Designing of anti-counterfeiting & Compliance solutions in a

1. Designing of anti-counterfeiting & Compliance solutions in a comprehensive patient centric healthcare system Prabuddha Ganguli, Ph.D. CEO – Vision IPR & Director - Bilcare Singapore And Praful Naik, Ph.D. CSO - Bilcare Limited The Oxford Conference on Innovation & Technology Transfer for Global Health, Oxford, U.K. September 9 – 13, 2007

2. Backdrop Global Pharma industry is undergoing a major transformation in all quarters of its value chain • Legitimate competition involving emerging technologies • Innovation processes are getting expensive • IPR & public policy taking centre stage • Clandestine industry of counterfeiting is a major barrier to genuine access to innovations & healthcare The Oxford Conference on Innovation & Technology Transfer for Global Health, Oxford, U.K. September 9 – 13, 2007

3. Impact of Counterfeit • Growing menace in developing & least developed countries • Revenue Loss – from 10% to 30% • Contribution Loss – almost equals to industry profit • Brand credibility ??? • Developed World also significantly impacted The Oxford Conference on Innovation & Technology Transfer for Global Health, Oxford, U.K. September 9 – 13, 2007

4. Perils of Counterfeit on Healthcare • look-alikes with “variable to no efficacy” are detrimental / fatal • Re-labeling/packaging of rejects/expired drugs: fairly common practice • Innovations in anti-counterfeiting: non-transparent for the consumer • Current Covert & Overt Technologies are open ended & generic • eg.: Ineffectiveness of Holograms • Track & Trace: Implementation challenges & not fool-proof in isolation • eg.: RFID The Oxford Conference on Innovation & Technology Transfer for Global Health, Oxford, U.K. September 9 – 13, 2007

5. Challenges • Counterfeit is increasingly recognized as a key challenge as it leads to • Non-Compliance resulting in frequent change of prescription; drug resistance • secondary care leading to significantincrease in healthcare management cost • Medicine as total cure recognized as Myth • Imbalance in diet and fitness management are major contributing factors • Solutions must • Empower consumer to participate in the global action on anti-counterfeiting • Be Commercially sustainable & yet simple for operability by the consumer • Be capable of addressing multiple concerns The Oxford Conference on Innovation & Technology Transfer for Global Health, Oxford, U.K. September 9 – 13, 2007

6. Challenges… • Avoidable Complications & Hospitalization • Enhanced burden of healthcare costs on Nations • Anti-Counterfeit – Who should tackle? • Producer, Regulator, Patient, Pharmacist or the Doctor? • Government, Healthcare Organizations, Insurance Cos.? “Means & process to facilitate Collaborative efforts of all stake holders” The Oxford Conference on Innovation & Technology Transfer for Global Health, Oxford, U.K. September 9 – 13, 2007

7. Challenges… • Clinical Research & Development of new medicines / therapies • Impact of Non - Compliance • Real time patient feedback • Timely professional interventions “Means & process to facilitate Robust Clinical Research Management” The Oxford Conference on Innovation & Technology Transfer for Global Health, Oxford, U.K. September 9 – 13, 2007

8. The Current Healthcare Scenario Stake Holders Doctor Care Giver Insurer Patient Pharmacy Hospital Manufacturer The Oxford Conference on Innovation & Technology Transfer for Global Health, Oxford, U.K. September 9 – 13, 2007

9. Bilcare’s Approach Patents Pending The Oxford Conference on Innovation & Technology Transfer for Global Health, Oxford, U.K. September 9 – 13, 2007

10. Doctor Patient The Oxford Conference on Innovation & Technology Transfer for Global Health, Oxford, U.K. September 9 – 13, 2007

11. Doctor Patient Interactive Companion Device The Oxford Conference on Innovation & Technology Transfer for Global Health, Oxford, U.K. September 9 – 13, 2007

12. HealthcareKnowledge Management System Doctor Patient Interactive Companion Device The Oxford Conference on Innovation & Technology Transfer for Global Health, Oxford, U.K. September 9 – 13, 2007

13. HealthcareKnowledge Management System Doctor Patient Interactive Companion Device ComplianceSupport The Oxford Conference on Innovation & Technology Transfer for Global Health, Oxford, U.K. September 9 – 13, 2007

14. HealthcareKnowledge Management System Doctor Patient Interactive Companion Device Anti - counterfeitSupport ComplianceSupport The Oxford Conference on Innovation & Technology Transfer for Global Health, Oxford, U.K. September 9 – 13, 2007

15. HealthcareKnowledge Management System Doctor Patient Interactive Companion Device Anti - counterfeitSupport ComplianceSupport The Oxford Conference on Innovation & Technology Transfer for Global Health, Oxford, U.K. September 9 – 13, 2007

16. National Health System Pharmacy Insurer Distribution Hospital Connectivity to Stake Holders HealthcareKnowledge Management System Care giver Manufacturer Doctor Patient Integrated Interactive Companion Device Anti - counterfeitSupport ComplianceSupport The Oxford Conference on Innovation & Technology Transfer for Global Health, Oxford, U.K. September 9 – 13, 2007

17. Key Deliverables • Registration & Exclusivity of the Companion device • Authentication of medicine • User compliance inclusive of Diet & Fitness • Online patient feedback • E- prescription • Generation and transmission of customized reports • Secured data & Information for stake holders • Real-time data in raw and analyzed form The Oxford Conference on Innovation & Technology Transfer for Global Health, Oxford, U.K. September 9 – 13, 2007

18. Key to Success For effective & successful implementation • Participation of major stakeholders • Involvement of regulatory & governing agencies • WHO, NHS & their likes • Test implementation in a region • Planned transfer of technology • Blending of various local regional requirements • Awareness & Training support The Oxford Conference on Innovation & Technology Transfer for Global Health, Oxford, U.K. September 9 – 13, 2007