SIMPOSI SOBRE EL PRESENT I EL FUTUR DELS MEDICAMENTS HOMEOPATICS A EUROPA
Sala d'Actes del COL.LEGI OFICIAL DE METGES DE BARCELONA
OBERT AL PUBLIC - D'especial interès per a farmacèutics. En anglès.
El proper divendres, dia 8, de 4 a 7'30 de la tarda, hi haurà un
Simposi sobre el present i el futur dels medicaments homeopàtics a
Europa, amb la participació entre d'altres del President de l'European
Committee for Homeopathy, del responsable de la Farmacopea Homeopàtica
dels Estats Units, de la portaveu del
Grup de treball dels medicaments homeopàtics de l'Agència Europea del
Medicament i de la coordinadora de les associacions de pacients
homeopàtics europees.
L'entrada és lliure però cal inscriure's abans per capacitat de la sala i coffee-break. L'idioma serà l'anglès.
Com secretària de la Secció de metges homeópates del COMB ho estic
coorganitzant. Si voleu assistir-hi, sisplau m'ho comuniqueu.
Dra. Anna Pla
ECH
Symposium Barcelona
- Viernes 8 noviembre 2013, COMB
16.00
a 17.30 (conferenciantes invitados)
16.00
– 16.15: Introducción y presentación por el Dr Thomas Peinbauer
(presidente del ECH )
16.15
– 16.35: Sra Marie- Anne Mouyart (HMPWG) (Grupo de Trabajo de
Productos Medicinales Homeopáticos)
La
justificación del uso de la homeopatía en el contexto de la
legislación de la UE sobre productos medicinales homeopáticos: un
reto para el futuro de la homeopatía y la protección de la salud
pública.
16.35
– 16.55: Dr Renzo Galassi (presidente de la LMHI )
La
definición del medicamento homeopático de la LMHI
16.55
– 17.15: Sr Nand de Herdt (presidente del ECHAMP past president,
Consultor
de la UE para temas de las Medicinas no Convencionales)
La
disponibilidad de los medicamentos homeopáticos
17.15
– 17.30: Sr Jack Hendrickx (farmacéutico)
Banco
de Remedios – ¿un modelo para asegurar la disponibilidad de los
productos medicinales homeopáticos en Europa?
17.30
– 18: pausa café
18.00
a 19.30 (ponentes del ECH )
18.00
– 18.15: Dr Michel Van Wassenhoven, ex coordinador del subcomité
de investigación del ECH
Contribución
de la investigación fundamental y clínica al registro de los
medicamentos homeopáticos
18.15
– 18.30: Dr Jean Pierre Jansen , coordinador del subcomité de
provings del ECH
El
Proyecto de harmonización de los provings homeopáticos del ECH/LMHI
18.30
– 18.45: Dra Fruzsina Gabor, coordinadora del subcomité de
farmacia del ECH
Contribución
del ECH al HMPWG en 2013
18.45
– 19.00 Sra. Sato Liu, coordinadora del subcomité de pacientes y
usuarios del ECH
La
opiníón de los pacientes ante la disponibilidad de los productos
medicinales homeopáticos
19.00
– 19.30: Mesa redonda con todos los ponentes, presidida por el Dr
Todd Hoover (HPUS)(Farmacopea Homeopática de los Estados Unidos)
Perspectivas
futuras para los productos medicinales homeopáticos en Europa.
Mme
Marie-Anne MOUYART
Marie-Anne
Mouyart, FAMHP, rapporteur of the HMPWG sub working group on
Justification of Homeopathic Use.
The
justification of homeopathic use in the context of the EU
legislation on homeopathic medicinal products: a challenge for the
future of homeopathy and the protection of the public health.
Taking
into account the requirements of the Directive 2001/83/EC on
medicinal products and in accordance with the criteria defined in the
document “Points to consider on Justification of Homeopathic
use”(HMPWG -Homeopathic Medicinal products Working Group- 2012)*, a
first list of stocks for which the homeopathic use is considered
justified has been adopted by the HMPWG after a public consultation
on the HMA (Heads of Medicines Agencies) website .
One
of the objectives of the HMPWG is to compile, as soon as possible, a
list of justified stocks as comprehensive as possible.
Indeed
due to the Principles of Homeopathy, in particular, the Similitude
law, the future and quality of homeopathy is linked to the
availability of a large number of well-defined stocks. Their quality
must be guaranteed in order to produce safe homeopathic medicinal
products.
We
are faced to a big challenge which involves a lot of actors and needs
the active collaboration of all of them (prescribers, pharmacists,
industry, experts in different fields). All those actors and
experts should be integrated in a large network including national
and EU authorities.
The
correct definition and characterization of the stocks and the
justification of their Homeopathic use is a key element from which
depends a lot of other aspects related to the quality and the safety
assessment of the homeopathic medicinal products put on the market.
The
HMPWG works thus also on the safety aspects and has already published
documents related to the project FSD (First Safe Dilution) on the HMA
website.
The
outcome of the public consultation on the first list of Justified
stock is taken as an example to illustrate the context we are faced
to.
Dr
Renzo Galassi
Since
1985
Dr. Renzo Galassi has been member of the Liga Medicorum Homoeopathica
Internationalis (LMHI).1990:
Degree
of "miembro correspondiente" of Homeopatia de Mexico
a.c.October
2001:Dr
Galassi was appointed Italian National Vice President of the LMHI for
a triennial mandate and was re-appointed for a further triennial
mandate in
2004.
He
is one of the founder members of the F.I.A.M.O (Federazione Italiana
delle Associazioni e dei Medici Omeopatici/Italian Federation of the
Homeopathic Doctors Associations).
Since
February 1999
he has been member of the non-conventional medicine committee as
homeopathic expert doctor at the medical Association of Macerata. In
1989
along with few colleagues he created the Hahnemannian Homeopathic
Academy of Marche Region which he still directs. He could thus
promote triennial courses for doctors and annual courses for
chemists.2007
he was appointed Prime General Secretary of the LMHI in Puebla,
Mexico.2010
he was appointed Prime Vice President of the LMHI in Los Angeles,
USA. In
2013
he was appointed PRESIDENT of the LMHI in Quito, Ecuador.
The
LMHI definition of the homeopathic remedy
The
presentation will be about the document initiated by Michel Van
Wassenhoven and Amarylis Cesar on Homeopathic remedies’ definition.
This document is, thanks to my initiative, under revision by our
working groups as well as all the other statements of the LMHI. We
are working to have better statements, with a more understandable
language, with new addition of the new members of EC and members of
the WGs.
Mr
Nand De Herdt
Nand
De Herdt graduated in Pharmacy at the University of Leuven (Belgium)
in 1972. He followed postgraduated educations in Homeopathy in Liège
– School of Dr. Clercx and the French homoeopathic doctor Gérard
Guéniot (1978-1979), Industrial Pharmacist in Basel and Stuttgart
(1984-1985) and Marketing in Leuven (1995-1996). He was dispensing
chemist from 1972 until 1987. In 1988 he created the Weleda Company
in Leuven - Belgium and stayed there as managing director until 1997.
In 1998 Nand De Herdt moved to France to start the Central
Registration Office of the Weleda Group. Since 1999 he is the
European Affairs Officer for the Weleda Group. In 1999 he has been
one of the co-founders of ECHAMP. Since the foundation he is a member
of the ECHAMP Board of Management. From 2004 until 2009 Nand De Herdt
has been the General Secretary of the Association. In April 2009 he
was elected President of ECHAMP. He retired from all his professional
functions in June 2013. Currently he still is active as independent
consultant for EU CAM Affairs (Healthcare and Medicinal Products)
The
homeopathic remedies’ availability
Since
a couple of years availability of medicinal products is in the centre
of the discussions in the European Union. A first report on the topic
have been made by the Heads of Medicines Agencies
http://www.hma.eu/221.html
The
Health and Environment committee (ENVI) of the European Parliament
made a report on the differences in costs and access to
pharmaceutical products in the EU in 2010.
The
European Commission has installed a so-called Platform on access to
medicines in Europe. This platform has published several reports.
And
last September the European Public Health Alliance has organised a
conference in the European Parliament. http://www.epha.org/a/5809
Out
of all these initiatives it became obvious that the regulatory
environment and especially the lack of assessment capacities in the
small and medium sized medicines agencies is one of the major reasons
that equal availability and accessibility all over the EU is a major
problem.
Homeopathic
medicinal products were not yet in the scope of these reports and
conferences. This might change in a next report from the European
Commission which is planned to be made public still in 2013.
In
January 2012 the European Commission ordered a preliminary study on
the availability of medicinal products for human use at the London
based consultancy office Matrix Insight
The
objectives of the study are:
• To
collate data on the availability of medicinal products for human use
across the EU.
• To
analyse the extent of unavailability problems, with a particular
focus on small Member
States.
• To
identify the causes of the problem in the different Member States
facing availability issues.
• To
analyse how, and to what extent, recent changes to EU pharmaceutical
legislation, and the modalities of application of regulatory
requirements at EU or national level, have served to alleviate the
problem.
Based
on an ‘informal suggestion’ of Mr. John Dalli the former European
Commissioner for health and consumer affairs ECHAMP started making
such a study for homeopathic and anthroposophic medicinal products
already in 2010.
With
support of two independent surveys by PriceWaterhouseCoopers ECHAMP
investigated in a very detailed way demand, availability, the
European legislation and the regulatory environment. We found very
interesting interconnections and four major deficits
The
report summary concludes as follows:
The
report represents a significant benchmark for analysis of this sector
of the pharmaceutical industry in the EU. It is hoped it will
initiate a discussion on the further actions needed to overcome the
deficits of the enforcement of the implementation of rules for these
products in the EU Member States, and, where needed, the
disproportionate requirements and high administrative burden of the
Community legislation. This is needed to guarantee not just the
quality and safety but also the availability of homeopathic and
anthroposophic medicinal products and to ensure freedom of choice for
the tens of thousands of prescribers and many millions of users in
the EU.
The
full report has not been made public so far. It has been sent to the
European Commission and to Matrix Insight before they started the
work on their report in the first half of 2012. We can almost be sure
that the ECHAMP report will serve as a basis for the chapter on
homeopathic medicinal products which will be part of the Matrix
Insight and European Commission report. Before the end of 2013 we can
be sure about this.
For
the first time an official European report will pay attention to the
availability problems of homeopathic medicinal products in the
European Union and in the Member States.
Mr
Jack Hendrickx
CV:
Remedy
Bank - A Model to ensure the Availability of Homeopathic Medicinal
Products in Europe?
Summary :
Dr
Michel Van Wassenhoven
Medical
doctor (Université Catholique de Louvain) 1974
Electrocardiography
(UCL) 1976 ; Specialist General Medicine (UCL) 1976
Homeopathic
MD (Ecole Belge d’Homéopathie, Bruxelles) 1979
Founder
and President of UNIO HOMEOPATHICA BELGICA 1986-2008
Founder
of ECH (1991), coordinator research sub-committee 1994-2012
Belgian
LMHI Vice President 1995-2007
GIRI
member (Groupe International de Recherche sur l’Infinitésimal)
since 1996,
GIRI
Vice President since 1999
President
of the Belgian registration committee for homeopathic medicinal
products (Service Public Fédéral Santé publique) since 2002.
LMHI
Secretary for Research 2007-2013
Organiser
of the 63th LMHI congress of the LMHI in 2008 in Belgium.
Contribution
of basic and clinical research to the registration of the homeopathic
medicines.
The
registration or the authorization of a homeopathic medicine in Europe
requires various types of scientific data, among them, in particular
the requirements relative to the justification of the homeopathic use
which are clearly specified in a published document on the website of
the HMA (Head of Medicine Agencies). These requirements of scientific
documentation of the homeopathic use are coming in addition to the
requirements for quality control and safety which remain naturally
essential and are the object of other criteria also published on this
website. General information and guidelines are also available on the
website Eudralex and on the website of the EMA.
For
the clinical aspects, the necessary data are, according to their
availability, the provings and the clinical verifications published
case by case or into specific traditional homeopathic books called "
material medica ". All other forms of clinical and fundamental
research allowing to better understand the mode of action of the
homeopathic remedy are useful for a simplified registration, and
compulsory for the complete registration procedure ending in an AMM (
marketing authorization) for this medicine. This presentation aims at
presenting these various aspects of registration but also at
underlining the last advances in basic research which should allow
considering homoeopathy as being a part of the nano-medicine. This
theme is considered in more and more publications in modern medicine
but could have an implication (if confirmed) on the registration, GPP
and delivery of the homeopathic medicines.
Dr
Jean Pierre Jansen
Jean
Pierre Jansen MD practices homeopathy, neural therapy and naturopathy
in Groningen, The Netherlands, and is coordinator of the ECH
Subcommittee for Provings since 2008.
The
ECH/LMHI Harmonization Project on Homeopathic Provings
Homeopathic
provings are essential for the development of new materia medica
knowledge. It was one of the first systematic research designs in
medicine, and in as early as 1835 the first context for serious
placebo research in medicine as well.
The
revival of homeopathy in the 1970's came with a re-evaluation of
quality aspects of provings. Bayr's inclusion criteria for symptoms
are a landmark publication (1986) for this development. Since the
early 1990's there is a trend to introduce concepts from conventional
trials into the design of provings. Jeremy Sherr's publication (1994)
inspired many, resulting in hundreds of provings since. In parallel,
many new approaches to patient case analysis developed, which played
a certain role in the way that provings are seen.
A
systematic review (2007) of provings until 1995 found problems, when
seen from a conventional scientific point of view. However, millions
of cases are helped worldwide based on 200 years of provings.
Furthermore, the maturation of a remedy's materia medica depends also
on the pitfalls during the phase of clinical verification, which in
the end is the yardstick for the validity of a proving. Therefore the
need for improvements must be answered in these perspectives.
The
ECH Subcommittee for Provings published its Proving Guidelines in
2004, taking first and for all into account two centuries of
homeopathic theory and proving experience, and integrating both legal
regulations and universally accepted documents on human experiments.
A common misunderstanding became apparent, leading to the publication
in 2005 of a position paper, concluding that provings are not phase I
trials. Gradually the ECH guidelines have helped many stakeholders,
including regulatory bodies, to gain insight into the purpose and
homeopathic logic of provings.
Since
2011 the LMHI published two editions of its Guidelines for Provings,
starting from the ECH Guidelines but with various major and minor
differences. In a globalising context it seems logical that ECH and
LMHI cooperate, so that all stakeholders can rely on a common
document that is supported by the homeopathic profession that
produces and uses the results of provings. Therefore a harmonisation
of ECH and LMHI guidelines for provings has been initiated, with the
aim to publish the first harmonised edition during the LMHI Congress
in Paris in July 2014.
During
the presentation today a report about the results until now will be
presented.
Dr. Ashley
Ross is head of the department of homeopathy at Durban University of
Technology, where he practices homeopathy, and is coordinator of the
LMHI Working Group for Provings.
Dr.
Ashley Ross on behalf of LMHI and Dr. Jansen coordinate the
harmonisation of proving guidelines of LMHI and ECH.
Dr
Fruzsina Gabor
…
Mrs
Sato Liu
…
Dr
Todd Hoover
Dr.
Todd Hoover is present here as a representative from the Homeopathic
Pharmacopeia of the United States (HPUS). Dr. Hoover has been in
homeopathic clinical practice and a Clinical Preceptor for Hahnemann
Medical College for over 20 years. He is immediate past president of
the American Institute of Homeopathy, current Trustee for the HPUS,
Chair of the HPUS Provings committee, and current U.S. National Vice
President for the Liga. Dr. Hoover has published research studies in
both homeopathic and allopathic journals, and has presented lectures
both in the U.S. and abroad on a wide array of homeopathic topics.
Dr. Hoover led the development of the recently published Proving
Guidelines for the HPUS and brings the insights gained through that
development to our meeting today.
