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^orr^or^^OL^^ 
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 
Articletof Council MirectiveD^BD^BEEC^ of ^]anuary 
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 ^]anuary t^ hasnotheen 
issued. 
Ar^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 indueform.lnthe 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 himuuderthelaws 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. 
Ar^cA^ 
without prejudiceto Articled, thefollowing provisions 
shall apply if an increase in the price of a medicinal 
productispermittedonly 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 shallcontainadetailed 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. 
^. Atleastonce 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 onceayear or when the national resale price inde^ 
hasincreasedhytO^Bo since the last review,whichever is 
the sooner.^ithin ^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.