Transcript Ellen `t Hoen

Equitable Access the need for a
new concept: The HIV Medicines
Patent Pool Initiative
Med4all conference, Berlin 23 - 24 April 2009.
Ellen 't Hoen
Senior Adviser Intellectual Property and Patent Pool
UNITAID, 20 Avenue Appia, 1211 Geneva 27, Switzerland
[email protected]
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Innovative Partnership for Public Good
2006: Founding
countries :
Brazil, Chile, France,
Norway, UK
2009: Supported by 29 countries
and the Gates foundation
UNITAID's Mission
Is to contribute to scale up access to treatment for HIV/AIDS,
malaria and tuberculosis for the people in developing countries by
leveraging price reductions of quality drugs and diagnostics, which currently
are unaffordable for most developing countries, and to accelerate the pace
at which they are made available.
To fulfill its mission, UNITAID will use sustainable, predictable and
additional funding to help generate a steady demand for drugs and
diagnostics, thereby significantly impacting market dynamics to reduce
prices and increase availability and supply. UNITAID will base its price
reduction strategy on market competition.
Where intellectual property barriers hamper competition and price
reductions, it will support the use by countries of compulsory licensing or
other flexibilities under the framework of the Doha declaration on the TradeRelated Aspects on Intellectual Property Rights (TRIPS) Agreement and
Public Health, when applicable.
…
Any other innovative solution that may overcome limitations to
market diversification in developing countries will also be pursued.
A flexible 'air ticket solidarity tax'
An aircraft with 300 passengers on board leaving from Paris will cover
the treatment for 1 person with multi drug resistant tuberculosis (approx.
US $ 4.000) or 60 HIV-positive children for one year
93 countries receiving UNITAID medicines and diagnostics
Malaria:
29 countries
TB: 72 countries
HIV/AIDS:
49 countries
A new concept:
President Obama on humanitarian licensing
• Increase Access to Affordable Drugs: Barack Obama
and Joe Biden believe that people in developing
countries living with HIV/AIDS should have access to
safe, affordable generic drugs to treat HIV/AIDS. They
will break the stranglehold that a few big drug and
insurance companies have on these life-saving drugs.
They support the rights of sovereign nations to access
quality-assured, low-cost generic medication to meet
their pressing public health needs under the WTO’s
Declaration on Trade Related Aspects of Intellectual
Property Rights (TRIPS). Barack Obama and Joe Biden
also support the adoption of humanitarian licensing
policies that ensure medications developed with U.S.
taxpayer dollars are available off-patent in developing
countries.
US public sector involvement in new drug
development
"Between 1980 and 2008 107 drugs,
vaccines and in vivo diagnostics that
received FDA approval and 2 that received
foreign approval were discovered in whole
or in part in the course of research carried
out at public sector institutions."
Jensen et al, presented at 2009 AUTM meeting,
Orlando Florida.
Humanitarian Licensing
The case of stavudine/d4T
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Developed by researchers at Yale University
Yale licensed the patent to BMS
2000 Yale's royalties > 40 mill$ from BMS
BMS sold d4t in South Africa at 34x generic price
March 2001, prompted by CPTECH, Yale
students, researchers and treatment advocates
launched a campaign  renegotiation of the
license agreement to ensure the availability of
generic versions of D4T in developing countries.
Access to Generic Medicines
• 2007- 2008, 92% of patients on antiretroviral in low and
middle income countries use generic drugs. Of them
99% uses d4T/3TC/NVP combination. (Source: WHO Global Price
Reporting Mechanism).
• “Generics fuel Aids Programme”: Generics accounted for
57% of $131 million U.S. PEPFAR spending in 2007
(WSJ, 31 July 08)
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• Until 2005 India ’s excluded pharmaceutical products
from patenting (1970 Patents Act)
Effect of Generic Competition
Source: http://www.msfaccess.org/fileadmin/user_upload/diseases/hivaids/Untangling_the_Web/Untanglingtheweb_July2008_English.pdf
Patent Barriers to Fixed Dose Combinations
New ARVs More Costly
Source: http://www.msfaccess.org
Responses 1
• Differential pricing
– Discounts not steep enough and not as effective
as generic competition
– No solution to patent barriers to the development
of FDCs and new formulations e.g. for children
• ‘Voluntary’ licenses
– Restrictions that hamper full effect of generic
competitions e.g on trade in API, export markets
– Rare and response to threats e.g CL or legal
action, e.g. TAC’s complaint at the South African
Competition Commission and pre grant
oppositions
Responses 2
• Compulsory licensing
• Thailand => EFV price 1400 Baht (45$) to 615 Baht (19$) a
bottle.
• Brazil ==> EFV 77% price drop ==> increase of patients from
23.300 to 75.000
• DC’s use “government use” powers to procure
generics
• LDC’s exclude product patents when patented
• India – strict patentability criteria
– 15 Patent-grant oppositions related to AIDS medicines by
Indian civil society
• Changed environment post TRIPS era
• Newer products patented in developing
countries
– Prices will not come down automatically
– IP barriers to FDC development
• Deliberate action needed to counter the
consequences of global pharmaceutical
patenting
Medicines Patent Pool
• 2006 MSF and KEI proposed to UNITAID to set
up a medicines patent pool.
• May 2008 WHO Global Strategy and Plan of
Action Public Health, Innovation and Intellectual
Property recognised the role of patent pools to
increase access to medicines
• July 2008 UNITAID EB decided in principle to
establish a voluntary medicines patent pool
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What is a Patent Pool?
• A Patent Pool is a portfolio of assets
consisting of the entire set of patents and
other relevant IP held by various actors
(companies, universities, government
institutions) related to a particular
technology that are made available on a
non-exclusive basis to third parties, (e.g.
generic manufacturers) against the
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payment of royalties.
WHO recommended improved 1st line ARV
Higher price/multiple IP owners
• New WHO recommended 1st line regimen:
– TDF/ 3TC or FTC/ EFV or NVP
– 4 to 11 fold increase in price compared to
3TC/d4T/NVP
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TDF and FTC – Gilead
3TC – GSK
EFV – Merck
NVP – BI
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TDF/FTC/EFV – Gilead/BMS joint patent application
Scope of the
Medicines Patent Pool
• Voluntary
• Existing ARVs
– Decrease price of newer 1st line ARVs by increasing
the number of generic producers
– Decrease price of 2nd line ARVs
• 'Missing Essential ARVs'
– Encourage the development of FDCs containing
'newer' ARVs for both 1st line and 2nd line by
overcoming the patent barrier.
– Encourage the development of paediatric
formulations for both 1st line and 2nd line.
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Patent Pool Process
• The 'standard' : Missing Essential ARVs
– In collaboration with WHO HIV and Essential
Medicines Department
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Identify the relevant patents
Call for patents
Start of negotiations with patent owners
Establishment of the licensing agency
(The 'Pool')
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• Day to day operation of the Pool
A Successful Pool will:
• Accelerate the availability of generic
versions of new ARVs well before patent
expiry
• Enable the development of FDCs of which
the patents are held by different entities
• Enable the development of adapted
formulations for children
• May provide a model for the future… 21
Is the Patent Pool Feasible?
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Political momentum - WHO GSPA paved the way
UNITAID commitment
NGO commitment
Companies’ initial responses positive:
– IFPMA “very interesting”
– GSK willing to put licensed patents in the pool
– Individual companies response positive e.g. Gilead:
'dipping the proverbial toe in the pool'.
– European generics “interesting”
– Indian generic industry endorsed the UNITAID board
decisison
Thank You!
For more information visit:
http://www.unitaid.eu/images/patent/
new/ppinfo.pdf
http://www.unitaid.eu/images/patent/
new/ppq&a.pdf