Dies ist eine HTML Version eines Anhanges der Informationsfreiheitsanfrage 'EMA & EBA relocation trilogues'.


 
European Parliament 
2014-2019 
 
2017/0328(COD) 
25.4.2018 
COLUMN TABLE FOR 
INTERINSTITUTIONAL 
NEGOTIATIONS 

Proposal for a regulation of the European Parliament and of the Council 
amending Regulation (EC) No 726/2004 as regards the location of the seat of 
the European Medicines Agency 
(COM(201)0735 – C8-0421/2017 – 2017/0328(COD)) 
Date of the trilogue: 25.4.2018 
Committee on the Environment, Public Health and Food Safety – 
Negotiating team 

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COMMISSION PROPOSAL 
EP AMENDMENTS 
COUNCIL  
COMMENTS / SUGGESTIONS 
COM(2017)0735 
(as adopted 15 March 2018) 
RECITALS 
 
AM 1 
Could accept the Commission 
 
(2)  Having regard to Article 50(3)   (2)  Having regard to Article 
proposal as is.  
of the Treaty on European Union, 
50(3) of the Treaty on European 
the European Medicines Agency 
Union, the European Medicines 
should take its new seat as from 
Agency (“the Agency”) should 
the date on which the Treaties 
take its new seat from 30 March 
cease to apply to the United 
2019. 
Kingdom or from 30 March 2019
whichever is the earlier

 
AM 2 
Could accept the Commission 
 
(3)  To 
ensure 
the 
proper  (3)  To ensure the proper 
proposal as is. 
functioning  of  the  European  functioning of the Agency in its 
Medicines  Agency  in  its  new  new location, a headquarters 
location, a headquarters agreement  agreement should be concluded as 
should  be  concluded  before  the  soon as possible. The 
European 

Medicines 
Agency  headquarters agreement should 
takes up its new seat
include the most appropriate 
terms and conditions for the 
successful relocation of
 the 
Agency and its staff members to 
Amsterdam

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AM 3 
 
 
 
(3a)  In order to ensure the 
Agency’s full business continuity, 
the temporary location in 
Amsterdam should be provided as 
of 1 January 2019 and the 
permanent headquarters of the 
Agency should be completed by 
15 November 2019.  
AM 4 
 
 
 
(3b)  It is to be welcomed that the 
new location of the Agency is in 
line with the preferences of its 
current staff members and that 
the Dutch authorities are making 
efforts to ensure that the double 
transfer will not jeopardise the 
operational effectiveness, 
continuity and uninterrupted 
functioning of the Agency. 
However, the double relocation of 
the Agency to Amsterdam means 
that the Agency will have to 
temporarily de-prioritise certain 
activities, such as its work on 
paediatric medicines and public 
health issues including its work 
on anti-microbial resistance and 
flu pandemics, while it resides in 
the temporary location. The 

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delays that the Dutch government 
has already announced, which 
have pushed back the handover of 
the permanent building, on which 
construction work has not yet 
started, raise concerns about 
potential further delays. The 
relocation to the temporary 
building should be limited to 10,5 
months to ensure that the Agency 
will be able to operate again at its 
full capacity as of 16 November 
2019 and avoid further loss of 
expertise. 

Article 1 – paragraph 1 – introductory part 
 
AM 5 
Could accept the Commission 
 
In Regulation (EC) No 726/2004, 
In Regulation (EC) No 726/2004, 
proposal as is. 
the following Article 71a is 
the following Article 71a and 
inserted: 
Article 71b are inserted:  
Article 1 – paragraph 1 
Regulation (EC) No 726/2004 – Article 71a 
 
AM 6 
Could accept the Commission 
 
Article 71a 
Article 71a 
proposal as is. 
The Agency shall have its seat in 
The Agency shall have its seat in 
Amsterdam, the Netherlands. 
Preliminary comments on the 
Amsterdam, the Netherlands. 
amendment: 
The Commission and the 
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competent authorities of the 
The provisions put forward by the 
Netherlands shall take all 
amendment are of a temporary effect 
necessary measures to ensure that  which will expire with the completion 
the Agency can move to its 
of the relocation process. No issue of 
temporary location no later than 
substance but the amendment should 
1 January 2019 and that it can 
be made to the amending regulation, 
move to its permanent location no  not to the amended one (726/2004). 
later than 16 November 2019. 
The Commission and the 
 
competent authorities of the 
Netherlands shall submit a 
written report to the European 
Parliament and the Council on 
the progress on the adjustments 
of the temporary premises and on 
the construction of the permanent 
building three months after the 
entry into force of this 
Regulation, and every three 
months thereafter, until the 
Agency has moved into its 
permanent headquarters.
  
Article 1 – paragraph 1 
Regulation (EC) No 726/2004 - Article 71b (new) 
 
AM 7 
Preliminary comments on the 
 
Article 71b 
amendment:  
A headquarters agreement 
While it is useful to set a deadline for 
allowing the Agency to take up its  the signature of the headquarter 
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duties at the premises approved by  agreement as indeed noted in recital 3 
the European Parliament and the 
of the Commission proposal, neither 
Council shall be concluded within  this agreement nor the premises 
three months from ... [date of 
(building) of EMA can be subject to 
entry into force of this 
the approval of the Council or the 
Regulation].  
Parliament. Clarification of the 
drafting and intention of the 
amendment is therefore needed. 
Article 2 – paragraph 2 
 
AM 8 
Could accept the Commission 
 
This  Regulation  shall  apply  from  This Regulation shall apply from 
proposal as is 
the  date  on  which  the  Treaties  30 March 2019. 
cease  to  apply  to  the  United 
Kingdom or from
 30 March 2019
whichever is the earlier

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Proposal for a regulation 
Statement (new) 
 
AM 15 
Council's preliminary comments: 
  
‘ATTACHMENT TO 
This is a unilateral statement which 
should therefore not be published 
REGULATION 2018/... 
as an integral part to the legislative 
STATEMENT OF THE 
act.  Besides, the statement refers to 
EUROPEAN PARLIAMENT 
procedures that concern future 
The European Parliament regrets 
selection processes, which are out 
that its role of co-legislator has not  of the scope of the current 
been duly taken into account since  Regulation. 
it was not involved in the 
procedure leading to the selection 
of the new seat of the European 
Medicines Agency. 

The European Parliament wishes 
to recall its prerogatives as co-
legislator and insists on the full 
respect of the ordinary legislative 
procedure in relation to the 
location of bodies and agencies. 

As the only directly elected Union 
institution and representative of 
the Union’s citizens, it is the first 
guarantor of the respect of the 
democratic principle in the Union. 

The European Parliament 
condemns the procedure followed 
for the selection of the new 

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location of the seat, which has de 
facto deprived the European 
Parliament of its prerogatives 
since it was not effectively involved 
in the process, but is now expected 
to simply confirm the selection 
made for the new location of the 
seat by means of the ordinary 
legislative procedure. 

The European Parliament recalls 
that the Common Approach 
annexed to the Joint Statement of 
the European Parliament, Council 
and European Commission on 
decentralised agencies signed in 
2012 is legally non-binding, as 
acknowledged in the Statement 
itself and that it was agreed 
without prejudice to the legislative 
powers of the institutions. 

Therefore, the European 
Parliament insists that the 
procedure followed for the 
selection of a new location for the 
agencies will be revised and not 
used anymore in this form in the 
future. 

Finally, the European Parliament 
wishes to recall as well that in the 

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Inter-institutional Agreement of 
13 April 2016 on Better Law-
Making 1 the three institutions 
committed to sincere and 
transparent cooperation while 
recalling the equality of both co-
legislators as enshrined in the 
Treaties. 

__________________ 
1  OJ L 123, 12.5.2016, p. 1.’ 
 
 
                                                 
 
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