UCL Workshop Dr Mary Moran Policy Cures December 2014.

UCL Workshop

Dr Mary MoranPolicy CuresDecember 2014

Outline

• Policy Cures

• The G-FINDER report on neglected disease R&D funding

• A troubling confusion (the Nature article)

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

• Annual survey of global neglected disease R&D funding

• Neutral, comparable, comprehensive analysis

• Commissioned by the Bill & Melinda Gates Foundation

G-FINDEROVERVIEW

• 34 neglected diseases • 138 product areas • All R&D stages• Data from 197 organisations• Over 8,900 entries

G-FINDERSCOPE & METHODOLOGY

$193m

FindingsOVERALL

$3.2 bn in 2013

FindingsDISEASES

2013 funding

FindingsTOP FUNDERS

50%

FindingsFUNDERS

2013 funding

DiscussionPUBLIC FUNDING

The US budget sequester had a big impact on neglected disease R&D funding

of total investment: low and declining

12%

DiscussionINDUSTRY FUNDING

The first increase in PDP funding in five years

DiscussionPDP FUNDING

First increase in Gates Foundation funding in five years, largely due to greater investment in industry and other mechanisms

DiscussionGATES FOUNDATION

A troubling confusion

• Nature article – Where patents and profits are/ are

not the problem– The role of the WHO

• The purpose/ hope for today

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

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

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

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

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

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)

Does it matter for access to commercial medicines?

• Neglected in the debate• Delinkage and the WHO

Pool are now all about NDs

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 …

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

Thank you