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New Delhi 12 May 2011

RIS and Indian Council of Medical Research. Pharmaceutical Innovation Issues & Challenges. by D G Shah Secretary General Indian Pharmaceutical Alliance. New Delhi 12 May 2011. 1.

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New Delhi 12 May 2011

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  1. RIS and Indian Council of Medical Research Pharmaceutical Innovation Issues & Challenges by D G Shah Secretary General Indian Pharmaceutical Alliance New Delhi 12 May 2011 1

  2. Pharmaceutical Innovation Issues & Challenges Outline of Presentation • Issues - Drivers of Innovation - Innovation Policy • Challenges - Funding - Technology Transfer 2 IPA: 05/11

  3. Drivers of Innovation Competition IP Laws are Designed to Provide Exclusive Rights as Incentives for Investment in R & D But In Many Sectors Competition (Absence of Exclusivity) Drives Technological Development There is Inherent Tension Between IPRs & Competition IPA: 05/11

  4. Drivers of Innovation Competition IPRs are Designed to Foster Innovation and Sustain Economic Growth But Kill Competition and thereby Restrict Innovation Need for Balancing IPRs & Competition IPA: 05/11

  5. Drivers of Innovation Necessity • Agricultural Implements • Carts and Wheels • Water Drawing Devices • Arms and Ammunition IPRs are Not Sole Drivers of Innovation IPA: 05/11

  6. Drivers of Innovation Commitment • Electricity • Telephone • Jaipur Foot Driven by Commitment, Not IPRs IPA: 05/11

  7. Innovation Policy Protection (P) vs. Innovation (I) I Maximal Innovation Level Minimal Protection Level Optimal Protection Level P Source: Swiss Federal Institute of Intellectual Property, October 2006 Beyond a Point, IPRs are Counterproductive IPA: 05/11

  8. Innovation Policy EU Experience IPR Scenario: USA & Europe 1990-2006 Europe had Stronger IPR Protection Through Out this Period, But…. IPA: 05/11

  9. Innovation Policy EU Experience • “Europe has been Losing Ground in Pharmaceutical Innovation” • Centre of Gravity for Research Moved to USA and Asia • Pharmaceutical R & D: • 1990: Europe (€ 7.8 Bn) vs USA (€ 5.3 Bn) • 2006: Europe (€ 22.5 Bn) vs USA (€ 27.1 Bn) • Similar Trend for Research Sites Between 2001 and 2006: • Europe:Shut Down 18 of 22 Sites, Opened Only 2 New Sites • USA: Opened 6 Sites (Shut Down 5) • Asia: Opened 14 Sites (Shut Down 1) Source : Communication from Commission to the European Parliament – Dec 2008 IPRs are Not Sole Drivers for Innovation IPA: 05/11

  10. Innovation Policy EU Experience Recognizing that “Global” Reorganization is Throwing New Challenges, EC Wrote Prescription for its Pharmaceutical Industry • Swiftly Adopt proposal to prevent the entry of illegal medicinal products into the legal supply chain (Objective#13) • Prepare by 2012 an intensified exchange of information on illegal distribution channels for counterfeit medicinal products (Objective#14) • Within IMPACT, assist third countries(e.g. Kenya & Uganda) in developing and enforcing legislation against counterfeit medicinal products (Objective#15) Source : Communication from Commission to the European Parliament – Dec 2008 Obsession with “Counterfeit” Has Muddled the Thinking IPA: 05/11

  11. Funding R & D Spend of Indian Generic Industry Source: AceEquity Balancing Short –Term Profitability with Sustainable Long-Term Growth 11 IPA: 05/11

  12. Funding R&D Expenditure as % Sales – 1995 to 2010 Source : CMIE – Analysis of Indian Pharmaceutical Industry Three-Fold Growth in R&D by IPA Companies 12 IPA: 05/11

  13. Discovery Pre-clinical R&D I/IIa Clinical Development IIb/III Submission and Approval Post-market Development Phase IV Technology Transfer Discovery – A Weak Link High throughput Screening Trial Management Preclinical Testing Data Analysis/ Publication Clinical Data Management Safety Surveillance Report Compilation Organic Synthesis Chemical Synthesis— Intermediates Already in Progress Growing Interest/Potential 13 IPA: 05/11

  14. Technology Transfer Discovery Research • Industry to Industry • University to Industry • Research Institute to Industry Let the Learning Begin IPA: 05/11

  15. Pharmaceutical Innovation Issues & Challenges Summing Up • Stronger IPR = More Innovations? Not So Simple • There is No “One-Size-Fits-All” Model • Need to Strike a Balance between IPR and Innovation • Need to Recognize Forces that Promote Innovation Instead of Blindly Linking Innovation to IPR • IPR Should Not Kill Pro-competitive Environment, Both are Needed for Innovation • Need to Provide Funding Support for Promoting Innovation • Need to Assist Technology Transfer for Discovery Research Developed World Should Honour its Obligations Under TRIPS IPA: 05/11

  16. THANK YOU dgshah@vision-india.com 16 IPA: 05/11

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