UNITAID
The HIV/AIDS
Medicines
Patent Pool
Initiative
October 2010
Overview
► Background
► Policy
Challenge
► What is a Patent Pool?
► Introduction: UNITAID & the Medicines
Patent Pool
Evolution of AIDS Drug Prices: 2000-2008
Source: MSF (2008) Untangling the Web of Antiretroviral Price Reductions. Geneva: MSF.
Millions
Number of people receiving antiretroviral therapy
in low- and middle countries, 2002-2008
Source: WHO, UNAIDS, UNICEF. (2009) Towards Universal Access: Scaling up priority HIV/AIDS
interventions in the health sector. Progress Report 2009. Geneva: World Health Organization.
The Policy Challenge
► Full
implementation of global IP rules
(WTO TRIPS Agreement) in key
developing countries
 new medicines increasingly patented in
DCs
► Limited competition
 impact on prices
► Financial crisis
 squeezing budgets for medicines
Patents on New ARVs
Product
+/- Expiry date
Atazanavir (BMS)
2017
Darunavir (Tibotec)
2023
Etravirine (Tibotec)
2019
Fosamprenavir (GSK)
2018
Raltegravir (MSD)
2025
Ritonavir hs (Abbott)
2024
Tenofovir DF (Gilead)
2018
Maraviroc (Pfizer)
2019
Price comparison of first-lines, second-lines and
possible third-lines
First-line
Second-line
Possible third-line
Price (US$) per patient per year
2500
2291+?
2000
1500
1000
500
151
169
425
470
Best CF price
TDF/3TC+ATV+r
Best CF price
AZT/3TC+ATV+r
210
0
Lowest generic price Lowest generic price
AZT/3TC/NVP
TDF/3TC+NVP
Source: www.msfaccess.org
Best CF price
TDF/3TC/EFV
RAL+DVR+r+?
What is a Patent Pool?
Portfolio of patents and other relevant
intellectual property held by various actors
made available on a non-exclusive basis to
third parties against the payment of
royalties.
 Patent Pools come in different shapes
and forms and are set up for different
purposes
 While we have learned from existing
'standards' pools, the Medicines Patent
Pool is quite different
UNITAID
• Founded in 2006 by Brazil, Chile, France, Norway, and UK; today
29 countries & Gates Foundation
• Innovative financing: small air ticket levy
• Raised ~ 1.5 billion USD
• Innovative spending: market-based tools to expand access to
quality medicines for HIV/AIDS, TB and Malaria
• e.g. stimulating higher volumes of production by
guaranteeing a market for pharmaceutical manufacturers
• promoting competition among producers; thereby
• lowering prices of quality health commodities
• Home of the Patent Pool Initiative  2010 Medicines Patent Pool
History of Medicines Patent Pool
2006
2008
2009
CIPIH 2006
recommendation:
"Patent pools of
upstream technologies
may be useful in some
circumstances to
promote innovation
relevant
to developing
countries.”
May 2008
WHO Global Strategy
and Plan of Action
included Voluntary
Patent Pools
Broad stakeholder
consultation
and
proposed to UNITAID to
set up a medicines
patent pool.
July 2008
UNITAID Executive
Board
Supports the principle
of establishing a
patent pool and
requests the
secretariat to
undertake all
necessary actions for
this establishment.
Developed the
implementation plan
for the medicines
patent pool
Ongoing dialogue with
patent holders and with
other ARV drug
manufacturers
Decision by UNITAID
Board to fund
2010
Establishment of the
Medicines Patent
Pool
Formal licensing
negotiations can
begin
13 Guiding
Principles
Medicines
13 Guiding
Principles of of
the the
Medicines
Patent Pool Patent Pool
1
Public health driven
8
Quality assurance
2
Antiretroviral initial focus
9
Standardized licenses
3
Voluntary
10
Non discriminatory licenses
11
Additional / complementary to
existing mechanisms
12
Operate within current
intellectual property framework
13
Independent entity
4
Developing country focus
(low & middle income)
5
Price reductions
6
Enable product development
7
Flexible
A successful patent pool will…
 Enable the development of fixed dose
combinations (FDCs) of which the patents
are held by different entities
 Enable the development of adapted
formulations for children or for specific
developing country needs (e.g. heat
stable)
 Accelerate the availability of generic
versions of new ARVs
Royalties
Royalties
Generic
Generic
Patent
Patent
Generic
Pool
Generic
Generic
Generic
Royalties
Priority ARVs
• Initial list of 19 products
identified for
Implementation Plan
• Possible FDCs and
pediatric formulations to
be targeted by the Pool
identified by WHO
Expert Committee on
Essential Medicines
• Further work is being
undertaken with expert
group to refine priorities
Support for the Patent Pool
"A successful
patent pool will
help in
accelerating the
scaling up of
access to care and
treatment and will
reduce the risk of
stock out of
medicines in the
developing world"
Michel Sidibe,
UNAIDS
Executive
Director (July
2010)
"One promising
initiative that can help
decrease the cost of
patents for the Index
Countries is the patent
pool initiative of
UNITAID. "
ATM Index 2010
(Engagement with
PP included as one
of the issues
measured in the
Index)
"The European
Parliament: (…) Calls on
the Commission, the
Council and the Member
States of the EU to
recognise the need for the
UNITAID patent pool to
ensure availability and
affordability of HIV
medicines for developing
countries and to actively
support the UNITAID HIV
patent pool"
"Pharmaceutical
companies and other
patent holders should
sign up to the
UNITAID patent pool
to enable new fixed
dose combinations
(FDCs) and paediatric
versions of HIV drugs,
in return for a fair
royalty on their
patents"
The UK All-Party
parliamentary Group
on AIDS (July 2009)
Declaration of the
European Parliament
(Feb 2010)
"This voluntary scheme provides an opportunity to improve access to affordable
medicines, but its success will depend on the willingness of both patent holders (to
put their patents into the pool) and generic manufacturers (to pay royalties, use the
patents and adapt the medicines)."
The UN MDG Gap Task Force Report 2009
NIH Jumps In
Sept 2010: NIH becomes first to license patents to the
Pool
• Research by NIH National Cancer Institute and
University of Illinois-Chicago (1999)
• Patents on protease inhibitors, including darunavir
• License text is publicly available
• License to benefit all low- and middle-income
countries
• Royalty-free
• License not enough to clear legal path to generic
production
• All HIV/AIDS medicine patent-holders invited to
share their patents with the Pool (universities, public
research institutions, companies)
• NIH and Pool discussing additional licenses
“This license underlines the U.S.
Government’s commitment to the
Medicines Patent Pool and its goal
to increase the availability of HIV
medicines in developing countries.
We are now discussing licensing
to the Medicines Patent Pool other
patents that could have a positive
impact on the treatment of
HIV/AIDS.”
-- NIH Director Francis S.
Collins, M.D., Ph.D.
“Kudos to the National Institutes of
Health (NIH) for being the first in the
world to share patents with the
newly established Medicines Patent
Pool! ….As a global leader in
research and development, the
United States has an important
catalyzing role to play in promoting
voluntary mechanisms that will
increase competition to provide
innovative, affordable health
technologies to people in low- and
middle-income countries.”
--The White House, Office of
Science & Technology Policy
Will it work?
Yes, if:
 Patent owners and generic manufacturers collaborate
 Global health financing remains of sufficient levels to ensure the
market
 Political support remains strong
and because:
No one can absorb the human and financial cost of failure
Thank You
UAEM
www.unitaid.eu
www.medicinespatentpool.org