"THE
EUROPEAN UNION, HOMEOPATHY AND OTHER UNCONVENTIONAL MEDICINES
Dr. Michel Van Wassenhoven.
Substitute Member at the European Parliament,
President of the action COST-B4 - (1993-1999) “Unconventional
Medicine” in 1997.
Your Serene Highness, Ladies and Gentlemen,
Before introducing the possibilities of future
research, the current works or the works already published within the framework
of the European Union concerning unconventional Medicine, I would like to
recall the organisation of Europe’s official structures.
Many “private” organisations recognised legally
in one of the European countries are active at the European level. Thus, the E.C.H.
(European Committee for Homeopathy) is an organisation recognised by the King
of Belgium as an “International Organisation pursuing a philanthropic and
scientific goal having its head office in Belgium”. We will revert later on to its
activities.
The European structures are split between the
European Union and the Council of Europe. The European Union is restricted to
the member countries (15 to this day), the Council of Europe is open to all the
countries interested in European ideas within the European continent. In the
case of scientific research activities, other countries may also associate with
it; for instance there has been recently an agreement with Israel.
The European Union is managed by “Councils of
Ministers” under the supervision of the “European Parliament”, the executive
power being the “European Commission”, not to be mistaken with the Commissions
of the European Parliament including members of parliament especially
interested in one community topic or the other.
The “European Commission” includes various “General
Boards” (D.G.’s), each of them responsible for a special topic. Therefore, D.G.
XII is concerned with Development, Research and Science in Europe. In this
capacity, further to a specific question from the Parliament (with an allocated
budget) concerning homeopathy, D.G. XII formed in 1994 a group of foreign
experts on the topic of homeopathy. This group was to answer the following
questions: Is homeopathy a phenomenon worthy of research in Europe? – What are
the restrictions which prevented it from being recognised officially to this
day? – Which research methodologies would possibly be useful? – Can one define
quality criteria for this research?
Within the “Council of Europe”, associated
countries may group together and finance actions on special topics. These
actions will be co-ordinated (secretariat) by the various D.G.’s concerned
within the “European Commission”. The action COST B4 concerned unconventional
Medicine. A participation convention, a “M.o.U;” (Memorandum of Understanding),
must be countersigned by the various countries wishing to take part in it.
These countries may then appoint two delegates to represent them. This “Memorandum”
contains specific questions to which the action must respond. For COST B4,
these questions are: What is the situation of unconventional Medicine in the
various European countries? – Can one facilitate a process of scientific
research in this respect and possibly propose norms of quality? – Is it
possible to co-ordinate the efforts of the various member countries? – What is
the situation of the research already published on these subjects in the
various European countries?
THE GROUP
“HOMEOPATHY” (1994-1996)
Under the chairmanship of Professor G. FÜLGRAFF
(Berlin University) this group included about twenty people. One third of methodologists
specialised in medical research, one third of research workers in “orthodox”
medicine and research workers known in the sector of homeopathy (appointed by
the European Commission from a list provided by the E.C.H.). This group began
its work in 1994 and lodged its final report with the European Commission in
July 1996. It may be obtained from the following address: Dr. FRACCHIA -–European
Commission – D.G. XII – Science Research & Development – 8 floor – square de
Meeus, 46 – B-1040 BRUSSELS – BELGIUM.
It was divided into 6 “sub-groups”: Review of
clinical literature – Dictionary – Methodologies of clinical research –
Restrictions – Methodologies of fundamental research – Reading of protocols,
judgements and decisions on future research.
The European Commission had decided to keep the
last sub-group active in order to respond to a call for research protocols in
the future, but it never convened since the group’s activities stopped.
In short, the conclusions of this work are as
follows:
There is an interesting clinical literature
concerning homeopathy, unfortunately its quality is unequal. Out of 377
references, only 21 could be used for a true inter-university audit
(Lyon-London-Milan-Amsterdam). While, from analysable studies, one may conclude
that there is an activity of homeopathic remedies higher than the placebo, one
cannot draw any final conclusions on the value of homeopathy since the number
of patients included in these studies is only 2.282. (For instance, the final
recognition of the anti-coagulating activity of aspirin required 45.000
patients included into 6.000 studies). However, these conclusions confirm
entirely the result of prior audits. Homeopathy is therefore worthy of
research.
To avoid word confusions during meetings between
experts, a dictionary of scientific & homeopathic terms was published.
A consensus was achieved between “orthodox” and “homeopathic”
experts concerning the methodologies to be used and the research priorities to
be stimulated in Europe in the future.
The analysis of the restrictions preventing a
process of research and recognition of homeopathy in Europe was carried out
thanks to the circulation of questionnaires within 4 European countries. These
questionnaires were sent to 7 different categories of individuals: patients –
physicians – university research workers – homeopaths – pharmacists, etc. One
restriction overrides the others: the use of high dilutions is a fact, which
would make homeopathy «impossible», and therefore any research useless.
A consensus among experts was also possible
concerning the methodologies of fundamental research to be used to analyse the
activity of high dilutions in homeopathy. Nevertheless, a review of fundamental
literature on this topic was refused by the “orthodox” experts (did we not
speak about restrictions!) but this review will take place within the action
COST B4.
A consensus concerning the norms to be used for
the writing and reading of research protocols was also possible and published.
It will serve as a reference for future research.
THE
ACTION COST B4 (1993-1999)
This action began in 1993 and ended in 1999.
A first concrete result of this action is a data
bank containing all the current research in Europe on the topic of
unconventional Medicine as well as the research workers’ co-ordinates. This
data bank was updated regularly during the action.
Yearly activity reports, the final report from
the executive Committee as well as its supplement were published by the
European Commission and may be obtained from the following address: Dr.
MANDENOFF – European Commission – COST Scientific Secretary for Medical
Research – rue de la Loi, 200 – B-68, 4/26 – B-1049 BRUSSELS – BELGIUM.
In June 1994, a conference entitled “Complementary
Medicine Research: An International Perspective” was organised in London; the
minutes of that conference are available at the above-indicated address. The
many participants of this conference expressed their satisfaction as to the
organisation of this meeting which brought together so many different people,
but this diversity was also the cause for often “stormy” discussions. A starting
point which underlines very well the difficulties of operating such a group.
Reviews of clinical, fundamental and
sociological literatures were carried out. Of course, the work already done by
the “Homeopathy Group” may serve as an example, but it was much more extensive
because it had to concern all the unconventional Medicines used in Europe (at
least the most important ones). Being responsible for the literature review in
fundamental research (and also member of its Homeopathy sub-group) I am pleased
to introduce today the first part of this review, the one concerning
homeopathy. It formed the subject of a PhD thesis in pharmacy at the University
of Montpellier, under the responsibility of Professor Madeleine Bastide. 455
references were used as the starting point of the first section of this review,
which shows very concretely that the activity of high dilutions, which can
remain difficult to understand, is nevertheless a fact worthy of research. Only
a few resumptions of research in independent laboratories are still missing to
treat these facts as final. An identical review came to a successful conclusion
concerning acupuncture, anthroposophy, chiropraxis, phytotherapy and other
unconventional Medicines.
As for the “homeopathy” group, a consensus was possible
between all the participants concerning research methodologies. The analysis of
the restrictions opposed to unconventional Medicine was also the subject of an
analysis by a work group.
You will note the existing similitude and
complementarity between the activities of this action COST B4 and the ones of
the “Homeopathy Group”.
The reports of the action COST B4 are also found
on the Internet, research terms: <COSTB4report> &
<COSTB4supplement>. This supplement includes 4 sections. Te first one contains
reports from experts invited during the 5 years of activity of this action, the
3 following ones are expert CONSENSUS concerning the recommendations for
research in these fields, a general overview of knowledge according to users
and practitioners and finally a first systematic review of the literatures
published concerning the understanding of the processes of activity of these
practices.
THE
EUROPEAN COMMITTEE FOR HOMEOPATHY
This organisation may be used as a model of
co-ordination of “European” activities within the framework of one type of
unconventional Medicine. The existence of this European organisation is not
irrelevant to the fact that homeopathy acts as a “driving force” in all these
steps. Of course, homeopathy is also the most widely used and prescribed
unconventional medicine in Europe.
An official group or action in Europe is
possible only if the European authorities can count on a “guarantor”
representative from all standpoints. Therefore, in a literature review, we ask
these “guarantors” to check the reference lists. The make-up of the groups will
be proposed by these organisations inasmuch as they can prove their
representativeness.
E.C.H. is presently chaired by Dr. J. IMBERECHTS
(also President of the International Homeopathic Medical League).
It groups together homeopathic medical
associations from all European countries as well as all individuals wishing to
defend homeopathy. Its latest General Meetings were impressive, both from the
point of view of the number of associations represented and from participating
countries (including several Eastern European countries!).
Various sub-committees take on specific actions:
The “Education” sub-committee elaborates,
updates and supervises the practice of a harmonised teaching programme of
homeopathy in Europe;
The “Provings” sub-committee cares about the
norms used for pathogeneses, i.e. for the experimentation of homeopathic
products on healthy individuals;
The “Clinical Research” sub-committee is a
discussion & exchange forum on the topic of clinical research in homeopathy;
the choice of priorities is discussed in it;
The “Fundamental Research” sub-committee enables
a yearly update of the literature review, prepares a research programme and
proposes its priorities;
The “Research & Society” sub-committee
concerns sociological studies;
The “Documentation” sub-committee updates an
international catalogue of books, reviews and publications, it provides
reference documents to other sub-committees;
The “Pharmacology” sub-committee follows up,
amends the texts and acts with the European authorities in charge of the
directives and pharmacopoeia of homeopathic medications; the industry is
broadly represented in these last 2 sub-committees;
The “Patients” sub-committee enables listening
and exchanges of information between physicians’ associations and patients’ associations;
common actions are thus possible;
The “Political” sub-committee elaborated norms
for a quality practice of homeopathy in Europe, it is in constant contact with
European authorities.
To receive these files, you can contact: Dr.
NICOLAI – E.C.H. Secretary – Mathenesserlaan, 209 – 3014 HD ROTTERDAM – The NETHERLANDS.
THE
PARLIAMENTARY COMMISSION ON ENVIRONMENT, PUBLIC HEALTH AND CONSUMER PROTECTION:
Address of the previous recorder of the file on unconventional
Medicine: Mr. Paul LANNOYE – European Parliament – Montoyer 3/35 – 97-113 rue
Belliard – B-1047 BRUSSELS – BELGIUM. Today, he is the head of the Green group
at the European Parliament.
The European Union projects concerning
unconventional Medicine were decided upon on the initiative of members of this
commission. (Directive concerning homeopathic Medications – Questions to D.G.
XII – Budget for these researches: 1.000.000 Ecus for homeopathy + 1.000.000
Ecus for other unconventional Medicines & more recently a budget for the
evaluation of unconventional medicine within the 5th outline
programme for European research 1998-2003).
But this commission did not wish to stop so
soon. A first attempted report aiming at the legalisation of unconventional
Medicine in Europe, for reasons of well-organised administrative blockage, was
not as successful as we had hoped (1994). But after the 1994 European
elections, the same recorder was elected to bring this file to a successful
issue.
This report was not adopted as such by the
European Parliament, but replaced by the “COLLINS” resolution which, before
this recognition of unconventional medicine, requires a full evaluation report
of these practices in Europe.
This is a true “combat course”, we set our minds
to surviving it!
Nevertheless, the “Paul LANNOYE” report, done in
close collaboration with the concerned professional organisations, paved the
way for unconventional practices in Europe. In Belgium it was the reference for
the outline law which must regulate the registration of acupuncture, chiropraxis,
homeopathy and osteopathy as a first step and other practices later on. When
the stage of evaluation of unconventional medicine has been accomplished, there
is no doubt that this report shall return to the foreground of the preoccupations
of the European members of parliament.
PRESENT
AND FUTURE EUROPEAN INITIATIVES
Always upon the initiative of the Paul LANNOYE
group, today head of the European Green group, the Council of Ministers of
Research in Europe adopted an amendment concerning the financing of the 5th
outline programme for research. The text of the “COLLINS” resolution is
recalled word for word: “… and evaluate the efficiency, security and field of
application of unconventional therapies, taking into account their preventive
role and the possibilities of an individual and holistic approach to health”.
In practice, submissions on these topics should
be introduced to the European Commission by 14 October 1999. The person in
charge of these projects is Mrs. Lisette SCHERMER who is in charge of the sector
“Public health and health services” within the unit B.II-3: Generic activities
and infrastructures. Phone +32-2.296.79.27 E-mail: elisabeth.schermer@dg12.cec.be
Experts will designate
the best research projects according to the answers they will be able to
provide to the questions asked. Two types of projects were lodged: some of them
including a great number of patients associate the sociological evaluation of
resorting to an unconventional practice with the one of its efficiency through
validated questionnaires. Others are clinical studies, more restricted as far
as number of patients, but possibly appealing to the methodology of double
unknown. A few projects of resuming prior literature reviews for the purpose of
updating and new evaluation (the search for convergence between certain
publications) also exist.
It is not impossible for a new action COST to be
decided upon in order to pursue the work achieved by the action COST B4, which
is now closed after the tolerated extension period. If such an action were to
see the light, it would certainly be much more geared to the promotion of
research activities and would no longer restrict itself to an inventory of the
present situation of unconventional medicine in Europe.
In the various reference documents you will find
the consensus between international experts concerning the situation of
unconventional Medicine in Europe. The work accomplished to this day is only a
small part of what remains for us to do but it went beyond a point of no
return. One can no longer disregard unconventional Medicine or hide behind
obsolete dogmatic assertions.
An unrelenting process is under way and wished
for by European authorities; the recognition of unconventional Medicine will be
done through scientific approaches accomplished outside of any feeling of
suspicion. Undoubtedly this approach will also be normative but this
harmonisation will have bases understood and accepted by everyone. Consumer
protection, a priority concern of European authorities, will thus be ensured.