The Status of Complementary Medicine in the European Union

Ladies and gentlemen! Let me bring you greetings from the European Parliament. Some of you are probably quite well aware that the Green Group in the European Parliament and particularly my Belgian colleague Mr Paul Lannoye have been very active in enhancing legislative actions in order to legitimise the overall status of complementary medicine and in order to harmonise the varying practises in different EU countries. Over the last decades complementary medicine has benefited from a growing demand both from doctors and from the public in most European countries.[:]

Opinion polls conducted within the EU countries reveal that the majority of the population agrees to treatment with such methods, as the awareness of the risks and side-effects of conventional drugs is increasing. Just think of the growing evidence of resistance of bacteria to antibiotics. We have just been informed of a study conducted over the period of 30 years in the USA that even every fourth death may be due to the side affects of conventional medicines. And in Finland authorities estimate that 10 percent of hospitalised elderly people are being treated because of these side effects. On the basis of statistics from countries where they are available it is estimated that non-conventional medicine is used by 20 to 50 per cent of the population. Today even presidents may admit to taking “health pills”. Although according to the European Commission’s figures, for example homeopathic medicinal products currently account for only approximately 1% of gross sales of the EU pharmaceutical industry, it is clear that the figure will grow considerably in the near future. In France, Germany and the Netherlands this figure is already over 2% in value and 5% in volume.

One not unimportant aspect of all this is the fact that normally non-conventional medicinal products are cheap and thus would not ruin any national health budget like the new wonder product Viagra is feared of doing. The growing interest in complementary medicine is due to a certain disaffection with conventional medicine, where despite extraordinary technological developments leading to undeniable successes, however at the same time, an imbalance exists in the doctor/patient relationship in addition to the mentioned side effects from medical products. There is a growing trend to seek out medicine with a more human face, medicine which deals with human beings not just their pathologies. This is why traditional therapies, such as reflexology, and other milder medical remedies attract people. We want to restore the human body’s capacity to resists illnesses in stead of only treating symptoms.

Today, however, two opposed concepts coexist in the European Union with regard to health care. The first believes that only the medical profession – that is to say doctors – is entitled to treat illnesses. More or less for others it is illegal to practice medicine. This is the case in the southern EU countries and also in France, Belgium and Luxemburg. There are some exceptions in these countries, too. This is clearly due to growing demand. For instance in France the practice of acupuncture is legal and recognised by the Académie de Médicine. Also homeopathic remedies are reimbursed by the social security if medically prescribed. The second attitude predominates in the northern Europe: anyone who wishes to practice health care may do so while some activities strictly reserved for doctors who also represent authority and are represented in the organisations of public health care. You have earlier heard a profound presentation by reflexologist Mr Hans van der Wurff on the status of reflexology in European countries, so you will by now know that the legal status of non-conventional medicine is far from harmonious in the EU.

The lack of any homogeneity as regards attitudes and legislation in EU Member States results in unequal treatment for European citizens. This is contrary to the basic principles of the EU – particularly the principle of the freedom of movement – and this is why the subject was taken up in the European Parliament in November 1994. In January 1995 the Conference of the Presidents of the Parliament formally gave green light to the proposal to draft a report on non-conventional medicine in the EU. Mr Lannoye was appointed the rapporteur of the report. This was a so called own initiative report meaning that the Committee on the Environment, Public Health and Consumer Protection decided to present it to the Parliament even though there was no legislative or other initiative from the European Commission. In May 1997 when the report was finally voted upon in the Parliament Plenary Session, it had been amended to such great extent that Mr Lannoye himself felt he had to vote against it: his original intention had been to ask the Commission to draw up legislation to make the status of complementary medicine clearer in the EU. At this point, however, the majority of the members wanted the Commission to carry out further studies before legislative actions.

So, unfortunately, the majority of the members of the Parliament were not ready to enhance overall legislation just as yet. This is unfortunate particularly of the obvious reason that you have heard earlier today: the status of reflexology as well as other disciplines in complementary medicine in the EU countries is far from homogeneous; we lack harmonious legislation, and due to this in some cases we seem to lack patient safety as well. All this leads to an unclear status for therapies outside conventional medicine. This did not mean, however, that all the work that had been done for the report would have been in vain. Maybe we were terribly disappointed at first but now there are some good signs in the air. But let me first tell you a little about the so called Lannoye report. The report tells its reader that although Europe lacks harmonised legislation in the field of non-conventional/complementary medicine, this does not however mean that the training and professional practices in the field would be totally wild. On the basis of the report the Parliament drew up a resolution in which it reminds how important it is that the 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. The Parliament also reminded in this resolution how important it is to protect patients against unqualified practitioners – and yet in only some member states do some non-conventional disciplines enjoy some form of legal recognition. All this ends up to heterogeneous practices as to professional registers and training.

Unlike some critics have claimed, the Parliament did not call for an EU-level recognition of just about any discipline but wanted to promote the best documented ones. Yet the report shows that both in training and in professional practice there are already have traditions in Europe. On the other hand it makes just as clear that these cannot be forced into one single mould. Thus the Parliament states that first of all it is necessary to clearly identify each of the non-conventional medical disciplines. This means evaluation of the effectiveness of the applied therapies using clinical trials as well as basic research, taking into account the special nature of non-conventional medicine, that is its holistic and personal approach. It also means clearing the state of training and assessment of non-conventional medicinal products. In this connection the Parliament was of the opinion that the European Pharmacopoeia should include the full range of pharmaceutical and herbal products used in non-conventional medicine. In the resolution the Parliament also asked the Commission to submit a proposal for a directive on foodstuffs which are frequently situated on the border between dietary and medicinal products. The parliament was of the opinion that such legislation would help to guarantee good manufacturing practise with a view to consumer protection without restricting freedom of access or choice and ensure the freedom of all practitioners to recommend such products. The parliament also asked the Commission to remove trade barriers between Member States by giving manufacturers of health products free access to all the markets in the EU. And, as I said earlier, today there seems to be some hope that the Commission is taking a slightly more positive attitude towards complementary medicine.

Just this week we happened to have a meeting of an informal, so-called intergroup dealing with complementary medicine and co-chaired by Paul Lannoye. All political groups are represented in these intergroups. In this meeting we heard some news from the Commission on the review of the two directives on homeopathic preparations. The current directives were adopted in 1992. Homeopathic medicinal products are officially recognised in certain Member States but only tolerated in others. Nevertheless, they are prescribed and used in all Member States and traded across the borders. Now the Commission has written a report on the effectiveness of these directives and the Parliament is presently discussing it. I have had a chance to draft the opinion of the Committee for Economic and Monetary Affairs and Industrial Plicy on this for the Committee of the Environment, Public Health and Consumer Protection which again has the chief responsibility. According to the directives all homeopathic medicinal products put on the market in the European Union must have either a registration or an authorisation, and each Member State “shall take due account” of registrations and authorisations previously granted by another Member State.

This formulation was interpreted by the Member States – while transposing the Directive into national law – in a wide variety of ways. The directives also provide for the creation of a simplified registration procedure in Member States for homeopathic medicinal products which are placed on the market without therapeutic indications. The main concern in the Commission’s report, which is based on a study performed by an independent consultant, is that differences currently exist between the provisions laid down by law, regulation or administrative action in the Member States and that these may hinder trade in homeopathic medicinal products within the Community and lead to discrimination and distortion of competition between manufacturers. I think it has to be ensured that no discrimination, which cannot be based on overriding public interest such as safety, between these products with origin in different Member States occur. The easiest technical way to guarantee non-discrimination is, of course, the unconditioned mutual recognition of national registrations. But the Parliament should follow the Commission down this road only if it can be secured that no Member State will be forced to accept homeopathic products on its market which are produced, tested on their quality and pureness, and registered under lower health and safety conditions than currently applicable in the respective country. Good Laboratory Practice and Good Manufacturing Practice will guarantee this.

At the same time, it has to be ensured that no competitive disadvantages exist for homeopathics compared to other medicinal products. Therefore, trials for the registration of homeopathic medicinal products have to respect the peculiarities of these medicines and any discrimination in the provisions for their labelling should be avoided. It has to be born in mind that millions of EU citizens see homeopathic medicinal products as valuable medicines which are also very cheap in relation to “normal” pharmaceuticals. Finally, anthroposophic medicinal products described in an official pharmacopoeia and prepared by a homeopathic method are to be treated, as regards registration and marketing authorization, in the same way as homeopathic medicinal products. We have to take into account the fact that the producers of homeopathic medicines are mainly small and medium sized firms, which suffer from the burden to register their products separately in the different Member States. In marketing, I think the EU should allow for fantasy names for homeopathic medicines and delete the discriminative demand that now exists in the directives to label homeopathic and anthroposophic medicinal products to be “without approved therapeutic indication”. A more neutral wording like “registered homeopathic medicinal product” should be enough.

In addition, the Parliament is likely to agree that homeopathic medicinal products could be used in the treatment of production animals and not just in the treatment of pet animals which is the present situation. The review of the directives is now largely in the hands of the health ministers of the 15 Member States. The current Austrian Presidency of the EU is said to be willing to have some progress with the work, and thus the health ministers will discuss it in November. The European Parliament is also calling in the context of the next, 5th Framework Programme for Research for funds for complementary medicine studies. This programme is now undergoing negotiations between representatives from the Parliament, the Commission as well as the Council of Ministers. One of the main four Thematic Programmes is Quality of Life and Management of Living Resources. One area which will need a lot of work is the question of EU-wide rules for practicing a profession of non-conventional medicine. Until there will be some major break-through we can hardly speak of harmonisation.

In March this year I tabled a written question to the Commission concerning the freedom to practice a profession in the EU. This time the question was about chiropractic which is legally recognised as a health care profession here in Finland. A practitioner of a discipline which is legally recognized in one country may find him/herself illegal in another country. Commissioner Mario Monti answered my question by pointing out that training and qualification criteria as well as the right to exercise a profession are matters to be included in the national legislation. He referred to differences in the legal framework in different Member States. He also seemed to have some disbelief as to the possibilities of reaching a necessary unanimous decision in the Council of Ministers from the 15 Member States. I can only advise you to create a lobby, an alliance with practioners of non-conventional medicine across national borders and from various disciplines. One way to try to progress would be to identify a basic framework which would be applied to several recognized disciplines on the horizontal level. I am sure that Members of the European Parliament are interested to look at this possibility. Nevertheless, one cannot underestimate the importance of trying to progress on the national level in the various Member States. This is bound to have affect on the European level one day. And here everyone is aware of the enormous differences between the countries. Ladies and Gentlemen! We are dealing here with the question whether two freedoms which sould be close to the basic beliefs of the European Union, will be established: freedom for patients to choose the medical therapy of medicinal product of their choice, and freedom for practitioners to exercise their profession. Both of course by maintaining the safety and quality of treatment. And in all the Member States of the Union. Thank you very much for your attention.

Third European Conference of Reflexology Tampere, September 18, 1998