43 Amendments of Christian EHLER related to 2013/0240(NLE)
Amendment 66 #
Proposal for a Regulation
Recital 4
Recital 4
(4) Regulation (EU) No …/2013 of the European Parliament and of the Council of … 2013 establishing Horizon 2020 - The Framework Programme for Research and Innovation (2014-2020)10 aims to achieve a greater impact on research and innovation by combining Horizon 2020 Framework Programme and private sector funds in public-private partnerships in key areas where research and innovation can contribute to the Union's wider competitiveness goals, leverage private investment, and help tackle societal challenges. Those partnerships should be based on a long-term commitment, including a balanced contribution from all partners, be accountable for the achievement of their targets and be aligned with the Union's strategic goals relating to research, development and innovation. The governance and functioning of those partnerships should be open, transparent, effective and efficient and give the opportunity to a wide range of stakeholders active in their specific areas to participate. Union involvement in those partnerships could take the form of financial contributions to joint undertakings established on the basis of Article 187 of the Treaty under Decision No 1982/2006/EC. __________________ 10 OJ … [H2020 FP] OJ … [H2020 FP]
Amendment 68 #
Proposal for a Regulation
Recital 5
Recital 5
(5) In accordance with Regulation (EU) No .../2013 of the European Parliament and of the Council of ... 2013 establishing Horizon 2020 and Decision (EU) No …/2013 of the Council of … 2013 establishing the Specific Programme implementing Horizon 2020 (2014-2020)11 further support should be provided to joint undertakings established under Decision No 1982/2006/EC under the conditions specified in Decision (EU) No […]/2013.. __________________ 11 OJ … [H2020 SP]
Amendment 79 #
Proposal for a Regulation
Recital 15
Recital 15
(15) The Union financial contribution should be managed in accordance with the principle of sound financial management and with the relevant rules on indirect management set out in Article 60(1-4) of Regulation (EU, Euratom) No 966/2012 and Commission delegated Regulation (EU) No 1268/2012 of 29 October 2012 on the rules of application of Regulation (EU, Euratom) No 966/201217 . __________________ 17 OJ L 362 31.12.2012, p. 1
Amendment 81 #
Proposal for a Regulation
Recital 19
Recital 19
Amendment 85 #
Proposal for a Regulation
Recital 19 a (new)
Recital 19 a (new)
(19a) Without prejudice to the interim evaluation referred to in Article 11 and in accordance with Article 26 of the Horizon 2020 Regulation, Joint Technology Initiatives as a particular funding instrument of Horizon 2020 should be subject to an in-depth interim assessment, which should include, inter alia, an analysis of their openness, transparency and efficiency.
Amendment 87 #
Proposal for a Regulation
Recital 21
Recital 21
(21) The IMI Joint Undertaking was set up for a period up to 31 December 2017. The IMI2 Joint Undertaking should provide continued support to the Innovative Medicines research programme by enlarging the scope of the activities under a modified set of rulesimplementing the remaining activities foreseen in the IMI research programme under the rules of the IMI Joint Undertaking. The transition from the IMI Joint Undertaking to the IMI2 Joint Undertaking should be aligned and synchronized with the transition from the Seventh Framework programme to the Horizon 2020 Framework Programme to ensure optimal use of the funding available for research. In the interest of legal certainty and clarity, Council Regulation (EC) No 73/2008 should therefore be repealed and transitional provisions should be set out.
Amendment 88 #
Proposal for a Regulation
Recital 21 a (new)
Recital 21 a (new)
(21a) With a view to the overall aim of Horizon 2020 to achieve greater simplification and harmonisation of the research and innovation funding landscape at European level, the duration of all public-private partnerships financed under Horizon 2020 should be aligned with the duration of the Framework Programme, to avoid different sets of rules running in parallel and related additional administrative burden for participants and Union bodies in the future;
Amendment 92 #
Proposal for a Regulation
Recital 21 b (new)
Recital 21 b (new)
(21b) Considering the importance of basic research to create breakthrough ideas that enable future innovation, calls for proposals for collaborative R&D projects should be issued in the field of health research under Horizon 2020 in addition and in parallel to the activities of the IMI2 Joint Undertaking, particularly regarding research at Technology Readiness Levels 1 to 4;
Amendment 93 #
Proposal for a Regulation
Recital 21 c (new)
Recital 21 c (new)
(21c) Taking due account of the intended synergies between Horizon 2020 and the Structural Funds as well as relevant national and regional R&D funding programmes, regions across the Union should be encouraged to contribute pro- actively to the activities of the IMI2 Joint Undertaking, e.g. by supporting financially relevant research infrastructure, the preparation of proposals, the exploitation of research results or networking activities of relevant actors, aiming at boosting the regional impact of IMI2 activities and their potential to create jobs and growth at regional level.
Amendment 95 #
Proposal for a Regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
1. For the implementation of the Joint Technology Initiative on Innovative Medicines, a joint undertaking within the meaning of Article 187 of the Treaty (hereinafter ‘'IMI2 Joint Undertaking'’), is established for a period from 1 January 2014 until 31 December 20240.
Amendment 113 #
Proposal for a Regulation
Article 2 a (new)
Article 2 a (new)
Article 2 a Scope of activities 1. In order to fulfil the objectives set out in Article 2 the IMI2 research programme may fund research and development activities comprising the Technology Readiness Levels from 2 to 6. 2. Should the IMI 2 research programme foresee innovation activities comprising the Technology Readiness Levels from 7 to 8, funding rates for indirect actions shall be reduced in accordance with [Art. 22] of the Rules for Participation.
Amendment 116 #
Proposal for a Regulation
Article 3 – paragraph 1 – subparagraph 1 – introductory part
Article 3 – paragraph 1 – subparagraph 1 – introductory part
The maximum Union contribution, including EFTA appropriations, to the IMI2 Joint Undertaking to cover administrative costs and operational costs shall be EUR 1 509.3725 million which shall consist of the following:
Amendment 119 #
Proposal for a Regulation
Article 3 – paragraph 1 – subparagraph 1 – point a
Article 3 – paragraph 1 – subparagraph 1 – point a
(a) up to EUR 1 500312.5 million to match the contribution of EFPIA, or its constituent entities or their affiliated entities;
Amendment 121 #
Proposal for a Regulation
Article 3 – paragraph 1 – subparagraph 1 – point b
Article 3 – paragraph 1 – subparagraph 1 – point b
(b) up to EUR 22196.875 million to match additional contributions from other Members Associated Partners, or from their constituent or their affiliated entities.
Amendment 122 #
Proposal for a Regulation
Article 3 – paragraph 1 – subparagraph 2
Article 3 – paragraph 1 – subparagraph 2
The contribution of the Union shall be paid from the appropriations in the general budget of the Union allocated to the Horizon 2020 Specific Programme implementing the Horizon 2020 Framework Programme in accordance with Article 58(1)(c)(iv) and Articles 60(1-4) and 61 of Regulation (EU, Euratom) No 966/2012 for bodies referred to in Article 209 of that Regulation.
Amendment 123 #
Proposal for a Regulation
Article 3 – paragraph 3 – introductory part
Article 3 – paragraph 3 – introductory part
3. The delegation agreement referred to in paragraph 2 shall address the elements set out in Article 58(3) and Articles 60(1-4) and 61 of Regulation (EU, Euratom) No 966/2012 and in Article 40 of the Commission delegated Regulation (EU) No 1268/2012 as well as inter alia the following:
Amendment 130 #
Proposal for a Regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
Amendment 139 #
Proposal for a Regulation
Article 11 – paragraph 1
Article 11 – paragraph 1
1. By 31 December 2017 the Commission shall conduct an interim evaluation of the IMI2 Joint Undertaking. The Commission shall communicate the conclusions thereof, accompanied by its observations, to the European Parliament and to the Council by 30 June 2018. The interim evaluation of the IMI2 Joint Undertaking shall form part of and be compiled with the interim evaluation of Horizon 2020.
Amendment 140 #
Proposal for a Regulation
Article 11 – paragraph 1 a (new)
Article 11 – paragraph 1 a (new)
1 a. The budget of the IMI2 Joint Undertaking may be subject to review in the course of the Midterm Review.
Amendment 142 #
Proposal for a Regulation
Article 12 – paragraph 1
Article 12 – paragraph 1
1. The discharge of the budget implementation with regard to the Union contribution to the IMI2 Joint Undertaking shall be part of the discharge given by the European Parliament, upon recommendation of the Council, to the Commissionbefore 15 May of year n+2 in accordance with thea procedure provided for in Article 319 of the Treatycomparable to the one outlined in Article 319 TFEU and Articles 164-165 of Regulation 966/2012 (EU/ Euratom) and provided for by the Financial rules of the IMI2 Joint Undertaking.
Amendment 148 #
Proposal for a Regulation
Article 17 – paragraph 1
Article 17 – paragraph 1
Regulation (EU) No … [Rules for participation and dissemination in Horizon 2020] and Commission Decisions relevant to its implementation shall apply to the indirect actions funded by the IMI2 Joint Undertaking. In accordance with that Regulation, the IMI2 Joint Undertaking shall be considered as a funding body and shall provide financial support to indirect actions as set out in Clause 1 of the Statutes contained in the Annex.
Amendment 150 #
Proposal for a Regulation
Article 17 – paragraph 1 a (new)
Article 17 – paragraph 1 a (new)
Amendment 151 #
Proposal for a Regulation
Article 17 – paragraph 1 b (new)
Article 17 – paragraph 1 b (new)
In accordance with the principles of transparency and non-discrimination as laid out in Article 60(1) and 128(1) of Regulation (EU, Euratom) No 966/2012 and Article 16 of this Regulation, calls for proposals organised by the IMI2 Joint Undertaking shall be published on the web-based Horizon 2020 Participant Portal.
Amendment 156 #
Proposal for a Regulation
Annex 1 – part 1 – paragraph 1 – point c
Annex 1 – part 1 – paragraph 1 – point c
(c) to establish and develop close and long- term cooperation between the Union, other Members, Associated Partners, and the other stakeholders such as other industries, regulatory bodies, patient organisations, academia, research bodies and clinical centres, as well as cooperation between industry and academia;
Amendment 185 #
Proposal for a Regulation
Annex 1 – part 6 – point 2 – paragraph 3
Annex 1 – part 6 – point 2 – paragraph 3
The chairperson of the States Representatives Group shall have the right to attend meetings of the Governing Board as an observernd take part in the deliberations, but shall have no voting rights.
Amendment 187 #
Proposal for a Regulation
Annex 1 – part 6 – point 2 – paragraph 3 a (new)
Annex 1 – part 6 – point 2 – paragraph 3 a (new)
The chairperson of the Scientific Committee shall have the right to attend meetings of the Governing Board and take part in the deliberations, but shall have no voting rights.
Amendment 188 #
Proposal for a Regulation
Annex 1 – part 6 – point 2 – paragraph 3 b (new)
Annex 1 – part 6 – point 2 – paragraph 3 b (new)
The chairperson of the Stakeholder Forum shall have the right to attend meetings of the Governing Board and take part in the deliberations, but shall have no voting rights.
Amendment 189 #
Proposal for a Regulation
Annex 1 – part 7 – point 1 a (new)
Annex 1 – part 7 – point 1 a (new)
1 a. The Commission shall ensure a constant coordination between the activities of Horizon 2020 and the activities of the IMI2 Joint Undertaking by regularly identifying possible complementarities and synergies, including desirable overlaps, and implementing a formal coordination process to attune the research priorities covered by collaborative research under the framework programme and the activities covered by the IMI2 Joint Undertaking.
Amendment 193 #
Proposal for a Regulation
Annex 1 – part 7 – point 2 – point l
Annex 1 – part 7 – point 2 – point l
(l) approve the calls for proposals as well as, where appropriate, the related rules for submission, evaluation, selection, award and evaluation review procedures, proposed by the Executive Director in close cooperation with advisory groups referred to in Clause 7(2)(q);
Amendment 194 #
Proposal for a Regulation
Annex 1 – part 7 – point 2 – point m
Annex 1 – part 7 – point 2 – point m
(m) approve the list of proposals selected for funding on the basis of the ranking list produced by a panel of independent experts in accordance with Article 37 of the Rules for Participation of Horizon 2020;
Amendment 195 #
Proposal for a Regulation
Annex 1 – part 7 – point 2 – point n a (new)
Annex 1 – part 7 – point 2 – point n a (new)
(na) inform the States Representatives Group, the Scientific Committee and the Stakeholder Forum regularly on all matters relevant to their advisory role;
Amendment 201 #
Proposal for a Regulation
Annex 1 – part 9 – point 4 – point m a (new)
Annex 1 – part 9 – point 4 – point m a (new)
(ma) draw up an annual report on the progress of the research and development activities;
Amendment 202 #
Proposal for a Regulation
Annex 1 – part 9 – point 4 – point m b (new)
Annex 1 – part 9 – point 4 – point m b (new)
(mb) follow-up on any recommendations resulting from the final evaluation of the IMI Joint Undertaking, the interim evaluation of the IMI2 Joint Undertaking or any other relevant assessment of the IMI2 activities in a timely manner;
Amendment 216 #
Proposal for a Regulation
Annex 1 – part 10 – point 5
Annex 1 – part 10 – point 5
5. The Scientific Committee shall meet at least ontwice a year. The meetings shall be convened by its chairperson.
Amendment 217 #
Proposal for a Regulation
Annex 1 – part 10 – point 6 a (new)
Annex 1 – part 10 – point 6 a (new)
6 a. The Scientific Committee shall receive information on a regular basis, in particular on the participation in indirect actions funded by the IMI2 Joint Undertaking, on the outcome of each call and project implementation, on synergies with other relevant Union programmes, on the execution of the IMI2 budget and on the dissemination and exploitation of research results.
Amendment 220 #
Proposal for a Regulation
Annex 1 – part 11 – point 2 – introductory part
Annex 1 – part 11 – point 2 – introductory part
2. The States Representatives Group shall meet at least ontwice a year. The meetings shall be convened by its chairperson. The chairperson of the Governing Board and the Executive Director or their representatives shall attend the meetings.
Amendment 223 #
Proposal for a Regulation
Annex 1 – part 11 – point 4 a (new)
Annex 1 – part 11 – point 4 a (new)
4 a. The States Representatives Group shall receive information on a regular basis, in particular on the participation in indirect actions funded by the IMI2 Joint Undertaking, on the outcome of each call and project implementation, on synergies with other relevant Union programmes, on the execution of the IMI2 budget and on the dissemination and exploitation of research results.
Amendment 226 #
Proposal for a Regulation
Annex 1 – part 12 – point 2
Annex 1 – part 12 – point 2
2. The Stakeholder Forum shall be informed of the activities of the IMI2 Joint Undertaking on a regular basis, in particular on the participation in indirect actions funded by the IMI2 Joint Undertaking, on the outcome of each call and project implementation, on synergies with other relevant Union programmes, on the execution of the IMI2 budget and on the dissemination and exploitation of research results, and shall be invited to provide comments.
Amendment 234 #
Proposal for a Regulation
Annex 1 – part 17 – paragraph 1
Annex 1 – part 17 – paragraph 1
Amendment 236 #
Proposal for a Regulation
Annex 1 – part 17 – point 3
Annex 1 – part 17 – point 3
3. The IMI2 Joint Undertaking shall report annually to the Commission in accordance with Article 60(5) of Regulation (EU, Euratom) No 966/2012and the budgetary authorities. Within two months after the end of each fiscal year, the Executive Director shall submit the annual accounts and balance sheet of the previous year to the Court of Auditors. The Court of Auditors may carry out inspections, including on-the- spot checks.
Amendment 238 #
Proposal for a Regulation
Annex 1 – part 17 – point 4
Annex 1 – part 17 – point 4
4. The accounts of the IMI2 Joint Undertaking shall be examined by an independent audit body as laid down in Article 60(5) of Regulation (EU, Euratom) No 966/2012the Court of Auditors in accordance with Article 287 of the Treaty.
Amendment 239 #
Proposal for a Regulation
Annex 1 – part 17 – point 4 a (new)
Annex 1 – part 17 – point 4 a (new)
4 a. The Court of Auditors shall prepare a Specific Annual Report on the IMI2 Joint Undertaking.
Amendment 241 #
Proposal for a Regulation
Annex 1 – part 20 – point 2
Annex 1 – part 20 – point 2
2. The IMI2 Joint Undertaking Governing Board mayshall adopt rules for the prevention and management of conflicts of interest in respect of its Members, Associated Partners, bodies and staff. In those rules, provision shall be made to avoid conflict of interest for the representatives of the Members serving the Governing Board.