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EU approach to address R&D needs for neglected diseases

EU approach to address R&D needs for neglected diseases. Michel Pletschette European Commission DG RTD –International Cooperation MSF campaign – access to medicines International Conference on Ensuring innovation for neglected diseases. EC Action based on a 4-pronged approach

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EU approach to address R&D needs for neglected diseases

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  1. EU approach to address R&D needs for neglected diseases Michel Pletschette European Commission DG RTD –International Cooperation MSF campaign – access to medicines International Conference on Ensuring innovation for neglected diseases

  2. EC Action based on a 4-pronged approach • Support R&D • Facilitate innovation • Incentivize innovation • Implement innovation MSF campaign – access to medicines International Conference on Ensuring innovation for neglected diseases 08/06/2005

  3. Support North-South R&D partnerships for better tools Long standing EU research effort on tropical diseases since ca. 1980 funded ca. 400 projects on malaria alone : up-scaling needed for this millennium Mechanism responsible for chronic R&D neglect for drugs is also true for new scientific knowledge in general : Ross , Chagas , Hoffman all pre-war Nobel laureates Continuous but increasing funds for collaborative research to tackle globally ( 3 big killers) and regionally relevant neglected health issues (schisto, Chagas) MSF campaign – access to medicines International Conference on Ensuring innovation for neglected diseases 08/06/2005

  4. Support North-South R&D partnerships • INCO interest in new treatments increasing : early success with FACT: AS/AQ project : 1,2 M€ from INCODEV . • Drug focus: should guard against weakness of health systems to deliver • INCO funds high quality research and high quality partnership :empowers DC scientists role in local and national strategies but also global coordination • 2 calls for proposals focussing on neglected diseases under FP 6 published already, next deadline in September : • Main component of international cooperation activities under FP7 with partnering in Africa, LA and Asia on the basis of comprehensive agendas for new tools to prevent and control diseases incl. new treatments ,more calls :larger portfolio • EDCTP to deliver more and better trials for interventions on malaria , HIV and TBC : option to extend its agenda nosologically and geographically MSF campaign – access to medicines International Conference on Ensuring innovation for neglected diseases 08/06/2005

  5. Facilitate Innovation • TRADE: tiered pricing regulation to limit re-importation of discounted drugs : EC favours application to all neglected diseases • TRIPS exemption clauses : EC favours application to all neglected diseases as defined public health emergencies • Pharm.regulation: reform of art.50a of Reg.75/75:EMA expertise can be recruited for extra-EU drug licensing • But also (PfA 2005) : support DC regulatory capacity building MSF campaign – access to medicines International Conference on Ensuring innovation for neglected diseases 08/06/2005

  6. Incentives for R&D beyond collaborative research • Focus on pull factors :need to change major purchasers attitude towards innovation : GFATM • Reform national DC drug policies :to buy and prescribe better means more room to buy innovation, but longer term financing needed MSF campaign – access to medicines International Conference on Ensuring innovation for neglected diseases 08/06/2005

  7. TIPR • Transfer of IP: give extension of marketing authorization to high value drug in case of successful R&D on tropical diseases • Strongest incentive to pharmaceutical industry • Easy to implement by modifying the existing EU Orphan Drug regulation; pediatric drug extension showed high impact in US • If tradable: high impact on SME and public research sector MSF campaign – access to medicines International Conference on Ensuring innovation for neglected diseases 08/06/2005

  8. Implement Innovation • More Health in EU ODA : MDG’s and neglected issues ? • Better strategic planning of health investment in countries /regions, more attention to human resources and institutional capacity building • Work with those initiatives /3P’s interested to introduce innovation where needs are MSF campaign – access to medicines International Conference on Ensuring innovation for neglected diseases 08/06/2005

  9. Conclusion • Innovation in health depends on a continuum of supports and policy coherence • EU FP7 need to deliver larger portfolio on ND and better contribute to critical mass : • more impact on unfinished ambitions: Onco ,Fil • more impact on structural orphan diseases:HAT • stimulate new research agendas: Chagas though strengthened and enlarged international collaboration in health research MSF campaign – access to medicines International Conference on Ensuring innovation for neglected diseases 08/06/2005

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