CELEX: 51972PC1375
Language: en
Date: 1972-11-17
Title: PROPOSAL FOR A DIRECTIVE ON THE COORDINATION OF CERTAIN LAWS, REGULATIONS AND ADMINISTRATIVE PROVISIONS CONCERNING THE RETAIL SALE OF MEDICINAL PRODUCTS BY SELF-EMPLOYED PERSONS#PROPOSAL FOR A DIRECTIVE CONCERNING THE ATTAINMENT OF FREEDOM OF ESTABLISHMENT AND FREEDOM TO PROVIDE SERVICES IN RESPECT OF THE RETAIL SALE OF MEDICINAL PRODUCTS BY SELF-EMPLOYED PERSONS (submitted by the Commission to the Council)

ARCHIVES HISTORIQUES
DE LA COMMISSION
COLLECTION RELIEE DES
DOCUMENTS "COM"
COM (72) 1375
Vol. 1972/0179
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 ---pagebreak--- Ο Μ Μ I 3 8II: Ο Ν   ΟΡ    Τ ΗΕ    ΕϋΗΟΡΕΑΝ^ Ο ΟΜΜϋΝ IΤ IΕ5
                                             COM(72 ) 1375 final
                                             Brussels » 17 November 1972
                        PROPOSAL FOR A DIRECTIVE
                  ON THE COORDINATION OF CERTAIN" LAWS , •
         REGULATIONS AND ADMINISTRATIVE PROVISIONS CONCERNING
   THE RETAIL SALE OP MEDICINAL PRODUCTS BY SELF-EMPLOYED PERSONS
                        PROPOSAL FOR A DIRECTIVE
         CONCERNING THE             OF FREEDOM OF ESTABLISHMENT
             AND FREEDOM TO PROVIDE SERVICES IN RESPECT OF
   THE RETAIL SALE OF MEDICINAL PRODUCTS H" SELF-EMPLOYED PERSONS
             ( submitted by the Commission to the Council ,?
COM(72 ) 1375 final
 ---pagebreak---                          CO?*' - . 1 375 final
            I
FBOPOSALS FOR DIRECTIVES
 ---pagebreak---                                                               COM (?: - '75 final
                                       m 1 m
                                         I
                , PROPOSAL FOR A DIRECTIVE Oil THE COORDINATION
          OP CERTAHT LAVi'S, REGULATIONS AND ADMINISTRATI'VE PROVISIONS •
                           COlTCErCTEG THE RETAIL SALE OP
                   MEDICINAL PRODUCTS BY SBLP-EMPLOYED PERSONS
THE COUNCIL OP THE EUROPEAN COMMUNITIES ,
Having regard to the Treaty establishing the European Economic Community ,
and in particular Articles 57(2 ) and 66 thereof ;
Having regard to the General Programme for the abolition of restrictions on
                             1
freedom of establishment ,     and in particular Title IV D and Annex III ,
Group 6 122 , thereof ;
Having regard to the General Programme for the abolition of restrictions on
                                2
freedom to provide services ,      and in particular Title V C thereof ;
                       • »
Having regard to the Proposal from the Commission ;
Having regard to the Opinion of the European Parliament ;
Having regard to the Opinion of the Economic and Social Committee ;
Whereas Article 57(3 ) of the Treaty provides that in the case of inter alia '
the pharmaceutical professions the abolition of restrictions shall be dependent
upon coordination of the conditions for the exercise of those professions in
the various Member States ;
Whereas in pursuance of Title V of the General Programmes for the abolition
of restrictions on freedom of establishment it is considered necessary to
accompany the removal , pursuant to the Council Directive of                    –■
 OJ No 2 , 15 January 1962 , p. 36/62 .
*03 No 2 , 15 January 1962 , p. 32/62 .
 ---pagebreak---                                                            COM(72 ) 1375 final
                      4
                                   - 2 -
concerning the attainment of freedom of establishment and freedom to provide
        »
cervices in respect of the retail Bale of medicinal products "by self-employed
persons , of restrictions relating to the retail sale of medicinal products "by
a degree of coordination of the laws , regulations and administrative provisions
governing the geographical distribution of dispensaries ;
Whereas the geographical distribution of dispensaries is regulated in certain
Member States and such regulation is justified on health protection grounds ;
whereas steps must be taken to ensure that following implementation of the
right of establishment adequate supplies of medicinal products are , or continue
to be , available to the population at large ; whereas efforts must also be made
to ensure that in all parts of the Community similar conditions obtain , since
otherwise the achievement of freedom of establishment will cause an abnormal
influx of applicants , particularly from countries which restrict the number of
dispensaries , into the Member States where dispensaries may be freely set up ;
Whereas the measures which the Member States must take or maintain , in accordance
with the provisions of this Directive , for the purpose of ensuring a proper
distribution of dispensaries on their territories , must have no other purpose
than the protection of public health , namely the population 's health requirements
in respect of medicinal products in each region and over the territory as a whole ;
whereas such measures must be based on objective , non-discriminatory criteria;
whereas the measures taken for this purpose must cover both the location of
dispensaries and the selection of applicants ;
Whereas the limitations imposed by the competent authorities or bodies on the
issue of authorizations for the opening of dispensaries have the effect int er alia
of modifying the normal rules of competition and, in certain cases , of making it
possible for persons to profit economically from such limitation ; whereas it is
necessary so to change this state of affairs that , in spite of the effects of
the differences in their laws , all Member States are placed on an equivalent
footing as regards competition , thereby facilitating the attainment of freedom
of establishment ;
 ---pagebreak---                                                          C0M(7 ?} ' V: 5 fi"al
                                      - 3 -
                                                                                  1
Whereas the coordination provided for in the Council Directive of
and in this Directive of the conditions for the exercise of the profession of
dispensing chemist is considered both necessary and adequate to enable the
Kenber States to abolish restrictions on the right to engage as a self– employcd _
person in the retail selling of medicinal products :
HAS ADOPTED THI5 DIRECTIVE ;
                                                   /
                                  Article 1
                                  ■ amiM itum ––m–
                                                           "                    ,      '
                                                                         '   "'     I
Member States may not refuse to grant the authorization provided for in              j
Article 3 of the Council Directive of                    ^ save on one of the        j
followmg grounds :
(a) the applicant does not satisfy one of the conditions laid down in Article 4
      of the abovementioned Directive ;
(b) the location proposed for the dispensary is contrary to the measures regulatin,
      the geographical distribution of dispensaries®
YJi^h a view to ensuring the most favourable conditions of distribution for
medicinal products the Member States shall , where freedom of location endangers
 public health, tike measures, subject as provided in paragraph 3» to regulate
 the geographical distribution of dispensaries .
 The measures referred to in paragraph 1(b ) shall be based on objective , non-
 discriminatory criteria. Their provisions shall- cover both the location of
 dispensaries and the selection of applicants and shall , in particular, specify
 the number of dispensaries for each region up to which applicants are free to
  set up nevi dispensaries9 or where appropriate are to be encouraged to do so by
 the public authorities in the interests of health .
   OJ ÎTo C 5/5 , 28 April 1969 .
 ---pagebreak---                                                          Cùi;(7<0 1.VO "final
                                     Article 2
1 . The Member States shall ensure that as from the date of the implementation of
    this Directive all new authorizations issued pursuant to Article 4 of the'
    Council Directive of                     are made out in the applicants' names
    and are non-transferable . They shall specify the period within which the
    authorization must be used or , in default , lapse .
2 . Notwithstanding the foregoing, the Member States may provide for special
    arrangements , of limited duration , in favour of the person entitled on the
    death of the holder of an authorization .
                                     Article 3
    The Member States shall adopt the measures necessary to comply with this
    Directive within one year of its notification and shall forthwith inform the
    Commission thereof •                                                       I
                                                                                I
                                     Article 4                                   I
    With effect from the notification of this Directive the Member States shall
    moreovor inform the Commission , in good time to enable it to submit its
    observations , of the terms of any subsequent provisions of importance by way
    of law , regulation or administrative action which they propose to adopt in
    respect of the matters governed by this Directive .
                                     Article 5
    This Directive is addressed to the Member States .
    Done at Brusseis ,                                    For the Council
                                                          The Président
 ---pagebreak---                                                       C0M(72 ) 1375 final
                                     ** § ®»
                                       II
              PROPOSAL FOR A DIRECTIVE CONCERNING THE ATTAINTTCIIT
       OP FREEDOM OF ESTABLISHMENT AND FREEDOM TO PROVIDE SERVICES IN
 RESPECT OF THE RETAIL SALE OF MEDICINAL PRODUCTS BY SEU^iPLOYEP PERSONS
THE COUNCIL OF THE EUROPE1N COL J CITIES ,
Having regard to the Treaty establishing the European Economic Community and
in particular Articles 54(2 ) and ( 3 ); 63(2 ) and ( 3 ) and 66 thereof ;
Having regard to the General Programme for the abolition of restrictions on
                           1
freedom of establishment ,    and in particular Title IV D and Annex III ,
Group 6 122 , thereof ;
Having regard to the General Programme for the abolition of restrictions on
                               2
freedom to provide services ,    and m particular Title V C thereof ;
Having regard to the Proposal from the Commission ;
Having regard to the Opinion of the European Parliament ;
                  m
Having regard to the Opinion of the Economic and Social Committee ;
Whereas the General^ Programmes provide for the abolition , before the end of
the second year of the third stage , of all discriminatory treatment based on
nationality regarding establishment and the provision of services in respect
of the retail sale by self-employed persons of pharmaceutical and medicinal
products , as covered by Sub-group 6 122 of the ISIC nomenclature ; .
Whereas , in order to ensure that this Directive is correctly applied , it is
necessary to define its scope by specifying what is meant by "the retail sale
                                                                       -A "
  OJ No 2 , 15 January 1962 , p. 36/62 .
^OJ No 2 , 15 January 1962 , p. 3?/o2 .
 ---pagebreak---                                                           COK(72 ) 1375 final
                                         – 6 –
   "by self-employed persons of pharmaceutical and medicinal products"; whereas for
    •this purpose it should "be expressly provided that the produots covered "by that
   term as used in this Directive are medicinal products as defined in the Council
                                     I                                             •
   Directive of 26 January 1965 ;                                     v
   Whereas the activities covered by the above term include not only sales toy
 " dispensing chemists , but also , where authorized by Member States , the retail
   sale of medicinal products by businesses other than dispensing chemists , namely
   by "drug stockists"; whereas in accordance with Article 57(3 ) both activities
                                                                                      2
   were excluded from the purview of the Council Directive of 15 October i960 ;
^ whereas the coordination referred to in the said Article 57(3 ) is provided for
   by the Council Directive of
   Whereas in this Directive the term " companies or firms" as used in Article 1
   refers only to associations of dispensing chemists , or where appropriate of
   drug stockists , which have taken the form of companies or firms within the
   meaning of Article 58 of the Treaty ; whereas in this connection this Directive
   provides only for the abolition of restrictions and consequently has no effect
   on the laws , regulations and administrative provisions of the Member States
 . which , irrespective of nationality , prohibit companies or firms from carrying
   on any activity to which this Directive applies or subject the pursuit thereof
   to specific conditions ; whereas , however , in view of the importance of the role
   which companies and firms can play in this field , there are grounds for initiating
   coordination as provided for by the Council Directive of                             ;
   Whereas in a number of Member States there exist professional or trade
   organizations governed by public lav;, registration with which is compulsory ;
   whereas it is consequently necessary to ensure that it is possible for nationals
   of Member States to whom this Directive applies to be registered with such
   organizations and whereas , moreover, in the case of a person providing services ,
   the requirement of such registration , which implies the carrying on of business
   in the host country on a long-term , permanent basis , would undeniably be a
   hindrance to such person owing to the temporary nature of his business ; whereas
                                                                          ♦/•            4
    'OJ No 22 , 9 February 1965 , P « 369/ 65 , amended on 28 July 1966 , OJ No 144 ,
      5 August 1966 , p.- 2658/66 .
   ^ OJ îïo L 260 , 22 October 1968 .
   30J Ko C 54 , 28 April 1969.
 ---pagebreak---                                                            COVih?) 1 " ; 'inal
                                       - 7 -
 such requirement should accordingly be dispensed with , out in that case it is
 necessary to take steps to ensure that professional discipline is maintained ;
 whereas this is the responsibility of the aforesaid professional        or trade
 organizations ; whereas to this end Member States are given the power , subject
 to Article 62 of the Treaty , to require those concerned to give the competent
 authority notice of their intention to provide services ;
Whereas Article 57(3 ) of the Treaty provides that in the case^ inter alia , of
 the pharmaceutical professions the abolition of restrictions shall be dependent
upon coordination of the conditions for the exercise of these professions in the
varioxxs Member States ; whereas such coordination is provided for by the Council
            1
Directive     of                     on the coordination of laws , regulations and
 administrative provisions concerning the retail sale of medicinal products ;
whereas it has also been considered expedient , in pursuance of Title V of the
 General Programmes , to provide simultaneously with the . lifting of restrictions
 in this branch of activity for a degree of coordination as regards the
 geographical distribution of dispensaries ; whereas such coordination is
                                            2
 provided for in the Council Directive        of                  on the retail sale
 of medicinal products by self-employed persons ;
 HAS ADOPTED THIS DIRECTIVE :
                 i
                                     Article 1
 Member States shall- abolish , in respect of the natural persons and companies or
 firms covered by Title I of the General Programmes for the abolition of
restrictions on freedom of establishment and freedom to provide services
 ( hereinafter called "beneficiaries") the restrictions referred to in Title III
 of those General Programmes affecting the right to take up and pursue the
 activities specified in Article 2 hereof .
   Doe . COM(69 ) 125 final , 5 March 1969 , p. 55 et sea.
   CJ Mo C 54 , 28 April                                 '
 ?
  "P-ages 11 et sna . of this document .
 ---pagebreak---                                                            COiï(72 ) 12' *? nal
                                         - 8 -
                                     Article 2
1 « The provisions of ihis Directive shall apply to the retail sale of medioinal
    products "by self-employed persons .
2 . For the purposes of this Directive " the retail sale of medicinal products "by
    self-employed persons" means the activities , as defined in Article 1 of the
    Council Directive of                     , of a self-employed dispensing chemist
    and , where this is permitted in the Member State concerned , the activities of
    self-employed persons in respect of the retail sale of medicinal products as
    defined "by the Council Directive of 26 January 19^5 "by "businesses other than
    dispensing chemists .
                                     Article 3
1 . Member States shall in particular abolish the following restrictions :
    ( a) those which prevent beneficiaries from establishing themselves or providing
         services in the host country under th § same conditions and with the same
         rights and duties as nationals of that country ;
    (b ) those existing by reason of administrative or professional or trade
         practices which result in treatment being applied to the beneficiaries
         that is discriminatory by comparison with that applied to nationals .
2 . The restrictions to be abolished shall include in particular those arising out
    of measures which prevent or limit establishment or provision of services by
    beneficiaries by the following means :
    ( a) in Oermany :                                 »
         the requirement as to nationality laid down in the Law of 20 August 1960 ;
    00 in Bel /rium :
         the authorisation referred to in the Law of 2 July 1956 ?
         the obligation to hold a carte ttrof essionnelle (Article 1 of the Law of
         19 February 1965 );
 ---pagebreak---                                                                     C0M(7 " . 275 final ■
                                            - 9 «
       ( c ) in France !
             the requirement of French nationality ( Code de la Santé Publique ! L 514 »
             paragraph B );                                                          '         !
             the obligation to hold a carte d'identite d f ctranger-comnercant ( Decret-loi
             of 12 November 1938 , Secret of 2 February 1939 » Law of 8 October 1940 »         /
      •" ! Law of 10 April 1954 ,. D^cret No 59-852 of 9 July 1959 );                           \
             exclusion from the right to renew commercial leases (Pecret of 30 September 1953 * '
             Article 38 );
       ( a) in Italyî
             the requirement of Italian nationality ( consolidated text of the
             Lepvri Sanitnrie of 27 June 1934 , Article 106 );
                                                                                                  l
       ( e ) in Luxembourp:!
             the requirement of Luxembourg nationality ( Law of 10 July 1910 ).
                                          Article 4
       Where a host Member State requires of its nationals wishing to take up or pursue
       any activity coming within Article 2 that they be registered with a professional
       or trade organization or body governed by public lav:, or where in a host Member
       State such registration is the legal consequence of being permitted to engage in
     . the activities in question , that State shall ensure that !
( i ) nationals from other Member States establishing themselves in the said State may
       be registered with the relevant organization or body under the same conditions
       and with the same rights and duties as its own nationals .
       A person so registered shall have the right to vote and to stand for election ,
       and shall be eligible to hold high office in the said organization or body .
       However , such posts may be reserved for the State 's own nationals where , in.
 ---pagebreak---                                                              COÎi(72 ) '•    final
                                        - 10 -
       pursuance of any provision laid down by lav; or regulation , the relevant
       organisation or "body participates in the exercise of public authority .
( ii ) Nationals of other Member States providing services are exempt from such
       requirement of registration . The Member State concerned may nevertheless
       require that , where the provision of services involves their temporary
       residence on its territory , such nationals shall first go to inform the
       competent authority responsible for professional discipline .
                                      Article 5
       Where there exists in a host Member State a professional organization or
       body governed by public law, registration with which is not compulsory , •
       that Member State shall ensure that nationals of other Member States have ,
       where their professional activities so require , the right to register with
       such organization under the same conditions and with the same rights and
       duties as its own nationals .
       A person so registered shall have the! right to vote , and in the case of
       establishment shall have the right to stand for election and shall be eligible
       to hold high office in the organization or body concerned . However , such posts
       may be reserved for the State 's own nationals where iri pursuance of any j
       provision laid down by law or regulation such organization or body participates
       in the exercise of public authority .
                                      Article 6
       Host Member States, shall ensure that nationals of other Member States have ,
       where there professional activities so require , the right to join professional
       or trade organizations governed by private law under the same conditions and
       with the same rights and duties as their own nationals .
                                                                          /•
 ---pagebreak---                                                      COM(72 ) 1375 final
                               •  - 11 -
Persons so joining such organizations shall have the right to vote , and in the
case of establishment shall have the right to stand for election and shall "be
eligible to hold high office in the organization concerned .
                                                                              %
                                 Article 7
Where a host Member State lays down for its own nationals wishing to take up
any activity coming within Article 2 a requirement as to good character or
good repute , that State shall accept from nationals of other Member States
a certificate issued by a competent authority in the Member State of origin
or provenance indicating that the requirements as to good character or good
repute laid down in that Member State for those wishing to take up the
activity in question have been satisfied .
Where the Member State of origin or provenance does not lay down any such
requirement for those wishing to take up the activity in question , the host
Member State shall accept from nationals of such Member State as aforesaid
an extract from the " judicial record", or failing that an extract from an
equivalent document issued by a competent judicial or administrative authority
in the country of origin or provenance certifying that these requirements have
been satisfied , and also , in so far as adequate proof that the requirements
laid down in the host Member State cannot be obtained from such extract , a
certificate issued by a competent authority in the Member State of origin or
provenance equivalent to the document required in the host Member State .
Where there exist both in the Member State of origin or provenance and in the
host Member State laws or regulations concerning the maintenance of standards
of professional conduct on the part of persons carrying on any activity
referred to in Article 2 , the host Member State shall on request be given the
relevant information concerning the disciplinary or professional sanctions
imposed on the person concerned .                                        –
Member States shall treat such information as confidential .
 ---pagebreak---                                                            COM(72 ) 1375 final
                                      - 12
3 . VHiere a host Member State requires of its own nationals wishing to take up
    or pursue any activity coming within Article 2 proof that they have not
    previously "been declared "bankrupt , and such proof cannot "be obtained from
    the information supplied in respect of nationals of other Member States
    pursuant to paragraphs 1 and 2 , that State shall accept from nationals of
    other Member States a declaration on oath sworn by the person concerned
    before a competent judicial or administrative authority , a notary , or a
    competent professional or trade body , in the Member State of origin or
    provenance .
    Where in the host Member State proof of financial standing is required , that
    State shall regard certificates issued by banks in the Member State of origin
    or provenance as equivalent to certificates issued in its own territory .
4 . Where the host Member State requires of its own nationals wishing to take up
    or pursue any activity coming within Article 2 a document relating to their
    physical or mental health , that State shall accept as adequate for thi's
    purpose production of the document required in the Member State of origin or
    provenance.                                             ^
    Where the Member State of origin or provenance does not impose any such
    requirement on persons wishing to take up the activity in question , the host
    Member State shall accept from nationals of such Member State as aforesaid a
    certificate issued by a competent authority in that State equivalent to the
    certificates required in the host Member State .
5 . The documents referred to in paragraphs 1 , 3 and 4 may not be produced more
    than three months after their date of issue .                    •
6 . The provisions of this Article apply where any national of one Member State
    sedes to establish himself in another Member State .                  .   • –
                                                                       /■
 ---pagebreak---                                                               COM(72 ) 1375 final
                                          - 13 -
7 . Member Sta-tes shall , within the tine limit laid down in Article 9 » designate
    the authorities and bodies competent to issue the abovementioned documents
    and to provide the aforesaid information and shall immediately inform the
    other Member States and the Commission thereof .
                                        Art i nie 8
1 » Where a host Member State imposes on it ? own nationals wishing to              up or
    pursue any Rotivity coming vathin Article Z wiy ef the retirements referred
    •to in Article 7t that Member State shall 1 in the cprq of a person providing
    services who is a national of another Member State , accept from such person ,
    in place of the documents , declarations and certificates required under
    Article 7 t a, single document issued by a competent authority in the Member
    State of origin or provenance .
2 . The single document provided for in the foregoing paragraph may not be
    produced more than three months after its date of issue .
3 . Member States shall , within the time limit laid down in Article           designate
    the authorities and bodies competent to issue the aboveraentioned document
    and to provide \he aforesaid information and shall immediately inform the
    other Member States and the Commission thereof .
                                        Article 9
    Where in a host Member State the right to use the professional style or title
    relating to any activity coming within Article 2 is subject to regulation ,
    nationals of the other Member States who possess the qualifications referred
    to in Articles 2 and 4 of the Council Directive of                •           on the
    mututal recognition of diplomas , certificates and other evidence of formal
    qualifications relating to self-employed dispensing chemists or who are
                                                         1
    covered by Article 10 of the Council Directive         of
    on the coordination of the laws , regulations end administrative provisions
    concerning the retail sale of medicinal products by self– employed persons
    shall use the professional style or title , including any recognized abbreviation ,
    corresponding in the host country to those Qualifications .
                                                                          ./•
      Doc . CO!'(69 ) 125 final , 5 "n-rch 19c9 » pages 55 et seer.
      (OJ No C 54 , 23 April 1363 ).                ^
 ---pagebreak---                                                         00MC72 ) 1375 firtal
                                 - 14 -
                              Article 10
VThere any host Member State requires of its own nationals wishing to take up
any activity coming within Article 2 that they swear an oath , that Member     »
State shall ensure that , if the form of such oath is such that it cannot "be
used "by the nationals of other Member States , a suitable and equivalent form
is available to the persons concerned .
          !                   Article 11
No Member State shall grant to any of its own nationals who go to another
Member State for the purpose of pursuing any activity coming within Article 2
any aid liable to distort the conditions of establishment .
                              Article 12
Member States shall adopt the measures necessary to comply with this Directive
within one year of its notification and shall forthwith inform the Commission
thereof .
                              Article 13
This Directive is addressed to the Member States .
Done at Brussels ,                                     For'the Council
                                                       The Président