Activities of Fiona HALL related to 2013/0243(COD)
Shadow reports (1)
REPORT on the proposal for a decision of the European Parliament and of the Council on the participation of the Union in a second European and Developing Countries Clinical Trials Partnership Programme jointly undertaken by several Member States PDF (391 KB) DOC (485 KB)
Shadow opinions (1)
OPINION on the proposal for a Decision of the European Parliament and of the Council on the participation of the Union in a second European and Developing Countries Clinical Trials Partnership Programme jointly undertaken by several Member States
Amendments (38)
Amendment 30 #
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 in developing countries and in particular in sub-Saharan Africa by accelerating the clinical development of effective, safe, accessible, suitable and affordable medical interventions for poverty-related diseasand neglected diseases, tailored to the specific needs and circumstances of the developing countries, 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 purpose.
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 35 #
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, suitable, accessible and affordable medical interventions for poverty-related diseases, in partnership withand neglected diseases, which are tailored to the specific needs and circumstances of the developing countries, in partnership with these countries in sub-Saharan Africa.
Amendment 37 #
Proposal for a decision
Annex 1 – point 2 – point a
Annex 1 – point 2 – point a
(a) an increased number of new or improved medical interventions for poverty related diseases such as HIV/AIDS, tuberculosis, and malaria, and other poverty-related and neglected 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 38 #
Proposal for a decision
Recital 7 a (new)
Recital 7 a (new)
Amendment 41 #
Proposal for a decision
Annex 1 – point 2 – point e
Annex 1 – point 2 – point e
(e) an increased impact due to effective cooperation with relevant European Union initiatives, including its development assistance, and with other initiatives working to improve research into poverty related and neglected diseases, including for example product development partnerships, the World Health Organisation and its Consultative Expert Working Group (CEWG), and other programmes.
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
Annex 1 – point 3 – point a – paragraph 1
Annex 1 – point 3 – point a – paragraph 1
(a) Support clinical trials on new or improved medical interventions for poverty-related and neglected diseases through partnerships between European and developing countries, in particular sub- Saharan Africa:
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 44 #
Proposal for a decision
Annex 1 – point 3 – point a – paragraph 2
Annex 1 – point 3 – point a – paragraph 2
Target: increase the number of supported clinical trials to at least 150, compared to 88 under EDCTP1, with a focus on clinical trials to develop new medical tools.
Amendment 45 #
Proposal for a decision
Annex 1 – point 3 – point a – paragraph 4
Annex 1 – point 3 – point a – paragraph 4
Target: Increase the number of peer- reviewed scientific articles published to at least 1000.
Amendment 46 #
Proposal for a decision
Annex 1 – point 3 – point b – paragraph 2
Annex 1 – point 3 – point b – paragraph 2
Target: sustain or increase the number of sub-Saharan African countries supported by the EDCTP2 to at least 30.
Amendment 46 #
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, 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 Pthose states' programmes.
Amendment 47 #
Proposal for a decision
Annex 1 – point 3 – point b – paragraph 3
Annex 1 – point 3 – point b – paragraph 3
Target: increase the number of fellowships to sub-Saharan African researchers and MSc/PhD students to at least 600 compared to 400 under EDCTP1, with at least 90 % offrom 400 under EDCTP1, strongly encouraging and supporting them to continuinge their research career in sub-Sahara Africa for at least one year afterllowing their fellowship.
Amendment 48 #
Proposal for a decision
Annex 1 – point 3 – point b – paragraph 4
Annex 1 – point 3 – point b – paragraph 4
Target: increase the number of capacity- building activities supported for conducting clinical trials in sub-Saharan Africa to at least 150 compared tofrom 74 under EDCTP1.
Amendment 51 #
Proposal for a decision
Annex 2 – point 1 – point a
Annex 2 – point 1 – point a
(a) promoting networking, coordination, alignment, open collaboration, cooperation and integration of national research programmes and activities on poverty- related infectiousand neglected diseases at scientific, management and financial level;
Amendment 52 #
Proposal for a decision
Annex 2 – point 1 – point b
Annex 2 – point 1 – point b
(b) supporting clinical trial research and related activities on poverty-related diseases, in particular HIV/AIDS, malaria, and tuberculosis, and neglected infectiousother poverty related and neglected diseases;
Amendment 53 #
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 in developing countries and in particular in sub-Saharan Africa by accelerating the clinical development of effective, safe, accessible and affordable medical interventions for poverty-related and neglected diseases, 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 purpose.
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 56 #
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 57 #
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, and its status, and measures taken to ensure access to emerging products for populations in developing countries.
Amendment 58 #
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 to emerging products.
Amendment 60 #
Proposal for a decision
Article 2 – paragraph 1 – point a
Article 2 – paragraph 1 – point a
Amendment 64 #
Proposal for a decision
Article 2 – paragraph 1 – point b
Article 2 – paragraph 1 – point b
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 78 #
Proposal for a decision
Article 5 – paragraph 1 – point b
Article 5 – paragraph 1 – point b
(b) in kind contributions consisting of the costs incurred by the participating states in implementing activities included upfront in the work plan referred to in Article 4(1) or in relation to the administrative budget of the EDCTP2-IS.
Amendment 84 #
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 and affordable medical interventions for poverty-related and neglected diseases, in partnership with sub-Saharan Africa.
Amendment 87 #
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 medical interventions for poverty-related diseases such as HIV/AIDS, tuberculosis, and malaria, and other poverty-related and neglected 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 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 98 #
Proposal for a decision
Annex 1 – paragraph 1 – point 3 – point a – introductory part
Annex 1 – paragraph 1 – point 3 – point a – introductory part
(a) Support clinical trials on new or improved medical interventions for poverty-related and neglected diseases through partnerships between European and developing countries, in particular sub- Saharan Africa:
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 100 #
Proposal for a decision
Annex 1 – paragraph 1 – point 3 – point b – paragraph 2
Annex 1 – paragraph 1 – point 3 – point b – paragraph 2
Target: increase the number of fellowships to sub-Saharan African researchers and MSc/PhD students to at least 600 compared to 400 under EDCTP1, with at least 90 % offrom 400 under EDCTP1, strongly encouraging and supporting them to continuinge their research career in sub-Sahara Africa for at least one year afterllowing their fellowship.
Amendment 109 #
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, cooperation and integration of national research programmes and activities on poverty-related infectiousand neglected diseases at scientific, management and financial level;
Amendment 112 #
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, and tuberculosis, and other poverty- related and neglected infectious diseases;
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 121 #
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, including activities initiated by participating states and 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.
Amendment 122 #
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, and its status, and measures taken to ensure access to emerging products for populations in developing countries.
Amendment 125 #
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 to emerging products.