1. ROAD TO MEDICAL INNOVATION & ACCESS: FROM A REAR-VIEW MIRROR Global Health Histories Seminar Series 11 July 2012 Geneva, WHO Headquarters Zafar Mirza Department of Public Health, Innovation and Intellectual Property

2. THE PRESENTATION 1.Unpacking the concepts 2.Evolution of medical innovation 3.Evolving business model 4.Conclusions

3. MEDICAL INNOVATION AND ACCESS unpacking the concepts 1.Medical Technologies? 2. Medical Innovation? 3. Access?

4. Purpose / Application Prevention: Vaccines; Iodized Salt Screening: pap smear; mammography Diagnosis: ECG; Blood Tests Treatment: ARVs, Appendectomy Rehabilitation :Hearing Aid; Physiotherapy MEDICAL TECHNOLOGIES Material Nature Pharmaceuticals Biologics Medical devices Miscellaneous Medical & surgical procedures Support systems Managerial systems

5. MEDICAL INNOVATION Health innovation & medical innovation Innovation & R&D Innovation in medical technologies Is it just R&D in medical technologies? Specific context of debate on innovation in medical technologies

6. HOW MEDICAL INNOVATION IS DIFFERENT? 1.Sine qua non of health development 2.Public good dimension 3.Discovery is supported by public sector 4.Drug development is long, expensive & risky 5.End products are protected through patents 6.End products are strictly regulated 7.Equitable access to innovations is critical.

8. ACCESS TO MEDICAL TECHNOLOGIES 1. Rational selection 4. Reliable health and supply systems 2. Affordable prices 3. Sustainable financing ACCESS MEDICAL INNOVATION

9. 1.Problems in access to generic medicines health system related issues ACCESS TO MEDICAL TECHNOLOGIES two main sets of issues medicines price surveys data: average availability12 of selected essential medicines was 51.8 per cent in public sector health facilities and 68.5 per cent in the private sector over the period 2007-2011 e.g. in 2000 very few people with HIV/AIDS in developing countries were on treatment, in 2011 6.6 million of them have access to first line ARVs, yet 8 million still wait for the treatment

10. 2.Problems in access to patent protected medicines ACCESS TO MEDICAL TECHNOLOGIES two main sets of issues In March 2012, India granted its first compulsory license, allowing a domestic drug maker to manufacture generic version of Nexavar, a cancer drug by Germany's Bayer. That enabled India's Natco Pharma to sell its generic version of Nexavar at INR 8,800 rupees ($160) per monthly dose, a fraction of the INR 280,000 ($5090) rupees Bayer's version cost.

11. EVOLUTION OF MEDICAL INNOVATION Medicine and medical technology… Two approaches…looking from which side Three mile-stone medical innovations: Vaccine: Small-pox vaccine1796 Medical device: Hypodermic syringe1844 Pharmaceutical: Arsphenamine:1910

12. EVOLUTION OF MEDICAL INNOVATION FROM EDWARD JENNER TO GAVI Up to 20% of deaths in Europe were dues to smallpox in 19 th century The last case of smallpox occurred in 1977. 2.5 million deaths each year are prevented. Between 80-90% of infants receive DPT vaccine VACCINE-PREVENTABLE INFECTIOUS AGENTS OR DISEASES ANTHRAX DIPHTHERIA CHOLERA H. INFLUENZAE TYPE B (HIB ) HEPATITIS A HEPATITIS B HEPATITIS E INFLUENZA JAPANESE ENCEPHALITIS MEASLES MENINGOCOCCAL DISEASE MUMPS PERTUSSIS (WHOOPING COUGH) PNEUMOCOCCAL DISEASE POLIO ROTAVIRUS (SEVERE DIARRHEA) RUBELLA (GERMAN MEASLES) TETANUS (LOCKJAW) TICK BORNE ENCEPHALITIS TUBERCULOSIS TYPHOID FEVER VARICELLA (CHICKENPOX) YELLOW FEVER

13. EVOLUTION OF MEDICAL INNOVATION FROM EDWARD JENNER TO GAVI Global vaccine market 2009 was US$24 billion US$ 1.5 billion on vaccine R&D in 2005 Few manufacturers, expanding in developing countries, public sector R&D HIV, TB, Malaria, DNA vaccines, recombinant vector vaccines, new delivery methods GAVI: committed US$ 7.2 billion by 2011

14. EVOLUTION OF MEDICAL INNOVATION MEDICAL DEVICES Range is broad, from adhesive plaster to MRI 1844, Francis Rynd, first recorded subcutaneous injection. 1956, plastic disposable syringe patented 1.3 million/year deaths due to unsafe injections Auto-destruct syringes, prefilled syringes

17. EVOLUTION OF MEDICAL INNOVATION MEDICAL DEVICES Global market was USD 210 billion in 2008 4/5 sales revenue comes from USA & Europe Future trends Robotics, genomics and nanotechnology Special needs of developing countries Regulation of medical devices in weak

18. EVOLUTION OF MEDICAL INNOVATION PHARMACEUTICALS Global market > USD 800 billion > USD 80 billion on R&D Emerging markets Growing mergers Generic market Rising costs of R&D and declining results

19. #MedicineyearImportance 1Morphine1827 Commercialized by a pharmacy (Merck), pain management (Germany) 2Aspirin1897Synthetic salicylic acid was commercialized (Germany) 3.Ether1842General anaesthetic, transformed surgery (US) Arsphenamine1910Syphillis Treatment (Hoechst, Germany) 4.Insulin19221st hormone therapy, transformed diabetes management 5.Penicillin1929Transformed the treatment of microbial diseases 6 Chlorpromazine and Haladol 1950 & 1958 Transformed management of psyschosis. (France) (Belgium) 7 Estrogen+ Progestin 1961Birth Control Pills, deep social impact (USA) 8Digoxin1962 Changed treatment of heart failure and hypertension (Germany) (France) 9Furosemide Loop diuretic, effective treatment of hypertension 10Atorvastatin1996Cholesterol lowering medicine (USA) 11 HAART1996-7Transforming effect on AIDS patients L-Dopa (Sweden); Hydrocortisone; Viagra (1996, USA); Ritalin EVOLUTION OF MEDICAL INNOVATION DEVELOPMENT OF MOST INFLUENTIAL PHARMACEUTICALS

20. No patents on penicillin and polio vaccine. There is no patent. Could you patent the sun? Jonas Salk interview 1955 "Patent medicine" and "patented medicine" US Patent Act in 1790, Patent Office in 1802. Era of "copying success" and US "Trading with Enemy Act 1917" Compounds, compositions, manufacturing processes and uses. HISTORY AND THE EVOLVING BUSINESS MODEL In 1876 when the German industry was in its infancy and the patent law was yet to be evolved, Bismarck appointed a committee to study the likely impact of the patent system on the industry. Committee members also included founders of Siemens and Hoechst. Their observations made an interesting reading: Today industry is developing rapidly........monopolization and abuse of patent rights will inevitably expose large segments of the industry to serious injury. The government must protect industry against these dangers...

21. Patent protection based model has worked in the USA and Europe but not in developing countries Blockbuster medicines (annual sales > 1$b) Patent cliff Pharmaceutical Executive salaries HISTORY AND THE EVOLVING BUSINESS MODEL

22. Annual compensation packages of top 5 CEOs in pharmaceutical industry 1 J&J William Weldon2011US$ 26.7 million 2PfizerIan Read2011 US$ 25 million 3AbbottMiles White2011 US$ 24 million 4MylanRobert Coury2011 US$ 21.3 million 5AmgenKevin Sharer2011US$ 18.9 million

23. What TRIPS changed? Concerns about innovation for developing countries Market failure of business model for NTDs Search for alternatives PDPs GSPA-PHI Consultative Expert Working Group on R&D: Financing and Coordination HISTORY AND THE EVOLVING BUSINESS MODEL

24. Medical innovation cannot be discussed today without discussion on access. Last 200 years of medical innovation have been more productive than rest of the recorded human history. Today the focus is on enhancing innovation for developing countries. Current business model is showing signs of exhaustion Era of innovation for innovation. CONCLUSIONS