BETA

21 Amendments of Jean-Pierre AUDY related to 2013/0243(COD)

Amendment 35 #
Proposal for a decision
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; training should be promoted and the capacities of developing countries reinforced; the integration of European national programmes should be further improved; collaboration with other major public and private fundpartners, including the pharmaceutical industry, and public-private partnerships such as the PDPs (Product Development Partnerships), non-governmental organisations and foundations, needs to be strengthened and extended; synergies with European external policy actions should be developed, in particularspecifically with EU 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.
2013/12/05
Committee: ITRE
Amendment 37 #
Proposal for a decision
Recital 5 a (new)
(5a) The European Union is a major funder of research into poverty-related diseases and neglected infectious diseases. The Commission and Member States contribute almost one quarter (22%) of government investment in this sector worldwide. The European Union is also a major player in the field of international health. For example, the Commission and Member States supply around a half of all the credits for international funds.
2013/12/05
Committee: ITRE
Amendment 47 #
Proposal for a decision
Recital 15
(15) A ceiling should be established for the Union's participation in EDCTP2 for the duration of Horizon 2020 Framework Programme. WIn that period, and within that ceiling, the Union contribution should be equal to the initial contributions committed by the participating statesof the states referred to in Article 1 of this Decision in order to achieve a high leverage effect and ensure a stronger integration of participating states' programmes. That ceiling should also provide for matching the contributions from any other Member State or country associated to Horizon 2020 Framework Programme joining the EDCTP2 Programme during the Horizon 2020 Framework Programmethose states' programmes.
2013/12/05
Committee: ITRE
Amendment 52 #
Proposal for a decision
Recital 28
(28) Since the objectives of this Decision, namely to contribute to the reduction of the social and economic burden of poverty- related diseases and neglected infectious diseases in developing countries and in particular in sub-Saharan Africa by accelerating the clinical development of effective, safe, straightforward and affordable medical interventions for poverty-related diseas(diagnoses, drugs, treatments and vaccines) which are tailored to developing countries’ specific circumstances, cannot be sufficiently achieved by the Member States due to the lack of necessary critical mass to be achieved, both in human and financial terms, and can therefore, by reason of the scale of the action, 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 the European Union. In accordance with the principle of proportionality, as set out in that Article, this Decision does not go beyond what is necessary for that purposein order to achieve those objectives.
2013/12/05
Committee: ITRE
Amendment 57 #
Proposal for a decision
Article 2 – paragraph 1 – introductory part
1. The maximum Union financial contribution, including EFTA appropriations, to the EDCTP2 Programme shall be EUR 683 million, as follows:matching the contributions of the participating states listed in Article 1.
2013/12/05
Committee: ITRE
Amendment 62 #
Proposal for a decision
Article 2 – paragraph 1 – point a
(a) EUR 594 million to equal the contributions of participating states listed in article 1.1;deleted
2013/12/05
Committee: ITRE
Amendment 66 #
Proposal for a decision
Article 2 – paragraph 1 – point b
(b) EUR 89 million to equal the contributions of any other Member State or any other country associated to Horizon 2020 Framework Programme participating in the EDCTP2 Programme in accordance with Article 1.2.deleted
2013/12/05
Committee: ITRE
Amendment 82 #
Proposal for a decision
Article 12 – paragraph 1
1. By 31 December0 June 20178, 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 June1 December 2018.
2013/12/05
Committee: ITRE
Amendment 83 #
Proposal for a decision
Annex 1 – paragraph 1 – point 1 – paragraph 1
EDCTP2 shall contribute to the reduction of the social and economic burden of poverty-related diseases in developing countries, in particular in sub-Saharan Africa, byand neglected infectious diseases, focussing on diseases that particularly affect women and children as the most vulnerable population groups. To that end, it shall target an acceleratingon of the clinical development of effective, safe, straightforward and affordable medical interventions for poverty-(diagnoses, drugs, trelated diseases, in partnership with sub-Saharan Africa. ments and vaccines) which are tailored to developing countries’ specific circumstances, in partnership with developing countries and particularly those of sub-Saharan Africa. That clinical development may cover all the stages in the process from Phase I to Phase IV.
2013/12/05
Committee: ITRE
Amendment 86 #
Proposal for a decision
Annex 1 – paragraph 1 – point 2 – point a
(a) an increased number of new or improved medical interventions for HIV/AIDS, tuberculosis, malaria and other poverty-related diseases, and by the end of the programme to have delivered at least one new medical intervention; to have issued at least 30against poverty-related diseases and neglected infectious diseases, and by the end of the programme to have issued guidelines for improved or extended use of existing medical interventions; and to have progressed the clinical development of at least 20 candidate medical intervention.s;
2013/12/05
Committee: ITRE
Amendment 92 #
Proposal for a decision
Annex 1 – paragraph 1 – point 2 – point d
(d) extended international cooperation with other public and private fundpartners;
2013/12/05
Committee: ITRE
Amendment 96 #
Proposal for a decision
Annex 1 – paragraph 1 – point 2 – point e a (new)
ea) a higher profile for actions carried out under the EDCTP2 Programme at European and international level.
2013/12/05
Committee: ITRE
Amendment 97 #
Proposal for a decision
Annex 1 – paragraph 1 – point 3 – point a – introductory part
(a) Support clinical trials on new or improved medical interventions for poverty-related diseases and neglected infectious diseases through partnerships between European and developing countries, in particular sub- Saharan Africa:
2013/12/05
Committee: ITRE
Amendment 102 #
Proposal for a decision
Annex 1 – paragraph 1 – point 3 – point e – introductory part
(e) Establish cooperation and launch joint actions with other public and private funderspartners and hence markedly increase the funding they contribute to the EDCTP-II Programme.
2013/12/05
Committee: ITRE
Amendment 103 #
Proposal for a decision
Annex 1 – paragraph 1 – point 3 – point e – paragraph 1
Target: increase the contributions received from developing countries to at least EUR 30 million compared to EUR 14 million under EDCTP1.deleted
2013/12/05
Committee: ITRE
Amendment 104 #
Proposal for a decision
Annex 1 – paragraph 1 – point 3 – point e – paragraph 2
Target: obtain additional contributions, either public or private, of at least EUR 500 million compared to EUR 71 million under EDCTP1.deleted
2013/12/05
Committee: ITRE
Amendment 105 #
Proposal for a decision
Annex 1 – paragraph 1 – point 3 – point f a (new)
(fa) Raise the profile of actions carried out under the EDCTP2 Programme at European and global level, in particular in developing countries, by making use of political dialogue fora such as the ACP-EU Joint Parliamentary Assembly and EU-Africa Summits.
2013/12/05
Committee: ITRE
Amendment 107 #
Proposal for a decision
Annex 2 – point 1 – paragraph 1 – point a
(a) promoting networking, coordination, alignment, cooperation and integration of national research programmes and activities on poverty-related diseases and neglected infectious diseases at scientific, management and financial level;
2013/12/05
Committee: ITRE
Amendment 113 #
Proposal for a decision
Annex 2 – point 1 – paragraph 1 – point c
(c) fostering capacity development for clinical trials and related research in developing countries, in particular in sub- Saharan Africa, 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 level;
2013/12/05
Committee: ITRE
Amendment 128 #
Proposal for a decision
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. In such cases, each member of the GA shall have a number of votes proportional to his/her financial contribution or contribution in kind to the EDCTP2 Programme in the preceding financial year.
2013/12/05
Committee: ITRE
Amendment 130 #
Proposal for a decision
Annex 3 – paragraph 1 – point 2 – introductory part
(2) The GA shall appoint a management board that. In doing so, the GA shall take due account of the contributions of the participating states and shall also ensure geographical balance in the membership of that board. At least one member of the board must come from a country in Sub-Saharan Africa. The management board 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 the following tasks:
2013/12/05
Committee: ITRE