The future prospects for clinical trials in Europe Richard Torbett Chief Economist, EFPIA

Europe 2020 strategy, March 2010: “The EU […] has a target of investing 3% of GDP in R&D”. “R&D spending in Europe is below 2% […] mainly as a result of lower levels of private investment.” “Europe needs […] to improve the conditions for private sector R&D in the EU.” COM(2010) 2020, page 10 International clinical trials (mostly phase 2/3) are a pivotal part of the R&D process Clinical trials for €20Bn every year in the EU (Commissioner for Health) Importance of Pharma R&D in EU 2

Clinical Trials going down…. 3

Just as important: Science is changing 4 Personalised Healthcare (or targeted medicine): Medicine & «companion» diagnostic Co-development adds to complexity of clinical development Identification of smaller subset of patients instead of large clinical trials Shift in clinical trial designs Shift in selecting endpoints, in particular for cancer medicines Need for flexibility in the design and architecture of clinical trials Need for consideration of entire development process when discussing clinical trials Pharmaceutical Legislation «meets» Medical Device Legislation

Industry has been calling for : patient access to therapeutic breakthroughs without administrative delay an attractive & harmonised environment for clinical development throughout the EU Recognition of the changes in pharmaceutical development, such as personalised healthcare Ensuring any changes to the European framework are relevant & effective for the next two decades Commission proposal: a good start 5 Proposal delivers a lot and is a good first fix for today’s problems: -Reduced or eliminated differences in process & requirements between MS -Timelines have been addressed -There is more predictability

But will it bring more investment? 6 Any COM proposal may take years to adopt and implement so it’s important to get it as right as possible. IssuePossible way forward Ethics Committee process remains at the national level Maximise patient safety and efficiency. Could create a European platform for exchange of best practice….EUnEthics?

But will it bring more investment? 7 Any COM proposal may take years to adopt and implement so it’s important to get it as right as possible. IssuePossible way forward Will the new system be fit for the future given developments in science – personalised medicines, orphan drugs etc? New system needs to be flexible enough to allow for novel research methods and techniques

Timelines are key to competitiveness 8 EU Proposal EU Old USCANADACHINABRAZILARGENTINA d*60d30d 90d60d90d Includes Ethics Reviews CT APPROVAL TIMELlNES Excludes Ethics Reviews It is important to retain the Commission’s proposed timelines if the EU is to retain its competitive position

The European Access Crisis needs to be addressed 9 Source: Innovation and Solidarity in Pharmaceuticals. EU Belgian Presidency Ministerial Conference, 09/2010.

1.This revision process provides a crucial opportunity to ensure the EU’s attractiveness for innovative pharmaceutical R&D for the coming two decades. 2.There is a needs to be enhanced co-operation on ethics committees if we are to both safe-guard patient safety AND retain competitive timelines 3.The Commissions ambitions on timelines should not be diluted 4.Changes in the political and economic environment will have an impact on the future of clinical trials. Revision needs to be seen in this broader context. The access crisis needs to be fixed Conclusions 10