ucl workshop dr mary moran policy cures december 2014
TRANSCRIPT
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UCL Workshop
Dr Mary MoranPolicy CuresDecember 2014
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Outline
• Policy Cures
• The G-FINDER report on neglected disease R&D funding
• A troubling confusion (the Nature article)
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POLICY CURES
• An independent non-profit research and analysis group
• Founded in 2004 at LSE
• Innovative ideas and rigorous analysis
• Focussed on R&D for neglected diseases of the developing world
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• Annual survey of global neglected disease R&D funding
• Neutral, comparable, comprehensive analysis
• Commissioned by the Bill & Melinda Gates Foundation
G-FINDEROVERVIEW
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• 34 neglected diseases • 138 product areas • All R&D stages• Data from 197 organisations• Over 8,900 entries
G-FINDERSCOPE & METHODOLOGY
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$193m
FindingsOVERALL
$3.2 bn in 2013
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FindingsDISEASES
2013 funding
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FindingsTOP FUNDERS
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50%
FindingsFUNDERS
2013 funding
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DiscussionPUBLIC FUNDING
The US budget sequester had a big impact on neglected disease R&D funding
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of total investment: low and declining
12%
DiscussionINDUSTRY FUNDING
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The first increase in PDP funding in five years
DiscussionPDP FUNDING
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First increase in Gates Foundation funding in five years, largely due to greater investment in industry and other mechanisms
DiscussionGATES FOUNDATION
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A troubling confusion
• Nature article – Where patents and profits are/ are
not the problem– The role of the WHO
• The purpose/ hope for today
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Two main R&D areasCommercial
Type INeglected
Type II/III
• Chronic (cancer, diabetes, heart)
• Limited public control over R&D and price
• … but no funding needed
• Patients fund R&D (linkage)• IP/patent monopolies allow
profit mark-ups to patients• Profits fund R&D• But mark-ups put products
out of reach of the poor
• Infectious (malaria, TB, worms ..)
• Full public has control over R&D and price
• …. but has to fund the R&D itself
• Already delinked from profits (since no profits by definition)
• Funded by from public & philanthropy, not from sales
• Low-or-no profit prices to DCs• Non-profit IP use, open-source,
collaborations common
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CommercialType I
• It’s about IP/ patents / access (industry has control)
• R&D funding is not a problem
• Cancer drugs (Glivec) - $22,000• Ambisome for HIV
(leishmaniasis) - $350• AIDS drugs …• Xpert anthrax test (DR-TB) -
$10/test• Hep C drug (Sovaldi) - $9,000
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NeglectedType II/III
• Few/ no IP issues (public has control over access provisions)
• It’s about securing R&D funding and coordination
• Polio vaccine • Human genome• Ivermectin for river blindness
(free)• Meningitis A vaccine ($0.50c)• Coartem kids anti-malarial
($0.38c)• GSK Tres Cantos/ academic hub
$3.2 billion annual public/nfp funding
Pipeline 350+ candidates
44 new ND products
registered
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History: The key to the confusion
AIDS drug crisis
Proposed R&D Treaty & pooled fund
TDR/ PDPs/ public research institutes/ academia/ nfp
industry
NDs
CommercialType I
NeglectedType II/III
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WHO process Outside WHO process
Proposed Treaty Fund (~2003)TDR Pilot Fund (2014-16) TDR Pooled Fund (2016 - )
• Public & nfp funding• Focus on delinkage (non-IP)• Medicines non-profit to all (HIC,
MIC, LIC)• Type I diseases as well as NDs
• Focus on IP, not on funding and R&D hurdles
ND R&D(PDPs; public research institutes;
academics; NFP industry)
• Public and nfp funding • IP-agnostic • Medicines non-profit to DCs (not
HICs)• Only NDs
• Focus is on the funding and R&D hurdles, not on IP
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A policy confusion
• The WHO Fund and the Treaty are designed to target access to commercial medicines (the IP system)
• BUT lack of political support for an overhaul of the commercial IP system meant that the WHO process instead focussed on NDs (four ND pilots)
• Doesn’t make sense …..– Focussing on NDs where we already have most of the things we’re asking for
• R&D is already delinked (funded by gov’ts/ phil, not from sales to patients)• Open source and collaborations already used, and allowed• Products made under nfp model – often generic producers• IP usually controlled by public/ nfp groups for DC use (part of standard agreements)
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Does it matter for access to commercial medicines?
• Neglected in the debate• Delinkage and the WHO
Pool are now all about NDs
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Does it matter for NDs?
– Focus on IP means we’re not focussing on the real problems – funding and coordination
– No new R&D funding proposals (just more public funding)
– Coordination via a central fund would be helpful but ….
– Can do unintended harm …
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Delink the debates
• Commercial medicines– Need to focus on IP and access in a
serious way; the WHO focus has let it drop down the agenda
• Non-profit medicines – Need to focus on funding and
collaboration, and stop sidetracking off into for-profit IP issues
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Thank you