Embedding Conservation & Access in R&D in GARD

Dr Manica BalasegaramExecutive Director

Access Campaign, MSF

Sustainable access

• Ensure quality, life saving tools are available to those in need, especially the most vulnerable to..

• Reduce morbidity and mortality from infectious diseasesand..

• Prolong lifespan of current and new anti-microbials thatare..

• Available, affordable, adapted and accessible with..

• Surveillance, Prevention, Universal coverage, Responsibleuse and Innovation

Problems

• The consultation failure: people are getting what they don’t need, people are not getting what they need

• Still see high mortality and morbidity to bacterial infection; late presentations

• Contexts vary widely: this affects access, use, uptake• Guidelines are often insufficient (IMCI, IMAI) or outdated• Don’t know extent of problem: difficult to define best

local practise• Lack of appropriate diagnostics (managing fever in kids!)

– 75% antimalarials/ 57% antibiotics vs 15% antimalarials/ 79% antibiotics Drug Quality (D’Acremont, NEJM, 2011)

– Inability to appropriately diagnose certain (serious) infections

• Population expectations and perceptions

Problems

• High cost of late generation antibiotics (carbapenems)..and yet inappropriate use

• Quality: substandard drugs with weak monitoring & ‘enforcement’ systems

• Lack of regulation on use: private sector vs weak (Public) system

• Lack of prevention: from basic hygiene to vaccination • Weak antibiotic pipeline: but exisiting tools can be

improved, e.g. stability, presentation, dose, duration, combos..

• And yet…anti-microbials are our bread & butter, are ‘transversal’

Cephalosporin Use, 2003-2013, MSF Supply

0

100000

200000

300000

400000

500000

600000

700000

800000

900000

1000000

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

Year

Un

its

Ord

ere

d

Shifts towards use of more broad spectrum antibiotics in projects

This strategy is not sustainable as bacteria continue to evolve new resistance mechanisms

MSF Access Campaign

High Cost of Late generation antibiotics: Carbapenems

MSF Surgical program: Amman, Jordan

Cost per day of antibiotics in the treatment of bone infection

0 20 40 60 80 100 120

Imipenem IV

Vancomycin IV

Ceftriaxone IV

Ciprofloxacin PO

Amoxicillin PO

Amoxicillin PO

Ciprofloxacin PO

Ceftriaxone IV

Vancomycin IV

Imipenem IV

MSF Access Campaign

WHAT CAN GARD DO?

Looking Ahead

1. Set a Renewed Agenda

• Priority setting & coordination: work withWHO (who can take a key role) and others

• A mixed portfolio approach (DNDi experience)

• Build in conservation and access as part of an

- overall R&D strategy

- and in each project team

2. Promote Relevant field studies

• Link diagnostic and treatment strategies in studies conducted

• Conduct trials (e.g. II-IV, PV studies) that:

inform field use

collect expanded safety data

change guidelines / protocols

• Pilot implementation projects in a range of contexts: MoH and NGOs can be key partners

3. Ensure Access & Conservation

• Prioritise registration according to public health needs (e.g. note recent TB example)

• Limit extent and sector of where marketing occurs: depends on context

• Use international mechansims to drive policy, demand creation and uptake: PQP, EML, International procurement agencies (Unicef)

3. Ensure Access & Conservation

• Consider testing & hosting alternative incentives for specific projects (market entry rewards) with specific(multi-lateral) partners- e.g. UNITAID, FIND Gene Xpert; and Gavi and PCV

• Innovative management of IP: example of MPP, with ‘IP stewardship’

• Should GARD actively manage incentives and /or play a role in procurement / supply for certain specialantibiotics (like GDF for TB drugs)?

• Advocacy & Communication (see next slides)

Broader perspective: enablers (to advocate for)

• Legal mechansim- Intl. treaty? WHO Regulation? Link with animal & agricultural use

• Special agency- like UNAIDS: coordination, target setting, a motor for change

• Global AMR fund- GFATM/ UNITAID; R&D and procurement; Coordination with bilateral funds

• New Incentives- De-linked R&D system? How / where/ mechanism of implementation?

• ‘Dis-incentives’- User fees: proposed in non-human use- Remove perverse reimboursement schemes; deal with OTC sales?

Broader perspective (cont’d)

• Creating special status for (certain) antimicrobials- Controlled substance? How does this work for access to opiods? E.g Ketamine

- GLC initiative for last line antibiotics: how did this work for TB (it ensures TB progsare technically sound).

• Country and regional regulatory strengthening- Look at country examples- India; Resources available to ensure QA and

enforcement?

- Need to partly restructure medical and pharmaceutical services? UHC?

• Health systems strengthening- Many anti-infectives need to be available at the base of the system: need

motivated, trained and correctly incentivised HCWs (HIV experience).