HMPWG Sub working group “Justification of homeopathic use”
FAMHP Brussels 28/08/2012 10 am – 4 pm
Participants:
Cornelia Hutterer-Siebert (Germany), Chris Potsides (Greece), Jasbinder Sumal (UK),
Michel Dr Van Wassenhoven, Patricia Bodart and Marie-Anne Mouyart (Belgium)
Apologies:
Catherine Printz (Fr) Laurence Girod (Chair), Gwen Glazsgow (Irl) Marie-Helena
Pinto Ferreira, Eva Mendes (Port), Emiel Van Galen( Nl), Aetor Olaso (Sp).
Note: After consultation of the members of the subgroup, and due to some logistic
opportunities, the invitation was sent to all the members of the HMPWG. Not any
reaction and/or response was received.
Conflicts of interest to be declared:
No conflict of interest was declared.Note:
Marie-Anne explained the attendance of Dr. Van Wassenhoven at the meeting as a
national expert, he is the chair of the Belgian commission for Homeopathic medicinal
products for human and veterinary use. Dr M Van Wassenhoven has signed the
declaration of interest (format EMA)Adoption of the agenda:
The agenda was adopted; it was just suggested beginning the work by the list of
justified stocks.
Mandate and Work program
Mandate:
Even if redundant (see point IV2 1st item), the change proposed by Catherine in order
to clarify the question of conflict of interests proposed in Copenhagen (see point III),
is accepted together with the change related to the appointment of the rapporteur for 3
years. It was also suggested to use the identical wording as in the general document
Rules of procedure.
About the amendment related to the use of Alfresco system: on basis of the exchange
of experience it was concluded that even if the necessity to use this kind of tool was
recognized, it was clearly observed that at the moment experience and training of
some members of HMPWG are not yet satisfying and that the use of this tool is not
yet enough efficient within the HMPWG.
Marie-Anne proposed that it should be discussed at the next HMPWG-meeting in
Gdansk .
It was thus proposed to adapt the text of point 3 as such (in blue):
“3. The work programme
The work programme should be adopted by the HMPWG.
The work programme shall be regularly reviewed and updated by the
subgroup if necessary with the agreement of the HMPWG. The documents,
should ideally be available in the Alfresco System. However the decision to
use Email system as a temporary alternative could to be taken within the
group with the rapporteur. The documents should be circulated for approval
by the subgroup members and adopted by the HMPWG members”.
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General Work Program:
A member asked clarification related to the procedure to be followed and whether the
industry will be involved in the compilation of data. The rapporteur mentioned that
this option (compilation of data by the industry and shared assessment by the
authorities) is the idea for the FSD project. About the Justification of Homeopathic
use, due to the work and the compilation of data already done by the HMPWG
members, by ECH and by Dr Van Wassenhoven (HMA jobs) it seems more
appropriate to continue the work within the sub group and the HMPWG and to ask at
the end to the industry to concentrate his resources on the problematic stocks for
which only poor data are available.
A member mentioned that it could be useful/ necessary to take into account ongoing
procedures in countries. Indeed in this case energy and resources can be spent taking
into account the data under assessment in the concerned countries.
The attention was also paid on the question of availability of stocks.
Cornelia stated that only monographs of Pharmacopoeias currently used officially in
the Member States could be used to identify the raw material used for the preparation
of the stock because the registration has to follow European law (Dir. 2001/83 EC).
The difficulty of Germany with the lists of ECH is that the description of the raw
material is not linked to the materia medicae. If according to the HMPWG in the
toxicological assessment of FSD an exact definition of raw material should be given,
it is necessary to be also exact in the clinical issues of “Homeopathic Use”.
It was thus suggested to amend the content of the first bullet point of the general
program taking into account the available data and the work already done in the
subgroup. The proposal will circulate between the members of the subgroup before to
be submitted to the HMPWG.
“The data available in the preliminary detailed table will be compiled together with
the data submitted by ECH and the data available within the HMA jobs. The
subgroup will analyze those data stock by stock taking into account the description of
the stocks (in the pharmacopoeias monographs currently used officially in the
Member States when they exist and in the homeopathic literature). A list of justified
stocks will be submitted after each sub working group to all the HMPWG members
for approval and publication”.
The second and third bullet points were accepted as already existing
Clarification related to the ECH work
After a meeting in February 2012 between ECH, the chair and Belgium, ECH
submitted a pilot list of 20 stocks (distributed for the HMPWG in Copenhagen).
ECH put his work on hold waiting the comments and reactions of HMPWG
The used tool is the tool available near ECH experts. It contains all the available
English literature and to-day the most extensive list of English books.
ECH is open to the idea to extend the extraction of data to other languages on demand
of the HMPWG. It was asked for mentioning reliable homeopathic authors.
The necessity of integrating the homeopathic literature in other languages) in general
was explained and discussed. It seems necessary to include also the literature in other
languages, because they are often not translated in English.
At the end, It was estimated during the WG that in some cases it could be useful when
the data are not sufficient and/or on a case by case (e.g. when difficult to
identify/define correctly the raw material) and on a step by stepbasis (not a one shot
action on the complete list already existing)
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clear.
Indeed a member though that some other literature references could not correspond to
the EU tradition which has to be taken into account in priority. Attention was alsopaid
on the fact that in some non EU literature (US or Indian) the definition and quality
level of the raw material/stock is not always clear.
The group discussed also on the value and significance of the number of symptoms. It
was concluded that this number gives only an indication which can demonstrate the
frequency of the remedy use and therefore constitutes a kind of validation factor
However it was concluded that it is important to have provings in the proposed
references (with an acceptable number of provers) in combination with materia
medica in order to justify the homeopathic use.
It was also specified that the Hahnemann provings are published by Stephenson.
Proposal of a first list of justified stocks:
The rapporteur explained that the list submitted to the members for the sub working
group is the result of the compilation of
- data of the list already prepared by Christine Werner and completed by the
members of the HMPWG, (this original list is called the HMPWG list)
- data issued from the works of ECH (pilot list submitted in June in
Copenhagen and HMA jobs submitted by Dr Van Wassenhoven in
12/2010 in Liège).
On this basis, a green list and a yellow list were submitted for discussion by the
subgroup.
The green list is a compilation of stocks mentioned in the HMPWG list and in the
pilot list of ECH; the yellow list is a compilation of data related to stocks mentioned
in the HMPWG list and in the HMA jobs (based on the English literature).
In those 2 lists, the slight differences in the description of the raw material/stocks
were mentioned in bold characters.
Before to begin the work on the lists, Cornelia explained clearly the link between the
commission D monographs and the selected materia medica mentioned in the so
called HMPWG list, she reminded the reference to the head to toes scheme and how
was managed the existence of a description of the raw material/stock in the mentioned
homeopathic literature.
Cornelia will check the number of available commission D monographs (from which
the revision is stopped).
(post-meeting note: there exist ca 1255 commission D monographs)
The question related to the need of a description of the stock put in front by Marie
Helena was also discussed; all the members agreed on the fact that this description is
necessary and was more or less implicitly required by the PTC under the point I.1.
Nomenclature.
Indeed, it is necessary from the quality and non clinical points of view (see also FSD
project) to clearly define the raw material/stock used, and the link has to be done in
the dossier between the different modules.
Dr Van Wassenhoven insists also on the fact that this kind of information could be
very useful for the prescribers.
After this introduction, the members go through the green and yellow lists, stock by
stock verifying the description of the stocks and the availability of documentation
justifying the homeopathic use.
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Each difference was discussed (and in some cases checked directly within the FP and
GHP) within the subgroup.
- In many cases it was concluded that the differences put in bold character
are related to a loss of precision in one of the official pharmacopoeias but
that those differences are only to be kept in mind when the revision of
those monographs will be done in the future or when a Ph. Eur.
Monograph will be prepared. They are colored in light green or yellow.
- It was agreed that the way the subgroup managed these small differences
should be explained at the next HMPWG meeting in Gdansk and that the
impact of more important differences in the description of the raw material
(e.g between dried and fresh) should be discussed during the next meeting
of the subgroup in presence of some specialized experts .
The homeopathic use of all those stocks (light colored) have been
considered justified taking into account the available homeopathic
literature references and the slight differences in the description..
(see Belladonna, Nux vomica, Thuya, Berberis vulgaris, Cactus, Ignatia,
Dulcamara, China, Viscum album, Carbo vegetabilis FP)
-
In some cases (Phosphorus, Calcarea fluor, Hepar Sulfur, Secale
Cornutum, Cantharis) there were two lines for the same stock in the
HMPWG list, but with only one official pharmacopoeia. In those cases, it
was decided to delete this second line but also to check if there was an
existing Ph. Eur. Monograph (it will be done in the few weeks). Note that
it will be done also for Cocculus (2013) but also for Argentums nitricum,
Kali Iodatum, Apis Mel, Ipeca, China rubra
-
Some stocks are colored in pink, they will not be included in the first list of
justified stocks because the description of those stocks doesn’t correspond
to the available data of the homeopathic literature; some stocks with the
same name but are chemically different even with the same name.
Further clarification is needed.(ex Calcarea Phosphorica, Kalium
Phosphoricum)
-
Some corrections of the description initially introduced in the HMPWG list
were introduced (in italic) in the table after verification of the description
in the FP or GHP.
-
Some precision (e.g. the species) related to the name of the stock were
deleted due to the fact that in the monograph and the available
homeopathic literature, it is mentioned that the corresponding stock may
be prepared from a mixing of species (see Bryonia , Lachesis, Calc Phos.).
-
The case of Pulsatilla was verified in depth, indeed the available
homeopathic literature refers to the Pulsatilla pratensis which is not a
synonym of Pulstatilla vulgaris. However there is an official
pharmacopoeia monograph related to Pulsatilla vulgaris. It was decided to
put Pulsatilla vulgaris on hold and to maintain only Pulsatilla pratensis in
the green list.
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Avena sativa was colored in orange, it was taken as an example for the future
management of data and procedure. Indeed,
- same description in France and Germany
- existence of an official pharmacopoeia monograph
- poor available homeopathic literature (one proving in the English literature)
However, a MRP has been finalized involving three countries, it was decided that
those countries will check the available and submitted data (may be in other
languages). This stock will be put on hold till clarification.
In conclusion, the light and dark green and yellow stocks on those lists are considered
justified and will be submitted to the members of the HMPWG for approval and
publication on the HMA website during the next meeting in Gdansk.
It was suggested to continue the work on this basis (compilation of HMPWG
available data and the ECH/HMA works) in order to be consistent with the
requirements of the PTC related to the (single) stock.
Points to consider on justification of homeopathic use: brainstorming
- How do we understand “homeopathic use”?
- Combinations assessment: what to do?
Some members asked why to discuss on this issue taking into account the fact that the
HMPWG has already adopted a PTC defining those criteria for single stocks.
However it was accepted to envisage the discussion on this issue when related to
combinationsDuring the discussion, it appears clearly that, even if the members
consider that the rationale justifying the combination, the level of dilutions used, the
question of synergie or antidotes are relevant aspects to be taken into account for the
justification of a combination and to guarantee his safe use from a public health point
of view; it appears clearly that the regulatory context is not clear and that the
decision of the court of Justice is applicable to all the EU MS. A member of the
subgroup mentioned that according to the judgement of the European Court of Justice,
a justification for a combination must not be claimed.
It was also recognized that the understanding of the content of the decision of the
court of Justice is not uniform between the EU MS.
It was suggested that, may be, this text should be submitted to the analyze of lawyers.
There are many other unclear points in the directive which could be more consistent
for what concerns the homeopathic medicinal products. Unfortunately until the
commission will not be convinced of those difficulties, we never find a satisfying
solution.
It was thus proposed and concluded that the best way should be to invite and to
involve the EU Commission representative who should attend all the meeting of
HMPWG in order to sensibilize the EU commission to all those problems and to the
specificities related to homeopathy. We need to take time enough for this work and
this sensibilisation in order to solve the regulatory questions which we are faced with..
It was thus suggested to put the idea to produce the second part of the PTC related to
combination on hold till more adapted circumstances.
Conclusions:
The rapporteur thanks with her heart all the colleagues who attended and who
contributed to this very fruitful meeting. She highlighted the efforts and involvement
of each the members in order to be present and to contribute so hardly to the outcome
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of this meeting. She thanks also cordialy Dr Van Wassenhoven for his presence and
his very important contribution on this issue.
A report and the lists including the list of justified stocks as described will be
circulated between the members who have attend the meeting of the subgroup for
comments before to be transmitted to the Chair and all the HMPWG members.
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