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

No C 129/14                                Official Journal of the European Communities                                    18. 5. 88
                                                                   II
                                                         . (Preparatory Acts)
                                                     COMMISSION
                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 (')
                                                         COM(88) 231 final
                (Submitted by the Commission to the Council pursuant to Article 149 (3) of the EEC Treaty on 21
                                                              April 1988)
                                                            (88/C 129/15)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                               Whereas 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
Having regard to the Treaty establishing the European                  cost; whereas however such measures should also be
Economic Community, and in particular Article 100A                     intended to promote efficiency in the production of
thereof,                                                               medicinal products and to encourage research and devel-
                                                                       opment into new medicinal products, on which the main-
Having regard to the proposal from the Commission,                     tenance of a high level of public health within the
                                                                       Community ultimately depends;
In cooperation with the European Parliament (2),                       Whereas disparities in such measures may hinder or
                                                                       distort intra-Community trade in medicinal products and
                                                                       thereby directly affect the functioning of the common
Having regard to the opinion of the Economic and
                                                                       market in medicinal products;
Social Committee (3),
                                                                       Whereas the objective of this Directive is to obtain an
Whereas marketing authorizations for proprietary                       overview of national pricing arrangements, including the
medicinal products issued pursuant to Council Directive                manner in which they operate in individual cases and all
65/65/EEC of 26 January 1965 on the approximation of                   the criteria on which they are based, and to provide
provisions laid down by law, regulation or administrative              public access to them for all those involved in the market
action relating to proprietary medicinal products (4), as              in medicinal products in the Member States; whereas this
last amended by Directive 87/21/EEC (5), may be                        information should be public;
refused only for reasons relating to the quality, safety or
efficacy      of the proprietary medicinal             products        Whereas, as a first step towards the removal of
concerned;                                                             disparities, it is urgently necessary to lay down a series of
                                                                       requirements intended to ensure that all concerned can
Whereas the Member States have adopted measures of                     verify that the national measures do not constitute quan-
an economic nature on the marketing of medicinal                       titative restrictions on imports or exports or measures
products in order to control public health expenditure on              having equivalent effect thereto; whereas, however, these
such products; whereas such measures include direct and                requirements do not effect the policies of the Member
indirect controls on the prices of medicinal products as a             States who rely primarily upon free competition to
consequence of the inadequacy or absence of compe-                     determine the price of medicinal products; whereas these
tition in the medicinal products market and limitations                requirements also do not affect national policies on price
on the range of products covered by the national health                setting and on the determination of social security
insurance system;                                                      schemes, except in the matter of certain procedures
                                                                       necessary to attain transparency within the meaning of
                                                                       this Directive;
(') OJ No C 17, 23. 1. 1987, p. 6.                                     Whereas the wide disparities in the prices of medicinal
(2)  Legislative resolution of 9. 3. 1988.                             products in the Community could be greatly reduced by
(J)  OJ No C 319, 30. 11. 1987.                                        an approximation of the rates of value added tax applied
(4) OJ No 22, 9. 2. 1965, p. 369/65.                                   and by the free movement of medicinal products within
(') OJ No 15, 17. 1. 1987, p. 36.                                      the Community;
 ---pagebreak--- 18. 5. 88                               Official Journal of the European Communities                               No C 129/15
Whereas the further approximation of such measures                 3. At least once a year, the competent authorities shall
must take place progressively,                                         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
HAS ADOPTED THE FOLLOWING DIRECTIVE:                                   may be charged for such products.
                           Article 1                                                          Article 3
1.     Member States shall ensure that any national                Without prejudice to Article 4, the following provisions
measure, whether laid down by law, regulation or                   shall apply if an increase in the price of a medicinal
administrative action, to control the prices of medicinal          product is permitted only after prior approval has been
products for human use or to restrict the range of                 obtained from the competent authorities:
medicinal products covered by their national health
insurance systems complies with the requirements of this
Directive.                                                         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 authori-
2.     The definition of 'medicinal product' laid down in              zation to increase the price of a medicinal product
Article 1 (2) of Directive 65/65/EEC shall apply for the               and communicated to the applicant within 90 days of
purposes of this Directive.                                            its receipt. The applicant shall furnish the competent
                                                                       authorities with adequate information including
                                                                       details of those events intervening since the price of
3.     Nothing in this Directive shall permit the marketing            the medicinal product was last determined which in
of a proprietary medicinal product in respect of which                 his opinion justify the price increase requested. If the
the authorization provided for in Article 3 of Directive               information supporting the application is inadequate,
65/65/EEC has not been issued.                                         the 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
                           Article 2                                   required.
                                                                       In the event of an exceptional number of applications,
The following provisions shall apply if the marketing of
                                                                       the time-limit may be extended once for a further 60
a medicinal product is permitted only after the
                                                                       days. The applicant shall be notified of such extension
competent authorities of the Member State concerned
                                                                       before the expiry of the time-limit.
have approved the price of the product:
                                                                       In the absence of such a decision within the
                                                                       abovementioned periods, the applicant shall be
 1. Member States shall ensure that a decision on the                  entitled to apply in full the price increase requested.
    price which may be charged for the medicinal product
    concerned is adopted and communicated to the
                                                                   2. Should the competent authorities decide not to permit
    applicant within 90 days of the receipt of an appli-
                                                                       the whole or part of the price increase requested, the
    cation submitted, in accordance with the requirements
                                                                       decision shall contain a statement of reasons based on
    laid down in the Member State concerned, by the                    objective and verifiable criteria and the applicant shall
    holder of a marketing authorization. The applicant                 be informed of the remedies available to him under
    shall furnish the competent authorities with adequate              the laws in force and the time-limits allowed for
    information. If the information supporting the appli-               applying for such remedies.
    cation 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         3. At least once a year, the competent authorities       shall
    information is required. In the absence of such a                  publish      in  an    appropriate      publication   and
    decision within the abovementioned time-limit, the                  communicate to the Commission a list of               the
    applicant shall be entitled to market the product at the           medicinal products for which price increases         have
    price proposed.                                                    been granted during the relevant period together     with
                                                                       the new price which may be charged for               such
                                                                       products.
 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                                   Article 4
    contain a statement of reasons based on objective and
    verifiable criteria. In addition, the applicant shall be        1.     In the event of a price freeze being imposed on all
    informed of the remedies available to him under the            medicinal products or on certain categories of medicinal
    laws in force and the time-limits allowed for applying         products by the competent authorities of a Member
    for such remedies.                                             State, that Member State shall check, at least once a
 ---pagebreak--- No C 129/16                           Official Journal of the European Communities                                   18. 5. 88
year, whether the macro-economic conditions justify the          control scheme, the provisions of Articles 2 to 4 shall,
continuation of the freeze unchanged. Within 90 days of          where relevant, apply to such price controls. However,
the commencement of this review, the competent auth-             Articles 2 to 4 shall not apply where the normal
orities shall announce what increases or decreases in            operation of a system of direct or indirect controls on
prices are being made, if any.                                   profits results exceptionnally in a price being fixed for an
                                                                 individual medicinal product.
2.     In exceptional cases, a person who is holder of a
marketing authorization for a medicinal product may
apply for a derogation from a price freeze if this is                                      Article 6
justified by particular reasons. The application shall           The following provisions shall apply if a medicinal
contain an adequate statement of these reasons. Member           product is covered by the national health insurance
States shall ensure that a reasoned decision on any such         system only after the competent authorities have decided
application is adopted and communicated to the                   to include the medicinal product concerned in a positive
applicant within 90 days of its receipt. If the information      list of medicinal products covered by the national health
supporting the application is inadequate, the time-limit         insurance system.
shall be extended by a further period of 90 days and the
competent authorities shall notify the applicant of what
                                                                 1. Member States shall ensure that a decision on an
detailed additional information is required. Should the
                                                                     application submitted, in accordance with the
derogation be granted, the competent authorities shall
                                                                     requirements laid down in the Member State
forthwith publish an announcement of the price increase
                                                                     concerned, by the holder of a marketing authori-
allowed.                                                             zation, to include a medicinal product in the list of
                                                                     medicinal products covered by the health insurance
In case of an exceptional number of applications, the                system is adopted and communicated to the applicant
time-limit may be extended once for a further 60 days.               within 90 days of its receipt.
The applicant shall be notified of such extension before
the expiry of the initial time-limit.                                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,
                          Article 5                                  or where a decision on the price of a medicinal
Where a Member State adopts a system of direct or                    product and a decision on its inclusion within the list
indirect controls on the profitability of persons                    of products covered by the health insurance system
responsible for placing medicinal products on the                    are taken after a single administrative procedure, the
market, the Member State concerned shall publish the                 time-limit shall be extended by a further 90 days. The
following information in an appropriate publication and              applicant shall provide the competent authorities with
communication it to the Commission:                                  adequate information. If the information supporting
                                                                     the application is inadequate, the time-limit shall be
(a) the method or methods used in the Member State                   suspended and the competent authorities shall
     concerned to define profitability: return on sales              forthwith notify the applicant of what detailed
     and/or return on capital;                                       additional information is required.
                                                                     Where a Member State does not permit an application
(b) the target rates of profit currently permitted to                to be made under this Article before the competent
     persons responsible for placing medicinal products              authorities have agreed the price to be charged for the
     on the market in the Member State concerned;                    product pursuant to Article 2, the Member State
                                                                     concerned shall ensure that the overall period of time
(c) the criteria according to which target rates of profit           taken by the two procedures does not exceed 180
     are accorded to persons responsible for placing                 days. This time-limit may be extended in accordance
     medicinal products on the market, together with the             with the provisions of Article 2 or suspended in
     criteria according to which they will be allowed to             accordance with the provisions of the preceding
     retain profits above their given targets in the                 paragraph.
     Member State concerned;
                                                                 2. Any decision not to include a medicinal product in
(d) the maximum percentage profit which any persons                  the list of products covered by the health insurance
     responsible for placing medicinal products on the               system shall contain a statement of reasons based on
     market are allowed to retain above their target in the          objective and verifiable criteria, including if appro-
     Member State concerned.                                         priate any expert opinions or recommendations on
                                                                     which it is based. In addition, the applicant shall be
This information shall be updated once a year or when                informed of the remedies available to him under the
significant changes are made.                                        laws in force, and the time-limits allowed for applying
                                                                     for such remedies.
Where, in addition to a system of direct or indirect
controls on profits, a Member State operates a system of         3. Before the date referred to in Article 12 (1), the
controls on the prices of certain types of medicinal                 Member States shall publish in an appropriate publi-
products which are excluded from the scope of the profit             cation and communicate to the Commission the
 ---pagebreak---  18. 5. 88                              Official Journal of the European Communities                            No C 129/17
    criteria which are to be taken into account by the                which have been excluded from the scope of its health
    competent authorities in deciding whether or not to                insurance system. This information shall be updated at
    include medicinal products on the lists.                           least every six months.
4. Within one year of the date referred to in Article
     12 (1), the Member States shall publish in an appro-                                     Article 8
    priate publication       and    communicate     to    the      1.     Before the date referred to in Article 12 (1), the
    Commission a complete list of the products covered             Member States shall communicate to the Commission
    by their health insurance system, together with their          any criteria concerning the therapeutic classification of
    prices fixed by the national competent authorities.            medicinal products which are used by the competent
    This information shall be updated at least once every          authorities for the purposes of the national social
    year.                                                          security system.
5. Any decision to exclude a product from the list of
    products covered by the health insurance system shall          2.     Before the date referred to in Article 12 (1), the
    contain a statement of reasons based on objective and          Member States shall communicate to the Commission
    verifiable criteria. Such decisions, including if appro-       any criteria which are used by the competent authorities
    priate any expert recommendation or opinion on                 for the purposes of the national social security system in
    which the decisions are based, shall be communicated          verifying the fairness and transparency of the prices
    to the person responsible, who shall be informed of            charged for transfers within a group of companies of
    the remedies available to him under the laws in force          active principles or intermediate products used in the
                                                                   manufacture of medicinal products or finished medicinal
    and the time-limits allowed for applying for such
                                                                  products.
    remedies.
6. Any decision to exclude a category of medicinal                                            Article 9
    products from the list of products covered by the
    health insurance system shall contain a statement of           1.     In the light of experience, the Commission shall,
    reasons based on objective and verifiable criteria and         not later than two years after the date referred to in
    shall be published in an appropriate publication.             Article 12(1), submit to the Council a proposal
                                                                  containing appropriate measures leading towards the
                           Article 7                              abolition of any remaining barriers to, or distortions of,
                                                                  the free movement of proprietary medicinal products, so
The following provisions shall apply if the competent             as to bring this sector more closely into line with the
authorities of a Member State are empowered to adopt              normal conditions of the internal market.
decisions to exclude individual medicinal products or
categories thereof from the coverage of its national              2.     The Council shall decide on the Commission
health insurance system (negative lists).                         proposal not later than one year after its submission.
1. Any decision to exclude a category of medicinal
    products from the coverage of the national health                                        Article 10
    insurance system shall contain a statement of reasons
                                                                   1.    A committee called the Consultative Committee for
   based on objective and verifiable criteria and be
                                                                  the implementation of Directive 88/.../EEC and the
   published in an appropriate publication.
                                                                  development of a European pharmaceuticals policy,
2. Before the date referred to in Article 12 (1), Member          hereinafter referrred to as 'the Committee', is hereby set
    States shall publish in an appropriate publication and        up under the auspices of the Commission.
    communicate to the Commission the criteria which
    are to be taken into account by the competent auth-           2.     The tasks of the Committee shall be:
    orities in deciding whether or not to exclude an indi-
                                                                  — to examine any question relating to the application of
   vidual medicinal product from the coverage of the
                                                                       this Directive which is raised by the Commission or
   national health insurance system.
                                                                       at the request of a Member State,
3. Any decision to exclude an individual medicinal
   product from the coverage of the national health               — to develop a European pharmaceuticals policy which
   insurance system shall contain a statement of reasons               satisfies the special demands of the health sector and
   based on objective and verifiable criteria. Such                    complies with the normal rules governing the internal
   decisions, including if appropriate any expert opinions             market.
   or recommendations on which the decisions are
   based, shall be communicated to the person                     3.     The Committee shall consist of one representative
   responsible, who shall be informed of the remedies             from each Member State. There shall be one deputy for
   available to him under the laws in force and the time-         each representative. This deputy shall be entitled to
   limits allowed for applying for such remedies.                 participate in meetings of the Committee.
4. Within one year of the date referred to in Article             4.     A representative of the Commission shall chair the
    12 (1), the competent authorities shall publish in an         Committee.
   appropriate publication and communicate to the
   Commission a list of the individual medicinal products         5.     The Committee shall adopt its rules of procedure.
 ---pagebreak--- N o C 129/18                             Official Journal of the European Communities                                  18. 5. 88
                          Article 11                                4.     By 31 December 1992, the Commission shall
                                                                    publish a list of medicinal products authorized in the
1.    The Commission shall set up a data bank in order              Community containing the information mentioned in
to improve competition in the pharmaceuticals sector and            paragraph 2.
to encourage the more efficient use of medicinal
products in the Community.                                                                    Article 12
2.    For each medicinal product authorized in the                  1.     Member States shall bring into force the laws,
Community, the data bank shall contain as a rule:                   regulations and administrative provisions necessary to
                                                                    comply with this Directive by 1 January 1989 at the
(a) a summary of the characteristics of the product as              latest. They shall forthwith inform the Commission
    mentioned in Articles 4a and 4b of Directive                    thereof.
    65/65/EEC;                                                      2.     Before the date referred to in paragraph 1, Member
                                                                    States shall communicate to the Commission the texts of
(b) its ex-factory and retail prices;
                                                                    any laws, regulations or administrative provisions
                                                                    relating to the pricing of medicinal products, the profit-
(c) an estimate of the cost of the usual daily dose;
                                                                    ability of manufacturers of medicinal products and the
(d) the manner in which it is dispensed to the patient              coverage of medicinal products by the national health
    (self-medication, prescription only, hospital use               insurance system. Amendments and modifications to
    only).                                                          these laws, regulations or administrative provisions shall
                                                                    be communicated to the Commission forthwith.
3.    The Member States, the manufacturers and                                                Article 13
importers shall cooperate with the Commission in setting
up the data bank, to which they shall have access.                  This Directive is addressed to the Member States.
              Proposal for a Council Regulation (EEC) amending Regulation (EEC) No 1883/78 laying down
              general rules for the financing of interventions by the European Agricultural Guidance and
                                               Guarantee Fund, Guarantee Section
                                                       COM(88) 195 final
                                (Submitted by the Commission to the Council on 27 April 1988)
                                                          (88/C 129/16)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                            Whereas the rules on the depreciation of products stored
                                                                    given in Articles 7 and 8 of that Regulation must, be
Having regard to the Treaty establishing the European               adapted to the new guidelines as regards the financing of
Economic Community,                                                 agricultural expenditure set out in the Conclusions of the
                                                                    European Council of 11 and 12 February 1988;
Having regard to Council Regulation (EEC) No 729/70
of 21 April 1970 on the financing of the common agri-
cultural policy (x), as last amended by Regulation (EEC)            Whereas from 1989 onwards, the value of agricultural
No 3183/87( 2 ), and in particular Article 3(2) thereof,            products bought in under the market organization regu-
                                                                    lations should generally be depreciated directly on
Having regard to the proposal from the Commission,                  buying in;
Having regard       to   the   opinion    of   the  European
Parliament,                                                         Whereas extraordinary depreciations will be effected
                                                                    during the years 1989 to 1992 on the basis of appropri-
Whereas Council Regulation (EEC) No 1883/78 (3), as                 ations entered for this purpose in the respective
last amended by Regulation (EEC) No 801/87 (4),                     Community budgets;
included basic rules for the financing of intervention
measures in the form of public storage;
                                                                    Whereas the provisions adopted in Council Regulation
                                                                    (EEC) No 1334/86 (5) amending Regulation (EEC) No
                                                                     1883/78 and authorizing the Commission to reduce the
O   OJ  No  L 94, 28. 4. 1970, p. 13.
                                                                    standard interest rate and the standard amounts used for
(2) OJ  No  L 304, 27. 10. 1987, p. 1.
(J) OJ  No  L 216, 5. 8. 1978, p. 1.
(4) OJ  No  L 79, 21. 3. 1987, p. 14.                               (') OJ No 119, 8. 5. 1986, p. 18.