Official Journ alof the EuropeanUnion 26.9.2009
RESOLUTION OF  THE EUROPEAN PARLIAMENT
of 23 
April 2009
with observations forming an integral part of the Decision on discharge in respect of the 
implementation of the bu dget 
of the Eu ropean 
Medicines Agency for the financial year 2007
THE EUROPEAN PARLIAMENT,
—having  reg ard  to the fin al  annual  accounts  of the European Medicin es  Agen cy for the fin ancial  year 
2007
(1) OJ C 278, 31.10.2008, p. 10. (1), 
—having 
regard 
to the Court of Auditors’ report on  
the final 
annual 
account
s of the E uropean 
Medicines 
Agency 
for the fin ancial 
year 2007, tog ether 
with the Ag ency’s 
replies
(2) OJ C 311, 5.12.2008, p. 27. (2), 
—having 
regard 
to the Coun cil’s 
recommen dation 
of 10 February 
2009 (5588/2009 — C6-0060/2009), 
—having 
regard 
to the EC 
Treaty, an d 
in 
particular Article 276 thereof, 
—having 
regard 
to Council 
Regulation 
(EC, 
Euratom) 
No 1605/2002 of 25 June 
2002 on 
the Financial 
Regu­
lation
 applicable
 to the general
 budget
 of the European Commun ities
(3) OJ L 248, 16.9.2002, p. 1. (3), and in particular Article 185 
thereof,
 
—having 
regard 
to Regulation 
(EC) 
No 726/2004 of the E uropean 
Parliamen t 
and 
of the Coun cil 
of 31 March 
2004 layin g 
down 
Community 
procedures for the authorisation  
and 
supervision  
of medicin al 
products 
for human  
and 
veterinary 
use and 
establishing 
a European 
Medicines 
Agency
(4) OJ L 136, 30.4.2004, p. 1. (4), and in particular 
Article 
68 thereof, 
—having
 regard
 to Commission Reg ulation
 (EC,
 Euratom)
 No 2343/2002 of 19 Novemb er
 2002 on the 
framework  
Financial 
Regulation 
for the bodies 
referred to in  
Article 185 of Reg ulation 
(EC, 
Euratom) 
No 
1605/2002
(5) OJ L 357, 31.12.2002, p. 72. (5), and in particular Article 94 thereof, 
—having 
regard 
to Rule 71 of, an d 
Annex 
V to, its Rules of Procedure, 
—having 
regard 
to the report of the Committee on  
Budgetary 
Control 
and 
the opinion 
of the Committee on  
the 
Environment, 
Public 
Health an d 
Food Safety (A6-0162/2009),
A. whereas the E uropean Court of Auditors (E CA) stated that it has ob tained reasonable assurance that the 
annual
 accounts
 for the fin ancial
 year 2007 are reliab le,
 and
 the underlyi
ng
 transactions
 are legal
 and
 
regular,
B. whereas on  22  April 2008 Parliamen t granted the Executive Director of the European  Medicines Agency 
discharge 
in 
respect of the implemen tation 
of the Agency’s 
budget 
for the fin ancial 
year 2006
(6) OJ L 88, 31.3.2009, p. 175. (6), and in 
its 
resolution  
accompan ying 
the discharg e 
decision, 
inter 
alia:
—noted 
the ECA’s 
statement 
in 
its 2006 report that as reg ards 
administrati
ve expenditure 
the utilisa­
tion 
for commitmen t 
appropriation s 
was less than  
60 %, 
—noted 
that a con siderable 
amount 
of budget 
appropriation s 
for 2006 had b e
en 
carried over to 2007 
due to the n ature 
of the projects dealt with b y 
the Agency,
 
—noted 
that in 
December 
2006 the Ag ency’s 
Management 
Board decided to un de
rtake 
a revision  
of 
the scale fees system in  
consultation 
with the competen t 
national 
authorities;N E 8 1 1 / 5 5 2 L
Official Journ alof the EuropeanUnion L 255/119
1. Underlines that the Ag ency’s budget is financed both from the E U Budget and mainly by fees paid by phar­
maceutical in dustry 
applicants 
for obtaining 
or maintain ing
 a Commun ity 
marketing 
authorisation . 
How­
ever notes 
that the EC 
general 
contribution 
increased 
by 
24,48 % b etween 
2006 and 
2007 and 
represents 
24,13 
% of the total 2007 reven ue; 
is aware in  
this context 
of newly 
assigned 
tasks 
arising 
from Regula­
tion 
(EC) 
No 1901/2006 of the E uropean 
Parliament an d 
of the Coun cil 
of 12 Decemb er 
2006 on 
medici­
nal 
products for paediatric use
(1) OJ L 378, 27.12.2006, p. 1. (1) and an increase in the orphan  medicines budget line;
2. Welcomes 
the efforts of the Ag ency 
to provide more scien tific 
advice at early stag es 
of the developmen t 
of 
new 
medicines 
as well as the in troduction 
of measures to accelerate the assessmen t 
of medicin es 
that 
are of critical importan ce
 to public
 health an d
 to accelerate the developmen t
 and
 implemen tation
 of 
Telematics prog rammes;
3.
 Considers
 the Agency
 as a source of importan t
 scientific
 advice, scien c
e-based
 recommen dations,
 best
 
practice for medicin es 
evaluation  
and 
supervision  
in 
Europe 
and 
welcomes the con tributions 
to the Com­
mission 
and 
the Memb er 
States towards the harmon isation 
of regulatory 
standards 
at international 
level;
4. Encourages 
the Agency 
to continue 
its action 
in 
the Orphan  
Medicines 
field; discourag es, 
however, the 
decrease in  
the Orphan  
Medicines 
contribution, 
mainly 
due to a chan ge 
in 
the policy for orphan  
fee reduc­
tions 
resulting 
from the flexib ility 
provided b y 
Council 
Regulation 
(EC) 
No 297/95 of 10 February 
1995 
on 
fees payab le 
to the European 
Agency 
for the Evaluation 
of Medicin al 
Products
(2) OJ L 35, 15.2.1995, p. 1. (2), which n one the less 
results 
in 
(generates) 
a reduction  
of 26,25 % in  
2007 compared to 2006;
5. Emphasises 
the role of the Ag ency 
to monitoring 
the safety of medicin es 
through 
the pharmacovig ilance 
network; 
calls, however, for con stant 
improvemen t 
of the vig ilance 
level;
Weaknesses in bu dgetary 
management concerning the Telematics programme
6. Notes the E CA’s 
criticism that, as in  
2006, the hig h 
level of carry-overs for admin i
strative expenditure was 
mainly 
due to the Telematics prog ramme; 
notes 
the ECA’s 
statement 
that this situation  
was at odds with 
the principle 
of annuality 
and 
that the Ag ency 
must ensure 
better 
planning 
and 
monitoring 
of the imple­
mentation 
of the prog ramme;
7.
 Notes the E CA’s
 recommen dation
 that the Ag ency
 should con sider
 using
 the differentiated appropria­
tions 
system for the Telematics prog ramme, 
which was more suitab le 
for the budgetary 
management 
of 
such prog rammes;
8. Calls 
on 
the Agency 
to implemen t 
the ECA’s 
recommen dation 
to use differen tiated 
appropriation s 
for the 
Telematics prog ramme 
promptly; requests that the Ag ency 
report on 
the action  
taken 
in 
its annual 
activ­
ity report for 2008;
Weaknesses as regards procu rement 
procedures
9. Notes 
the ECA’s 
finding 
with regard 
to procuremen t 
procedures, statin g 
that:
—in 
two cases the procedures chosen  
were not 
sufficiently 
justified, 
—in 
three cases the evaluation  
methods for the price criteria were in adequ
ate, 
—in 
one 
case of a join t 
procuremen t 
procedure with five other ag encies 
the volume of the services to 
be 
procured had n ot 
been 
adequately iden tified;N E 9 0 0 2 . 9 . 6 2
Official Journ alof the EuropeanUnion 26.9.2009
10. Notes the Ag ency’s replies accordin g to which:
—it established
 a formula for the ob jective
 evaluation of price as an award criteria with effect from
17 March 2008, 
—in 
the case of the join t 
procuremen t 
procedure the orig inal 
estimate had to b e 
revalued due to the 
technological 
advances 
that occurred b etween 
the defini
tion of services to b e 
provided an d 
the launch 
of 
the procuremen t 
procedure;
11. Requests the Ag ency 
to address the weak nesses 
in 
the procuremen t 
procedures men tioned 
above 
and 
to 
report on 
the action  
taken 
in 
its annual 
activity report for 2008;
Progress towards ensu ring 
compliance with the fee regu lation
12. Notes 
that the E CA, 
in 
its 2006 an nual 
report, foun d 
that the Ag ency’s 
practice was in  
breach 
of its fee 
regulation 
for the followin g 
reasons: 
the Agency’s 
customers were b illed 
an 
amount 
which was divided 
into 
two parts, the Ag ency’s 
costs and 
an 
amount 
which was repaid to the Member States’ rapporteurs to 
cover their own  
costs; and 
the Memb er 
States’ rapporteurs however n ever 
provided full eviden ce 
of their 
actual costs;
13. Notes that the E CA, 
in 
its 2007 an nual 
report, followed up on  
these findi
ngs, 
stating 
that the Ag ency’s 
Management 
Board set up a costin g 
group 
which made a proposal for an  
alterna
tive option  
for remu­
nerating 
the rapporteurs at the en d 
of 2007;
14. Insists, 
in 
accordance 
with the E CA’s 
recommen dation, 
that the Ag ency 
make 
further prog ress 
to resolve 
this issue an d 
report on 
the follow-up action  
taken 
in 
its annual 
activity report for 2008;
15. Refers for other ob servations 
accompan ying 
its Decision  
on 
discharge 
which are of a horizon tal 
nature 
to 
its Resolution  
of 23 April 2009 on  
financial 
management 
and 
control 
of EU 
agencies
(1) See page 206 of this Official Journ al. (1).N E 0 2 1 / 5 5 2 L