23 Amendments of Michèle RIVASI related to 2013/0243(COD)
Amendment 34 #
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; collaborationsynergies with other major public and private fundpartners, including the pharmaceutical industry, civil society, non- governmental organisations needs to be strengthened and extended; synergies with European external policy actions should be developed, in particular with Union development assistance in the field of health; 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 39 #
Proposal for a decision
Recital 11 a (new)
Recital 11 a (new)
(11 a) The Union and the Member States are the major funders of the Global Fund to fight HIV, malaria and tuberculosis. In this context, consideration should be given to orient part of the Union contribution to the Global Fund towards actions aiming at facilitating the transfer of EDCTP results to the populations concerned.
Amendment 40 #
Proposal for a decision
Recital 11 b (new)
Recital 11 b (new)
(11 b) 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 41 #
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 must be ensured, that projects receiving money from the Horizon 2020 Framework Programme are not in breach of international human rights law.
Amendment 48 #
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 49 #
Proposal for a decision
Recital 16
Recital 16
(16) The Union's financial contribution should be subject to formal commitments from the participating states to contribute to implement the EDCTP2 Programme and their fulfilment. In particular, clinical trials should only get Union's financial contribution where they are performed in accordance with the declaration of Helsinki and where the same standards for data transparency apply as in Regulation [2012/0192].
Amendment 50 #
Proposal for a decision
Recital 16 a (new)
Recital 16 a (new)
(16 a) It is essential that informed consent for clinical trials conducted in developing countries is always obtained in a way that is truly informed and truly voluntary.
Amendment 51 #
Proposal for a decision
Recital 17 a (new)
Recital 17 a (new)
(17 a) To ensure that the programme is implemented according to the highest ethical standards, an Ethics Committee should be established within EDCTP2 to review clinical trials protocols and perform on site ethics audits.
Amendment 58 #
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 follows:to equal the contribution of participating states.
Amendment 61 #
Proposal for a decision
Article 2 – paragraph 1 – point a
Article 2 – paragraph 1 – point a
Amendment 65 #
Proposal for a decision
Article 2 – paragraph 1 – point b
Article 2 – paragraph 1 – point b
Amendment 72 #
Proposal for a decision
Article 3 – paragraph 1 – point e a (new)
Article 3 – paragraph 1 – point e a (new)
(e a) the demonstration by the sponsor of any clinical trial, funded totally or partially by EDCTP2, that the informed consent of any subject is obtained in accordance with the Declaration of Helsinki;
Amendment 73 #
Proposal for a decision
Article 3 – paragraph 1 – point e b (new)
Article 3 – paragraph 1 – point e b (new)
(e b) any clinical trial funded or co- funded by EDCTP2 shall not start before: - approval of the protocol by an ethics committee established within EDCTP2 - registration with a trial number on the website managed by the EDCTP secretariat - demonstration by the sponsor of sufficient insurance coverage for the compensation of direct or indirect health damage caused to the subject(s) of the clinical trial
Amendment 76 #
Proposal for a decision
Article 4 – paragraph 3 – subparagraph 2 a (new)
Article 4 – paragraph 3 – subparagraph 2 a (new)
The EDCTP2-IS shall set up and manage a website based on the same model as Eudravigilance at the European Medicines Agency, where it will make publicly available the clinical study report of any EDCTP2 funded clinical trial, be the results positive, negative or inconclusive.
Amendment 77 #
Proposal for a decision
Article 4 – paragraph 3 – subparagraph 2 b (new)
Article 4 – paragraph 3 – subparagraph 2 b (new)
The EDCTP2-IS shall perform at least one on-site audit for each clinical trial funded or co-funded by EDCTP2, in order to control the ethical conditions of the trial and the full implementation of the protocol. After each audit, a report will be sent to the Commission and the ACP delegation at the European Parliament.
Amendment 85 #
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, 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 88 #
Proposal for a decision
Annex 1 – paragraph 1 – point 2 – point a
Annex 1 – paragraph 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 115 #
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; aiming at reinforcing national health systems and facilitating transfers of results to the population concerned;
Amendment 117 #
Proposal for a decision
Annex 2 – point 1 – paragraph 1 – point e a (new)
Annex 2 – point 1 – paragraph 1 – point e a (new)
(e a) 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 118 #
Proposal for a decision
Annex 2 – point 1 – paragraph 1 – point e b (new)
Annex 2 – point 1 – paragraph 1 – point e b (new)
(e b) assuring no infringement of Human rights, notably via: - on-site ethics audits - the publication of the clinical study reports in an easily searchable form on EDCTP website, within one year after the termination of the trial - the publication of binding rules for sponsors relating to the record of serious events and to pharmacovigilance
Amendment 124 #
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 127 #
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.
Amendment 138 #
Proposal for a decision
Annex 3 – paragraph 1 – point 3 a (new)
Annex 3 – paragraph 1 – point 3 a (new)
(3 a) The GA, cooperation with the Scientific Committee, shall establish an Ethics Committee. The Ethics Committee shall approve ex- ante the protocol for any clinical trial funded or co-funded by EDCTP2 and conduct regular on-site ethics audits. It shall report to the GA. The GA shall establish the number of members of the Ethics Committee and the modalities of their appointment.