2017/0328(COD) | [ParlTrack]

Nicola CAPUTO, Simona BONAFÈ

Draft legislative resolution
Paragraph 2

2. Regrets that the European Parliament - and ultimately the representatives of the Union’s citizens - were not fully involved in the procedure to select the new seat of the European Medicines Agency (EMA), which was eventually concluded by drawing lots, despite it being such an important decision, a method that disregards democratic rules and is ill-advised, given the respective qualities of each application; decisions in relation to the location of bodies and agencies need, and legally should, be taken under the ordinary legislative procedure, fully respecting the European Parliament's prerogatives, whereby the European Parliament and the Council are equal co- legislators;

Amendment 12 #

Catherine BEARDER

Draft legislative resolution
Paragraph 2 a (new)

2 a. Notes that while expertise will be developed over time, the loss of the UK’s national competent authority, the Medicines and Healthcare products Regulatory Agency (MHRA), to the joint pool of expertise available under the EMA could be detrimental to the scientific approval of medicines for the EU market in the interim. In 2016, the MHRA led 20 per cent of scientific evaluations of new medicines for the EMA.1b _________________ 1bhttp://www.nhsconfed.org/regions-and- eu/nhs-european-office/brexit/brexit- health-alliance/access-to-medicines-and- medical-technologies

Amendment 13 #

Draft legislative resolution
Paragraph 2 a (new)

2a. Regrets that the procedure for the selection of the new EMA headquarters was concluded by drawing lots, despite the importance of this decision; considers that a decision of such vital importance for Europe cannot be left to chance and that the European Parliament, as co- legislator, must be involved in the selection of the new EMA headquarters;

Amendment 14 #

Miroslav MIKOLÁŠIK, József NAGY, Biljana BORZAN, Kateřina KONEČNÁ, Daciana Octavia SÂRBU, Andrzej GRZYB

Draft legislative resolution
Paragraph 2 a (new)

2a. Welcomes the fact that the new location of the EMA is in line with the preferences of its current staff members,1a thereby minimising the loss to the agency of valuable experience, knowledge and expertise;

Amendment 15 #

Draft legislative resolution
Paragraph 2 a (new)

2 a. Regrets the decision of the Council which leads to a deepening of the geographical disproportionality with only 9 out of 37 EU decentralised agencies being located in new Member States contrary to the European Council Conclusions 5381/04 and 11018/1/08 which both give priority to new Member States.

Amendment 16 #

Nicola CAPUTO, Simona BONAFÈ

Draft legislative resolution
Paragraph 2 b (new)

2b. Considers that the details of the two-stage transfer process, entailing operational restrictions during the transition period, were unclear and lacking transparency and that such obfuscation adversely affected the position of the other Member States during consideration of their applications and the procedure for selecting the new EMA headquarters;

Amendment 17 #

Catherine BEARDER

Draft legislative resolution
Paragraph 2 b (new)

2 b. Regrets that the relocation of the EMA to Amsterdam has meant that the agency has had to temporarily de- prioritise certain activities, such as its work on paediatric medicines and public health issues. This includes its work on anti-microbial resistance and flu pandemics.1a _________________ 1a http://www.ema.europa.eu/docs/en_GB/do cument_library/Other/2017/10/WC500236 755.pdf

Amendment 18 #

Luke Ming FLANAGAN

Draft legislative resolution
Paragraph 3

3. ~~Calls on the budgetary authorities and the Commission to ensure that the costs relating to the change in the seat of EMA will be~~Regardless of the negotiating directives of the Council of 22 May 2017 for the negotiation of an agreement with the United Kingdom setting out the arrangements for its withdrawal from the European Union, which states the the United Kingdom should fully cover the specific costs related to the withdrawal process; given that the United Kingdom withdrawal is partially the result of the European Union's own refusal to listen to reasoned and reasonable argument against the direction in which it is headed, towards a full federal USA-style union, arguments now likewise being heard from various other Member States across the European Union, and likewise being ignored, and in line with the Joint report on the Brexit withdrawal negotiation approved on December 08th, where paragraph 86 reads as fuoll~~y covered by the current host country;~~ows: “The Commission welcomes the United Kingdom Government's offer to discuss with Union Agencies located in London how they might facilitate their relocation, in particular as regards reducing the withdrawal costs”, the cost of this relocation should be shared between the United Kingdom and the European Union, proportionate to Gross National Product.

Amendment 19 #

Biljana BORZAN

Draft legislative resolution
Paragraph 3

3. Calls on the budgetary authorities and the Commission to ensure that the costs relating to the change in the seat of EMA will be fully covered by the current host country; points out that some of the costs of the relocation from the current location may have to be pre-financed by the EU budget, prior to the financial settlement with the current host country;

Amendment 2 #

Piernicola PEDICINI, Eleonora EVI, Marco VALLI

Draft legislative resolution
Citation 5 a (new)

- whereas decisions regarding the establishment of decentralised EU agencies cannot taken on a random basis but only and exclusively by a democratic process based on measurable criteria of merit;

Amendment 20 #

Matteo SALVINI, Angelo CIOCCA, Mara BIZZOTTO, Mario BORGHEZIO, Lorenzo FONTANA

Draft legislative resolution
Paragraph 3

3. Calls on the budgetary authorities and the Commission to ensure that the costs relating to the change in the seat of EMA will be fully covered by the ~~current host country~~general budget of the Union;

Amendment 21 #

Draft legislative resolution
Paragraph 3

3. Calls on the budgetary authorities and the Commission to ensure that the costs relating to the change in the seat of EMA will be fully covered by the ~~current host country~~Union budget;

Amendment 22 #

Draft legislative resolution
Paragraph 3

3. ~~Calls on~~Urges the budgetary authorities and the Commission to ensure that the costs relating to the change in the seat of EMA will be fully covered by the current host country;

Amendment 23 #

Draft legislative resolution
Paragraph 3

3. Calls on the budgetary authorities and the Commission to ensure that the costs relating to the change in the seat of the EMA will be fully covered by the current host country;

Amendment 24 #

Draft legislative resolution
Paragraph 3 a (new)

3 a. Calls upon the UK Government to work with both the Commission and the EMA to ensure all measures are taken to make the transition as smooth as possible; further calls upon them to ensure adequate support is in place for EMA staff throughout the relocation;

Amendment 25 #

Draft legislative resolution
Paragraph 4

4. Calls on the budgetary authorities and the Commission to ensure that ~~the additional~~any unexpected costs relating to the ~~double~~ transfer of the seat of EMA~~, first to a temporary location, and then to the Vivaldi Building, will be fully covered by the Dutch government and thus~~ will not adversely affect the general budget of the Union;

Amendment 26 #

Matteo SALVINI, Angelo CIOCCA, Mara BIZZOTTO, Mario BORGHEZIO, Lorenzo FONTANA

Draft legislative resolution
Paragraph 4

4. Calls on the budgetary authorities and the Commission to ensure that ~~the~~any unexpected additional costs relating to the ~~double~~ transfer of the seat of EMA~~, first to a temporary location, and then to the Vivaldi Building, will be fully covered by the Dutch government and thus~~ will not adversely affect the general budget of the Union;

Amendment 27 #

Draft legislative resolution
Paragraph 4

4. ~~Calls on~~Urges the budgetary authorities and the Commission to ensure that the additional costs relating to the double transfer of the seat of EMA, first to a temporary location, and then to the Vivaldi Building, will be fully covered by the Dutch government and thus will not adversely affect the general budget of the Union, which is already high, and the contributions to which weigh heavily on Member States' finances, particularly those of the net contributors;

Amendment 28 #

Frédérique RIES

Draft legislative resolution
Paragraph 4 a (new)

4a. Is alarmed by the serious delays that the Dutch Government has already announced, which have pushed back the handover of the Vivaldi building, construction work on which has not yet started, by more than seven months; is concerned about the consequences that the delays will have for the EMA's work, and the resulting need to prioritise some activities over others and repeated changes to its moving schedule to take account of the delays;

Amendment 29 #

Nicola CAPUTO, Simona BONAFÈ

Draft legislative resolution
Paragraph 4 a (new)

4a. Welcomes the saving to the general budget of the Union resulting from the undertaking by the Dutch Government to shoulder, from January 2018, the additional costs relating to the double transfer of the seat of EMA, first to a temporary location in the Spark Building and then to the Vivaldi Building in Amsterdam;

Amendment 3 #

Elisabetta GARDINI

Draft legislative resolution
Paragraph 1

1. ~~Adopts its position at first reading, taking over~~Rejects the Commission proposal;

Amendment 30 #

Draft legislative resolution
Paragraph 4 a (new)

4a. Considers that the two-stage transfer procedure will prolong the period during which the EMA will be unable to operate to capacity; urges, therefore, that the decision regarding the location of the EMA be reconsidered in the light of the delays occurring in Amsterdam, which are undermining the right to health of our citizens, infringing the principle of continuity and incurring additional costs for the European budget;

Amendment 31 #

Draft legislative resolution
Paragraph 5

5. ~~Calls on~~Urges the budgetary authorities and the Commission to ensure that the double transfer will not jeopardise the normal operational needs of EMA, and will guarantee business continuity and EMA’s smooth functioning, without disruption, beyond March 2019;

Amendment 32 #

Draft legislative resolution
Paragraph 5

5. Calls on the budgetary authorities and the Commission to ensure that the ~~double~~ transfer will not jeopardise the normal operational needs of EMA, and will guarantee business continuity and EMA’s smooth functioning, without disruption, beyond March 2019; calls on the Member States to anticipate disruption to pharmacovigilance operations and to take the requisite measures to cope with the disruption at their national health agencies;

Amendment 33 #

Matteo SALVINI, Angelo CIOCCA, Mara BIZZOTTO, Mario BORGHEZIO, Lorenzo FONTANA

Draft legislative resolution
Paragraph 5

Amendment 34 #

Draft legislative resolution
Paragraph 5

5. Calls on the budgetary authorities and the Commission to ensure that the double transfer will not jeopardise the normal operational needs of EMA, and will guarantee business continuity and EMA’s smooth functioning, without disruption, beyond March 2019, including the current work being undertaken to set up the European Portal and Database for Clinical Trials, as required under the Clinical Trials Regulation EU No 536/2014;

Amendment 35 #

Draft legislative resolution
Paragraph 5 a (new)

5a. Welcomes the spirit of close cooperation shown by the Dutch Government in responding to the requests of the EEA administration to make the Vivaldi Building available by mid- November 2019 and the fact that EMA meetings can be organised centrally in a provisional location between April and November 2019, as well as the efforts being made by the Dutch authorities to ensure that the double transfer will not jeopardise the operational effectiveness, continuity and uninterrupted functioning of the EMA;

Amendment 36 #

Luke Ming FLANAGAN

Draft legislative resolution
Paragraph 5 a (new)

5 a. 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; the building contract should include an 'end of lease' clause which stipulates that should the Member State leave the European Union, the contract is automatically terminated on the exit date; this should become standard practice for all such building leases henceforth, and should also be negotiated into all existing building leases;

Amendment 37 #

Simona BONAFÈ, Patrizia TOIA

Draft legislative resolution
Paragraph 5 a (new)

5 a. Calls on the budgetary authorities and the Commission to publish regular reports pertaining to the financial burden incurred as a result of the relocation;

Amendment 38 #

Kateřina KONEČNÁ

Draft legislative resolution
Paragraph 6 a (new)

6a. Calls on the Commission to use the changing of the Agency's seat to review its mandate, tasks and the powers conferred to it, and to immediately begin a dialogue with Parliament on this issue;

Amendment 39 #

Matteo SALVINI, Angelo CIOCCA, Mara BIZZOTTO, Mario BORGHEZIO, Lorenzo FONTANA

Proposal for a regulation
Recital 1

(1) In the context of the United Kingdom's notification on 29 March 2017 of its intention to leave the Union, pursuant to Article 50 of the Treaty on European Union, the other 27 Member States, meeting on 20 November 2017 in the margins of the General Affairs Council (‘Article 50’), selected Amsterdam, the Netherlands, as the new seat of the European Medicines Agency. However, the Executive Director was subsequently forced to acknowledge1a that the Amsterdam headquarters would not enable the Agency to become fully operational on schedule. The new seat should therefore be located in Milan (Italy), which was initially unsuccessful purely as a result of a random draw but fully satisfies all the logistic requirements

Amendment 4 #

Draft legislative resolution
Paragraph 1

1. ~~Adopts its position at first reading, taking over~~Rejects the Commission proposal;

Amendment 40 #

Elisabetta GARDINI

Proposal for a regulation
Recital 1

(1) In the context of the United Kingdom's notification on 29 March 2017 of its intention to leave the Union, pursuant to Article 50 of the Treaty on European Union, the other 27 Member States, meeting in the margins of the General Affairs Council (‘Article 50’), selected Amsterdam, the Netherlands, as the new seat of the European Medicines Agency. However, it now emerges that the Amsterdam headquarters will not be ready when the transfer is due to take place and that the provisional location falls short of requirements in terms of space available and the sound administration of public funds; this could detract from the efficiency of the Agency, causing delays in the registration of innovative medicines and advanced life-saving treatments, resulting in enormous harm to European citizens.

Amendment 41 #

Patrizia TOIA, Simona BONAFÈ, Damiano ZOFFOLI, Renata BRIANO, Nicola CAPUTO, Elena GENTILE, Caterina CHINNICI

Proposal for a regulation
Recital 1 a (new)

(1a) However, that decision must take into account the need to find a suitable headquarters by March 2019, and no suitable premises are yet available. Furthermore, the building chosen must be immediately fit for purpose to avoid inconvenience, additional costs and repercussions regarding citizens' right to health;

Amendment 42 #

Giovanni LA VIA, Biljana BORZAN

Proposal for a regulation
Recital 2

(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~~from 30 March 2019.

Amendment 43 #

Biljana BORZAN

Proposal for a regulation
Recital 3

(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~~as soon as possible. The headquarters agreement should include the most appropriate terms and conditions for the successful relocation of the European Medicines Agency and its staff members to Amsterdam.

Amendment 44 #

Proposal for a regulation
Article 1 – paragraph 1

Regulation (EC) No 726/2004
Article 71a

The seat of the Agency shall ~~have its seat in Amsterdam, the Netherlands.~~ be located in a city of a European Union Member State on the basis of absolute assurance that: - it meets, without any exception or limitation, as from January 2019, all requirements, conditions and criteria necessary to ensure that the Agency can function effectively; - it ensures the full and immediate operational continuity of the Agency’s activities, which are highly important to society and of great scientific value. The Agency's remit shall relate to what is recognised as a fundamental right of European citizens to health protection. Its headquarters shall be selected under the ordinary legislative procedure pursuant to Articles 114 and 168(4)(b) TFEU.

Amendment 45 #

Elisabetta GARDINI, Massimiliano SALINI, Stefano MAULLU, Lara COMI, Alberto CIRIO, Aldo PATRICIELLO, Fulvio MARTUSCIELLO, Barbara MATERA, Salvatore Domenico POGLIESE, Salvatore CICU, Alessandra MUSSOLINI, Lorenzo CESA, Herbert DORFMANN

Proposal for a regulation
Article 1 – paragraph 1

Regulation (EC) No 726/2004
Article 71a

The Agency shall have its seat in ~~Amsterdam, the Netherlands.~~ a city of the European Union that meets the following criteria: 1. the assurance that, at the time when the United Kingdom leaves the EU, the agency will remain operational in a suitable location, ensuring that its activities are not disrupted; 2. accessibility of the location; 3. schools for the children of the agency staff; 4. access to the labour market and health care for employees' spouses and children; 5. the assurance of operational continuity, given the need to protect the health and safety of EU citizens; Its headquarters shall be selected under the ordinary legislative procedure pursuant to Articles 114 and 168(4)(b) TFEU.

Amendment 46 #

Proposal for a regulation
Article 1 – paragraph 1

Regulation (EC) No 726/2004
Article 71a

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

Amendment 47 #

Elisabetta GARDINI, Alessandra MUSSOLINI, Alberto CIRIO, Stefano MAULLU, Lara COMI, Aldo PATRICIELLO, Barbara MATERA, Salvatore Domenico POGLIESE, Salvatore CICU, Massimiliano SALINI, Lorenzo CESA, Herbert DORFMANN, Fulvio MARTUSCIELLO

Proposal for a regulation
Article 1 – paragraph 1

Regulation (EC) No 726/2004
Article 71a

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

Amendment 48 #

Matteo SALVINI, Angelo CIOCCA, Mara BIZZOTTO, Mario BORGHEZIO, Lorenzo FONTANA

Proposal for a regulation
Article 1 – paragraph 1

Regulation (EC) No 726/2004
Article 71a

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

Amendment 49 #

Biljana BORZAN

Proposal for a regulation
Article 1 – paragraph 1 – introductory part

In Regulation (EC) No 726/2004, the following Article 71a ~~is inserted:~~and Article 71b are inserted: "Article 71b A headquarters agreement allowing the Agency to take up its duties at the premises approved by the European Parliament and the Council must be concluded within 3 months from the date this Regulation enters into force."

Amendment 5 #

Piernicola PEDICINI, Eleonora EVI, Marco VALLI

Draft legislative resolution
Paragraph 1

1. Adopts its position at first reading, ~~taking over~~amending the Commission proposal, which makes choices of decisive importance for the health of European citizens on the basis of nothing more than random criteria that are equivalent to the toss of a coin;

Amendment 50 #

Piernicola PEDICINI, Eleonora EVI, Marco VALLI

Proposal for a regulation
Article 2 – paragraph 2

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~~30 March 2019.

Amendment 51 #

Giovanni LA VIA, Biljana BORZAN

Proposal for a regulation
Article 2 – paragraph 2

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~~30 March 2019.

Amendment 6 #

Draft legislative resolution
Paragraph 1 a (new)

1a. Reiterates that this Regulation will apply from the date on which the Treaties cease to apply to the United Kingdom or from 30 March 2019, whichever is the earlier.

Amendment 7 #

Draft legislative resolution
Paragraph 2

2. Regrets that the European Parliament - and ultimately the representatives of the Union’s citizens - were not fully involved in the procedure to select the new seat of the European Medicines Agency (EMA), which was eventually concluded by drawing lots, despite it being such an important decision; decisions in relation to the location of bodies and agencies need, and legally should, be taken under the ordinary legislative procedure, fully respecting the European Parliament's prerogatives, whereby the European Parliament and the Council are equal co- legislators;deleted

Amendment 8 #

Frédérique RIES

Draft legislative resolution
Paragraph 2

2. Regrets that the European Parliament - and ultimately the representatives of the Union’s citizens - were not fully involved in the procedure to select the new seat of the European Medicines Agency (EMA), which was eventually concluded by drawing lots, despite it being such an important decision; decisions in relation to the location of bodies and agencies need, and legally ~~should~~must, be taken under the ordinary legislative procedure, fully respecting the European Parliament's prerogatives, whereby the European Parliament and the Council are equal co-legislators;

Amendment 9 #