18 Amendments of Françoise GROSSETÊTE related to 2013/0243(COD)
Amendment 35 #
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; 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.
Amendment 37 #
Proposal for a decision
Recital 5 a (new)
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.
Amendment 47 #
Proposal for a decision
Recital 15
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.
Amendment 52 #
Proposal for a decision
Recital 28
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.
Amendment 57 #
Proposal for a decision
Article 2 – paragraph 1 – introductory part
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.
Amendment 62 #
Proposal for a decision
Article 2 – paragraph 1 – point a
Article 2 – paragraph 1 – point a
Amendment 66 #
Proposal for a decision
Article 2 – paragraph 1 – point b
Article 2 – paragraph 1 – point b
Amendment 83 #
Proposal for a decision
Annex 1 – paragraph 1 – point 1 – paragraph 1
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.
Amendment 86 #
Proposal for a decision
Annex 1 – paragraph 1 – point 2 – point a
Annex 1 – paragraph 1 – point 2 – point a
Amendment 92 #
Proposal for a decision
Annex 1 – paragraph 1 – point 2 – point d
Annex 1 – paragraph 1 – point 2 – point d
Amendment 96 #
Proposal for a decision
Annex 1 – paragraph 1 – point 2 – point e a (new)
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.
Amendment 97 #
Proposal for a decision
Annex 1 – paragraph 1 – point 3 – point a – introductory part
Annex 1 – paragraph 1 – point 3 – point a – introductory part
Amendment 102 #
Proposal for a decision
Annex 1 – paragraph 1 – point 3 – point e – introductory part
Annex 1 – paragraph 1 – point 3 – point e – introductory part
Amendment 103 #
Proposal for a decision
Annex 1 – paragraph 1 – point 3 – point e – paragraph 1
Annex 1 – paragraph 1 – point 3 – point e – paragraph 1
Amendment 104 #
Proposal for a decision
Annex 1 – paragraph 1 – point 3 – point e – paragraph 2
Annex 1 – paragraph 1 – point 3 – point e – paragraph 2
Amendment 105 #
Proposal for a decision
Annex 1 – paragraph 1 – point 3 – point f a (new)
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.
Amendment 107 #
Proposal for a decision
Annex 2 – point 1 – paragraph 1 – point a
Annex 2 – point 1 – paragraph 1 – point a
Amendment 113 #
Proposal for a decision
Annex 2 – point 1 – paragraph 1 – point c
Annex 2 – point 1 – paragraph 1 – point c