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
Unpacking the concepts
Evolution of medical innovation
Evolving business model
Conclusions

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

4. 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

5. 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?
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.

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

9. 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 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

10. 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.

11. 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

12. 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

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
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

19. 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

20. 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...

21. 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.

22. Annual compensation packages of top 5 CEOs in pharmaceutical industry1
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

23. 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.

24. 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.