The European Union delivered the following intervention at the February 2014 WTO TRIPS Council on agenda item 10 (Technical cooperation and capacity building).
EU intervention – 25 February 2014
Point 10 TRIPS Council Agenda – Technical cooperation and capacity buildingI would like to call your attention to the EU’s efforts to improve global accessibility of medicines through technical cooperation. Findings of a study by DSW EU (a German development and advocacy organisation) and Policy Cures London (2012) showed that Europe plays an important role in the development of medicines for new poverty-related and neglected diseases. Funding from the EU includes funding from both the European Commission (EC) and Member States. This funding has increased over the recent years and has been essential to bringing new products to the market. The EU contributes almost a quarter (22%) of public R&D investment worldwide for the development of new poverty-related and neglected disease pharmaceutical products and 15% of the total global investment (public and private), with an average of € 341 million a year. Three quarter of funding (76%) goes to the development of medicines for HIV & AIDS, Tuberculosis and Malaria. The EU funds a wide range of organisations to conduct poverty-related and neglected diseases R&D (i.e. academic organisations, national research institutes, industry, Product Development Partnerships (PDP), and also to unique mechanisms such as the European and Developing Countries Clinical Trials Partnership (EDCTP). European funding for poverty-related and neglected diseases treatment has contributed to the creation of 43 new products that are already improving health and productivity in developing countries while reducing healthcare costs and helping to alleviate poverty.
The Commission has been funding health research which addresses not only specifically the access to medicines problem in the developing countries, but also broader health system problems and health research capacity building.
Most of the funding comes from the special EU research and innovation programmes for global health. The last research programme was called FP 7 (Framework Programme 7). The International Cooperation pillar had a budget of €6.1 billion.
Since the beginning of 2014, the eighth programme for innovation and research has commenced and is called Horizon 2020 (2014-2020). It has a total budget of € 70 200 million and foresees € 7 400 million in its pillar on “Health, Demographic Change and Wellbeing”. During the first two years of Horizon 2020 the EU will invest some € 1 200 million in this challenge. The objective of the actions in this domain is to support research in order to provide a scientific base for International Cooperation with partner countries to improve their health service delivery, including aspects of accessibility, effectiveness, efficiency and quality of care and user friendliness. The mandate also covers public health concepts and interventions beyond health services through cross-sectorial and multidisciplinary research approaches. These actions on particular priorities, such as health systems, health policy, maternal and child care, reproductive health and neglected communicable diseases, aim to reinforce the research and cooperative capacities of candidate, neighbourhood, developing and emerging countries.
Let me briefly introduce you some of our projects under the last Framework Programme for Research 7 (2007-2013) and some of the new projects which are in the pipeline under the new Horizon 2020 programme (2014-2020) for research and innovation.
A first project is the Accessing Medicines in Africa and South Asia (AMASA). It ran from 2010 to 2013 and had a budget of approximately 3 million euro. The main aim of the project was to map patterns of production, distribution, supply and consumption of medicines within seven health care areas – i.e. HIV/AIDS, Malaria, Reproductive Health, Tuberculosis (TB), Mental Health, Pain Management and Diabetes. A second programme is the Access to Pharmaceuticals (ATP). The project was in place from 2009 until 2013 and had a budget of approximately 1.8 million euro. The Access to Pharmaceuticals project addressed three ways of accomplishing equitable access to pharmaceuticals. The first is how academic licensing practices under socially responsible stewardship can ensure that future drugs that have resulted from inventive activity in academia will be available at low cost with improved access in the future. Secondly, the project investigated how existing public-private or product-development partnerships are addressing the issue of altruistic development of drugs for relatively neglected populations with unmet health needs and the lessons they have for future drug development. Lastly, it addressed the current state and future improvements in compulsory licensing legislative instruments to enable access through generic manufacture of patented drugs. A third programme under FP 7 was the MONITORING MEDICINES project which also ran from 2009-2013 with a total budget of 2 million euro. This project aimed at strengthening what is known about medicines, sharing that knowledge and putting that knowledge to use, to reduce patient deaths and adverse effects due to medicines. Specifically, the project supports building patient safety networks.
Under the Horizon 2020 programme, there are also new programmes in the pipeline. There will be a specific programme for Rare Diseases. The programme aims at maximising scarce resources and coordinating research efforts. There will be transnational cooperation and coordination to pool resources and avoid duplication of efforts, while also developing common standards and research priorities will be essential. Two other programmes are on Vaccine development for poverty-related and neglected infectious disease. There will be one specific programme for HIV/AIDS and another one for Tuberculosis. Vaccines offer a safe and cost-effective way to protect large populations against infectious diseases, or at least to mitigate the clinical course of these diseases. Furthermore, they may in combination with other treatment modalities contribute to an eradicative cure for HIV and Tuberculosis. Many poverty-related and neglected infectious diseases however continue to escape attempts to develop effective vaccines against them. Disappointing results of recent clinical trials pointed to bottlenecks in identifying viable candidate vaccines, which if unaddressed will continue to present significant risks of failure at relatively late stages of the development process. The specific challenge for these programmes will therefore be to shift the ‘risk curve’ in order to better select successful vaccine candidates (and discard those with a higher risk of failure) at an earlier stage of the vaccine development process, for preventive as well as therapeutic vaccines.
In addition to the above projects, the EU is also co-funding with its Member States the European and Developing Countries Clinical Trials Partnership (EDCTP). The EDCTP aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria, with a focus on phase II and III clinical trials in sub-Saharan Africa. The basis of EDCTP is ‘partnership’. It currently unites 14 participating EU Member States plus Norway and Switzerland with sub-Saharan African countries. The partnership ensures synergy and optimal use of resources, and creates a win-win situation for all parties involved. In 2014 the EDCTP II programme under Horizon 2020 commenced.
Next to the programmes on medicines development the EU also funds programmes which aim to strengthen health systems and health research capacity. We have the Consortium for Health Policy and Systems Analysis in Africa (2011-2015), which aims to extend sustainable African capacity to produce and use high quality health policy and systems research. There is also the Poverty related diseases college. This project aims to reorganize and educate young African and European scientists to perform research, on poverty related and neglected diseases that is relevant to development. A third programme is the REDMAL programme, which intends to develop a malaria transmission blocking vaccine (2010-2014), with partners from Tanzania and India. And a last example is the More Medicines for Tuberculosis project, with partners from South Africa and India.
These are only a few examples to the type of supporting research programmes funded by the Commission for facilitating access to medicines in the developing countries.