UCL Workshop Dr Mary Moran Policy Cures December 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-FINDER OVERVIEW

34 neglected diseases 138 product areas All R&D stages Data from 197 organisations Over 8,900 entries G-FINDER SCOPE & METHODOLOGY

$193m Findings OVERALL $3.2 bn in 2013

Findings DISEASES 2013 funding

Findings TOP FUNDERS

50% Findings FUNDERS 2013 funding

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

of total investment: low and declining 12% Discussion INDUSTRY FUNDING

The first increase in PDP funding in five years Discussion PDP FUNDING

First increase in Gates Foundation funding in five years, largely due to greater investment in industry and other mechanisms Discussion GATES 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 areas Commercial Type I Neglected 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

Commercial Type 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

Neglected Type 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 Commercial Type I Neglected Type II/III

WHO processOutside WHO process Proposed Treaty Fund (~2003) TDR Pilot Fund ( ) TDR Pooled Fund ( ) 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