No C 225/18 Official Journal of the European Communities 10. 9. 90 
Opinion on the proposal for a Council Directive on the wholesale distribution of medicinal 
products for human use (]) 
(90/C 225/10) 
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 Industry, Commerce, Crafts and Services, which was responsible for preparing the 
Committee's work on the subject, adopted its opinion on 6 June 1990. The rapporteur was 
Mr Rolao Goncalves. 
At its 278th plenary session (meeting of 4 July 1990), the Economic and Social Committee adopted 
unanimously the following opinion. 
1. Introduction 
1.1. As the link between the manufacturer and the 
retailer of medicinal products, the wholesaler is a key 
element in the distribution chain of these vital goods. 
1.2. The wholesaler must provide a swift, efficient and 
highly economic service, without this under any circum­
stances jeopardizing the quality of the product. 
1.3. The handling, storage and transport arrangements 
must ensure that the products are distributed where and 
when required and are of the same quality as they were 
when they left the factory, whether this be inside or outside 
the Community. 
1.4. Arrangements are also needed for the withdrawal of 
products from the market when the relevant authorities feel 
that this must be done in the interests of patient safety. 
1.5. As a general measure, a code of conduct must be 
drawn up for wholesalers, modelled on those in existence in 
other areas of the medicinal products sector. This code 
could either be adopted voluntarily by wholesalers or could 
be based on harmonization laid down by the Community in 
the public interest. The completion of the internal market 
at the start of 1993 will increase intra-Community trade, 
and thus makes action particularly necessary. 
1.6. The market in medicinal products has various 
special features: the consumer does not generally choose 
the prescription, and in many cases the product is paid for 
by a third party. These factors work against market 
transparency, particularly in cases where there is an 
(J) OJ No C 58, 8. 3. 1990, p. 16. exclusive supplier. Distribution is only one link in the chain 
from production to consumption, and it may be affected by 
externalities. 
2. The principles behind the proposal 
2.1. The proposal forms part of the package of measures 
contained in the 1985 White Paper for completing the 
internal market. It has three main aims: 
— to adapt the responsibilities of wholesalers to the new 
conditions governing cross-frontier trade over a wider 
economic area, 
— to perfect the arrangements for withdrawing medicinal 
products efficiently and rapidly from the single 
Community market when necessary, 
— to step up the fight against counterfeit products, which 
will become a greater problem with the expansion of the 
market. 
2.2. The Commission's proposal, whose objectives 
cover both economic and safety aspects, states that: 
— wholesalers must be registered, and must adhere to 
certain administrative requirements, 
— wholesalers must follow certain rules in their work and 
must have suitable storage premises manned by 
qualified staff, 
— wholesalers must keep detailed records of their 
transactions and stocks, conduct checks on these 
records and make them available to the competent 
authorities. 
2.3. Whilst taking account of national public health 
laws and certain specific circumstances within Member 
States, the proposal aims to harmonize the present systems 
so that they can operate within a frontier-free market. 
10. 9. 90 Official Journal of the European Communities No C 225/19 
3. General comments 
3.1. The Committee endorses the aims of the Commis­
sion proposal, subject to the following comments. 
3.2. The economies of scale brought by the internal 
market should cut costs. If there is free competition, this 
must ultimately lead to a drop in consumer prices. The 
Committee considers it essential not to jeopardize this goal 
with red tape which would generate additional structural 
expenditure, affecting costs and thus limiting the scope for 
reducing retail prices. Steps will also have to be taken to 
counter any developments which could threaten the 
transparency of the market. 
3.3. The desire to speed up stock rotation — dictated by 
the need to improve financial management — has been the 
reason for the rapid computerization of the wholesale 
sector. However, lack of information and finance means 
that computerization is not yet widespread, particularly 
among smaller firms in the most disadvantaged Member 
States. The Committee asks for this to be borne in mind. It 
must also be ensured that the new administrative rules 
(especially the keeping of records) are phased in gradually, 
with the backing of financial programmes (Tedis). 
3.4. The Committee is concerned about a confluence of 
activities in certain Member States, in the form of either 
upstream expansion by the retail trade or downstream 
expansion by wholesalers. This is likely to reduce the 
transparency of the marketing chain and limit the free 
competition which is necessary at each stage, to the 
detriment of the consumer or of whoever is paying for the 
products. 
3.5. Rules on wholesale distribution should not threaten 
imports and exports from/to third countries when these 
can help satisfy personal health needs and lessen price 
differences between regions. Experience has shown that 
third-country trade can be reconciled with the higher 
quality standards demanded of medicinal products. 
3.6. Community legislation on medicinal products 
should remain flexible, by adapting to socio-economic 
trends and taking account of traditional habits in the 
Member States whilst not forgetting the general principles 
of free competition and the elimination of monopolies. 3.7. The Committee draws the Commission's attention 
to the need for Member States to set up monitoring 
mechanisms to ensure that procedures are followed 
uniformly throughout the Community, in order to prevent 
discrepancies which could give rise to unfair competition. 
3.8. The Committee recognizes the seriousness of the 
problems referred to by the Commission with regard to the 
need to withdraw faulty or counterfeit medicines from the 
market. It therefore calls for public programmes involving 
all interested parties, from manufacturers to consumers, 
with support from the relevant national and Community 
authorities. 
4. Specific comments 
4.1. Preamble 
The Committee suggests that the Commission include a 
recital highlighting the abiding concern of Community 
pharmaceutical legislation to accord priority to achie­
vement of a high level of protection, in line with Article 100 
a (3) of the Treaty. 
4.2. Article 1 (2) 
The Committee considers that the definition of 'wholesale 
distribution of medicinal products' is incomplete and could 
generate confusion, particularly as the proposal takes the 
form of a Directive which Member States will have to 
translate into national law. At the very least, the text should 
be made more precise by amending 'all activities' to read 
'all commercial activities' and adding 'to any bodies other 
than the final consumer' after 'supplying'. 
4.3. Article 3 
The end of Article 3 (1) should be amended to read 
'medicinal products for human use'. 
The Committee suggests the addition of the following new 
points: 
'8. Branches of authorized wholesalers shall be required 
to meet the conditions laid down in Article 5 as if 
they were independent establishments. 
No C 225/20 Official Journal of the European Communities 10. 9. 90 
9. Manufacturers who supply retailers directly with 
products not manufactured by themselves shall be 
required to meet the same conditions as whole­
salers.' 
4.4. Article 4 
A new Article 4 (2) should be inserted to read as follows: 
'2. Failure to take a decision within the period referred 
to in Article 4 (1) shall for all legal purposes be 
interpreted as signifying the provisional granting of 
the authorization referred to in Article 3 (1).' 
It would also be advisable to adopt similar provisions in the 
Member States of manufacture and distribution. 
The existing Article 4 (2) would then become Article 4(3). 
4.5. Article 5 
To avoid serious distortions of competition, the Commit­
tee considers it vital that the requirements for obtaining 
authorization should be specified more clearly, with a view 
to closer harmonization between Member States. The 
Committee therefore proposes: 
— in point (a), the addition of the following: 
'..., and appropriate procedures to ensure that they are 
handled and transported correctly', 
— in point (b), the addition of the following: 'qualified 
personnel who have had appropriate technical training 
and meet...', 
— the addition of the following new points (d), (e), (f) and 
(g): 
'(d) they must have appropriate repackaging facilities, 
as required for holders of a manufacturing author­
ization (Article 16 of Directive 75/319/EEC); 
(e) they must have appropriate facilities for the storage 
of dangerous and inflammable products; 
(f) they must have appropriate facilities and equipment 
for the storage of medicinal products which have to 
be stored at a particular temperature; (g) they must have a sufficient stock of the medicinal 
products habitually prescribed in the area they 
serve.' 
4.6. Article 6 (b) 
The Committee is surprised that there is no mention of any 
authorization for wholesalers to obtain supplies from 
manufacturers. It therefore recommends that 'who are 
themselves in possession of the authorization' be amended 
to read: 'who are in possession either of a manufacturing 
authorization or the authorization ...'. 
4.7. Article 6 (e) 
The words 'no minimo' ('at least') in the Portuguese 
version of the first sentence should be deleted. (Translator's 
note: the English version of the Commission document 
omits this phrase). Inclusion of the phrase 'at least' brings a 
danger that stiffer conditions could be set, and this would 
distort competition between Member States. 
The Committee also questions the feasability and point of 
referring to the production batch number 'for each 
transaction ... received or dispatched' except when 'the 
delivery is destined for a retailer'. 
4.8. Article 9 
The Committee proposes that the text of this Article be 
transferred to a new Article 8 (3). 
4.9. Article 10 
The Committee thinks that the qualifying phrases ('if 
appropriate' ... 'in that case') should be deleted, and that 
the Commission should take a firmer and more concrete 
stance. At all events, the Committee should be consulted on 
any such proposal. 
Done at Brussels, 4 July 1990. 
The Chairman 
of the Economic and Social Committee 
Alberto MASPRONE