Activities of Alda SOUSA
Plenary speeches (103)
Pakistan: recent cases of persecution
Syria: situation of certain vulnerable communities
Alarming shortage of payments for financing EU external aid (debate)
One-minute speeches (Rule 150)
Clinical trials on medicinal products for human use (debate)
General guidelines for the 2015 budget - Section III (debate)
Remuneration and pensions of the officials and other servants of the European Union (adjustment as of 1 July 2011) (A7-0165/2014 - Dagmar Roth-Behrendt)
Remuneration and pensions of the officials and other servants of the European Union (adjustment as of 1 July 2012) (A7-0164/2014 - Dagmar Roth-Behrendt)
Production and making available on the market of plant reproductive material (plant reproductive material law) (debate)
Situation in Iraq (debate)
Third programme for the Union's action if the field of health (2014-2020) (debate)
Undocumented women migrants in the European Union (A7-0001/2014 - Norica Nicolai)
Homophobia and discrimination on grounds of sexual orientation and gender identity (A7-0009/2014 - Ulrike Lunacek)
One-minute speeches (Rule 150)
EU citizenship for sale (RCB7-0015/2014, B7-0015/2014, B7-0017/2014, B7-0028/2014, B7-0029/2014, B7-0030/2014, B7-0031/2014)
Recent elections in Bangladesh
Recent moves to criminalise LGBTI people
Civil protection mechanism (debate)
Sexual and reproductive health and rights (A7-0426/2013 - Edite Estrela)
European Globalisation Adjustment Fund 2014-2020 (debate)
Common provisions on European funds (A7-0274/2013 - Lambert van Nistelrooij, Constanze Angela Krehl)
2014 budgetary procedure: joint text (debate)
Multiannual financial framework 2014-2020 (A7-0389/2013 - Jean-Luc Dehaene, Ivailo Kalfin)
European Globalisation Adjustment Fund (application EGF/2013/004 ES/Comunidad Valenciana building materials from Spain) (A7-0341/2013 - Andrej Plenković)
Erasmus for all programme (A7-0405/2012 - Doris Pack)
One-minute speeches (Rule 150)
Migratory flows in the Mediterranean, with particular attention to the tragic events off Lampedusa (RCB7-0474/2013, B7-0474/2013, B7-0475/2013, B7-0476/2013, B7-0477/2013, B7-0478/2013, B7-0479/2013, B7-0480/2013)
Suspension of the SWIFT agreement as a result of NSA surveillance (B7-0467/2013, RCB7-0468/2013, B7-0468/2013, B7-0471/2013, B7-0472/2013, B7-0481/2013)
Draft amending budget No 6/2013 (A7-0347/2013 - Giovanni La Via)
Migracijski tokovi u Sredozemlju, s posebnim naglaskom na tragične događaje nedaleko od Lampeduse (RCB7-0474/2013, B7-0474/2013, B7-0475/2013, B7-0476/2013, B7-0477/2013, B7-0478/2013, B7-0479/2013, B7-0480/2013) HR
Suspenzija sporazuma SWIFT zbog nadzora Agencije za nacionalnu sigurnost (B7-0467/2013, RCB7-0468/2013, B7-0468/2013, B7-0471/2013, B7-0472/2013, B7-0481/2013) HR
Nacrt izmjene proračuna br. 6/2013 (A7-0347/2013 - Giovanni La Via) HR
In vitro diagnostic medical devices - Medical devices (debate)
Draft general budget of the European Union for the financial year 2014 - all sections (debate)
Sexual and reproductive health and rights (A7-0306/2013 - Edite Estrela)
European Border Surveillance System (EUROSUR) (A7-0232/2013 - Jan Mulder)
Alleged transportation and illegal detention of prisoners in European countries by the CIA (B7-0378/2013, B7-0378/2013, B7-0379/2013, B7-0380/2013, B7-0381/2013)
Technical requirements and administrative procedures related to air operations (B7-0440/2013)
EU and Member State measures to tackle the flow of refugees as a result of the conflict in Syria (B7-0442/2013)
Mobilisation of the European Globalisation Adjustment Fund: application EGF/2011/025 IT/Lombardy - Italy (A7-0294/2013 - Salvador Garriga Polledo)
Manufacture, presentation and sale of tobacco and related products (A7-0276/2013 - Linda McAvan)
Maritime dimension of the common security and defence policy (A7-0220/2013 - Ana Gomes)
EU's military structures: state of play and future prospects (A7-0205/2013 - Marietta Giannakou)
EU internal security strategy (B7-0377/2013)
European cultural and creative sectors as sources of economic growth and jobs (A7-0248/2013 - Marie-Thérèse Sanchez-Schmid)
Draft amending budget No 2/2013 - Increase in forecasts concerning other revenue stemming from fines and penalties - Increase in payment appropriations (A7-0287/2013 - Giovanni La Via)
Draft amending budget No 3/2013 - Surplus resulting from the implementation of the budget year 2012 (A7-0284/2013 - Giovanni La Via)
Draft amending budget No 4/2013 - Staff of the European GNSS Agency - Staff of the Education, Audiovisual and Culture Executive Agency (EACEA) - Staff of the Court of Justice of the European Union (Rule 138) (vote) (A7-0285/2013 - Giovanni La Via, Derek Vaughan)
Draft amending budget No 5/2013 - Mobilisation of the Solidarity Fund following flooding in Slovenia, Croatia and Austria in 2012 (A7-0286/2013 - Giovanni La Via)
Draft amending budget No 2/2013 - Increase in forecasts concerning other revenue stemming from fines and penalties - Increase in payment appropriations (debate)
One-minute speeches (Rule 150)
US NSA surveillance programme, surveillance bodies in various Member States and impact on EU citizens' privacy (RCB7-0336/2013, B7-0336/2013, B7-0337/2013, B7-0338/2013, B7-0341/2013, B7-0342/2013, B7-0343/2013)
Practical arrangements for the holding of the European elections in 2014 (A7-0219/2013 - Andrew Duff)
Opening of negotiations on a plurilateral agreement on services (B7-0314/2013, B7-0317/2013)
Review of the Irish Presidency, including the MFF agreement (B7-0332/2013, RCB7-0334/2013, B7-0334/2013, B7-0335/2013, B7-0339/2013, B7-0340/2013)
Conclusions of the European Council meeting (27-28 June 2013) (debate)
Staff Regulations of officials and Conditions of employment of other servants of the EU (A7-0156/2012 - Dagmar Roth-Behrendt)
Situation in Turkey (RCB7-0305/2013, B7-0305/2013, B7-0306/2013, B7-0307/2013, B7-0308/2013, B7-0309/2013, B7-0310/2013, B7-0311/2013)
EU trade and investment agreement negotiations with the US (B7-0187/2013, B7-0195/2013)
Fight against tax fraud, tax evasion and tax havens (A7-0162/2013 - Mojca Kleva Kekuš)
Asset recovery to Arab Spring countries in transition (debate)
Adequate, safe and sustainable pensions (A7-0137/2013 - Ria Oomen-Ruijten)
One-minute speeches (Rule 150)
Impact of the financial and economic crisis on human rights (A7-0057/2013 - Inese Vaidere)
European Globalisation Adjustment Fund: application EGF/2012/023 IT/Antonio Merloni SpA (A7-0111/2013 - Frédéric Daerden)
European Globalisation Adjustment Fund: application EGF/2011/016 IT/Agile (A7-0133/2013 - Angelika Werthmann)
European Globalisation Adjustment Fund: application EGF/2011/010 AT/Austria Tabak (A7-0134/2013 - Frédéric Daerden)
Timing of auctions of greenhouse gas allowances (A7-0046/2013 - Matthias Groote)
Scheme for greenhouse gas emission allowance trading (A7-0060/2013 - Peter Liese)
Estimates of revenue and expenditure for 2014 - Section I - Parliament (debate)
Preparations for the European Council meeting (14-15 March 2013) (debate)
Online consumer dispute resolution (A7-0236/2012 - Róża Gräfin von Thun und Hohenstein)
Guidelines for the 2014 budget - Section III (debate)
Preparations for the European Council meeting (7-8 February 2013) (debate)
Preparations for the European Council meeting (7-8 February 2013) (debate)
Transparency of measures regulating the prices of medicinal products for human use (A7-0015/2013 - Antonyia Parvanova) (vote)
Guidelines for the 2014 budget - sections other than the Commission (debate)
Transparency of measures regulating the prices of medicinal products for human use (debate)
One-minute speeches (Rule 150)
Explanations of vote
Explanations of vote
Explanations of vote
Explanations of vote
Draft amending budget No 6/2012 - Revenue from own resources and other resources - Increase in payment appropriations in headings 1a, 1b, 2, 3a and 4 of the Multiannual Financial Framework - Reduction in the level of commitment appropriations entered in the budget - New general budget of the European Union for the financial year 2013 - all sections (debate)
Preparations for the European Council meeting (22-23 November 2012) with particular reference to the Multiannual Financial Framework (debate)
One-minute speeches (Rule 150)
Explanations of vote
Explanations of vote
Explanations of vote
Explanations of vote
Explanations of vote
General budget of the European Union for the financial year 2013 - all sections (debate)
One-minute speeches (Rule 150)
Outcome of the Rio+20 Summit (20-22 June 2012) (debate)
Explanations of vote
Explanations of vote
2013 budget - mandate for trialogue (debate)
Food intended for infants and young children and food for special medical purposes (debate)
Explanations of vote
Explanations of vote
Explanations of vote
Major-accident hazards involving dangerous substances (debate)
One-minute speeches (Rule 150)
Reports (2)
REPORT on the proposal for a decision of the European Parliament and of the Council on the mobilisation of the European Globalisation Adjustment Fund in accordance with point 28 of the Interinstitutional Agreement of 17 May 2006 between the European Parliament, the Council and the Commission on budgetary discipline and sound financial management (application EGF/2013/000 TA 2013 - Technical assistance at the initiative of the Commission) PDF (185 KB) DOC (100 KB)
REPORT on the proposal for a decision of the European Parliament and of the Council on mobilisation of the European Globalisation Adjustment Fund, in accordance with point 28 of the Interinstitutional Agreement of 17 May 2006 between the European Parliament, the Council and the Commission on budgetary discipline and sound financial management (application EGF/2012/006 FI/Nokia Salo from Finland) PDF (192 KB) DOC (109 KB)
Shadow reports (10)
REPORT on the Council position on Draft amending budget No 1/2014 of the European Union for the financial year 2014, Section III – Commission PDF (126 KB) DOC (56 KB)
REPORT on the proposal for a decision of the European Parliament and of the Council on the mobilisation of the European Globalisation Adjustment Fund, in accordance with point 13 of the Interinstitutional Agreement of 2 December 2013 between the European Parliament, the Council and the Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management (application EGF/2012/007 IT/VDC Technologies from Italy) PDF (186 KB) DOC (85 KB)
REPORT on the proposal for a decision of the European Parliament and of the Council on the mobilisation of the European Globalisation Adjustment Fund, in accordance with point 13 of the Interinstitutional Agreement of 2 December 2013 between the European Parliament, the Council and the Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management (application EGF/2012/004 ES/Grupo Santana from Spain) PDF (191 KB) DOC (86 KB)
REPORT on general guidelines for the preparation of the 2015 budget, Section III – Commission PDF (158 KB) DOC (73 KB)
REPORT on the Council position on the draft general budget of the European Union for the financial year 2014 PDF (562 KB) DOC (329 KB)
REPORT on the proposal for a regulation of the European Parliament and of the Council on in vitro diagnostic medical devices PDF (1 MB) DOC (1 MB)
REPORT on the proposal for a regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 PDF (1 MB) DOC (1 MB)
REPORT on the proposal for a regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC PDF (1 MB) DOC (2 MB)
REPORT on the protection of public health from endocrine disrupters PDF (191 KB) DOC (126 KB)
REPORT on the proposal for a directive of the European Parliament and of the Council relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance systems PDF (517 KB) DOC (660 KB)
Opinions (1)
OPINION on the proposal for a regulation of the European Parliament and of the Council on the European Globalisation Adjustment Fund (2014-2020)
Shadow opinions (5)
OPINION on the proposal for a regulation of the European Parliament and of the Council amending Council Regulation (EC) No 2012/2002 establishing the European Union Solidarity Fund
OPINION on EU Member States preparedness for an effective and timely start of the new Cohesion Policy Programming period
OPINION on the proposal for a regulation of the European Parliament and of the Council amending Council Regulation (EC) No 1083/2006 as regards the financial allocation for certain Member States from the European Social Fund
OPINION on the proposal for a regulation of the European Parliament and of the Council establishing Horizon 2020 - The Framework Programme for Research and Innovation (2014-2020)
OPINION on the proposal for a Council decision on establishig the Specific Programme Implementing Horizon 2020 - The Framework Programme for Research and Innovation (2014-2020)
Amendments (419)
Amendment 1 #
2013/2145(BUD)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Recalls that its priorities for the 2014 budget are economic and sustainable growth, competitiveness, the creation of employment and the fight against youth unemployment; reiterates, therefore, its support for policies contributing to the fight against youth unemployment, research, development and innovation, digital agenda, competitiveness, small and medium enterprises (SMEs),while still in the context of one of the most dramatic social, economic and financial crisis, which has had a particularly appalling impact in some EU Member States in terms of unemployment, increase of poverty, closure of essential sectors, deterioration of public services, its priorities for the 2014 budget should be an ambitious set of investments aimed at boosting economic and sustainable growth, competitiveness, the creation of employment and the fight against youth unemployment; reiterates, therefore, the need to allocate the adequate resources to the policies contributing to smart, sustainable and inclusive growth based on the five EU headline targets, namely promoting employment, in particular for the youth improving the conditions for innovation, research and development, meeting our climate change and energy objectives, promoting high education, and professional training and mobilitystandards and social policies, in particular social inclusion and poverty reduction; recalls that the Member States themselves have fully endorsed these five targets;
Amendment 4 #
2013/2145(BUD)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Recalls its determination to ensure a sufficient and realisticn adequate level of commitment and payment appropriations to allow the programmes to kick-off with sufficient funds in the multiannual financial framework (MFF) for the period 2014 - 2020 and to avoid delays in their implementation, as well as to ensure the successful conclusion of the programmes started under the 2007 - 2013 MFF;
Amendment 7 #
2013/2145(BUD)
Motion for a resolution
Paragraph 3
Paragraph 3
3. DeploreCondemns therefore the Council's decision to proceedinsist again this year with the usual approach of horizontal cuts to the draft budget (DB), aimed at artificially reducing the level of the Union's resources for 2014 by an overall total of EUR 240 million (-0,2%) in commitment appropriations (CA) and EUR 1 061 million (-0,8%) in payment appropriations (PA) as compared to the DB, thus leading to a significant decrease compared to the 2013 budget (including amending budgets No 1 to 5) both in commitments (-6%) and in payments (-6,6%);
Amendment 8 #
2013/2145(BUD)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Is surprisedDeplores that, once more the European Council has fully ignored not only the European Parliament’s but its own previous positions; underlines that, in its position, the Council has not only not taken into account the agreement on the 2014 - 2020 MFF, regarding the frontloading of the Erasmus for All, COSME and Horizon 2020 programmes but has even further decreased the appropriations for some of those programmes;
Amendment 10 #
2013/2145(BUD)
Motion for a resolution
Paragraph 5
Paragraph 5
5. NoteDeeply regrets that the Council has introducedinsists in introducing nothing but cuts in both CA and PA in all headings; noterecalls that the most affected ones are Heading 1a (-0,36% in CA and -3,6% in PA as compared to the DB), Heading 4 (- 0,21% in CA and -2,5% in PA as compared to the DB) and Heading 5 (-1,78% in CA and PA as compared to the DB); noteunderlines that significant cuts are de facto operated in Heading1b, vis-à- vis, the needs of appropriations to overcome, in 2014, the 2013 rolled-over payment claims, namely within the framework of the European Social Fund and European Cohesion Fund, this might specially affect the Member States already facing the most dramatic social, economical and financial effects of the crisis; especially recalls that these headings contain programmes and initiatives responsible for the delivery of the objectives of the Europe 2020 strategy and are priority areas for Parliament or appropriations ensuring the successful administrative and operational support for the implementation of those programmes;
Amendment 17 #
2013/2145(BUD)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Notes the declaration on payments adopted by the Council in its position on the draft budget 2014; is not convinced, however, that it could serve as a guarantee for a sufficient and adequate level of payments for all headings; welcomestakes note of the statement by some Member States that a better balance between commitments and payments should be sought in order to avoid the situation where the Union cannot meet its legal obligations;
Amendment 18 #
2013/2145(BUD)
Motion for a resolution
Paragraph 9
Paragraph 9
9. CanReiterates its position that it does not accept Council's decision to reduce CA and PA; remind, in particular while still in the context of one of the most dramatic social, economic and financial crisis; underlines that commitments reflect the Union political priorities and should be set with a long- term perspective where the economic downturn might have ended; takes the view, therefore, that in general principle, commitments should be restored at draft budget level; intends, however,priority and adequate allocation of resources should be given to policies of real convergence, social and territorial cohesion, focused on job creation, social progress, solidarity, the sustainable use of natural resources and protection of the environment; insists, therefore, that commitments should go much beyond the draft budget level, namely in Headings 1a and 1b; reiterates its position that it is clearly insufficient to increase CA appropriations slightly above the DB on a selected number of budget lines relating to the programmes of direct benefit for European citizens, and contributing to the delivery of the Europe 2020 priorities - which are crucial for the growth and competitiveness of the Union - as well as those projecting the European values and solidarity abroad;
Amendment 22 #
2013/2145(BUD)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Calls, therefore, for the mobilisation of the flexibility instrument for an amount of EUR [XXX million] in commitment appropriations to reinforce the Fund for European Aid to the Most Deprived, to the European Social Fund, to the European Cohesion Fund, to provide further support for humanitarian aid in the Middle East, namely to UNWRA, taking into account the rise in the increase of tension in the region and in order to be able to attend to all those in need, and to grant additional assistance to Cyprus from the Structural Funds, as agreed by the Heads of States and Governments at their meeting of 27-28 June 2013;
Amendment 24 #
2013/2145(BUD)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Deeply deplores the cuts in payments bproughtposed by the Council, which could result in a decrease of at least EUR 9,5 billion (9 500 million) (-6,6%) in PA as compared to the adopted budget for 2013 (including amending budgets No 1 to 5); reiteratunderlines the fact that despite the adoption of a lower MFF for 2014-2020 and the absolute need to keep honouring past commitments, the Council kepteps following blindly its past strategy to artificially cut the level of payments, without taking into consideration the real needs and relativelyfor investment, with particular emphasis on the programmes and projects aimed at boosting growth and decent employment, smart, sustainable, green development and eradicating poverty and simultaneously the Council keeps sparing expenditure under shared management to ensure Member States' apparent «return on investment»;
Amendment 29 #
2013/2145(BUD)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Stresses the fact that the Council position does not take account offully ignores the dramatic shortage of payments, notably in the field of the cohesion policy, with some estimates pointing to a likely lack of payment appropriations and, accordingly, an implementation deficit of some EUR 20 billion at the end of 2013, even with the second tranche of the draft amending budget No. 2/2013 adopted in full; recalls that the outstanding payments carried over from 2013 will have to be deducted from - and consequently reduce - the level of payment appropriations available for 2014, which has already been reduced by the 2014-2020 MFF agreement; stresses that this will put 2014 budget under tightunbearable pressure, not the least, against the background of an the unprecedented level of unpaid claims and, more generally, of the outstanding commitments (RALs);
Amendment 30 #
2013/2145(BUD)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Is astonishedReiterates its indignation to the fact that some of the cuts in payments proposed by the Council affect the Horizon 2020, COSME and the ESF programmes, in plain opposition with the previous positions of the Council itself, the spirit and the letter of the recent political agreement on the 2014-2020 MFF to frontload some appropriations in 2014 and 2015 to these programmes and with the institutions' commitment at the highest level to tackle youth unemployment; recalls, moreover, thatreiterates its position that more resources should be allocated to these programmes, underlines that the frontload will not sort out the problem in the long-run, youth unemployment will still have to be tacled and addressed after 2016; recalls, moreover, the apparent lack of logic in the Council's position: part of the Council's cuts concern lines which were reinforced in the framework of the agreement on the first tranche of draft amending budget No. 2/2013;
Amendment 32 #
2013/2145(BUD)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Strongly rejects, therefore, the Council's approach on payments and amends its position on payments as the level of appropriations proposed does noto ensure that the fall between 2013 and 2014 ceilings is not detrimental to the proper implementation and completion of 2007- 2013 MFF programmes; namely, bearing in mind that, in the Commission's proposal, 52% of payment appropriations address outstanding commitments, nor to the start of new programmes;
Amendment 33 #
2013/2145(BUD)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Takes the approachReiterates its position that to restore the draft budget in payments for most lines cut by the Council; note will not be sufficient; recalls that, despite contained reinforcements in payment appropriations on a limited number of budget items and several decreases on other budget items, the payment ceiling does not allow for an adequate financing of priorities selected by the Parliament, with particular emphasis on the programmes and projects aimed at boosting growth and decent employment, smart, sustainable, green development and eradicating; proposes accordingly, after having examined all possibilities for re- allocating payment appropriations, to mobilise the Flexibility instrument in payments for an amount of EUR 213XXX million to finance humanitarian aid, integration and cohesion policies;
Amendment 73 #
2013/2145(BUD)
Motion for a resolution
Paragraph 49 a (new)
Paragraph 49 a (new)
49a. Reiterates the need to the increase the commitment and payment appropriations for the European Refugee Fund and of the Asylum and Migration Fund with at least EUR 100 million; notes that the EU must do all to avoid the dramatic humanitarian disasters, the endless disasters such as the one we have witnessed in Lampedusa last 3 October 2013; appropriations made available for Frontex could be proportionally reduced, as it has been clearly ineffective and inadequate to deal with the situations of humanitarian emergency which have to be dealt upon daily in the European Mediterranean shores;
Amendment 74 #
2013/2145(BUD)
Motion for a resolution
Paragraph 50
Paragraph 50
50. Recalls the importance of transparency as an underlying budgetary principle; calls, therefore, for a split of the EUSR line to allow for a better overview of the allocations for the individual EUSRs; proposes to fully transfer the budget lines for EUSRs to the EEAS budget;
Amendment 78 #
2013/2145(BUD)
Motion for a resolution
Paragraph 52
Paragraph 52
52. Proposes the mobilisation of the Flexibility Instrument for EUR 50 million in order to finance the real needs for the Union's contribution to the Middle East peace process; reiterates, therefore, its support for long term programming and sufficient funding for assistance to United Nations Relief and Works Agency, Palestine and the Peace process; suggests to put the EUR 50 million of additional appropriations in reserve pending an assessment from the Commission of the sound management of the aid by the Palestinian authorities and the measures taken in the fight against corruption;
Amendment 79 #
2013/2145(BUD)
Motion for a resolution
Paragraph 52 a (new)
Paragraph 52 a (new)
52a. Deeply regrets the fact that the allocations forseen for the Aid to UNWRA, Palestine and Peace Process have seen no increase since the last 3 years, meaning that the EU assistance to this area of the Middle East has in fact been decreasing on the past few years while the humanitarian situation is growing systematically more complex and with increased needs; fully rejects the attempt to establish a reserve of EUR 50 million to the EU aid for UNWRA, Palestine and Peace Process, much more than the problems caused by the lack of means, will be the dramatical political consequences of the impact of such allegations over resources which have been administered toguether with an Agency of the United Nations, without any concrete full assessment of these allegations;
Amendment 82 #
2013/2145(BUD)
Motion for a resolution
Paragraph 54
Paragraph 54
54. NoteDeeply regrets the Council's cuts to Heading 5, amounting to a total of EUR - 153.283 million in commitments and payments (- 1,8 % compared to DB levels), where the highest cuts are in Pensions and European schools (EUR -5,2 million , -3,2 %) and on expenditure related to officials and temporary staff in policy areas (EUR - 69,7 million or -3,5 %);
Amendment 83 #
2013/2145(BUD)
Motion for a resolution
Paragraph 55
Paragraph 55
55. NoteDeeply regrets that in its draft budget, the Commission already largely included the savings brought about by the new Staff Regulation and the 1 % reduction of posts, as agreed by the institutions; these proposed staff reductions will endanger dramatically the capacity of the EU institutions to deal with the entire new set of increased tasks and competences; notes that the EU institutions are supposed to perform, within a fully democratic context, with the highest degree of technical and administrative excellenc; naturally this becomes impossible while its institutions are not provided with the adequate level of human resources, in an increasing multilingual environment;
Amendment 85 #
2013/2145(BUD)
Motion for a resolution
Paragraph 56
Paragraph 56
56. ViewReiterates its position that it considers the additional cuts on administrative expenditure made by the Council as unjustified and disregarding statutory and contractual obligations and the Union's new competences and tasks; notstresses that «excluding the amounts relating to the salary adjustment for 2011 and 2012» couldshall further imbalance the Union budget;
Amendment 89 #
2013/2145(BUD)
Motion for a resolution
Paragraph 68 a (new)
Paragraph 68 a (new)
68a. Insists that the appropriations for the European Refugee Fund be increased;
Amendment 4 #
2013/2042(INI)
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Insists that in a period of deep economic crisis and increased divergence in the EU it is necessary to provide an adequate level of resources in the EU budget with particular emphasis on the programmes and projects aimed at boosting growth and decent employment, eradicating poverty, investing in programmes aimed at smart, sustainable, green development; underlines that it is extremely important to increase support to Member States, especially those already facing economic recession;
Amendment 1 #
2013/2032(BUD)
Proposal for a decision
Recital C
Recital C
C. whereas the Union’s financial assistance to workers made redundant should be dynamic and efficient, namely by ensuring adequate assistance on finding and retaining new jobs, and made available as quickly and efficiently as possible, in accordance with the Joint Declaration of the European Parliament, the Council and the Commission adopted during the conciliation meeting on 17 July 2008, and having due regard for the IIA of 17 May 2006 in respect of the adoption of decisions to mobilise the EGF,
Amendment 8 #
2013/2032(BUD)
Proposal for a decision
Paragraph 8
Paragraph 8
8. Recalls the importance of improving the employability of all workers by means of adapted training and the recognition of skills and competences gained throughout a worker's professional career and the equal access to EGF independently of their type of employment contract and employment relationship; expects the training on offer in the coordinated package to be adapted not only to the level and needs of the dismissed workers but also to the actual business environment;
Amendment 1 #
2013/2018(BUD)
Motion for a resolution
Recital C
Recital C
C. whereas, in the a context of continuingheavy social, economic and financial difficulties, as reflected in the austerity measures taken by many Member States in response to the debt crisis, Parliament should continue to exercise a constraints, and even recession in several Member States, Parliament should strongly enhance investment to boost synergies whigch degree of budgetary responsibility, control and self-restraint; whereas Parliament, at the same time must strike a delicate balance between budgetary rigour and structural savings on one hand, and a concerted drive for efficiency on the other handensure efficiency and excellence through decent job creation and maintenance, increase the quality of working conditions, promote and implement organisational and infrastructural innovation within the highest degree of budgetary responsibility, assessment and liability;
Amendment 23 #
2013/2018(BUD)
Motion for a resolution
Paragraph 10
Paragraph 10
10. WelcomesDeeply regrets several of the proposed decreases compared with the 2013 budget in the areas; recalls that some of these decreases were made at the cost of jeopardising working conditions, such as the reduction of translation (-56%) and interpreting costs (-23%), without endangeringation expenditure; reiterates the need to ensure that the principlrease of multi- lingualism, lease payments (-60%), web TV (-38%) and fitting-out of premises (- 31%)competences of the institutions should be accompanied by the due and adequate reinforcement of human resources;
Amendment 2 #
2013/2010(BUD)
Motion for a resolution
Citation 7 (new)
Citation 7 (new)
– having regard to the Council conclusions of 29th of June 2012 and 19th October on the Compact for Growth and Jobs;
Amendment 3 #
2013/2010(BUD)
Motion for a resolution
Recital A
Recital A
A. whereas the Treaty of Lisbon confers significant new prerogatives on the European Union in fields such as external action, sport, space, climate change, energy, tourism and civil protection, external action, sport, space;
Amendment 11 #
2013/2010(BUD)
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Insists that in a period of deep economic crisis and increased divergence in the EU it is necessary to provide a significant increase in the Community budget to ensure the adequate level of resources in next year's budget to secure the EU political priorities with particular emphasis on the programs and projects aimed at boosting growth and decent employment, eradicating poverty, investing in smart, sustainable, green development; reiterates that it is extremely important to increase support to Member States, especially those already facing economic recession, for investment in infrastructure, social facilities, research, innovation and development;
Amendment 19 #
2013/2010(BUD)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Insists ofn the opinion that budgeting a realisticneed to budget the adequate level of payments at the beginning of the budgetary cycle wouldto avoid unnecessary complications during the implementation of the budget, as witnessed in particular with the 2012 budsituations such as the one witnessed in particular in 2012 , during the implementation of the budget; emphasises that the EU Budget can have a crucial role to help some of its member states to recover from the crisis and come out stronger, through smart, sustainable and inclusive growth based on the five EU headline targets, namely promoting employment, improving the conditions for innovation, research and development, meeting our climate change and energy objectives, promoting high education standards and social policies, in particular social inclusion and poverty reduction; recalls that the Member States themselves have fully endorsed these five targets;
Amendment 32 #
2013/2010(BUD)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Attaches the greatestTakes note of the political importance tof the joint statements signed by Parliament, the Council and the Commission at their highest political level in December 2012, which are an integral part of the agreement between the two arms of the budgetary authority on the 2013 budget and according to which the necessary additional resources will be provided by Member States next year in order for the Union to be able to pay its bills and preserve its institutional credibility and solvability;
Amendment 35 #
2013/2010(BUD)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Recalls that, in line with the provisions of the joint statement on payments 2012, the Commission shall present at an early stage in 2013 a draft amending budget devoted to the sole purpose of covering the suspended claims from 2012, amounting to at least EUR 2.9 billion, and other pending legal obligations, without prejudice to the proper implementation of the 2013 budget; recalls that in November and December 2012 additional payment requests under shared management for an overall amount of around EUR 16 billion were submitted to the Commission, which will need tomust be paid out in 2013; therefore urges the Commission to submit this draft amending budget already during the first trimester of 2013, in order to avoid any interference with the budget 2014 procedure;
Amendment 51 #
2013/2010(BUD)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Is deeply concerned about the high level of unused appropriations (RALs) accumulated at the end of the year 2012; proposes to organise once again this year inter- institutional meetings on the difference between commitment and payment appropriations, to establish a dialogue with the Commission in order to fully clarify the composition of RAL; insists that the Council refrain from deciding a priori the level of payments, without taking account of actual needs and legal obligations; notes further that accruing RAL actually undermines a transparent EU budget in which the relation between commitments and payments in any specific budgetary year is clearly visible;
Amendment 60 #
2013/2010(BUD)
13. Is of the opinionnsists that the 2013 budget negotiations have demonstrated once more that the system of financing the EU budget – with national contributions amounting to more than 75 % of EU revenue – is today on its last legsclearly insufficient; urges that the structure of Union revenue be reformed by introducing new and genuine own resources, namely the Financial Transaction Tax and recalls its support to the Commission proposal for reforming the own resources system;
Amendment 73 #
2013/2010(BUD)
Motion for a resolution
Paragraph 17
Paragraph 17
17. RecallInsists that all the macroeconomic financial stabilisation measures taken since 2008 have not yet brought an end to the economic and financial crisis; believes, therefore,insists, therefore, that the austerity measures taken both at EU and Member States level, comprised within the "Economic Governance", The Pact for the Euro and the Fiscal Compact, led to the deepening and aggravation of the economic and social crises, particularly in countries which already had a difficult economic and social situation; reiterates that in order to return to growth and generate employment in Europe, Member States should continue their efforts to unlock their potential for sustainable growth and that a well-targeted, robust and sufficient EU budget is needed to further help coordinate and enhance the national efforts;
Amendment 78 #
2013/2010(BUD)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls, therefore, on the Member States to consider synergies between the national consolidation effortMember States and the added value of a well- prioritised EU budget, allowing the implementation of the political commitments already made at the highest level; recallinsists that implementation of political commitments and priorities is much more effective when there is a synergy between national and EU budgets and underlines the importance of inter- parliamentary debatthe EU budget should give priority to policies of real convergence, social and territorial cohes ion the common economic and budgetary orientations of the Member States and of the Union, within the framework of European Parliamentary Week on the European Semester for Economic Policy Coordination, focused on job creation, social progress, solidarity, the sustainable use of natural resources and protection of the environment;
Amendment 87 #
2013/2010(BUD)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Recalls, in this regard, that the EU 2020 strategy should be at the heart of the next MFF (2014-2020) and invites the Commission to clearly prioritise it already in 2014 and to place emphasis on spending for SMEson job creation, to eradication of poverty, the promotion of cooperation and solidarity towards a social and sustainable development, research, SMEs, development and innovation, renewable energy, sustainable development, and skills;
Amendment 101 #
2013/2010(BUD)
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22a. Reiterates that a budgetary shift away from military action and security- oriented policies to civil conflict prevention is a necessary alternative in order to reduce military expenditure;
Amendment 104 #
2013/2010(BUD)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Takes note of the letter dated 7 January 2013 from the Commissioner for Budgets and Financial Programming confirming that 2014 will be the second year in which the Commission will reduce its staffing levels by another 1 %, meaning that any new tasks will be met through available (and decreasing)rejects the proposed reduction of human ressources and by counting on the simplification of delivery modes, as proposed in the new generation programmes; takes note of the Commission’s call on all other institutions to introduce a nominal freeze at 2013 level of all non-salary related expenditure; intends to continue a close examination of the Commission’s intention of reducing by 2018 the staffing level in EU institutions and bodies by 5 % as compared with 2013, and recalls that this is to be seen as an overall goal; recalls that any change to the establishment plan has a direct impact on the budget and should in no way compromise the budgetary prerogatives of the Committee on Budgets and of the European Parliament; considers that any short-term or long-term reduction in staff should be based on a prior impact assessment and should take full account of, inter alia, the Union’s legal obliginsists in strongly enhancing efficiency and excellence through decent job creation and maintenance, increase the quality of working conditions, promote and implement organisationsal and the institutions’ new competences and increased tasks arising from the Treinfrastructural innovatieson;
Amendment 11 #
2013/0248(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation 2012/2002
Article 2 – paragraph 3
Article 2 – paragraph 3
3. For the purposes of this Regulation, a ‘regional natural disaster’ shall mean any natural disaster resulting, in a region in direct damage in excess of 1% of GDP in a region at NUTS 2 level, or in several neighbouring NUTS 3 level regions that together constitute a territory corresponding to the minimum criteria for NUTS 2 level, of a Member State or a country involved in accession negotiations with the Union at NUTS 2 level,; in direct damage in excess of 1,5 % of the region's gross domestic product (GDP)certain cases the GDP criterion may be weighted by using an indicator that reflects the actual socio- economic situation of the territory affected before and after the disaster occurred, as envisaged in the Common Provisions Regulation. Where the disaster concerns several regions at NUTS 2 or NUTS 3 level, the threshold shall be applied to the weighted average GDP of those regions.
Amendment 12 #
2013/0248(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation 2012/2002
Article 2 – paragraph 3 a (new)
Article 2 – paragraph 3 a (new)
3a. Particular attention shall be paid to the outermost regions as defined in Article 349 of the Treaty, which are more vulnerable to extreme weather events.
Amendment 23 #
2013/0222(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) The work carried out at Union level in respect of the assessment of non- interventional post- authorisation safety studies imposed by an authority and of which the protocol has been endorsed by the Pharmacovigilance Risk Assessment Committee, involves the supervision of these studies, starting from the assessment of the draft protocol, and is not limited to the assessment of the final study reports. Therefore, the fee levied for this procedure in respect of studies that have been finalised should cover all the work relating to the study. In order to avoid double charging, marketing authorisation holders who are charged the fee for the assessment of non-interventional post-authorisation safety studies imposed by an authority, should be exempted from any other fee charged by a competent authority for the submission of those studies.
Amendment 34 #
2013/0222(COD)
Proposal for a regulation
Article 1 – paragraph 2
Article 1 – paragraph 2
2. This Regulation determines the pharmacovigilance activities performed at Union level for which fees are due, the amounts and the rules of payment of those fees and the level of remuneration of the Agency, the rapporteurs and the co- rapporteurs.
Amendment 61 #
2013/0222(COD)
Proposal for a regulation
Article 8 – paragraph 3
Article 8 – paragraph 3
3. Any marketing authorisation holder claiming to be entitled to a reduced annual flat fee under Article 7(5) shall make a declaration to that effect to the Agency. The Agency shall apply the reduction on the basis of that declaration where the required conditions are met. Where the declaration is made by the marketing authorisation holder after the receipt of the invoice from the Agency, the declaration shall be done within 30 calendars days from the receipt of that invoice. For the purpose of this paragraph, the Commission shall publish guidelines on how this declaration is to be formulated by the marketing authorisation holder.
Amendment 79 #
2013/0222(COD)
Proposal for a regulation
Article 15 – paragraph 2
Article 15 – paragraph 2
2. The Executive Director of the Agency shall provide the Commission and the Management Board annuallyin the annual report delivered to the European Parliament, the Council, the Commission, the European Economic and Social Committee, the Court of Auditors and the Member States according to Article 65 paragraph 10 of Regulation (EC) No 726/2004 with information on the components that may have a bearing on the costs to be covered by the fees provided for in this Regulation. This information shall include a cost breakdown related to the previous year and a forecast for the following year. The Agency shall also publish this overview in its public annual report. The Executive Director of the Agency shall also provide the Commission and the Management Board once per year with the performance information set out in Part V of the Annex based on the performance indicators referred to in paragraph 3.
Amendment 84 #
2013/0222(COD)
Proposal for a regulation
Article 16 – paragraph 2
Article 16 – paragraph 2
2. Any amendments to the amounts shall be based on an transparent evaluation of the costs of the Agency and the costs of the assessments provided by the rapporteurs as laid down in Article 9 or on the monitoring of the inflation rate referred to in Article 15(4).
Amendment 10 #
2013/0156(COD)
Proposal for a regulation
Recital 1
Recital 1
(1) The unprecedented global financial crisis and economic downturn have seriously increased social disparities in the Union and damaged economic growth and financial stability and, provokeding a strong deterioration in social, financial and economic conditions in several Member States. In particular, certain Member States are experiencing seriousdramatic difficulties or are threatened with such difficulties, notably with unemployment, poverty, social exclusion, income inequalities, problems in their sustainable economic growth and financial stability, and with a serious deterioration in their deficit and debt position, also as a result of the current Union policies and the international economic and financial environment.
Amendment 11 #
2013/0156(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) Whilst important actiThe impact of the financial crisis ons to counterbalance the negative effects of the crisis have already been taken, including amendments of the legislative framework, the impact of the financial crisis on the real economy, the labour market and citizens is being widely felhe real economy, the labour market and citizens is being widely felt. A new strategy is needed to secure an adequate level of resources with particular emphasis on the programs and projects aimed at boosting growth and decent employment, eradicating poverty, investing in smart, sustainable green development. It is fundamental to increase support to Member States, especially those already facing economic recession, for investment in infrastructure, social facilities, research, innovation and development. Pressure on national financial resources is increasing and further steps should be taken to alleviate that pressure through the maximum and optimal use of the funding from the Structural Funds and the Cohesion Fund. In view of the persisting financial difficulties, it is necessary to extend the application of the measures adopted by amending Regulation (EU) No 1311/2011 of the European Parliament and of the Council. These measures were adopted pursuant to to Articles 122(2), 136 and 143 of the Treaty on the Functioning of the European Union (TFEU).
Amendment 6 #
2013/0045(CNS)
Proposal for a directive
Recital 2 a (new)
Recital 2 a (new)
(2a) The initiative of the 11 Member States to proceed with the establishment of FTT under enhanced cooperation is the first ever attempt to establish FTT among several Member States. The successful implementation of FTT under enhanced cooperation will be the first step towards a Union-wide and ultimately a global FTT.
Amendment 7 #
2013/0045(CNS)
Proposal for a directive
Recital 15 a (new)
Recital 15 a (new)
(15a) Tax avoidance should be made a high-cost and low-profit venture and in order to ensure better enforcement, the residence and issuance principle should be complemented by the "transfer of legal title principle".
Amendment 8 #
2013/0045(CNS)
Proposal for a directive
Recital 21
Recital 21
(21) In order to allow the adoption of more detailed rules in certain technical areas, regarding registration, accounting, reporting obligations and other obligations intended to ensure that FTT due to the tax authorities is effectively paid to the tax authorities, and their timely adaptation as appropriate, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of specifying the measures necessary to this effect. It is of particular importance that the Commission carries out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a timely and appropriate transmission of relevant documents to the European Parliament and the Council.
Amendment 15 #
2013/0045(CNS)
Proposal for a directive
Article 9 – paragraph 3 a (new)
Article 9 – paragraph 3 a (new)
3a. Notwithstanding paragraph 3, participating Member States may apply a higher rate to OTC financial transactions referred to in Articles 6 and 7.
Amendment 16 #
2013/0045(CNS)
Proposal for a directive
Article 11 – paragraph 2
Article 11 – paragraph 2
2. The Commission mayshall, in accordance with Article 16 adopt delegated acts specifying the measures to be taken pursuant to paragraph 1 by the participating Member States.
Amendment 17 #
2013/0045(CNS)
Proposal for a directive
Article 11 – paragraph 5 – subparagraph 2
Article 11 – paragraph 5 – subparagraph 2
The Commission mayshall adopt implementing acts providing for uniform methods of collection of the FTT due. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 18(2).
Amendment 18 #
2013/0045(CNS)
Proposal for a directive
Article 15 – paragraph 1 a (new)
Article 15 – paragraph 1 a (new)
Amendment 2 #
2013/0000(BUD)
Motion for a resolution
Recital B
Recital B
B. whereas, in a context of a heavy burden of public debt and of restraintsocial, economical and financial constraints, even of recession in several Member States and in times of ongoing national budgetary consolidation efforts, the European Parliament, and all the EU institutions, should continue to exercise a strongly enhance investment to boost synergies whigch degree of budgetary responsibility, control and self-restraint 1 The Heading 5 ceiling includes the staff contribution to the retirement scheme. 2 The Heading 5 ceiling includes the staff contribution to the retirement scheme. 3 Article 24 of the Interinstitutional Agreement between the European Parliament, the Council and the Commissionensure efficiency and excellence through decent job creation and maintenance, increase the quality of working conditions, promote and implement organisational and infrastructural innovation within the highest degree onf budgetary discipline and sound financial management, OJ C 139, 14.6.2006, p.3 responsibility, assessment and liability.
Amendment 5 #
2013/0000(BUD)
Motion for a resolution
Paragraph 1
Paragraph 1
1. MaintainStresses that the institutions should continue toEU administrative spending is under x % of the EU annual Budget; underlines that insisting on the limitation or freeze theirof the EU institutions administrative budgets in solidarity with the difficult economic and budgetary conditions in the Member States, without prejudice towill most certainly jeopardise the quality of institutional operations and the quality of services, respect for legal obligations and the imperative of development investment; calls for the increase of smart, innovative and inclusive investment, in solidarity with the difficult economic and budgetary conditions in the Member States;
Amendment 12 #
2013/0000(BUD)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Underlines the fact that institutional self- restraint has, considering the level of relevant inflation rates, resulted in reducing the EP budget in real terms; recalls that this was made possible mainly through strict budgetary planning and control, and through reorganisation in the form, for example, of cuts in travel-related budget lines, reduced length and number of missions, increased use of video- conferencing and optimisedrestriction of translation and interpretation services; recalls that savingthe cuts resulting from structural reforms have amounted to EUR XX million in recent years, even thoughdespite the increase of competences in addition to the costs of 18 additional Members resulting from the entry into force of the Lisbon Treaty and the preparation for Croatia’s accession had to be absorbed;
Amendment 14 #
2013/0000(BUD)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Recalls that visibldespite some signs of self-restraint aresuch as the freeze on all of the Members’ allowances at the 2011 level until the end of the current parliamentary term and the fact that staff mission allowances have not been indexed since 2007; others, where made at the cost of jeopardizing working conditions, such as the reduction of translation and interpretation expenditure and ensuring that the increase of competences of the institutions would be accompanied by the due and adequate reinforcement of human resources;
Amendment 17 #
2013/0000(BUD)
Motion for a resolution
Paragraph 4a (new)
Paragraph 4a (new)
4a. Underlines that further savings can still be made if a further decrease of the General Expenditure Allowance would be pursued;
Amendment 21 #
2013/0000(BUD)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Encourages the continuation of structural and organisational reforms, without sacrificing legislative excellence and the quality of working conditions, in accordance with the ILO Conventions, and supports organisational innovation to help improve Parliament’s efficiency and the Members’ quality of working conditions in 2014 and subsequent years, including, but not limited to, more efficient structuring of Parliament’s working rhythm, ‘demand- driven’ensuring the adequate translation and interpretation services (without endangering the principle of multilingualism), optimal logistical solutions for Members and their assistants, further upgrading of in-house research assistance, and developing a paperless Parliament and e-meetings;
Amendment 30 #
2013/0000(BUD)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Welcomes, more generally, Underlines the need for a further enhanced cooperation between the Committee on Budgets and the Bureau during the annual budget procedure, in particular ensuring the participation and representation, in all the meetings, of all political groups; stands ready to further strengthen the cooperation between the Secretary-General, the Bureau, and the Committee on Budgets throughout the year with a view to ensuring a smooth budgetary process and effective implementation of the budget; expects the Bureau to present prudentadequate needs-based draft estimates that take account of possible subsequent increases arising from legally binding obligations;
Amendment 44 #
2013/0000(BUD)
Motion for a resolution
Paragraph 11
Paragraph 11
Amendment 1 #
2012/2307(BUD)
Motion for a resolution
Citation 8 a (new)
Citation 8 a (new)
– having regard to Council Decision EUCO 76/12, on the 28th and 29th of June 2012 on the Compact for Growth and jobs, agreed by the Member States,
Amendment 4 #
2012/2307(BUD)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Recalls that the "draft package" agreed, afterwas object of difficult negotiations, by Parliament and Council during the Trilogue of 29 November 2012 and thatit consists of three elements: the Amending Budget No 6/2012 for EUR 6 billion, partially covering the shortage of payments in 2012, the Union Budget for the year 2013 set to a level of EUR 150 898,391 million and EUR 132 836,988 million, respectively in commitment and payment appropriations and three joint statements ensuring partially that the actual payment needs in 2012 and 2013 will be duly covered;
Amendment 8 #
2012/2307(BUD)
Motion for a resolution
Paragraph 2
Paragraph 2
2. WelcomNotes the overall level of commitments appropriations agreproposed, which represents an increase of EUR 1,1 billion compared to the original reading of the Council; is pleased that the biggestdeeply regrets that an essential part of its political priorities iswill not be adequately secured in next year's budget, with particular emphasis on the proper implementation of the EU commitment for growth and jobsgrams and projects aimed at boosting growth and decent employment, smart, sustainable, green development and eradicating, as identified in the Europe 2020 strategy;
Amendment 16 #
2012/2307(BUD)
Motion for a resolution
Paragraph 3
Paragraph 3
3. NoteDeeply regrets that, due to the intransigent position of the Council in the negotiations, the overall level of payments set is EUR 5 billion lower than the Commission's draft budget for 2013; is concerned that this level of appropriations will be insufficient to cover the actual payments needs of next year; is convinced, however, that the cost of a non agreement would imply much moredeeply concerned that this might imply serious consequences and a much morehave a negative impact on the implementation of the Union actions and programmes;
Amendment 23 #
2012/2307(BUD)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Reaffirms that the only way to come out from this impasse, which renders the budgetary negotiations each year more difficult, is to urgently and responsibly solve the issue of the Union's financing, through a genuine system of own resources, in particular a Financial Transaction Tax, to come into force as from the next Multiannual Financial Framework, removing once for all the division of the EU between net contributors and net beneficiariesactively contributing to reduce the imbalances in the regions and Member States within the EU by boosting social integration, environmental sustainability and territorial cohesion;
Amendment 1 #
2012/2281(BUD)
Motion for a resolution
Citation 5 a new
Citation 5 a new
– having regard to the European Council Decision EUCO 76/12 of 28 and 29 June 2012 on the Compact for Growth and jobs, agreed by the Member States,
Amendment 2 #
2012/2281(BUD)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Strongly reminds the Council and the Commission that the Joint statement on payment needs for 2012 must be understood as a political agreement regarding the need to come to an agreement at an early stage in 2013 on an amending budget devoted to the sole purpose of covering this EUR 2,9 billion, the additional remaining legitimate payment claims for 2012 as well as other eventual pending payment claims that have not yet been satisfied, and providing additional appropriations as compared to the payment appropriations adopted in the 2013 initial budget, without prejudice to the proper implementation of the 2013 budget;
Amendment 1 #
2012/2092(BUD)
Draft opinion
Section 1 – paragraph 2
Section 1 – paragraph 2
2. NoReiterates that climate action and environmental objectives are of a cross- cutting nature which must be translated into concrete actions to be implemented under the various programmes and policies to foster sustainable growth in Europe; welcomesis deeply concerned, however, that the precurrsent ecommitment by all EU institutions for a more sunomic, social and financial crisis has lead to dramatic budgetary constrainable, resource-efficient and ecological European economy; is worried, however, that the pts in some Member States; calls for improving solidarity and responsibility sharing between Member States, including through increasent economic and fiscal constraints in some Member States lead tod practical cooperation, either absolute or proportional financial responsibility sharing, to overcome the current negligence oftowards achieving climate action and environmental objectives; recalls the recurrent commitment by all EU institutions for a more sustainable, resource-efficient and ecological European economy;
Amendment 3 #
2012/2092(BUD)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Recalls that its priorities for the 2013 budget, as detailed in its above-mentioned resolution of 4 July 2012 on the mandate for the trilogue and especially taking into account the current social, economic and financial dramatic constraints lived in several Member States, consist in enhancing support for employment, growth, and competitiveness and employment, particularly for SMEs and youth; points out once again that the Commission's draft budget (DB) reflects Parliament's priorities as regards the programmes and initiatives to be reinforced towards these objectives;
Amendment 5 #
2012/2092(BUD)
Draft opinion
Section 1 – paragraph 3
Section 1 – paragraph 3
3. Is aware that the main responsibility for Public Health measures lies with the Member Sates, underlines, however, the complementarity role of the Union's supported programs and actions, offering economies of scale; is convinced that the European Union has a fundamental role as a catalyst for action and reform within Member States in this policy area; considers, therefore, EU related actions in this regard as key factor in securing Europe's competitivenesssmart, sustainable and inclusive growth;
Amendment 6 #
2012/2092(BUD)
Draft opinion
Section 1 – paragraph 4
Section 1 – paragraph 4
4. Is aware that the 2012 Draft Budget shows for Title 07 ‘Environment and Climate Action’ an overall amount for operational expenditure of EUR 418,5 million, an increase of 0.72 % in commitment appropriations (CA) in comparison to the voted 2012 budget; notedeeply regrets at the same time that the increase is below the inflation rate of 2% and de facto a decrease;
Amendment 9 #
2012/2092(BUD)
Draft opinion
Section 1 – paragraph 5
Section 1 – paragraph 5
5. Takes note thatRegrets that only an overall level of EUR 366,591 million is suggested for the last year of implementation for LIFE+, the main financial instrument in support and implementation of Environment Policy and Climate Action; underlines the increase of 3.34% compared to 2012 budget level but is concerned that the level is slightly below the multi-annual financial programming for 2013; explores all provisions as stated in paragraph 37 of the Inter-Institutional Agreement;
Amendment 10 #
2012/2092(BUD)
Draft opinion
Section 1 – paragraph 7
Section 1 – paragraph 7
7. Observes aDeeply regrets the decrease of EUR 61 million of operational appropriations proposed under Title 17 for Public Health actions compared to the 2012 voted amount of EUR 334 million; is alarmed that with the decreased resources foreseen for the Public Health Programme the number of activities in the Member States is limited; notunderlines therefore, that action at EU level needs to focus solely on real added value in those areas where Member States can not act on their own initiative, such as, cross-boarder health issues, the exchange of best practise and transfer of knowledge, data collection and measuring as well as pooling resources at EU level e.g. for rare diseases and orphan drugs;
Amendment 12 #
2012/2092(BUD)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Points outUnderlines that the EU budget is to be seen instead as a complementary instrument of support for the Member States' economies, capable of concentrating initiatives and investments in areas strategic for growth and, creation of jobs and of bringing an actual added value in sectors overcoming national boundaries; highlights that such a role is legitimised by the same Member States, who, together with Parliament, are responsible for the decisions from which most of the EU law stems;
Amendment 12 #
2012/2092(BUD)
Draft opinion
Section 1 – paragraph 7 a (new)
Section 1 – paragraph 7 a (new)
7a. Recalls that due to the economic and social crisis, severe cuts and constraints have been imposed to the health care sector in several Member States; calls, therefore, for an increase of appropriations to all programs and projects which have a complementary nature to the health systems, in particular, to the Member States facing economic difficulties;
Amendment 14 #
2012/2092(BUD)
Draft opinion
Section 1 – paragraph 9
Section 1 – paragraph 9
9. Is generally concerned on theDeeply regrets the proposed level of payment appropriations; points out that the slow start of 2007-2013 programmes resulted in a low level of payment needs during the first half of the programming period; stresses that commitments made in the past need to be paid in the final year of the current financial period; reminds Member States in this context on their political and budgetary commitment which needs to be converted into payment appropriations for the successful implementation of programmes and measures in the area of environment, public health and food safety;
Amendment 17 #
2012/2092(BUD)
Draft opinion
Section 1 – paragraph 11
Section 1 – paragraph 11
11. Stresses that the successful implementation and monitoring of legislation needs sufficient and skilled administrative support; reminds that the Public Health Programme is implemented by the Executive Agency for Health and Consumers (EAHC); is concerned that theregrets the proposed freeze or even reduction of administrative expenditure and underlines that it will have a negative impact on the quality of Commission's activities;
Amendment 19 #
2012/2092(BUD)
Draft opinion
Section 1 – paragraph 12
Section 1 – paragraph 12
12. Recalls that decentralised agencies deliver diverse tasks, inter alia adopting individual decisions which are legally binding to third parties, providing direct assistance to the Commission and, where necessary, to Member States and gathering and analysing objective, reliable information and data; reiterates that decentralised agencies need adequate funding and staffing in order to fulfil their existing and newly assigned tasks; is concerned in general about thedeeply regrets the proposed reduction of more than 1% in real terms of expenditure for EU agencies , despite the extension of tasks and some ongoing start- up phases;
Amendment 20 #
2012/2092(BUD)
Motion for a resolution
Paragraph 5
Paragraph 5
5. DStrongly deplores, therefore, the decision of the Council to proceed again this year with the usual approach of horizontal cuts to the DB, aimed at artificially reducing the level of the EU resources for 2013 all in all by EUR 1 155 million (-0,8%) in commitment appropriations (CA) and by EUR 5 228 million (- 3,8%) in payment appropriations (PA) as compared to the DB, leading thereby to a clearly insufficient and very modest increase compared to the 2012 budget both in commitments (+1,27% vs. 2% of the DB) and in payments (+2,79% vs. 6,8% of the DB);
Amendment 22 #
2012/2092(BUD)
Draft opinion
Section 1 – paragraph 14
Section 1 – paragraph 14
14. Is not convinced that financial statements accompanying legislative proposals by the Commission will not meet the budgetary and staff requirements after the completion of the legislative procedure defining new tasks for agencies such ECHA for handling biocides and the PIC regime and EMA to implement the pharmacovigilance legislation; calls on the Commission to adapt timely the financial statements after the adoption by the legislator and to inform Parliament accordingly;
Amendment 24 #
2012/2092(BUD)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Is surprised that, in this exercise, the Council hasinsists on not takening into account the latest Commission's forecasts for programmes' implementation, based on estimates of the same Member States, which on the one hand clearly highlight areas of over- performances where reinforcements are needed already in 2012 and on the other hand warn about the severe risk of shortages of payments, in particular under Headings 1a, 1b and 2; recalls in this context the letter that President Barroso addressed to the 27 Member States in July 2012 expressing his concern about the cuts made to the DB by the Council's reading, as a result of which there is a risk that sufficient funds are not made available to enable the EU to honour its debts;
Amendment 24 #
2012/2092(BUD)
Draft opinion
Section 1 – paragraph 15
Section 1 – paragraph 15
15. NoteRegrets that the Draft Budget foresees a reduction of the ECDC establishment plan by two and for the EFSA by four posts; recognises at the same time that the EEA receives two additional posts which need to be budgetary neutral achieved by a reduction of two national experts and two contract agents; is aware that 36 additional posts are foreseen for ECHA of which 16 posts will be financed from additional fees as well as 21 posts for EMA; is in this context concerned that the recruitment of staff needs towill be postponed when the fee income is lower than estimated for 2013; will not accept unjustified deletion of AD grades in any establishment plan.
Amendment 37 #
2012/2092(BUD)
Motion for a resolution
Paragraph 13
Paragraph 13
13. RDeeply regrets that the Council departed substantially (all in all by EUR 2,15 billion), as regards commitments, from the financial programming figures, which result from a joint decision with Parliament at the beginning of the programming period, as well as that Council completely disregarded Parliament's priorities, as expressed in Parliament's mandate for the trilogue; recalls that Parliament's reading is based instead upon, and coherent with, these benchmarks;
Amendment 42 #
2012/2092(BUD)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Is of the opinionUnderlines that the answer to the crisis must be more Europe and not less Europe, in order to restart investments, boost the creation of jobs and help rebuild confidence in the economy; having already criticised the proposed freezing in commitment appropriations at the level of the expected inflation rate in the DB, cannot accept Council's decision to reduce them further down to 1,27% compared to budget 2012; recalls that commitments reflect EU political priorities and should be set having in mind a long term perspective where the economic downturn might be over; therefore takes the view that, as a general principle, commitments should be restored at the DB level; intends, however, to increase commitment appropriations above the DB on a selected number of budget lines directly related to the delivery of the Europe 2020 prioritiesU objectives for growth and the creation of jobs, in line with the "decent employment programme" of the International Labour Organization and in line with traditional Parliament's priorities;
Amendment 45 #
2012/2092(BUD)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Deplores that, although this is the key heading for the delivery of the Europe 2020U objectives for smart, inclusive and sustainable growth, Heading 1a bears practically the totality of the Council's cuts in commitments (-2,9% compared to DB) in Heading 1 and is the most affected as regards decreases in payments (-EUR 1,9 billion or -14% compared to DB); decides to undo almost all cuts by Council and to reinforce above DB in commitment and payments only a selected number of lines directly linked to the objectives of the Europe 2020 Strategy and characterised by high levels of implementation and strong absorption capacity;
Amendment 49 #
2012/2092(BUD)
Motion for a resolution
Paragraph 17
Paragraph 17
17. In particular, highlights that the strong cuts affecting Seventh Framework Programme (FP7) and the Competitiveness and Innovation Framework Programme (CIP) programmes are in clear contradiction with the recent European Council's decision to create a «Compact for growth and employment» supporting, among others, research and development, innovation and employment; recallunderlines the very good performances of these programmes, for which Commission reports accelerated implementation in 2012 compared to last year;
Amendment 58 #
2012/2092(BUD)
Motion for a resolution
Paragraph 21
Paragraph 21
21. DStrongly deplores the substantial cuts in payments (-EUR 1,6 billion or -3,3 % as compared to DB) by the Council affecting the Regional Competitiveness and Employment objective (-12,9%), the European Territorial Cooperation objective (-18,7%) and the Cohesion Fund (-4,7%); notes instead that the Convergence objective is left practically untouched;
Amendment 63 #
2012/2092(BUD)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Recalls the doubts expressed in its mandate for the trilogue as to whether the level of payments proposed in the DB will be sufficient to reimburse the totality of the expected payment claims in the absence of an amending budget this year; recallunderlines that the same Commission's proposal is based on the assumption that all payment needs from previous years up to 2012 are covered;
Amendment 66 #
2012/2092(BUD)
Motion for a resolution
Paragraph 24
Paragraph 24
24. RStrongly rejects the cuts introduced by the Council on Heading 1b, which would lead to a much more serious shortage in payments than already expected and, would idefinitely hampeder the correct execution of projects during the last year of the programming period, with dramatic consequences specially for the Member States which are already under social, economical and financial constraints; points out again that this heading is responsible for two thirds of the current outstanding commitments and that cutting the level of payments for 2013 would also lead to a strong increase in the level of RAL by the end of next year;
Amendment 78 #
2012/2092(BUD)
Motion for a resolution
Paragraph 31
Paragraph 31
31. Confirms its commitment to act in preventing and responding to crises in the fruit and vegetable sector, and therefore supports a commensurate level for producer groups for preliminary recognition; advocates a sufficient increase of the Union's contribution to the crisis fund within operational funds for producer organisations, especially those representing small and medium producers;
Amendment 90 #
2012/2092(BUD)
Motion for a resolution
Paragraph 38
Paragraph 38
38. RStrongly rejects the cuts performed by the Council in payment appropriations in the following areas: European Return Fund (- EUR 18 million), European Refugee Fund (-EUR 1,8 million), European Fund for the Integration of third-country nationals (- EUR 3,2 million) and Fundamental Rights and Citizenship (- EUR 1 million); decides, therefore, to restore the level of the DB on the corresponding lines;
Amendment 93 #
2012/2092(BUD)
Motion for a resolution
Paragraph 39
Paragraph 39
39. Rejects the Council's unilateral decision to change the legal basis of the proposal on the «Schengen evaluation mechanism» from ordinary legislative procedure to Article 70 of the Treaty on the Functioning of the European Union; supports the Conference of Presidents' decision to block cooperation with the Council on the 2013 budget as regards internal security aspects; endorses, therefore, the position taken by its Committee on Civil Liberties, Justice and Home Affairs to put into the reserve some budgetary lines in Title 18 which relate to internal security (in commitment and payment appropriations) until a satisfactory outcome is achieved on the Schengen governance package; is of the opinion that this reserve should not be applied to the agencies working under Heading 3a in order not to jeopardise their work;
Amendment 96 #
2012/2092(BUD)
Motion for a resolution
Paragraph 40
Paragraph 40
40. Stresses that measures aimed at combating gender violence must be sufficientadequately funded; emphasises the important role that the programme for preventing and combating all forms of violence (DAPHNE) has playeds in eliminating violence against women and girls in the ,EU, especially in the current context of social, economic and financial crisis and therefore increases its payment appropriations above the level of the DB;
Amendment 113 #
2012/2092(BUD)
Motion for a resolution
Paragraph 51
Paragraph 51
51. Introduces separate budget lines for all CFSP missions and EU Special Representatives in the different geographical areas, as proposed in the reform of the Financial Regulation, which will provide and enable a more transparent and complete overview of missions conducted under this policy; underlines its commitment to a strictly peaceful resolution of conflicts, to eradicate poverty, to the promotion of cooperation and solidarity towards a social and sustainable development;
Amendment 10 #
2012/2066(INI)
Motion for a resolution
Citation 8 a (new)
Citation 8 a (new)
- Having regard to the European Environment and Health Strategy and the EU Action Plan on Environment and Health (2004-2010), which inter alia recognise a need to take into account combined exposure of chemicals in risk assessments;
Amendment 17 #
2012/2066(INI)
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. Whereas an increasing number of scientific studies have suggested that endocrine disrupting chemicals, particularly in combination, play a role in both chronic diseases, including hormone related cancers, obesity, diabetes, cardiovascular disease and also in reproductive problems;
Amendment 32 #
2012/2066(INI)
Motion for a resolution
Recital E a (new)
Recital E a (new)
E a. Whereas, at EU level, there are no coordinated or combined monitoring programmes specifically dedicated to endocrine disruptors;
Amendment 34 #
2012/2066(INI)
Motion for a resolution
Recital E b (new)
Recital E b (new)
E b. Whereas there is little if any co- ordination regarding the way that data are collected, managed, assessed and reported across the different monitoring programmes;
Amendment 39 #
2012/2066(INI)
Motion for a resolution
Recital G a (new)
Recital G a (new)
G a. Whereas a number of EU laws are aimed at protecting citizens from exposure to harmful chemicals; however, current EU legislation assess each exposure individually and does not provide for a comprehensive, integrated assessment of cumulative effects taking into account different routes of exposure and different product types;
Amendment 47 #
2012/2066(INI)
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1 a. Invites the Commission to pay appropriate attention to the precautionary principle and the potential risks of chemical combination effects when drawing up future proposals;
Amendment 63 #
2012/2066(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Calls, therefore, on the Commission to submit as soon as possible proposals for overarching criteria together with testing and information requirements for chemicals on the commercial market, and for EU legislation to make clear what is regarded as a substance with endocrine- disrupting properties; advocates considering the introduction of ‘endocrine disruptor’ as a regulatory hazard class;
Amendment 70 #
2012/2066(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4 a. Calls on the Commission to take further action in the field of chemicals policy and step up research that provides both for the assessment of the endocrine disrupting potential of individual chemicals as well as the possibility to assess the cumulative impact of identified combinations of substances on the endocrine system;
Amendment 7 #
2012/2041(INI)
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas much of the antimicrobial resistance problem stems from the misuse of antibiotics, particularly of excessive use;
Amendment 8 #
2012/2041(INI)
Motion for a resolution
Recital B b (new)
Recital B b (new)
Bb. whereas many Member States do not have a solid legal and regulatory framework to mandate and support the rational use of medicines;
Amendment 12 #
2012/2041(INI)
Motion for a resolution
Recital D a (new)
Recital D a (new)
Da. whereas effective surveillance in both the human health and the veterinary sector is the cornerstone of national and international efforts to control antimicrobial resistance;
Amendment 22 #
2012/2041(INI)
Motion for a resolution
Recital G a (new)
Recital G a (new)
Ga. whereas the widespread use of powerful and persistent chemical agents in livestock and poultry production operations, aquaculture and agriculture, is associated with the emergence of drug- resistant infections in these settings and has been linked to the establishment and spread of drug-resistant infections in humans;
Amendment 26 #
2012/2041(INI)
Motion for a resolution
Recital H a (new)
Recital H a (new)
Ha. whereas there is a need to educate and raise awareness among those involved in antimicrobial use, including policy-makers, health professionals and the general public, to bring about the necessary changes in prescribers', dispensers' and citizens' behaviour;
Amendment 100 #
2012/2041(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Stresses the importance of establishing an effective European network of national surveillance systems in the human health and veterinary sectors in order to facilitate the compilation of clear, comparable, transparent and timely reference data on antimicrobial drug usage; calls for the transmission to surveillance systems of data on the prescription and sales of all antimicrobial agents for use in humans and animals; believes this should be based on the existing monitoring networks operated by EFSA, the ECDC European Surveillance of Antimicrobial Consumption Network (ESAC-net), the ECDC European Antimicrobial Resistance Surveillance Network (EARS-net), and the EMA European Surveillance of Veterinary Antimicrobial Consumption (ESVAC);
Amendment 104 #
2012/2041(INI)
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14a. Calls on Member States to establish infection control programmes, based on current best practice, with the responsibility for effective management on antimicrobial resistance in hospitals, long-term care institutions and herds of food production animals;
Amendment 120 #
2012/2041(INI)
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Calls on the Member States to raise awareness on over-the-counter sales of antibiotics and to prevent all illegal sales of antimicrobials including illegal sales over the Internet in both the human health sector and the veterinary sector;
Amendment 125 #
2012/2041(INI)
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20a. Supports an international approach to the control of counterfeit antimicrobials in line with the WHO guidelines;
Amendment 7 #
2012/2016(BUD)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Recognises the persistent economic and budgetary constraints at national level, as well as the need for fiscal consolidation; reiterates, however, its conviction that the EU budget represents a common and effective instrument of investment and solidarity, which is needed particularly at the present time to trigger economic growth, competitiveness and job creationemployment and social progress in the 27 Member States; stresses that, despite its limited size that does not exceed 2% of total public spending in the Union, the EU budget has had a real economic impact and successfullyattempts to complemented so far Member States‘ recovery policies;
Amendment 11 #
2012/2016(BUD)
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Emphasises that the EU Budget can have a crucial role to help some of its member states to recover from the crisis and come out stronger, through smart, sustainable and inclusive growth based on the five EU headline targets, namely promoting employment, improving the conditions for innovation, research and development, meeting our climate change and energy objectives, promoting high education standards and social policies, in particular social inclusion and poverty reduction; recalls that the Member States themselves have fully endorsed these five targets;
Amendment 12 #
2012/2016(BUD)
Motion for a resolution
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Rejects the "Economic Governance" and the Pact for the Euro which enshrine the austerity measures taken both at EU and Member States level; these led to the deepening and aggravation of the economic and social crises, particularly in countries which already had a difficult economic and social situation; reiterates that the EU budget should give priority to policies of real convergence, social and territorial cohesion, focused on job creation, social progress, solidarity, the sustainable use of natural resources and protection of the environment;
Amendment 17 #
2012/2016(BUD)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Intends, therefore, to strongly defend an adequate level of resources for next year's budget, as defined in the Draft Budget, and to oppose any attempt to cut down the resources especially for policies delivering growth and employment; believes that the EU budget, which cannot run a deficit, should not be the victim of unsuccessful economic policies at national level; not; underlines that in 2012 several Member States are increasing the size of their national budgets;
Amendment 34 #
2012/2016(BUD)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Considers the proposed increase of 6,8% in PA compared to 2012 as an initial response to Parliament's request for a responsible and realistic budgeting; notes that the increases in payments are concentrated in the areas of competitiveness and cohesionHeadings 1b and 2, due to a greater level of claims expected by running projects in these fields; fully endorses such increase that results not only from past commitments that need to be honoured but also from the actual implementation of programmes that is expected to reach at the last year of the current MFF a cruising speed;
Amendment 49 #
2012/2016(BUD)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Takes note of the Commission's proposal for increasing commitments under this Heading by 4,1% (to EUR 16.032 million) as compared to Budget 2012; notes, that the proposal of CA below the Financial programming possibilities (i.e. TEN-T, EIT, Progress) leaves an increased margin of EUR 90,9 million compared to the EUR 47,7 million foreseen in the Financial programming; is pleased to see that the highest increases in CA are concentrated in Heading 1a, where most of the policies and programmes triggering growth, competitiveness and jobemployment and social progress are placed and that they reflect the priorities highlighted by Parliament for 2013;
Amendment 50 #
2012/2016(BUD)
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15a. Recalls the importance of the inclusion of payment appropriations for the European Globalisation Fund; reiterates that the use of a transfer for the EGF should mean a speedier process, and underlines the need for the further simplification of the practical modalities of the procedure, as mentioned on the report from the Commission to the European Parliament and Council on the functioning of the Interinstitutional Agreement on the Budgetary discipline and sound financial management of 27 April, 2010;
Amendment 54 #
2012/2016(BUD)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Takes note of the rationale adopted by the Commission when proposing reductions as compared to the Financial programming, which has led, in the view of the Commission, to the identification of potential savings within under- implemented lines of –among others- FP7, TEN- T, Marco Polo, Progress, Statistical programme, Customs and Fiscalis; is determined to carefully analyse the performance under each of these programmes in order to check the appropriateness of the proposed cuts and exclude negative impacts on the programmes concerned;
Amendment 65 #
2012/2016(BUD)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Recognises the fundamental role played by small and medium enterprises as drivers of the EU economy and creators of 85% of jobs in the last ten years; stresses the traditional difficulties faced by SMES to access capital markets for research and innovation projects, exacerbated by the current financial crisis; is firmly convinced that the EU budget should contribute to overcoming this market failure, by facilitating access to debt and equity financing for innovative SMEs; welcomnotes, in this context, that the Draft Budget includes already appropriations for the Project bond initiative as a way to increase payment capacity in this sector through the opening to the private market; supports as welltakes note of the proposed increase for the financial instruments under the CIP-EIP programme (by EUR 14,7 million), in line with their positive performance so far and their increased demand by SMEs;
Amendment 74 #
2012/2016(BUD)
Motion for a resolution
Paragraph 22
Paragraph 22
22. RDeeply regrets that the contribution to Youth on the Move Flagship Initiative is slightly reduced when compared to last year; highlights in this context the added value of the Lifelong Learning, Erasmus and Erasmus Mundus programmes which, against a modest financial dimension, have a great return in terms of effective implementation and positive image of the Union vis-à-vis its citizens; opposes therefore to the proposed reduction by EUR 10,2 million as compared to the Budget 2012 for Lifelong Learning and, in line with its established position in the last budgetary procedures and the excellent performance rates of this programme, intends to reinforce commitment appropriations for the corresponding budget line;
Amendment 76 #
2012/2016(BUD)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Stresses that the TEN-T programme plays a central role in the attainment of the objectives of competitivenessgrowth and employment in the Europe 2020 Strategy by creating the missing infrastructure, removing bottlenecks and ensuring the future sustainability of the EU transport networks; welcomes the Commission's proposed increase by ca. EUR 85 million compared to the Budget 2012 but asks for further clarifications on the proposed reduction by EUR 118 million as compared to the Financial programming;
Amendment 80 #
2012/2016(BUD)
Motion for a resolution
Paragraph 24
Paragraph 24
24. Deeply deplores the Commission's proposed decreases for the European Supervisory Authorities compared what originally foreseen in the Financial programming; considers the current level of appropriations insufficient to allow these agencies to cope efficiently with their tasks; strongly expresses therefore the intention to reinstatforce appropriations at least atbove the 2012 level for the European Banking Authority (EBA) and the European Insurance and Occupational Pensions Authority (EIOPA) as well as to further reinforce the European Securities and Markets Authority (ESMA) due to the new tasks entrusted to it;
Amendment 89 #
2012/2016(BUD)
Motion for a resolution
Paragraph 26
Paragraph 26
26. Considers the Structural Funds a crucial instrument - both for their financial size and for the objectives pursued - to accelerate the EU economic recovery and to deliver the objectives of growth and , employment enshrinedand social progress in the Europe 2020 Strategy; welcomes therefore the Commission's initiative of re- programming EUR 82 billion of unallocated Structural funds in some Member States in favour of SMEs and youth employment, in line with EP's priorities for 2013; asks to be kept duly informed about implementation of this initiative at national level, its expected impact on growth and job, employment, social progress and its possible impact for the 2013 budget;
Amendment 100 #
2012/2016(BUD)
Motion for a resolution
Paragraph 34
Paragraph 34
34. Points out that Heading 2 is instrumental in realising the EU 2020 strategy goals of growth and, employment, and social progress in particular through its rural development programmes; highlights the need to support SMEs in the rural areas, as main creators of jobs with a particular target on young people; welcomes in this respect the proposed increase of CA by 1,3% (to EUR 14.808 million) for rural development;
Amendment 120 #
2012/2016(BUD)
Motion for a resolution
Paragraph 41
Paragraph 41
41. AskCalls for a continuedthe reduction of the support forto FRONTEX,; as well as for the number of recently set-up agencies under this heading (ks to reinforce the support for the European Asylum Support Office, and large-scale IT systems recently set-up agency under this heading, in particular; notes the 8,9 % decrease (- EUR 7,3 million) for the contribution to the European Police Office (EUROPOL) compared to the Budget 2012 and expects the Commission to provide additional details on this proposed cut;
Amendment 122 #
2012/2016(BUD)
Motion for a resolution
Paragraph 43
Paragraph 43
43. Appreciates theRegrets the modest increase, by EUR 9,8 million compared to the Budget 2012, proposed by the Commission for the European Refugee Fund, which is coherent with the line taken in the previous years; takes notes of; deeply regrets the 19% increase in the External Borders Fund's budget allocation up to EUR 415,5 million which is limited to half that foreseen by the Financial programming; recalls its strong request for an appropriate; regrets that the Commission's draft budget continues to focus on migration policies and on the monitoring and management of borders of the Union to the detriment of the promotion of justice and the protection and balenhanced answer to the challenges, withment of civil liberties; recalls that a that a vinew to the management of legal migration and slowing down of illegal migrationand broader strategic approach to development aid and the regulation of migratory flows is needed;
Amendment 128 #
2012/2016(BUD)
Motion for a resolution
Paragraph 47
Paragraph 47
47. Is criticalTakes note of the decreased volume of commitments for communication actions compared to the 2012 Budget at the moment when the gap between the European Union and its citizens is more evident than ever, as shown in ever- diminishing turnout in European elections; is convinced of the need for reinforced communication efforts and commensurate funding to ensure the visibility of the European Union institutions and showing their contribution to overcoming the economic and financial crisitakes note of the communication efforts to ensure the visibility of the European Union institutions;
Amendment 131 #
2012/2016(BUD)
Motion for a resolution
Paragraph 50 a (new)
Paragraph 50 a (new)
50a. Reiterates that a budgetary shift away from military action and security- oriented policies to civil conflict prevention is a necessary alternative in order to reduce military expenditure during a period of austerity;
Amendment 137 #
2012/2016(BUD)
Motion for a resolution
Paragraph 52
Paragraph 52
52. ConsiderReiterates that a sufficient level of EU financial assistance to the Palestinian Authority and UNRWA is still needed in order to adequately and comprehensively respond to the political and humanitarian situation in the Middle East and the Peace Process;
Amendment 140 #
2012/2016(BUD)
Motion for a resolution
Paragraph 54
Paragraph 54
54. Acknowledges the fact that with the accession of Croatia to the Union, a reduction of EUR 67,6 million will be made to IPA allocations; is nevertheless concerned that the Commission proposes a significant cut in support for institutional capacity building for candidate countries (- 29,14 million EUR compared to 2012), while the same line for potential candidates is reinforced (+10,5 million EUR compared to 2012); reminds that institutional capacity is of utmost importance for the rightful use of Union funding and is equally important for candidates and potential candidates; notwelcomes the proposed increase in CA for IPA rural development of 10,2% compared to Budget 2012;
Amendment 142 #
2012/2016(BUD)
Motion for a resolution
Paragraph 56
Paragraph 56
56. Recognizes the need for reaction to trans-regional threats of organised crime, trafficking, protection of critical infrastructure and threats to public health and fight against terrorism; however; calls on the Commission to provide evidence why an increase of 50% is needed for these measures in 2013;
Amendment 145 #
2012/2016(BUD)
Motion for a resolution
Paragraph 59
Paragraph 59
59. UnderstandRegrets that this was achieved through a reduction in the number of posts in its establishment plans by more than 1% already for 2013, notably in administrative support, budgetary management and anti- fraud, as well as through further cuts in other items of administrative expenditure; requires further explanation as to the actual need to proceed to such staff reductions to freeze administrative expenditure in real terms, when Commission managed to freeze its administrative expenditure in nominal terms in 2012 without resorting to any staff reduction;
Amendment 147 #
2012/2016(BUD)
Motion for a resolution
Paragraph 60
Paragraph 60
60. WelcomeRegrets this effort towards budget consolidationthe decrease in administrative expenditure, it goes against the objectives of job creation and employment in the EU 2020 strategy, specially at a time of economic and budgetary constraints at national level; is however concerned about the adverse impact such measures may have on the swift, regular and effective implementation of EU actions and programmes, especially at a time when EU competences keep increasing and new Member States join the Union; welcomes the presentation of those areas reinforced in staffing, such as European economic governance, Single Market, Security and Justice but requires similar information as to those policy areas and types of posts where cuts in staffing were made as compared to 2012;
Amendment 150 #
2012/2016(BUD)
Motion for a resolution
Paragraph 61
Paragraph 61
61. Reiterates against this background thatthat before considering any such staff reduction should be based on, a prior impact assessment has to be made and take full account of, inter alia, the Union's legal obligations, EU priorities, as well as the institutions‘ new competences and increased tasks arising from the treaties; stresses that within the EU 2020 growth, employment and social progress objectives, reassignment and job creation is to be prioritised; underlines that such assessment should also take carefully into account the effects for the different directorates-general and services, given their size and workload notably, as well as on the different types of posts concerned as presented in Commission's annual screening of human resources (policy making, programmes management, administrative support, budgetary management and antifraud, linguistic, etc.);
Amendment 156 #
2012/2016(BUD)
Motion for a resolution
Paragraph 63
Paragraph 63
63. Takes the viewReiterates that the European Schools shouldmust be adequately funded in the interests of addressing the specific situation of the children of agents of the EU institutions; underlines the need to enhance the support to multicultural pedagogical programmes and to reinforce intercultural projects; takes note of the proposed overall allocation of 180,7 million, which is a 6,8% increase as compared to 2012, and above the Financial programming amounts; will nonetheless carefully scrutinise each of the European Schools‘ budget lines, and make, during its reading, any modification it considers appropriate in this respect;
Amendment 162 #
2012/2016(BUD)
Motion for a resolution
Paragraph 69
Paragraph 69
69. Is however worried that for the first time the Commission cut the budgetary requests of almost all agencies, which were in line with Financial programming amounts overall, including of those agencies which belong to Parliament's priorities, for a total amount of some EUR 44 million; will carefully analyse the methodology, rationale and possible impact of such cuts; Underlines once more that EU agencies‘ budget allocations are far from consisting in administrative expenditure alone, but instead contribute to achieving the Europe 2020 goals and EU objectives in general, in particular job creation, employment and social progress as decided by the legislative authority;
Amendment 14 #
2012/0336(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EU, Euratom) No 966/2012
Article 204b – paragraph 1
Article 204b – paragraph 1
1. CThe contributions referred to in Article 204a(2) shall only be used to reimburse a percentage of the operating costs of European political parties that are directly linked to objectives of those parties. Contributions shall not be used to grant directly or indirectly any personal advantage, in cash or in kind, to any individual member or staff of a European political party.
Amendment 16 #
2012/0336(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EU, Euratom) No 966/2012
Article 204 b – paragraph 3
Article 204 b – paragraph 3
3. Contributions shall be subject toin full compliance with the principles of transparency and equal treatment, in accordance with the criteria laid down in Regulation (EU) No [….]. Furthermore, all contributions regardless of their amount are to be registered.
Amendment 19 #
2012/0336(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EU, Euratom) No 966/2012
Article 204g – paragraph 1 – point a
Article 204g – paragraph 1 – point a
(a) reimbursement of a percentage of the eligible expenditures actually incurred;
Amendment 21 #
2012/0336(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EU, Euratom) No 966/2012
Article 204k – paragraph 3
Article 204k – paragraph 3
3. European political parties shall respect the maximum co-financing rate established in Regulation xx/xxxx. Remaining amounts of the previous two years' contributions mayshall not be used to finance the part which European political parties must provide from their own resources. Furthermore, services provided or paid by third parties within the context of joint events shall not be taken into account when calculating the European political parties' share of own resources.
Amendment 22 #
2012/0336(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EU, Euratom) No 966/2012
Article 204l – paragraph 1
Article 204l – paragraph 1
The European political party shall, in accordance with the conditions and time limits laid down in the call for contributions, submit annually to the authorising officer for approval a final report on the use of the contribution and its accounts.
Amendment 12 #
2012/0295(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) The Fund for European Aid to the Most Deprived (hereinafter the ‘Fund’) should strengthen social cohesion by contributing to the reduction of poverty in the Union by supporting, primarily through the provision of food supplies, national schemes that provide non-financial assistance to the most deprived persons to alleviate food deprivation, homelessness and material deprivation of children.
Amendment 15 #
2012/0295(COD)
Proposal for a regulation
Recital 4 a (new)
Recital 4 a (new)
(4a) The Fund can not replace public policies undertaken by Member State governments to limit the need for emergency food aid and to develop sustainable targets and policies for the full eradication of hunger, poverty and social exclusion.
Amendment 21 #
2012/0295(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) It is necessary to establish a maximum level of co-financing from the Fund to the operational programmes to provide for a multiplier effect of Union resoThe Member States most in need of the Fund are least likely to be able to afford to co-finance the measurces, while the situation of Member States facing temporary budget difficulties should be addressetherefore the Fund should be 100% funded by the Union in order to ensure the highest possible uptake of the Fund.
Amendment 31 #
2012/0295(COD)
Proposal for a regulation
Article 2 – subparagraph 1 – point 7
Article 2 – subparagraph 1 – point 7
(7) ‘end recipient’final beneficiary" means the most deprived persons receiving the food or goods and/or benefiting from the accompanying measures;
Amendment 35 #
2012/0295(COD)
Proposal for a regulation
Article 4 – paragraph 1 a (new)
Article 4 – paragraph 1 a (new)
1a. The Member States most in need of the Fund are least likely to be able to afford to co-finance the measures, therefore the Fund should be 100% funded by the Union in order to ensure the highest possible uptake of the Fund.
Amendment 37 #
2012/0295(COD)
Proposal for a regulation
Article 5 – point 12 a (new)
Article 5 – point 12 a (new)
Amendment 41 #
2012/0295(COD)
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. The global resources available for budgetary commitment from the Fund for the period 2014-2020 shall be at least EUR 23 500 000 000 at 2011 prices, in accordance with the annual breakdown set out in Annex II.
Amendment 51 #
2012/0295(COD)
Proposal for a regulation
Article 10 – subparagraph 1 a (new)
Article 10 – subparagraph 1 a (new)
This platform shall include encouraging an exchange between all those working on immediate material deprivation alleviation and organisations working for longer-term, sustainable social reintegration, and looking at how links could be developed between these different objectives.
Amendment 53 #
2012/0295(COD)
Proposal for a regulation
Article 13 – paragraph 1 a (new)
Article 13 – paragraph 1 a (new)
Amendment 61 #
2012/0295(COD)
Proposal for a regulation
Article 18 – paragraph 1
Article 18 – paragraph 1
1. The co-financing rate at the level of the operational programme shall not be higher than 85be 100% of the public eligible expenditure.
Amendment 65 #
2012/0295(COD)
Proposal for a regulation
Article 18 – paragraph 2
Article 18 – paragraph 2
2. The Commission decision adopting an operational programme shall fix the co- financing rate applicable to the operational programme and the maximum amount of support from the Fund.
Amendment 70 #
2012/0295(COD)
Proposal for a regulation
Article 21 – paragraph 3 – subparagraph 2
Article 21 – paragraph 3 – subparagraph 2
They may also be purchased by a public body and made available free of charge to the partner organisations. In that case, the food may be obtained from the use, processing or sale of the products in intervention stocks made available in accordance with Article 15 of the Regulation (EU) No [CMO], provided that this is economically the most favourable option and does not unduly delay the delivery of the food products to the partner organisations. Any amount derived from a transaction concerning those stocks shall be used for the benefit of the most deprived persons, and. It shall not be applied so as to diminish the obligation of the Member States, provided in Article 18 of this Regulation, to co-finance the programmein addition to the obligations and allocated budgets, of and for the Member States.
Amendment 76 #
2012/0295(COD)
Proposal for a regulation
Article 35 – subparagraph 2 a (new)
Article 35 – subparagraph 2 a (new)
Any unused funds shall remain within the programme and shall be made available to other Member States using this programme or other beneficiaries as defined in Article 2.
Amendment 80 #
2012/0267(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) To ensure the highest level of health protection, the rules governing in vitro diagnostic medical devices manufactured and used, including measurement and delivery of results, only within a single health institutionsite should be clarified and strengthened.
Amendment 81 #
2012/0267(COD)
Proposal for a regulation
Recital 9 a (new)
Recital 9 a (new)
(9a) Having regard to the principle of subsidiarity, devices which are produced within health institution laboratories for use in that environment and are not subject to commercial transactions are not covered by this Regulation.
Amendment 84 #
2012/0267(COD)
Proposal for a regulation
Recital 9 b (new)
Recital 9 b (new)
(9b) However, devices which are manufactured within non-health- institution laboratories and put into service without being placed onto the market are subject to this Regulation.
Amendment 86 #
2012/0267(COD)
Proposal for a regulation
Recital 27
Recital 27
(27) The traceability of in vitro diagnostic medical devices by means of a Unique Device Identification (UDI) system based on international guidance should significantly enhance the effectiveness of the post-market safety of in vitro diagnostic medical devices due to improved incident reporting, targeted field safety corrective actions and better monitoring by competent authorities. It should also help to reduce medical errors and to fight against counterfeit devices. Use of the UDI system should also improve purchase-policy and stock- management by hospitals, wholesalers and pharmacists and be compatible with other authentication systems already in place in those settings.
Amendment 91 #
2012/0267(COD)
Proposal for a regulation
Recital 32
Recital 32
(32) For high-riskClass C and Class D in vitro diagnostic medical devices, manufacturers should summarise the main safety and performance aspects of the device and the outcome of the clinical evaluation in a document that should be publicly available.
Amendment 111 #
2012/0267(COD)
Proposal for a regulation
Article 1 – paragraph 6
Article 1 – paragraph 6
6. This Regulation requires that certain devices may only be supplied on a medical prescription but shall not affect national laws which require that certain other devices may also only be supplied on a medical prescription. Direct to consumer advertising of devices classed as prescription only by this regulation shall be illegal. The following devices may only be supplied on a medical prescription: 1) Class D devices 2) Class C devices in the following categories: (a) devices for genetic testing; (b) companion diagnostics. The Commission shall be empowered to adopt delegated acts in accordance with Article 85 to decide on other category C tests after consultation with stakeholders.
Amendment 115 #
2012/0267(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 4
Article 2 – paragraph 1 – subparagraph 1 – point 4
(4) ‘device for self-testing’ means any device intended by the manufacturer to be used by lay persons, including testing services offered to lay persons by means of information society services;
Amendment 117 #
2012/0267(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 6
Article 2 – paragraph 1 – subparagraph 1 – point 6
(6) ‘companion diagnostic’ means a device specifically intended to select patients with a previously diagnosed condition or predisposiintended to provide information that is essential for the safe and effective use of a corresponding therapeutic product. The use of a companion diagnostic with a particular therapeutic product is indicated as desirable in the instructions for use in the labelling of both the diagnostic device and the corresponding therapeutic product, as well as in the labelling of any generic equivalents of the therapeutic product or is the stated intended purpose of the diagnostic device. An IVD companion diagnostic device could be essential for the safe and effective use of a corresponding therapeutic product to: – identify patients who are most likely to benefit from a particular therapeutic product; – identify patients likely to be at increased risk for serious adverse reactions as eligible for a targeted therapy; a result of treatment with a particular therapeutic product; – monitor response to treatment for the purpose of adjusting treatment (e.g. schedule, dose, discontinuation) to achieve improved safety or effectiveness.
Amendment 118 #
2012/0267(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 10
Article 2 – paragraph 1 – subparagraph 1 – point 10
(10) ‘label’ means the written, printed, or graphic information appearing either on the device itself, or on the packaging of each unit, or on the packaging of multiple devices or on the manufacturer’s website;
Amendment 119 #
2012/0267(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 12 a (new)
Article 2 – paragraph 1 – subparagraph 1 – point 12 a (new)
(12a) ‘novel device’ means: – a device which incorporates technology (the analyte, technology or test platform) not previously used in diagnostics, or; – an existing device which is being used for a new intended purpose for the first time;
Amendment 120 #
2012/0267(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 12 a (new)
Article 2 – paragraph 1 – subparagraph 1 – point 12 a (new)
(12a) ‘ device for genetic testing’ means an in vitro diagnostic medical device the purpose of which is to identify a genetic characteristic of a person which is inherited or acquired during prenatal development.
Amendment 122 #
2012/0267(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 3 – point 21
Article 2 – paragraph 1 – subparagraph 3 – point 21
(21) ‘health institution’ means an organisation within a Member State’s public healthcare system whose primary purpose is the care or treatment of patients or the promotion of public health; commercial laboratories which provide diagnostic services are not health institutions.
Amendment 125 #
2012/0267(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 5 – point 32
Article 2 – paragraph 1 – subparagraph 5 – point 32
(32) ‘clinical performance’ means the ability of a device to yield results that are correlated with a particular clinical condition or a physiological state in accordance with the target popuclinical validity, and if appropriate, the clinical utility of the device in relation andto its intended upurposer;
Amendment 126 #
2012/0267(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 5 – point 32 a (new)
Article 2 – paragraph 1 – subparagraph 5 – point 32 a (new)
(32a) ‘clinical validity’ means a device’s ability to detect or predict a particular clinical condition or physiological state in relation to its intended purpose (e.g. screening, diagnosis, prognosis);
Amendment 127 #
2012/0267(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 5 – point 32 b (new)
Article 2 – paragraph 1 – subparagraph 5 – point 32 b (new)
(32b) ‘clinical utility’ means the anticipated effect(s) of the clinical use of the test result, including on health outcomes, where the intended purpose of a device, as stated by the manufacturer, includes a clinical use such as selection of a therapy (e.g. companion diagnostic);
Amendment 128 #
2012/0267(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 5 – point 38
Article 2 – paragraph 1 – subparagraph 5 – point 38
(38) ‘diagnostic specificity’ means the ability of a device to recognize the absence of a target marker associated with a particular disease or conditionproportion of subjects who do not have or a specified clinical disorder whose test results are negative or within the defined decision limit;
Amendment 129 #
2012/0267(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 5 – point 39
Article 2 – paragraph 1 – subparagraph 5 – point 39
(39) ‘diagnostic sensitivity’ means the ability of a device to identify the presence of a target marker associated with a particular disease or condition; proportion of subjects with a well-defined clinical disorder whose test values are positive or exceed a defined decision limit (i.e. a positive result and identification of the subjects who have a disease);
Amendment 133 #
2012/0267(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 7 – point 58 a (new)
Article 2 – paragraph 1 – subparagraph 7 – point 58 a (new)
(58a) ‘laboratory-developed test’ means a device that is manufactured and used only within a single site. This includes devices which a laboratory develops de novo, or develops or modifies from a published source, or develops or modifies from any other source, and devices for which a laboratory: – changes the intended purpose of a device already placed on the market or put into service; – modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected.
Amendment 137 #
2012/0267(COD)
Proposal for a regulation
Article 4 – paragraph 5 – subparagraph 1
Article 4 – paragraph 5 – subparagraph 1
With the exception of Article 59(4), the requirements of this Regulation shall not apply to devices classified as class A, B and C, in accordance with the rules set out in Annex VII, andlaboratory-developed tests manufactured and used only within a single health institution, provided manufacture and use occur solely under the health institution’s single quality management system, and the health institution is compliant withaccredited to standard EN ISO 15189 or any other equivalent recognised standard. Member States may require that the health institutions submit to the competent authority a list of such devices which have been manufactured and used on their territory and may make the manufacture and use of the devices concerned subject to further safety requirements.
Amendment 139 #
2012/0267(COD)
Proposal for a regulation
Article 4 – paragraph 5 – subparagraph 2
Article 4 – paragraph 5 – subparagraph 2
Amendment 144 #
2012/0267(COD)
Proposal for a regulation
Article 4 a (new)
Article 4 a (new)
Amendment 145 #
2012/0267(COD)
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
2. Without prejudice to national legislation regarding the exercise of the medical profession, aA device that is not placed on the market but is used in the context of a commercial activity for the provision of a diagnostic or therapeutic service offered by any means of information society services as defined in Article 1(2) of Directive 98/34/EC or by other means of communicationcommunication (including by means of information society services) to a natural or legal person established in the Union shall comply with this Regulation.
Amendment 174 #
2012/0267(COD)
Proposal for a regulation
Article 12 – paragraph 4
Article 12 – paragraph 4
4. Distributors who consider or have reason to believe that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, his authorised representative and the importer and make sure that, within the limits of its respective activities, the necessary corrective action to bring that device into conformity, withdraw or recall it, if appropriate, is taken. Where the device presents a risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available, giving details, in particular, of the non- compliance and of any corrective action taken.
Amendment 186 #
2012/0267(COD)
Proposal for a regulation
Article 21 – paragraph 1 – point c
Article 21 – paragraph 1 – point c
(c) any health instituorganization or healthcare professional to whom they have supplied a device.
Amendment 189 #
2012/0267(COD)
Proposal for a regulation
Article 22 – paragraph 8 – point e a (new)
Article 22 – paragraph 8 – point e a (new)
(ea) the compatibility with other traceability systems used by the stakeholders involved with medical devices.
Amendment 239 #
2012/0267(COD)
Proposal for a regulation
Article 39 – paragraph 1
Article 39 – paragraph 1
1. Devices shall be divided into class A, B, C and D, taking into account their intended purpose, novelty, complexity and inherent risks. Classification shall be carried out in accordance with the classification criteria set out in Annex VII.
Amendment 273 #
2012/0267(COD)
Proposal for a regulation
Article 42 – paragraph 1
Article 42 – paragraph 1
1. Notified bodies shall notify the Commission of applications for conformity assessments for devices classified as class D and for devices classified as class C which fulfil the definition of novelty set out in Article 2(12a), with the exception of applications to supplement or renew existing certificates. The notification shall be accompanied by the draft instructions for use referred to in Section 17.3 of Annex I and the draft summary of safety and performance referred to in Article 24. In its notification the notified body shall indicate the estimated date by which the conformity assessment is to be completed. The Commission shall immediately transmit the notification and the accompanying documents to the MDCG.
Amendment 291 #
2012/0267(COD)
Proposal for a regulation
Article 50 – paragraph 3 – point b
Article 50 – paragraph 3 – point b
Amendment 309 #
2012/0267(COD)
Proposal for a regulation
Article 59 – paragraph 3 – subparagraph 1
Article 59 – paragraph 3 – subparagraph 1
The Member States shall take all appropriate measures to encourage healthcare professionals, including doctors and pharmacists, users and patients to report to their competent authorities suspected serious incidents referred to in point (a) of paragraph 1. They shall record such reports centrally at national level. Where a competent authority of a Member State obtains such reports, it shall take the necessary steps to ensure that the manufacturer of the device concerned is informed of the incident. The manufacturer shall ensure the appropriate follow-up.
Amendment 345 #
2012/0267(COD)
Proposal for a regulation
Annex 1 – part II – point 6 – point 6.1 – point b
Annex 1 – part II – point 6 – point 6.1 – point b
(b) the clinical performance, including measures of clinical validity such as diagnostic sensitivity, diagnostic specificity, positive and negative predictive value, likelihood ratio, expected values in normal or affected populations; and, where appropriate, measures of clinical utility. In the case of companion diagnostics, evidence of the clinical utility of the device for the intended purpose (selection of patients with a previously diagnosed condition or predisposition eligible for a targeted therapy) is required. For a companion diagnostic, the manufacturer should supply clinical evidence relating to the impact of a positive or negative test on (1) patient care; and (2) health outcomes, when used as directed with the stated therapeutic intervention.
Amendment 348 #
2012/0267(COD)
Proposal for a regulation
Annex 1 – part III – point 17 – point 17.1 – paragraph 1 – introductory part
Annex 1 – part III – point 17 – point 17.1 – paragraph 1 – introductory part
Each device shall be accompanied by the information needed to identify the device and its manufacturer, and communicate safety and performance related information to the user, professional or lay, or other person, as appropriate. Such information may appear on the device itself, on the packaging or in the instructions for use, and must be made available on the manufacturer's website taking into account the following:
Amendment 350 #
2012/0267(COD)
Proposal for a regulation
Annex 1 – part III – point 17 – point 17.3 – point 17.3.1 – point ii – indent 2
Annex 1 – part III – point 17 – point 17.3 – point 17.3.1 – point ii – indent 2
– its function (e.g. screening, monitoring, diagnosis or aid to diagnosis, prognosis, companion diagnostic);
Amendment 351 #
2012/0267(COD)
Proposal for a regulation
Annex 1 – part III – point 17 – point 17.3 – point 17.3.1 – point ii – indent 7 a (new)
Annex 1 – part III – point 17 – point 17.3 – point 17.3.1 – point ii – indent 7 a (new)
- for companion diagnostics, the relevant target population and directions for use with associated therapeutic(s).
Amendment 354 #
2012/0267(COD)
Proposal for a regulation
Annex 2 – point 1 – point 1.1 – point c – point ii
Annex 2 – point 1 – point 1.1 – point c – point ii
(ii) its function (e.g. screening, monitoring, diagnosis or aid to diagnosis, prognosis, companion diagnosis);
Amendment 355 #
2012/0267(COD)
Proposal for a regulation
Annex 2 – point 1 – point 1.1 – point c – point viii a (new)
Annex 2 – point 1 – point 1.1 – point c – point viii a (new)
(viii a) for companion diagnostics, the relevant target population and directions for use with the associated therapeutic(s).
Amendment 385 #
2012/0267(COD)
Proposal for a regulation
Annex 7 – part 1 – point 1.1
Annex 7 – part 1 – point 1.1
1.1. Application of the classification rules shall be governed by the intended purpose, novelty, complexity and inherent risk of the devices.
Amendment 386 #
2012/0267(COD)
Proposal for a regulation
Annex 7 – part 2 – point 2.3 – paragraph 1 – point f – point i
Annex 7 – part 2 – point 2.3 – paragraph 1 – point f – point i
(i) Devices intended to be used as companion diagnostics; or are classified as a Class C, except when intended to identify patients at risk of life-threatening adverse event, or where the selection decision may lead to the withholding of a potentially life-saving treatment, in which case they are Class D
Amendment 387 #
2012/0267(COD)
Proposal for a regulation
Annex 7 – part 2 – point 2.3 – paragraph 1 – point f – point ii
Annex 7 – part 2 – point 2.3 – paragraph 1 – point f – point ii
(ii) Devices intended to be used for disease staging or prognosis; or
Amendment 388 #
2012/0267(COD)
Proposal for a regulation
Annex 7 – part 2 – point 2.3 – paragraph 1 – point j a (new)
Annex 7 – part 2 – point 2.3 – paragraph 1 – point j a (new)
(j a) IVDs for the detection and identification of antibodies directed against erythrocytes, platelets, or leucocytes.
Amendment 389 #
2012/0267(COD)
Proposal for a regulation
Annex 7 – part 2 – point 2.6 – paragraph 1
Annex 7 – part 2 – point 2.6 – paragraph 1
Devices not covered by the above- mentioned classification rules are classified as class B. However, novel class B devices will be classified as class C.
Amendment 398 #
2012/0267(COD)
Proposal for a regulation
Annex 12 – section 1 – point 1 – point 1.2.2 – point 1.2.2.6 – indent 2
Annex 12 – section 1 – point 1 – point 1.2.2 – point 1.2.2.6 – indent 2
– For devices classified as class C and class D according to the rules set out in Annex VII, the clinical performance study report shall include the method of data analysis, the study conclusion and, the relevant details of the study protocol; and the individual data points.
Amendment 399 #
2012/0267(COD)
Proposal for a regulation
Annex 12 – section 1 – point 1 – point 1.2.2 – point 1.2.2.6 – indent 3
Annex 12 – section 1 – point 1 – point 1.2.2 – point 1.2.2.6 – indent 3
Amendment 491 #
2012/0266(COD)
Proposal for a regulation
Article 30 – paragraph 4 a (new)
Article 30 – paragraph 4 a (new)
4a. The annual assessment of notified bodies as provided for in Article 35(3) shall include verification of the compliance of the subcontractor(s) or the subsidiary(ies) of notified bodies according to the requirements set out in Annex VI.
Amendment 494 #
2012/0266(COD)
Proposal for a regulation
Article 32 – paragraph 3
Article 32 – paragraph 3
3. Within 14 days of the submission referred to in paragraph 2, the Commission shall designate a joint assessment team made up of at least two experts chosen from a list of experts who are qualified in the assessment of conformity assessment bodies and free of conflicts of interest with the applicant conformity assessment body. The list shall be drawn up by the Commission in cooperation with the MDCG. At least one of these experts shall be a representative of the Commission who shall lead the joint assessment team.
Amendment 504 #
2012/0266(COD)
Proposal for a regulation
Article 33 – paragraph 9
Article 33 – paragraph 9
9. Where no objection is raised in accordance with paragraph 7 or where the MDCG or the Commission, after having been consulted in accordance with paragraph 8, is of the opinion that the notification may be accepted fully or partially, the Commission shall publish the notification accordingly, and shall also add the information relating to the notification of the notified body to the electronic system referred to in Article 27(2).
Amendment 510 #
2012/0266(COD)
Proposal for a regulation
Article 35 – paragraph 3
Article 35 – paragraph 3
3. At least once a year, the national authority responsible for notified bodies shall assess whether each notified body under its responsibility still satisfies the requirements set out in Annex VI, including an assessment of whether its subcontractor(s) and subsidiary(ies) satisfy these requirements. This assessment shall include an on-site visit to each notified body.
Amendment 514 #
2012/0266(COD)
Proposal for a regulation
Article 35 – paragraph 4
Article 35 – paragraph 4
4. Three years after notification of a notified body, and again every third year thereafter, the assessment to determine whether the notified body still satisfies the requirements set out in Annex VI shall be conducted by the national authority responsible for notified bodies of the Member State in which the body is established and a joint assessment team designated in accordance with the procedure described in Article 32(3) and (4). At the request of the Commission or of a Member State, the MDCG may initiate the assessment process described in this paragraph at any time when there is reasonable concern about the ongoing compliance of a notified body, or a subsidiary or subcontractor of a notified body, with the requirements set out in Annex VI.
Amendment 747 #
2012/0266(COD)
Proposal for a regulation
Article 83 – paragraph 1
Article 83 – paragraph 1
The Commission and the Member States shall take all appropriate measures to encourage the establishment of registers for specific types ofmedical devices to gather post- market experience related to the use of such devices. Such registers shall contribute to the independent evaluation of the long-term safety and performance of devices and to the traceability of such devices.
Amendment 763 #
2012/0266(COD)
Proposal for a regulation
Annex 1 – part II – point 7 – point 7.4 – introductory part
Annex 1 – part II – point 7 – point 7.4 – introductory part
7.4. The devices shall be designed and manufactured in such a way as to reduce as far as possible and appropriate the risks posed by substances that may leach or leak from the device. Special attention shall be given to shazardous substances. Substances. which are carcinogenic, mutagenic or toxic to reproduction, in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 , and to substances having endocrine disrupting properties for which there is scientific evidence of probable serious effects to human health and which are identified in accordance with the procedure set out in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) . shall be phased out within 5 years from the entry into force of this Regulation, unless no safer alternative substances are available. In the case that no safer alternatives exist, the medical device shall be labelled and the manufacturer shall provide a specific justification for the use of these substances with regard to compliance with the general safety and performance requirements, in particular of this paragraph, the technical documentation and, within the instructions for use, information on residual risks for patient groups and, if applicable, on appropriate precautionary measures. Devices containing substances having endocrine disrupting properties that come into contact with the body of patients and for which there is scientific evidence of probable serious effects to human health and which are identified in accordance with the procedure set out in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) , or are known or presumed endocrine disruptors pursuant to Commission Recommendation (2013/.../EU) on criteria for the identification of Endocrine Disrupters, shall be phased out within 5 years from the entry into force of this Regulation, unless no safer alternative substances are available. In the case that no safer alternatives exist, the medical device shall be labelled and the manufacturer shall provide a specific justification for the use of these substances with regard to compliance with the general safety and performance requirements, in particular of this paragraph, the technical documentation and, within the instructions for use, information on residual risks for patient groups and, if applicable, on appropriate precautionary measures.
Amendment 767 #
2012/0266(COD)
Proposal for a regulation
Annex 1 – part II – point 7 – point 7.4 – paragraph 1 – indent 3 – paragraph 1
Annex 1 – part II – point 7 – point 7.4 – paragraph 1 – indent 3 – paragraph 1
contain, in a concentration of 0.1% by mass of the plasticised material or above, phthalates which are classified as carcinogenic, mutagenic or toxic to reproduction of category 1A or 1B in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008, these devices shall be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging as devices containing phthalates. If the intended use of such devices includes treatment of children or treatment of pregnant or nursing women,, these substances shall be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging as devices containing phthalates, phased out within 5 years from the entry into force of this Regulation, unless no safer alternatives are available. In the case that no safer alternatives exist, the medical devices shall be labelled and the manufacturer shall provide a specific justification for the use of these substances with regard to compliance with the general safety and performance requirements, in particular of this paragraph, within the technical documentation and, within the instructions for use, information on residual risks for these patient groups and, if applicable, on appropriate precautionary measures. If the intended use of such devices includes treatment of children or treatment of pregnant or nursing women, phthalates shall be banned as of 1st January 2017.
Amendment 810 #
2012/0266(COD)
Proposal for a regulation
Annex 6 – point 3 – point 3.1 – point 3.1.1 – paragraph 1
Annex 6 – point 3 – point 3.1 – point 3.1.1 – paragraph 1
In particular, it shall have the necessary personnel and shall possess or have access to all equipment and facilities needed to perform properly the technical, scientific and administrative tasks entailed in the conformity assessment activities in relation to which it has been notified.
Amendment 816 #
2012/0266(COD)
Proposal for a regulation
Annex 6 – point 3 – point 3.1 – point 3.1.3
Annex 6 – point 3 – point 3.1 – point 3.1.3
3.1.3. The notified body shall clearly document the extent and the limits of the duties, responsibilities and authorities in relation of the personnel, including any subcontractors and subsidiaries, involved in conformity assessment activities and inform the personnel concerned about it.
Amendment 819 #
2012/0266(COD)
Proposal for a regulation
Annex 6 – point 3 – point 3.2 – point 3.2.2 – paragraph 1
Annex 6 – point 3 – point 3.2 – point 3.2.2 – paragraph 1
Specific qualification criteria shall be defined for the assessment of biocompatibility aspects, safety, clinical evaluation and the different types of sterilisation processes.
Amendment 829 #
2012/0266(COD)
Proposal for a regulation
Annex 6 – point 3 – point 3.2 – point 3.2.5 – indent 4 a (new)
Annex 6 – point 3 – point 3.2 – point 3.2.5 – indent 4 a (new)
- appropriate knowledge and experience of clinical evaluation;
Amendment 70 #
2012/0192(COD)
Proposal for a regulation
Article 3 – paragraph 1 – indent 1 a (new)
Article 3 – paragraph 1 – indent 1 a (new)
- the evaluation of the ethical acceptability of the clinical trial is positive;
Amendment 83 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 5 a (new)
Article 5 – paragraph 5 a (new)
5a. The assessment report shall be submitted through the EU portal and made publicly available.
Amendment 127 #
2012/0192(COD)
Proposal for a regulation
Recital 23
Recital 23
(23) This Regulation should provide for clear rules concerning informed consent in emergency situations. Such situations relate to cases where for example a patient has suffered a sudden life-threatening medical condition due to multiple traumas, strokes or heart attacks, necessitating immediate medical intervention. For such cases, intervention within an ongoing clinical trial, which has already been approved, may be pertinent. However, in certain circumstances, due to the unconsciousness of the patient and the absence of an immediately available legal representative, it is not possible to obtain informed consent prior to the intervention. The Regulation should therefore set clear rules whereby such patients may be enrolled in the clinical trial under very strict conditions. In addition, the said clinical trial should relate directly to the medical condition which causes the impossibility of the patient to give informed consent. Any previously expressed objection by the patient must be respected, and informed consent from the subject or the legal representative should be sought as soon as possible. An ethics committee should positively assess the direct benefit of the clinical trial to the patient, as well as the fact that the clinical trial poses a minimal risk to, and imposes a minimal burden on, the subject;
Amendment 134 #
2012/0192(COD)
Proposal for a regulation
Article 27a (new)
Article 27a (new)
Amendment 144 #
2012/0192(COD)
Proposal for a regulation
Article 34 – paragraph 3 – subparagraph 1
Article 34 – paragraph 3 – subparagraph 1
Within one year from the end of a clinical trial, the sponsor shall submit to the EU database a summary of the results of the clinical trial, whether the results are positive or negative or inconclusive.
Amendment 149 #
2012/0192(COD)
Proposal for a regulation
Recital 37
Recital 37
(37) The information generated in the clinical trial should be recorded, handled and stored adequately for the purpose of ensuring subject rights and, safety, and well- being, and the robustness and reliability of the data generated in the clinical trial, accurate reporting and interpretation, effective monitoring by the sponsor and effective inspection by Member States or the Commission.
Amendment 179 #
2012/0192(COD)
Proposal for a regulation
Recital 66
Recital 66
(66) Since the objective of this Regulation, namely to ensure that, throughout the Union, clinical trial data are reliable and robust while ensuring the safety, well- being and rights of subjects, cannot sufficiently be achieved by the Member States and can, by reason of the scale of the measure, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective,
Amendment 187 #
2012/0192(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 2 – point a
Article 2 – paragraph 2 – point 2 – point a
(a) the investigational medicinal products are not authorised in any Member State;
Amendment 224 #
2012/0192(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 12
Article 2 – paragraph 2 – point 12
(12) ‘Substantial modification’: any change to any aspect of the clinical trial which is made after notification of the decision referred to in Articles 8, 14, 19, 20 and 23 and which is likely to have a substantial impact on the safety or, rights or well-being of the subjects or on the reliability and robustness of the data generated in the clinical trial;
Amendment 243 #
2012/0192(COD)
Proposal for a regulation
Article 3 – paragraph 1 – indent 1
Article 3 – paragraph 1 – indent 1
– the rights, safety, dignity and well-being of subjects are protected; and
Amendment 245 #
2012/0192(COD)
Proposal for a regulation
Article 3 – paragraph 1 – indent 1 a (new)
Article 3 – paragraph 1 – indent 1 a (new)
- the evaluation of the ethical acceptability of the clinical trial is positive;
Amendment 253 #
2012/0192(COD)
Proposal for a regulation
Article 4 a (new)
Article 4 a (new)
Article 4 a Ethics Committee 1. Authorisation of a clinical trial shall not be granted before an independent ethics committee has made a positive decision on the clinical trial. The Ethics Committee assessment shall include, in particular, the compliance with the requirements specified in Chapter V, Article 46, Article 47 and Chapter XII. 2. The Ethics Committee shall ensure that the rights, safety and well-being of subjects are protected. It shall be independent of the researcher, independent of the sponsor, and free of any other undue influence. It shall act in accordance with the laws and regulations of the country or countries in which the research is to be conducted and shall abide by all relevant international norms and standards. The Ethics Committee shall consist of a reasonable number of members, who collectively possess the relevant qualifications and experience to be able to review and evaluate the scientific, medical and ethical aspects of the proposed trial. 3. Member States shall take the necessary measures to establish Ethics Committees and facilitate their work.
Amendment 260 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 2
Article 5 – paragraph 1 – subparagraph 2
The sponsor shall propose one of the Member States concerned as reporting Member StateMember States concerned shall determine which state shall be the reporting Member State according to an established procedure based on objective criteria which are set by the Commission.
Amendment 264 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 3
Article 5 – paragraph 1 – subparagraph 3
Amendment 269 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 2 – introductory part
Article 5 – paragraph 2 – introductory part
2. Within six14 days following submission of the application dossier, the proposed reporting Member State shall notify the sponsor through the EU portal of the following:
Amendment 276 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 3
Article 5 – paragraph 3
3. Where the proposed reporting Member State has not notified the sponsor within the time period referred to in paragraph 214 days, the clinical trial applied for shall be considered as falling within the scope of this Regulation, the application shall be considered complete, the clinical trial shall be considered a low-intervention clinical trial if this is claimed by the sponsor, and the proposed reporting Member State shall be the reporting Member State.
Amendment 286 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 5 a (new)
Article 5 – paragraph 5 a (new)
5 a. The assessment report shall be submitted through the EU portal and made publicly available.
Amendment 305 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
2. The reporting Member State shall draw up an assessment report. Simultaneously the concerned Member States shall assess the ethical aspects of paragraph 1. The assessment of the aspects referred to in paragraph 1 shall constitute Part I of the assessment report, which shall include the assessment of the ethical aspects provided by the Member States involved in the procedure.
Amendment 308 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – introductory part
Article 6 – paragraph 4 – subparagraph 1 – introductory part
4. The reporting Member State shall submit Part I of the assessment report, including its conclusion, to the sponsor and to the other Member States concerned within the following time periods, within which the concerned Member States shall also be obliged to submit their comments on the ethical aspects to the parties involved:
Amendment 310 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point a
Article 6 – paragraph 4 – subparagraph 1 – point a
(a) within 10 days from the validation date25 days, but no earlier than 15 days after receipt of the successfully validated application, for low-intervention clinical trials;
Amendment 313 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point b
Article 6 – paragraph 4 – subparagraph 1 – point b
(b) within 25 days from the validation date35 days but no earlier than 20 days after receipt of the successfully validated application for clinical trials other than low- intervention clinical trials;
Amendment 317 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point c
Article 6 – paragraph 4 – subparagraph 1 – point c
(c) within 30 days from the validation date40 days but no earlier than 30 days after receipt of the successfully validated application for any clinical trial with an advanced therapy investigational medicinal product.
Amendment 321 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 5
Article 6 – paragraph 5
5. Until the assessment date, any Member State concerned may communicate to the reporting Member State any considerations relevant to the application. The reporting Member State shall take those considerations duly into account and shall document them in the assessment report. If the assessment report of the reporting Member State deviates from the considerations of the Member States concerned, it shall state the reasons for this deviation in the assessment report.
Amendment 333 #
2012/0192(COD)
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – point a
Article 7 – paragraph 1 – subparagraph 1 – point a
(a) compliance with the requirements for the protection of the subjects and informed consent as set out in Chapter V;
Amendment 354 #
2012/0192(COD)
Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 2 – point b a (new)
Article 8 – paragraph 2 – subparagraph 2 – point b a (new)
(ba) well-founded ethical concerns that emerge from the assessment in Article 6, paragraph 1;
Amendment 356 #
2012/0192(COD)
Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 3
Article 8 – paragraph 2 – subparagraph 3
Where the Member State concerned disagrees with the conclusion onf the basis of point (a) of the second subparagraph, it shall communicate its disagreement, together with a detailed justification based on scientific and socio-economic arguments, and a summary thereof,reporting Member State, it shall communicate its disagreement through the EU portal to the Commission, to all Member States, and to the sponsor.
Amendment 385 #
2012/0192(COD)
Proposal for a regulation
Article 10 – paragraph 3 a (new)
Article 10 – paragraph 3 a (new)
3a. Where national provisions on the protection of clinical trial subjects are more comprehensive than the provisions of this Regulation, the most protective measures shall apply.
Amendment 409 #
2012/0192(COD)
Proposal for a regulation
Article 15
Article 15
A substantial modification may only be implemented if it has been approved in accordance with the procedure set out in this Chapter, and if it has been approved by an independent ethics committee before its implementation.
Amendment 447 #
2012/0192(COD)
Proposal for a regulation
Article 27 a (new)
Article 27 a (new)
Article 27a Public access to clinical study reports Free and easy access to clinical data held in the Agency's database and particularly to clinical study reports shall be granted to the public. To this end, an hyperlink shall be included to the clinical study reports of the clinical trials.
Amendment 451 #
2012/0192(COD)
Proposal for a regulation
Article 28 – paragraph 1 – point c
Article 28 – paragraph 1 – point c
(c) the subject or, where the subject is not able to give informed consent, his or her legal representative has given informed consent. Any person asked to participate in a clinical trial shall have the right to refuse such participation without any resulting liability or detriment;
Amendment 454 #
2012/0192(COD)
Proposal for a regulation
Article 28 – paragraph 1 – point d
Article 28 – paragraph 1 – point d
(d) the subject or, where the subject is not able to give informed consent, his or her legal representative has had the opportunity, in a prior interview with a medical doctor who is the investigator or a member of the investigating team, to understand the objectives, risks and inconveniences of the clinical trial, and the conditions under which it is to be conducted and has also been informed of the right to withdraw from the clinical trial at any time without any resulting detriment;
Amendment 464 #
2012/0192(COD)
Proposal for a regulation
Article 29 – paragraph 1
Article 29 – paragraph 1
1. Informed consent shall be written, dated and signed and given freely by the subject or his or her legal representative after having been duly informed of the nature, significance, implications and risks of the clinical trial. It shall be appropriately documented. Where the subject is unable to write, oral consent in the presence of at least one impartial witness may be given in exceptional cases and the identity of this impartial witness shall be registered. The subject or his or her legal representative shall be provided with a copy of the document by which informed consent has been given.
Amendment 467 #
2012/0192(COD)
Proposal for a regulation
Article 29 – paragraph 2
Article 29 – paragraph 2
2. Written information shall be given to the subject and/or the legal representative fprior the purposes ofo the obtaining of his or her informed consent. It shall be kept concise, clear, relevant, and understandable to a lay person. It shall include both medical and legal information. It shall inform the subject about his or her right to revoke his or her informed consent at any time of the clinical trial.
Amendment 474 #
2012/0192(COD)
Proposal for a regulation
Article 30 – paragraph 1 – point a
Article 30 – paragraph 1 – point a
(a) the informed consent of the legal representative has been obtained, whereby; consent shall represent the subject's presumed will and may be revoked at any time, without detriment to the subject;
Amendment 478 #
2012/0192(COD)
Proposal for a regulation
Article 30 – paragraph 1 – point c
Article 30 – paragraph 1 – point c
(c) the explicit wish of an incapacitated subject who is capable of forming an opinion and assessing this information to refuse participation in, or to be withdrawn from, the clinical trial at any time is consideredduly taken into account by the investigator;
Amendment 481 #
2012/0192(COD)
Proposal for a regulation
Article 30 – paragraph 1 – point h a (new)
Article 30 – paragraph 1 – point h a (new)
(ha) the Ethics Committee, with expertise in the relevant disease and the patient population concerned, or after taking advice in clinical, ethical and psychosocial questions in the field of the relevant disease and patient population concerned, has endorsed the protocol;
Amendment 491 #
2012/0192(COD)
Proposal for a regulation
Article 31 – paragraph 1 – point c
Article 31 – paragraph 1 – point c
(c) the explicit wish of a minor who is capable of forming an opinion and assessing this information to refuse participation in, or to be withdrawn from, the clinical trial at any time, is duly taken into consideration by the investigator in accordance with his or her age and maturity;
Amendment 496 #
2012/0192(COD)
Proposal for a regulation
Article 31 – paragraph 1 – point h b (new)
Article 31 – paragraph 1 – point h b (new)
(hb) the corresponding scientific guidelines of the Agency have been followed;
Amendment 498 #
2012/0192(COD)
Proposal for a regulation
Article 31 – paragraph 1 – point h d (new)
Article 31 – paragraph 1 – point h d (new)
(hd) the Ethics Committee, with paediatric expertise or after taking advice in clinical, ethical and psychosocial problems in the field of paediatrics, has endorsed the protocol;
Amendment 513 #
2012/0192(COD)
Proposal for a regulation
Article 32 – paragraph 1 – point e
Article 32 – paragraph 1 – point e
(e) the Ethics committee positively assesses that a direct benefit of the clinicial trial for the patient is to be expected, as well as the fact that the clinical trial poses a minimal risk to, and imposes a minimal burden on, the subject.
Amendment 528 #
2012/0192(COD)
Proposal for a regulation
Article 34 – paragraph 3 – subparagraph 1
Article 34 – paragraph 3 – subparagraph 1
3. Within one year from the end of a clinical trial, the sponsor shall submit to the EU database a summary of the results of the clinical trial, whether the results are positive or negative and inconclusive.
Amendment 570 #
2012/0192(COD)
Proposal for a regulation
Article 40 – paragraph 2 a (new)
Article 40 – paragraph 2 a (new)
2 a. The responsible Ethics Committee shall be involved in the assessment of this information.
Amendment 45 #
2012/0035(COD)
Proposal for a directive
Citation 1
Citation 1
Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 168(7) and 114 thereof,
Amendment 46 #
2012/0035(COD)
Proposal for a directive
Recital 2
Recital 2
(2) In order to take into account the evolution of the pharmaceutical market and of national policies to control public expenditure on medicineal products, substantive changes are necessary to all major provisions of Directive 89/105/EEC. Therefore, in the interest of clarity, Directive 89/105/EEC should be replaced.
Amendment 49 #
2012/0035(COD)
Proposal for a directive
Recital 4
Recital 4
(4) Member States have been confronted to a steady rise in pharmaceutical expenditure over the last decades, leading to the adoption of increasingly innovative and complex policies to manage the consumption of medicineal products in the framework of their public health insurance systems. In particular, Member States‘ authorities have implemented a broad range of measures to control the prescription of medicineal products, to regulate their prices or to establish the conditions of their public funding. Such measures mainly aim at promoting public health for all citizens by ensuring the availability of adequate supplies of effective medicinal products at reasonable costs, while ensuring the financial stability of public health insurance systemsan equal access to high quality healthcare for all.
Amendment 60 #
2012/0035(COD)
Proposal for a directive
Recital 12
Recital 12
(12) In its Communication ‘Executive Summary of the Pharmaceutical Sector Inquiry Report’ the Commission demonstrated that pricing and reimbursement procedures often unnecessarily delay the launch of generic medicineor biosimilar medicinal products in Union markets. Approving the price of generic or biosimilar medicinal products and their coverage by the health insurance system should not require any new or detailed assessment when the reference product has already been priced and included in the health insurance system. It is therefore appropriate to lay down shorter time limits for generic or biosimilar medicinal products in those cases.
Amendment 65 #
2012/0035(COD)
Proposal for a directive
Recital 14
Recital 14
(14) The quality, safety and efficacy of medicinal products, including orphan medicinal products and the bioequivalence of generic or biosimilar medicinal products with the reference product, are ascertained in the framework of marketing authorisation procedures. In the framework of pricing and reimbursement procedures, Member States should therefore not re-assess the elements on which the marketing authorisation is based, including the quality, safety, efficacy or bioequivalence of the medicinal product.
Amendment 74 #
2012/0035(COD)
Proposal for a directive
Recital 15 a (new)
Recital 15 a (new)
(15a) ) Member States should ensure the public availability of documents and information in an appropriate publication, in accordance with national practice, which should include electronic and online formats.
Amendment 76 #
2012/0035(COD)
Proposal for a directive
Recital 15 b (new)
Recital 15 b (new)
(15b) The principles of transparency, integrity and independence of the decision-making processes should be carried out by national competent public authorities, who are responsible for pricing and reimbursement decisions.
Amendment 78 #
2012/0035(COD)
Proposal for a directive
Recital 16
Recital 16
(16) Member States have frequently amended their health insurance schemes or adopted new measures falling within the scope of Directive 89/105/EEC. It is therefore necessary to establish information mechanisms intended, on the one hand, to ensure the consultation of interested stakeholders including patient and consumer organisations and, on the other hand, to facilitate preventive dialogue with the Commission as regards the application of this Directive.
Amendment 239 #
2012/0035(COD)
Proposal for a directive
Article 13
Article 13
Amendment 257 #
2012/0035(COD)
Proposal for a directive
Article 15
Article 15
Where a Member State intends to adopt or amend any measure falling within the scope of this Directive, it shall give interested parties, including patient and consumer organisations, the opportunity to comment on the draft measure within a reasonable period. The competent authorities shall publish the rules applicable to consultations. The results of consultations shall be made publicly available, with the exception of confidential information in accordance with Union and national legislation regarding business confidentiality.
Amendment 262 #
2012/0035(COD)
Proposal for a directive
Article 16
Article 16
Amendment 1 #
2011/2152(ACI)
Draft opinion
Paragraph 1
Paragraph 1
1. WelcomeRejects the political agreement reached on 27 June 2013 at the highest political level between Parliament, the Irish Presidency and the Commission on the Multiannual Financial Framework (MFF) 2014-2020 package (MFF Regulation and IIA), as the maximum achievable under the current circumstances and procedures; Is determined to make full use, is agreement, does not reflect any of the priorities and concerns that could contribute to a turn- around in the current social, economic and financial crisis that could obviate the current social emergency situation existing in so many EU Member States; underlines, that this agreement, which will bind the course of forthcoming budgetary procedures, of the new instruments established, notably as regards flexibilityUnion for the next seven years, and the measures of the European Council, the European Commission, the European Central bank and the International Monetary Fund to fight the social, economic and financial crisis will only bring about a dramatic increase in unemployment, deep wage cuts, a higher pension age, lower public spending in areas such as research, innovation, education and health;
Amendment 7 #
2011/2152(ACI)
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Deeply regrets that this agreement was achieved and deeply rejects the secretive, undemocratic procedure which lead to the political agreement, without prior consultation with all political groups in the European Parliament; regrets the European Council disregard for the Parliament’s role and competences as set out in the Treaty of Lisbon;
Amendment 8 #
2011/2152(ACI)
Draft opinion
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Underlines the failure of the negotiations with the Council on all provisions of the MFF Regulation and the Interinstitutional Agreement, which were supposed to ensure that the Union would be provided with a modern, forward- looking, flexible and transparent EU budget that would deliver growth and decent jobs and bridge the gap between the EU’s political commitments and budgetary means;
Amendment 14 #
2011/2152(ACI)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Reiterates the need to increase transparency and to ensure a democratic procedure which enables and guarantees the presence of representatives of all political groups of the EP in all stages of negotiation; insists that it must have all relevant information at the disposal of the Commission on the level of agreed national allocations under cohesion and agricultural policies, including the derogations and specific allocations to each Member State; also requests all relevant information on the impact per Member State of the decisions taken on the revenue side of the MFF;
Amendment 44 #
2011/0461(COD)
Proposal for a decision
Recital 4
Recital 4
(4) The Civil Protection Mechanism constitutes a visible expression of European solidarity by ensuring a practical integrated, effective and timely contribution to prevention of and preparedness for disasters and the response to major disasters and imminence thereof. This Decision should therefore not affect the reciprocal rights and obligations of the Member States under bilateral or multilateral treaties, which relate to the matters covered by this Decision, nor Member States’ responsibility to protect people, the environment and property on their territory.
Amendment 47 #
2011/0461(COD)
Proposal for a decision
Recital 6
Recital 6
(6) The Mechanism should include a general policy framework for Union disaster risk prevention actions aimed at achieving a high level of protection and resilience against disasters by preventing or reducing their effects and by fostering a culture of prevention. Risk management plans are essential to ensure an integrated approach to disaster management, linking risk prevention, preparedness and response actions. Therefore, the Mechanism should include a general framework for their communication and implementation, whereas the Commission should develop general guidelines in order to ease the comparability and integration of Member States' risk management plans.
Amendment 62 #
2011/0461(COD)
Proposal for a decision
Recital 19
Recital 19
(19) Where the use of military capacities is considered inunder civilian oversight is considered as a last resort necessary to support of civil protection operations to be appropriate, while ensuring that disaster relief is never subordinate to trading or political and strategic concerns, cooperation with the military should follow the modalities, procedures and criteria established by the Council or its competent bodies, under the Oslo Guidelines, for making available to the Mechanism military capacities relevant to the protection of civilian populations
Amendment 64 #
2011/0461(COD)
Proposal for a decision
Recital 29
Recital 29
(29) The reimbursement of expenses and award of public procurement contracts and grants under the Civil Protection Financial Instrument should be implemented in accordance with Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (the Financial Regulation). Due to the specific nature of action in the field of civil protection, it is appropriate to provide that grants may also be awarded to private law persons. It is also important that the rules of that Regulation have been met, in particular regarding the principles of economy, efficiency and effectiveness laid down therein.
Amendment 67 #
2011/0461(COD)
Proposal for a decision
Article 1 – paragraph 1
Article 1 – paragraph 1
1. The Union Civil Protection Mechanism (hereinafter referred to as ‘the Mechanism’) shall aim to support, coordinate and supplement the actions of the Member States in the field of civil protection in improving thea European integrated effectiveness of systems for preventing, preparing for and responding to natural and man-made disasters.
Amendment 95 #
2011/0461(COD)
Proposal for a decision
Article 3 – paragraph 2 – subparagraph 1 – point a
Article 3 – paragraph 2 – subparagraph 1 – point a
(a) progress in implementing the disaster prevention framework measured by the number of Member States with risk and disaster management plans as set out in Articles 4 and 6;
Amendment 113 #
2011/0461(COD)
Proposal for a decision
Article 4 – point 9
Article 4 – point 9
9. ‘risk management plan’ means planning instrument prepared by a Member State to foresee potential risks, to estimate their impacts, and to develop, select and implement measures to reduce, adapt to and mitigate the risks and their impacts cost-effectively, as well as to set the framework for integrating different sector or hazard-specific risk management instruments into a common overall plan;
Amendment 122 #
2011/0461(COD)
Proposal for a decision
Article 5 – point d
Article 5 – point d
(d) promote and support the development and implementation of Members States‘ risk management plans including guidelines on their content and provide forin order to facilitate their coordination and compatibility, as well as providing adequate incentives, where needed;
Amendment 205 #
2011/0461(COD)
Proposal for a decision
Article 15 – paragraph 3 – point d
Article 15 – paragraph 3 – point d
(d) facilitate theand hasten a quick timed mobilisation of teams, experts, modules and intervention support other than that from the European Emergency Response Capacity;
Amendment 211 #
2011/0461(COD)
Proposal for a decision
Article 16 – paragraph 1
Article 16 – paragraph 1
1. In the event of a major disaster occurring outside the Union, or the imminence thereof, the affected country, the United Nations and its agencies, or a relevant international humanitarian and/or civil organisation may request assistance through the ERC.
Amendment 228 #
2011/0461(COD)
Proposal for a decision
Article 18 – paragraph 1 – point a
Article 18 – paragraph 1 – point a
(a) providing and sharing information on existing equipment and transport resources that can be made available by the Member States, with a view to facilitating the pooling of such equipment or transport resources;
Amendment 230 #
2011/0461(COD)
Proposal for a decision
Article 19 – paragraph 1 – subparagraph 2
Article 19 – paragraph 1 – subparagraph 2
Amendment 248 #
2011/0461(COD)
Proposal for a decision
Article 22 – point c
Article 22 – point c
(c) supporting Member States in obtaining access to equipment, transport resources and related logistics as specified in Article 23, giving priority to those Member States that do not have the equipment and resources to respond to natural or manmade disasters;
Amendment 251 #
2011/0461(COD)
Proposal for a decision
Article 23 – paragraph 1 – point d – bullet point 4
Article 23 – paragraph 1 – point d – bullet point 4
– the assistance has been accepted by a requesting country, the United Nations or its agencies, or a relevant international civil and/or humanitarian organisation, under the Mechanism;
Amendment 256 #
2011/0461(COD)
Proposal for a decision
Article 24
Article 24
Grants awarded under this Decision may be awarded to legal persons, whether governed by private or public law.
Amendment 36 #
2011/0406(COD)
Proposal for a regulation
Recital 9 a (new)
Recital 9 a (new)
(9a) The European Union is strongly committed to gender equality as a human right, a question of social justice and a core value of the Union development policy; gender equality is central in achieving all MDGs; the Council has adopted the EU Plan of Action on Gender equality and Women's Empowerment in Development (2010-2015).
Amendment 73 #
2011/0406(COD)
Proposal for a regulation
Annex 5 – part A – paragraph 4 – point b – point iii
Annex 5 – part A – paragraph 4 – point b – point iii
(iii) strengthening social inclusion and gender equality with cooperation on equitable access to basic services, employment for all, empowerment and respect of rights of specific groups, notably youth, persons with disabilities, women and minority groups to let all population participate and benefit from wealth creation and cultural diversity.
Amendment 74 #
2011/0406(COD)
Proposal for a regulation
Annex 5 – part A – paragraph 4 – point c – point i
Annex 5 – part A – paragraph 4 – point c – point i
(i) Supporting local, regional and country level programmes to promote women's economic and social empowerment and political participation;
Amendment 75 #
2011/0406(COD)
Proposal for a regulation
Annex 5 – part A – paragraph 4 – point c – point ii
Annex 5 – part A – paragraph 4 – point c – point ii
(ii) supporting nationlocal, regional, national and global programmes and initiatives, to promote the integration of this issue inand implement gender equality, women and girls' empowerment, namely through micro-credit assistance, and the aid effectiveness agenda.
Amendment 76 #
2011/0406(COD)
Proposal for a regulation
Annex 5 – part A – paragraph 4 – point c – point ii a (new)
Annex 5 – part A – paragraph 4 – point c – point ii a (new)
(ii a) promoting, providing and expanding essential services and psychological support for victims of gender-based violence.
Amendment 77 #
2011/0406(COD)
Proposal for a regulation
Annex 5 – part A – paragraph 4 – point d – point i
Annex 5 – part A – paragraph 4 – point d – point i
(i) Improvn line with the priorities set out in the European Consensus for Development, supporting the health and well-being of people in developing countries through increasing access to, and equitable provision of, good quality essential public health services and more specifically:
Amendment 78 #
2011/0406(COD)
Proposal for a regulation
Annex 5 – part A – paragraph 4 – point d – point ii
Annex 5 – part A – paragraph 4 – point d – point ii
(ii) supporting and shaping the policy agenda of global initiatives of direct significant benefit to partner countries, in the context of poverty eradication and in the areas of health and basic education, considering result orientation, aid effectiveness and effects on health systems, including supporting partner countries to better engage with these initiatives;
Amendment 79 #
2011/0406(COD)
Proposal for a regulation
Annex 5 – part A – paragraph 4 – point d – point iii
Annex 5 – part A – paragraph 4 – point d – point iii
(iii) supporting specific initiatives especially atat local, regional and global levels, which strengthen health systems and help countries develop and implement sound, evidence-based national health policies, and in priority areas (e.g., child and maternal health, and sexual and reproductive health and rights, access to family planning; global public goods and response to global health threats, such as HIV/AIDS, TB and Malaria and other poverty related and neglected diseases).
Amendment 80 #
2011/0406(COD)
Proposal for a regulation
Annex 5 – part A – paragraph 4 – point d – point iii a (new)
Annex 5 – part A – paragraph 4 – point d – point iii a (new)
(iii a) promoting, providing and expanding essential services and psychological support for victims of violence, especially children.
Amendment 81 #
2011/0406(COD)
Proposal for a regulation
Annex 5 – part A – paragraph 4 – point e – point iii
Annex 5 – part A – paragraph 4 – point e – point iii
(iii) improvenhancing equal access and quality of education, including fowith particular emphasis on women, girls and other vulnerable groups, women and girls, and countries furthest from achieving global targets.
Amendment 82 #
2011/0406(COD)
Proposal for a regulation
Annex 5 – part A – paragraph 4 – point e a (new)
Annex 5 – part A – paragraph 4 – point e a (new)
(e a) Children and youth: (i) promotion of policies taking into consideration children's and youth's particular vulnerability, protection of their rights, education, health and livelihoods, starting with participation and empowerment; (ii) promoting and helping on the implementation and development of policies, projects and programmes benefiting children and youth and enhancing the role of children and youth as actors for development; (iii) promoting and helping on the implementation and development of policies, projects and programmes to eradicate child labour, trafficking of children and violence against children.
Amendment 115 #
2011/0402(CNS)
Proposal for a decision
Annex 1 – part III – point 1 – paragraph 2
Annex 1 – part III – point 1 – paragraph 2
Successful efforts to prevent, diagnose, manage, treat and cure disease, disability and reduced functionality are underpinned by the fundamental understanding of their causes, processes and impacts, as well as factors underlying good health and wellbeing. Effective collection and sharing of data and the linkage of these data with real-world large scale cohort studies is also essential, as is the timely translation of research findings into the clinic, in particular through the conduct of clinical trials and through support for medical research focusing on the post-diagnostic phase of disease and for translational research.
Amendment 153 #
2011/0402(CNS)
Proposal for a decision
Annex 1 – part III – point 1 – point 1.16 – paragraph 1 A (new)
Annex 1 – part III – point 1 – point 1.16 – paragraph 1 A (new)
Adequate funding should be allocated to research fields directly linked to the post- diagnostic phase, particularly in cases of cancer and cardiovascular and respiratory illnesses, and to improving quality of life.
Amendment 30 #
2011/0401(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) Horizon 2020 - the Framework Programme for Research and Innovation in the European Union (hereinafter ‘Horizon 2020’), focuses on three priorities, namely generating excellent science in order to strengthen the Union's world-class excellence in science, fostering industrial leadership to support business, including small and medium-sized enterprises (SME) and innovation and tackling societal challenges, in order to respond directly to the challenges identified in the Europe 2020 strategy by supporting activities covering the entire spectrum from research to market. Horizon 2020 should support all stages in the innovation chain, especiallyincluding activities closer to the market includingeconomies and innovative financial instruments, as well as non-technological and social innovation, and aims to satisfy the research needs of a broad spectrum of Union policies by placing emphasis on the widest possible use and dissemination of knowledge generated by the supported activities up to its commercial exploitation. The priorities of Horizon 2020 should also be supported through a programme under the Euratom Treaty on nuclear research and training.
Amendment 32 #
2011/0401(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) Horizon 2020 should contribute to the aims of the European Innovation Partnerships in line with the flagship initiative Innovation Union, bringing together all relevant actors across the whole research and innovation chain, with special attention to include SMEs, small and medium universities (SMUs) and small scale research centers and civil society, in view of streamlining, simplifying and better coordinating instruments and initiatives.
Amendment 36 #
2011/0401(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) The implementation of Horizon 2020 may give rise - under specific and transparent conditions - to supplementary programmes involving the participation of certain Member States only, the participation of the Union in programmes undertaken by several Member States, or the setting up of joint undertakings or other arrangements within the meaning of Articles 184, 185 and 187 TFEU.
Amendment 39 #
2011/0401(COD)
Proposal for a regulation
Recital 22
Recital 22
(22) Horizon 2020 should contribute to the attractiveness of the research profession in the Union, promoting and implementing all the necessary measures to guarantee and improve decent working conditions for scientific workers in the Union. Adequate attention should be paid to the European Charter for Researchers and Code of Conduct for the Recruitment of Researchers, together with other relevant reference frameworks defined in the context of the European Research Area, while respecting their voluntary nature.
Amendment 40 #
2011/0401(COD)
Proposal for a regulation
Recital 26
Recital 26
(26) To achieve maximum impact, Horizon 2020 should develop close synergies with other Union programmes in areas such as education, space, environment, competitiveness and SMEs, the internal security, culture and media and with the Cohesion Policy funds and Rural Development Policy, which can specifically help to strengthen national and regional research and innovation capabilities in the context of smart specialisation strategies.
Amendment 48 #
2011/0401(COD)
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
Horizon 2020 shall play a central role in the delivery of the Europe 2020 strategy for smart, sustainable and inclusive growth by providing a common strategic framework for the Union's research and innovation funding, thus acting as a vehicle for leveraging private investment, creating new job opportunities and ensuring Europe's long- term sustainable growth and competitiveness.
Amendment 53 #
2011/0401(COD)
Proposal for a regulation
Recital 25
Recital 25
(25) The European Commission does not explicitly solicit the use of human embryonic stem cells. The use of human stem cells, be they adult or embryonic, if any, depends on the judgement of the scientists in view of the objectives they want to achieve and is subject to stringent Ethics Review. No project involving the use of human embryonic stem cells should be funded that does not obtain the necessary approvals from the Member States. No activity should be funded that is forbidden in all Member States. No activity should be funded in a Member State where such activity is forbiddenThe creation and maintenance of public human embryonic stem cell banks should be considered.
Amendment 71 #
2011/0401(COD)
Proposal for a regulation
Article 13 – paragraph 1
Article 13 – paragraph 1
1. Linkages and interfaces shall be implemented across and within the priorities of Horizon 2020. Particular attention shall be paid in this respect to the development and application of key enabling and industrial technologies, to bridging from discovery to market application, to cross-disciplinary research and innovation, to social and economic sciences and humanities, to fostering the functioning and achievement of the ERA, to cooperation with third countries, to responsible research and innovation including gender, governance of research and participatory research and to enhancing the attractiveness of the research profession and to facilitating cross-border and cross- sector mobility of researchers.
Amendment 72 #
2011/0401(COD)
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
Horizon 2020 shall be implemented in a manner ensuring that the priorities and actions supported are relevant to changing needs and take account of the evolving nature of science, technology, innovation, marketeconomies and society, where innovation includes business, organisational and soci, social and environmental aspects.
Amendment 74 #
2011/0401(COD)
Proposal for a regulation
Article 16 – paragraph 1 – subparagraph 2
Article 16 – paragraph 1 – subparagraph 2
Particular attention shall be paid to the principle of proportionality, the right to privacy, the right to the protection of personal data, the right to the physical and mental integrity of a person, the right to non-discrimination based on nationality, ethnic origin, disability, religion or belief, age, gender or sexual orientation and the need to ensure high levels of human health protection.
Amendment 75 #
2011/0401(COD)
Proposal for a regulation
Article 16 – paragraph 3 – point c
Article 16 – paragraph 3 – point c
Amendment 77 #
2011/0401(COD)
Proposal for a regulation
Article 16 – paragraph 4
Article 16 – paragraph 4
4. Research on human stem cells, both adult and embryonic, may be financed, depending both on the contents of the scientific proposal and the legal framework of the Member States involved. Research activities intended to create human embryos solely for the purpose of research or for the purpose of stem cell procurement, including by means of somatic cell nuclear transfer, may also be financed if the research cannot be accomplished using supernumerary embryos, depending on the legal framework of the Member States involved. No funding shall be granted for research activities that are prohibited in all the Member States. No activity shall be funded in a Member State where such activity is forbidden.
Amendment 80 #
2011/0401(COD)
Proposal for a regulation
Article 22 – subparagraph 2
Article 22 – subparagraph 2
Activities to disseminate information and carry out communication activities shall be an integral task under all of the actions supported by Horizon 2020, taking particular care of providing this information in a way that facilitates easy access by all, notably persons with disabilities.
Amendment 81 #
2011/0401(COD)
Proposal for a regulation
Article 22 – subparagraph 3 – point a
Article 22 – subparagraph 3 – point a
(a) initiatives aimed at widening awareness and facilitating access to funding under Horizon 2020, in particular for those regions or types of participant that are underrepresented, as is the case of researchers and participants with disabilities;
Amendment 82 #
2011/0401(COD)
Proposal for a regulation
Article 22 – subparagraph 3 – point e a (new)
Article 22 – subparagraph 3 – point e a (new)
(ea) initiatives that include and promote the participation in the research and innovation process of civil society; and its organizations or institutions.
Amendment 89 #
2011/0401(COD)
Proposal for a regulation
Annex I – Part I – paragraph 1 – point d a (new)
Annex I – Part I – paragraph 1 – point d a (new)
Amendment 90 #
2011/0401(COD)
Proposal for a regulation
Annex I – Part III – paragraph 1 – point e
Annex I – Part III – paragraph 1 – point e
(e) Climate action, resource efficiency and sustainable use of raw materials;
Amendment 91 #
2011/0401(COD)
Proposal for a regulation
Annex I – Part III – paragraph 2
Annex I – Part III – paragraph 2
All the activities shall take a challenge- based approach, focusing on policy priorities without predetermining the precise choice of technologies or solutions that should be developed. The emphasis shall be on bringing together a critical mass of resources and knowledge across different fields, technologies and scientific disciplines in order to address the challenges. The activities shall cover the full cycle from research to market, as well as its impact on society, with a new focus on innovation-related activities, such as piloting, demonstration, test-beds, support for public procurement, design, end-user driven innovation, social innovation and market take-up of innovations.
Amendment 92 #
2011/0401(COD)
Proposal for a regulation
Annex I – Part II – point 1 – paragraph 10
Annex I – Part II – point 1 – paragraph 10
For all the enabling and industrial technologies, including the KETs, a major aim will be to foster interactions between the technologies, and with the applications under the societal challenges. This shall be fully taken into account in developing and implementing the agendas and priorities. It requires that stakeholders representing the different perspectives are fully involved in priority setting and implementation. In certain cases, it will also require actions that are jointly funded by the enabling and industrial technologies, and by the relevant societal challenges. This will include joint funding for public-private partnerships and for partnerships with civil society organisations that aim to develop technologies and methods and apply them to address societal challenges.
Amendment 95 #
2011/0401(COD)
Proposal for a regulation
Annex I – Part III – point 1.1 – paragraph 5
Annex I – Part III – point 1.1 – paragraph 5
In the Union, CVD annually accounts for more than 2 million deaths and costs the economy more than EUR 192 billion while cancer accounts for a quarter of all deaths and is the number one cause of death in people aged 45-64. Over 27 million people in the Union suffer from diabetes and over 120 million from rheumatic and musculoskeletal conditions and the total cost of brain disorders (including, but not limited to those affecting mental health) has been estimated at EUR 800 billion. Environmental, life-style and socio- economic factors are relevant in several of these conditions with up to one third of the global disease burden estimated to be related to these.
Amendment 96 #
2011/0401(COD)
Proposal for a regulation
Annex I – Part III – point 5.1 – paragraph 4
Annex I – Part III – point 5.1 – paragraph 4
The growing impacts from climate change and environmental problems, such as ocean acidification, ice melting in the Arctic, land degradation and use, water shortages, chemical pollution and biodiversity loss, indicate that the planet is approaching its sustainability boundaries. For example, without improvements in efficiency, water demand is projected to overshoot supply by 40 % in 20 years time. Forests are disappearing at an alarmingly high rate of 5 million hectares per year. Interactions between resources can cause systemic risks – with the depletion of one resource generating an irreversible tipping point for other resources and ecosystems. Based on current trends, the equivalent of more than two planet Earths will be needed by 2050 to support the growing global population. Societies face a major challenge to establish a sustainable balance between human needs and the environment. Environmental resources, including water, air, biomass, fertile soils, biodiversity, ecosystems, as well as human made resources, including cultural heritage and cultural landscapes, and the services they provide, underpin the functioning of the European and global economy and quality of life.
Amendment 97 #
2011/0401(COD)
Proposal for a regulation
Annex I – Part III – point 6.2 – paragraph 3
Annex I – Part III – point 6.2 – paragraph 3
Fostering new modes of cooperation between countries within the Union and worldwide, as well as across relevant research and innovation communities, will therefore be a central task under this challenge. Engaging citizens and industry, supporting social and technological innovation processes, encouraging smart and participatory public administration, as well as promoting evidence based policymaking will be systematically pursued in order to enhance the relevance of all these activities for policymakers, social and economic actors and citizens. In this regard, research and innovation will be a precondition for the competitiveness of European industries and services, in particular in the areas of security, digital development and privacy protection. The success of the implementation of necessary changes really depends of the public engagement with science and innovation and its benefits. In order to achieve that it is essential to focus on the social aspects in the societal challenges involving not only industry players, but also researchers and universities, as well as civil society and its organisations and institutions.
Amendment 98 #
2011/0401(COD)
Proposal for a regulation
Annex I – Part III – point 6.3.2 – paragraph 2 – point c
Annex I – Part III – point 6.3.2 – paragraph 2 – point c
(c) ensure societal engagement in research and innovation; in order to achieve science with and for society;
Amendment 130 #
2011/0401(COD)
Proposal for a regulation
Article 16 – paragraph 4
Article 16 – paragraph 4
4. Research on human stem cells, both adult and embryonic, may be financed, depending both on the contents of the scientific proposal and the legal framework of the Member States involved. No funding shall be granted for research activities that are prohibited in all the Member States. No activity shall be funded in a Member State wheResearch and funding priorities shall be defined in accordance with the evidence provided by acquired such activity is forbiddencientific knowledge.
Amendment 231 #
2011/0401(COD)
Proposal for a regulation
Annex I – part III – point 1.1 – paragraph 2
Annex I – part III – point 1.1 – paragraph 2
The cost of Union health and social care systems is rising with care and prevention measures in all ages increasingly expensive, the number of Europeans aged over 65 expected to nearly double from 85 million in 2008 to 151 million by 2060, and those over 80 to rise from 22 to 61 million in the same period. Reducing or containing these costs such that they do not become unsustainable depends in part on ensuring the lifelong health and wellbeing of all and therefore on the effective prevention, treatment and management of disease and disability. There is a lack of health policies and policies in other areas geared to promoting the quality of life. There is also a lack of investment in research into the post-diagnosis stages of disease.
Amendment 264 #
2011/0401(COD)
Proposal for a regulation
Annex I – part III – point 1.2 – paragraph 2
Annex I – part III – point 1.2 – paragraph 2
The response depends on excellence in research and on the efficient dissemination of research results to improve our fundamental understanding of health, disease, disability, development and ageing (including of life expectancy), and on the seamless and widespread translation of the resulting and existing knowledge into innovative, scalable and effective products, strategies, interventions and services. Furthermore, the pertinence of these challenges across Europe and in many cases, globally, demands a response characterised by long term and coordinated support for co- operation between excellent, multidisciplinary and multi-sector teams, not only at Union but also at global level, by supporting for instance research and development capacity in endemic areas and diseases, in particular malaria, dengue fever and tuberculosis.
Amendment 276 #
2011/0401(COD)
Proposal for a regulation
Annex I – part III – point 1.3 – paragraph 2
Annex I – part III – point 1.3 – paragraph 2
Successful efforts to prevent, manage, treat and cure disease, disability and reduced functionality are underpinned by the fundamental understanding of their determinants and causes, processes and impacts, as well as factors underlying good health and wellbeing. Building on the results of biomedical research in developing medicine for the various diseases, with diagnosis, treatment and healthcare accessible to all citizens, is a powerful tool for improving the coverage and efficacy of healthcare and patients' quality of life. Effective sharing of data and the linkage of these data with large scale cohort studies is also essential, as is the translation of research findings into the clinic, in particular through the conduct of clinical trials.
Amendment 293 #
2011/0401(COD)
Proposal for a regulation
Annex I – part III – point 1.3 – paragraph 5
Annex I – part III – point 1.3 – paragraph 5
Specific activities shall include: understanding the determinants of health (including environmental and climate , poverty and gender-related factors), improving health promotion and disease prevention; understanding disease and improving diagnosis; developing effective screening programmes and improving the assessment of disease susceptibility; improving surveillance and preparedness; developing better preventive vaccines; using in-silico medicine for improving disease management and prediction; treating diseasimproved treatment of disease, addressing universal access to diagnosis, treatment and healthcare; transferring knowledge to clinical practice more quickly and effectively and scalable innovation actions; better use of health data; activehealthy ageing, independent and assisted living; improvement of and conditions for access to palliative medicine, reproductive health and individual empowerment for self- management of health; promotion of integrated care; improving scientific tools and methods to support policy making and regulatory needs; and optimising the efficiency and effectiveness of healthcare systems and reducing inequalities by evidence based decision making and dissemination of best practice, and innovative technologies and approaches.
Amendment 16 #
2011/0371(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) The Council of the European Union called on 12 May 2009 for a strategic framework for European cooperation in education and training (ET 2020) setting up four strategic objectives with a view to responding to the challenges that remain in creating a knowledge-based Europe and making lifelong learning a reality for all. These objectives will only be attained if the adequate level of funding is made available.
Amendment 17 #
2011/0371(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) To support mobility, equity and study excellence, the Union should establish a robust European loan guarantee facilitysystem of grants to enable students, regardless of their economical and social background, to take their Masters degree in another participating country. This facility should be available toalso take into account the particular economical and financial iconstitutions which agree to offer loans for Masters' studies in other participating countries on favourable terms for the studentraints in several EU member states which have lead to a huge drop in all financial supports available for students in these countries.
Amendment 18 #
2011/0371(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point a
Article 7 – paragraph 1 – point a
(a) transnational mobility of higher education and vocational training students as well as of young people involved in non-formal activities between the participating countries as referred in Article 18. This mobility may take the form of studying at a partner institution, traineeships abroad or participating in youth activities, notably volunteering. Degree mobility at Masters level shall also be supported throughpreferably through a system of grants rather than the student loan guarantee facility as referred to in Article 14 (3).
Amendment 11 #
2011/0369(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) In the field of drugs, demand and supplyNational and transnational crime, namely trafficking of human beings, particularly women and children, smuggling of arms and ammunition, traffic in drugs and nuclear material, fraud, money laundering and corruption create a real threat that Member States cannot tackle sustainably on their own. Union intervention under this Regulation should support Member States actions to prevent and reduce drug demand and supplyorganised crime, notably by supporting cross- border cooperation on enforcement.
Amendment 12 #
2011/0369(COD)
(9a) The aim of this regulation is to prevent and reduce national and transnational crime, namely trafficking of human beings, particularly women and children, smuggling of arms and ammunition, traffic in drugs and nuclear material, fraud, money laundering and corruption.
Amendment 13 #
2011/0369(COD)
Proposal for a regulation
Article 5 – subparagraph 1 – point b – introductory part
Article 5 – subparagraph 1 – point b – introductory part
(b) to facilitate access to justiceguarantee access to justice and to court, right to free legal aid, right to an independent trial within a reasonable time, without discrimination and regardless of administrative, economic, social, cultural and linguistic aspects.
Amendment 14 #
2011/0369(COD)
Proposal for a regulation
Article 5 – subparagraph 1 – point c – introductory part
Article 5 – subparagraph 1 – point c – introductory part
(c) to prevent and reduce drug demand and supply. national and transnational organised crime, namely traffic in human beings, particularly women and children, smuggling of arms and ammunition, traffic in illegal drugs and nuclear material, fraud, money laundering and corruption.
Amendment 15 #
2011/0369(COD)
Proposal for a regulation
Article 5 – subparagraph 2
Article 5 – subparagraph 2
The Programme shall aim to promote equality between women and men and combat discrimination based on sex, racial or ethnic origin, religion or belief, disability, age or, sexual orientation as well as discrimination based on social inequalities in all its activities.
Amendment 16 #
2011/0369(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point a
Article 6 – paragraph 1 – point a
(a) enhancing public awareness and knowledge of Union law and policies, policies and access to justice;
Amendment 17 #
2011/0369(COD)
(d) improving the knowledge and understanding of potential issues affecting the smooth functioning of a European area of justice with a view to ensuring evidence- based policy making and, legislation and access to justice.
Amendment 18 #
2011/0369(COD)
Proposal for a regulation
Article 6 – paragraph 2 – point d
Article 6 – paragraph 2 – point d
(d) support for main actors, such as support for Member States when implementing Union law and policies; support for key European level networks, national, regional and local level networks, social partners, non- governmental organisations, whose activities are linked to the implementation of the objectives of the Programme; networking among specialised bodies and organisations, national, regional and local authorities at European level; funding of experts' networks; funding of European level observatories.
Amendment 19 #
2011/0369(COD)
2. Public and/or private bodies and, social partners, non-governmental organisations, local, regional and national entities legally established in other third countries, notably countries where the European Neighbourhood Policy applies, may be associated to actions of the Programme, if this serves the purpose of these actions.
Amendment 23 #
2011/0369(COD)
Proposal for a regulation
Article 12 – paragraph 1
Article 12 – paragraph 1
1. The Commission shall take appropriate measures ensuring that, when actions financed under this Regulation are implemented, the financial interests of the Union are protected by the application of preventive measures against fraud, corruption and any other illegal and/or irregular activities, by effective checks and, if irregularities are detected, by the recovery of the amounts wrongly paid and, where appropriate, by effective, proportionate and deterrent penalties.
Amendment 24 #
2011/0369(COD)
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 1
Article 12 – paragraph 2 – subparagraph 1
2. The Commission or its representatives and the Court of Auditors shawill have the power of audit, on the basis of documents and on-the-spot, over all grant beneficiaries, contractors and subcontractors who have received Union funds under the Programme.
Amendment 25 #
2011/0369(COD)
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 2
Article 12 – paragraph 2 – subparagraph 2
The European Anti-fraud Office (OLAF) maywill carry out on-the-spot checks and inspections on economic operators concerned directly or indirectly by such funding in accordance with the procedures laid down in Regulation (Euratom, EC) No 2185/96 with a view to establishing whether there has been fraud, corruption or any other illegal or irregular activity affecting the financial interests of the Union in connection with a grant agreement or grant decision or a contract concerning Union funding.
Amendment 26 #
2011/0369(COD)
Proposal for a regulation
Article 13 – paragraph 1
Article 13 – paragraph 1
1. The Commission shall monitor the Programme regularly in order to follow the implementation of actions carried out under it in the areas of actions referred to in Article 6 (1) and the achievement of the specific objectives referred to in Article 5. The monitoring will also provide a means of assessing the way in which gender equality and anti-discrimination issues have been addressed across the programme's activities. Where relevant, indicators should be disaggregated by sex, age and disabi, disability and social inequality.
Amendment 27 #
2011/0369(COD)
Proposal for a regulation
Article 13 – paragraph 2 – point aa (new)
Article 13 – paragraph 2 – point aa (new)
(aa) annual evaluation reports;
Amendment 28 #
2011/0369(COD)
Proposal for a regulation
Article 13 – paragraph 3
Article 13 – paragraph 3
3. The annual and interim evaluation shall report on the achievement of the Programme's objectives, the efficiency of the use of resources and the Programme's European added value with a view to determining whether funding in areas covered by the Programme shall be renewed, modified or suspended after 2020. It shall also address the scope for any simplification of the Programme, its internal and external coherence, as well as the continued relevance of all objectives and actions. It shall take into account the results of the ex- post evaluations of the programmes mentioned in Article 14.
Amendment 15 #
2011/0366(COD)
Proposal for a regulation
Recital 1
Recital 1
(1) The Union's objective to constitute an area of freedom, security and justice, should be achieved, inter alia, through common measures framing a policy on asylum and immigration, based on solidarity between Member States, which is fair towards third-countries and their nationals. The European Council of 2 December 2009 recognised that financial resources within the Union should be made increasingly flexible and coherent, both in terms of scope and of applicability, to support policy developments in the field of asylum and migration. It is regrettable that the appropriations proposed for the Asylum and Migration Fund are disproportionately lower than the appropriations proposed to the Instrument for financial support for police cooperation, prevention and combating crime and crisis management.
Amendment 23 #
2011/0366(COD)
Proposal for a regulation
Recital 24
Recital 24
(24) The Fund should be implemented in full respect with the rights and principles enshrined in the Charter of Fundamental Rights of the European Union, the Geneva Convention of 28 July 1951 and in other international instruments. In particular, eligible actions should take account of the specific situation of vulnerable persons, in particular, with special attention and dedicated responses to unaccompanied minors and other minors at risk.
Amendment 26 #
2011/0366(COD)
Proposal for a regulation
Article 2 – point a – introductory part
Article 2 – point a – introductory part
(a) ‘resettlement’ means the process whereby, on a request from the United Nations High Commissioner for Refugees (UNHCR) based on a person's need for international protection, third-country nationals or stateless persons having the status defined by the Geneva Convention of 28 July 1951 and who are permitted to reside as refugees in one of the Member States are transferred from a third-country and established in a Member State where they are permitted to reside with one of the following statuses:
Amendment 27 #
2011/0366(COD)
Proposal for a regulation
Article 2 – point e
Article 2 – point e
(e) ‘family members’ means any persons who are dependant relatives in the descending or ascending line, including adopted children, spouses, unmarried partners with a duly attested long-termin a stable relationship or in a registered partnership, if applicable, under the national law of the Member State concerned;
Amendment 28 #
2011/0366(COD)
Proposal for a regulation
Article 2 – point f – point i
Article 2 – point f – point i
(i) heavy migratory pressure in one or more Member States characterised by a large and disproportionatone or more Member States facing disproportionate asylum requests and a large inflow of third- country nationals which place significant and urgent demands on their reception and detentiontechnical, administrative, reception infrastructure facilities, and asylum systems and procedures,
Amendment 29 #
2011/0366(COD)
Proposal for a regulation
Article 2 – point f – point iii
Article 2 – point f – point iii
(iii) heavy migratory pressurea large inflow of migrants in third countries where refugees are stranded due to events such as political developments or conflicts.
Amendment 30 #
2011/0366(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point b – subparagraph 2
Article 3 – paragraph 2 – point b – subparagraph 2
The achievement of this objective shall be measured by indicators, inter aliaqualitative and quantitative indicators, inter alia, access to justice and free legal assistance, healthcare, housing, the level of increased participation of third- country nationals in employment, education and in democratic processes.
Amendment 31 #
2011/0366(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point c – subparagraph 2
Article 3 – paragraph 2 – point c – subparagraph 2
The achievement of this objective shall be measured by indicators, inter alia, the number of returneespeople having benefited from integration measures (prior or subsequent to their return), the number of voluntary returns and the quality of the systems ensuring a safe return and its adequate monitoring.
Amendment 32 #
2011/0366(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point d – subparagraph 1
Article 3 – paragraph 2 – point d – subparagraph 1
(d) to enhance the solidarity and responsibility sharing between the Member States, in particular towards those most affected by migration and asylum flows, including through practical cooperation, either absolute or proportional financial responsibility sharing and enhanced support to those with less developed hosting and processing systems.
Amendment 34 #
2011/0366(COD)
Proposal for a regulation
Article 3 – paragraph 2 a (new)
Article 3 – paragraph 2 a (new)
2a. The objectives referred to in paragraph 2 shall be measured by both qualitative and quantitative cross-cutting criteria, such as child protection provisions, promotion of family life, free access to justice and legal assistance, healthcare, housing, education and ensuring the adequate support and assistance to unaccompanied minors regardless of their residence status.
Amendment 35 #
2011/0366(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point g
Article 4 – paragraph 1 – point g
(g) any third-country national who is on the territory of a third country, who intend to migrate to the Union and who comply with specific pre-departure measures and/or conditions set out in national law, including those relating to the ability to integrate in the society of a Member State;
Amendment 36 #
2011/0366(COD)
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
2. The target group shall comprise family members of persons referred to above, where appropriate, and in so far as the same conditions apply.
Amendment 37 #
2011/0366(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point a a (new)
Article 5 – paragraph 1 – point a a (new)
(aa) establishment and improvement of administrative structures, systems and training for staff, administrative and judicial authorities, judicial assistance to ensure a free, easy, efficient and smooth regularisation process for all claims of asylum and migration;
Amendment 38 #
2011/0366(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point a b (new)
Article 5 – paragraph 1 – point a b (new)
(ab) establishment, improvement and maintenance of accommodation infrastructures and services;
Amendment 39 #
2011/0366(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point a c (new)
Article 5 – paragraph 1 – point a c (new)
(ac) establishment, development and improvement of immediate measures to substitute detention;
Amendment 40 #
2011/0366(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point a d (new)
Article 5 – paragraph 1 – point a d (new)
(ad) abolishment of all detention centres in the Member States and associated third countries;
Amendment 41 #
2011/0366(COD)
Proposal for a regulation
Article 5 – paragraph 2 – point b
Article 5 – paragraph 2 – point b
(b) setting up of administrative structures, systems and training of staff and relevant judicial authorities and free judicial assistance to ensure smooth access to asylum procedures for asylum seekers and efficient and quality asylum procedures.
Amendment 42 #
2011/0366(COD)
Proposal for a regulation
Article 7 – point f
Article 7 – point f
(f) information and free assistance upon arrival, including interpretation services;
Amendment 43 #
2011/0366(COD)
Proposal for a regulation
Article 7 – point f a (new)
Article 7 – point f a (new)
(fa) actions to promote family reunification for persons being resettled in a Member State;
Amendment 44 #
2011/0366(COD)
Proposal for a regulation
Article 9 – paragraph 1 – point b
Article 9 – paragraph 1 – point b
(b) free advice and assistance in areas such as housing, means of subsistence, employment, administrative and legal guidance, medical, psychological and social care, child care and family reunification;
Amendment 45 #
2011/0366(COD)
Proposal for a regulation
Article 11 – point a
Article 11 – point a
(a) establishment and improvement of accommodation infrastructure or services and reception or detentionhosting conditions;
Amendment 46 #
2011/0366(COD)
Proposal for a regulation
Article 11 – point a a (new)
Article 11 – point a a (new)
(aa) establishment, development and improvement of immediate measures to substitute detention;
Amendment 47 #
2011/0366(COD)
Proposal for a regulation
Article 11 – point c
Article 11 – point c
(c) provision of material aid, free health and psychological care, including for third country nationals whose removal has been postponed in accordance with Article 9 and Article 14(1) of Directive 2008/115/EC;
Amendment 53 #
2011/0366(COD)
Proposal for a regulation
Article 14 – paragraph 5 – point a
Article 14 – paragraph 5 – point a
(a) EUR 3,232 million80% for national programmes of Member States;
Amendment 54 #
2011/0366(COD)
Proposal for a regulation
Article 14 – paragraph 5 – point b
Article 14 – paragraph 5 – point b
(b) EUR 637 million20% for Union actions, emergency assistance, European Migration Network and technical assistance of the Commission.
Amendment 56 #
2011/0366(COD)
Proposal for a regulation
Article 15 – paragraph 1 – introductory part
Article 15 – paragraph 1 – introductory part
1. EUR 3,232 millAppropriations shall be allocated to the Member States indicatively as follows:
Amendment 57 #
2011/0366(COD)
Proposal for a regulation
Article 15 – paragraph 1 – point a
Article 15 – paragraph 1 – point a
(a) EUR 2,372 million73% as indicated in Annex I;
Amendment 58 #
2011/0366(COD)
Proposal for a regulation
Article 15 – paragraph 1 – point b
Article 15 – paragraph 1 – point b
(b) EUR 700 million22% based on the distribution mechanism for specific actions as referred to in Article 16, for the Union Resettlement Programme as referred to Article 17 and for relocation as referred to in Article 18;
Amendment 59 #
2011/0366(COD)
Proposal for a regulation
Article 15 – paragraph 1 – point c
Article 15 – paragraph 1 – point c
(c) EUR 160 million5% in the framework of the mid-term review and from the period as of budget year 2018, to take into account important changes in migration flows and/or address the specific needs established by the Commission provided for in Article 19.
Amendment 61 #
2011/0366(COD)
Proposal for a regulation
Article 17 – paragraph 4 – indent 2 a (new)
Article 17 – paragraph 4 – indent 2 a (new)
- persons who have been subjected to acts of violence and/or torture;
Amendment 62 #
2011/0366(COD)
Proposal for a regulation
Article 18 – paragraph 2 a (new)
Article 18 – paragraph 2 a (new)
2a. The Commission shall establish strict procedural guarantees and clear criteria for relocation measures, namely transparent, non-discriminatory criteria; information to the potential beneficiaries of relocation; communication in writing of the selection or non-selection of the interviewed applicants and of the criteria which underpinned the decision; reasonable time limits for candidates for relocation, enabling them to take an informed decision and if necessary obtain adequate assistance for their departure; the requirement for their voluntary consent to benefit from relocation measures;
Amendment 63 #
2011/0366(COD)
Proposal for a regulation
Article 18 – paragraph 2 b (new)
Article 18 – paragraph 2 b (new)
2b. Relocation measures shall be taken within the framework of an action plan to improve and maintain the quality of reception and asylum systems and integration conditions in the Member State concerned;
Amendment 64 #
2011/0366(COD)
Proposal for a regulation
Article 19 – paragraph 1 – subparagraph 2
Article 19 – paragraph 1 – subparagraph 2
The Commission shall use for its assessment, inter alia, the information collected from Eurostat, the European Migration Network, the EASO and the Frontex Agency risk analysis and relevant international organisations including HCR, civil society and other relevant stakeholders.
Amendment 65 #
2011/0366(COD)
Proposal for a regulation
Article 19 – paragraph 1 – subparagraph 3 – point b – introductory part
Article 19 – paragraph 1 – subparagraph 3 – point b – introductory part
(b) migratory pressurein-flows:
Amendment 66 #
2011/0366(COD)
Proposal for a regulation
Article 19 – paragraph 1 – subparagraph 3 – point b – point i
Article 19 – paragraph 1 – subparagraph 3 – point b – point i
(i) factor 1 for no particular pressurein-flow
Amendment 67 #
2011/0366(COD)
Proposal for a regulation
Article 19 – paragraph 1 – subparagraph 3 – point b – point ii
Article 19 – paragraph 1 – subparagraph 3 – point b – point ii
(ii) factor 1,5 for medium particular pressurein- flow
Amendment 68 #
2011/0366(COD)
Proposal for a regulation
Article 19 – paragraph 1 – subparagraph 3 – point b – point iii
Article 19 – paragraph 1 – subparagraph 3 – point b – point iii
(iii) factor 3 for high particular pressurein-flow
Amendment 72 #
2011/0366(COD)
Proposal for a regulation
Article 22 – paragraph 1
Article 22 – paragraph 1
1. The Fund shall provide financial assistance to address urgent and specific needs in the event of an emergency situation, as mentioned in Article 2(f).
Amendment 73 #
2011/0366(COD)
Proposal for a regulation
Annex 2 – point 3 a (new)
Annex 2 – point 3 a (new)
(3a) Programmes and projects in the area of integration in order to improve coordination of relevant policies at several levels between Members States, local and regional authorities, civil society and relevant stakeholders
Amendment 32 #
2011/0276(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) A performance framework should be defined for each programme with a view to monitoring progress towards the objectives and targets set for each programme over the course of the programming period. The Commission should undertake a performance review in cooperation with the Member States in 2017 and 2019. A performance reserve should be foreseen and allocated in 2019 where milestones set in the performance framework have been attained. Due to their diversity and multi-country character, there should be no performance reserve for ‘European Territorial Cooperation’ programmes. In cases where the shortfall in the achievement of milestones or targets is significant, the Commission should be able to suspend payments to the programme or, at the end of the programming period, apply financial corrections, in order to ensure that the Union budget is not used in a wasteful or inefficient way.
Amendment 33 #
2011/0276(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) Establishing a closer link between social and territorial cohesion policy and the economic governance of theEuropean Union will ensure that the effectiveness of expenditure under the CSF Funds is underpinned by sound economic policies and that the CSF Funds can, if necessary, be redirected to addressing the economic problems a country is facing. This process has tocan be gradual, starting with amendments to the Partnership Contract and to the programmes in support of Council recommendations to address macroeconomic imbalances and social and economic difficulties. Where, despite the enhanced use of CSF Funds, a Member State fails to take effective action in the context of the economic governance process, the Commission should have the right to suspend all or part of the payments and commitments. Decisions on suspensions should be proportionate and effective, taking into account the impact of the individual programmes for addressing the economic and social situation in the relevant Member State and previous amendments to the Partnership Contract. When deciding on suspensions, the Commission should also respect equality of treatment between Member States, taking into account in particular the impact of the suspension on the economy of the Member State concerned. The suspensions should be lifted and funds be made available again to the Member State concerned as soon as the Member State takes the necessary actionto address social and economic difficulties.
Amendment 38 #
2011/0276(COD)
Proposal for a regulation
Recital 58
Recital 58
Amendment 39 #
2011/0276(COD)
Proposal for a regulation
Recital 59
Recital 59
(59) As regards the Funds and with a viewdespite trying to ensuringe an appropriate allocation to each category of regions, resources should cannot be transferred betweenfrom less developed, transition and more developed regions except in duly justified circumstances linked to the delivery of one or more thematic objectives and for no more than 2 % of the total appropriation for that category of and transition to more developed regions.
Amendment 52 #
2011/0276(COD)
Proposal for a regulation
Part 2 – article 12 – paragraph 1
Part 2 – article 12 – paragraph 1
Amendment 56 #
2011/0276(COD)
Proposal for a regulation
Part 2 – article 14 – paragraph 1 a (new)
Part 2 – article 14 – paragraph 1 a (new)
Amendment 60 #
2011/0276(COD)
Proposal for a regulation
Part 2 – article 18
Part 2 – article 18
Amendment 61 #
Amendment 62 #
Amendment 14 #
2011/0275(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) The ERDF should contribute to the Europe 2020 strategyeconomic, social and territorial cohesion, thus ensuring greater concentration of ERDF support on the priorities of the Union. According to the category of regions supported, the support from the ERDF should be concentrated on research and innovation, small and medium-sized enterprises and climate change mitigation. The degree of concentration should take into account the level of development of the region as well as the specific needs of regions whose GDP per capita for the 2007-13 period was less than 75% of the average GDP of the EU-25 for the reference perioda number of priorities. The cohesion policy contributes to a great extent to the achievement of the EU 2020 strategy objectives. As Article 176 of the Treaty on the Functioning of the European Union points out the aim of the ERDF is to help to overcome regional imbalances in the Union, taking into account regional and local development needs.
Amendment 18 #
2011/0275(COD)
Proposal for a regulation
Article 3 – paragraph 1 – subparagraph 1 – point a
Article 3 – paragraph 1 – subparagraph 1 – point a
(a) productive investment, which contributes to creating and safeguarding sustainable jobs, primarily through direct aid to investment in small and medium- sized enterprises (SMEs) and social economy;
Amendment 20 #
2011/0275(COD)
Proposal for a regulation
Article 3 – paragraph 1 – subparagraph 1 – point c
Article 3 – paragraph 1 – subparagraph 1 – point c
(c) investments in social, health and educational infrastructure as well as housing, childcare and cultural heritage;
Amendment 22 #
2011/0275(COD)
Proposal for a regulation
Article 3 – paragraph 1 – subparagraph 1 – point d – point ii
Article 3 – paragraph 1 – subparagraph 1 – point d – point ii
(ii) support for and services to enterprises, in particular SMEs and social economy;
Amendment 24 #
2011/0275(COD)
Proposal for a regulation
Article 3 – paragraph 1 – subparagraph 1 – point d – point iv
Article 3 – paragraph 1 – subparagraph 1 – point d – point iv
(iv) networking, cooperation and exchange of experience between regions, towns, and relevant social, economic and enviro, environmental and non-governmental actors;
Amendment 35 #
2011/0275(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point 4 – point c
Article 5 – paragraph 1 – point 4 – point c
(c) supporting energy efficiency and renewable energy use in public infrastructures and in the housing sector with targeted support for poor households, ensuring efficiency measures contribute to reducing energy poverty;
Amendment 40 #
2011/0275(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point 10
Article 5 – paragraph 1 – point 10
(10) investing in childcare, education, skills and lifelong learning by developing education and training infrastructure;
Amendment 41 #
2011/0275(COD)
Proposal for a regulation
Article 6 – title
Article 6 – title
Indicators for the Investment for growth and jobs goal, employment and social progress
Amendment 43 #
2011/0275(COD)
Proposal for a regulation
Annex 1 – table title 1 – introductory part
Annex 1 – table title 1 – introductory part
Common indicators for ERDF support under the Investment for growth and jobs goal, employment and social progress (Article 6)
Amendment 19 #
2011/0177(APP)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Is fully aware that the negotiations on the MFF 2014-2020 are taking place in a very difficult economicsocial, economic and financial context, in which Member States are engaging in considerable efforts and constraints to make fiscal adjustments to their national budgets, with a view to the stability of the banking sector and the single currency; insists that the Union should cannot be seen as adding an extra fiscal burden on taxpayers; is,recalls however, convinced that the EU budget ishould be a part of the solution to enable Europe to emerge from the current crisis by helping Member States tackle, collectively and in concerted fashion, the present social, economical and financial structural challenges, in particular loss of competitiveness, rising unemployment and poverty;,
Amendment 22 #
2011/0177(APP)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Recalls that the European Council has, on numerous occasions, insisted on the need for a strengthened European economic governance and has endorsed the objectives set out in the EU 2020 strategy for smart, sustainable and inclusive growth, namely promoting and creating employment, improving the conditions for –and public spending on– innovation, research and development, meeting our climate change and energy objectives, improving education levels and promoting social inclusion, in particular through and the reduction of poverty;
Amendment 25 #
2011/0177(APP)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Recalls that all the macroeconomic financial stabilisation measures taken since 2008 have not yet proved sufficproved to be insufficient and absolutely inconvenient to overcome the economic and financial crisis; believes, therefore, that in order to return to growth and generate employment in Europe, a well- targeted and sufficient EU budget is needed to further help coordinate and enhance the national efforts;
Amendment 36 #
2011/0177(APP)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Stresses that the EU budget is an investment budget and that 94 % of its total returns are invested in the Member States themselves or for external priorities of the Union; emphasises that, for the regions and Member States, public investment would be minimised or impossible without the contribution of the EU budget; believes that any decrease of the EU budget would inevitably hamper the growth and competitive strength of the entire Union econom, aggravate imbalances and heavily compromise cohesion in the entire Union economy, namely increasing unemployment and poverty;
Amendment 43 #
2011/0177(APP)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Recalls that delivering on the Europe 2020 strategy’s seven flagship initiatives willould require a huge amount of future- oriented investment, estimated at no less than EUR 1 800 billion up to 2020 ; stresses that one of the main objectives of the Europe 2020 strategy, namely, to promote and create jobs and high-quality employment for all Europeans, will only be achieved if the necessary investment in education, in favour of a knowledge society, and in research and innovation, SMEs, and green and new technologies is made now and not delayed any longer; favours combining the reduction of public deficits and debt with the promotion of such investments;
Amendment 49 #
2011/0177(APP)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Considers that the alarming youth- related problems, includingsituation of the youth in Europe, namely an unprecedentedly high unemployment rate, increasing poverty and educational challenges, existing across the EU require a particular effort to keep the new generations bound to the EU values of social justice, peace, democracy and, human rights, and economic prosperity and social justice, among others, through EU programmes with an increased and adequate budgetary support;
Amendment 54 #
2011/0177(APP)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Strongly supports the Commission’s proposal to mainstream measures to combat climate change across the whole EU budget; believerecalls that the EU budget willmust be able to mobilise investment for a sustainable and prosperous low-carbon economy, provide adequate support for achieving the EU 2020Union's targets for climate, energy and biodiversity, and benefit the EU’s citizens by ensuring a more healthy environment;
Amendment 59 #
2011/0177(APP)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Stresses that since 1988 national budgets have grown on average more rapidly than the EU budget; notes that even since the start of the crisis in 2008 total government expenditure in the Member States has risen at an annual nominal rate of 2 %; draws the conclusion that this shrinkage of the EU budget with respect to the national budgets is in flagrant contradiction with the extension of competences and tasks conferred on the Union by the Treaty and with major political decisions taken by the European Council itself, notably the development of a strengthened European economic governanceGrowth and Employment Compact within a cohesive European Union;
Amendment 62 #
2011/0177(APP)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Considers that the Commission proposal, which represents a freeze of the MFF 2014- 2020 ceilings at the level of the 2013 ceilings, will not be sufficient to finance existing policy priorities linked to the Europe 2020's strategy for smart, sustainable and inclusive growth, the new tasks provided for by the Treaty of Lisbon, or unforeseen events, not to mention the political objectives and commitments set by the European Council itself;
Amendment 63 #
2011/0177(APP)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Strongly rejects, therefore, any attempt by the CouncilWarns the Council against any attempt to reduce further the level of EU expenditure as proposed by the Commission as it is determined not to grant consent to any proposal fixing the MFF ceilings until 2020 below the 2013 level; firmly opposes, in particular, any plead for linear, across-the-board cuts that would jeopardise the implementation and effectiveness of all EU policies, irrespective of their European added value, political weight or performance; instead, challenges the Council, in case it proposes cuts, to clearly and publicly identify which of its political priorities or projects should be dropped altogether ;
Amendment 69 #
2011/0177(APP)
19. Reaffirms, in this context, its position in favour of a significant increase - notably through the Connecting Europe Facility - in the funding available for the Union programmes in the fields of competiveness, SMEs and infrastructures, which arethat in view of the long lifetime of major infrastructure projects - notably through the Connecting Europe Facility and financial instruments such as Project Bonds - that it is a priority to ensure that these make a measurable contribution, by 2050, to the achievement of the goals of the Europe 2020 strategy, the "20-20-20" energy and climate targets, as well ats the heart of the Europe 2020 strategCommission's road map for moving to a low-carbon economy; strongly believereaffirms that further cuts with respect to the Commission proposal will seriously jeopardise the EU’s credibility and its political commitment in favour of growth and jobs;
Amendment 86 #
2011/0177(APP)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Considers that EU cohesion policy is a strategic tool for smart investment, growth and competitivenesssustainable growth and to boost the creation of employment, with an undisputed EU added value; insists that, in order to effectively reduce macroeconomic imbalances within the EU and contribute to social, economic, social and territorial cohesion, it should be able to rely on a stable, solid and sustainable financial framework; reaffirms its position that cohesion policy funding should be maintained at least at the level of the 2007-2013 period;
Amendment 104 #
2011/0177(APP)
Motion for a resolution
Paragraph 23
Paragraph 23
23.Recognis Underlines the serious challengedifficulties and in some cases, even dramatic constraints that young people in the EU face with the economic crisis; considers that employment, education, non-formal education, training, mobility and the social inclusion of young Europeans are issues of strategic importance for the development of the EU and European society; insists on mainstreaming and prioritising these issues in all relevant policies financed from the EU budget, alongside with the due increase financing of the concrete youth- related instruments proposed by the Commission;
Amendment 113 #
2011/0177(APP)
Motion for a resolution
Paragraph 25
Paragraph 25
25. Recalls that the EU’s education, non- formal education, youth, media and culture programmes are close to the citizens, enjoy extraordinary high implementation rates, produce noticeable leverage and spillover effects including significant economic results, and generate clear and proven European added value by pooling resources, encouraging mobility and enhancing cooperation among different sectors and stakeholders;
Amendment 171 #
2011/0177(APP)
Motion for a resolution
Paragraph 50
Paragraph 50
50. AgreUnderlines withs strong support to the Commission proposal that the Emergency Aid Reserve, the European Union Solidarity Fund, the European Globalisation Adjustment Fund and the reserve for crises in the agriculture sector, given their non-programmablespecific nature, should be entered in the budget over and above the ceilings for the relevant headings;
Amendment 177 #
2011/0177(APP)
Motion for a resolution
Paragraph 53
Paragraph 53
53. Strongly requestUrges the Member States to make a firm commitment to the incorporation of the European Development Fund into the EU budget as of 20214;
Amendment 180 #
2011/0177(APP)
Motion for a resolution
Paragraph 56
Paragraph 56
56. Firmly believes that the financing of the Union budget should return to a genuine system of own resources, as provided for in the Treaty of Rome and all successive EU treaties; deeply regrets the fact that the current system, whereby the vast majority of the financing comes from national contributions, is non-transparent and unfair, excludes any due contribution from the financial sector, which led to the current crisis, and is not subject to parliamentary control at either European or national level; stresses that such a system violates, in essence, the letter and spirit of the Treaty;;
Amendment 181 #
2011/0177(APP)
Motion for a resolution
Paragraph 58
Paragraph 58
58. Points out that the restructuring of the system of own resources as such does not concern the size of the EU budget, but is aimed at finding a more effective and fair mix of resources to fund agreed EU policies and objectives; stresses that the introduction of a new system wouldmust not increase the overall tax burden for citizens, butand would, instead, reduce the burden on national treasuries;
Amendment 186 #
2011/0177(APP)
Motion for a resolution
Paragraph 59 – point 3
Paragraph 59 – point 3
3) urges those Member States willing to introduce a financial transaction tax musto now proceed now with a formal request to the Commission for a proposal on enhanced cooperation in this field; the Commission will then have tomust react immediately with the publication of such a proposal together with a set of revised proposals on the own resources package, in order to ensure that revenues from this tax are wholly or partly allocated to the EU Budget as an own resource, thus reducing the national contributions of those Member States introducing this tax;