What are the market failures in EU?

Transcription

1 ESTHER AN INDUSTRY DRIVEN INITIATIVE ON EMERGING AND STRATEGIC TECHNOLOGIES FOR HEALTHCARE PAT R I C K B O I S S E AU, V P H E A LT H C A R E, C E AT E C H / C H A I R M A N O F T H E E S T H E R TA S K F O R C E S E R G E B E R N A S CONI, CE O, M E D T E C H - E U R O P E

2 What are the market failures in EU? High difficulties for SMEs to access market Non R&D failures, sometimes funding Limited knowledge about translation Leakage of start-up to USA Born in Europe, grown-up in USA, back to EU Access to reimbursement is very challenging in EU New EC regulations will severely impact SMEs Higher regulatory criteria but necessary Higher validation costs 6/24/2016 ESTHER GENERAL PRESENTATION 2

3 Impact of Medical Technologies Costs to Healthcare Transform Medical Practices Infrastructures 75% Pharma Biotechnologies 17% Transform Health Care Structure Medical Technologies Transform Patient Life Medical technologies 8% Per capita spending : 195 in MedTech (vs 450 in drugs and vs in Education) Transform Health Care Systems 6/24/2016 ESTHER GENERAL PRESENTATION 3

4 Economic drivers companies, jobs, medical devices, IVD products Turn over 100bn/y in EU 1/3 of global market R&D +4,2% in 2015, to $30,5bn ww in 2020 R&D intensity* : 4 to 15% 1 st industry in terms of patents Cost to Health Care 7.5% of total HC expenditure (6.7% for MDs, 0.8% for IVDs) Per capita spending 195 in MedTech vs 450 in drugs vs in Education M&A 211 (2014), +363% compared to 2013 only US companies : Medtronics /Covidien or Zimmer/Biomet megadeals Venture financing -14% Exports + 1.5bn Germany, Ireland, Switzerland, Netherlands, Belgium, Denmark and Finland CAGR +3 to +7%/year *R&D/turnover 6/24/2016 ESTHER GENERAL PRESENTATION 4

5 The Medical Technologies transition Cross Technologies Cross Industries Cross Business Models 6/24/2016 ESTHER GENERAL PRESENTATION 5

6 Cross KETs Medical Technologies Advanced materials Photonics Micro/nano electronics Manufacturing IT Biotechnologies Nano technologies The Argus II Retinal Prosthesis System 6/24/2016 ESTHER GENERAL PRESENTATION 6

7 Cross Industry Medical Technologies Medical Devices Pharma Biotech ICT 6/24/2016 ESTHER GENERAL PRESENTATION 7

8 Cross Business Models IVD for therapy MD for therapy Companion tests Drug delivery devices ICT for health Connected Medical Devices 6/24/2016 ESTHER GENERAL PRESENTATION 8

9 What is ESTHER? A European initiative launched by the EU Commission and the healthcare industry within the framework of Horizon 2020 to raise competitiveness of European Medical Technologies industries by developing and manufacturing innovative healthcare technologies, in a changing regulatory environment Rudolf Strohmeier, CLINAM, June /24/2016 ESTHER GENERAL PRESENTATION 9

10 Vision Create an European R&D positive SMEs ecosystem which will support the development and blossoming of an innovative European Medical Technology Industry generating economic growth, creating jobs and providing solutions for patients and HealthCare systems 6/24/2016 ESTHER GENERAL PRESENTATION 10

11 Concept Open and flexible industrial platform With participation of a wide range of organisations Improved coordination along the value chain Increased visibility of the Medtech industry as an important economic stakeholder 6/24/2016 ESTHER GENERAL PRESENTATION 11

12 Tasks Open Science 1. Foster research, development and innovation towards smart and connected medical devices Strategic Research and Innovation Agenda (SRIA) for smart connected Medtech MultiKETs collaborative project to de-risk the opportunity sufficiently to enable private investment Open Innovation 2. Accelerate the translation process of smart medical solutions on healthcare markets Access to public finance Market access Regional clusters Regulatory sciences Open to the World 3. International interactions Increase attractiveness of Europe for global healthcare industries Training and exchange of personnel between EU and emerging economies 6/24/2016 ESTHER GENERAL PRESENTATION 12

13 Stakeholders More to come. 6/24/2016 ESTHER GENERAL PRESENTATION 13

14 Stakeholders along the value chain Patients Hospitals, patients Buyers Medtech companies HTA agencies, health insurances EMA, national agencies Regulatory approval HTA, reimbursement Marketing Basic research CMO, OEM Technology development CE marking Universities Clinical validation RTOs Manufacturing Notified bodies Hospitals, CROs 6/24/2016 ESTHER GENERAL PRESENTATION 14

15 Time Line 1st stakeholders workshop 2 nd stakeholders workshop Meeting Comm. MOEDAS Publication SRIA and budget 3rd stakeholders workshop Implementation /24/2016 ESTHER GENERAL PRESENTATION 15

16 Conclusions 1. ESTHER will drive the convergence of technologies, business models and industries 2. ESTHER will facilitate the efficient translation of clinical needs into healthcare solutions based on smart medical devices 3. ESTHER will enable sustainable healthcare systems within the EU 4. ESTHER will ensure that the EU smart Medtech products and services become the global benchmark in safety and affordability 6/24/2016 ESTHER GENERAL PRESENTATION 16

17 ESTHER Task Force EC Units «Rest of the world» Heico FRIMA NMBP Fergal DONNELLY NMBP Jyrki SUOMINEN NMBP Bernd RAINER Health Andreas LYMBERIS Connect Jaakko AARNIO Connect Ronan BURGESS Connect Michel CATINAT Grow Patrick BOISSEAU CEA Françoise CHARBIT CEA Klaus-Michael WELTRING Bioanalytik-muenster Paul GALVIN Tyndall Furio GRAMATICA Don Gnocchi Matteo SANTIN ESB Serge Bernasconi MedTech Europe Martina GLIBER BioMerieux Bertrand LOUBATON Adaptherapy/EFPIA Casper GAROS Philips/COCIR David TALLON Stryker Hans-Otto MAIER BBraun Ekkehard LEBERER Sanofi/EFPIA Didier BAZILE Sanofi Contacts 6/24/2016 ESTHER GENERAL PRESENTATION 17

18 Thank you for your attention 6/24/2016 ESTHER GENERAL PRESENTATION 18