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MSF Procurement experience for HIV commodities WHO AMDS meeting GNV – May 7th

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Agenda

MSF Organisation overview for procurement and advocacy

ARV sourcing and procurement key principles

HIV diagnostics perpsectives

• International independent medical organisation

• Present in around 40 countries in the world

• Emergencies (natural or man made disaster, epidemics)

• Medical (HIV, TB, Malaria, surgery, vaccination, nutrition, training, hospital, sanitation)

• Witnessing & Advocacy

220 000 HIV patients registered under care + procurement gap filling for local MoH

MSF - Programmes

MSF – Organisation

• OCB = Operational Center Brussels

• OCP = Operational Center Paris

• OCG = Operational Center Geneva

• OCBa = Operational Center Barcelona

• OCA = Operational Center Amsterdam

• Around 30 000 employees (90% local

staff)

• Around 1bn EUR Expenses budget in 2013

50% procurement

• 80% spent on our operations

• 90% of revenue from private donors / 10%

insitutional funds

MSF Logistique

Bordeaux – France +1 hub in Dubaï

missions of OCP, OCG, et OCBa

MSF Supply

Brussels – Belgium +1 hub in Kenya (KSU)

OCB

APU

Amsterdam - OCA

3 Levels for Purchasing & Procurement of medical and non medical items

• Local at the project level (only non medical items)

• Capital city / Regional level

• International : Medicines, medical equipments, HiTech equipments

(MSF policy for pharmaceutical procurement is only international purchased, except

when high constraints of importation)

Through 3 European Procurement Centres (ESC)

MSF – General Procurement overview

Manufacturers

Distributors

Manufacturers

UPSTREAM & Inter ESC FLOW

Manufacturers Manufacturers

ESCs

Hub Dubai

Port / Airport / Custom

Projects

DOWNSTREAM FLOW

Hub Kenya

MISSION CAPITAL

• Turnover 50M € in 2011

• 5,000 orders handled per year

• 150,000 boxes shipped per year

• Warehouse of 13,500 m²

• Storage capacity : 12,000 pallets

• 83 staff

• +/- 10,000 different medical and non-medical items.

• 80 % drugs and medical material

MSF Supply example

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MSF Access Campaign (1999) Medical staff frustrated at inability to adequately diagnose and treat

patients:

• Unaffordable:

Existing medicines, vaccines and diagnostics are priced out of reach

• Unavailable:

Certain diseases ‘neglected’ few or no drugs or diagnostics exist or are being developed. (ND, TB) Production of essential medicines and diagnostics that are needed but do not make profits are abandoned

• Unsuitable:

Not adapted for needs of developing countries e.g heat stable, child formulations, diagnostic tools

MSF Access Campaign Mission

• To improve access and stimulate development of medical tools (drugs, diagnostics, vaccines) that have or could have a major impact on morbidity and mortality in contexts where MSF works or similar contexts.

• Overall objective: improve medical care available to the most vulnerable populations; directly for MSF patients and indirectly for vulnerable populations beyond MSF’s reach.

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Agenda

MSF Organisation overview for procurement and advocacy

ARV sourcing and procurement key principles

HIV diagnostics perpsectives

ARV Sourcing

• WHO Prequalified Medicines website

– http://apps.who.int/prequal/

• US FDA tentative Approval Website and Drugs@FDA website

– http://www.fda.gov/InternationalPrograms/FDABeyondOurBor

dersForeignOffices/AsiaandAfrica/ucm119231.htm

– http://www.accessdata.fda.gov/scripts/cder/drugsatfda/

• Global Fund ERP website

– http://www.theglobalfund.org/en/procurement/quality/pharmac

eutical/#A_B

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Search for drugs in WHO PQ list

MSF ARV Purchase Table

Date approved / modified

Manufacturer

MSF Supply + MSF Log ARV Portfolio

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4.298

2.752

0

500

1000

1500

2000

2500

3000

3500

4000

4500

5000

2010 2011 2012 2013 (est)

TOTAL TDF FDC

Value in k EUR of total ARV portfolio and focus on TDF FDC

ARV Commercial Approach

• Based on forecasts

• Working with the key generic ARV Suppliers

• Price commitment for a year

• Aim to share volumes for the same references between several

suppliers when possible

• Validation of Hetero Labs for TDF FDC a game changer

• As well as the SA tender for impact on global volumes

• Focus on TDF FDC due to the weight in the portfolio, but also on

key 2nd and 3lines treatment for the future 18

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Agenda

MSF Organisation overview for procurement and advocacy

ARV sourcing and procurement key principles

HIV diagnostics perpsectives

HIV Diagnostics & UNITAID

Lab Based technology

•3 year Long Term Agreement with BioMerieux with their NucliSens platforms for DBS

Viral Load (100 000 tests per year)

•Agreement with BioCentric for Viral Load and EID

•Monitoring other potential platforms (such as Roche or Abbott)

POC technology

•Eagerly waiting on the new CD4 products to come onto the market (such as Daktari,

BD, etc…) as well as POC EiD/VLs (such as Alere Q, LIAT, GeneXpert, etc…)

•Currently sourcing only from Alere for POC CD4 (PIMA)

Potential of 150 000 tests per year

•One OCP project using SAMBA for VL testing (and OCA Partec Mini Poc)

•Link with CHAI and UNICEF for pool procurement as part of the UNITAID grant

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THANK YOU

ANY QUESTIONS?

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Qualification of the pharmaceuticals (non ARVs) • The MSF qualification of pharmaceutical products is site specific.

• The assessment of the manufacturing site for compliance with WHO GMP is the

necessary first step of the evaluation. MSF usually appoints independent experts

to conduct GMP audits. However, the intention is not to duplicate the work of

stringent regulatory authorities or the WHO pre qualification team. The outcome of

recent WHO PQ, PIC/S or ICH members inspections (conducted in the last 24

months) can be taken into consideration for the evaluation of the manufacturing

site.

• Only products that are manufactured in WHO GMP compliant facilities will be

evaluated. Any product that is pre qualified by the WHO PQ or that is registered in

a highly regulated country is automatically qualified by MSF. Products that are

neither WHO pre qualified nor registered in a highly regulated country and that

present an interest for the organization will be fully evaluated by the MSF

pharmacists. The evaluation is carried out against WHO norms and standards.

Details of the evaluation are given in the MSF Qualification Scheme.

• For more information: http://www.msf.org/msf-drugs-procurement

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First, Second and Third Line ARV prices at present

• The price of

a third line

regimen is

14 x more

expensive

than the

most

affordable

first line

regimen and

over 6 x

more than

the most

affordable

second line

regimen

UTW 15th edition

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