30.7.81 Official Journal of the European Communities No C 189/39 
Opinion on the proposal for a Council Directive amending Directives 65/65/EEC, 
75/318/EEC and 75/319/EEC on the approximation of provisions laid down by law, 
regulation or administrative action relating to proprietary medicinal products 
The text referred to the Committee has been published in Official Journal of the 
European Communities No C 355 of 31 December 1980, pages 1 and 6. 
A. LEGAL BASIS FOR THE OPINION 
On 16 December 1980 the Council referred the abovementioned proposal to the 
Economic and Social Committee in accordance with Article 100 of the Treaty estab­
lishing the European Economic Community. 
B. OPINION OF THE ECONOMIC AND SOCIAL COMMITTEE 
The Economic and Social Committee prepared its opinion on the above matter at its 
188th plenary session held in Brussels on 26 and 27 May 1981. The full text of the 
opinion is as follows: 
THE ECONOMIC AND SOCIAL COMMITTEE, 
Having regard to the Treaty setting up the European 
Economic Community, and in particular Article 100 
thereof, 
Having regard to the request made by the Council 
of the European Communities on 16 December 
1980 for an opinion on the proposal for a Council 
Directive amending Directives 65/65/EEC, 75/318/ 
EEC and 75/319/EEC on the approximation of 
provisions laid down by law, regulation or adminis­
trative action relating to proprietary medicinal 
products, / 
Having regard to the Decision taken by its Bureau 
on 9 December 1980, instructing the Section for 
Industry, Commerce, Crafts and Services to draw up 
an opinion and a report on the matter, 
Having regard to the opinion adopted by the Sec­
tion for Industry, Commerce, Crafts and Services at 
its meeting on 6 May 1981, 
Having regard to the report submitted by the rappor­
teur, Mr De Bievre, 
Having regard to the discussions at its 188th plenary 
session held on 26 and 27 May 1981 (meeting of 
27 May 1981), 
Whereas in submitting the proposal for a Directive 
the Commission is carrying out the following man­
date conferred upon it by Article 15 (2) of Directive 75/319/EEC of 20 May 1975: Tn the light of experi­
ence the Commission shall, not later than four years 
after the entry into force of this Directive, submit to 
the Council a proposal containing appropriate mea­
sures leading towards the abolition of any remain­
ing barriers to the free movement of proprietary 
medicinal products'; 
Whereas the free movement of goods within the 
Community represents one of the fundamental 
objectives of the Treaty of Rome and whereas this 
free movement has not yet been achieved in respect 
of proprietary medicinal products; 
Whereas there is a need to continue and ultimately 
to achieve the approximation of the laws, regula­
tions and administrative provisions of Member 
States with regard to proprietary medicinal products, 
as initiated by Council Directive 65/65/EEC of 
26 January 1965 and Council Directives 75/318/ 
EEC and 75/319/EEC of 20 May 1975; 
Whereas the barriers to the free movement of these 
products linked to the system of national marketing 
authorizations have not been removed to a substan­
tial extent by the use of the procedure involving the 
Committee for Proprietary Medicinal Products 
(CPMP) as set out in Chapter III of Directive 75/ 
319/EEC, 
HAS ADOPTED THE FOLLOWING OPINION: 
by 61 votes to 45, with 10 abstentions: 
1.1. The Committee is in agreement with the views 
expressed by the Commission with regard to: 
No C 189/40 Official Journal of the European Communities 30. 7. 81 
— the unsatisfactory situation prevailing four years 
after the entry into force of the most recent 
Directives on the approximation of national 
provisions; 
— the inadequacy, given the objective being pur­
sued, of measures designed simply to improve 
current procedures as such measures would not 
fundamentally alter the problems; 
— the establishment of a body for issuing Com­
munity authorizations would ensure direct 
Community monitoring but would involve pol­
itical, legal, financial, and practical difficulties; 
— the need to amend the procedure involving 
reference to the CPMP. 
1.2. In view of these considerations, the Com­
mittee endorses mutual recognition of authoriza­
tions, as proposed by the Commission, but urges the 
latter to work out ways of making the authorization 
procedure more effective by ensuring: 
— a better and quicker flow of information 
between authorizing bodies, if possible through 
the use of computer systems; 
— more effective alignment and monitoring of 
analysis methods. 
1.3. The Committee also agrees with the Commis­
sion's proposal that the Directives already adopted 
be amended and supplemented firstly in order to 
update them and secondly in order to bring them 
into line with the solution adopted for the achieve­
ment of freedom of movement. 
1.4. Finally, the Committee calls upon the Com­
mission to put forward concrete proposals as soon 
as possible with regard to advertising and the prices 
of medicinal products. 
1.5. The Committee therefore proposes that the 
draft Directive be approved, subject to the sugges­
tions, comments and proposed amendments set out 
below. 
2. General comments 
Third recital 
2.1. The Committee shares the views of the Com­
mission with regard to the need for a document to 
enable the competent authorities to have a record, in 
summary form, of the details of the national author­
ization and any subsequent amendments to the 
authorization. 
2.2. In the Committee's view this is a very impor­
tant provision as it is designed to improve and sup­plement the other means of information, comple­
menting the provisions set out in the earlier Direc­
tives with regard to labelling and accompanying 
leaflets. The proposed document is also important 
as, under the responsibility of the Member States, it 
is to be used as the common basis for the communi­
cations, in different forms depending on the reci­
pients, to be sent to the trade circles concerned and 
the general public. 
2.3. From a drafting point of view the Committee 
considers that the use of the term 'data sheet' and its 
French equivalent 'fiche technique' may lead to 
confusion as these terms are already used elsewhere 
in the provisions with a very specific meaning dif­
ferent from that envisaged by the Commission in the 
present case. 
2.4. The Committee therefore proposes that the 
third recital be reworded to read as follows: 
'Whereas it is necessary from the point of view 
of public health and the free movement of prod­
ucts that the competent authorities and manu­
facturers have at their disposal a detailed infor­
mation sheet on which will be based the communi­
cations to trade circles and useful information for 
consumers, the latter complementing information 
provided by the labels and accompanying leaflets'. 
3. Specific comments 
Article I 
3.1. In order to avoid the abovementioned confu­
sion with regard to the third recital, the Committee 
proposes that the first two lines of the new 
Article 4 (a) be amended to read as follows: 
'The application referred to in Article 4 shall 
also be accompanied by a sheet containing the 
following information:'. 
Article 1 (3) (8) Economic particulars 
3.2. The Committee has taken account of the 
explanations provided by the Commission which 
considers that it would be advisable to bring the 
economic particulars together with the mandatory 
health and administrative particulars, even though 
the listing of the economic particulars is not obliga­
tory as they do not remain constant. 
3.3. The Committee does, however, consider that 
the incorporation of optional requirements is incon­
sistent with the principle of approximating laws. 
30. 7. 81 Official Journal of the European Communities No C 189/41 
Furthermore, as these particulars refer to purely 
national conditions, they do not have to be taken 
into account by other Member States as a factor in 
the free movement of goods. If these particulars 
were, nonetheless, taken into consideration they 
could provoke distortions in competition and discri­
minatory decisions. 
3.4. The Committee therefore proposes that the 
following be deleted: 
— the final sentence of Article 1 (3) (7) ('Moreover, 
the data sheet may be supplemented ...'); 
— all of point 8 in Article 1 (3). 
Article 1 (5) 
3.5. The Committee agrees with the need to take 
account of technical and scientific progress but con­
siders that the use of the term 'more reliably 
checked' does not express this need adequately. The 
Committee also notes that, according to the Com­
mission's line of reasoning, the manufacturer is not 
obliged to change his methods solely because new 
methods have been introduced. 
3.6. The Committee therefore proposes that the 
last sentence of point 5 be amended to read as fol­
lows: 
'... and introduce any changes that may be 
required in order to ensure that the proprietary 
medicinal product is checked in accordance with 
generally accepted scientific methods'. 
4. Article 2 
Article 2 (2) 
4.1. The paragraph 3 which it is proposed to insert 
concerns the active principles and the Committee 
recognizes the need for this provision. From the 
explanations provided by the Commission the Com­
mittee has understood that the proposed provision 
does not cover routine tests carried out on each 
batch of starting materials. Nonetheless, the Com­
mittee considers that it should be stated more clearly 
that the required information has to be supplied 
only when the dossier accompanying the applica­
tion for authorization is submitted. 
4.2. The Committee therefore proposes that the 
following be inserted after the words 'shall be pro­
vided' in the second line: 
'to supplement the general discription of the 
active principles'. Article 2 (3) 
4.3. In the light of the explanations provided by 
the Commission the Committee has understood that 
the proposed definition of the term 'batch' would 
not exclude the preparation of part-batches and 
their consolidation into a single batch for the pur­
poses of analysis. This operation is carried out at the 
present time and is generally accepted. 
4.4. The Committee therefore does not wish to 
propose a precise amendment but suggests to the 
Commission that the drafting of this paragraph be 
viewed so that the aforementioned possibility is 
clearly indicated. 
Article 2 (6) 
4.5. In the third line after the word 'functions' it is 
proposed that the following be added: 'when taken 
in the normally utilized dose'. 
Article 2 (8) 
4.6. The Committee shares the views of the Com­
mission with regard to the importance of the study 
of mutagenic potential. The Committee notes that 
the guiding principles for carrying out tests in this 
field will be set out in a recommendation once 
agreement has been reached by the Council of Min­
isters on the methodology to be employed and the 
conclusions to be drawn from this type of experi­
mentation. In this way it will be possible to take 
account of this work from the point of view of the 
free movement of proprietary medicinal products. 
Article 2 (10) 
4.7. It is proposed that the last line of the new sub­
paragraph be amended to read as follows: 
'bio-availability of the active principle or its main 
metabolites'. 
5. Article 3 
5.1. The Committee is in agreement with the 
method adopted by the Commission for achieving 
freedom of movement. It is proposed that harmon­
ized provisions be introduced for the recognition of 
marketing authorizations issued by national au­
thorities. This solution has been adopted in prefer­
ence to the establishment of an EC body for issuing 
for authorizations within the Community and in 
preference to making specific improvements to the 
existing procedure. 
No C 189/42 Official Journal of the European Communities 30. 7. 81 
5.2. The Committee also notes that the solution 
adopted by the Commission is, in spirit and i,n gen­
eral form, very similar to that approved by the 
Economic and Social Committee in its opinion of 
29 May 1968 (Official Journal of 22 July 1968) on a 
draft Directive which never came to fruition. 
5.3. The Committee notes that the system of 
mutual recognition is based on the fact that a pro­
prietary medicinal product manufactured and mar­
keted in one Member State in accordance with the 
harmonized provisions must, without exception, be 
admitted to the markets of the other Member States. 
In the event of disputes the CPMP is called upon to 
giVe an opinion. 
5.4. The Committee also notes from the explana­
tions provided by the Commission that the adoption 
of the system of mutual recognition will lead to a 
change in the role of the CPMP. The Committee 
will henceforth simply be informed of applications 
for authorizations (Article 9) and will only give its 
views in exceptional cases where recognition is dis­
puted (Article 10 and 11). The CPMP does, how­
ever, retain the right, which was already provided 
for in Article 14 of Directive 75/319, to give an opi­
nion on matters of common interest submitted to it 
by a national authority before that authority takes a 
decision (Article 12). 
5.5. The Committee is in agreement with these var­
ious measures. It simply wonders whether they are 
stated sufficiently clearly in the proposed provi­
sions. The amendments proposed by the Committee 
have the sole aim of ensuring consistency in this res­
pect. 
6. Article 8 (2) 
6.1. The Committee considers that the summary of 
the functions of the CPMP, which relate to very dif­
ferent situations depending on the grounds on 
which it is being asked for its opinion, would be 
made clearer if these grounds were set out separ­
ately. The Committee therefore proposes the follow­
ing wording: 
'The Committee shall have the following func­
tions: 
— in pursuance1 of Article 9, it shall notify the 
Member States of the request for the recogni­
tion of an authorization made by the holder 
of the authorization; 
— in pursuance of Article 10, it shall consider 
the reasoned objections forwarded by the 
Member State or Member States which con­
sider that they are unable to recognize the 
authorization; — in pursuance of Article 11, it shall consider, at 
the request of one of its members, cases in 
which Member States take different decisions 
on requests for authorization, suspension and 
withdrawals of authorization; 
— in pursuance of Article 12, it shall consider, at 
the request of one of its members and prior to 
a decision being taken to grant or refuse 
authorization, all matters relating to the 
quality, safety and efficacy of the proprietary 
medicinal product, and, particularly, matters 
relating to the application of Articles 5 and 11 
of Directive 65/65/EEC 
7. Article 11 
7.1. In order to ensure parellelism in the texts it is 
proposed that a third paragraph be added as fol­
lows: 
'The Committee shall give a reasoned opinion 
based on Articles 5 and 11 of Directive 65/ 
65/EEC. 
8. Article 12 
8.1. The Committee is in agreement with the pro­
posed text of this Article. It would, however, point 
out that too broad an interpretation of the term 'spe­
cific cases where the interests of the Community are 
involved' would change the nature of the proposed 
system since the mutual recognition of authoriza­
tions is based on the decision-making responsibility 
of the national authorities and the confidence which 
national authorities must show in each other. If 
extreme use was made of the procedure in question 
it would be necessary to have prior agreement at 
Community level before authorizations were issued. 
This would be tantamount to the solution which has 
been formally rejected. 
8.2. For this reason the Committee recommends 
that the Council and the Commission ensure, by 
appropriate means, such as the Rules of Procedure 
of the CPMP, that the use of the procedure set out 
in Article 12 is indeed limited to specific cases 
where the interests of the Community are involved. 
9. Article 13 (1) 
9.1. In the light of the explanations provided by 
the Commission, the Committee understands that it 
is the Commission's intention that the national 
authorities 
(a) be obliged to draw up an assessment report in 
respect of the results of tests on any proprietary 
30. 7.81 Official Journal of the European Communities NoC 189/43 
medicinal product containing a substance not 
yet used in products marketed in the territory of 
the Member State concerned, even if the sub­
stance is used in products marketed in other 
Member States; 
(b) shall be free to draw up assessment reports on 
the results of tests on any proprietary medicinal 
product already being offered for sale on the 
national market of the Member State concerned 
in cases where the manufacturer is seeking 
mutual recognition. 
9.2. The Committee is in agreement with the aim 
of the Commission, namely to facilitate any dicus-
sions which the CPMP may have. In order to avoid 
any difficulties in interpretation the Committee pro­
poses that the following amendments, which are of 
a purely stylistic nature, be made to the final clause 
of Article 13(1): 
— delete the words 'or of any other proprietary 
product they may choose'; 
— add the following sentence in place of the 
deleted clause: 
'The competent authorities may also draw up such 
assessment reports on proprietary products in res­
pect of which the holder of the authorization 
wishes to follow the procedure set out in Article 9'. 
10. Article 13 (2) 
10.1. The Committee has interpreted the phrase 'or 
:o proprietary product containing the same active 
substance' (fourth line) as implying that a compari­
son between the products in question was envis­
aged. 
10.2. The Committee considers that this provision 
s in contradiction with Articles 5 and 11 of Direc-
:ive 65/65/EEC in pursuance of which decisions are 
:o be based solely on the quality, safety and efficacy 
of the products. The Committee therefore proposes 
:hat the phrase 'or to proprietary product containing 
:he same active substance' be deleted. 
11. Article 14(1) 
11.1. The Commission provides for a shorter regis-
.ration period for new products since it is also possi­
ble to obtain data on the secondary effects after the 
product has been placed on the market. The Econo­
mic and Social Committee considers that the regis-
xation periods for new products should not be shor-
:ened. 
Done at Brussels, 27 May 1981. 11.2. Furthermore, the drug monitoring system 
should not lead to a reduction of the toxicity criteria 
in the registration documents. In other words, 
checks after the product has been placed on the 
market should be developed but must not wholly or 
partially replace the checks before the product is 
placed on the market, so as not to inordinately 
increase the risk to patients. 
11.3. A period of 120 days would seem acceptable 
for well-known (old) products on which a great deal 
of published and statistically significant work has 
already been carried out and which have had a long 
period of large-scale use. 
11.4. If this is not the case — old products that 
have been little used or that have not been properly 
studied, new products that have not been used for a 
sufficiently long period (in commercial networks) — 
this period of 120 days should be extended by 
90 days (period specified in Directive 65/65/EEC). 
11.5. It is important that July and August be 
excluded from the periods, owing to the absence of 
experts in these months. 
11.6. The Committee also proposes that the second 
paragraph be reworded to read as follows: 
'This period may be extended by 90 days in the 
case of proprietary medicinal products contain­
ing a new active substance for which marketing 
authorization is being requested for the first 
time, as well as in exceptional cases and where 
the person responsible for placing the product 
on the market requests an opportunity to 
explain himself orally or in writing before the 
Committee expresses its opinion. The months of 
July and August shall not be taken into account 
in any period.' 
12. Article 15 
12.1. The Committee proposes that the words 'and 
public health' be added on at the end of Article 
15(1). It also proposes that the word 'reduction' in 
Article 15 (2) be replaced by the words 'possible 
alterations to' so as not to prejudge the outcome 
even before the observation period. It would also 
ask the Commission to forward to the Economic 
and Social Committee the reports on the operation 
of the procedure provided for iri Article 15(1). 
The Chairman 
of the Economic and Social Committee 
Tomas ROSEINGRAVE 
No C 189/44 Official Journal of the European Communities 30. 7. 81 
APPENDIX 
to the Economic and Social Committee opinion 
I. Result of voting on the opinion as a whole 
The following Members, present or represented, voted in favour of the opinion: 
Mr Ammundsen, Mr Bernaert, Mr Berns, Mr Blamoutsis, Mr Blasig, Mr Bos, Mrs Bredima, 
Mr Breitenstein, Mr Broicher, Mr Burnel, Mr de Caffarelli, Mr Cammann, Mr van Campen, 
Mr Chabrol, Mr du Closel, Mr Colimvas, Mr Couture, Mr Cremer, Mr de Bievre, Mr de Taver-
nier, Mrs Engelen-Kefer, Mr Evain, Mr Fredersdorf, Mr Gingembre, Mr Goris, Mr Hatry, 
Mr Hemmer, Mr Hennig, Mrs Heuser, Mr Hilkens, Mr Jonker, Mr Kazazis, Mr Kenna, Mr Kol-
benschlag, Mr Lauga, Mr Law, Mr Leo, Mr Loebl, Mr Loughrey, Mr Margot, Mr Marvier, 
Mr Masprone, Mr Neumann, Mr Paggi, Mr Papadopoulos, Mr Pearson, Mr Pfeiffer, Mr de Preci-
gout, Mr Rizos, Mr Savini, Mr Schnieders, Mr Seydaack, Mr Staratzke, Mr Storm-Hansen, 
Mrs Strobel, Mr Wagner, Mrs Weber, Mr Wick, Mr Wylie, Mr Zinkin, Mr Zunkler. 
The following Members, present or represented, voted against the opinion: 
Mr Basnett, Mr Beretta, Mr Bonety, Mr Buckton, Mr Cavazzuti, Mr Chappie, Mr Christensen, 
Mrs Clark, Mr Curlis, Mr Dassis, Mr Debunne, Mr de Grave, Mr Delourme, Mr Douros, 
Mr Drago, Mr Drain, Mr Etty, Mr Glesener, Mr Gormley, Mr van Greunsven, Mr Hicks-Beach, 
Mr Houthuys, Mr Karakitsos, Mr Kirschen, Mr Laval, Mr Massabieaux, Mr Masucci, Mr Mera-
viglia, Mr Mills, Mr Milne, Mr Nielsen, Mr Ognibene, Mrs Patterson, Mr Pronk, Mr van Rens, 
Miss Roberts, Mr Rouzier, Mr Saitis, Mr Scharrenbroich, Mr Schneider, Mr Sorensen, Mr Soulat, 
Mr Theisen, Mr Vanni, Mr Walsh. 
The following Members, present or represented, abstained: 
Mr Bornard, Mr Doble, Mr Friedrichs, Mrs Gredal, Mr Muhr, Mrs Nielsen, Mr Nierhaus, 
Mr Piga, Mr Rollinger, Mr Wagenmans. 
* 
11. Amendments rejected 
The following amendments, tabled in accordance with the Rules of Procedure, were rejected 
during the discussions: 
1. Page 2 
Add a fifth recital: 
'Whereas legislation on proprietary medicinal products must not be considered solely from 
the point of view of the industry's albeit legitimate interests; and whereas public health 
requirements and the patients' interests should be given priority.' 
Reasons 
The Industry Section's concerns (and the absence of a supplementary opinion from the Section 
responsible for public health matters) maybe explain why there are four recitals about the free 
movement of proprietary medicinal products but none about public health requirements or the 
patients' interests. 
In addition, the words 'health' and 'patient' are nowhere to be found in the Industry Section's 
text. 
Such a unilateral and partisan approach is not likely to lend much credibility to Committee 
opinions. 
30. 7. 81 Official Journal of the European Communities No C 189/45 
Voting 
For : 48, Against : 48, Abstentions : 8. 
2. Page 2 
Delete the following points: 1.1, third indent, 1.2. Replace them by the following: 
'1.2. The Committee notes that the Commission has abandoned its earlier stance and is 
now proposing mutual, almost automatic recognition of decisions by individual Member 
States on applications for marketing authorizations. 
The Committee feels that the requirements of public health are at least as important as those 
of free trade. It therefore opposes the principle of mutual recognition on the grounds that 
this system is only as strong as its weakest link. Not only has nothing been done to remedy 
the current shortcomings of national registration procedures, but in addition the least rigo­
rous or worst equipped national registration committee may in effect set standards for the 
entire Community. 
Moreover the Commission proposals raise certain questions: 
(a) Acceptance of a registration authorization by one Member State is applicable to the 
entire Community. This is designed to reduce formalities for industry and to facilitate 
free trade. Will the same princple be applied if a Member State decides to suspend or 
withdraw from the market an ineffective or dangerous medicinal product in order to 
satisfy public health requirements (i.e. not commercial interests)? In other words, if one 
Member State suspends the marketing of a medicinal product will this suspension apply 
automatically throughout the Community? 
(b) How will the information contained on the data sheet be adopted uniformly? In the 
Member States the data sheets of identical medicinal products contains different refer­
ences to indication, contra-indications, side-effects, precautions for use. 
(c) The Committee wonders how the Commission proposes to ensure via a simple recom­
mendation on tests, that all Member States will implement arrangements guaranteeing 
minimum standards of protection for health and the interests of patients.' 
Reasons 
It is somewhat contradictory to maintain ten national registration structures, to ask each of the 
Member States to quickly support the views of the Member State with the poorest equipment for 
assessing the toxicity and effectiveness of medicinal products — and then to claim that the EEC 
is incapable of setting up such an assessment system. 
This approach seems to encourage manufacturers to avail themselves of the authorization proce­
dures of those States which are under-equipped as regards experts and evaluation facilities (clini­
cal laboratories organized for well-structured tests) or which are simply less stringent. 
One might think that sufficiently precise scientific criteria would lead to genuine, consistent tests. 
This overlooks the fact that in the Member States, as in the Economic and Social Committee, the 
industrial and commercial aspect of the medicinal product often carries more weight than its 
public health aspect. 
Differences exist as regards: 
(a) authorization 
Thus the 'Commission Alexandre' set up in France by Mrs Veil, the former Public Health 
Minister, notes that in the case of certain drugs (Pilosuril, for example), 'the specific activi-
No C 189/46 Official Journal of the European Communities 30. 7. 81 
ties have not yet been established', yet these drugs continue to be authorized although they 
are banned in other countries. 
(b) indication 
Adalat (Nifedipine) is authorized: 
— in Belgium for the treatment and prevention of symptoms associated with angina pecto­
ris and other forms of coronary disease. This is a very widely used drug because of its 
broad range of indications; 
— in France and the United Kingdom for angina pectoris only; 
— in the Netherlands for a single very rare form of angina pectoris (Prinz Metal angina: 
only 1 % of all cases of angina pectoris). 
Clearly, under a mutual recognition arrangement, it is in the manufacturer's interests to use 
the Belgian authorization procedure rather than the Dutch one whose rules — in this case at 
least — are much more strict. On the other hand, it is against the interests of the patient to: 
— raise false hopes that a drug can cure him, or to 
— restrict the use of a drug and possibly deprive the patient of treatment not authorized in 
his country. 
A wide-ranging exchange of views at European level would make a more objective assess­
ment possible. 
(c) posology 
The recommended basic doses for amoxycilline (Clamoxil, Amoxil) are as follows (the dose 
is double in case of chronic or severe infection): 
France 1 x 500 mg = 500 mg 
United Kingdom 3 x 250 mg = 750 mg 
Netherlands 3 x 375 mg = 1 125 mg 
Belgium 2 to 3 x 500 mg = 1 000 to 1 500 mg 
Germany 3 x 500 mg = 1 500 mg 
As the basic dose can be three times higher in one country than another, it is obvious that 
here, too, mutual recognition of authorizations can triple turnover if the manufacturer 
chooses the country where consumption is liable to be highest. The interests of the patient, 
public health and therapeutic needs may be different. 
(d) contra-indications 
In the United Kingdom, for example, doxylamine-based drugs are not recommended for 
pregnant women because of their teratogenic action. This is not the case in France, Belgium 
or Germany. 
It can be seen from this that the Member States frequently adopt widely different attitudes. 
Rather than curbing any excessive liberalism or severity, or protectionist or conciliatory atti­
tudes (according to whether or not a drug is produced by domestic industry), by setting up a 
European Committee, the system which the Section for Industry has approved provides for 
mutual recognition of decisions of the national system chosen by the pharmaceuticals indus­
try (according to its own interests, naturally), instead of reaching the decision which is most 
consistent with public health requirements, on the basis of the most extensive and open dis­
cussion possible. 
Voting 
For: 49, Against: 53, Abstentions: 12. 
30. 7. 81 Official Journal of the European Communities No C 189/47 
3. Page 3, paragraph 1.4. 
Delete. 
Reasons 
The Committee has been asked to give an opinion on a draft Council Directive amending earlier 
Directives on the approximation of provisions dealing with proprietary medicinal products. 
Four Directives have already been adopted in this field with the aim of removing barriers to the 
free movement of medicinal products whilst maintaining appropriate public health guarantees at 
the product formulation and manufacturing stages. 
The draft Directive under consideration derives from a mandate given to the Commission by the 
Council in 1975 and seeks to remove the shortcomings which have been noted, whilst at the same 
time taking a new step forward towards achieving the free movement of medicinal products. The 
draft Directive thus deals only with the approximation of laws in the field of public health. 
Aside from the draft Directive, the Commission has put forward its views elsewhere on the estab­
lishment of a transparent and orderly common market in this field and has stated that it had no 
plans to deal with the question of prices and advertising. 
Furthermore, the measures necessary to ensure that users of medicinal products are kept 
informed and are protected have already been taken, by approximating the provisions dealing 
with labelling, packaging and the accompanying leaflets, without these impeding measures which 
the Member States wish to take in order to regulate other fields (prices, social security, dispen­
sing, etc.). 
Voting 
For: 44, Against: 54, Abstentions: 16. 
4. The following extracts from the Section opinion have been replaced by amendments approved 
during the discussions: 
'1.2. In view of these considerations the Section welcomes the fact that the Commission 
has decided to opt for the mutual recognition of marketing authorizations.' 
Voting 
Unanimous. 
Ml. Article 14(1) 
11.1. The Section considers that giving the person responsible for placing the product on 
the market the right to provide the CPMP with explanations before the latter issues its opi­
nion represents a step forward which may lead to an improvement and a speeding-up of the 
procedure. The Section sees no overriding reason why this right should apply only in the 
case of the provisions of Article 10. 
11.2. The Section therefore proposes that the words "in the cases referred to in Article 10" 
in the first line of the second paragraph be deleted.' 
Voting 
For the amendment: 55, Against: 53, Abstentions: 8. 
'12. Article 15 (2) 
12.1. The Section recognizes the soundness of the arguments put forward by the Commis­
sion in favour of a step-by-step approach to the achievement of the free movement of goods, 
No C 189/48 Official Journal of the European Communities 30. 7. 81 
with the mutual recognition of authorizations being regarded as the best method of achiev­
ing this result. The Section does, however, consider that it should be possible to gain suitable 
experience in a shorter timer than that currently envisaged by the Commission and it further 
believes that it would be preferable to make provision for a reconsideration of the situation 
by an earlier date than 1 January 1988. 
12.2. In putting forward these proposals, the Section is following the approach adopted by 
the Economic and Social Committee in its abovementioned opinion of 29 May 1968.' 
Voting 
Unanimous. 
III. Following the vote by name, the Members of the Workers' Group who voted against the 
opinion: 
Mr Basnett, Mr Beretta, Mr Bonety, Mr Buckton, Mr Cavazzuti, Mr Chappie, Mr Christensen, Mr 
Curlis, Mr Dassis, Mr Debunne, Mr de Grave, Mr Delourme, Mr Douros, Mr Drago, Mr Drain, 
Mr Etty, Mr Glesener, Mr Gormley, Mr van Greunsven, Mr Houthuys, Mr Karakitsos, Mr 
Kirschen, Mr Laval, Mr Massabieaux, Mr Masucci, Mr Meraviglia, Mr Milne, Mr Sorensen, Mr 
Nielsen, Mrs Patterson, Mr Pronk, Mr van Rens, Mr Rouzier, Mr Saitis, Mr Scharrenbroich, Mr 
Schneider, Mr Soulat, Mr Theisen, Mr Vanni, Mr Walsh. 
made the following declaration: 
'Legislation on proprietary medicinal products must not be considered solely from the point 
of view of the industry's albeit legitimate interests. Public health requirements and patients' 
interests, which are not even mentioned in the opinion, should have been considered on at 
least equal terms with the desire to promote free trade. 
One might think that sufficiently precise scientific criteria would lead to the adoption of a 
uniform approach by the Member States; far from it! The industrial and commercial aspect 
of a medicinal product often carries more weight than its public health aspect. 
As data sheets prove, the Member States are today taking conflicting decisions on authoriza­
tion, posology, indications, contra-indications and side-effects. 
Instead of harmonizing procedures on the basis of unanimity or a majority decision, after 
wide-ranging discussions between national experts, the Commission is proposing that, in 
principle, a single Member State, even the least equipped or the least strict, may serve as a 
reference. 
The manufacturer will be able to register his produce in the Member State allowing the 
broadest range of indications, doses ensuring the highest possible sales or the least stringent 
labelling on contra-indications. 
The Workers' Group considers that patients' interests and public health requirements should 
constitute the two most important elements of a registration policy. It regrets the fact that the 
opinion neglects these objectives and gives priority to the industrialists' desire for greater 
freedom of trade. 
For the rest, the Group would refer to 1 and 2 above. Amendment 1 was rejected by 48 votes 
to 48 with 8 abstentions and Amendment 2 by 49 to 53 with 12 abstentions.'