13 Amendments of Keith TAYLOR related to 2013/0243(COD)
Amendment 25 #
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 integration of European national programmes should be further improved; collaboration with other major public and private fundpartners, 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 26 #
Proposal for a decision
Recital 11 a (new)
Recital 11 a (new)
(11a) In 2010, in its "Council Conclusions on the EU's role in global health", the Council called on the EU to promote effective and fair financing of research that benefits the health of all and ensures that innovations and interventions lead to affordable and accessible solutions. In particular, models that dissociate costs of R&D and the prices of medicines should be explored, including the opportunities for technology transfer to developing countries.
Amendment 27 #
Proposal for a decision
Recital 13
Recital 13
(13) In line with the objectives of Horizon 2020 Framework Programme, any Member State and any country associated to the Horizon 2020 Framework Programme should be entitled to participate in the EDCTP2 Programme. It should be ensured that projects receiving money via the Horizon 2020 Framework Programme are not in breach of international human rights law.
Amendment 28 #
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. Within that ceiling, tThe Union contribution should be equal to the inititotal contributions committed by the participating states in order to achieve a high leverage effect and ensure a stronger integration of participating states' programmes. That ceiling shoul and 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 Programme.
Amendment 31 #
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 at least EUR 683 million, as followto equal the contribution of participating states:
Amendment 32 #
Proposal for a decision
Article 2 – paragraph 1 – point a
Article 2 – paragraph 1 – point a
Amendment 33 #
Proposal for a decision
Article 2 – paragraph 1 – point b
Article 2 – paragraph 1 – point b
Amendment 36 #
Proposal for a decision
Annex 1 – point 1 – paragraph 1
Annex 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, by accelerating the clinical development of effective, safe, accessible, appropriate and affordable medical interventions for poverty-related diseases, in partnership with sub-Saharan Africa.
Amendment 38 #
Proposal for a decision
Annex 1 – point 2 – point a
Annex 1 – point 2 – point a
(a) an increased number of new or improved, accessible and appropriate medical interventions for HIV/AIDS, tuberculosis, malaria, neglected infectious diseases 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 30 guidelines for improved or extended use of existing medical interventions; and to have progressed the clinical development of at least 20 candidate medical interventions;
Amendment 54 #
Proposal for a decision
Annex 2 – point 1 – point d
Annex 2 – point 1 – point d
(d) establishing cooperation and launching joint actions with other public and private funders aiming at reinforcing national health systems and facilitating transfers of results to the population concerned ;
Amendment 55 #
Proposal for a decision
Annex 2 – point 1 – point e a (new)
Annex 2 – point 1 – point e a (new)
(ea) Establishing robust obligations to ensure access and availability of products, including requirements to register products in all endemic countries and with a stringent regulatory authority, to ensure manufacture of the product and affordability in all low and middle-income countries.
Amendment 56 #
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 ensure access to emerging products and its status.
Amendment 59 #
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 ensure access.