Transcript Presentation - Consumer Project on Technology

Access to Essential Medicines and
Intellectual Property Rights
in Developing Countries
Rachel M. Cohen
Access to Essential Medicines Campaign
Doctors Without Borders/Médecins Sans Frontières (MSF)
5th Meeting of the Transatlantic Consumer Dialogue
Workshop on Intellectual Property Rights:
October 31, 2002
The Access to Medicines Crisis
Communicable diseases = leading causes of
death in developing countries, accounting for
over 25% of all deaths globally
14 million die each year, 97% in developing
countries
- HIV/AIDS: 3 million per year
- Tuberculosis: 2 million per year
- Malaria: 1-2 million per year
1/3 of world lacks access to essential quality
drugs, diagnostics, vaccines
The Example of HIV/AIDS…
HIV/AIDS: The Price Barrier
HIV/AIDS
- 40 million people infected with HIV worldwide
- Antiretroviral (ARV) therapy proven to dramatically
extend and improve lives of people living with
HIV/AIDS in wealthy countries, reducing AIDSrelated deaths by over 70%.
- Average cost of antiretroviral “cocktail” in the US =
$10,000-$15,000 per patient per year
- Over 95% of PWAs in developing countries lack
access to ARVs, largely because of the price of drugs
8,000 people with HIV/AIDS will die today
High Prices Linked to Patent Protection
Effects of Generic Competition
Sample AIDS Triple Combination: Lowest World Prices
(stavudine (d4T) + lamivudine (3TC) + nevirapine)
12000
10000
8000
Brand
Generic
6000
4000
2000
1
00
pr
2
M
ar
A
b
Fe
n
Ja
ec
D
ov
N
O
ct
pt
Se
ug
A
ly
Ju
ne
Ju
M
ay
0
Best offers for first-line regimens
proposed in the WHO guidelines
October 2002
Best offer
generic
com panies
Best offer
proprietary
com panies
ZDV/3TC/NVP
316
1,059
ZDV/3TC/NVP as FDC
419
N.A.
ZDV/3TC/EFZ
642
1,121
ZDV/3TC/ABC
1,576
1,607
ZDV/3TC/ABC as FDC
1,648
1,624
ZDV/3TC/NFV
1,737
3,325
ZDV/3TC/IND/r
1,129
1,304
Yearly cost in US$
Differential
3.35
...
1.75
1.02
0.99
1.91
1.16
TRIPS Agreement: What Is It?
World Trade Organization Agreement on TradeRelated Aspects of Intellectual Property Rights
(1994 Uruguay Round)
Most comprehensive international agreement
on intellectual property rights such as patents,
copyrights, and trademarks
Sets forth minimum standards for intellectual
property protection that must be met by all
WTO Members (by 2005 at the latest)
TRIPS Agreement: What Is It?
Research-based pharmaceutical
companies key architects of TRIPS
Medicines treated like any other
commodity (Barbie dolls, computer
software, CDs, etc.)
Commercial interests protected over
public health
Patent Rights vs. Patient Rights
Correcting the Imbalance
Impact of TRIPS is not fully visible today
In years to come, new medicines invented since
the signing of the TRIPS Agreement in 1994 will
be potentially patentable in all WTO Member
States depending on the will of the patent
owner only
Challenge to correct imbalance
WTO Members can provide for a number of
“public health” safeguards in national legislation
to protect public health, e.g. in cases of patent
abuses or emergencies
What Was Accomplished in Doha?
The fundamental argument was settled:
“We agree that the TRIPS Agreement does not and should not
prevent Members from taking measures to protect public health.
Accordingly, while reiterating our commitment to the
TRIPS Agreement, we affirm that the Agreement can and
should be interpreted and implemented in a manner
supportive of WTO Members' right to protect public health
and, in particular, to promote access to medicines for all.
In this connection, we reaffirm the right of WTO Members to use,
to the full, the provisions in the TRIPS Agreement, which provide
flexibility for this purpose.”
-
Ministerial Declaration on the TRIPS Agreement and Public Health
November 2001
Unresolved Issues
Paragraph 6: “production for export” =>
How countries with insufficient or no
manufacturing capacity in the
pharmaceutical sector will be able to
make effective use of compulsory
licensing under the TRIPS Agreement
Paragraph 7: How to encourage and
promote technology transfer to LDCs
The CIPR Report: IPRs & Health
September 2002
Patents are tools of public policy and must operate to serve the
greater public good.
Developing countries should narrow to an absolute minimum the
type and scope of pharmaceutical patents, and LDCs should
consider delaying the granting of pharmaceutical patents for as
long as possible.
Need quick, easy-to-use measures to ensure generic competition
to bring drug prices down in developing countries (e.g. compulsory
licensing as rule rather than exception to ensure that patent
system does not hamper the development of a competitive
pharmaceutical market).
Solution to production for export problem must be quick and easy
to implement, give long term security and be economically viable
(Article 30 approach).
Patent system is failing to stimulate innovation to meet many
medical needs, particularly the needs in developing countries.
Further recognition of the need for greater action and support to
help developing countries put health first.
What More Is Needed for
Existing Medicines?
Equity pricing for
equitable access…
Generic
competition
Differential
pricing
TRIPS
safeguards
High
volume
Prices of essential medicines
in developing countries
Monopolies
Low volume, low
demand
Local
production
What About Future Medicines?
The Crisis in R&D for Neglected Diseases
An Empty Pipeline for
Neglected Diseases
1975-1999: 1,393 new chemical entities marketed
Tropical diseases: 13
Tuberculosis: 3
Trouiller, et al., Lancet
Will Strengthening IP Protection
in Developing Countries
Stimulate R&D for Diseases of
the Poor?
A Fatal Imbalance
Market Failure
• Drug development is almost exclusively
confined to the R&D-based pharmaceutical
industry, operating in a global market economy
• Market forces skew the direction of drug R&D
towards those diseases and patients
(consumers) that assure the highest financial
returns
• Market potential does not mirror health needs
Market Failure = Public Policy Failure
Societal choice: drug development can be
confined to the private sector
Medicines are considered commodities that need
to generate profit in return for private investment
- public policy initiatives only stimulate R&D for
diseases that affect wealthy markets
- drug R&D capacity in developing countries is not
adequately cultivated
What Kinds of Solutions
Are Needed?
• Market “push/pull mechanisms” mechanisms?
Push: e.g. tax credits, R&D grants, support for clinical trials
Pull: e.g. purchase funds, temporary monopolies, patent
extensions
• Public Private Partnerships (PPPs)?
e.g. IAVI, GATB, MMV
• WHO/UNDP/World Bank Special Program on
Tropical Disease Research (TDR)?
Very broad mandate, chronically under-funded, political constraints
• A Drugs for Neglected Diseases Initiative
(DNDi): Partnership for Public Response?
Needs-based, field-driven, with clear public sector responsibility
What Kinds of Solutions
Are Needed?
Increased public sector funding for R&D for
neglected diseases (including support for notfor-profit R&D)
“Essential research obligation” (mandatory
reinvestment of percentage of profits toward
R&D for neglected diseases either directly or
through public R&D programs)
Global treaty on R&D for neglected diseases
Overcoming the Gap:
Toward a New R&D Paradigm
Ensuring access to medicines is a public
sector responsibility (when the market
fails, governments have a duty to step in)
Must develop an R&D agenda that is
needs-driven, not profit-driven
Must acknowledge differences between
neglected and most neglected diseases,
and develop strategies accordingly
Thank You
[email protected]
www.doctorswithoutborders.org
www.accessmed-msf.org