The 2010 Access to Medicine Index: methodology and indicators

28 June 2010

Afshin Mehrpouya

RiskMetrics Group (MCSI Inc.)

WHO, Geneva

Presentation Outline

The Methodology of the Access to Medicine Index Key Improvements Compared to Index 2008 Major Findings for Each Technical Area

3

Methodology of the Index 2010

5

The Access to Medicine Index Methodology Report 2010 was published in March

You can download report from

http://www.atmindex.org/research_and_assessment/method

Geographical Scope: Index 2010 focuses on the Low and Medium Human Development Countries based on

the UN Human Development Index (UN HDI) 2006. Countries classified as ‘medium-high’ and ‘high’ according to the World Bank Country Classifications, are excluded

Disease Scope: Index 2010 covers a total of 33 diseases, consisting of a

combination of the WHO Neglected Tropical Diseases, the top-10 non communicable diseases and the top-10 communicable diseases based onDisability Adjusted Life Years (DALY)

Increased company coverage to 27 (from 20 in Index I) 20 Originator (19+1) and 7 Generics Manufacturers

6

Highlights of Changes from Index 2008 to Index 2010 Scope

Highlight of Changes from Index 2008 to Index 2010

Rating along the ATM Index focus areas of innovation, transparency, performance and long term commitment

Focus on Performance• Pricing• Patents and Licensing• R&D Pipeline• Marketing Approval• Sales trends

New weighting systemBased on share of generics and originator revenue streams Deeper coverage of non-communicable diseases, pediatric

formulations and vaccines New Approach to analysis of generics manufacturingSpecific data points relevant to generics manufacturingA separate list for generics manufacturers

7

Index 2008

Public Policy & Advocacy

R&D

Patents &Licensing

Capacity

Equitable Pricing

Donations

Philanthropy

ATM Management

Index 2010

Strategic Pillars

Commitments Transparency Performance Innovation

Technical Areas

General Access to Medicine Management

Public Policy and Market Influence

Research & Development

Equitable Pricing, Manufacturing & Distribution

Patents & Licensing

Capability Advancement Advancement in Product Development and Distribution

Product Donations & Philanthropic Activities

8

The New Structure

30% 30% 30% 10%

9

The New Structure

Strategic Pillars

Commitments 30%Transparency

30%Performance 30% Innovation 10%

Technical AreasA. General Access to Medicine Management

ATM Governance

ATM Management System

Stakeholder Engagement

B. Public Policy and Market Influence

Advocacy and Lobbying

Competition Behavior

Marketing Behavior

C. Research and Development

Innovative R&D

Adaptive R&D

Intellectual Property Sharing

D. Equitable Pricing, Manufacturing and Distribution

Marketing Approval (Registration)

Equitable Pricing

Manufacturing & Distribution

E. Patents & LicensingPatents

Non-Exclusive Voluntary LicensingF. Capability Advancement in Product Development and Distribution

Capacity Building in Research and Development

Capacity Building in Quality Management and Distribution

G. Product Donations and Philanthropic Activities

Donations

Philanthropy

Methods and Findings

Highlights of Analysis

11

• Analysis across 111 indicators -106 used for analysis• Neutral scoring used to ensure companies are ranked only on

relevant indicators• Attempted to diversify sources of data• Used interviews for better understanding of context• Focused on data partnerships to avoid redundant data

collections

General Access to Medicine Management

12

ATM GovernanceSenior Governance representation of

ATM in most companiesATM Management System

Six companies report ATM targets and performance at least for some initiativesATM reporting carried out by most

companiesStakeholder Engagement

Eleven companies have active participation and sponsorship of conferences related to ATMGilead has a stakeholder advisory board

Ab

bo

tt (

AB

T-N

)

As

tra

Ze

ne

ca

(A

ZN

-LN

)

Ba

ye

r (B

AY

-FF

)

Bri

sto

l-M

ye

rs S

qu

ibb

(B

MY

-N)

Eli

Lil

ly (

LL

Y-N

)

Gil

ea

d (

GIL

D-O

)

Gla

xo

Sm

ith

Kli

ne

(G

SK

-LN

)

Jo

hn

so

n &

Jo

hn

so

n (

JN

J-N

)

Me

rck

(M

RK

-N)

Me

rck

KG

aA

(M

RK

-FF

)

No

va

rtis

(N

OV

N-V

X)

No

vo

No

rdis

k (

NO

VO

'B-K

O)

Pfi

zer

(PF

E-N

)

Ro

ch

e (

RO

G-V

X)

Sa

no

fi-A

ve

nti

s (

SA

N-F

R)

As

tell

as

(4

50

3-T

O)

Da

iic

hi

Sa

nk

yo

(4

56

8-T

O)

Eis

ai

(45

23-

TO

)

Ta

ke

da

(4

50

2-T

O)

Bo

eh

rin

ge

r-In

ge

lhe

im

Go

vern

an

ce Board Level

Oversight of

ATM

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

No

No

No

Yes

Yes

AT

M M

an

age

men

t S

yste

ms

Publicly

Disclosed,

Time-

bounded

Quantitative

Targets*

No

Yes

Yes

No

No

No

Yes

No

Yes

Yes

Yes

No

No

Yes

Yes

No

No

No

No

No

Annual

Reporting

on ATM

Pol

icie

s

Pol

icie

s

Pol

icie

s an

d O

bjec

tives

***

Pol

icie

s

Not

Ann

ual

Pol

icie

s

Pol

icie

s an

d O

bjec

tives

***

Pol

icie

s

Pol

icie

s an

d O

bjec

tives

***

Not

Ann

ual

Pol

icie

s an

d O

bjec

tives

***

Pol

icie

s

Not

Ann

ual

Pol

icie

s an

d O

bjec

tives

***

Pol

icie

s an

d O

bjec

tives

***

Non

e

Non

e

Non

e

Pol

icie

s

Pol

icie

s

Sta

keh

olde

r E

ng

age

men

t

Existence of

Clear

Strategy and

Platform for

Stakeholder

Engagement

**

Yes

Yes

No

Yes

Yes

Yes

Yes

Yes

Yes

No

No

Yes

Yes

No

No

No

No

No

No

Yes

General AtM Management

Public Policy & Market Influence

14

Lobbying & Advocacy• Low level of detail on lobbying positions in

16 companies• Low disclosure of lobbying activities in the

Index CountriesCompetition Behavior

• Top companies showing more flexibility on competition issues through non-exclusive distribution and licensing

• Only two companies have made partial concessions about data exclusivity

• Only three companies explicitly commit to not engage in pay for delay practices

Marketing Behavior• No disclosure in the Index Countries

regarding payments to providers and patient associations – three companies have commited to start to disclose in the new future (GSK, Merck and AstraZeneca)

Ab

bo

tt (

AB

T–

N)

Ast

raZ

en

eca

(AZ

N-L

N)

Bay

er (

BA

Y-F

F)

Bri

sto

l-M

yers

Sq

uib

b (

BM

Y-N

)

Eli

Lill

y (L

LY

-N)

Gile

ad (

GIL

D-O

)

Gla

xo

Sm

ith

Kli

ne

(GS

K-L

N)

Joh

nso

n &

Jo

hn

son

(JN

J-N

)

Mer

ck (

MR

K-N

)

Mer

ck K

GaA

(M

RK

-FF

)

No

vart

is (

NO

VN

-VX

)

No

vo N

ord

isk

(NO

VO

'B-K

O)

Pfi

zer

(PF

E-N

)

Ro

che

(RO

G-V

X)

Sa

no

fi-A

ven

tis

(S

AN

-FR

)

Ast

ella

s (

450

3-T

O)

Dai

ich

i S

anky

o(4

568-

TO

)

Eis

ai (

452

3-T

O)

Tak

eda

(450

2-T

O)

Bo

ehri

ng

er-I

ng

elh

eim

Go

vern

ance

Level of Public Policy

Disclosure on ATM related

Issues* MED

IUM

HIG

H

MED

IUM

MED

IUM

MED

IUM

MED

IUM

HIG

H

MED

IUM

MED

IUM

MED

IUM

HIG

H

MED

IUM

MED

IUM

HIG

H

HIG

H

MED

IUM

LOW

LOW

MED

IUM

MED

IUM

Ma

rke

ting

Be

havi

or

Public Disclosure of

Marketing Activities in the

Index Countries**

NO

NO

NO

NO

NO

NO

NO

NO

NO

NO

NO

NO

NO

NO

NO

NO

NO

NO

NO

NO

Co

mp

etit

ion

Beh

avi

or

Public Disclosure of

Competition-related

Policies *** MED

IUM

MED

IUM

MED

IUM

LOW

LOW

LOW

MED

IUM

LOW

MED

IUM

LOW

LOW

LOW

LOW

LOW

MED

IUM

LOW

LOW

LOW

LOW

LOW

Overview of Public Policy and Market Influence

Analysis Methods and FindingsResearch & Development

16

Innovative R&D• Five companies undertaking R&D for

multiple Index Diseases• Increased scope of discovery stage

research for NTDsAdaptive R&D

• High activity for paediatric formulations and FDCs mostly for HIV and Malaria

• No activity for non-communicable diseases

Intellectual Property Sharing & Collaborations• 11 companies and 15 cases of providing

access to compound libraries• So far, has led to 18 discovery stage

projects• No example of out-licensing of later stage

molecules during the period of analysis• Increased PDP activity• Low disclosure on access & IP terms of

collaborations

Overview of R&D Pipeline

Compound/s through acquisition during survey period (not scored)

Discovery (inc; Compound Library Screening)

Pre-Clinical (from Lead Identification to iNDA)

Innovative Molecules (Phase I–III)

Adaptive Drug R&D (excludes trials to establish new indications)

All Vaccine (V) or Diagnostic (D) Development

Equitable Pricing, Manufacturing & Distribution

18

Equitable Pricing• Inter-country tiered pricing with some access

provisions undertaken by 13 companies• Intra-country tiered pricing carried out by seven

companies with logistics difficulties• Most efforts focused on the Big-Three• Low transparency on not-for-profit prices and

impact of programs (disclosed by three and four companies respectively)

Manufacturing & Distribution• Few examples of custom packaging for different

environments• Five companies providing pictograms and color

coding for ease of use (for the illiterate)• WHO prequalification and FDA tentative

approval both on the rise• Generally, low disclosure on recalls

Marketing Approval (Registration)• Few companies commiting to need based

registration – mostly for HIV• Low public disclosure on registration

A

bb

ott

(A

BT

-N)

Ast

raZ

en

eca

(AZ

N-L

N)

Bay

er (

BA

Y-F

F)

Bri

sto

l-M

yers

Sq

uib

b (

BM

Y-N

)

Eli

Lill

y (L

LY

-N)

Gile

ad (

GIL

D-O

)

Gla

xo

Sm

ith

Kli

ne

(GS

K-L

N)

Joh

nso

n &

Jo

hn

son

(JN

J-N

)

Mer

ck (

MR

K-N

)

Mer

ck K

GaA

(M

RK

-FF

)

No

vart

is (

NO

VN

-VX

)

No

vo N

ord

isk

(NO

VO

'B-K

O)

Pfi

zer

(PF

E-N

)

Ro

che

(RO

G-V

X)

Sa

no

fi-A

ven

tis

(S

AN

-FR

)

Ast

ella

s (

450

3-T

O)

Dai

ich

i S

anky

o (

456

8-T

O)

Eis

ai (

452

3-T

O)

Tak

eda

(450

2-T

O)

Bo

ehri

ng

er-I

ng

elh

eim

Ma

rke

ting

app

rova

l

Products

Prequalified

Under WHO

pre-

qualification

/ FDA

tentative

approval *

X X X X X X X X X X X X

Pri

cing

Inter-

country

tiered

pricing

X X X X X X X X X X X X X

Intra-

country

tiered

pricing**

X X X X X X X

Overview of Equitable Pricing, Manufacturing and Distribution

Patents & Non-Exclusive Voluntary Licensing

20

Trade Aspects of Patents• Top companies have adopted more flexible

approaches to patents• Several ongoing cases: patent-registration

linkages, compulsory licenses in the MDCs, patent extensions, patent infringement

• Eight companies disclose specific stance on patent related issues

Non-Exclusive Voluntary Licensing• Four companies engaging in NEVL• All accompanied by technology transfer on

request• Used as a last resort solution• License territories mostly limited to LDCs

with exceptions such as Boehringer-Ingelheim

Ab

bo

tt (

AB

T-N)

As

traZ

en

ec

a (

AZ

N-LN

)

Ba

yer

(BA

Y-FF

)

Bri

sto

l-My

ers

Sq

uib

b (

BM

Y-N)

Eli

Lilly

(L

LY-N

)

Gilea

d (

GIL

D-O)

Gla

xo

Sm

ith

Kli

ne (

GS

K-LN

)

Jo

hn

so

n &

Jo

hn

so

n (

JN

J-N

)

Merc

k (

MR

K-N)

Merc

k K

GaA

(M

RK-F

F)

No

va

rtis

(N

OV

N-VX

)

No

vo

No

rdis

k (

NO

VO

'B-KO

)

Pfi

zer

(PF

E-N)

Ro

ch

e (

RO

G-VX

)

Sa

no

fi-A

ven

tis

(S

AN-F

R)

As

tella

s (4

50

3-T

O)

Da

iich

i S

an

ky

o (

45

68-TO

)

Eis

ai (4

52

3-TO

)

Take

da (

4502-T

O)

Bo

eh

rin

ge

r-In

gelh

eim

Tra

de a

spe

cts

of p

ate

nts

Public disclosure on

TRIPS and/or “TRIPS

flexibilities”

Me

diu

m

Me

diu

m

Lo

w

Lo

w

Me

diu

m

Lo

w

Me

diu

m

Lo

w

Ye

s

Lo

w

Me

diu

m

Me

diu

m

Lo

w

Me

diu

m

Me

diu

m

Lo

w

Lo

w

Lo

w

Lo

w

Lo

w

General commitment to

respect TRIPS

“flexibilities”

-

Ye

s

Ye

s

-

Ye

s

Ye

s

Ye

s

Ye

s

Ye

s

-

Ye

s

Ye

s

Ye

s

Ye

s

Ye

s

Ye

s

-

Ye

s

-

Ye

s

Commitment not to file or

enforce patents in Least

Developed Countries Ye

sI

Ye

s

Ye

s

Ye

sII

Ye

s

-

Ye

sII

-

Ye

s

-

Ye

s

-

Ye

s I

Ye

s

-

Ye

s

-

Ye

sIII

-

Ye

sI

No

n-E

xclu

sive

Lic

en

sin

g

Senior-level company

engagement with

UNITAID patent pool (to

date)

- - - - -

Ye

s

-

Ye

s

Ye

s

- - - - - - - - - - -

Grants multiple, non-

exclusive, voluntary

licenses to generics

companies for Index

Disease medicines

- - -

Ye

s

-

Ye

s

Ye

s

-

Ye

s

- - - - ** - - - - - **

Accompanies voluntary

licenses with detailed

technology transfer

- - -

Ye

s

-

Ye

s

If r

equ

est

ed

- - - - - -

Ye

s

- - - - -

Overview of Patents and Licensing

Capability Advancement Advancement in Product Development & Distribution

22

Capacity building in supply chain• Most efforts focusing on anti-

counterfeiting• One company involved in initiatives

targeting stock-outs

Capacity Building in Quality Management• Six companies in involved , through non-

exclusive licensing or outsourcing manufacturing

Capacity Building in Research• Most efforts focused on fellowships and

research collaborations

Product Donations & Philanthropic Activities

23

Donations• Nine companies undertaking single drug

donations for NTDs• Low disclosure of decision process,

volume and destination for multi-drug donations which are mostly managed through donations management organizations

• Top performers audit the external agencies

Philanthropy• Most efforts focusing on awareness

programs and training• Six companies have undertaken

comprehensive donations programs with capacity building components

Ab

bo

tt (

AB

T-N

)

As

traZ

enec

a (A

ZN

-LN

)

Ba

yer

(BA

Y-F

F)

Bri

sto

l-M

yer

s S

qu

ibb

(B

MY

-N)

Eli

Lil

ly (

LL

Y-N

)

Gile

ad

(G

ILD

-O)

Gla

xoS

mit

hK

lin

e (G

SK

-LN

)

Joh

ns

on

& J

oh

ns

on

(JN

J-N

)

Me

rck

(M

RK

-N)

Me

rck

KG

aA (

MR

K-F

F)

No

va

rtis

(N

OV

N-V

X)

No

vo

No

rdis

k (N

OV

O'B

-KO

)

Pfi

zer

(PF

E-N

)

Ro

ch

e (

RO

G-V

X)

Sa

no

fi-A

ven

tis

(SA

N-F

R)

As

tell

as (

450

3-T

O)

Da

iich

i Sa

nk

yo(4

568-

TO

)

Eis

ai (

452

3-T

O)

Ta

ked

a (4

50

2-T

O)

Bo

eh

rin

ge

r-In

gel

he

im

Pro

duc

t Do

natio

ns

Single-Drug

Donation

Programs for

Neglected

Tropical

Diseases

Sle

epi

ng

Sic

knes

s -

Ch

agas

L

ymp

hatic

Fila

riasi

s (e

lep

han

titis

) H

ook

wo

rms/

Ro

und

wor

ms

Riv

er

blin

dn

ess-

Lym

pha

tic

Fila

rias

is

Sh

isto

som

iasi

s (a

nd o

the

r h

elm

inth

(w

orm

) in

fect

ions

L

epro

sy -

Fas

ciol

iasi

s

Tra

cho

ma

S

lee

pin

g S

ickn

ess

- L

eish

ma

nia

sis

Ph

ilan

thro

pic

Act

iviti

es

Philanthropic

Activities

Focused on

Index Country

Health

Infrastructure

Ye

s

Ye

s

Ye

s

Ye

s

Ye

s

Ye

s

Ye

s

Ye

s

Ye

s

Ye

s

Ye

s

Ye

s

Ye

s

Ye

s

Ye

s

Ye

s

Ye

s

Ye

s

Ye

s

Ye

s

Public

Disclosure of

Resources

and/or

output*

Pa

rtia

l

Fu

ll

Pa

rtia

l

Pa

rtia

l

Pa

rtia

l

Pa

rtia

l

Fu

ll

Pa

rtia

l

Fu

ll

Pa

rtia

l

Pa

rtia

l

Pa

rtia

l

Pa

rtia

l

Pa

rtia

l

Pa

rtia

l

No

ne

No

ne

No

ne

Fu

ll

Pa

rtia

l

Overview of Donations and Philanthropy

Highlight of Findings - Generics

• Ranbaxy, Cipla and Mylan undertaking adaptive R&D• Ranbaxy, Cipla and Mylan collaborate with international

programs such as PEPFAR, AMFm, UNITAID-CHAI etc.• Only Ranbaxy and Cipla undertaking non-exclusive voluntary

licensing• Cipla has been innovative in capacity building• Apotex under CAMR has been the first company to benefit from

the 31f clause of TRIPS• Reporting is very weak across the sector• Authorized generics is a fast growing trend• Teva and Sunpharma have no strategies or disclosure on access

related issues

Key Analysis Challenges

• Lack of firm academic backing for several indicators• Low and variable disclosure by companies and their

counterparts• Insufficiency of independent sources for different

technical areas• Analyzing litigations and fines in Index Countries

Thank you

Afshin Mehrpouya

RiskMetrics GroupAfshin.mehrpouya@riskmetrics.com

+33 6 21269092

Index 2010 Communicable Diseases - WHO Neglected Tropical Diseases

 Disease

Reference List

DiseaseReference List

1 Lymphatic filariasis GBD, NTD 8 Onchoceriasis NTD

2 Shistosomiasis NTD 9 Chagas disease NTD

3Human African trypanosomiasis

NTD 10 Leprosy NTD

4Soil-transmitted helminthiasis

NTD 11 Buruli ulcer NTD

5 Trachoma NTD 12Dracunculiasis (uinea-worm disease)

NTD

6 Leishmaniasis NTD 13 Fascioliasis NTD

7 Dengue NTD 14 Yaws NTD

Index 2010 Communicable Diseases - The WHO Global Burden of Diseases List

  DiseaseReference List

DALYs in LMIC – 2004

Annual Mortality in LMIC – 2004

1 Lower respiratory infections GBD 93233137 3866897

2 Diarrheal diseases GBD 72306348 2148340

3 HIV/AIDS GBD 57843070 2017193

4 Tuberculosis GBD 34014278 1447854

5 Malaria GBD 33941524 888158

6 Measles GBD 14839141 423333

7 Meningitis GBD 11312859 336298

8 Pertussis GBD 9832373 254323

9 Lymphatic filariasis GBD, NTD 5940056 289

10 Tetanus GBD 5277017 162606

Index 2010 Non-Communicable Diseases - The WHO Global Burden of Diseases

  DiseaseReference List

DALYs in LMIC – 2004

Annual Mortality in LMIC - 2004

1 Unipolar depressive disorders GBD 55423705 11868

2 Ischemic heart disease GBD 54800761 5861587

3 Cerebrovascular Disease GBD 31595000 41793423

4Non-communicable obstructive pulmonary disease

GBD 26522091 2737049

5 Diabetes mellitus GBD 16062898 914998

6 Asthma GBD 14383499 265893

7 Osteoarthritis GBD 12797915 3744

8 Cirrhosis of the liver GBD 11977815 655083

9 Nephritis / Nephrosis GBD 8421239 611418

10 Epilepsy GBD 7308772 131050