No C 60/40 Official Journal of the European Communities 8. 3. 91 
Opinion on the proposal for a Council Directive on advertising of medicinal products for 
human use (*) 
(91/C 60/13) 
On 21 June 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 
4 December 1990. The Rapporteur was Mr Colombo. 
At its 282nd plenary session (meeting of 19 December 1990), the Economic and Social 
Committee adopted the following Opinion with no dissenting votes and one abstention. 
1. Preliminary comments 
1.1. The proposal represents a further step in the 
Commission's drive to harmonize the pharmaceutical 
sector and eliminate barriers to the free movement of 
medicinal products in the run-up to an internal market, 
ensuring a high level of production of public health. 
1.2. The proposal forms part of the programme 
announced in the 1985 White Paper on completing the 
internal market. It follows the proposals [discussed in 
the respective Committee Opinions (2)] on: 
— wholesale distribution of medicinal products for 
human use, 
— legal status for the supply of medicinal products for 
human use, 
— labelling and package leaflets of medicinal products 
for human use. 
1.3. The proposal seeks to harmonize the rules on 
advertising of medicinal products to the general public, 
doctors, and health professionals. 
1.4. This is an important matter—the pharmaceuti­
cal industry spends considerable sums on advertising 
to the general public, promotion to health professionals 
and medicinal information. 
1.5. The products of this sensitive sector are designed 
to improve human health and it is reasonable to intro­
duce Community legislation, without prejudice to the 
general rules laid down in Directive 84/450/EEC on misleading advertising and Directive 89/552/EEC on 
television broadcasting. 
1.6. All Member States have specific legislation on 
pharmaceutical advertising. 
1.7. Analysis of the situation in the Member States 
shows significant points of convergence, but also dis­
crepancies as regards both authorization and the sys­
tems and levels of advertising control. Community har­
monization is thus needed. 
1.8. Member States' legislation on the information 
provided to health professionals presents fewer diver­
gencies. This is partly because of the existence of deon-
tological codes of conduct at both national and EC 
level, which can provide a useful point of reference. 
2. General comments 
2.1. The Committee endorses the need for and struc­
ture of the proposed Directive, subject to the comments 
and recommendations which follow. 
2.2. Advertising to the public and to health pro­
fessionals is treated separately because different mess­
ages are being conveyed and because current legislation 
in the two areas differs. While it is common practice 
in the Member States to include the two areas in a 
single legal instrument, the Committee is concerned 
that failure to draw a precise distinction between adver­
tising to the public and information/promotion to 
health professionals could give rise to ambiguities. 
(J) OJ No C 163, 4. 7. 1990, p. 10. 
(2) OJ No C 225, 10. 9. 1990. 2.3. The ban on public advertising of prescription 
drugs deserves particular endorsement. However, the 
8. 3. 91 Official Journal of the European Communities No C 60/41 
Committee notes the concern espressed in its Opinion 
on legal status of medicines, as regards the latitude 
allowed to the Member States in the classification of 
prescription and OTC drugs. Differing interpretations 
of the classification criteria would have an effect on the 
authorization of advertising to the public. 
2.4. The Committee notes the importance of proper 
health education in order to ensure the 'rational use' 
of medicinal products with advertising is supposed to 
encourage under the terms of Article 2(3) of the present 
proposal. 
2.5. Although advertising can be an information 
vehicle, it is not the main one. In no way can it replace 
the information on the product's labelling and in the 
package leaflet, nor that provided by health pro­
fessionals. 
2.6. Lastly, the Committee asks the Commission to 
examine possible ways and fora for achieving closer 
harmonization of the instruments and bodies respon­
sible for pharmaceutical advertising. 
3. Specific comments 
3.1. Definitions — Article 1(3) 
3.1.1. The definition of advertising in Article 1(3) 
includes information and promotion for health pro­
fessionals. There is a danger here of confusing proper 
scientific information activity with improper incentives 
to prescribe a particular drug. 
3.1.2. For example, it has to be determined whether 
attendance at congresses is a form of illicit pressure, or 
whether these provide an updating necessary for the 
doctor's further training and are potentially in the pati­
ent's interest. 
3.1.3. The vague reference to 'invitations ... to con­
gresses' in the third indent of Article 1(3) should there­
fore be deleted, as it seems to imply that any infor­
mation or training initiatives aimed at health pro­
fessionals are a form of commercial incitement. 
3.2. Article 2(3) 
The term 'rational use' seems rather vague. The Com­
mittee suggests the wording 'appropriate correct use'. 
3.3. Article 4 
3.3.1. In the interests of improved consumer protec­
tion, the Committee is concerned at the alternative offered in the second indent, between (a) inclusion of 
'the information necessary for correct usage of the 
medicinal product, such as indications for use and 
special precautions' and (b) a mere 'invitation to read 
the package leaflet carefully'. 
3.3.2. The package leaflet is of the utmost import­
ance if the consumer is to be fully informed. Advertise­
ments should always include a reminder to read the 
leaflet. However, it will only be read after the medicine 
has been purchased; patients could make the wrong 
purchase if no explicit counter-indications are provided. 
3.3.3. Lack of space is no excuse for not providing 
vital information in a clear and legible form, even if it 
is not advisable to include a welter of technical and 
scientific details in advertising targetted to the general 
public. 
3.3.4. However, where the vital information is avail­
able on the outer pack, the Committee accepts that, in 
the case of medicines for which no special precautions 
are necessary a message to read the label and or the 
package leaflet is the best alternative means. 
3.4. Article 5(d) 
Drug advertising directed at children should be banned 
outright. The words 'solely or mainly' could offer a 
loophole for getting round this ban. 
3.5. Chapter III — Wording of the title 
The term 'advertising' is an oversimplification for 
describing the complex promotional and information 
activity aimed at health professionals. The title should 
include a reference to information activity. 
3.6. Article 3(2) 
This Article should specify that the list of prohibited 
therapeutic indications is indicative and not exhaustive. 
3.7. Article 8(1) 
3.7.1. Although it is not possible to give a full defi­
nition of a 'medical sales representative' in a Directive 
on drug advertising, the fact remains that the definition 
given is very vague ('shall be given adequate training 
and shall have sufficient scientific knowledge') con­
sidering the responsibilities which these representatives 
have. 
No C 60/42 Official Journal of the European Communities 8. 3. 91 
3.7.2. Provision should be made to ensure that rep­
resentatives have had higher education and special 
training and refresher courses from the company, the 
health authorities or universities on the scientific, legal 
and deontological aspects of the profession. The pos­
ition of the medical sales representative within the 
pharmaceutical business also requires clarification. 
3.7.3. These points are important because represen­
tatives are required to provide information on the prod­
ucts and promptly report any side effects. 
3.8. Article 8(3) 
3.8.1. It should be specified that the feedback to the 
company provided by the medical sales representative 
is not the same as the fourth stage of clinical trials 
and is subject to different regulations. The information 
covered by the present Article is provided free of charge 
by the doctor during normal talks with the sales rep­
resentative. 
3.8.2. Moreover, neither this feedback nor stage four 
can replace a general drug monitoring service as envis­
aged by the World Health Organization (WHO). 
3.9. Article 9 
3.9.1. Clarification is needed of the term 'insignifi­
cant intrinsic value' in Article 9(1). The Committee 
suggests the following wording: 
'objects whose value is not sufficient to induce the 
health professional to prescribe the drug other than 
in accordance with good clinical practice.' 
3.9.2. If the reference to congresses in Article 1(3) 
(definitions) is not deleted, the Committee proposes 
that a clause be inserted in Article 9 to exclude from 
the ban refresher conferences held solely to inform and 
train health professionals. The pharmaceutical indus­
try's work in this area should not be discouraged. 
3.10. Article 10 
3.10.1. The maximum of two free samples (obvi­
ously per product) per year seems very rigid. It appears 
to conflict with the need for doctors to familiarize 
themselves with new drugs and learn to use them better. 
Furthermore, Article 10(b) requires the doctor to make 
a written request for the samples, thus assuming direct 
responsibility for them. The doctor should be given a 
wider margin of discretion. 
3.10.2. The list of products of which samples may 
not be provided should include thermolabile or other­
wise easily perishable products. Representatives do not 
have proper premises or facilities for storing samples correctly—and these samples are fully-fledged med­
icinal products. 
3.11. Article 11 
3.11.1. The proposal should identify the body which 
is to monitor advertising and the relation between 
image and content of the message, particularly where 
this exceeds the bounds of proper information and 
constitutes an incentive to use a particular drug. 
3.11.2. It is necessary to harmonize the monitoring 
systems of the Member States, which range from spec­
ific authorization bodies to self-policing arrangements. 
The free movement which will soon be achieved by the 
Single Market makes Commission consideration of this 
point particularly important. 
3.11.3. The moves to draw up a European Code of 
Practice in this sector are to be welcomed. The Euro­
pean pharmaceutical industry has so far only drawn up 
a code for drugs promotion to health professionals, 
and this does not lay down sufficient implementing 
guarantees. 
3.11.4. The Committee asks the Commission to 
investigate possible ways and fora for dealing with this 
matter at Community level. 
3.12. Article 12 
The in-company scientific service must be headed by 
a health specialist offering a maximum guarantee of 
professional skills and legal responsibility. The exist­
ence of such a service does not of course preclude the 
existence of (or indeed, the need for) other information 
channels for health professionals, such as national or 
European-level data banks. 
3.13. Article 13 
3.13.1. Further consideration is needed of the clause 
[Article 13(1)] allowing marketing authorizations to be 
suspended if the Directive is not observed. 
8.3.91 Official]ournal of the European Communities ^oC^43 
3.13.2. If drugs of proven therapeutic value and 
novelty had to be withdrawn, this would unfairly 
deprive patients ofavital drug. 3.13.3. It seems right to impose financial and legal 
penalties ifacompanycommitsaserious offence. 
3.13.4. however, the punishment should be in keep^ 
ing with the severity of the risks engendered for human 
health. 
Done at Brussels, 19 December 1990. 
Opinion on the proposal foraCouncil Directive amending Directive ^4B432BEEC as regards 
the diagnosis ofbovine brucellosis and enzootic bovine leukosis 
t^lBC^uBl^ 
On3Decemberl990, the Council decided to consult the Economic and social Committee, 
under Articlel98 of theTreatyestablishing the European Economic Community, on the 
abovementioned proposal. 
The section for Agriculture and Eisheries, which was responsible for preparing the Commits 
tee'sworlo on the subject, adopted its Opinion on7Decemberl990.The Rapporteur was 
^irProumens. 
At its282nd plenary session ^meetingof 18 December 1990^, theEconomic and social 
Committee unanimously adopted the following Opinion. 
The Committee fully endorses the proposed Directive, 
although it feels that certain comments are called for. 1.3. A specialist scientific group has studied the mat^ 
ter and carried outanumber of international trials, and 
has recommended thattheELl^A method beincluded as 
an alternative test. 
1. General comments 
1.1. The draft Directive introducesanew diagnostic 
test, known as ELl^A, for bovine brucellosis and enzo^ 
otic bovine leukosis. 1.4. The ELl^A method uses samples of milk taken 
from storage tanks, whereas samples previously had to 
be taken direct from each cow individually. 
1.2. The draft Directive amends the Annexes to 
Directive ^4B432BEEC in the light of new scientific 
knowledge on thediagnosis and control of the two 
diseases. IBo. The ELl^A method is thus quicker, equally 
efficient, and cheaper for the member ^tate authorities 
responsible for testing.