33 Amendments of Maria da Graça CARVALHO related to 2013/0243(COD)
Amendment 32 #
Proposal for a decision
Recital 2
Recital 2
(2) Horizon 2020 - The Framework Programme for Research and Innovation (2014-2020) established by Regulation (EU) No …/2013 of the European Parliament and of the Council of … 20134 (hereinafter ‘Horizon 2020 Framework Programme’) aims at achieving a greater impact on research and innovation by contributing to the strengthening of pdeveloping closer synergies, increasing coordination and avoiding unnecessary duplication with international, national and regional research programmes. Public-public partnerships, including through Union participation in programmes undertaken by several Member States in accordance with Article 185 of the Treaty, should achieve these goals, meet the conditions specified in that Regulation, in particular in Articles 20, and fully comply with the general principles applying to Horizon 2020. __________________ 4 OJ... [Horizon 2020 Framework Programme].
Amendment 33 #
Proposal for a decision
Recital 4
Recital 4
(4) In 2009, independent experts adopted the report of the interim evaluation of EDCTP18 . The opinion of the expert panel was that EDCTP1 provided a unique platform for a genuine dialogue with African scientists and it has started to bridge the gap between North and South in building research capacities and in providing learning and working opportunities for young African researchers. Following this report, there are fundamental issues to be taken into consideration for a second European and Developing Countries Clinical Trials Partnership Programme (hereinafter ‘'EDCTP2 Programme'’): the current scope of EDCTP1 needs to be changed and extended; the capabilities in developing countries for sound conduct and management of clinical trials should, where necessary, be further developed and strengthened, in particular the role and development of ethical review committees and the corresponding regulatory environment, the coordination, collaboration and where appropriate integration of European national programmes should be further improved; collaboration with other major public and private funders, including the pharmaceutical industry, needs to be strengthened and extended; synergies with European external policy actions should be developed, in particular with Union development assistance; co-funding rules should be clarified and simplified; monitoring tools need to be strengthened. __________________ 8 Van Velzen et al., Independent External Evaluation Report, December 2009.
Amendment 36 #
Proposal for a decision
Recital 5
Recital 5
(5) According to Regulation (EU) No .../2013 of the European Parliament and of the Council of ... 2013 establishing Horizon 20208a and Council Decision … /2013/EU of … 2013 establishing the Specific Programme implementing Horizon 2020 - The Framework Programme for Research and Innovation (2014-2020)9 further support may be provided to the EDCTP2 Programme. __________________ 8a OJ L ... [Horizon 2020]. 9 OJ L … [Horizon 2020 Specific Programme].
Amendment 38 #
Proposal for a decision
Recital 7 a (new)
Recital 7 a (new)
Amendment 42 #
Proposal for a decision
Recital 13 a (new)
Recital 13 a (new)
(13 a) With a view to the overall aim of Horizon 2020 of achieving greater simplification and harmonisation of the European research and innovation funding landscape Public/Public Partnerships should establish simple governance models and avoid different sets of rules from Horizon 2020.
Amendment 43 #
Proposal for a decision
Recital 13 b (new)
Recital 13 b (new)
(13 b) Barriers preventing the participation of newcomers to the programme should be identified and addressed. In this context the participation of SMEs, universities and research centres should be promoted.
Amendment 54 #
Proposal for a decision
Recital 28 a (new)
Recital 28 a (new)
(28 a) The results of clinical trials and other research activities carried out under the EDCTP2 programme should be disseminated as soon as possible by appropriate means and in compliance with Regulation (EU) No ... [Rules for the participation and dissemination in Horizon 2020], and in particular open access shall apply with regard to the dissemination through research publications.
Amendment 55 #
Proposal for a decision
Recital 28 a (new)
Recital 28 a (new)
(28 a) Barriers preventing the participation of new comers to the program should be identified and addressed. In this context, the participation of SME, universities and research centres should be promoted.
Amendment 68 #
Proposal for a decision
Article 3 – paragraph 1 – point a a (new)
Article 3 – paragraph 1 – point a a (new)
(a a) the demonstration by the Participating States that EDCTP2 is set up in accordance with the objectives and research priorities of the health research challenge laid down in Regulation (EU) No .../2013 of the European Parliament and of the Council of ... 2013 establishing Horizon 2020 and Council Decision ... /2013/EU of ... 2013 establishing the Specific Programme implementing Horizon 2020 - The Framework Programme for Research and Innovation (2014-2020);
Amendment 69 #
Proposal for a decision
Article 3 – paragraph 1 – point a b (new)
Article 3 – paragraph 1 – point a b (new)
(a b) the demonstration by the Participating States that EDCTP2 is set up in accordance with the general principles governing the Horizon 2020 Framework;
Amendment 70 #
Proposal for a decision
Article 3 – paragraph 1 – point a c (new)
Article 3 – paragraph 1 – point a c (new)
(a c) the demonstration by the Participating States that EDCTP2 is set up in accordance with the conditions laid down in Article 20 of Regulation (EU) No .../2013 of the European Parliament and of the Council of ... 2013 establishing Horizon 2020;
Amendment 74 #
Proposal for a decision
Article 4 – paragraph 1 – subparagraph 2
Article 4 – paragraph 1 – subparagraph 2
Activities may include activities undertaken by public or private not-for- profit research organisations included in the national programme activities of participating states and new activities, including calls for proposals managed by the EDCTP2-IS.
Amendment 80 #
Proposal for a decision
Article 6 – paragraph 4 a (new)
Article 6 – paragraph 4 a (new)
(4 a) 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, calls for proposals organised by EDCTP2 shall be published on the web-based Horizon 2020 Participant Portal.
Amendment 81 #
Proposal for a decision
Article 12 – paragraph 1
Article 12 – paragraph 1
1. By 31 December 2017 the Commission shall conduct an interim evaluation of the EDCTP2 Programme. The Commission shall prepare a report on that evaluation which includes conclusions of the evaluation and observations by the Commission. The Commission shall send that report to the European Parliament and to the Council by 30 June 2018. The interim evaluation of EDCTP2 shall form part of and be compiled with the interim evaluation of Horizon 2020.
Amendment 89 #
Proposal for a decision
Annex 1 – paragraph 1 – point 2 – point c
Annex 1 – paragraph 1 – point 2 – point c
(c) better coordination, alignment and, where appropriate, integration of relevant national programmes to increase the cost- effectiveness of European public investments;investments. Moreover, the research priorities should be established in an objective-orientated manner in order to accelerate results and contribute to the eradication of poverty-related and neglected diseases.
Amendment 90 #
Proposal for a decision
Annex 1 – paragraph 1 – point 2 – point c
Annex 1 – paragraph 1 – point 2 – point c
(c) better coordination, alignment and integration of relevant national programmes to increase the cost- effectiveness of European public investments. Moreover, the research priorities should be established in an objective-oriented manner in order to accelerate results and contribute to the eradication of poverty related and neglected diseases;
Amendment 91 #
Proposal for a decision
Annex 1 – paragraph 1 – point 2 – point d
Annex 1 – paragraph 1 – point 2 – point d
(d) extended international cooperation with other public and/or private funders; to ensure that the impact of all research is maximised and that synergies can be taken into consideration and achieve leveraging of resources and investments.
Amendment 93 #
Proposal for a decision
Annex 1 – paragraph 1 – point 2 – point e
Annex 1 – paragraph 1 – point 2 – point e
(e) an increased impact due to effective cooperation with relevant European Union initiatives, including its development assistance.better coordination, alignment and, where appropriate, integration with relevant European Union initiatives in order to better take advantage of synergies, create a more complete innovation chain from clinical trials to treatment delivery and increase the effectiveness of European public investments. In this context, synergies between EDCTP2 and the European Development Fund are essential;
Amendment 94 #
Proposal for a decision
Annex 1 – paragraph 1 – point 2 – point e
Annex 1 – paragraph 1 – point 2 – point e
(e) an increased impact due to effective coopebetter coordination, alignment and, where appropriate, integration with relevant European Union initiatives, including its development assistance and other key initiatives to enhance research and development for poverty-related diseases, product development partnerships and other government-led programmes in order to better take advantage of synergies, create a more complete innovation chain from clinical trials to treatment delivery and increase the effectiveness of European public investments.
Amendment 99 #
Proposal for a decision
Annex 1 – paragraph 1 – point 3 – point a a (new)
Annex 1 – paragraph 1 – point 3 – point a a (new)
(a a) Where appropriate the strategic advisory committee shall advise on target product profiles in order to guide investment decisions according to agreed priorities.
Amendment 101 #
Proposal for a decision
Annex 1 – paragraph 1 – point 3 – point b – paragraph 2
Annex 1 – paragraph 1 – point 3 – point b – paragraph 2
Amendment 108 #
Proposal for a decision
Annex 2 – point 1 – paragraph 1 – point a
Annex 2 – point 1 – paragraph 1 – point a
(a) promoting networking, coordination, alignment, collaboration and cooperation and integration of national research programmes and activities on poverty- related infectious diseases at scientific, management and financial level;
Amendment 110 #
Proposal for a decision
Annex 2 – point 1 – paragraph 1 – point b
Annex 2 – point 1 – paragraph 1 – point b
(b) supporting clinical trial research and related activities on poverty-related diseases, in particular HIV/AIDS, malaria, tuberculosis and neglected infectious diseases;diseases that are poverty-related. Special attention should be devoted to neglected diseases that are already affecting Sub-Saharan Africa and Europe.
Amendment 114 #
Proposal for a decision
Annex 2 – point 1 – paragraph 1 – point c
Annex 2 – point 1 – paragraph 1 – point c
(c) fostering capacity development for clinical trials and related research in developing countries through grants for: career development of junior/senior fellows, promoting mobility, staff exchange grants, research training networks, strengthening ethics and regulatory bodies, mentoring and partnerships at individual or institutional or regional level;
Amendment 116 #
Proposal for a decision
Annex 2 – point 1 – paragraph 1 – point d
Annex 2 – point 1 – paragraph 1 – point d
(d) establishing cooperation and launching joint actions with other public and private funders;, including industry and product development partnerships.
Amendment 119 #
Proposal for a decision
Annex 2 – point 2 – paragraph 1
Annex 2 – point 2 – paragraph 1
The EDCTP2 Programme shall be implemented by the EDCTP2-IS on the basis of an annual work plan and a multiannual strategic work plan prepared by the EDCTP2- IS, with the consultation of the relevant stakeholders, and adopted by the General Assembly of the EDCTP2- IS following international peer-review and subject to the prior approval by the Commission. The annual work plan shall identify topics and activities to be implemented, in coordination with national programmes, including calls for proposals to be launched by EDCTP-IS to select and fund indirect actions, as well as the budgets and EDCTP2 funding for those topics and activities EDCTP2 should seek scientific coordination and exchange of information with relevant public or private initiatives, including those under Horizon 2020, such as the Innovative Medicines Initiative and the strategic panel for health.
Amendment 120 #
Proposal for a decision
Annex 2 – point 2 – paragraph 2
Annex 2 – point 2 – paragraph 2
The annual work plan shall identify topics and activities to be implemented, in coordination, where appropriate, with national programmes, including calls for proposals to be launched by EDCTP-IS to select and fund indirect actions, as well as the budgets and EDCTP2 funding for those topics and activities. EDCTP2 should seek scientific coordination and, where relevant, exchange of information with relevant public or private initiatives including those under Horizon 2020 such as the Innovative Medicines Initiative and the Strategic Panel for Health.
Amendment 123 #
Proposal for a decision
Annex 2 – point 3 – paragraph 1
Annex 2 – point 3 – paragraph 1
An annual report shall be provided by EDCTP2-IS, which shall give a detailed overview of the implementation of the EDCTP2 Programme. That overview shall provide information on each activity selected in accordance with the work plan, including indirect actions selected through calls for proposals managed by EDCTP-IS. Such information shall include a description of each activity, including indirect action, its budget, the value of the funding allocated to it if any, measures taken to enable access to emerging products and its status.
Amendment 126 #
Proposal for a decision
Annex 2 – point 3 – paragraph 2
Annex 2 – point 3 – paragraph 2
With regards to calls managed by EDCTP- IS, the annual report shall moreover include information on the number of projects submitted and selected for funding, the detailed use of the Union financial contribution, the distribution of national and other contributions, the types of participants, country statistics, brokerage events and dissemination activities and measures taken to enable access.
Amendment 129 #
Proposal for a decision
Annex 3 – paragraph 1 – point 1 – paragraph 2
Annex 3 – paragraph 1 – point 1 – paragraph 2
The GA shall decide by consensus. Failing consensus, the GA shall take its decisions by a majority of at least 75 % of the votes.
Amendment 131 #
Proposal for a decision
Annex 3 – paragraph 1 – point 2 – introductory part
Annex 3 – paragraph 1 – point 2 – introductory part
(2) The GA shall appoint a management board that shall supervise the secretariat of the EDCTP2-IS (hereinafter ‘''SEC'’') established by the GA as the executive body of the EDCTP2 Programme. SEC shall have at least the following tasks:
Amendment 135 #
Proposal for a decision
Annex 3 – paragraph 1 – point 3 – introductory part
Annex 3 – paragraph 1 – point 3 – introductory part
(3) A Scientiftrategic Advisory Committee (hereinafter ‘'SAC’') shall advise the GA on the strategic priorities of the EDCTP2 Programmeprovide strategic and scientific advice to the GA, the Board and the SEC.
Amendment 137 #
Proposal for a decision
Annex 3 – paragraph 1 – point 3 – paragraph 2 – point b
Annex 3 – paragraph 1 – point 3 – paragraph 2 – point b
(b) review and advise the GA on the content, scope and dimension of the EDCTP2 draft annual work plan, including diseases covered and approaches to be adopted, from a scientific and technical standpoint