Time to stop wasting time Getting novel medicines to patients. 4 th World Health Summit, Berlin Severin Schwan, 22 October 2012

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1 Time to stop wasting time Getting novel medicines to patients 4 th World Health Summit, Berlin Severin Schwan, 22 October 2012

2 Pharma Business Model for Innovation Challenges Summary

3 Pharma Industry Unlimited demand Efficacy Drug response rate [%] Analgesics Two-thirds of diseases untreatable (i.e. >3000 diseases) Existing treatments often inadequate (efficacy, safety) Oncology 20 0 Spear et al., Trends Mol Med, 2001; Lazarou et al., JAMA,

4 Pharma Industry but a high-risk business swiss francs investment candidate molecules years development 1 medicine maybe... 4

5 Pharma business model The company view + annual net benefit years launch 5 patent expiry

6 Pharma business model The company view + company investment company profit annual net benefit years launch patent launch expiry patent expiry 6

7 Pharma business model The societal view + company investment company profit benefit to society Examples (WHO List of Essential Medicines): Isoniazide Tuberculosis Fluorouracil-5 Cancer Sulfamethoxazole/Trimethoprim Infections Levodopa Parkinson Diazepam Anxiety Sulfadoxine/Pyrimethamine Malaria annual net benefit years launch patent expiry 7

8 Pharma Business Model for Innovation Challenges Summary

9 Pharma Industry Decling financial returns 1 the end of an era? Return on R&D investment Cost of Capital: 8%-10% 1 Different methodologies (e.g. IRR, economic returns) Sources: Bernstein Research 2011, McKinsey 2011, KPMG 2011, Deloitte 2011, Roche analysis; Different methodologies! 9

10 Pharma business model Challenges + company investment company profit benefit to society annual net benefit years Development 1 science 2 regulations Commercialisation 3 intell. property 4 reimbursement launch patent expiry 10

11 Pharma business model Challenges + company investment company profit benefit to society annual net benefit years Development 1 science 2 regulations Commercialisation 3 intell. property 4 reimbursement launch patent expiry 11

12 2 Regulatory challenges Dramatic increase in required clinical data/evidence Example: Documentation for filing of product approval s 1980 s 1990 s pages pages pages 1 Indicative only; may vary substantially from country to country and product to product 12

13 > pages

14 2 Regulatory challenges Complex, labour-intensive processes particularly EU Comparison US EU27 China Population [million] Number of national health authorities Filing requirement for subsequent phases II, III Supplement New New Approval timelines (typical) 1 for: - clinical trials by health authorities [weeks] clinical trials by ethics committees [weeks] marketing authorisations [weeks] Roche analysis of various external and internal data sources 2 In China, duration of ethics review is about 4 weeks, but starts only after clinical trial approval by health authorities 14

15 2 Regulatory challenges Complex, labour-intensive processes Illustrative Example Roche Scope R&D investment: # patients: $7 bn per year patients in clinical trials Examples APHINITY trial 1 : Perjeta approval: patients, 600 sites, 44 countries over 300 review boards US approved (within 6 months) EU pending (expected within months) 1 Comparison of chemotherapy plus trastuzumab plus placebo versus chemotherapy plus trastuzumab plus pertuzumab as adjuvant therapy in patients with operable HER2-positive primary breast cancer 2 EU Commission, Impact assessment report on the revision of the Clinical Trials Directive 2001/20/EC ; 17 July

16 2 Regulatory challenges Complex, labour-intensive processes particularly EU Implications: -25% trial applications in EU ( ) 1 vs. increase in US, China Less R&D investment in academia, hospitals, qualified jobs, etc. Proposed mitigation (EU): Harmonize authorization bodies (Minimum: Adopt EU Clinical Trial Regulation) Expand use of accelerated approvals addressing serious/life-threatening diseases Consider surrogate clinical endpoints likely to predict clinical outcome 1 EU Commission, Impact assessment report on the revision of the Clinical Trials Directive 2001/20/EC ; 17 July

17 4 Undifferentiated pricing limits access Value for different societies e.g. Germany e.g. Italy Access One global price e.g. Vietnam No access 17

18 4 Undifferentiated pricing limits access Example: Herceptin in Emerging Markets 18

19 4 Undifferentiated pricing limits access Value for different societies e.g. Germany e.g. Italy Access One global price e.g. Vietnam No access 19

20 4 Differentiated pricing can improve access Requires solidarity across regions and countries Value for different societies Solidarity within EU e.g. Italy e.g. Germany Solidarity across economic development stages Access e.g. Vietnam Access Solidarity within country Access 20

21 4 Differentiated pricing can improve access Requires solidarity across regions and countries Proposed mitigation (EU): Eliminate parallel trade for price-regulated products Modify reference pricing rules to reflect purchasing power 1 Health Technology Assessment 21

22 4 Differentiated pricing can improve access Example: Herceptin in China Quarterly Herceptin Patient Initiations new pricing model 22

23 Pharma Business Model for Innovation Challenges Summary

24 Summary Drivers Mitigation options Science Complexity of untreated diseases Personalized Healthcare, Stakeholder collaboration Regulations Intellectual property Public and political pressure for 100% efficacy and zero safety risks No incentive for less developed countries to respect IP Strengthened independence of regulatory authorities, EU: harmonisation, accelerated approvals Compliance with WTO-TRIPS 1, Build-up of local life science industry Reimbursement Loss of solidarity leading to limited access for patients 1 World Trade Organisation Agreement on Trade-Related Aspects of Intellectual Property Rights Differentiated pricing models, EU: no parallel trade, purchasing power-based pricing 24

25 We Innovate Healthcare 25

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