CELEX: 51986PC0765
Language: en
Date: 1986-12-23
Title: 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 17/6                                  Official Journal of the European Communities                                23.1.87
               6. Article 3 (1) (e) is amended as follows:
                   ' "Community shipowners" means:
                   — all cargo shipping companies established under the Treaty in a Member State of the
                       Community,
                   — nationals of Member States established outside the Community or cargo shipping
                       companies established outside the Community and controlled by nationals of Member
                       States, if their ships are registered in a Member State in accordance with its legislation.'
               7. Article 3 (2) is deleted.
               8. Article 4 (1) (b) is deleted.
               9. In Article 5, after 'unfair pricing practices' insert:
                   'and any group of seafarers or their representatives, employed by Community shipowners,
                   who are affected or consider themselves threatened by such practices,
              10. In Article 12 insert new paragraph 2:
                   Tn deciding on the redressive duties, the Council and the Commission shall also take due
                   account of the external trade policy considerations as well as the port interests and the
                   shipping policy considerations of the Member States concerned.'
                   Existing paragraph 2 becomes paragraph 3.
              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(86) 765 final
                               (Submitted by the Commission to the Council on 30 December 1986)
                                                            (87/C 17/04)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                              Whereas Member States have adopted measures of an
                                                                      economic nature on the marketing of medicinal products
Having regard to the Treaty establishing the European                 in order to control or reduce public health expenditures
Economic Community, and in particular Article 100                     on medicinal products; whereas such measures include
thereof,                                                              direct and indirect controls on the prices of medicinal
Having regard to the proposal from the Commission,                    products and limitations on the range of products
                                                                      covered by the national health insurance system;
Having regard to the opinion of the European Par-
liament,
                                                                      Whereas the primary objective of such measures is the
Having regard to the opinion of the Economic and                      promotion of public health by ensuring the availability of
Social Committee,                                                     adequate supplies of medicinal products at a reasonable
                                                                      cost; whereas however such measures should also be
Whereas marketing authorizations for proprietary                      intended to promote efficiency in the production of
medicinal products issued pursuant to Council Directive               medicinal products and to encourage research and
65/65/EEC of 26 January 1965 on the approximation of                  development into new medicinal products, on which the
provisions laid down by law, regulation or administrative             maintenance of a high level of public health within the
action relating to proprietary medicinal products (') may             Community ultimately depends;
be refused only for reasons relating to the quality, safety
or efficacy of the proprietary medicinal product
                                                                      Whereas disparities in such measures may hinder or
concerned;
                                                                      distort intra-Community trade in medicinal products and
                                                                      thereby directly affect the functioning of the common
(') OJ No 22, 9. 2. 1965, p. 369/65.                                  market in medicinal products;
 ---pagebreak--- ^m.^                                              COfficial journal of the European communities                                              ^oCtBBB
whereas as a first step towards the removal of these                          ^. At least once every si^ months the competent auth
disparities, it is urgently necessary to lay downaseries of                        orities shall puhlish in an appropriate official puh
requirements intended to ensure that all concerned can                             lication and communicate to the C^ommissionalist of
verify that the national measures do not constitute                                the medicinal products whose price has heen fi^ed
quantitative restrictions on imports or exports or                                 during the relevant period together with the prices
measures having equivalent effect thereto^ whereas,                                which may he charged for such products.
however,theserequirements do not effect the policies of
the Iviemher states who rely primarily upon free
competition to determine the price of medicinal
                                                                                                                        Ar^cA^
products^
                                                                              without prejudiceto Articled, thefollowing provisions
                                                                              shall apply if an increase in the price of a medicinal
whereas the further approximation of such measures
                                                                              p r o d u c t i s p e r m i t t e d o n l y after prior approval has heen
must take place progressively,
                                                                              ohtained from the competent authorities^
^A^A^orr^or^^OL^^                                                              n ^viemher states shall ensure thatadecision is adopted
                                                                                   on an application suhmitted in due form to increase
                                                                                   the price ofamedicinal product and communicated to
                                                                                   the applicant within ^0 days of its receipt. In the
                                                                                   ahsence of such a decision, the applicant shall he
P        ^viemher states shall ensure that any national                            entitled to apply in full the price increase requested.
measure, whether laid down hy law, regulation or
administrative action, to control theprices of medicinal
products for human use or to restrict the range of                            ^. should the competent authorities decide not to permit
medicinal products covered hy their national health                                the whole or part of the price increase requested,the
insurance systems complies withthe requirements of this                           decision shallcontainadetailed statement of reasons
Mirective.                                                                         and the applicant shall he informed of the remedies
                                                                                   availahle to him under the laws in force and the timeD
                                                                                   limits allowed for applying for such remedies.
^        The definition of ^medicinal products^ laid down in
A r t i c l e t o f Council MirectiveD^BD^BEEC^ of ^ ] a n u a r y
r ^ shall apply to this Mirective.                                            ^. A t l e a s t o n c e every si^ months the competent auth
                                                                                  orities shall puhlish in an appropriate official puhD
                                                                                  lication and communicate to the Commissionalist of
^        nothing in this POirective shall permit the marketing
                                                                                  the medicinal products for which price increases have
of a proprietary medicinal product in respect of which
                                                                                  heen granted during the relevant period together with
the authorisation provided for in Article ^ of council
                                                                                  the new price which may he charged for such
directive D^BD^BEEC of ^ ] a n u a r y t ^ h a s n o t h e e n
                                                                                  products.
issued.
                               Ar^c^^
Thefollowing provisions shall apply if the marketingof                         t.     In the event ofafree^eheing imposed on the prices
a medicinal product is permitted only after the                               of all medicinal products or certain categories of
competent authorities of the Iviemher ^tate concerned                         medicinal products, Iviemher states shall ensure that
have approved the price of the products                                       prices are reviewed, andwhere appropriate adjusted, at
                                                                              least o n c e a y e a r or when the national resale price inde^
                                                                              hasincreasedhytO^Bo since the last review,whichever is
P ^viemher states shall ensure that a decision on the
    price which may he charged for the medicinal product                      the s o o n e r . ^ i t h i n ^Odays of the commencement of this
    concerned is adopted and communicated to the                              review the competent authorities shall announce what
    applicant within ^0 days of the receipt of an                             increases or decreases in prices are heing made.
    application suhmitted i n d u e f o r m . l n t h e ahsenceof
    such a decision, the applicant shall he entitled to
                                                                              ^.      Any person who is responsihle for marketing a
    market the product at the price proposed.
                                                                              medicinal product may apply for a derogation from a
                                                                              price freeze, stating his reasons in detail, ^ e m h e r states
^. should the competent authorities decide not to permit                      shall ensure that a reasoned decision on any such
    the marketingof the medicinalproductconcernedat                           application is adopted and communicated to the
    the price proposed hy the applicant,the decision shall                    applicant within ^0 days. In the ahsence of^ such a
    contain a detailed statement of reasons. In addition,                     decision, the applicant shallhe entitled to apply in full
    the applicant shall he informed of the remedies                           the price increase requested, should the derogation he
    available to h i m u u d e r t h e l a w s in force and the timeD         granted, the competent authorities shall forthwith puhlish
    limits allowed for applying for such remedies.                            an announcement of the price increase allowed.
 ---pagebreak---  No C 17/8                                Official Journal of the European Communities                                    23.1. 87
                            Article 5                                 2. Any decision not to include a medicinal product in
                                                                          the list of products covered by the health insurance
 Where a Member State adopts a system of direct or                        system shall state in detail the reasons upon which it is
 indirect controls on the profitability of manufacturers                  based. In addition the applicant shall be informed of
 and importers of medicinal products, the Member State                    the remedies available to him under the laws in force,
 concerned shall publish the following information in an                  and the time limits allowed for applying for such
 appropriate official publication and communicate it to                   remedies.
 the Commission:
 (a) the method or methods used to define profitability;              3. Before the date referred to in Article 11 (1) of this
      return on sales and/or return on capital,                           Directive the Member States shall publish in an
                                                                          appropriate official publication and communicate to
 (b) the criteria according to which target rates of profit               the Commission the criteria which are to be taken
      are accorded to individual manufacturers or                         into account by the competent authorities in deciding
      importers together with the criteria according to                   whether or not to include medicinal products on the
      which manufacturers or importers will be allowed to                 lists.
      retain profits above their given targets,
 (c) the range of target profit, including the average               4. Within one year of the date referred to in Article 11
      target rate of profit for manufacturers or importers                (1) of this Directive, the Member States shall pub-
      for the previous year and the current year,                         lish in an appropriate official publication and
                                                                          communicate to the Commission a complete list of the
(d) whether any company failed to reach their allocated                  products covered by their health insurance system,
      target,                                                            together with their prices. This information shall be
                                                                          updated at least once every six months.
(e) the maximum percentage profit which any manu-
      facturer or importer has been allowed to retain
      above their target.                                                                        Article 7
                                                                     The following provisions shall apply if the competent
This information shall be updated at least once a year.
                                                                     authorities of a Member State are empowered to adopt
                                                                     decisions to exclude individual or categories of medicinal
Where, in addition to a system of direct or indirect                 products from the coverage of its national health
controls on profits, a Member State operates a system of             insurance system (negative lists).
controls on the prices of certains types of medicinal
products, which are excluded from the scope of the
profit control scheme, the provisions of Articles 2 to 4
shall apply to such price controls. However, Articles 2 to           1. Any decision to exclude a category of medicinal
4 shall not apply where the normal operation of a system                 products from the coverage of the national health
of direct or indirect controls on profits results                        insurance system shall state in detail the reasons on
exceptionally in a price being fixed for an individual                   which it is based and be published in an appropriate
medicinal product.                                                       official publication.
                           Article 6                                 2. Before the date referred to in Article 11 (1) of this
                                                                         Directive, Member States shall publish in an appro-
The following provisions shall apply if a medicinal                      priate official publication and communicate to the
product is covered by the national health insurance                      Commission the criteria which are to be taken into
system only after the competent authorities have decided                 account by the competent authorities in deciding
to include the medicinal product concerned in a positive                 whether or not to exclude an individual medicinal
list of medicinal products covered by the national health                product from the coverage of the national health
insurance system.                                                        insurance system.
1. Member States shall ensure that a decision on an
    application submitted in due form to include a                   3. Any decision to exclude an individual medicinal
    medicinal product in the list of medicinal products                  product from the coverage of the national health
    covered by the health insurance system is adopted and                insurance system shall state in detail the reasons on
    communicated to the applicant within 90 days of its                  which it is based. Such decisions shall be
    receipt. An application under this Article may be                    communicated to the person responsible, who shall be
    made before the competent authorities have agreed                    informed of the remedies available to him under the
    the price to be charged for the product pursuant to                  laws in force and the time limits allowed for applying
    Article 2.                                                           for such remedies.
 ---pagebreak--- 23.1.87                                   Official Journal of the European Communities                                 No C 17/9
4. Within one year of the date referred to in Article 11                                        Article 10
    (1) of this Directive, the competent authorities shall
   published in an appropriate official publication and              1.    A Committee called the Consultative Committee on
   communicate to the Commission a list of the                       Pharmaceutical Pricing and Reimbursement shall be set
    individual medicinal products which have been                    up and attached to the Commission.
   excluded from the scope of its health insurance
                                                                     2.    The tasks of the committee shall be:
    system. This information shall be updated at least
    every six months.                                                — to examine any question relating to the application of
                                                                         this Directive which is brought up by its chairman
                                                                         either on his initiative or at the request of a Member
                            Article 8                                    State,
                                                                     — to discuss and provide an opinion on matters referred
1.     Before the date referred to in Article 11 (1) of this             to it by the Commission pursuant to Article 8 of this
Directive, the Member States shall communicate to the                    Directive or in accordance with the provisions of any
Commission any therapeutic classification of medicinal                   future directive. When seeking the opinion of the
products which is used by the competent authorities for                  Committee, the Commission may set a time limit
the purposes of the national social security system. If it               within which such an opinion shall be given. No vote
considers it necessary, the Commission may, after                        shall be taken. However any member of the
considering the opinion of the Committee referred to in                  Committee may demand that his views be set down
Article 10, adopt a directive on the approximation of                    in the minutes.
national provisions relating to the classification of
medicinal products for social security purposes.                     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
2.     Before the date referred to in Article 11 (1) of this         participate in meetings of the committee.
Directive, the Member States shall communicate to the
Commission the criteria which are used by the competent              4.    A representative of the Commission shall chair the
authorities in verifying the fairness of the prices charged          committee.
for transfers within a group of companies of active                  5.    The committee shall adopt its rules of procedure.
principles or intermediate products used in the manu-
facture of medicinal products. If it considers it necessary,                                    Article 11
the Commission may, after considering the opinion of
the Committee referred to in Article 10, adopt a directive           1.    Member States shall bring into force the laws, regu-
or issue guidelines on the approximation of national                 lations and administrative provisions necessary to comply
criteria for the verification of the fairness of such prices.        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
                            Article 9
                                                                     States shall communicate to the Commission the texts of
1.     In the light of experience, the Commission shall,             any law, regulations or administrative provisions relating
not later than two years after the date referred to in               to the pricing of medicinal products, the profitability of
Article 11 (1) of this Directive, submit to the Council a            manufacturers of medicinal products and the coverage of
proposal containing appropriate measures leading                     medicinal products by the national health insurance
towards the abolition of any remaining barriers to or                system. Amendments and modifications to these laws,
distortions of the free movement of proprietary                      regulations or administrative provisions shall be
medicinal products.                                                  communicated to the Commission forthwith.
                                                                                                Article 12
2.     The Council shall decide on the Commission
proposal not later than one year after its submission.               This Directive is addressed to the Member States.