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 Unpacking the concepts Evolution of medical innovation Evolving business model Conclusions

Medical innovation and Access unpacking the concepts Medical Technologies? Medical Innovation? Access?

Purpose / Application Material Nature 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

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? Sine qua non of health development Public good dimension Discovery is supported by public sector Drug development is long, expensive & risky End products are protected through patents End products are strictly regulated Equitable access to innovations is critical.

Access to medical technologies 1. Rational selection 4. Reliable health and supply systems 2. Affordable prices 3. Sustainable financing ACCESS Medical innovation

Access to Medical technologies two main sets of issues Problems in access to generic medicines health system related issues 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 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

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 approaches…looking from which side Three mile-stone medical innovations: Vaccine: Small-pox vaccine 1796 Medical device: Hypodermic syringe 1844 Pharmaceutical: Arsphenamine: 1910

Evolution of Medical innovation From edward jenner to gavi Up to 20% of deaths in Europe were dues to smallpox in 19th 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 Mumps Pertussis (whooping cough) Pneumococcal disease Polio Anthrax Rotavirus (severe diarrhea) Diphtheria Rubella (German measles) cholera Tetanus (lockjaw) H. Influenzae type b (Hib) Tick borne encephalitis Hepatitis A Tuberculosis Hepatitis B Typhoid fever Hepatitis e Varicella (chickenpox) Influenza Yellow fever Japanese encephalitis Measles Meningococcal disease

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 Emerging markets Growing mergers Generic market Rising costs of R&D and declining results IMS estimates the share of the US and European markets will decline from 68% to 50% in the period between 2005 and 2015.By contrast, the global market share of 17 high-growth emerging markets will increase from 12% to 28% in the same period. A massive round of mergers and acquisitions in the industry has taken place. Out of the 42 members of PhRMA in 1988, only 11 remain today. The NCEs approved by USFDA have declined from an average of over 33 in 1995−2001 to under 19 in 2005−2011. "a staggering US$60bn of the industry’s US$85bn annual global R&D spending is wasted." former MEA head

Commercialized by a pharmacy (Merck), pain management (Germany) 2 Evolution of Medical innovation development of most influential Pharmaceuticals # Medicine year Importance 1 Morphine 1827 Commercialized by a pharmacy (Merck), pain management (Germany) 2 Aspirin 1897 Synthetic salicylic acid was commercialized (Germany) 3. Ether 1842 General anaesthetic, transformed surgery (US)   Arsphenamine 1910 Syphillis Treatment (Hoechst, Germany) 4. Insulin 1922 1st hormone therapy, transformed diabetes management 5. Penicillin 1929 Transformed the treatment of microbial diseases 6 Chlorpromazine and Haladol 1950 & 1958 Transformed management of psyschosis. (France) (Belgium) 7 Estrogen+ Progestin 1961 Birth Control Pills, deep social impact (USA) 8 Digoxin 1962 Changed treatment of heart failure and hypertension (Germany) (France) 9 Furosemide Loop diuretic, effective treatment of hypertension 10 Atorvastatin 1996 Cholesterol lowering medicine (USA) 11 HAART 1996-7 Transforming effect on AIDS patients L-Dopa (Sweden); Hydrocortisone; Viagra (1996, USA); Ritalin

History and the Evolving business model 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. 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...

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) Patent cliff Pharmaceutical Executive salaries 7 of the world’s 15 top-selling drugs in 2009, that collectively account for nearly US$50bn in sales, due to lose patent protection in 2011 and 2012.

Annual compensation packages of top 5 CEOs in pharmaceutical industry 1 J&J William Weldon 2011 US$ 26.7 million 2 Pfizer Ian Read US$ 25 million 3 Abbott Miles White US$ 24 million 4 Mylan Robert Coury US$ 21.3 million 5 Amgen Kevin Sharer US$ 18.9 million

History and the Evolving business model 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 …of 1393 new chemical entities (NCEs) marketed between 1975 and 1999, only 16 targeted ‘‘tropical diseases’’ and tuberculosis.

Today the focus is on enhancing innovation for developing countries. 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.