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, 
Having regard to the Treaty establishing the European 
Economic Community, and in particular Article 100A 
thereof, 
Having regard to the proposal from the Commission, 
In cooperation with the European Parliament (2), 
Having regard to the opinion of the Economic and 
Social Committee (3), 
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 (4), as 
last amended by Directive 87/21/EEC (5), may be 
refused only for reasons relating to the quality, safety or 
efficacy of the proprietary medicinal products 
concerned; 
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 compe­
tition in the medicinal products market and limitations 
on the range of products covered by the national health 
insurance system; 
(') OJ No C 17, 23. 1. 1987, p. 6. 
(2) Legislative resolution of 9. 3. 1988. 
(J) OJ No C 319, 30. 11. 1987. 
(4) OJ No 22, 9. 2. 1965, p. 369/65. 
(') OJ No 15, 17. 1. 1987, p. 36. 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 devel­
opment into new medicinal products, on which the main­
tenance 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 
overview of national pricing arrangements, including the 
manner in which they operate in individual cases and all 
the criteria on which they are based, and 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; 
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 quan­
titative 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 in 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; 
18. 5. 88 Official Journal of the European Communities No C 129/15 
Whereas the further approximation of such measures 
must take place progressively, 
HAS ADOPTED THE FOLLOWING DIRECTIVE: 
Article 1 
1. Member States shall ensure that any national 
measure, whether laid down by law, regulation or 
administrative 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 appli­
cation submitted, in accordance with the requirements 
laid down in the Member State concerned, by the 
holder of a marketing authorization. The applicant 
shall furnish the competent authorities with adequate 
information. If the information supporting the appli­
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 
information is required. In the absence of such a 
decision within the abovementioned time-limit, the 
applicant shall be entitled to market the product at the 
price proposed. 
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 authori­
zation 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. 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 
applicant of what detailed additional information is 
required. 
In the event of an exceptional number of applications, 
the time-limit may be extended once for a further 60 
days. The applicant shall be notified of such extension 
before the expiry of the time-limit. 
In the absence of such a decision within the 
abovementioned periods, the applicant shall be 
entitled to apply in full the price increase requested. 
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 
No C 129/16 Official Journal of the European Communities 18. 5. 88 
year, whether the macro-economic conditions justify the 
continuation of the freeze unchanged. Within 90 days of 
the commencement of this review, the competent auth­
orities 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 authorization 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 adequate statement of these 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 applicant of what 
detailed additional information is required. Should the 
derogation be granted, the competent authorities shall 
forthwith publish an announcement of the price increase 
allowed. 
In case of an exceptional number of applications, the 
time-limit may be extended once for a further 60 days. 
The applicant shall be notified of such extension before 
the expiry of the initial time-limit. 
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 
communication it to the Commission: 
(a) 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 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; 
(d) 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 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 exceptionnally 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 accordance with the 
requirements laid down in the Member State 
concerned, by the holder of a marketing authori­
zation, 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, 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. 
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 appro­
priate 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 publi­
cation and communicate to the Commission the 
18. 5. 88 Official Journal of the European Communities No C 129/17 
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 appro­
priate 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 appro­
priate 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. 
Article 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 auth­
orities in deciding whether or not to exclude an indi­
vidual 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. 
Article 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 referrred to as 'the Committee', is hereby set 
up under the auspices of the Commission. 
2. The tasks of the Committee shall be: 
— to examine any question relating to the application of 
this Directive which is 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. 
NoC 129/18 Official Journal of the European Communities 18. 5. 88 
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 authorized 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; 
(d) the manner in which it is dispensed to the patient 
(self-medication, prescription only, hospital use 
only). 
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 authorized in the 
Community containing the information mentioned in 
paragraph 2. 
Article 12 
1. Member States shall bring into force the laws, 
regulations 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 laws, regulations or administrative provisions 
relating to the pricing of medicinal products, the profit­
ability 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 13 
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, 
Having regard to the Treaty establishing the European 
Economic Community, 
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) 
No 3183/87(2), and in particular Article 3(2) thereof, 
Having regard to the proposal from the Commission, 
Having regard to the opinion of the European 
Parliament, 
Whereas Council Regulation (EEC) No 1883/78 (3), as 
last amended by Regulation (EEC) No 801/87 (4), 
included basic rules for the financing of intervention 
measures in the form of public storage; 
O OJ No L 94, 28. 4. 1970, p. 13. 
(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. Whereas the rules on the depreciation of products stored 
given in Articles 7 and 8 of that Regulation must, be 
adapted to the new guidelines as regards the financing of 
agricultural expenditure set out in the Conclusions of the 
European Council of 11 and 12 February 1988; 
Whereas from 1989 onwards, the value of agricultural 
products bought in under the market organization regu­
lations should generally be depreciated directly on 
buying in; 
Whereas extraordinary depreciations will be effected 
during the years 1989 to 1992 on the basis of appropri­
ations entered for this purpose in the respective 
Community budgets; 
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 
standard interest rate and the standard amounts used for 
(') OJ No 119, 8. 5. 1986, p. 18.