No C 69/22 Official Journal of the European Communities 18. 3. 91 
Point 4.1 
In line 1, make the following insertion: '... the Commission's proposal for a Council Regulation should 
spell...'. 
Reason 
Same as for 3.4.1 and 3.4.2. 
Voting 
For: 32, against: 52, abstentions: 17. 
Point 4.2 
In lines 1-2, delete 'the commitment of the Commission on' and substitute 'in regard to'. 
Reason 
Consequential change. 
Voting 
For: 33, against: 54, abstentions: 15. 
Opinion on the proposal for a Council Regulation (EEC) concerning the creation of a 
supplementary protection certificate for medicinal products^) 
(91/C 69/06) 
On 3 May 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 9 January 1991. The Rapporteur 
was Mr Hilkens. 
At its 283rd plenary session (meeting of 30 January 1991), the Economic and Social Committee 
adopted the following Opinion with 81 votes in favour and 5 abstentions. 
Whilst essentially endorsing the Commission proposal 
and the greater protection for the European pharmaceu­
ticals industry for which it provides, the Committee 
would make the following observations and sugges­
tions. 
1. Introduction 
1.1. This proposal, which is based on article 100A 
of the EEC Treaty, falls within the framework of a 
Community health policy or, more specifically, of an 
Internal Market for medicinal products. 
I1) OJ No C 144, 8. 5. 1990, p. 10. 1.2. In assessing the draft, all the consequences of 
the proposed legislation must be taken into account. 
The pharmaceuticals sector and market exhibit certain 
peculiarities which affect both producers and con­
sumers. 
1.3. On the supply side, the need for extensive 
research makes patent protection necessary. Effective 
patent protection is, however, subject to gradual 'ero­
sion' owing to the numerous tests called for by the 
application dossier. On the demand side, medicinal 
products are of crucial importance for public health 
and therefore rate highly on the scale of consumer 
18. 3. 91 Official Journal of the European Communities ^oC^B^ 
preferences^ even thou^ at least in thecaseofprescrip 
tiondru^s^ the decision to purchase does not rest with 
the consumer himself. 
L^. The R.e^ulation is intended to ensure greater 
protection for innovation in the pharmaceuticals sector. 
The best means of providing such protection is through 
patents. Although under the European Patent Convene 
tion whichcoversallproductsincludin^pharmaceu 
ticals^ patent protection is ^enerallv granted for ^O^ears 
in Europe^ the numerous^ obli^atorv^phvsiochemical^ 
biolo^icalormicro^biolo^ical^to^icolo^ical^pharma 
colo^ical and clinical^ tests reduce the exclusive e^ploP 
tation period to onlv^l^vears in the case of pharma 
ceuticals.This situation is the result of administrative 
procedures which are reco^ni^ed as necessarv pre 
cautions for the marketing of medicinal products. Eur^ 
thermore^ the effect ofbrandlovaltv over longer eo^ploP 
ration periods should not be underestimated in the case 
of manv products. 
Leo. Inoutlinin^ the contentand scope of itspro 
posal^ the Commission makes clear that the purpose of 
the draft R.e^ulation is to restore the effective period of 
patent protection so as to encourage innovation in the 
Communitv^s pharmaceuticals industry while at the 
same timeavoidin^ discrimination visavis other indus^ 
trial sectors. Another aim is to close the ^ap between 
the Communitv and the U^AB]apan with regard to 
patent protection for basic innovations in the pharma 
ceuticals industry 
^. B^oad outlines of the proposal fora^e^dation 
^.L I^he proposal assumes that research is vitaL both 
for the pharmaceuticals industry itself and for societv as 
awhole.Accordin^lv^in Europe the industry allocates 
between l^andleo^ of its turnover forpharmaceuticals 
research onaselffinancin^basis.Thepatentprotection 
svstem is therefore of crucial importances since it makes 
it possible to recoup research investment durin^aper 
iod of exclusive exploitations therebv securing the self 
financing process and guaranteeing future research. 
^. C^ver the last ten vears^ the level of the European 
pharmaceuticals industry research—e^pressedas its 
share of the total number of molecules developed— 
has declined from Deo^ to ^^. This situation could 
enable competitors^ particularlv in the U^ and ]apan^ to 
increase their market share further at Europe^se^pense. 
^.o. The principal aims of the proposed R.e^ulation 
relate to the efficient operation of the Internal A^arket^ 
the improved competitiveness of Community industry 
and the promotion of research and development in the 
health field 
^. I^he proposed certificate will be issued bv 
national patent offices at the request of the holder ofa 
national or European patent r^the ^basic^ patents in 
respect ofaproduct authorised to be marketed in the 
countrv concerned. It does not protect the expired 
patent in its entirety but onlv the basic innovation which has also been authorized to beplaced on the 
market. 
^3. General comments 
^.L The Committee reco^ni^sthat^ in the interests 
of health protections the marketing of medicinal prod 
nets in the Community must be subject to stringent 
qualitv and therapeutic requirements. It therefore 
approves of the e^istin^Communitv authorisation pro 
cedures and those still to be introduced. Patent protec 
tion for innovation in the Communitv pharmaceuticals 
industrv can also be said to contribute to health protec 
tion. 
^. whilst the Committee is aware that the ^in^le 
European Act states ^in Eoeclaration ^lo ^ that the 
Commission should ^ive precedence to the use of a 
Eoirectiveunder Article 100A^ it nevertheless believes 
that the Commission is correct in preferring the use of 
aRe^ulation in this instance and endorses the proposal 
It is important that all Aiember^tatesimplement the 
e^tendedperiodof apatentsimultaneouslv^ a Re^u 
lation can achieve this^ but the legislation to enact the 
requirements ofaPoi^cctive in each member ^tate can 
be of indeterminate duration. 
^L TheCommittee thinks thattheadditional period 
of patent protection provided bv the proposed certifP 
cate should also be looked at. 
Afair solution would be to ali^n on U^and]apanese 
patent protection laws so as to safeguard the competP 
tive position of the Communhags pharmaceuticals 
industry worldwide. 
^.^. The Committee calls on the Commission to 
examine all the economic consequences of the proposals 
with particular reference to the duration of the protec 
tion certificate. 
3.4.1. The interests of generics producers (!), who 
have an influence on price competition in a number of 
(!) Generic medicinal products are pharmaceuticals which con­
tain the same chemically active principle as proprietary prod­
ucts—i.e. having chemical and therapeutic equivalence and 
the same bioavailability—and which are marketed after the 
proprietary products' protection has expired. 
No C 69/24 Official Journal of the European Communities 18. 3. 91 
market segments, must also be born in mind. In this 
connection, a balance must be maintained between 
the interests of this industry and pharmaceuticals 
research. 
3.4.2. The Committee urges the Commission to ver­
ify whether the direct interests of generics producers 
will be damaged by the transitional provisions set out 
in Article 13(2) of the proposal. 
3.5. The Committee thinks that consideration must 
also be given to the scope of the proposed Regulation. 
Thus, the concept of a 'basic patent' used, inter alia, 
in Article 3 appears to bear no relation in most cases 
to the concept of a 'basic innovation'. Since, in its view, 
the Regulation should be restricted to pharmaceutical 
discoveries which genuinely involve a basic innovation, 
Done at Brussels, 30 January 1991. the Committee urges the Commission to lay down 
explicit criteria to this end. 
3.6. The introduction of the supplementary protec­
tion certificate would seem likely to produce a sharp 
increase in the cost of, and expenditure on, medicinal 
products, particularly if the scope of the Regulation 
were to be broadly defined. This increased burden will 
be borne by consumers and health-insurance schemes. 
On the basis of a number of general conditions, the 
Commission puts this overall increase at 1% of the 
total turnover in medicinal products in the first year. 
The Committee calls on the Commission to take 
account of these factors and introduce appropriate 
measures to deal with them. 
3.7. The Committee proposes that, after the Regu­
lation has been in force for five years, the Commission 
should drawn up an evaluation report on which the 
European Parliament and the Economic and Social 
Committee may comment. 
The Chairman 
of the Economic and Social Committee 
Francois STAEDELIN