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,
Having regard to the Treaty establishing the European
Economic Community, and in particular Article 100
thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Par-
liament,
Having regard to the opinion of the Economic and
Social Committee,
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
action relating to proprietary medicinal products (') may
be refused only for reasons relating to the quality, safety
or efficacy of the proprietary medicinal product
concerned;
(') OJ No 22, 9. 2. 1965, p. 369/65.
Whereas Member States have adopted measures of an
economic nature on the marketing of medicinal products
in order to control or reduce public health expenditures
on medicinal products; whereas such measures include
direct and indirect controls on the prices of medicinal
products and limitations on the range of products
covered by the national health insurance system;
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
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;
^ m . ^ COfficial journal of the European communities ^oCtBBB
whereas as a first step towards the removal of these
disparities, it is urgently necessary to lay downaseries 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,theserequirements do not effect the policies of
the Iviemher states who rely primarily upon free
competition to determine the price of medicinal
products^
whereas the further approximation of such measures
must take place progressively,
^ A ^ A ^ o r r ^ o r ^ ^ O L ^ ^
P ^viemher states shall ensure that any national
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
medicinal products covered hy their national health
insurance systems complies withthe requirements of this
Mirective.
^ The definition of ^medicinal products^ laid down in
Ar t i c le to f Council MirectiveD^BD^BEEC^ of ^ ] a n u a r y
r ^ shall apply to this Mirective.
^ nothing in this POirective shall permit the marketing
of a proprietary medicinal product in respect of which
the authorisation provided for in Article ^ of council
directive D^BD^BEEC of ^ ] a n u a r y t ^ h a s n o t h e e n
issued.
A r ^ c ^ ^
Thefollowing provisions shall apply if the marketingof
a medicinal product is permitted only after the
competent authorities of the Iviemher ^tate concerned
have approved the price of the products
P ^viemher states shall ensure that a decision on the
price which may he charged for the medicinal product
concerned is adopted and communicated to the
applicant within ^0 days of the receipt of an
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
market the product at the price proposed.
^. should the competent authorities decide not to permit
the marketingof the medicinalproductconcernedat
the price proposed hy the applicant,the decision shall
contain a detailed statement of reasons. In addition,
the applicant shall he informed of the remedies
available to h imuuder the laws in force and the timeD
limits allowed for applying for such remedies.
^. At least once every si^ months the competent auth
orities shall puhlish in an appropriate official puh
lication and communicate to the C^ommissionalist of
the medicinal products whose price has heen fi^ed
during the relevant period together with the prices
which may he charged for such products.
A r ^ c A ^
without prejudiceto Articled, thefollowing provisions
shall apply if an increase in the price of a medicinal
product ispermit tedonly after prior approval has heen
ohtained from the competent authorities^
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
entitled to apply in full the price increase requested.
^. should the competent authorities decide not to permit
the whole or part of the price increase requested,the
decision shallcontainadetai led statement of reasons
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.
^. A t l ea s tonce every si^ months the competent auth
orities shall puhlish in an appropriate official puhD
lication and communicate to the Commissionalist of
the medicinal products for which price increases have
heen granted during the relevant period together with
the new price which may he charged for such
products.
t. In the event ofafree^eheing imposed on the prices
of all medicinal products or certain categories of
medicinal products, Iviemher states shall ensure that
prices are reviewed, andwhere appropriate adjusted, at
least onceayea r or when the national resale price inde^
hasincreasedhytO^Bo since the last review,whichever is
the sooner .^ i thin ^Odays of the commencement of this
review the competent authorities shall announce what
increases or decreases in prices are heing made.
^. Any person who is responsihle for marketing a
medicinal product may apply for a derogation from a
price freeze, stating his reasons in detail, ^emher states
shall ensure that a reasoned decision on any such
application is adopted and communicated to the
applicant within ^0 days. In the ahsence of^ such a
decision, the applicant shallhe entitled to apply in full
the price increase requested, should the derogation he
granted, the competent authorities shall forthwith puhlish
an announcement of the price increase allowed.
No C 17/8 Official Journal of the European Communities 23.1. 87
Article 5
Where a Member State adopts a system of direct or
indirect controls on the profitability of manufacturers
and importers of medicinal products, the Member State
concerned shall publish the following information in an
appropriate official publication and communicate it to
the Commission:
(a) the method or methods used to define profitability;
return on sales and/or return on capital,
(b) the criteria according to which target rates of profit
are accorded to individual manufacturers or
importers together with the criteria according to
which manufacturers or importers will be allowed to
retain profits above their given targets,
(c) the range of target profit, including the average
target rate of profit for manufacturers or importers
for the previous year and the current year,
(d) whether any company failed to reach their allocated
target,
(e) the maximum percentage profit which any manu-
facturer or importer has been allowed to retain
above their target.
This information shall be updated at least once a year.
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 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
4 shall not apply where the normal operation of a system
of direct or indirect controls on profits results
exceptionally in a price being fixed for an individual
medicinal product.
Article 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 due form 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. An application under this Article may be
made before the competent authorities have agreed
the price to be charged for the product pursuant to
Article 2.
2. Any decision not to include a medicinal product in
the list of products covered by the health insurance
system shall state in detail the reasons upon 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 11 (1) of this
Directive the Member States shall publish in an
appropriate official 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 11
(1) of this Directive, the Member States shall pub-
lish in an appropriate official publication and
communicate to the Commission a complete list of the
products covered by their health insurance system,
together with their prices. This information shall be
updated at least once every six months.
Article 7
The following provisions shall apply if the competent
authorities of a Member State are empowered to adopt
decisions to exclude individual or categories of medicinal
products 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 state in detail the reasons on
which it is based and be published in an appropriate
official publication.
2. Before the date referred to in Article 11 (1) of this
Directive, Member States shall publish in an appro-
priate official 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 state in detail the reasons on
which it is based. Such decisions 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.
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
(1) of this Directive, the competent authorities shall
published in an appropriate official 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.
Article 8
1. Before the date referred to in Article 11 (1) of this
Directive, the Member States shall communicate to the
Commission any therapeutic classification of medicinal
products which is used by the competent authorities for
the purposes of the national social security system. If it
considers it necessary, the Commission may, after
considering the opinion of the Committee referred to in
Article 10, adopt a directive on the approximation of
national provisions relating to the classification of
medicinal products for social security purposes.
2. Before the date referred to in Article 11 (1) of this
Directive, the Member States shall communicate to the
Commission the criteria which are used by the competent
authorities in verifying the fairness of the prices charged
for transfers within a group of companies of active
principles or intermediate products used in the manu-
facture of medicinal products. If it considers it necessary,
the Commission may, after considering the opinion of
the Committee referred to in Article 10, adopt a directive
or issue guidelines on the approximation of national
criteria for the verification of the fairness of such prices.
Article 9
1. In the light of experience, the Commission shall,
not later than two years after the date referred to in
Article 11 (1) of this Directive, 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.
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 on
Pharmaceutical Pricing and Reimbursement shall be set
up and attached to the Commission.
2. The tasks of the committee shall be:
— 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
State,
— to discuss and provide an opinion on matters referred
to it by the Commission pursuant to Article 8 of this
Directive or in accordance with the provisions of any
future directive. When seeking the opinion of the
Committee, the Commission may set a time limit
within which such an opinion shall be given. No vote
shall be taken. However any member of the
Committee may demand that his views be set down
in the minutes.
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. Member States shall bring into force the laws, regu-
lations and 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 law, 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 Commission forthwith.
Article 12
This Directive is addressed to the Member States.
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