Transcript EC Research for Development: Current Issues

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 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
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
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 /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
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