EU approach to address R D needs for neglected

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 • 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

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

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 FP 7 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

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. 50 a of Reg. 75/75: EMA expertise can be recruited for extra-EU drug licensing • But also (Pf. A 2005) : support DC regulatory capacity building MSF campaign – access to medicines International Conference on Ensuring innovation for neglected diseases 08/06/2005

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

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

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 /3 P’s interested to introduce innovation where needs are MSF campaign – access to medicines International Conference on Ensuring innovation for neglected diseases 08/06/2005

Conclusion • Innovation in health depends on a continuum of supports and policy coherence • EU FP 7 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