CELEX: 51988PC0231
Language: en
Date: 1988-04-20
Title: Amended proposal for a COUNCIL DIRECTIVE relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion within the scope of the national health insurance system (presented by the Commission pursuant to Article 149(3) of the EEC Treaty)

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COM (88) 231
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 ---pagebreak---   COMMISSION OF THE EUROPEAN COMMUNITIES
                                                    COM(88 ) 231 final - SYN 79
                                                    Brussels , 20 April 1988
                             Amended proposai for a
                                COUNCIL DIRECTIVE
relating to the transparency of measures regulating the pricing of medicinal
      products for human use and their inclusion within the scope of the
                        national health insurance system
            (presented by the Commission pursuant to Article 149(3 )
                                of the EEC Treaty )
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 ---pagebreak---                                         - 2 -
                               EXPLANATORY MEMORANDUM
At its part session OT      of March 1988 , the European Parliament approved
21 amendments to the proposal of 23 December 1986 for a Council Directive
relating to the transparency of measures regulating the pricing of medicinal
products for human use and their inclusion within the scope of the national
                           1
health insurance system .        The Commission has  decid
                                                     decided ,  in accordance with
Article 149(3 ) of the EEC Treaty , to amend          its proposal    in order to
incorporate all 21 of these amendments into the      text .
In addition ,      following technical discussions      in the framework of the
Council , the Commission has decided to make certain other detailed changes
to its proposal . The main effect of these other changes is as follows :
i)       In Article 3 ( price increases ) and Article 4 ( price freezes ), it is
         proposed that the competent national authorities should have the power
         to extend the time-limits by a single additional period of 60 days in
         exceptional cases where the authority receives a mass influx of
         applications for price increases and it is realistically not possible
         for the authority to process all the applications within the normal
         time-limit of 90 days ;
ii )     Article 4(1 ) has been changed to clarify the intention of the original
         proposal that the annual review of the need for the continuance of a
         freeze on pharmaceutical prices should be conducted on the basis of
         the general evolution of macro-economic indicators rather than on a
         product by product basis ;
iii )    Article 5 ( price controls ) has been amended slightly in order to
         eliminate any possibility of the publication of confidential data ;
 iv )    Two new    paragraphs 5    and 6 have
                                             have been
                                                   been   added
                                                          added   to
                                                                  to Article
                                                                     Article 66  to
                                                                                 to
         specifically deal with the procedural rules concerning the deletion of
         products or categories of products from a positive list of products
         covered by the health insurance system .
The     Commission    considers that these additional changes are entirely
 compatible with the spirit of the opinion of the European Parliament .
      C0M(86)765 final ; O.J. N° C 17 of 23.1.87
 ---pagebreak---                                   - 3 -
                        Amended proposai for a
                            COUNCIL DIRECTIVE
  relating to the transparency of measures regulating the pricing
   of medicinal products for human use and their inclusion within
         the scope of the national health insurance system
THE COUNCIL OF THE EUROPEAN COMMUNITIES ,
Having regard to the Treaty establishing the European Economic Community ,
and in particular Article 100a thereof ,
                                                   1
Having regard to the proposal from the Commission ,
                                              2
In cooperation with the European Parliament ,
Having regard to the opinion of the Economic and Social Committee3,
Whereas marketing authorizations for proprietary medicinal products issued
pursuant to Council Directive 65 / 65 / EEC of 26 January 1965 on the
approximation of provisions laid down by law , regulation or administrative
                                                    4
action relating to proprietary medicinal products , as last amended by
Directive 87/ 21 /EEC3, may be refused only for reasons relating to the
quality , safety or efficacy of the proprietary medicinal products concerned ;
1
2
  Legislative resolution of 9.3.1988
30J No C 319, 30.11.1987, p.
40J No 22 , 9.2.1965 , p . 369/65
50J No 15 , 17.1.1987, p . 36
 ---pagebreak---                                   - 4 -
Whereas the Member States have adopted measures of an economic nature on the
marketing of medicinal     products   in order to control     public  health
expenditure on such products ; whereas such measures include direct and
indirect controls on the prices of medicinal products as a consequence of
the inadequacy or absence of competition in the medicinal products market
and limitations on the range of products covered by the national health
insurance system;
Wheras the primary objective of such measures is the promotion of public
health by ensuring the availability of adequate supplies of medicinal
products at a reasonable cost ; whereas however such measures should also be
intended to promote efficiency in the production of medicinal products and
to encourage research and development into new medicinal products / on which
the maintenance of a high level of public health within the Community
ultimately depends ;
Whereas disparities in such measures may hinder or distort intra-Community
trade in medicinal products and thereby directly affect the functioning of
the common market in medicinal products ;
Whereas the objective of this Directive is to obtain an over-view of
national pricing arrangements/ including the manner in which they operate in
individual cases and all the criteria on which they are based /       and
                                                                      and to
                                                                          to
provide public access to them for all those involved in the market in
medicinal products in the Member States ; whereas this information should be
public ;
 ---pagebreak---                                     - 5
Whereas, as a first step towards the removal of disparities , it is
urgently necessary to lay down a series of requirements intended to ensure
that all concerned can verify that the national measures do not constitute
quantitative restrictions on imports or exports or measures having
equivalent effect thereto ; whereas , however , these requirements do not
effect the policies of the Member States who rely primarily upon free
competition to determine the price of medicinal products ; whereas these
requirements also do not affect national policies on price setting and on
the determination of social security schemes , except in the matter of
certain procedures necessary to attain transparency within the meaning of
this Directive ;
Whereas the wide disparities in the prices of medicinal products i n the Community
could be greatly reduced by an approximation of the rates of value added tax
applied and by the free movement of medicinal products within the Community ;
Whereas   the   further approximation   of such  measures  must  take  place
progressively ,
HAS ADOPTED THE FOLLOWING DIRECTIVE :
 ---pagebreak---                                            - 6 -
Article 1
1 . Member States shall ensure that any national measure i      ,  whether laid down
    by taw
    Dy    law,,   regulation or
                  regulation or administrative
                                 administrative action
                                                 action,,  to control the prices of
    medicinal products for human use or to restrict the range of medicinal
    products covered by their national health insurance systems complies with
    the requirements of this Directive .
2 . The definition of "medicinal product" laid down in Article 1(2 ) of Directive
    65 / 65 / EEC shall apply for the purposes of this Directive .
3 . Nothing in this Directive shall permit the marketing of a proprietary
    medicinal product in respect of which the authorization provided for in
    Article 3 of Directive 65 / 65 / EEC has not been issued .
Article 2
The following provisions shall apply if the marketing of a medicinal product
is permitted only after the competent authorities of the Member State
concerned have approved the price of the product :
1 . Member States shall ensure that a decision on the price which may be
    charged for the medicinal product concerned is adopted and communicated
    to the applicant within 90 days of the receipt of an application
    submitted , in accordance with the requirements laid down in the Member
    State concerned , by the holder of a marketing authorisation .               The
                                                                                 The
    applicant shall furnish the competent authorities with adequate
    information .         If  the   information    supporting  the   application  is
    inadequate, the time-limit shall be extended by a further 90 days and the
    competent authorities shall notify the applicant of what detailed
    additional information is required
    additional                      reauired .   In the absence of such a decision
    within the above-mentioned time-limit , the applicant shall be entitled to
    market the product at the price proposed .
 ---pagebreak---                                      - 7
2 . Should the competent authorities decide not to permit the marketing of
    the medicinal product concerned at the price proposed by the applicant ,
    the decision shall contain a statement of reasons based on objective and
    verifiable criteria . In addition , the applicant shall be informed of the
    remedies available to him under the laws in force and the time-limits
    allowed for applying for such remedies .
3 . At least once a year , the competent authorities shall publish in an
    appropriate publication and communicate to the Commission a list of the
    medicinal products whose price has been fixed during the relevant period
    together with the prices which may be charged for such products .
Article 3
Without prejudice to Article 4 , the following provisions shall apply if an
increase in the price of a medicinal product is permitted only after prior
approval has been obtained from the competent authorities :
1 . Member States shall ensure that a decision is adopted on an application
    submitted in accordance with the requirements laid down in the Member
    State concerned , by the holder of a marketing authorisation to increase
    the price of a medicinal product and communicated to the applicant within
    90 days of its receipt .     The applicant shall furnish the competent
    authorities with adequate information including details of those events
    intervening since the price of the medicinal product was last determined
    which in his opinion justify the price increase requested   ted .     If the
    information supporting the application is inadequate , the the time-limit
                                                                      time-limit
    shall be extended by a further period of 90 days and the competent
    authorities shall notify the applicant of what detailed additional
    information is required .
    In the event of an exceptional number of applications , the time-limit may
                                                     applicant shall be notified
    be extended once for a further sixty days . The applic
    of such extension before the expiry of the time-limit .
    In the absence of such a decision within the above-mentioned periods , the
    applicant shall be entitled to apply in full the price increase
    requested .
 ---pagebreak---                                            - 8 -
2 . Should the competent authorities decide not to permit the whole or part
    of the price increase requested , the decision shall contain a statement
    of reasons based on objective and verifiable criteria and the applicant
    shall be informed of the remedies available to him under the laws in
    force and the time-limits allowed for applying for such remedies .
3 . At least once a year , the competent authorities shall publish in an
    appropriate publication and communicate to the Commission a list of the
    medicinal products for which price increases have been granted during the
    relevant period together with the new price which may be charged for such
    products .
Article 4
1 . In the event of a price freeze being imposed on all medicinal products or
    on certain categories of medicinal products by the competent authorities
    of a Member State , that Member State shall check , at least once a year ,
    whether the macro-economic conditions justify the continuation of the
    freeze unchanged . Within 90 days of the commencement of this review , the
    competent authorities shall announce what increases or decreases in
    prices are being made , if any .
2 . In exceptional cases , a person who is holder of a marketing authorisation
    for a medicinal product may apply for a derogation from a price freeze if
    this is justified by particular reasons .          The application shall contain
    an adeauate
    an  adequate statement
                    statement of
                               of these
                                   these reasons
                                         reasons . Member States shall ensure that
    a reasoned decision on any such application is adopted and communicated
    to the applicant within 90 days of its receipt . If the information supporting the
    application is inadequate, the time-limit shall be extended by a further
    period of 90 days and the competent authorities shall notify the
    arm I leant n-f
    applicant    of uhat
                      what Hatai Led additional
                            detailed  additional information
                                                  information is is reauired
                                                                    required .. Should
                                                                                Should
    the deroqation
           derogation be granted , the competent authorities
                                                          authoriti    shall forthwith
    publish an announcement of the price increase allowed .
    In case of an exceptional number of applications , the       the time-limit
                                                                     time-limit may
                                                                                ma) be
    extended once
    extended     once forfor aa Turtner
                                  further sixty
                                            sixty aays
                                                   days .. The
                                                             me applicant shall be
    notified of such extension before the expiry of the initial time-limit .
 ---pagebreak---                                          - 9 -
  Article 5
  Where a Member State adopts a system of direct or indirect controls on the
  profitability of persons responsible for placing medicinal products on the
  market , the Member State concerned shall publish the following information
   in an appropriate publication and communicate it to the Commission .
.Ca ) the method or methods used in the Member State ‘ concerned to define
       profitability : return on sales and / or return on capital ;
 ( b ) the target rates of profit currently permitted to persons responsible for
       placing medicinal products on the market in the Member State concerned ;
 ( c ) the criteria according to which target rates of    profit are accorded to
       persons
       persons     responsible for placing medicinal      products on the market ,
       together with the criteria according to which      they will be allowed to
       retain profits above their given targets in the    Member State concerned ;
 Cd ) the maximum percentage profit which any persons responsible for placing
       medicinal products on the market are allowed to retain above their target
       in the Member State concerned .
  This information shall be updated once a year or when significant changes
  are made .
  Where , in addition to a system of direct or indirect controls on profits , a
  Member State operates a system of controls on the prices of certain types of
  medicinal products which are excluded from the scope of the profit control
   scheme , the provisions of Articles 2 to 4 shall , where relevant , apply to sisuch
  price controls .                                                            normal
                        However , Articles 2 to 4 shall not apply where the norma
  operation of a system of direct or indirect controls on profits results
  exceptionally in a price being fixed for an individual medicinal product .
 ---pagebreak---                                      - 10 -
Artide 6
The following provisions shall apply if a medicinal product is covered by
the national health insurance system only after the competent authorities
have decided to include the medicinal product concerned in a positive list
of medicinal products covered by the national health insurance system .
1 . Member States shall ensure that a decision on an application submitted,
    in accordance with the requirements laid down in the Member State
    concerned , by the holder of a marketing authorisation, to include a
    medicinal product in the list of medicinal products covered by the health
    insurance system is adopted and communicated to the applicant within
    90 days of its receipt .
    Where an application under this Article is made before the competent
    authorities have agreed the price to be charged for the product pursuant
    to Article 2 , or where a decision on the price of a medicinal product and
    a decision on its inclusion within the list of products covered by the
    health   insurance   system  are  taken  after   a   single   administrative
    procedure ,   the time-limit shall be extended by a further 90 days . The
    applicant shall provide the competent authorities with adequate
    information .      If the information supporting the application is
    inadequate ,
    inadéquate      the time-limit shall be suspended and the competent
    authorities shall forthwith notify the applicant of what detailed
    additional information is required .
    Where a Member State does not permit an application to be made under this
    Article before the competent authorities have agreed the price to be
    charged for the product pursuant to Article 2 , the Member State concerned
    shall ensure that the overall period of time taken by the two procedures
    does not exceed 180 days . This time-limit may be extended in accordance
    with the provisions of Article 2 or suspended in accordance with the
    provisions of the preceding paragraph .
 ---pagebreak---                                      - 11
2 . Any decision not to include a medicinal product in the list of products
    covered by the health insurance system shall contain a statement of
    reasons based on objective and verifiable         criteria ,  including if
    appropriate any expert opinions or recommendations on which it
    is based .   In addition , the applicant shall be informed of the remedies
    available to him under the laws in force , and the time-limits allowed for
    applying for such remedies .
3 . Before the date referred to in Article 12(1 ), the
    Member States shall publish in an appropriate publication and communicate
    to the Commission the criteria which are to be taken into account by the
    competent authorities in deciding whether or not to include medicinal
    products on the lists .
4 . Within one year of the date referred to in Article 12(1 ),
    the Member States shall publish in an appropriate publication
    and communicate to the Commission a complete list of the products covered
    by their health insurance system, together with their prices fixed by the
    national competent authorities .      This information shall be updated at
    least once every year .
5 . Any decision to exclude a product from the list of products covered by
    the health insurance system shall contain a statement of reasons based on
    objective and verifiable criteria .         Such decisions , including if
    appropriate any expert recommendation or opinion on which the decisions
    are based , shall be communicated to the person responsible , who shall be
    informed of the remedies available to him under the laws in force and the
    time-limits allowed for applying for such remedies .
6 . Any decision to exclude a category of medicinal products from the list of
    products covered by the health insurance system shall contain a statement
    of reasons based on objective and verifiable criteria and shall be
    published in an appropriate publication .
 ---pagebreak---                                      - 12 -
Artide 7
The following provisions shall apply if the competent authorities of a
Member State are empowered to adopt decisions to exclude individual
medicinal products or categories thereof from the coverage of its national
health insurance system ( negative Lists ).
1 . Any decision to exclude a category of medicinal products from the
    coverage of the national health insurance system shall contain a
    statement of reasons based on objective and verifiable criteria and be
    published in an appropriate publication .
2 . Before the date referred to in Article 12(1 ), Member
    States shall publish in an appropriate publication and communicate to the
    Commission the criteria which are to be taken into account by the
    competent authorities in deciding whether or not to exclude an individual
    medicinal product from the coverage of the national health insurance
    system .
3 . Any decision to exclude an individual medicinal product from the coverage
    of the national health insurance system shall contain a statement of
    reasons based on objective and verifiable criteria .       Such decisions ,
    including if appropriate any expert opinions or recommendations on which
    the decisions are based , shall be communicated to the person responsible ,
    who shall be informed of the remedies available to him under the laws in
    force and the time-limits allowed for applying for such remedies .
4 . Within one year of the date referred to in Article 12(1 ),
    the competent authorities shall publish in an appropriate
    publication and communicate to the Commission a list of the individual
    medicinal products which have been excluded from the scope of its health
    insurance system ., This information shall be updated at least every six
    months .
 ---pagebreak---                                         - 13 -
Artide 8
1 . Before   the   date    referred to   in  Article  12(1 ),  the
    Member States shall communicate to the Commission any criteria concerning
    the therapeutic classification of medicinal products which are used by
    the competent authorities for         the purposes   of the    national social
    security system .
2 . Before   the   date    referred to   in  Article   12(1 ), the
    Member States shall communicate to the Commission any criteria which are
    used by the competent authorities for the purposes of the national social
    security system in verifying the fairness and transparency of the prices
    charged for transfers within a group of companies of active principles or
    intermediate products used in the manufacture of medicinal products or
    finished medicinal products .
Article 9
1 . In the light of experience ,      the Commission shall ,   not later than two
    years after the date referred to           in Article 12(1 ),
    submit to the Council a proposal containing appropriate measures leading
    towards the abolition of any remaining barriers to or distortions of the
    free movement of proprietary medicinal products , so as to bring this
    sector more closely into Line with the normal conditions of the internal
    market .
2 . The Council shall decide on the Commission proposal not later than one
    year after its submission .
Article 10
1 . A Committee called the Consultative Committee for the implementation of
    Directive 88 //. ../ EEC and the development of a European pharmaceuticals
                    • • •
    policy , hereinafter referred to as 'the Committee' , is hereby set up under
    the auspices of the Commission .
 ---pagebreak---                                          - 14 -
2 . The tasks of the Committee shall be :
    - to examine any question relating to the application of this Directive
         which
         which isis raised
                    raised    by the Commission or at the request of a Member
         State ;
     - to develop a European pharmaceuticals policy which satisfies the
         special demands of the health sector and complies with the normal rules
         governing the internal market .
3 . The Committee shall consist of one representative from each Member State .
     There shall be one deputy for each representative ,.   This deputy shall be
     entitled to participate in meetings of the Committee .
4 . A representative of the Commission shall chair the Committee .
5 . The Committee shall adopt its rules of procedure .
Article 11
1 . The Commission shall set up a data bank in order to improve competition
     in the pharmaceuticals sector and to encourage the more efficient use of
     medicinal products in the Community .
2 . For each medicinal product authorised in the Community, the data
     bank shall contain as a rule :
    ( a) a summary of the characteristics of the product as mentioned in
          Articles 4a and 4b of Directive 65 / 65 / EEC ;
    ( b ) its ex-factory and retail prices ;
    ( c ) an estimate of the cost of the usual daily dose ;
          the manner in which it is dispensed to the patient ( self-medication ,
    ( d ) the manner in
          prescription only , hospital use only ).
 ---pagebreak---                                     - 15 -
3 . The Member States , the manufacturers and importers shall cooperate with
    the Commission in setting up the data bank , to which they shall have
    access .
4 . By 31 December 1992 ,  the Commission shall publish a list of medicinal
    products authorised    in the Community containing the information
    mentioned in paragraph 2 .
Article 12
1 . Member States shall bring into force the laws ,           regulations and
                                                              régulations
    administrative provisions necessary to comply with this Directive by
    1 January 1989 at the latest . They shall forthwith inform the Commission
    thereof .
2 . Before the date referred to in paragraph 1 ,         Member States shall
    communicate to the Commission the texts of any laws , regulations or
    administrative provisions relating to the pricing of medicinal products ,
    the profitability of manufacturers of medicinal products and the coverage
    of medicinal products by the national health insurance system .
    Amendments and modifications to these laws , regulations or administrative
    provisions shall be communicated to the Commision forthwith .
Article 13
This Directive is addressed to the Member States .
Done at Brussels ,                                    For the Counci l