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
e.g. in 2000
few data:
people
with
medicines
pricevery
surveys
average
HIV/AIDS in
countries
were
availability12
of developing
selected essential
medicines
on
in 2011
6.6 million
of them
wastreatment,
51.8 per cent
in public
sector health
have access
toper
firstcent
lineinARVs,
yet 8
facilities
and 68.5
the private
million
still wait
for the
treatment
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
VACCINE-PREVENTABLE
•
Up
to
20%
of
deaths
in
Europe
were
MUMPS
INFECTIOUS AGENTS OR
th century
PERTUSSIS
(WHOOPING COUGH)
dues to smallpox in 19
DISEASES
PNEUMOCOCCAL DISEASE
POLIO
ROTAVIRUS (SEVERE DIARRHEA)
RUBELLA (GERMAN MEASLES)
TETANUS (LOCKJAW)
TICK BORNE ENCEPHALITIS
TUBERCULOSIS
TYPHOID FEVER
VARICELLA (CHICKENPOX)
YELLOW FEVER
• The last case of smallpox occurred in 1977.
ANTHRAX
DIPHTHERIA
CHOLERA
H. INFLUENZAE TYPE B (HIB)
HEPATITIS A
HEPATITIS B
HEPATITIS E
INFLUENZA
JAPANESE ENCEPHALITIS
MEASLES
MENINGOCOCCAL DISEASE
• 2.5 million deaths each year are prevented.
• 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
• Emerging markets
• Growing mergers
• Generic market
• Rising costs of R&D and declining results
EVOLUTION OF MEDICAL INNOVATION
DEVELOPMENT OF MOST INFLUENTIAL PHARMACEUTICALS
#
1
Medicine
Morphine
year
1827
2
3.
Aspirin
Ether
Arsphenamine
Insulin
Penicillin
Chlorpromazine
and Haladol
Estrogen+
Progestin
Digoxin
1897
1842
1910
1922
1929
1950
& 1958
1961
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 sun?
yet to be
•
There
is
no
patent.
Could
you
patent
the
evolved,Jonas
Bismarck
appointed a committee to study the likely impact of the patent system
Salk interview 1955
on the industry. Committee members also included founders of Siemens and Hoechst.
Their
an interestingand
reading:
• observations
"Patentmade
medicine"
"patented medicine"
• US
Patent
in 1790,
Patent Office in 1802.
Today
industry
is Act
developing
rapidly........monopolization
and
abuse
of patent
rights will
inevitably
expose
large segments
• Era
of "copying
success"
and
US "Trading
with of
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$b)
• Patent cliff
• Pharmaceutical Executive salaries
Annual compensation packages of top 5 CEOs in
pharmaceutical industry
1 J&J
William Weldon
2011 US$ 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?
• 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
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.