30. 11. 87 Official Journal of the European Communities No C 319/47 
Opinion on the proposal for a Council Directive relating to the transparency of measures 
regulating the prices of medicinal products for human use and their inclusion within the 
scope of the national health insurance system (*) 
(87/C 319/15) 
On 20 January 1987 the Council decided to consult the Economic and Social Committee, 
under Article 100 of the Treaty establishing the European Economic Community, on the 
abovementioned proposal. 
The Section for Industry, Commerce, Crafts and Services, which was responsible for preparing 
the Committee's work on the subject, adopted its Opinion on 2 September 1987, in the light 
of the report by Mr Frandi. 
The Section for Social, Family, Educational and Cultural Affairs was responsible for preparing 
a Supplementary Opinion (rapporteur: Mr Pearson). 
At its 248th plenary session (meeting of 23 September 1987) the Economic and Social 
Committee adopted the following Opinion by 132 votes to 11 with 13 abstentions (vote 
recorded): 
The Committee endorses the draft Directive subject to 
the following comments: 
1. Preliminary remarks 
1.1. The Committee welcomes any effort to achieve, 
by the proposed deadline of 1992, a true common 
market in medicinal products, in order to encourage a 
balance between social-security requirements and the 
development of Community industrial research in com­
petition with non-Community industrial systems, in a 
market which is basically atypical, inter alia in the sense 
that it is not guided by the independent choices of 
individual consumers. Needless to say, measures to 
harmonize price control and refund arrangements for 
medicines are contingent on better knowledge and 
greater transparency of the pharmaceuticals market, to 
be achieved via appropriate research, including a study 
of competition in the sector. Consumers' choices are 
conditioned in most cases by the need for prescription 
by doctors, who influence the market; they are also 
conditioned by the political decisions reflected in the 
various national social-security systems. In such cases, 
it is not possible to talk of price competition in the 
usual sense. 
1.2. The draft Directive constitutes a possible 
starting point for further action in the pharmaceutical 
sector. In the Committee's view such action should be 
mainly orientated towards: 
— medico-scientific information, aimed at updating 
doctors' and pharmacists' knowledge of the thera-
(!) OJ No C 17, 23. 1. 1987, p. 6. peutic properties of medicaments and the forms of 
treatment available, 
— innovative research, 
— systematic information of doctors about medic­
ament prices, on a comparative basis, 
— problems connected with the distribution of medic­
aments and the impact of the various distribution 
systems on the cost of the product to the consumer 
and to social-security schemes, at the same time of 
course taking into account the overriding require­
ments of public health, 
— the marketing of medicaments in all Member States 
at an optimum price (i.e. one which reconciles the 
legitimate requirements of manufacturers with the 
equally legitimate needs of consumers), 
— the drawing-up of provisions and rules to ensure 
that advertising on medicaments and their use meets 
the highest possible ethical standards. 
1.3. The Committee regards the above as essential if 
all Community citizens are to have access to a pharma­
ceutical service commensurate with their health needs. 
The Committee takes the view that all patients should 
be able to benefit from the most recent research and 
from the best possible health service. Member States 
have developed differently as regards social security 
and health protection, and it is understandable that the 
proposals do not seek to change the systems operating 
at present. 
2. General comments 
2.1. The Committee regards as useful the Com­
mission proposal to make 'transparent' the arrange-
No C 319/48 Official Journal of the European Communities 30. 11. 87 
ments for control of prices and eligibility of medic­
aments for refunds in those Member States where such 
controls exist — this should stimulate competition. The 
Committee takes the view that, in order to achieve a 
clearer and more objective relationship between the 
pharmaceutical industry and the controlling authorities, 
the draft Directive must (a) require firms to indicate the 
economic data and therapeutic properties of individual 
medicaments, (b) require the Member States to publish 
'transparency lists', (c) urge the Commission to set up 
a data base covering the pharmaceutical market. 
2.2. The Committee notes that price and refund eligi­
bility controls are applied in most of the Member States 
and that in those Member States, there is a considerable 
disparity in price control systems, and even more as 
regards eligibility for refund. The application of 'trans­
parency' criteria to such disparate systems is therefore 
an extremely complex matter, but it is an aim worth 
pursuing. 
2.2.1. The Committee notes that all the parties con­
cerned must .therefore have the opportunity to appeal 
using the appropriate procedures. 
The Committee also notes that there is a certain dispar­
ity in the matter of appeals. On this the Committee 
endorses the Commission proposal providing for the 
applicant to be informed of all the legal means of appeal 
and the time-limits for lodging such appeals; indeed, 
the possibility of appeal is an essential principle of any 
legal system. 
2.3. Given that in some Member States there are a 
number of decision-making centres for prices and 
refunds, the Committee hopes that the Directive will 
help to distinguish more clearly between the different 
types of problem. 
3. In the past, some Member States have taken a 
variety of measures to regulate pharmaceutical prices, 
ranging from monitoring systems to strict controls. 
The abolition of such national price control systems is 
therefore contingent on genuine competition on the 
pharmaceutical market. As the Commission correctly 
states, it is therefore neither desirable nor possible in 
current circumstances, to simply extend the system of 
completely free competition. For precisely this reason, 
the Directive must contain clear-cut provisions designed 
to prevent distortions of competition and the resulting 
perverse effects. 3.1. If there are price controls, the Committee con­
siders that it is necessary to distinguish between (a) 
a blanket freeze for all products under exceptional 
measures and (b) a freeze confined to medicinal prod­
ucts and designed to contain social-security costs. 
3.1.1. In the first scenario, medicinal products' prices 
would clearly be subject to the blanket freeze. But a 
price freeze affecting medicinal products alone (second 
scenario) would not appear to be justifiable and would 
constitute a discriminatory measure aimed at one par­
ticular sector. 
3.1.2. Moreover, a prolonged price freeze which 
made it totally uneconomic to manufacture therapeuti­
cally useful products could gradually force them off the 
market by concentrating consumption on more recent, 
but more expensive products; the result would be an 
increase in total expenditure which would be to the 
detriment of consumers, the social-security system and 
employers. Needless to say, national price controls must 
not jeopardize a fair return on therapeutically effective 
products. 
3.2. That said, in the interests of completing the 
common market, the decisive factor is clarity in upward 
or downward revision of prices within binding dead­
lines. 
While the proposed 90-days' deadline may be regarded 
as inadequate by both industry and authorities because 
of conflicting requirements, it would be worse to 
shorten or increase this period. 
3.3. The Committee thinks it preferable to refer (in 
Article 3) to 'price variations', so as to link price move­
ments to positive or negative inflation and to the struc­
tural changes which interact with price formation. 
4. The Committee regards innovative research as the 
driving force of the pharmaceutical sector and therefore 
feels that the requisite human and financial resources 
must be harnessed to develop research designed (a) to 
discover products capable of curing hitherto incurable 
diseases (b) to enhance the therapeutic effects or reduce 
the toxicity of existing products. 
4.1. It is in the general interest — of firms, consumers 
and the Member States — for innovative research to 
be stepped up. Hence it is essential to provide the Research 
Price control 
30. 11. 87 Official Journal of the European Communities No C 319/49 
resources for a gradual increase in research activity 
(even beyond the Member States' frontiers), thereby 
making it possible to move in the direction of meeting 
social objectives. In this context, account must be taken 
of international competitiveness which is becoming 
keener day by day. 
Transfer prices 
5. The Committee endorses the provisions on trans­
fer pricing and stresses that such problems are common 
to most industrial products of multinational firms and 
should therefore be dealt with in a multisectoral con­
text, using appropriate methods to which the pharma­
ceutical industry will have to adjust. The problems 
have been studied by the Organization of Economic 
Cooperation and Development (OECD) ('Transfer 
Pricing and Multinationals', Paris, 1979) and EC for all 
industrial branches and in all their implications. 
Refund 
6. Eligibility for refund is an important factor for 
consumers as well as manufacturers in the context of 
'transparency' measures. While the aim of the Directive 
is transparency of procedures, it is equally true that a 
more precise, harmonized method of defining eligibility 
also benefits consumers, as does maximum certainty 
about (a) the time-limits for updating lists, and (b) 
access to the medicinal products available under the 
social-security systems. 
6.1. In the interests of both manufacturers and con­
sumers it would be desirable to harmonize the systems 
of lists, since the existence of 'negative' and 'positive' 
lists can create complications. The situation could be 
simplified by adopting one of the two criteria. Although 
Done at Brussels, 23 September 1987. the difference in terms of actual refunds would be 
marginal, the Committee, in the interests of clarity, 
would opt for a positive list, provided that the national 
authorities take a decision within the 90-days' deadline 
from the date on which the application is submitted. On 
expiry of this deadline, the medicinal product should be 
automatically put on the positive list for admission for 
reimbursement. 
6.2. As to the time-scale envisaged for admission to 
refund, the points made on prices in 3.2 above, apply 
here also. Equally effective procedures must be intro­
duced in regard to the various refund arrangements. 
Consultative Committee 
7. The Committee notes that the Consultative Com­
mittee to be established under Article 10 is consistent 
with the recent Council arrangements for the exercise 
of the Commission's executive powers. While re­
cognizing the need for speed and efficiency in Com­
mission decision-making, the Committee nevertheless 
stresses the need to ensure that the parties directly 
concerned are consulted. The Committee also notes 
that the new procedures enshrined in the Single Act and 
the new Community approach to technical harmon­
ization do not affect consultation of the Economic and 
Social Committee pursuant to Article 100 A, para­
graph 1 of the amended version of the Treaty. 
Final consideration 
8. The Committee trusts that the Commission will 
pursue its efforts to establish a genuine single market 
for medicinal products. 
The Chairman 
of the Economic and Social Committee 
Alfons MARGOT 
No C 319/50 Official Journal of the European Communities 30. 11. 87 
APPENDIX 1 
to the Committee Opinion 
The following members, present or represented, voted for the Opinion: 
Mr/Mrs/Miss: 
ALEXOPOULOS 
APARICIO BRAVO 
ARENA 
ARETS 
BAGLIANO 
BELTRAMI 
BENTO GONCALVES 
BERETTA 
BERNASCONI 
BERNS 
BLESER 
BODDY 
BOS 
BREDIMA 
BREYIANNIS 
BRIGANTI 
BURNEL 
LOBO BRANDAO R. CAL 
CALVET CHAMBON 
CAMPBELL 
CARROLL 
CASHMAN 
CAVAZZUTI 
CEVALLO HERRERO 
CEYRAC 
CLAVEL 
CHRISTIE 
COLLAS 
ALVES CONDE 
CORELL AYORA 
COYLE 
CURLIS 
van DAM 
DASSIS 
DELHOMENIE 
DELLA CROCE 
DODD 
DONCK 
DOS SANTOS 
DRILLEAUD 
DROULIN 
EULEN 
FLUM 
FORJAS FRANDI 
FRESI 
GARDNER 
GAYETOT 
GEUENICH 
GIACOMELLI 
GLESENER 
GOMEZ MARTINEZ 
GORIS 
GREEN 
HAAS 
HAMMOND 
HANCOCK 
JENKINS 
KAARIS 
KAZAZIS 
KELLY 
KROGER 
LACA MARTIN 
LANDABURU 
LAUR 
LOPEZ DE LA PUERTA 
LOW 
MADDOCKS 
MAINETTI 
MARGALEF MASIA 
MARTIN ALMENDRO 
MARTIN CASTELLA 
MARVIER 
MASPRONE 
MEYER-HORN 
MORALES 
MORELAND 
MORSELLI 
MOURGUES 
MUHR 
MULLER 
MURPHY 
NETO DA SILVA 
NIELSEN B. 
NIELSEN P. 
NIERHAUS 
NIEUWENHUIZE 
de NORMANN NUGEYRE 
ORSI 
PARDON 
PEARSON 
PELLETIER 
PERRIN-PELLETIER 
PETROPOULOS 
POETON 
PROENCA 
PROUMENS 
QUEVEDO ROJO 
RAFTOPOULOS 
RAMAEKERS 
RIERA MARSA 
ROBINSON 
ROLAO GONCAL VES 
ROMOLI 
SAlU 
SALMON 
SALOMONE 
SANTILLAN CABEZA 
SCHMITZ 
SCHNIEDERS 
SCHOEPGES 
SILVA 
SOLARI 
SPEIRS 
SPRINGBORG 
STAEDELIN 
STORIE-PUGH 
TAMLIN 
TERMES CARRERO 
TUKKER 
VALLEJO CALDERON 
VASSILARAS 
VIDAL 
VELASCO MANCEBO 
VERCELLINO 
VLASSOPOULOS 
WAGNER 
WICK 
WHITWORTH 
YVERNEAU 
ZUFIAUR NARVAIZA 
The following members, present or represented, voted against the Opinion: 
Mr/Mrs/Miss: 
CORTOIS 
DUNET 
GREDAL 
HAGEN HILKENS 
HORSKEN 
HOUTHUYS 
PRONK TIEMANN 
TIXIER 
WILLIAMS 
The following members, present or represented, abstained: 
Mr/Mrs/Miss: 
ATAIDE FERREIRA 
BERGER 
BOISSEREE 
BROICHER 
von der DECKEN van EECKERT 
ETTY 
LOJEWSKI 
NOORDWAL 
PETERSEN RANGONI-MACHIAVELLI 
SPIJKERS 
VANDEN BROUCKE 
30. 11. 87 Official Journal of the European Communities No C 319/51 
APPENDIX 2 
to the Committee Opinion 
Rejected amendements 
The following amendements, based on the Section Opinion and presented in accordance with the rules of 
procedure, were rejected during the debate: 
Point 1.1. 
Reword last sentence but one to read: 
'Consumers' choices are conditioned in most cases by the need for prescription by doctors, who are sometimes 
informed by the pharmaceutical industry, which thereby contributes to influencing the market; ...' (rest 
unchanged). 
Reasons 
As well as the doctors, who prescribe patients certain medicines as they think fit, the information given to 
doctors by the pharmaceutical industry has a not insignificant influence on market behaviour. 
Voting 
For: 44, against: 50, abstentions: 15. 
Point 1.2, first indent 
To read: 
'-medico-scientific information, through an independent organization, ...' 
Reasons 
It is important that the information supplied to doctors and chemists be objective and neutral. 
Voting 
For: 36, against: 71, abstentions: 6.