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Proposals Dir 2001/83/EC
Proposals for Trad Use
Proposals for Reg 2309/93/EC
Goetheanum (Main page)
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International Federation of
Anthroposophical Medical Associations IVAA
Joint
Communiqué
on
the occasion of the Hearing held under the auspices of Dagmar
Roth-Behrendt
MEP in the European Parliament on homeopathic and anthroposophic medicinal
products in the European Union:
On
14th October 2003 the following organisations, representing
patients,
practitioners and manufacturers
-
European
Committee for Homeopathy (ECH)
-
European
Council for Classical Homeopathy (ECCH)
-
European
Coalition on Homeopathic and Anthroposophic Medicinal
Products
(ECHAMP)
-
European
Federation for Naturopathy (EFN)
-
European
Federation of Homeopathic Patients' Associations
(EFHPA)
-
European
Federation of Patients for Anthroposophical Medicine
(EFPAM)
-
European
Council of Doctors for Pluralism in Medicine (ECPM)
-
International
Association for Veterinary Homeopathy (IAVH)
-
International
Federation of Anthroposophical Medical Associations
(IVAA)
unanimously
expressed themselves to be in support of the Common
Resolution
signed in 2002, drawing attention to the fact that:
-
increasing
numbers of consumers, patients and health
practitioners
are using non-conventional medicinal products
-
29%
of the European citizens use or are familiar with
homeopathic
or anthroposophic medicinal products
-
it
is important that patients have access to a range of treatment
options
and the freedom to choose
-
homeopathic
and anthroposophic medicinal products boast a long
tradition
of safe and beneficial use for individuals
-
they
pose no significant risk for public health or the environment
-
eleven
years after publication of Directives 92/73 and 92/74 the
internal
market is far from being harmonised and this has led to
severe
problems in availability and circulation of the relevant
medicinal
products in the European Union
-
restrictive
and unclear paragraphs in the Directives are causing
severe
problems in the registration/marketing authorisation of
homeopathic
and anthroposophic medicinal products resulting in
major
availability problems
-
the
disproportionate costs and requirements with regard to
registration/marketing
authorisation and the unharmonised fees
are
leading to restrictions in the full range of products necessary
for
consumers and for practitioners.
-
health
economic evaluations of homeopathic and anthroposophic
medicinal
products suggest a positive cost-risk-benefit profile.
The
united field of stakeholders express their deep concern about the
lack
of interest in the homeopathic dossier by the European
Commission
and the Council and call on the European Parliament to
strongly
maintain its position with respect to the following
Amendments
adopted in the first reading on 22nd
October
2002 of the
Review
of Directive 2001/83/EC:
-
Amendment
45, widening the scope of simplified registration to
all
pharmaceutical forms mentioned in a pharmacopoeia,
including
injections
-
Amendment
91, changing the confusing and discriminatory
disclaimer
on medicinal products registered according to the
simplified
procedure, into “homeopathic medicinal product
registered
without indications”.
-
Amendment
179, allowing a marketing authorisation of
homeopathic
medicinal products under Art. 16.2 with specific
rules
in all Member States, aiming at a later framework of
mutual
recognition
And
to make it possible that:
-
a
rephrasing of Art 14.1/ indent 3 concerning the rule of 1:10,000
to
remove the arbitrary and unscientific division within the range
of
single homeopathic medicinal products, and stops to be
counter
productive to the objectives of Directive 2001/83
-
in
Art. 68 and 69 a reference should be made to anthroposophic
nature
All
stakeholders agree that the patient's right to be treated according
to
his/her wish should be respected as a fundamental right.
Brussels,
14th
October
2003
The
Proposals are in detail:
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Anthroposophic
Medicine