CELEX: 51991PC0313(02)
Language: en
Date: 1991-08-02
Title: AMENDMENT TO THE PROPOSAL FOR A COUNCIL DIRECTIVE WIDENING THE SCOPE OF DIRECTIVE 81/851/EEC ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES ON VETERINARY MEDICINAL PRODUCTS AND LAYING DOWN ADDITIONAL PROVISIONS ON HOMEOPATHIC VETERINARY MEDICINAL PRODUCTS

COMMISSION OF THE EUROPEAN COMVTUNITIES
                                          C0M(91) 313 final - SYN 251 and 252
                                          Brussels,  2 August 1991
                        Amendment to the proposal for a
silt
                                COUNCIL DIRECTIVE
       widening the scope of Directives 65/65/EEC and 75/319/EEC on the
          approximation of the laws of the Member States on medicinal
                                                                         SYK 251
               products and laying down additional provisions on
                         homeopathic medicinal products
                          Amendment to the proposal for a
                                 COUNCIL DIRECTIVE
       widening the scope of Directive 81/851/EEC on the approximation of
         the laws of the Member States on veterinary medicinal products
               and laying down additional provisions on homeopathic       SYN 252
                           veterinary medicinal products
            (presented by the Commission pursuant to Article 149(3)
                               of the EEC-Treaty)
 ---pagebreak---                                             - 2 -
                                EXPLANATORY MEMORANDUM
At its plenary session on 13 June 1991, the European Parliament, on first reading
of the co-operation procedure, gave its opinion upon two proposals for Directives
relating to homeopathic medicines for human and veterinary use - COM(90)72 of
22.03.90, SYN 251-252.
The Commission has decided, in accordance with Article 149, paragraph 3 of the EEC
Treaty, to amend its proposals in order to incorporate into the text 17 out of the
28 amendements adopted by the Parliament.
The primary aims of the amendments accepted by the Commission are :
- to avoid the distortion of competition between manufacturers
- to maintain the principle of a free choice of therapies
- to assimilate anthroposophic medicines as homeopathic medicines when described
  in an off I cal pharmacopoeia
- to introduce appropriate references to homeopathic and anthroposophic
  principles.
 ---pagebreak---                                              - 3 -
By contrast, the Commission rejected other amendments for three principal reasons.
Certain of the amendments go far beyond the limits of those proposals which deal
with the free movement of medicines, for example; training for and engaging in
professional practice, and the way in which the cost of medicines to the patient
is met by public funding.
Some amendments show excessive partiality towards particular medical traditions,
bearing in mind that the Commission must remain neutral in the debate between
"conventional" and "alternative" medicine.
Other amendments would widen excessively the scope of the simplified registration
procedure   (Article 7 ) , to the extent that a full marketing authorization
(Article 9) would become an exception to the normal rule.
It is worth recalling that since 1965 throughout the Community the normal basis
for a marketing authorization has been three standard criteria (quality, safety
and efficacy) leading the competent authorities to undertake an evaluation of the
risks and benefits expected of the medicament in question.
 ---pagebreak---                                             4 -
However, the simplified registration procedure, in the form proposed by the
Commission, constitutes rather an administrâtive notification, adequate for
homeopathic medicines which do not present any known risk by virtue of their
method of administration (oral) and the low concentration of their active
constituents, which is fixed at less than one part per million.  Manufacturing
quality can be verified from the dossier supplied.
The other routes of administration described by the pharmacopoeias, especially
injectibles, or stronger concentrations of active constituents, can, in certain
cases, expose patients to potential risks and necessitate because of this a more
comprehensive authorization procedure based upon an evaluation of the risks and
benefits by the competent authorities in accordance with the provisions of
Article 9.
 ---pagebreak---                                              - 5 -
                           Amendment to the proposal for a
                                   COUNCIL DIRECTIVE
          widening the scope of Directives 65/65/EEC and 75/319/EEC on the
             approximation of the laws of the Member States on medicinal
                                                                              SYN 251
                  products and laying down additional provisions on
                            homeopathic medicinal products
            (Presented by the Commission in accordance with article 149,
                              paragraph 3 of EEC Treaty)
Original proposal                             Amended proposal
                              Titles and visas unchanged
                                      First recital
Whereas differences currently existing        Whereas differences currently existing
between the provisions laid down by            between the provisions laid down by
 law, regulation or administrative             law, regulation or administrative
action in the Member States may hinder         action in the Member States may hinder
trade in homeopathic medicinal                 trade in homeopathic medicinal
products within the Community;                 products within the Community and thus
                                               lead to discrimination and distorsion
                                               of competition between manufacturers of
                                               these products;
                                 2nd recital unchanged
                                    Recital 2a (new)
                                               Whereas freedom of choice with regard
                                               to therapy needs to be safeguarded;
                                               whereas, despite considerable dif-
                                               ferences in the status of alternative
                                               medicines in the various Member States,
                                               patients should be guaranteed free
                                               access to the therapy of their choice,
                                               provided all precautions are taken to
                                               ensure the quality and safety of
                                               products;
                                 3rd recital unchanged
 ---pagebreak---                                            - 6 -
Original proposal                           Amended proposa
                                   Fourth recital
Whereas homeopathic medicine is             Whereas homeopathic medicine is
officially recognized in certain            officially recognized in certain
Member States but is only tolerated         Member States but is only tolerated
in other Member States; whereas,            in other Member States;
therefore, it is appropriate to
recognize certain national homeopathic
traditions without imposing them
throughout the Community;
                        5th, 6th and 7th recitals unchanged
                                   Eighth recital
Whereas, having regard to the               Whereas, having regard to the
particular characteristics of these         particular characteristics of these
medicinal products, such as their           medicinal products, such as their '
very low content of active principles       very low content of active principles
and the difficulty of applying to them      and the difficulty of applying to them
the conventional statistical methods        the conventional statistical methods
relating to clinical trials, it is          relating to clinical trials, it is
appropriate to provide a simplified         appropriate to provide a simplified
registration system for those               registration system for those
traditional homeopathic medicinal           traditional homeopathic medicinal
products which are placed on the market     products which are placed on the market
without specific therapeutic                without specific therapeutic
indications in a preparation which          indications in a preparation and dosage
does not present a risk for the patient;    which does not present a risk for the
                                            patient;
                               9th recital unchanged
 ---pagebreak---                                             - 7 -
Original proposal                            Amended proposal
                                      Art icle 1
For the purposes of this Directive            For the purposes of this Directive
"homeopathic medicinal product" shall         "homeopathic medicinal product" shall
mean any medicinal product prepared in       mean any pharmaceutical preparation
accordance with a homeopathic manufac-        prepared in accordance with a
turing procedure described by the             homeopathic manufacturing procedure
European Pharmacopoeia, or in the             described by the European
absence thereof, by the official              Pharmacopoeia, or in the absence
pharmacopoeia of a Member State.              thereof, by the official pharmacopoeia
                                              of a Member State.
                                              For the purposes of this Directive
                                              anthroposophical medicinal products
                                              described by an official pharmacopoeia
                                              shall be treated as equivalent to
                                              homeopathic medicinal products.
Homeopathic preparations are                  Homeopathic preparations are produced
produced from products, substances            from products, substances or composi-
or compositions called homeopathic            tions called homeopathic stocks by
stocks by successive dilutions.               successive dilutions and potentiation.
                                              A homeopathic medicinal product may
                                              also contain a member of different
                                              components.
                                              A homeopathic preparation may contain,
                                              with the exception of catalysts, only
                                              homeopathic stocks in a minimum
                                              dilut ion of 1:10.
                        Articles 2, 3, 4, 5 and 6 unchanged
                         Article 7, paragraph 1 unchanged
                                    Article 7 (2)
                               Seventh indent a (new)
                                              - a sentence advising the user to
                                                consult a competent therapist whilst
                                                using the medicinal product if the
                                                 if the symptoms persist.
                           Rest of the article unchanged
 ---pagebreak---                                            - 8 -
Original proposal                           Amended proposa
               Article 8, introductory phrase and first three indents
An application for a simplified             An application for a simplified
registration submitted by the person        registration submitted by the person
responsible for marketing may cover         responsible for marketing may cover
a series of preparations derived from       a series of preparations derived from
the same homeopathic stock.    The          the same homeopathic stock or stocks.
following documents shall be included       The following documents shall be
with the application in order to            included with the application in order
demonstrate, in particular, the             to demonstrate, in particular, the
pharmaceutical quality and the batch        pharmaceutical quality and the batch
consistency of the products concerned :     consistency of the products concerned
  scientific name of the homeopathic        - scientific name of the homeopathic
  stock, together with a mention of           stock or stocks, together with a
  the various routes of administra-           mention of the various routes of
  tion, pharmaceutical forms and              administration, pharmaceutical forms
  dilut ions to be registered;                and strengths to be registered;
  dossier describing how the                - dossier describing how the
  homeopathic stock is obtained and           homeopathic stock or stocks is/are
  controlled, and Justifying its              obtained and controlled, and
  homeopathic nature, on the basis            Justifying its homeopathic nature,
  of an adequate homeopathic biblio-          on the basis of an adequate homeopa-
  graphy;                                     thic or anthroposophical bib Iio-
                                              graphy;
  manufacturing and control file            - manufacturing and control file
  for each pharmaceutical form and            for each pharmaceutical form and
  a description of the method of              a description of the method of
  dilut ion;                                  dilution and potent iat ion;
                           Rest of the article unchanged
 ---pagebreak---                                              - 9 -
Original proposal                             Amended proposal
                                     Article 9 (1)
1. Homeopathic medicinal products             1. Homeopathic and antroposophical
other than those referred to in               medicinal products other than those
Article 7 shall be authorized and             referred to in Article 7 shall be
label led in accordance with the              authorized and labelled pursuant to
provisions of Articles 5 to 21 of             the provisions of Articles 5 to 21 of
Directive 65/65/EEC and Articles 1            Directive 65/65/EEC and Articles 1
to 7 of Directive 75/319/EEC,                 to 7 of Directive 75/319/EEC,
including the provisions concerning           including the provisions concerning
proof of therapeutic effect.                  proof of therapeutic effect, in
                                              accordance with the basic principles
                                              and special nature of homeopathic or
                                              anthroposophlcal medicine.
                               Article 9(2) unchanged
                          Article 10 (1) and (2) unchanged
                                 Article 10 (3) (new)
                                              3. Not later than 31 December 1995 the
                                              Commission shall present a report to
                                              the Council and to the European
                                              Parliament concerning the operation of
                                              this Directive.
                                 Article 11 unchanged
 ---pagebreak---                                              - 10 -
                           Amendment to the proposal for a
                                   COUNCIL DIRECTIVE
        widening the scope of Directive 81/851/EEC on the approximation of
          the laws of the Member States on veterinary medicinal products
                                                                                SYN 252
                and laying down additional provisions on homeopathic
                             veterinary medicinal products
            (presented by the Commission in accordance with Article 149,
                            paragraph 3 of the EEC Treaty)
Original proposal                             Amended proposal
                                      First recital
Whereas differences currently                 Whereas differences currenlty
existing between the provisions laid          existing between the provisions laid
down by law, regulation or administra-         down by law, regulation or administra-
tive action by the Member States may           tive action in the Member States may
hinder trade in homeopathic medicinal          hinder trade in homeopathic medicinal
products within the Community;                products within the Community and thus
                                               lead to discrimination and distorsion
                                              of competition between manufacturers of
                                               these products;
                                 2nd recital unchanged
                                    Recital 2a (new)
                                              Whereas freedom of choice with
                                               regard to therapy needs to be
                                              safeguarded;
                                 3rd recital unchanged
                                     Fourth recital
Whereas homeopathic medicine is               Whereas homeopathic medicine is
officially recognized in certain              officially recognized in certain
Member States but is only tolerated           Member States but is only tolerated
in other Member States; whereas,               in other Member States;
therefore, it is appropriate to
recognize certain national homeopathic
traditions without imposing them
throughout the Community;
                        5th, 6th and 7th recitals unchanged
 ---pagebreak---                                            - 11 -
Original proposal                            Amended proposal
                                   Eighth recital
Whereas, having regard to the                Whereas, having regard to the
particular characteristics of these          particular characteristics of these
medicinal products, such as their            medicinal products, such as their
very low content of active principles        very low content of active principles
and the difficulty of applying to them       and the difficulty of applying to them
the conventional statistical methods         the conventional statistical methods
relating to clinical trials, it is           relating to clinical trials, it is
appropriate to provide a simplified          appropriate to provide a simplified
registration system for those                registration system for those
traditional homeopathic veterinary           traditional homeopathic veterinary
medicinal products which are placed          medicinal products which are placed
on the market without specific               on the market without specific
therapeutic indications in a                 therapeutic indications in a
preparation which does not present           preparation and dosage which does not
a risk for the animal or the consumer        present a risk for the animal or the
of animal products;                          consumer of animal products;
                                9th recital unchanged
                                      Art icle 1
 For the purposes of this Directive           For the purposes of this Directive
 "homeopathic veterinary medicinal            "homeopathic veterinary medicinal
 product" shall mean any veterinary           product" shall mean any pharmaceuticai
 medicinal product prepared in                preparation prepared in accordance with
 accordance with a homeopathic                a homeopathic manufacturing procedure
 manufacturing procedure described by         described by the European
 the European Pharmacopoeia, or in            Pharmacopoeia, or in the absence
 the absence thereof, by the official         thereof, by the official pharmacopoeia
 pharmacoposia of a Member State.             of a Member State.
 Homeopathic preparations are produced        Homeopathic preparations are produced
 from products, substances or                 from products, substances or
 compositions called homeopathic stocks       compositions called homeopathic stocks
 by successive dilutions.                     by successive dilutions and
                                              potentiation.  A homeopathic medicinal
                                              product may also contain a number of
                                              different components.
 ---pagebreak---                                             - 12 -
                                             Homeopathic preparations may contain,
                                             with the exception of catalysts, only
                                             homeopathic stocks, in a minimum of
                                              1:10.
                      Articles 2, 3, 4, 5, 6 and 7 unchanged
Original proposa                             Amended proposa
                                      Art icle 8
An application for a simplified              An application for a simplified
registration submitted by the person          registration submitted by the person
responsible for marketing may cover           responsible for marketing may cover
a series of preparations derived from         a series of preparations derived from
the same homeopathic stock.  The              the same homeopathic stock or stocks.
following documents shall be included        The following documents shall be
with the application in order to              included with the application in order
demonstrate, in particular, the               to demonstrate, in particular, the
pharmaceutical quality and the batch          pharmaceutical quality and the batch
to batch consistency of the products          to batch consistency of the products
concerned :                                   concerned :
  scientific name of the homeopathic            scientific name of the homeopathic
  stock, together with a mention of             stock or stocks, together with a
  the various routes of administration,         mention of the various routes of
  pharmaceutical forms and dilut Ions           administration, pharmaceutical forms
  to be registered;                             and strengths to be registered;
  dossier described how the stock is            dossier describing how the
  obtained and controlled, and                  homeopathic stock/stocks is/are
  Justifying its homeopathic nature,            obtained and controlled, and
  on the basis of an adequate                   Justifying its/their homeopathic
  homeopathic bibliography;                     nature, on the basis of an
                                                adequate homeopathic bibliography;
 ---pagebreak---                                   - 13 -
manufacturing and control file     - manufacturing and control file
for each pharmaceutical form and     for each pharmaceutical form and
a description of the method of       a description of the method of
dilution;                            d iI ut i on and potent I at ion;
manufacturing authorization for    - manufacturing authorization for
the preparations concerned;          the preparations concerned;
copies of any registrations or       copies of any registrations or
authorizations obtained for the      authorizations obtained for the
same preparations in other Member    same preparations in other Member
States;                              States;
one or more specimens or mock-ups    one or more specimens or mock-ups
of the sales presentation of the     of the sales presentation of the
preparations to be registered.       preparations to be registered;
                                     documents quaranteeing the safety
                                     of the preparation and, in the case
                                     of veterinary medicinal products
                                      intended for administration to food-
                                     producing animals, quaranteeing the
                                     absence of harmful residues.
 ---pagebreak---                                            - 14 -
Original proposal                           Amended proposal
                                     Art icle 9
Homeopathic veterinary medicinal             Homeopathic veterinary medicinal
products other than those referred           products other than those referred
to in Article 7 shall be authorized          to in Article 7 shall be authorized
and labelled in accordance with the          and labelled in accordance with the
provisions of Articles 5 to 15 of            provisions of Articles 5 to 15 of
Directive 81/851/EEC, including the          Directive 81/851/EEC, including the
provisions concerning proof of               provisions concerning proof of
therapeutic effect, and shall be             therapeutic effect, and shall be
labelled in accordance with the              label led pursuant to the provisions
provisions of Articles 43 to 50 of          of Articles 43 to 50 of Directive
Directive 81/851/EEC.                       81/851/EEC, in accordance with the
                                             basic principles and special nature
                                            of homeopathic or anthroposophlcal
                                            medicine.
                     Article 10, paragraphs 1 and 2 unchanged
                               Article 10 (3) (new)
                                             3. Not later than 31 December 1995
                                             the Commission shall present a
                                             report to the Council and to the
                                            European Parliament concerning
                                            the operation of this Directive.
                               Article 11 unchanged
 ---pagebreak---                                                                      ISSN 0254-1475
                                                              COM(91)313final
                                                      DOCUMENTS
                                                                      03
EN                                                                         °5 °6
                                 Catalogue number : CB-CO-91-353-EN-C
                                                             ISBN 92-77-74898-2
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