Activities of Françoise GROSSETÊTE related to 2013/0240(NLE)
Shadow reports (1)
REPORT on the proposal for a Council regulation on the Innovative Medicines Initiative 2 Joint Undertaking PDF (413 KB) DOC (539 KB)
Amendments (29)
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 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 99 #
Proposal for a Regulation
Article 2 – paragraph 1 – point b – point i
Article 2 – paragraph 1 – point b – point i
i) increase the success rate in clinical trials of priority medicines identified by the World Health Organisation to meet therapeutic and public health needs;
Amendment 102 #
Proposal for a Regulation
Article 2 – paragraph 1 – point b – point iii
Article 2 – paragraph 1 – point b – point iii
iii) develop new vaccines, diagnostics, medicines and therapies for diseases for which there is a high unmet need, such as Alzheimer's disease and limited market incentives, such as antimicrobial resistance;
Amendment 137 #
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. This evaluation should take into account the recommendations of the IMI2 Scientific Committee. This evaluation should furthermore focus on a detailed examination of the interim results of IMI2 with regard to the specific indicators to be defined by the IMI2 Governing Board. The interim evaluation of the IMI2 Joint Undertaking should form part of the interim evaluations in the Horizon 2020 Framework Programme. The Commission shall communicate the conclusions thereof, accompanied by its observations, to the European Parliament and to the Council by 30 June 2018.
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 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 157 #
Proposal for a Regulation
Annex 1 – part 1 – paragraph 1 – point e
Annex 1 – part 1 – paragraph 1 – point e
(e) to effectively support research, including phase III and IV clinical trials where these deal with unmet medical needs, and innovation in life sciences mainly through grants;
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 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 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 212 #
Proposal for a Regulation
Annex 1 – part 10 – point 4 – point b a (new)
Annex 1 – part 10 – point 4 – point b a (new)
(ba) draw up recommendations to the Commission for the interim evaluation of the IMI2 Joint Undertaking to be conducted by 31 December 2017.
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.