Opinion of the Advocate General — ECLI:EU:C:1998:21
Date: 1998-01-22
Based on: Treaty establishing the European Economic Community (1957)
Subject matter: Approximation of laws
Procedure: Reference for a preliminary ruling
Origin: United Kingdom

summary of
the characteristics of medicinal products,
which includes, inter alia, therapeutic indica­
tions, methods of administration and dosage
schedules. The inclusion of those data in the
summary of characteristics of the medicinal
product docs not mean that those elements
must be taken into account in determining
essential similarity between two medicinal
products, because the purpose of that sum-
19 — Sec Case C-112/89 Upjohn [1991] ECR I-1703, paragraph
16, and Case 227/82 Van Bennckom [1983] ECR 3883, para­
graph 17.
20 — Council Directive 83/570/EEC of26 October 1983 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 prod­
ucts (OJ 1983 L 332, p. 1).
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OPINION OF MR RUIZ-JARABO— CASE C-368/96
mary is to give useful information concerning
a medicinal product, once it has been defined,
to the competent authorities of the Member
States. In no case does the summary form
part of the definition of the medicinal product.
40. Having regard to the foregoing consider­
ations, I am of the opinion that two medicinal
products are essentially similar where they
have the same qualitative and quantitative
composition in terms of active principles,
their pharmaceutical form is the same and,
where necessary, their bioequivalence has been
demonstrated by means of appropriate bio­
availability studies.
The use of those three objective criteria to
determine essential similarity between two
medicinal products for the purposes of
applying point 8(a)(iii) of the second para­
graph of Article 4 of Directive 65/65 enables
the simplified procedure for the grant of mar­
keting authorisations for generic medicinal
products to be applied uniformly throughout
the Community.
Moreover, those criteria limit the margin of
discretion available to the competent authori­
ties of the Member States when determining
whether two medicinal products are essen­
tially similar in order to grant an authorisa­
tion for a generic medicinal product, on the
basis of documentation submitted earlier for
a marketing authorisation for the original
medicinal product. In the same sense, it is
clearly to be inferred from the case-law of the
Court of Justice 21 that the national authori­
ties do not enjoy a margin of discretion in
applying the exceptions in point 8(a) of the
second paragraph of Article 4 of Directive
65/65, which enable authorisations to be issued
for medicinal products under the simplified
procedure.
To allow the competent authorities of the
Member States a margin of discretion in deter­
mining essential similarity between two medic­
inal products would also make it more dif­
ficult to apply the procedure for mutual
recognition of marketing authorisations
granted by Member States, established by
Directive 93/39.
The second, third and fourth questions
41. By its second, third and fourth prelimi­
nary questions, the High Court asks the Court
of Justice to determine the extent to which a
marketing authorisation may be granted for a
generic medical product which is essentially
similar to an original medicinal product autho-
21 — Scotia Pharmaceuticals, cited above, paragraph 24, and Case
C-210/94 Smith & Nephew and Primecrown [1996] ECR
1-5819, paragraph 30.
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THE QUEEN v THE MEDICINES CONTROL AGENCY, EX PARTE GENERICS (UK) AND OTHERS
rised in the Community or a Member State
for at least 10 years.
In the questions submitted, the High Court
sets out in part the views of the innovating
pharmaceutical undertakings, the producers
of generic medicinal products and the MCA.
The undertakings specialising in the produc­
tion of innovative medicinal products con­
sider that a marketing authorisation for a
generic medical product essentially similar to
an original medicinal product authorised in
the Community or in a Member State should
extend only to the therapeutic indications,
routes of administration and dosage schedules
which have been authorised for at least 10
years. In their opinion, the period of protec­
tion of 10 years must apply also to all new
indications for the original medicinal product
which were introduced after the issue of the
marketing authorisation for it and for which
the said protection period has not expired.
The undertakings producing generic medicinal
products consider that the marketing autho­
risation for those medicinal products extends
to all indications, routes of administration and
dosage schedules authorised for the essen­
tially similar original medicinal product up to
the very moment when authorisation is applied
for in respect of the generic medicinal product.
In their view, the period of 10 years should
not protect each of the subsequent modifica­
tions authorised for the original medicinal
product.
The MCA adopts an intermediate position,
taking the view that the marketing authorisa­
tion for the generic medicinal product will
extend to all therapeutic indications autho­
rised for the essentially similar original medic­
inal product, both the initial indications and
those introduced subsequently for which the
10-year period has not expired, except where
those modifications constitute an innovation
of considerable therapeutic importance. In its
view, an innovation displays such importance
where it requires a fresh application for a
marketing authorisation under Annex II to
Regulation No 541/95.
42. Directive 65/65, as amended by Directive
87/21, provides no direct and clear answer to
the questions submitted by the High Court,
a fact which accounts for the differing inter­
pretations referred to above. The interpreta­
tion to be adopted of point 8(a)(iii) of the
second paragraph of Article 4 of Directive
65/65 will, however, have extremely far-
reaching economic repercussions on the mar­
keting of medicinal products in the Commu­
nity and the development of the
pharmaceutical industry as a whole.
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OPINION OF MR RUIZ-JARABO— CASE C-368/96
43. Both those factors, it seems to me, make
it necessary to undertake a detailed analysis
of the various objectives pursued by Direc­
tive 65/65, as amended by Directive 87/21, 22
in order to arrive at an interpretation of point
8 of the second paragraph of Article 4 which
strikes the best possible balance between those
objectives.
The objectives of point 8 of the second para­
graph of Article 4 of Directive 65/65
44. Point 8(a)(iii) of the second paragraph of
Article 4, inserted in Directive 65/65 by Direc­
tive 87/21, introduced a third way of obtaining
a marketing authorisation for generic medic­
inal products, under the simplified procedure,
which makes it unnecessary to incur the
research costs involved in riling the results of
pharmacological and toxicological tests and
clinical trials, since those tests and trials were
described previously in connection with the
marketing authorisation for an essentially
similar original medicinal product. This form
of application has become the one most used
to obtain marketing authorisations for generic
medicinal products, since the other two pos­
sibilities (consent from the undertaking
holding the marketing authorisation for the
original medicinal product and reference to
scientific literature) involve greater difficul­
ties.
45. When point 8(a)(iii) of the second para­
graph of Article 4 of Directive 65/65 is applied,
the following essential interests must basi­
cally be taken into account:
(a) Protection of public health
46. The essential purpose pursued by Direc­
tive 65/65 and all the subsequent measures
amending and implementing it is to safeguard
public health. 23 That purpose is achieved prin­
cipally by the control mechanism of the autho­
risations which must be issued by the com­
petent national authorities before any
medicinal product is marketed. Thus, the first
recital in the preamble to Directive 87/21
states:
'... point 8 of the second paragraph of Article
4 of Council Directive 65/65/EEC, as last
amended by Directive 83/570/EEC, provides
that various types of proof of the safety and
efficacy of a proprietary medicinal product
may be put forward in an application for
22 — See the Opinion of Advocate General Léger in Scotia Phar­
maceuticals, cited above, point 9 et seq. 23 — First recital in the preamble to Directive 65/65.
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THE QUEEN v THE MEDICINES CONTROL AGENCY, EX PAKTE GENERICS (UK) AND OTHERS
marketing authorisation depending upon the
objective situation of the proprietary medic­
inal product in question'.
47. The case-law of the Court of Justice 24
has made it clear that the simplified proce­
dure for marketing authorisations provided
for in point 8 of the second paragraph of
Article 4 does not affect the objective of safe­
guarding public health since it merely shortens
the period for preparing an application for
authorisation without in any way relaxing the
requirements of safety and efficacy which
must be met by medicinal products.
48. The safeguarding of public health also
accounts for the last part of point 8(a)(iii) of
the second paragraph of Article 4 of Direc­
tive 65/65, which requires the undertaking
manufacturing the generic medicinal product
to submit the results of pharmacological and
toxicological tests and clinical trials when
applying for a marketing authorisation for
indications, routes of administration or dosage
schedules different from those authorised for
the essentially similar original medicinal
product marketed for more than 6 or 10 years
in the Community.
49. Finally, I would point out that the pro­
tection of public health is compatible with an
extension of the marketing authorisation for
generic medicinal products so as to include all
indications, routes of administration and
dosage schedules authorised for the original
medicinal product up to the time of issue of
that authorisation.
(b) Protection of research and innovation in
the pharmaceutical sphere
50. The importance of experience as a deci­
sive criterion in the achievement of medicinal
innovations was highlighted by many Renais­
sance researchers, 25 who emphasised the role
played by the passage of time in relation to
the discovery not only of new remedies but
also of new therapeutic properties of existing
remedies. The idea of progress is inseparable
from scientific advances relating to health.
24 — Scotia Pharmaceuticals, cited above, paragraph 17.
25 — N. Monardes, La Historia medicinal de les cosas que se traen
de nuestras Indias Occidentales (1565/1574), Ministerio de
Sanidad y Consumo, Madrid, 1989, attaches importance in
the introduction to his work to 'the many things that there
arc in diverse parts of the world which were unknown until
the present time; they were unknown in ancient times, but
time, which is the discoverer of all things, has shown them
to us' (pp. 92 and 93). In the chapter devoted to 'sangre de
drago', used to treat stomach disorders and to strengthen the
gums, he refers to the 'thousand follies' spoken by 'the
ancients, whether Greek, Roman or Arab', which have been
rendered outmoded by what 'time, which is the discoverer
of all things, has revealed to us and taught us' (pp. 218 and
219).
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OPINION OF MR RUIZ-JARABO— CASE C-368/96
Innovative pharmaceutical undertakings make
substantial investments in research and devel­
opment to develop new medicinal products.
Such innovation is essential to ensure the
existence of a sound pharmaceutical industry
in the Community. For that reason, it is stated
in the second recital in the preamble to Direc­
tive 65/65 that Community harmonisation
should not hinder the development of the
pharmaceutical industry. Similarly, it is stated
in the second recital to the preamble in Direc­
tive 87/21 that it is necessary to define more
precisely the cases in which the simplified
procedure may be used '... while ensuring that
innovative firms are not placed at a disadvan­
tage'.
51. In the Commission's travaux prepara­
toires 26 prior to the adoption of Directive
87/21 it is clearly stated that one of the objec­
tives pursued is the protection of research
and innovation in the pharmaceutical sphere.
The Commission laid stress on the costs which
had to be borne by innovative undertakings
to obtain the initial marketing authorisation
for a medicinal product and stated that cer­
tain national authorities too easily allowed
recourse to the simplified procedure, based
on references to scientific literature, by under­
takings producing generic medicinal prod­
ucts. According to the Commission, that prac­
tice was prejudicial to innovative undertakings
holding marketing authorisations for original
medicinal products.
52. The 6 or 10 year protection period of the
marketing authorisation for original medicinal
products is specifically intended to safeguard
the interests of innovative undertakings and
foster research in the pharmaceutical sector.
Moreover, Directive 87/21 incorporates spe­
cifically in point 8 of the second paragraph of
Article 4 of Directive 65/65 the principle that
the simplified procedure will not be available
where it might undermine rights under the
law relating to the protection of industrial
and commercial property.
53. Innovation in the pharmaceutical sphere
is also safeguarded by other Community,
national and international provisions relating
to protection of intellectual property, in par­
ticular patents. 27
Article 52(4) of the 1973 Munich Convention
on the Grant of European Patents does not
regard as patentable inventions those relating
to methods for treatment of the human or
animal body by surgery or therapy or diag­
nostic methods practised on the human or
animal body. Nevertheless, Article 54(5) allows
the patenting of substances for use in the
preparation of medicinal products, and there­
fore the latter can benefit from the 20-year
protection provided for in the convention. In
the domestic laws of the Member States there
has been a similar trend and they recognise
26 — COM(84) 437finalof 25 September 1984, paragraphs 14 and
15.
27 — See, in that connection, P. Leardini, 'Brevets', Joly Com­
munautaire, Paris, December 1997.
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THE QUEEN v THE MEDICINES CONTROL AGENCY, EX PARTE GENERICS (UK) AND OTHERS
the possibility of granting patents for medic­
inal products. 28
In Community law, a supplementary protec­
tion certificate was introduced by Regulation
(EEC) No 1768/92, 29 in order to compensate
for the period extending from the filing of a
patent application for a medicinal product to
the grant of a marketing authorisation. 30
54. In my opinion, in order to protect inno­
vation and pharmaceutical research, it is advis­
able to apply the 6 or 10 year protection
period to all new indications of considerable
therapeutic importance authorised for an orig­
inal medicinal product essentially similar to a
generic medicinal product.
(c) Non-repetition of tests on persons or ani­
mals
55. The fourth recital in the preamble to
Directive 87/21 states that 'there are reasons
of public policy for not conducting repetitive
tests on humans or animals without over­
riding cause'. The limitation of repetitive trials
on persons or animals, whenever they arc not
strictly necessary, is a well-established rule in
Community law, 31 which is logically mir­
rored by the simplified procedure for applying
for marketing authorisations for generic
medicinal products. If the innovative under­
taking has carried out the relevant tests to
obtain an authorisation for the original medic­
inal product, there is no need to repeat those
same tests to obtain an authorisation for an
essentially similar generic medicinal product.
56. As regards therapeutic indications, routes
of administration and dosage schedules autho­
rised for the original medicinal product for
less than 6 or 10 years, the rule precluding the
repetition of tests on persons or animals pro­
vides a basis for arguing that the marketing
authorisation for the generic medicinal
product should be extended as far as possible,
so as to cover all indications, routes of admin­
istration and dosage schedules of the original
medicinal product, even if authorised for less
than 6 or 10 years.
28 — The present situation has been described by Advocate Gen­
eral Fennelly in his Opinion in Joined Cases C-267/95 and
C-268/95 Merck and Beechimi [1996] ECR I-6285, points 75
to 87.
29 — Council Regulation (EEC) No 1768/92 of 18 June 1992 con­
cernine the creation of a supplementary protection certifi­
cate for medicinal products (OJ 1992 L 182, p. 1).
30 — This regulation has been interpreted by the Court of Justice
in, inter alia. Case C-350/92 Spain v Council [1995] ECR
I-1985; Case C-181/95 Biogen [1997] ECR I-357, and Case
C-110/95 Yamanouchi Pharmaceutical [1997] ECR I-3251.
31 — See Council Directive 86/609/EEC of 24 November 1986 on
the approximation of laws, regulations and administrative
provisions of trie Member States regarding the protection of
animals used for experimental and other scientific purposes
(OJ 1986 L 358, p. 1).
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OPINION OF MR RUIZ-JARABO— CASE C-368/96
Extension of the marketing authorisation for
generic medicinal products
57. The different objectives which come
together in the application of point 8(a)(iii) of
the second paragraph of Article 4 of Direc­
tive 65/65 are difficult to reconcile because
each of them justifies a different reading of
that provision. Nevertheless, I consider that
the best accommodation of the interests
involved in recourse to the simplified proce­
dure for obtaining marketing authorisations
for generic medicinal products follows from
the interpretation of that provision which I
propose below.
Marketing authorisations for generic medic­
inal products, applied for under that provi­
sion, will cover all indications, routes of
administration and dosage schedules autho­
rised up to that time for the essentially similar
original medicinal product marketed in the
Community for 6 or 10 years. Nevertheless,
new indications for the original medicinal
product, which have been authorised for at
least 6 or 10 years, will also enjoy the 6 or 10
year protection period where they constitute
therapeutic innovations of considerable impor­
tance. New routes of administration and
dosage schedules for the original medicinal
product do not constitute significant thera­
peutic innovations and, consequently, are not
covered by that protection period.
58. That interpretation of point 8(a)(iii) of
the second paragraph of Article 4 of Direc­
tive 65/65, which basically coincides with that
contended for by the Commission, respects
the requirement of protection of public health
because the extension of a marketing autho­
risation for a generic medicinal product so as
to cover new indications for the original
medicinal product which are of scant thera­
peutic relevance and to cover new routes of
administration and dosage schedules is based
on the existence of the relevant results of the
pharmacological and toxicological tests and
clinical trials submitted by the innovative
undertaking. Moreover, the documents and
reports needed for an application for a mar­
keting authorisation for a generic medicinal
product will be prepared by experts having
the necessary technical or professional quali­
fications, as required by Directives 75/318 and
75/319.
Furthermore, it is conducive to the protec­
tion of public health for a generic medicinal
product to be marketed on the basis of refer­
ence to all the therapeutic indications, routes
of administration and dosage schedules
accepted by the competent authorities for the
essentially similar original medicinal product.
In that way the maximum therapeutic yield is
obtained from generic medicinal products.
Finally, the proposed interpretation prevents
innovative undertakings which obtain a mar­
keting authorisation for an original medicinal
product from resorting to an obstructive
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THE QUEEN v THE MEDICINES CONTROL AGENCY, EX PARTE GENERICS (UK) AND OTHERS
strategy regarding essentially similar generic
medicinal products. Such a strategy might
consist in seeking, at intervals, authorisation
for new therapeutic indications, routes of
administration and/or dosage schedules in
order to extend the 6 or 10 year protection
period and hamper the bringing to market of
generic medicinal products. Such practices
would be incompatible with the free move­
ment of medicinal products in the Commu­
nity and would restrict freedom of competi­
tion in the pharmaceutical industry, without
in any way enhancing the protection of public
health.
59. The interpretation suggested is also in
harmony with the rule requiring non-
repetition of tests on persons and animals
unless strictly necessary. New therapeutic
indications, routes of administration and/or
dosage schedules authorised for an original
medicinal product are supported by the tests
carried out by the innovative undertaking and
it is not advisable that they be repeated merely
because there has not been a time lapse of
more than 6 or 10 years since the authorisa­
tion of those modifications.
60. The encouragement of pharmaceutical
innovation and research, and the protection
of the industrial and commercial property of
innovative undertakings, are also ensured to
the proper extent by the interpretation which
I propose of point 8(a)(iii) of the second
paragraph of Article 4 of Directive 65/65.
When the undertaking holding the marketing
authorisation for the original medicinal
product obtains authorisations for new routes
of administration or dosage schedules, it does
not need to carry out significant research
deserving of special protection because the
innovation involved in those modifications is
of little significance. The same reasoning
applies to new therapeutic' indications for the
original medicinal product which fall into the
same category as those authorised earlier.
In my opinion, there is a significant innova­
tion only where the undertaking holding the
marketing authorisation for the original
medicinal product obtains a subsequent autho­
risation for a new indication of great thera­
peutic importance. In such a case, it is appro­
priate to apply the 6 or 10 year protection
period to the new indication in order to pro­
tect the innovation achieved by the pharma­
ceutical undertaking, because it is thereby
possible to amortise the substantial invest­
ments normally required to achieve a signifi­
cant innovation. A new indication of consid­
erable therapeutic importance will normally
require new pharmacological and toxicological
tests and clinical trials of a scope similar to
those needed to obtain a marketing authorisa­
tion for any new medicinal product.
61. The application of that interpretation of
point 8(a)(iii) of the second paragraph of
Article 4 of Directive 65/65 calls for details of
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OPINION OF MR RUIZ-JARABO— CASE C-368/96
the criteria which may be applied to deter­
mine which new indications for the original
medicinal product constitute a therapeutic
innovation of great significance deserving of
additional protection.
62. For that purpose, the MCA relied upon
Regulation No 541/95 as a basis for deter­
mining when a new therapeutic indication is
of great importance. The Commission, Glaxo,
Wellcome, Squibb, Generics and the Swedish
and Danish Governments consider recourse
to that regulation to be inappropriate.
In my opinion, it is not possible to derive
from Regulation No 541/95 criteria by which
to determine whether or not a new indication
for an original medicinal product is of great
therapeutic importance. That regulation is a
measure of a procedural nature which supple­
ments Articles 7 and 7a of Directive 65/65,
which were amended by Directive 93/39, con­
cerning procedures for mutual recognition of
marketing authorisations for medicinal prod­
ucts issued by the competent authorities of
the Member States. Regulation No 541/95
extends the provisions on mutual recognition
to changes in the terms of marketing autho­
risations for medicinal products. That regula­
tion distinguishes between minor variations
and major variations. The latter, enumerated
in Annex II to the regulation, involve a radical
alteration of the terms of the marketing autho­
risation, which means that a new application
for an authorisation must be submitted.
There is no basis for the view taken by the
MCA that those major variations constitute
new indications of great therapeutic impor­
tance which require additional protection by
virtue of point 8(a)(iii) of the second para­
graph of Article 4 of Directive 65/65. In the
first place, Annex II to Regulation No 541/95
states that 'This Annex is without prejudice
to the provisions of Article 4 of Directive
65/65/EEC...'. Secondly, a therapeutic inno­
vation is not a relevant factor for the purpose
of classifying variations as being major or
minor. Finally, that regulation is of a merely
formal nature and does no more than harmo­
nise administrative practices applicable to
changes in the terms of marketing authorisa­
tions, which renders it inapplicable so far as
concerns determining the substantive condi­
tions to be met for the grant of authorisations
for generic medicinal products under the
abridged procedure.
63. In my opinion, it is for the national com­
petent authorities to determine in each spe­
cific case whether a new indication for an
original medicinal product authorised for less
than 6 or 10 years constitutes a therapeutic
innovation of great significance deserving sup­
plementary protection in relation to an essen­
tially similar generic medicinal product. In
carrying out that assessment, the competent
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THE QUEEN v THE MEDICINES CONTROL AGENCY, EX PARTE GENERICS (UK) AND OTHERS
authorities of the Member States must, as the
Commission indicates, take account inter alia
of the following criteria:
— The eligibility of the new indication for
the issue of a Community marketing
authorisation, by virtue of the third indent
of part B of the Annex to Regulation No
2309/93, which requires that the signifi­
cance of its therapeutic benefit be proved
to the European Agency for the Evalua­
tion of Medicinal Products.
— The possibility that the new therapeutic
indication may be eligible for a patent 32
under the Munich Convention or the
national legislation of aMember State. The
initial therapeutic indications for an orig­
inal medicinal product can be patented
and it is also possible to patent subse­
quent therapeutic indications provided that
they constitute a novelty deriving from
inventive effort and are capable of being
put to practical therapeutic use. The eli­
gibility for patent protection of a new
therapeutic indication for an original
medicinal product is indicative of the ther­
apeutic innovation embodied in it and for
that reason is a factor to be taken into
account in determining whether or not
the new indication deserves additional pro­
tection in relation to the marketing of an
essentially similar generic product.
— The scope of the pharmacological and the
toxicological tests and clinical trials car­
ried out by the innovative undertaking in
order to discover the new therapeutic indi­
cation for the original medicinal product.
64. Those criteria enable the competent
national authorities to carry out their assess­
ment with a sufficient measure of objectivity.
The fifth question
65. This question raises the question of the
possible invalidity of point 8(a)(iii) of the
second paragraph of Article 4 of Directive
65/65 on the ground that it breaches the prin­
ciples of protection of innovation, non­
discrimination, proportionality and/or respect
for property.
66. In its order for reference, the High Court
does not indicate the reasons which prompted
it to raise the possibility that the provision in
question may be invalid as being incompat­
ible with those general principles of Commu­
nity law. Personally, I perceive nothing in
32 — The Court ofJustice has considered the relationship between
patents and marketing authorisations from another stand­
point in Case C-316/95 Generics [1997] ECR 1-3954.
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OPINION OF MR RUIZ-JARABO — CASE C-368/96
point 8(a)(iii) of the second paragraph of
Article 4 of Directive 65/65 which might be
contrary to any of those general principles.
67. Protection of innovation has not been
formally recognised as a general principle of
law by the case-law of the Court of Justice.
It is a purpose pursued by the Community
rules on the marketing of medicinal products
which, as such, is mentioned in various Com­
munity measures. 33 On the other hand, the
principles of non-discrimination 34 and pro­
portionality 35 are enshrined in settled case-law
of the Court of Justice.
Point 8(a)(iii) of the second paragraph of
Article 4 of Directive 65/65 provides for a
simplified marketing authorisation procedure
for generic medicinal products essentially sim­
ilar to original medicinal products that have
been marketed for 6 or 10 years, in which use
is made of the results of the pharmacological
and toxicological tests and clinical trials sub­
mitted by the innovative undertaking. That
procedure is in conformity with the principle
of proportionality since it is appropriate in
order to ensure the protection of public health,
non-repetition of tests on persons and ani­
mals, and protection of innovation and phar­
maceutical research. 36 Moreover, it does not
give rise to discrimination between innovative
undertakings and those which produce generic
medicinal products, since the former enjoy a
protection period of 6 or 10 years for their
innovations, enabling them to amortise their
investments in research and development of
medicinal products, and the latter are able to
market generic medicinal products essentially
similar to the original medicinal products fol­
lowing a simplified and less costly procedure
which relies on the results of the research car­
ried out by the innovative undertakings.
68. As regards respect for property, the Court
of Justice has held that it is a right upheld in
the Community legal order but one which
may be subject to restrictions which corre­
spond to objectives of general interest and do
not constitute, having regard to the aim pur­
sued, a disproportionate and intolerable inter­
ference impairing the very substance of the
rights guaranteed. 37 The use, upon expiry of
the protection period of 6 or 10 years, by
undertakings producing generic medicinal
products of the results of the pharmacological
and toxicological tests and clinical trials sub­
mitted by the innovative undertakings in order
33 — See paragraphs 51 to 55 above.
34 — Case 203/86 Spain v Council [1988] ECR 4563, paragraph
14, and Case C-22/94 Irish Farmers Association and Others
v Minister for Agriculture, Food and Forestry, Ireland, and
the Attorney General [1997] ECR 1-1809, paragraph 34.
35 — Joined Cases C-296/93 and C-307/93 France and Ireland v
Commission [1996] ECR I-795, paragraph 30; Case C-280/93
Germany v Council [1994] ECR I-4973, paragraph 90, and
Case C-331/88 Fedesa and Others [1990] ECR I-4023, para­
graph 14.
36 — See points 45 to 56 above.
37 — Case 5/88 Wachauf [1989] ECR 2609, paragraph 18; Case
C-177/90 Kühn [1992] ECR I-35, paragraph 16, and Case
C-280/93 Germany v Council [1994] ECR I-4973, paragraph
78.
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THE QUEEN v THE MEDICINES CONTROL AGENCY, EX PARTE GENERICS (UK) AND OTHERS
to obtain a marketing authorisation for the
original medicinal product does not consti­
tute a disproportionate interference impairing
their property rights in respect of those results.
69. Consequently, I do not perceive any factor
such as to affect the validity of point 8(a)(iii)
of the second paragraph of Article 4 of Direc­
tive 65/65.
Conclusion
70. In view of the foregoing considerations I propose that the Court of Justice
answer the questions referred to it as follows:
(1) Two medicinal products are essentially similar where they have the same quali­
tative and quantitative composition in terms of active principals, their pharma­
ceutical form is identical and, where necessary, their bioequivalence has been
demonstrated by means of appropriate bioavailability studies.
(2) The competent national authorities enjoy no margin of discretion in assessing
essential similarity between two medicinal products for the purposes of point
8(a)(iii) of the second paragraph of Article 4 of Directive 65/65 of the Council
of 26 January 1965 on the approximation of provisions laid down by law, regu­
lation or administrative action relating to proprietary medicinal products.
(3) Marketing authorisations for generic medicinal products will extend to all indi­
cations, routes of administration and dosage schedules authorised until that
time for the essentially similar original medicinal product which has been mar­
keted in the Community for 6 or 10 years. Nevertheless, new therapeutic indi­
cations for the original medicinal product, authorised less than 6 or 10 years
earlier, will enjoy protection for a period of 6 or 10 years where they constitute
therapeutic innovations of great significance.
(4) Commission Regulation (EC) No 541/95 of 10 March 1995 concerning the
examination of variations to the terms of a marketing authorisation granted by
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OPINION OF MR RUIZ-JARABO— CASE C-368/96
a competent authority of a Member State has no bearing on the application of
point 8(a)(iii) of the second paragraph of Article 4 of Directive 65/65.
(5) In this case, no factor has been disclosed of such a nature as to affect the
validity of point 8(a)(iii) of the second paragraph of Article 4 of Directive
65/65.
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