2001/571/EC: Commission Decision of 18 July 2001 on the national provisions notified by Germany in the field of pharmacovigilance (Text with EEA relevance) (notified under document number C(2001) 1974)
Date: 2001-07-18
Institutions: European Commission
Subjects: Germany, approximation of laws, drug surveillance, national implementing measure, pharmaceutical legislation, pharmacology

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Official Journal of the European Communities

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COMMISSION DECISION

of 18 July 2001

on the national provisions notified by Germany in the field of pharmacovigilance

(notified under document number C(2001) 1974)

(Only the German text is authentic)

(Text with EEA relevance)

(2001/571/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community, and in particular Article 95(6) thereof,

Whereas:

several points of
the abovementioned provisions by
Directive 2000/38/EC. In so doing the Commission took
as a base a high level of protection pursuant to Article
95(3) of the EC Treaty and in particular it has taken
account of all new scientifically based developments. For
the sake of legal clarity and irrespective of the scope of
each amendment, the individual provisions have been
entirely redrafted.

I. THE FACTS

1. Relevant Community legislation

(4)

(1)

(2)

The current Community provisions on pharmacovigi-
lance,
i.e. the supervision of medicinal products once
they have been authorised, are contained in Chapter Va
(Article 29a to 29i) of Council Directive 75/319/EEC of
20 May 1975 on the approximation of provisions laid
down by law, regulation or administrative action relating
to proprietary medicinal products (1), as last amended by
Directive 2000/38/EC (2). Chapter Va was added to
Directive 75/319/EEC by Directive 93/39/EEC (3).

to Article 29d(1)

The provisions on reporting adverse reactions which are
relevant for this notification are contained primarily in
Article 29d. Pursuant
the person
responsible for placing the medicinal product on the
market shall be required to recall and to report all
suspected serious adverse reactions which are brought to
his attention by a health-care professional immediately
to the competent authority, and in any case within 15
days at the latest. Pursuant to Article 29d(2) records
shall be maintained of all other suspected adverse reac-
tions and shall be sumitted to the authorities at regular
intervals. In Article 29i the Commission is authorised to
update the provisions of Chapter Va, in accordance with
the procedures laid down in Article 37a of Directive
75/319/EEC, to take account of scientific and technical
progress.

(3)

In the light of new knowledge in the field of pharmaco-
vigilance, continued efforts
to achieve international
harmonisation of pharmacovigilance data and techno-
logical developments in electronic data collection and
the
transmission,
authorisation contained in Article 29i and has amended

the Commission has made use of

(1) OJ L 147, 9.6.1975, p. 13.
(2) OJ L 139, 10.6.2000, p. 28; corrected in OJ L 249, 4.10.2000, p.

26 and in OJ L 262, 17.10.2000, p. 46.

(3) OJ L 214, 24.8.1993, p. 22.

level,

The main objective of Directive 2000/38/EC is to
remodel the pharmacovigilance systems, which to date
have primarily been paper-based and organised at
national
into a Community-wide electronic data
system. All pharmacovigilance information will be
entered in this and then automatically stored in a data
bank, to be set up by the European Agency for the
Evaluation of Medicinal Products (hereafter referred to as
the EMEA) established by Council Regulation (EEC) No
2309/93 of 22 July 1993 laying down Community
procedures for the authorisation and supervision of
medicinal products for human and veterinary use and
establishing a European Agency for the Evaluation of
Medicinal Products (4). From there the data can be
the
retrieved at any time by the member States,
Commission and the EMEA itself. This
electronic
network will be based on new knowledge and advances
in the field of information technology, thereby making
the collection and exchange of data more efficient,
authorisation holders of
relieving
generally
and
unnecessary
improving the surveillance of medicinal products in the
Community.

the marketing
reporting

obligations

(5)

The central provisions on reporting adverse reactions are
contained in the revised version of Article 29d(2) and (4)
from the year 2000. Pursuant to the new version of
Article 29d(2), the marketing authorisation holder is
required to record and to report all suspected serious
adverse reactions which are brought to his attention by a
health-care professional immediately to the competent
authority of the Member State, in whose territory the
incident occurred, and in no case later than 15 days after

(4) OJ L 214, 24.8.1993, p. 1.

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(6)

(7)

the receipt of the information. Pursuant to the new
version of Article 29d(4) (1), the marketing authorisation
holder shall also ensure that all suspected serious unex-
pected adverse reactions occurring in the territory of a
non-member country and brought to his attention by a
health-care professional are reported immediately to the
EMEA and to the competent authorities of the Member
State where the medicinal product is authorised, and in
no case later than 15 days after the receipt of
the
information.

products marketed

Under the new version of Article 29f(1), the EMEA is
required, in collaboration with the Member States and
the Commission, to set up a data-processing network to
facilitate the exchange of pharmacovigilance information
regarding medicinal
the
Community, in order to allow all competent authorities
to share the information at the same time. Pursuant to
paragraph 2 of this Article, making use of the above-
mentioned network Member States shall ensure that
reports of suspected serious adverse reactions that have
taken place on their territory are immediately made
available to the Agency and the other Member States
and in any case within 15 days of their notification.

in

2. National provisions

The provisions notified by the Federal Republic of
Germany relate to the provisions of sentences 2 to 8 of
Section 29(1) of the Law on trade in medicinal products
(hereafter AMG),
in the version of the Notice of 11
December 1998 (2). Pursuant to sentence 2 of Section
29(1) AMG, the applicant shall notify the competent
national autorities of any suspected case of serious
adverse reaction or serious case of interaction with other
products known to him and also of certain cases of
abuse immediately and in any case within 15 days of
notification. Without further restrictions in the text, this
obligation exists irrespective of whether the suspected
case occurred inside or outside the Federal Republic of
Germany and of whether the adverse effect has been
confirmed or not. Senctences 3 to 8 of Section 29(1)
AMG contain further provisions relating to the docu-
mentation on adverse reactions and its presentation to
the competent authorities.

(9)

(10)

(11)

from the obligation under the amended Article 29d of
Directive 2000/38/EC in two respects.

Firstly, sentence 2 of Section 29(1) AMG requires the
applicant to report any suspected case of serious adverse
reaction notified to him, in other words irrespective of
whether the suspected case occurred inside or outside
Germany. Under the new version of Article 29d(2), the
marketing authorisation holder is required to report the
adverse reactions only to the competent authority of the
Member State in which the adverse reaction took place.

To the extent that the suspected serious adverse reaction
took place in a non-Member country,
i.e. outside the
Community, the new version of Article 29d(4) estab-
lishes an obligation to report the suspected case only
where the adverse reaction is unexpected. Such a restric-
tion is not contained in the second sentence of Section
29(1) AMG.

II. PROCEDURE

the Permanent Representation of

By letter of 18 January 2001, received on 25 January
2001,
the Federal
Republic of Germany to the European Union applied to
the Secretariat-General of the Commission to be allowed
to maintain the provisions of sentences 2 to 8 of Section
29(1) AMG regarding the obligation to report adverse
reactions. In Germany's opinion, this is justified on the
grounds of major needs within the meaning of Article
30 of the EC Treaty, i.e. the protection of health and
lives of humans.

(12)

By letter of 2 March 2001, the Commission informed
the German authorities that it had received the noti-
fication pursuant to Article 95(4) of the EC Treaty and
that the period of six months provided under Article
95(6) of the EC Treaty to examine the notification had
begun to run from 26 January 2001, the day after it was
received.

3. Comparison between the German provisions and

the Community legal provisions

(13)

(8)

The obligation to report adverse reactions of a medicinal
product under sentence 2 of Section 29(1) AMG differs

(1) In the light of the corrigendum in OJ L 262, 10.7.2000, p. 46.
(2) BGBl. I p. 3586; as last amended by Article 2 of the Law of 20

July 2000, BGBl. I p. 1045.

By letter of 17 April 2001 the Commission informed
the other Member States about the notification of the
Federal Republic of Germany and gave them an oppor-
tunity to express an opinion within one month. Notice
of the notification was also published in the Official
Journal of the European Communities (3) in order to inform
other interested parties of the provisions notified and to
be maintained by Germany.

(3) OJ C 130, 1.5.2001, p. 2.

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III. ASSESSMENT

ining the relevance of the elements which are submitted
by the requesting Member State, without itself having to
seek possible grounds of justification.

1. Consideration of admissibility

(14)

The notification submitted by the German Government
aims to maintain the obligations to report adverse reac-
tions contained in Section 29 AMG, which derogate
from those of Directive 2000/38/EC. This Directive was
adopted on the basis of Article 29i of Directive 75/
319/EEC, which in turn is based on ex-Article 100a
(current Article 95) of the EC Treaty. Directive 2000/
38/EC thus represents a harmonisation measure adopted
by the Commission within the meaning of Article 95(4)
of the EC Treaty.

(15)

In accordance with the requirements of Article 95(4) of
the EC Treaty, Germany has notified the Commission of
the text of the national provisions it wishes to maintain
as well as the grounds which,
in Germany's opinion,
justify the application.

(16) Accordingly,

it is the Commission's opinion that the
notification with which Germany requests the Commis-
sion to approve maintenance of
the provisions of
sentences 2 to 8 of Section 29(1) AMG, derogating from
Directive 2000/38/EC, is admissible on the basis of the
provisions of Article 95(4) of the EC Treaty.

2. Assessment of merits

(17)

The Commission can only approve a notification
pursuant to Article 95(4) of the EC Treaty if all of the
conditions listed in Article 95 of the EC Treaty are met.
In particular, maintaining the national provisions must
be justified on grounds of major needs referred to in
Article 30 of the EC Treaty, or relating to protection of
the environment or the working environment (Article
95(4) of the EC Treaty). In addition the national provi-
sions may neither be a means of arbitrary discrimination
or a disguised restriction on trade between Member
States; neither can they constitute an obstacle to the
functioning of the internal market (Article 95(6) of the
EC Treaty).

(a) Major needs

(18) When examining whether the national measures notified
under Article 95(4) are justified by major needs, the
Commission has to take as a basis ‘the grounds’ put
forward by the Member State to justify the maintenance
of its national provisions. This means that, according to
the provisions of
the responsibility for
proving that these measures are justified lies with the
requesting Member State. Given the procedural frame-
work established by Article 95 of the EC Treaty,
in
principle the Commission has to limit itself to exam-

the Treaty,

(19) Germany invokes major needs to protect the health and
life of humans and consequently one of the circum-
sances referred to in Article 30 of the EC Treaty. Main-
taining the obligations to report as provided for in the
current provisions of sentences 2 to 8 of Section 95(1)
AMG would attain the highest possible level of health
protection for the population in their use of medicinal
level of protection was
products. This high national
firstly,
endangered by Directive 2000/38/EC since,
adverse reactions will in future only be reported to the
Member state in which they take place and, secondly,
adverse reactions which take place in a non-member
country are only covered by the obligation to report
when they are ‘unexpected’.

(aa) R e p o r t i n g a d v e r s e r e a c t i o n s f r o m M e m b e r

S t a t e s

(20) Germany considers that it is ‘not acceptable on health
grounds’ to report adverse reactions only to the Member
State in which the suspected case occurred. As justifica-
tion Germany points out that the data network to be
established under Directive 2000/38/EC does not yet
exist. Therefore, on the basis of
the restricted noti-
fication requirements, it could not be guaranteed in the
foreseeable future that the authorities of all Member
States would receive information of equivalent quality
and at the same time.

(21) Major needs within the meaning of Article 30 of the EC
Treaty cannot be invoked on this basis for two reasons.

(22)

the

statement of

Firstly,
the Federal Republic of
Germany that the data network referred to in Directive
2000/38/EC does not yet exist and cannot be established
in the foreseeable future, at least not by 5 December
2001, is incorrect. In so far as the establishement of the
data network provided for in the new version of Article
29f requires preliminary work on the part of the EMEA
and the Commission, this will be completed on schedule
by 5 December 2001. According to the current time-
table, the EMEA, will make the basic version of the
central bank databank available by 1 December 2001.
From that date individual case reports within the
meaning of the new Article 29d(2) to (5) can be entered
in the databank and shared by the authorities of all
Member States. Contrary to Germany's statement there-
fore,
the technical and procedural preconditions for
establishing and using the data network will exist by the
end of the transposition period for Directive 2000/38/
EC.

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However, account must be taken of the fact that the
establishment of the databank is not the task of the
EMEA alone. Rather it is the responsibility of the author-
ities of the Member States, pursuant to the new version
of Article 29f(2),
to use the newly established data
network to forward the reports of adverse reactions
transmitted to them to the EMEA and to the other
Member States. However, for this the information must
first be entered by the Member States and subsequently
transmitted to the EMEA databank, where it is automati-
cally fed into the central databank and is retrievable. To
ensure that the reports are generally comparable and to
make them more intelligible,
the participants have
agreed to use the standards developed in the framework
of the International Conference on Harmonisation of
Technical Requirements for Registration of Medicinal
products for Human Use when collecting and entering
data.

It is only in the course of 2002 that most Member States
will be able to convert their national computer systems
to the uniform standard and begin electronic data trans-
mission to the EMEA using this standard. Where a
Member State has not yet made the conversion and in
the event of a suspected case in this Member State, only
the basic information on the product concerned, the
patient and the type of adverse reaction will be entered
in the central databank of the EMEA and be electroni-
cally retrievable. However, this will not interfere with the
overall dissemination of pharmacovigilance information
within the Community. Where the Member States have
not converted their systems by the due date of 5
December 2001,
the new
version of Article 29f(2) to transmit the relevant reports
in another appropriate form. The restricted operating
capacity of the data network will therefore not have any
adverse consequences on health protection.

they are required under

(23)

the legal position in most Member States
Secondly,
counters Germany's argument
that major needs of
health protection require it to maintain the obligation to
report also adverse reactions from other Member States.
According to the current
legal position, only four
Member States require that their own authorities should
also be informed when the suspected case of a serious
adverse reaction occurs in another Member State.
In
addition to Germany, this is the case in Austria, Portugal
and the United Kingdom. All other Member States
require such a communication to the national authori-
ties only when the adverse reaction occurred on their
national
territory. With regard to information on
adverse reactions in other Member States, the informa-
tion
the
Community is for the most part evidently considered to
be adequate. This must be even more true for the mark-
edly improved data network to be established on the
basis of Directive 2000/38/EC.

network which

exists within

already

(24) Altogether therefore no major needs within the meaning
of Article 30 of the EC Treaty can be recognised which
could justify maintaining the obligation to report
adverse reactions from other Member States. Rather the
restriction contained in the new version of Article
29d(2) represents a logical conclusion to the establish-
ment of the new data network. This will make the same
information available to the Member States as previ-
ously, but presentation will be improved. Maintaining
the previous obligations to report would place an
unnecessary and unjustifiable burden on the respective
marketing authorisation holders.

(bb) R e p o r t i n g a d v e r s e
m e m b e r c o u n t r i e s

r e a c t i o n s

f r o m n o n -

It claims that

(25) With regard to restricting the obligation to report
adverse reactions from non-member countries to those
which are unexpected, as contained in the new version
of Article 29d(4), Germany claims that this could lead to
a substantial increase in the risk of transmitting infec-
tious pathogens via medicinal products with biological
information
components.
mentions the risk of virus transmission via medicinal
products obtained from human body parts. Thus, in the
event of a suspected case of virus transmission,
for
example of the HIV or hepatitis viruses through such a
medicinal product, then the adverse reaction could not
be classified as ‘unexpected’ and for this reason would
not have to be reported if it occurs in a non-member
country. This could interfere with batch recalls and
efforts to identify other possibly infected patients and
with follow-up measures such as diagnosis and therapy.

the product

(26)

that Germany's remarks relate to the
To the extent
specific example of a transmission of HIV or hepatitis
viruses, they are based on a misconception. Germany
assumes that contamination of a medicinal product with
the HIV or hepatitis virus is to be classified as an ‘expec-
ted’ adverse reaction and consequently to be excluded
from the obligation to report which, in accordance with
Directive 2000/38/EC,
restricted to ‘unexpected’
adverse reactions. This interpretation is not correct.
Blood products are examined for such viruses as part of
the manufacturing and authorisation process. In prin-
ciple therefore they are used on the understanding that
the medicinal products are not infected. However,
if
such an infection does exist, then it is an unexpected
adverse reaction, which under the new legal position is
fully covered by the notification requirement.

is

(27)

Irrespective of whether virus infections in medicinal
products can ever be classified as expected adverse reac-
tions, there is a further reason why Germany's argu-
ments are not grounds for major needs within the
meaning of Article 30 of the EC Treaty. This considera-
tion is based on the fact that any expected adverse

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reactions have to be taken into account during the
testing and authorisation of a product, while obviously
this is not possible when these are unexpected, During
the subsequent monitoring of a medicinal product in the
framework of pharmacovigilance, special significance is
thus attached to unexpected as opposed to expected
adverse reactions. For this reason, the general reporting
and evaluation of adverse reactions, even when they
occur outside the Community, appears necessary only
when these are unexpected.

This conclusion is based on scientific evidence acquired
in recent years
relating to the medicinal products
approved as part of the centralised Community proce-
dure pursuant to Regulation (EEC) 2309/93. This proce-
dure is obligatory for certain products of the biotech-
nology and high technology industries, which are
regarded as particularly complex and sensitive. None the
less the second subparagraph of Article 22(1) of Regula-
tion (EEC) 2309/93 restricts the obligation to report the
adverse reactions of such medicinal products which
occur in non-member countries to those which are
unexpected. Analyses and evaluations of the information
on adverse reactions generated from centrally authorised
medicinal products have confirmed that it is also not
necessary to report
information on
expected adverse reactions from non-member countries.

and evaluate

This assessment is further supported by the fact that the
Federal Republic of Germany is the only Member State
which does not restrict the obligation to report adverse
reactions occurring in non-member countries to those
which are unexpected, but extends this obligation to
adverse reactions which are expected. This highlights the
fact that none of the other Member States considers it
necessary,
in order to protect the health and life of
humans, to include reports of suspected serious expected
adverse reactions from non-member countries in the
pharmacovigilance systems.

Consequently,
in maintaining an obligation to report
suspected serious expected adverse reactions from non-
member countries, Germany is not able to invoke major
needs within the meaning of Article 30 of the EC Treaty.
The provision of
the new version of Article 29d(4)
applies new scientific evidence without prejudicing the
high level of health protection in the Community.

(28)

(29)

(30)

(31)

(32)

(b) Arbitrary discrimination, disguised restriction on trade, an
obstacle to the functioning of the internal market

Pursuant to Article 95(6) of the EC Treaty the Commis-
sion is required to approve the national provisions or
reject them after it has ensured that they do not consti-
tute a means of arbitrary discrimination or a disguised
restriction on trade between the Member States and are
not an obstacle to the functioning of
the internal
market.

Since, in the light of the conditions referred to in Article
95(4) of
the EC Treaty, Germany's application is
unfounded, the Commission does not need to examine
whether the said national provisions constitute a means
of arbitrary discrimination and a disguised restriction on
trade between the Member States nor whether they are
an obstacle to the functioning of the internal market.

IV. CONCLUSION

(33)

In the opinion of the Commission Germany's applica-
tion is therefore
— admissible,
— but unfounded.

(34)

The Commission has therefore decided to reject this
application pursuant to Article 95(6) of the EC Treaty,

HAS ADOPTED THIS DECISION:

Article 1

The national provisions on the obligation to report the adverse
reactions of medicinal products notified to the Commission by
the Federal Republic of Germany by letter of 18 January 2001,
and which derogate from Directive 2000/38/EC are rejected.

This Decision is addressed to the Federal Republic of Germany.

Article 2

Done at Brussels, 18 July 2001.

For the Commission

Erkki LIIKANEN

Member of the Commission