# C_2019162EN.01014801.xml

| 10.5.2019 | EN | Official Journal of the European Union | C 162/148 |
| --- | --- | --- | --- |

10.5.2019

EN

Official Journal of the European Union

C 162/148

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P8_TA(2018)0086

Location of the seat of the European Medicines Agency ***I

Amendments adopted by the European Parliament on 15 March 2018 on the 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 EuropeanMedicines Agency (COM(2017)0735 – C8-0421/2017 – 2017/0328(COD)) (1)

(Ordinary legislative procedure: first reading)

(2019/C 162/28)

Amendment 1

Proposal for a regulation

Recital 2

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (2) | Having regard to Article 50(3) of the Treaty on European Union, the European Medicines Agency should take its new seat
  as from the date on which the Treaties cease to apply to the United Kingdom or
  from 30 March 2019,
  whichever is the earlier
  . |

Text proposed by the Commission

Amendment

(2)

Having regard to Article 50(3) of the Treaty on European Union, the European Medicines Agency should take its new seat
  as from the date on which the Treaties cease to apply to the United Kingdom or
  from 30 March 2019,
  whichever is the earlier
  .

| (2) | Having regard to Article 50(3) of the Treaty on European Union, the European Medicines Agency (“the Agency”) should take its new seat from 30 March 2019. |
| --- | --- |

(2)

Having regard to Article 50(3) of the Treaty on European Union, the European Medicines Agency (“the Agency”) should take its new seat from 30 March 2019.

Amendment 2

Proposal for a regulation

Recital 3

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (3) | To ensure the proper functioning of the
  European Medicines
  Agency in its new location, a headquarters agreement should be concluded
  before
  the
  European Medicines
  Agency
  takes up its new seat
  . |

Text proposed by the Commission

Amendment

(3)

To ensure the proper functioning of the
  European Medicines
  Agency in its new location, a headquarters agreement should be concluded
  before
  the
  European Medicines
  Agency
  takes up its new seat
  .

| (3) | To ensure the proper functioning of the Agency in its new location, a headquarters agreement should be concluded
  as soon as possible. The headquarters agreement should include the most appropriate terms and conditions for the successful relocation of
  the Agency
  and its staff members to Amsterdam
  . |
| --- | --- |

(3)

To ensure the proper functioning of the Agency in its new location, a headquarters agreement should be concluded
  as soon as possible. The headquarters agreement should include the most appropriate terms and conditions for the successful relocation of
  the Agency
  and its staff members to Amsterdam
  .

Amendment 3

Proposal for a regulation

Recital 3 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (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. |

Text proposed by the Commission

Amendment

(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.

Amendment 4

Proposal for a regulation

Recital 3 b (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (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 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. |

Text proposed by the Commission

Amendment

(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 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.

Amendment 5

Proposal for a regulation

Article 1 – paragraph 1 – introductory part

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| In Regulation (EC) No 726/2004, the following Article 71a
  is
  inserted: | | In Regulation (EC) No 726/2004, the following Article 71a
  and Article 71b are
  inserted: |

Text proposed by the Commission

Amendment

In Regulation (EC) No 726/2004, the following Article 71a
  is
  inserted:

In Regulation (EC) No 726/2004, the following Article 71a
  and Article 71b are
  inserted:

Amendment 6

Proposal for a regulation

Article 1 – paragraph 1

Regulation (EC) No 726/2004

Article 71a

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| Article 71a
  The Agency shall have its seat in Amsterdam, the Netherlands. | | Article 71a
  The Agency shall have its seat in Amsterdam, the Netherlands.


  The Commission and the competent authorities of the Netherlands shall take all necessary measures to ensure that the Agency can move to its temporary location no later than 1 January 2019 and that it can move to its permanent location no 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. |

Text proposed by the Commission

Amendment

Article 71a

The Agency shall have its seat in Amsterdam, the Netherlands.

Article 71a

The Agency shall have its seat in Amsterdam, the Netherlands.

The Commission and the competent authorities of the Netherlands shall take all necessary measures to ensure that the Agency can move to its temporary location no later than 1 January 2019 and that it can move to its permanent location no 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.

Amendment 7

Amendment 7

Proposal for a regulation

Proposal for a regulation

Article 1 – paragraph 1

Article 1 – paragraph 1

Regulation (EC) No 726/2004

Article 71 b (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | Article 71b


  A headquarters agreement allowing the Agency to take up its duties at the premises approved by the European Parliament and the Council shall be concluded within three months from ... [date of entry into force of this Regulation]. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

Article 71b

A headquarters agreement allowing the Agency to take up its duties at the premises approved by the European Parliament and the Council shall be concluded within three months from ... [date of entry into force of this Regulation].

Amendment 8

Amendment 8

Proposal for a regulation

Proposal for a regulation

Article 2 – paragraph 2

Article 2 – paragraph 2

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| This Regulation shall apply from
  the date on which the Treaties cease to apply to the United Kingdom or from
  30 March 2019,
  whichever is the earlier
  . | | This Regulation shall apply from 30 March 2019. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

This Regulation shall apply from
  the date on which the Treaties cease to apply to the United Kingdom or from
  30 March 2019,
  whichever is the earlier
  .

the date on which the Treaties cease to apply to the United Kingdom or from

whichever is the earlier

This Regulation shall apply from 30 March 2019.

Amendment 15

Amendment 15

Proposal for a regulation

Proposal for a regulation

Statement (new)

Statement (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | ‘
  ATTACHMENT TO REGULATION 2018/...




  STATEMENT OF THE EUROPEAN PARLIAMENT




  The European Parliament regrets that its role of co-legislator has not been duly taken into account since 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 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 Inter-institutional Agreement of 13 April 2016 on Better Law-Making

   (2)

  the three institutions committed to sincere and transparent cooperation while recalling the equality of both co-legislators as enshrined in the Treaties. |
| | |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

‘
  ATTACHMENT TO REGULATION 2018/...

STATEMENT OF THE EUROPEAN PARLIAMENT

The European Parliament regrets that its role of co-legislator has not been duly taken into account since 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 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 Inter-institutional Agreement of 13 April 2016 on Better Law-Making

   (2)

  the three institutions committed to sincere and transparent cooperation while recalling the equality of both co-legislators as enshrined in the Treaties.

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(1)  The matter was referred back for interinstitutional negotiations to the committee responsible pursuant to Rule 59(4), fourth subparagraph (A8-0063/2018).

1

(2)  

  OJ L 123, 12.5.2016, p. 1.
  ’

2

OJ L 123, 12.5.2016, p. 1.

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