Explanatory Memorandum to COM(2013)498 - Participation of the Union in a second European and Developing Countries Clinical Trials Partnership Programme jointly undertaken by several Member States - Main contents
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| dossier | COM(2013)498 - Participation of the Union in a second European and Developing Countries Clinical Trials Partnership Programme jointly ... |
|---|---|
| source | COM(2013)498  |
| date | 10-07-2013 |
The European and Developing Countries Clinical Trials Partnership (EDCTP) was established in 2003 in response to the global health crisis caused by the three main poverty-related diseases — HIV/AIDS, malaria and tuberculosis — and to the EU’s commitment to achieving the United Nation’s Millennium Development Goals by 2015. The first EDCTP programme (EDCTP1, 2003-2012) is now beyond its active funding period.
Despite the results and impact of EDCTP so far, the health and socio-economic burden of poverty-related diseases persists and hinders the sustainable development of developing countries, in particular in sub-Saharan Africa. More than one billion people, including 400 million children, are suffering from one or more poverty-related diseases, including neglected infectious diseases such as sleeping sickness and worm infections. HIV/AIDS alone kills an estimated 2 million people, while malaria and tuberculosis together kill an estimated 2.2 million people annually. In addition to creating unnecessary suffering and premature deaths these diseases undermine productivity and increase insecurity and infirmity, thus perpetuating the cycle of poverty. Sub-Saharan Africa is disproportionately affected by such diseases, with approximately 90 % of all malaria-related deaths occurring in Africa. This region also accounts for over two thirds of all people living with HIV and for nearly three quarters of AIDS-related deaths.
While general improvements in nutrition, sanitation and health infrastructure are important, the effective long-term control of poverty-related diseases also requires the development of new or improved medical interventions (products, treatments and vaccines). While there is a general lack of such medical products, many of the existing drugs and vaccines currently used date back to the early 20th century and, moreover, are no longer effective due to the emergence of drug resistance in these diseases. Most of the new drugs and vaccines under development, however, are stuck at the stage of early clinical development. This is mainly due to the significant costs involved in the clinical development and testing needed in humans to prove the effectiveness and safety of new or improved medical interventions. These costs are linked to three key problem drivers: (i) insufficient investment by the private sector due to a lack of return on investment (market failures), (ii) weak clinical research capacity in sub-Saharan African countries, and (iii) fragmented public support.
Following the recommendations from the independent interim evaluation of EDCTP1 and the conclusions from the Member States’ meeting in September 2010, the Belgian EU Council Presidency proposed to the Competitiveness Council on 26 November 2010 the launch of a second EDCTP joint programme (EDCTP2) with at least ten years duration. To that end, the EDCTP1 participating states published a Strategic Business Plan 2014-2024 for EDCTP2.
On these grounds, the Commission puts forward a proposal for a Decision on the participation of the EU in a second European and Developing Countries Clinical Trials Partnership Programme (EDCTP2) based on Article 185 of the Treaty on the Functioning of the EU, which makes provision for the EU to participate in research and development programmes undertaken by several Member States.
The general objective of EDCTP2 is to improve the EU'’s capacity to invest more efficiently in the research and development of new or improved medical interventions against poverty-related diseases for the benefit of and in partnership with developing countries, in particular sub-Saharan African countries.
More specifically, EDCTP2 aims to achieve the following specific objectives:
· 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, such as a new drug or a new vaccine against TB or any other poverty-related disease; 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.
· Strengthened cooperation with sub-Saharan African countries, in particular on building their capacity for conducting clinical trials in full compliance with fundamental ethical principles and relevant national, Union and international legislation, including the EU’s Charter of Fundamental Rights, the European Convention on Human Rights and its Supplementary Protocols, the 2008 version of the World Medical Association’s Declaration of Helsinki and the standards on good clinical practice of the International Conference on Harmonisation.
· Better coordination, alignment and integration of relevant national programmes to increase the cost-effectiveness of European public investments.
· Extended international cooperation with other public and private funders.
· An increased impact due to effective cooperation with relevant EU initiatives, including EU development assistance.
EDCTP2 has been conceived to complement the actions implemented under the European Development Funds and the Development Cooperation Instruments, and to respond to the Union’s commitment to the 2012 Rio+20 conference conclusions on developing and achieving internationally agreed Sustainable Development Goals, following and including the Millennium Development Goals.
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The preparation of the proposal has taken full account of the responses received to an extensive stakeholder consultation, including a public consultation. Views were expressed by European and African policy makers as well as stakeholders from industry, academia and civil society. The proposal also relies on the external interim evaluations of the EDCTP1 programme and the in-depth impact assessment of the prospective EDCTP2 programme. These consultations, evaluations and assessments of the EDCTP consistently call for it to be continued but with the next programme lasting 10 years and covering a scope that extends to other poverty-related diseases (beyond HIV/AIDS, tuberculosis and malaria) and to all phases of clinical development. The geographical focus should continue to be on sub-Saharan Africa, which is disproportionally affected by poverty-related diseases and with which the Union has established a strategic partnership.
The proposal for the EDCTP2 Programme is based on Article 185 of the Treaty on the Functioning of the EU, which allows the Union, in implementing the multiannual framework programme, to make provision, for participation in research and development programmes undertaken by several Member States, in agreement with the Member States concerned, including participation in the structures created for the execution of those programmes.
The fundamental basis of the EDCTP initiative is the joint programme being based on and composed of national programmes and activities of the participating Member States and Associated Countries, with the support and participation of the Union.
It improves cost-effectiveness of Europe’s investment in clinical research programmes by providing a common platform that can better exploit research results for the development of new or improved medical interventions against HIV/AIDS, malaria, tuberculosis and other poverty-related diseases for the benefit of the developing countries, in particular in sub-Saharan Africa. The expected impact at the European level will be greater than the sum of the impacts of national programmes and activities. It will allow the required critical mass to be achieved, both in human and financial terms, by bringing together available complementary expertise and resources to accelerate the development of new or improved medical interventions that are urgently needed to reduce the devastating impact of poverty-related diseases in developing countries. Furthermore, at the global level it contributes to a unified voice to represent European research efforts in the fight against these diseases in developing countries. Finally, it promotes a long-term structuring effect on European and developing countries’ research policies and systems alike, and helps to integrate the EU’s research and development policies and systems in a coherent context.
The Commission’s proposal for Horizon 2020 makes provision for the Union’s continued participation in a second EDCTP programme under Article 185 of the Treaty, which is the appropriate instrument for the Union to support the EDCTP since it allows for both the coordination of national research programmes and the participation of the Union in the joint programme.
The proposal does not go beyond what is necessary to achieve its objectives. Union participation in the EDCTP2 Programme will take place within the limits of the competence provided by the Treaty and will only facilitate and support, including financially, the fulfilment of the EDCTP2 objectives by the participating states. They will have to collaborate and work towards reaching better coordination, alignment and integration of relevant national programmes or activities and ultimately developing more and better medical interventions against HIV/AIDS, tuberculosis, malaria, as well as other poverty related diseases.
The Legislative Financial Statement presented with this decision sets out the indicative budgetary implications. The Union contribution shall be up to EUR 683 million including EFTA contribution. The envelope is in current prices. The Union contribution shall be made from the ‘Health, demographic change and wellbeing’ challenge, DG Research & Innovation envelope, as part of the implementation of Horizon 2020 – The Framework Programme for Research and Innovation. The maximum amount of Union contribution for administrative costs is up to EUR 41 million.
During the course of the action, the Union may consider matching additional commitments from Participating Member States or countries associated to Horizon 2020 Framework Programme.