Transcript Innovation and Access: Intersection of Public Health and Intellectual Property EMP - Technical Briefing Seminar 1 November, 2013 WHO HQ, Geneva Zafar Mirza Public Health, Innovation.

Innovation and Access:
Intersection of Public Health and Intellectual Property
EMP - Technical Briefing Seminar
1 November, 2013
WHO HQ, Geneva
Zafar Mirza
Public Health, Innovation and Intellectual Property Unit
Essential Medicines & Health Products Department
Essential Medicines and Health Products Department (EMP)
Office of the Director
Policy, Access and Use (PAU)
Public Health, Innovation and
Intellectual Property (PHI)
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Global Strategy and Plan of Action PHI
Local production
Transfer of technology for vaccine
production
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Technologies Standards and
Norms (TSN)
• Expert Committee Biological
Standardization
• Expert Committee
Pharmaceutical preparations
• INN
• International Pharmacopeia
• Reference standards
Medicines policy; regional & country
collaboration & support
Indicators & tools for pharmaceutical sector
monitoring & assessment
Transparency & good governance in
medicines
Supply management systems
Medicines pricing policies
Selection of essential medicines
Psychotropics & narcotics, including
substance evaluation
Access to controlled medicines
Rational use and anti-microbial resistance
Regulatory Systems
Strengthening (RSS)
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NRA assessment
Capacity building
Harmonization initiatives
ICDRA support
Regulation of Medicines and other
Health Technologies (RHT)
• Norms/standards (including
nomenclature)
• Quality assurance (including blood
products)
• Safety /pharmacovigilance
• Prequalification of medicines; vaccines,
and diagnostics Regulation
Prequalification Team
(PQT)
Prequalification of
medicines, vaccines,
Diagnostics, …
• Dossier assessments
• Inspection
• Testing
• Scientific advice
Safety and Vigilance (SAV)
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Pharmacovigilance
Advisory group on PV
ATC/DDD committee
Vaccine safety initiative
Advisory group on
vaccine safety
• SSFFC ( cross cutting)
Access and its determinants
1. Rational
3. Sustainable
selection
financing
MEDICAL
ACCESS
INNOVATION
(R&D)
2. Affordable
prices
4. Reliable
health and
supply
systems
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.
Learning Objectives
1
2
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4
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Introduction to the concept of intellectual property
protection.
To understand the intersection of Intellectual
property protection and innovation (R&D) of
medical technology.
To understand the intersection of Intellectual
property protection and access to medical
technology.
To appreciate WHO response: an introduction to
GSPA-PHI.
What is intellectual property protection (IPP)?
 Intellectual property rights are the rights given to
people over the creation of their minds inorder to
reward them and encourage them to create more.
 The legal system for the protection of these
rights is called IPP system?
 IP rights are private rights.
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Types of Intellectual property protection
Different types of intellectual property?
1.
2.
3.
4.
5.
6.
7.
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Copyrights
Trademarks
Geographical Indications
Industrial Designs
Patents
Layout-Designs (Topographies) of ICs
Protection of Undisclosed Information
What are patents and patent protection?
 A patent is a form of intellectual property. It consists
of a set of exclusive rights granted by a sovereign
state to an inventor for a limited period of time in
exchange for the public disclosure of an invention.
 Difference between a "trade secret" and a "patent".
 Inventions must be “new” and capable of industrial
application.
 Process and product patents.
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What is the TRIPS Agreement?
 Trade Related Aspects of Intellectual Property Rights.
 One of the agreements under WTO.
 “patents shall be available for any inventions,
whether products or processes, in all fields of
technology”
 The term of protection granted ...shall last for at least
20 years from the time of filling of the application for
patent protection”
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TRIPS Flexibilities
Government Use
allow government agencies to use an invention, for
public, non-commercial purposes.
Compulsory License
permit 3rd parties to use an invention, without the
patent holder's consent on grounds of public interest.
Parallel Imports
import at a lower price and resale of patented product
in another country
Exceptions and limitations
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Learning Objectives
1
2
3
4
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Introduction to the concept of intellectual property
protection.
To understand the intersection of Intellectual
property protection and innovation (R&D) of
medical technology.
To understand the intersection of Intellectual
property protection and access to medical
technology.
To appreciate WHO response: an introduction to
GSPA-PHI.
Medical Innovation
1. Essential for health development
2. Public good dimension
3. Discovery is supported by public sector
4. Drug development is long, expensive & risky
5. Protected through patents
6. End products are strictly regulated
7. Equitable access to innovations is critical
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EVOLUTION OF MEDICAL INNOVATION
DEVELOPMENT OF MOST INFLUENTIAL PHARMACEUTICALS
Medicine
Morphine
year
1827
Importance
Commercialized by a pharmacy (Merck), pain
management (Germany)
Aspirin
1897
Synthetic salicylic acid was commercialized (Germany)
Ether
1842
General anaesthetic, transformed surgery (US)
Arsphenamine
1910
Syphillis Treatment (Hoechst, Germany)
Insulin
1922
1st hormone therapy, transformed diabetes management
Penicillin
1929
Transformed the treatment of microbial diseases
Chlorpromazine and 1950
Transformed management of psyschosis. (France)
Haladol
& 1958 (Belgium)
Estrogen+ Progestin 1961
Birth Control Pills, deep social impact (USA)
Digoxin
1962
Changed treatment of heart failure and hypertension
(Germany) (France)
Furosemide
Loop diuretic, effective treatment of hypertension
Atorvastatin
1996
Cholesterol lowering medicine (USA)
HAART
1996-7 Transforming effect on AIDS patients
L-Dopa (Sweden); Hydrocortisone; Viagra (1996, USA); Ritalin
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.
Medical Innovation & IPP
 Patent protection
 Market based incentive
 Return on investment
 Time limited monopoly
 Market failure
 Type III and Type II diseases
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Diseases that disproportionately affect developing
countries?
1.
Dengue
Type I diseases are incident in both rich and poor countries,
2.
Rabies
with large numbers of vulnerable population in each.
3.
Trachoma
of communicable diseases include measles,
4. Examples
Buruli ulcer
B, and
Haemophilus influenzae type b (Hib), and
5. hepatitis
Endemic
treponematoses
6. examples
Leprosyof noncommunicable diseases abound (e.g.
and tobacco-related
7. diabetes,
Chagascardiovascular
disease (Americandiseases,
trypanosomiasis)
8. illnesses).
Human African trypanosomiasis (sleeping sickness)
9.
Leishmaniasis
Type
10. II diseases
Cysticercosisare incident in both rich and poor countries,
a substantial
proportion
of the cases in the poor
11.but with
Dracunculiasis
(guinea-worm
disease)
and tuberculosis are examples.
12.countries…HIV/AIDS
Echinococcosis
13.
Foodborne trematode infections
Type
diseasesfilariasis
are those that are overwhelmingly or
14. III Lymphatic
incident
inblindness)
the developing countries - NTDs
15.exclusively
Onchocerciasis
(river
16.
Schistosomiasis (bilharziasis)
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1817.
Soil-transmitted helminthiases
Learning Objectives
1
2
3
4
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Introduction to the concept of intellectual property
protection.
To understand the intersection of Intellectual
property protection and innovation (R&D) of
medical technology.
To understand the intersection of Intellectual
property protection and access to medical
technology.
To appreciate WHO response: an introduction to
GSPA-PHI.
ACCESS TO HEALTH TECHNOLOGIES
1. Rational
3. Sustainable
MEDICAL
ACCESS
INNOVATION
(R&D
selection
2. Affordable
prices
financing
4. Reliable
health and
supply
systems
Intellectual property protection and access to
medicines
Potential impact of IPP on access to medicines
 Availability
Patent protection can encourage companies to invest more
on development of new medicines [?]
 Affordability
During the patent protection period prices of medicines are
high and generally unaffordable for patients especially in
developing countries.
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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.
Issues in access to patent protected
medicines and medical technologies
 TRIPS flexibilities, exceptions and limitations
should be fully incorporated in the national
patent laws
 Political issues in the use of TRIPS flexibilities
 TRIPS Plus in Free Trade Agreements
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DATA
AsEXCLUSIVITY
a part of the US-Jordan FTA, Jordan
implemented data exclusivity. A study
conducted
by Oxfam
in 2007
found that of
 Test
data protection
(TRIPS
39.3)
103 medicines registered and launched since
2001 that had no patent protection in Jordan,
 Data exclusivity is independent of patent
at
least
79%
had
no
competition
from
a
protection and introduce another kind of
generic equivalent as a consequence
monopoly rights with serious implications for
of data
The study also found that
access
toexclusivity.
generic medicines
prices of these medicines under data
exclusivity were up to 800% higher than in
 Patent link…
neighboring Egypt.
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Learning Objectives
1
2
3
4
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Introduction to the concept of intellectual property
protection.
To understand the intersection of Intellectual
property protection and innovation (R&D) of
medical technology.
To understand the intersection of Intellectual
property protection and access to medical
technology.
To appreciate WHO response: an introduction to
GSPA-PHI.
WHO & Intellectual Property Protection
GSPA-PHI confirms and expands the mandate of WHO
in the field of public health & intellectual property:
"… the WHO shall play a strategic and central role in
the relationship between public health and
innovation and intellectual property within its
mandates (…), capacities and constitutional
objectives, bearing in mind those of other relevant
intergovernmental organizations. "
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History of debate and developments in WHO
2003
WHA56.2
7
Intellectual property rights,
innovation and public
health
Commission on Intellectual
Property Rights, Innovation
and Public Health
2006
WHA59.24
2008
2010
WHA61.2
1
WHA63.2
8 of a
Establishment
Public Health, innovation,
Global strategy and plan of
essential health research and
action on public health,
intellectual property rights:
innovation and intellectual
towards a global strategy and
property
plan of action
Intergovernmental
Working Group
Expert Working Group on
Research and Development:
Financing and Coordination
consultative expert working
group on research and
development: financing and
coordination
Consultative Expert Working
Group on R&D: Financing and
Coordination
Global Strategy on
Public Health, Innovation and Intellectual Property
The Aim
to promote new thinking on innovation
and access to medicines, as well as,
[…], provide a medium-term
framework for securing an enhanced
and sustainable basis for needsdriven essential health research and
development relevant to diseases
which disproportionately affect
developing countries,
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Global Strategy and Plan of Action on Public
Health, Innovation & Intellectual Property 2006-09
1. Prioritizing research and development needs.
2. Promoting research and development.
3. Building and improving innovative capacity.
4. Transfer of technology.
5. Application and Management of intellectual property to contribute to
innovation and promote public health.
6. Improving delivery and access.
7. Promoting sustainable financing mechanisms for needs driven R&D.
8. Establishing monitoring and reporting systems
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Element 5. Application and management of intellectual
property to contribute to innovation and promote PH
(5.1)
supporting information sharing and capacity building in the
application and management of intellectual property with
respect to health related innovation and the promotion of
public health in developing countries
(5.2) providing as appropriate, upon request, in collaboration with
other competent international organizations technical support,
including, where appropriate, to policy processes, to countries
that intend to make use of the provisions contained in the
TRIPS Agreement, including the flexibilities recognized by the
Doha Ministerial Declaration on the TRIPS Agreement and
Public Health and other WTO instruments related to the TRIPS
Agreement, in order to promote access to pharmaceutical
products
(5.3) exploring and, where appropriate, promoting possible
incentive schemes for research and development on Type II
and Type III diseases and on developing countries’ specific
research and development needs in relation to Type I diseases
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Learning Objectives
1
2
3
4
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Introduction to the concept of intellectual property
protection.
To understand the intersection of Intellectual
property protection and innovation (R&D) of
medical technology.
To understand the intersection of Intellectual
property protection and access to medical
technology.
To appreciate WHO response: an introduction to
GSPA-PHI.
For more information
www.who.int/phi/en/
THANK YOU
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