No C 225/24 Official Journal of the European Communities 10. 9. 90 
APPENDIX II 
The following Members, present or represented, voted in favour of the opinion: 
ALEXOPOULOS, ARENA, ARETS, ATAlDE FERREIRA, BAGLIANO, BERGER, BERNASCONI, BERNS, 
BERTON, BLESER, BODDY, BOISSEREE, BORDES-PAGES, BOS, BREDIMA SAVOPOULOU, BROIC-
HER, Vasco CAL, CALVET CHAMBON, CHRISTIE, COLLAS, COLOMBO, ALVES CONDE, CORELL 
AYORA, CORTOIS, COYLE, van DAM, DECAILLON, DELLA CROCE, VAN DIJK, DOS SANTOS, 
ELSTNER, ETTY, EULEN, FORGAS, FRANDI, GARDNER, GAYETOT, GREDAL, GREEN, HAAS, 
HAGEN, HILKENS, HOUTHUYS, JASCHICK, JENKINS, JESUS SEQUEIRA, KAARIS, KENNA, 
KIRCHFELD, de KNEGT, KROGER, LAPP AS, LARSEN, LIVERANI, LOW, LUCHETTI, MACHADO 
VON TSCHUSI, MADDOCKS, MAINETTI, MANTOVANI, MARGOT, MATTEOLI, MAYAYO BELLO, 
MEYER HORN, MORSELLI, MOURGUES, NIELSEN P., NIERHAUS, NOORDWAL, de NORMANN, 
PARDON, PEARSON, PELLETIER R., PERRIN-PELLETIER, PETERSEN, PROUMENS, QUEVEDO 
ROJO, RANGONI-MACHIAVELLI, RIBIERE, ROBINSON, ROLAO GONgALVES, ROUZIER, 
SALMON, SANTILLAN CABEZA, SCHADE-POULSEN, SCHNITKER, SCHOEPGES, SCHWEITZER, 
SMITH A.R., SMITH L.J., TELLES, TIEMANN, TIXIER, TUKKER, VIDAL, YVERNEAU. 
The following Members, present or represented, voted against the opinion: 
ASPINALL, BEALE, BENTO GONCALVES, FLUM, FRESI, LUSTENHOUWER, MORELAND, MUHR, 
STORIE-PUGH, STRAUSS, TAMLIN, WILLIAMS. 
The following Members, present or represented, abstained: 
CAMPBELL, CEYRAC, DODD, van EEKERT, HOVGAARD JAKOBSEN, NIEUWENHUIZE, PET-
ROPOULOS, VANDEN BROUCKE, WAGNER. 
Opinion on the proposal for a Council Directive on the labelling of medicinal products for human 
use and on package leaflets (*) 
(90/C 225/11) 
On 8 February 1990 the Council decided to consult the Economic and Social Committee, under 
Article 100a of the Treaty establishing the European Economic Community, on the 
abovementioned proposal. 
The Section for Protection of the Environment, Public Health and Consumer Affairs, which was 
responsible for preparing the Committee's work on the subject, adopted its opinion on 5 June 1990. 
The rapporteur was Mr Hilkens. 
At its 278th plenary session (meeting of 4 July 1990), the Economic and Social Committee adopted 
the following opinion by a majority vote, with 10 abstentions. 
The Committee approves the draft Directive subject to the 
following comments. 
1. Introduction 
1.1. It should be pointed out that the Commission's 
proposal to provide the consumer with more complete and 
comprehensible information by means of labelling and 
leaflets is required by Article 100a (3), which states that 
'The Commission in its proposals ... concerning health, 
safety, environmental protection and consumer protection, 
0) OJ No C 58, 8. 3. 1990, p. 21. will take as a base a high level of protection.' The 
Committee is pleased to note that the Commission studied 
this question when drafting its proposal. 
1.2. The Committee notes that the Commission pro­
posal is to be seen in the context of the completion of the 
internal market. For both public health and economic 
reasons a higher degree of regulation is undoubtedly 
required in the medicinal products market than in many 
other sectors of the economy. This applies particularly to 
information for patients with regard to pharmaceutical 
products. 
1.3. The Commission proposal follows on from Direct­
ives 65/65/EEC and 75/319/EEC and the amendments 
10. 9. 90 Official Journal of the European Communities No C 225/25 
thereto in Directive 89/341/EEC which regulate respect­
ively labelling and the information which leaflets must 
contain. The proposed Directive lays down detailed 
requirements for labelling and package leaflets. 
1.4. Generally speaking it should be pointed out that 
this approach is also consistent with new social trends 
regarding the provision of information. As far as medicines 
are concerned, this means that in a modern society an ever 
increasing number of people insist on being informed in 
readily understandable language of the effects, advantages 
and disadvantages of medicines. 
1.5. The Committee notes that the Commission's draft 
Directive was drawn up after intensive consultations with 
all interested parties, including consumers. In view of the 
preceding comments (points 1.1 and 1.4.) the Committee 
urges the Commission to extend the dialogue initiated here 
in the field of medicinal products to other regulations and 
not to forget the consumer's role in this process. 
In this connection the Committee would refer to the 
Commission proposal still being drawn up on the 
information to be supplied to doctors, pharmacists and 
other medical experts. 
2. General comments 
2.1. With regard to patient leaflets, the Committee 
would refer to its opinion of 2 June 1988 (*) in which it 
urged the Commission to hold consultations with the 
consumer organizations with a view to establishing 
adequate rules on the content and form of patient leaflets. 
The Committee is pleased that so many of the points on 
which consensus was achieved in the course of those 
consultations are to be found in the proposed Directive 
(Article 8). The Committee urges the Commission to 
incorporate the remaining points in Article 8, i.e. the points 
with regard to the legal status and the pharmacology of the 
medicinal product. 
2.2. The Committee wonders whether the Com­
mission's aims would not be served by laying down 
guidelines for the wording of leaflets for which the 
manufacturer is responsible. This would have a twofold 
purpose: 
(a) to make the job easier for those responsible for writing 
package leaflets; 
(b) to make the presentation of leaflets more uniform. 
The Committee points out that some Member States 
already apply such guidelines. 
(!) OJ No C 208, 8. 8. 1988. In the Committee's view the guidelines referred to in Article 
13 of the proposed Directive are too narrow and should be 
widened to cover all aspects of patient leaflets. 
2.3. The Committee would even go one step further and 
urge that, with a view to ensuring that product information 
corresponds as closely as possible to the actual needs of 
patients, manufacturers of identical products listed in the 
official monograph of the European Pharmacopoeia be 
required to use a standard leaflet, since the active 
ingredients in the products are the same and have virtually 
the same bioavailability. 
2.4. The Committee urges the Commission to ensure 
that representatives of consumers and all other interested 
parties are involved in the drafting of guidelines for patient 
leaflets. In addition, it must be possible to take action if, 
after evaluation, a patient leaflet appears to be un­
satisfactory. 
3. Specific comments 
3.1. Article 3 
3.1.1. Subparagraph (d) 
The Committee would like to see the Commission append 
to the Directive, besides the excipients, a list of E-number 
substances, including and highlighting those which induce 
hypersensitivity reactions. These hypersensitivity reactions 
must be confirmed by independent scientific evidence. 
3.1.2. The Committee urges the Commission to ex­
amine the feasibility of using pictograms as a means of 
informing patients. Such a method could be considered in 
particular for psychotropics and narcotics as defined in the 
UN Convention. EC pictograms for potentially dangerous 
dependency-producing psychotropics and narcotics should 
be made mandatory for the whole Community. The use of 
different colours for different doses of the same product is 
recommended. Finally, the normal side-effects of medicines 
must be mentioned, along with any special warnings about 
driving. 
3.2. Article 4 
3.2.1. Paragraph 1, second indent 
The English version should read 'quantity of active 
ingredients' instead of 'quantity of active constituents'. 
No C 225/26 Official Journal of the European Communities 10. 9. 90 
3.2.2. Paragraph 2 
The Committee feels that, both in order to prevent this 
exception finding ever broader application and in view of 
the need to provide basic information on small packages, 
the common name of the product, the quantities of active 
ingredients and the batch number should appear on the 
product packaging. 
3.3. Article 6 
3.3.1. Paragraph 2 
The Committee approves the provisions set out in Article 6 
(2) regarding price labelling, reimbursement and legal 
status. The Committee urges the Commission to include in 
the Directive an obligation on the part of chemists to have 
information available on arrangements concerning re­
imbursement and prices. 
3.4. Article 8 
3.4.1. Paragraph 1 (a), third indent 
This indent should be reworded as follows: 
'—pharmaco-therapeutic group, if there exists a term 
easily comprehensible for the patient, supplemented 
by 'or failing this the thereapeutic characteristics'.' 
3.4.2. Paragraph 1 (b) 
Insert after 'the therapeutic indications': 'the pharmacolo­
gical properties'. 
3.4.3. Paragraph 1 (d) 
It is pointed out that antidotes do not exist for all medicinal 
products. Furthermore, in the case of overdoses antidotes 
may be administered only under medical supervision. 3.4.4. Paragraph 1 (e) 
Patients should be invited to communicate any undesirable 
effect not only of new medicinal products but of all 
medicinal products to their doctor or pharmacist. 
3.4.5. Paragraph 2 
The Committee would point out that in its opinion of 
2 June 1988 (*) it stated that: 'it is vital that the leaflet 
provide the patient with all necessary information on the 
medicine. While every effort should be made to avoid 
alarming the patient, this must clearly not be at the expense 
of the clarity and completeness of the information.' 
3.4.6. Paragraph 3 
Regarding pictograms, see the comments under 3.1.2. 
3.5. Article 12 
3.5.1. Paragraph 1 
The correct application of this Directive is of considerable 
importance for public health; hence the Committee feels 
that the imposition of adequate penalties, both general and 
financial, by the competent authorities of a Member State 
should be made mandatory where the provisions of this 
Directive are not observed. 
3.6. Article 13 
See Point 2.2. which urges that the guidelines be widened. 
They should also be mandatory. 
Done at Brussels, 4 July 1990. 
The Chairman 
of the Economic and Social Committee 
Alberto MASPRONE 
0) OJ No C 208, 8. 8. 1988.