Transcript Global Strategy and Plan of Action on Public Health, Innovation & Intellectual Property Technical Briefing Seminar 1 November, 2011 WHO HQ, Geneva Zafar Mirza Department of.

Global Strategy and Plan of Action on
Public Health, Innovation & Intellectual Property
Technical Briefing Seminar
1 November, 2011
WHO HQ, Geneva
Zafar Mirza
Department of Public Health, Innovation and Intellectual Property
Learning Objectives
1
To understand the relationship between intellectual
property protection (patents) and access to
medicines.
2
How innovation is important to access to
medicines?
3
To know about the origin of GSPA-PHI and its
content.
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Intellectual property protection & access to
medicines
1/1
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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Intellectual property protection and access to
medicines
2/1
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
Intellectual property protection and access to
medicines
3/1
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.
 Inventions must be “new” and capable of industrial
application.
 Process and product patents.
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Intellectual property protection and access to
medicines
4/1
What is the TRIPS Agreement?
 Trade related aspects of intellectual property.
 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...”
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Intellectual property protection and access to
medicines
TRIPS Flexibilities
5/1
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
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Intellectual property protection and access to
medicines
5/1
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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Learning Objectives
1
To understand the relationship between intellectual
property protection (patents) and access to
medicines.
2
How innovation is important to access to
medicines?
3
To know about the origin of GSPA-PHI and its
content.
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The importance of innovation for access to
medicines
1/2

Availability of medicines has two dimensions:
1. Availability in health facilities and private
pharmacies
2. Development of new medicines (R&D) for effective
health care, for example…
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
R&D dimension of availability of medicines is
especially important for development countries.

Is there a difference between R&D and innovation.
The importance of innovation for access to
medicines
2/2

If IPP encourages companies to invest more in R&D then
has it worked for poor developing countries: not really.

Between 1975 and 2004, 1,556 new chemical entities were
marketed globally. Only 20 of these – a mere 1.3 per cent –
were for tropical diseases and tuberculosis.

So, despite patent protection system, development of new
medicines for developing countries has been scarce, why

In 2007, the pharmaceutical industry made 87 percent of its
global profits in North America, the European Union and
Japan.
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Learning Objectives
1
To understand the relationship between intellectual
property protection (patents) and access to
medicines.
2
How innovation is important to access to
medicines?
3
To know about the origin of GSPA-PHI and its
content.
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Milestones in the debate I
1/3

Jan 1995 – WTO is created and the TRIPS Agreement is
enforced


May 1996 – WHA 49.14 Revised Drug Strategy



1999 – WHA 52.19 – Revised Drug Strategy
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1998 - 2002 – pharm. industry lawsuit against the government of
South Africa
1999 – UNDP/HDR – Globalization with a human face
2000 WHA 53.14 HIV/AIDS confronting the epidemic
Milestones in the debate II
2/3






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Sep 2000 – 55th UNGA - the UN Millennium Declaration (MDG)
2001 WHA 54.10 Scaling up the response to HIV/AIDS
Jun 2001 – 4th WTO Ministerial Conference –The Declaration on
the TRIPS Agreement and public health – (the Doha Declaration)
2002 WHA 55.14 Ensuring accessibility of essential medicines
Sep 2002 – Report of the UK CIPR – Integrating intellectual property
rights and development policy
2003 WHA 56.27 Intellectual property rights innovation and
public health - CIPIH
A GLOBAL CAMPAIGN FOR ACCESS TO MEDICINES
Commission on Public Health, Innovation, and
Intellectual Property Rights
3/3
http://www.who.int/intellectualproperty/report/en/index.html
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Diseases that disproportionately affect developing
countries?
4/3
Commissions on Macroeconomics and Health’s
classification of diseases:
Type I diseases are incident in both rich and poor countries, with
large numbers of vulnerable population in each. Examples of
communicable diseases include measles, hepatitis B, and
Haemophilus influenzae type b (Hib), and examples of
noncommunicable diseases abound (e.g. diabetes,
cardiovascular diseases, and tobacco-related illnesses).
Type II diseases are incident in both rich and poor countries, but
with a substantial proportion of the cases in the poor
countries…HIV/AIDS and tuberculosis are examples.
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Which are the Diseases that disproportionately
affect developing countries?
1.
Dengue
2.
Rabies
Type
IIITrachoma
diseases are those that are overwhelmingly or
3.
exclusively
incident in the developing countries, such
4.
Buruli ulcer
as
sleeping
sickness (trypanosomiasis) and
5. African
Endemic
treponematoses
African
river blindness (onchocerciasis). Such diseases
6.
Leprosy
7.
Chagas
disease little
(American
trypanosomiasis)
receive
extremely
R&D,
and essentially no
8.
Human African
trypanosomiasis
sickness)
commercially
based
R&D in the(sleeping
rich countries.
9.
Leishmaniasis
10.
Cysticercosis
Type
II
diseases are often termed neglected diseases
11.
Dracunculiasis (guinea-worm disease)
and
III diseases very neglected diseases.
12. Type
Echinococcosis
13.
Foodborne trematode infections
14.
Lymphatic filariasis
15.
Onchocerciasis (river blindness)
16.
Schistosomiasis (bilharziasis)
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17.
Soil-transmitted helminthiases
5/3
Commission on Intellectual Property Rights,
Innovation and Public Health
6/3
 Moral imperative
 Innovation cycle (discovery – development – delivery)
 “(IPP) can do little to stimulate innovation in the absence of
a profitable market”
 60 recommendations.
 “the need is to develop a
Global Plan of Action which
would provide a medium term
framework for action”
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7/3
Timeline
2003
2006
2008
2010
Resolution WHA56.27 Resolution WHA59.24 Resolution WHA61.21 Resolution WHA63.28
Intellectual property rights,
innovation and public
health
Public Health, innovation,
essential health research and
intellectual property rights:
towards a global strategy and
plan of action
Global strategy and plan of
action on public health,
innovation and intellectual
property
Establishment of a
consultative expert working
group on research and
development: financing and
coordination
Commission on Public
Health, Innovation and
Intellectual Property Rights
Intergovernmental
Working Group
Expert Working Group
Consultative Expert
Working Group
Collect data and proposals from
the different actors…produce an
analysis of intellectual property
rights, innovation and public
health, including the question of
appropriate funding and
incentive mechanisms for the
creation of new medicines and
other products against diseases
that disproportionately affect
developing countries.
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Draw up a global strategy and
plan of action in order to provide
a medium-term framework based
on the recommendations of the
Commission; such strategy and
plan of action would aim , inter
alia, at securing an enhanced
and sustainable basis for needsdriven, essential health research
and development relevant to
diseases that disproportionately
affect developing countries,
proposing clear objectives and
priorities for research and
development and estimating
funding needs in this area.
Examine current financing and
coordination of research and
development, as well as
proposals for new and innovative
sources of funding to stimulate
research and development
related to Type II and Type III
diseases and the specific
research and development
needs of developing countries in
relation to Type I diseases.
(a) take forward the work of the
Expert Working Group;
(b) deepen the analysis of the
proposals in the Expert Working
Group’s report, and in
particular: (i) examine the … four
innovative sources of financing
proposed (ii) review the five
promising proposals …; and
(iii) further explore the six
proposals that did not meet the
criteria …
(c) consider additional
submissions and proposals
Global Strategy on
Public Health, Innovation and Intellectual Property
8/3
The aim
The global strategy on public health, innovation and intellectual
property aims 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 needs-driven essential health research and development
relevant to diseases which disproportionately affect
developing countries, proposing clear objectives and
priorities for R&D, and estimating funding needs in this area.
The global strategy is designed to promote innovation, build
capacity, improve access and mobilize resources.
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Global Strategy and Plan of Action on Public
Health, Innovation & Intellectual Property 2006-09
9/3
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
10/3
(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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GSPOA & Intellectual Property
11/3
GSPOA 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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Learning Objectives
1
To understand the relationship between intellectual
property protection (patents) and access to
medicines.
2
How innovation is important to access to
medicines?
3
To know about the origin of GSPA-PHI, its content
and implementation.
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