of each discipline; whereas the levels of training must be appropriate to the general medical/health principles governing any therapeutic act and to the specific nature of various non-conventional medical disciplines,

L. whereas the training of conventional medical practitioners should include an introduction to certain non-conventional medical disciplines,

M. whereas, if therapists are to have the opportunity to exercise their profession properly and if, at the same time, patients are to be provided with guarantees that non-conventional medicines will be carefully assessed, the European Pharmacopoeia should include the full range of pharmaceutical and herbal products used in non-conventional medicine; whereas, for the same reason, it is necessary to review Directives 65/65/EEC, 75/319/EEC and 92/73/EEC and Regulation (EEC) No. 2309/93 establishing the European Agency for the Evaluation of Medicinal Products, so as to provide patients with guarantees as to the quality and safety of non-conventional medicines,

N. whereas the Council in its resolution of 20 December 1995 on medicinal plant preparations ((OJ C 350, 30.12.1995, p. 6.)) calls on the Commission to clarify the 'legal status of medicinal plant preparations, having regard to the Community provisions on proprietary medical products' and to study 'the specific conditions required to ensure the protection of public health',

O. whereas there is a need to indicate the quality, effectiveness and safety of the therapeutic products under consideration and provide for the publication of monographs on each product,

P. whereas, given the current state of legislation, legislation in the field of food supplements (vitamins, oligo-elements etc.) would help protect consumers without restricting their freedom of access and of choice, and would guarantee that qualified practitioners were at liberty to prescribe such products,

Q. whereas a transition phase will be necessary in order to allow all those currently practising to meet the requirements of the new legislation; whereas it will be necessary to set up an 'equivalence commission' with the remit of examining the situation of the practitioners concerned on a case-by-case basis,

1. Calls on the Commission, if the results of the study allow, to launch a process of recognizing non-conventional medicine and, to this end, to take the necessary steps to encourage the establishment of appropriate committees;

2. Calls on the Commission to carry out a thorough study into the safety, effectiveness, area of application and the complementary or alternative nature of all non-conventional medicines and to draw up a comparative study of the various national legal models to which non-conventional medical practitioners are subject;

3. Calls on the Commission, in formulating European legislation on non- conventional forms of medicine, to make a clear distinction between non- conventional medicines which are 'complementary' in nature and those which are 'alternative' medicines in the sense that they replace conventional medicine;

4. Calls on the Council after completion of the preliminary work referred to in paragraph 2 above to encourage the development of research programmes in the field of non-conventional medicines covering the individual and holistic approach, the preventive role and the specific characteristics of the non- conventional medical disciplines; undertakes to do likewise;

5. Urges the Commission to submit a report as soon as possible to the Council and European Parliament on the results of the studies and research already carried out under budget item B-7142 which, since 1994, has been earmarked for research into the effectiveness of homeopathy and other non-conventional medicines;

6. Calls on the Commission, in examining the effectiveness of forms of therapy used in non-conventional medicine, to ensure that none of the treatments used in the Member States makes use of medicines made from the organs of threatened animal species, which would constitute involvement in illegal trafficking;

7. Calls on the Commission to submit a proposal for a Directive on food supplements which are frequently situated on the border between dietary and medicinal products. Such legislation should help guarantee good manufacturing practice with a view to consumer protection without restricting freedom of access or choice and ensure the freedom of all practitioners to recommend such products; calls on the Commission to remove trade barriers between Member States by giving manufacturers of health products free access to all the markets in the EU;

8. Instructs its President to forward this resolution to the Council, the Commission and the governments of the Member States.