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 THE PRESENTATION 1. Unpacking the concepts 2. Evolution of medical innovation 3. Evolving business model
4. Conclusions MEDICAL INNOVATION AND ACCESS unpacking the concepts 1. Medical Technologies? 2. Medical Innovation? 3. Access? MEDICAL TECHNOLOGIES Purpose / Application Prevention : Vaccines; Iodized Salt Screening
: pap smear; mammography Diagnosis : ECG; Blood Tests Treatment : ARVs, Appendectomy Rehabilitation:Hearing Aid; Physiotherapy Material Nature Pharmaceuticals Biologics Medical devices Miscellaneous
Medical & surgical procedures Support systems Managerial systems 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 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. ACCESS TO MEDICAL TECHNOLOGIES 1. Rational 3. Sustainable selection financing MEDICAL ACCESS INNOVATION 2. Affordable prices 4. Reliable health and
supply systems ACCESS TO MEDICAL TECHNOLOGIES two main sets of issues 1. Problems in access to generic medicines health system related issues medicines e.g. in 2000 pricevery surveys few data: people average with availability12 HIV/AIDS in of developing selected essential countries
medicines were on wastreatment, 51.8 per cent in 2011 in public 6.6 million sector health of them facilities have access and 68.5 toper firstcent lineinARVs, the private yet 8 million sector over still wait
the period for the 2007-2011 treatment ACCESS TO MEDICAL TECHNOLOGIES two main sets of issues 2. Problems in access to patent protected medicines 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. EVOLUTION OF MEDICAL INNOVATION Medicine and medical technology
Two approacheslooking from which side Three mile-stone medical innovations: Vaccine: Small-pox vaccine 1796 Medical device: Hypodermic syringe Pharmaceutical: Arsphenamine: 1844 1910 EVOLUTION OF MEDICAL INNOVATION FROM EDWARD JENNER TO GAVI Up to 20% of deaths in Europe were dues to smallpox in 19th century 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 VACCINE-PREVENTABLE The last case of smallpox occurred in
1977. INFECTIOUS AGENTS OR DISEASES 2.5 million deaths each year are prevented. ANTHRAX DIPHTHERIA CHOLERA H. INFLUENZAE TYPE B (HIB ) HEPATITIS A HEPATITIS B HEPATITIS E INFLUENZA Between 80-90% of infants receive DPT vaccine 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 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 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 EVOLUTION OF MEDICAL INNOVATION PHARMACEUTICALS Global market > USD 800 billion > USD 80 billion on R&D IMS estimates the share of the US and European markets will decline from Emerging markets 68% to 50% in the period between 2005 and 2015.By contrast, the global
market share of 17ofmergers high-growth markets increase 12% A massive round mergers andemerging acquisitions in thewill industry hasfrom taken Growing to 28%Out in the same place.
of the 42 period. members PhRMA in 1988, 11 remainoftoday. The NCEs approved by USFDAofhave declined fromonly an average over 33 in Generic market 19952001 to under 19 in 20052011. "a staggering US$60bn of the industrys US$85bn annual global R&D Rising
costsformer of R&D and declining results spending is wasted." MEA head EVOLUTION OF MEDICAL INNOVATION DEVELOPMENT OF MOST INFLUENTIAL PHARMACEUTICALS # 1 Medicine Morphine year 1827 2 3.
4. 5. 6 7 8 1962 Importance Commercialized by a pharmacy (Merck), pain management (Germany) Synthetic salicylic acid was commercialized (Germany) General anaesthetic, transformed surgery (US) Syphillis Treatment (Hoechst, Germany) 1st hormone therapy, transformed diabetes management Transformed the treatment of microbial diseases Transformed management of psyschosis. (France) (Belgium) Birth Control Pills, deep social impact (USA) Changed treatment of heart failure and hypertension
(Germany) (France) 9 Furosemide Loop diuretic, effective treatment of hypertension 10 Atorvastatin 1996 Cholesterol lowering medicine (USA) 1996-7 Transforming effect on AIDS patients 11 HAART L-Dopa (Sweden); Hydrocortisone; Viagra (1996, USA); Ritalin HISTORY AND THE EVOLVING BUSINESS MODEL No patents on penicillin and polio vaccine. 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 Jonas Salk interview 1955 on the industry. Committee members also included founders of Siemens and Hoechst. Their observations made an interesting reading: There is no patent. Could you patent the sun? "Patent medicine" and "patented medicine"
US Patent Act in 1790, Patent Office in 1802. Today industry is developing rapidly........monopolization and abuse of patent rights will inevitably expose large segments of Era of "copying success" and US "Trading with the industry to serious injury. The government must protect Enemy Act 1917" industry against these dangers... Compounds, compositions, manufacturing
processes and uses. HISTORY AND THE EVOLVING BUSINESS MODEL Patent protection based model has worked in the USA and Europe but not in developing countries Blockbuster medicines (annual sales > 1$b) 7 ofthe worlds 15cliff top-selling drugs in 2009, that collectively account for Patent nearly US$50bn in sales, due to lose patent protection in 2011 and 2012. Pharmaceutical Executive salaries Annual compensation packages of top 5 CEOs in pharmaceutical industry 1 J&J William Weldon 201
1 US$ 26.7 million 2 Pfizer Ian Read 2011 US$ 25 million 3 Abbott Miles White 2011 US$ 24 million 4 Mylan Robert Coury 2011 US$ 21.3 million
5 Amgen Kevin Sharer 2011 US$ 18.9 million HISTORY AND THE EVOLVING BUSINESS MODEL What TRIPS changed? of 1393 new chemical (NCEs) for marketed between Concerns aboutentities innovation developing 1975countries and 1999, only 16 targeted tropical diseases and
tuberculosis. Market failure of business model for NTDs Search for alternatives PDPs GSPA-PHI Consultative Expert Working Group on R&D: Financing and Coordination CONCLUSIONS 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.
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