Access to Medicine Index 2022 ▶ Company report cards

RA N KSCO R E18

2.15

15 (2021)*

Merck & Co, Inc
Stock exchange: NYSE • Ticker: MRK • HQ: Rahway, New Jersey, US • Employees: ~68,000

PERFORMANCE IN THE 2022 INDEXHow score was achieved

18th place. MSD performs below average in two of the

3.14

Governance of Accessthree Technical Areas. In Governance of Access, there was

2.38

Research & Development

no publicly-available evidence found of policies governing

1.75

Product Delivery

responsible promotional practices. In the Product Delivery
Technical Area, it performs below average in its approach01

to equitable access strategies. Research & Development
however, the company has strengthened its access planning

2

3

Average

Leader4

5

framework and has access plans in place for several latestage candidates in the pipeline.
Governance of Access: 20th place. MSD performs poorly inaccess planning framework in place, but evidence was notthis area. It has an access-to-medicine strategy with measura-found that it applies this to all late-stage candidates. It has a

ble objectives integrated within its overall corporate strategy,

small-sized priority pipeline but does participate in R&D capac-

but there is no evidence that sales incentives are decoupled

ity building.

from sales volume targets, nor is there evidence that senior
management and in-country/regional managers are incentiv-

Product Delivery: 19th place. MSD performs poorly in thisised to perform on access-related goals. It also lacks evidence

area. One access strategy was identified for one product inof a robust set of compliance controls to mitigate the risk ofan upper-middle income country. MSD has an average per-non-compliance in countries in scope of the Index.

formance with regard to its participation in inclusive businessmodels. The company engages in health systems strengthen-

Research & Development: 11th place. MSD has an average per-ing and supply chain capacity building, but evidence of engage-formance in this area. The company now has a structured

ment in manufacturing capacity building was not found.

OPPORTUNITIES FOR MERCK & CO

CHANGES SINCE THE 2021 INDEX

Organise governance of access. MSD has an access-to-medicine strategy, guided by its• Entered into an agreement with UNICEF to supply up

Access to Health Statement of Guiding Principles. Financial and non-financial incentives

to 3 million courses of COVID-19 antiviral molnupiravir

for senior executives, the CEO and in-country managers can be linked to this strategy.
Furthermore, the company can decouple sales incentives for its sales agents from sales
volume in countries in scope of the Index.

(Lagevrio®) to LMICs through the first half of 2022.
• Invested USD 100 million into the newly launched
Antimicrobial Resistance (AMR) Action Fund.
• Licensed its COVID-19 antiviral molnupriravir (Lagevrio®)

Ensure all late-stage R&D projects have comprehensive access plans. MSD has an R&D
access planning process in place and project-specific access plans for 43% of its late-

through the Medicines Patent Pool, covering 106 countries,
95 within the scope of the Index.

stage R&D projects. The company can apply this process to all late-stage R&D projects,• Agreed with UNICEF to establish the world’s first global

including tedizolid (Sivextro®) for S. pneumoniae, islatravir (MK-8591) for the treatment

Ebola vaccine stockpile of the Zaire ebolavirus vaccineof HIV infection and its chikungunya virus vaccine (V184).

(Ervebo®).
• Issued a USD 1 billion sustainability bond to support projects

Expand access to patented medicines on the WHO Model List of Essential Medicines.

and partnerships that contribute to the advancement of

MSD has a non-exclusive voluntary license in place for paediatric raltegravir (Isentress®),

the UN SDGs including access to healthcare and infectiousfor HIV, with one generic company already manufacturing it under this licence. The

disease research and development and to support initiatives

company can expand access to raltegravir in countries with a high disease burden bythat address access barriers and strengthen health systems.

expanding registration and applying equitable pricing. The company can also expand
access to products such as pembrolizumab (Keytruda®), which has multiple cancer
indications, through equitable pricing strategies and/or non-exclusive voluntary
licensing.

49

All companies were assessed based on
information that was valid in the latest
period of analysis (ending at 31 May2022). This data was either submitted bycompanies, found in the public domain or
was accessible through other sources. For

the 2022 Index, MSD declined to submit
data to the Access to Medicine Index.
The term LMICs is used to denote all
low- and middle-income countries inscope of the Index, except when analysing
companies’ access strategies where

the use of LMIC refers to lower-middle
income countries as per the World Bank
income groups classification. Likewise, theterms LIC and UMIC refer to low income
countries and upper-middle income
countries.

*In the 2021 Index, dense ranking wasused. In the 2022 Index, standard
competitive ranking is used. Therefore, adirect comparison with MSD's previous
rank is not possible.

Access to Medicine Index 2022 ▶ Company report cards

SALES AND OPERATIONSBusiness segments: Animal health,

MSD’s products are sold in 81* out of 108

pharmaceuticals and other segments.

countries in scope of the Index. MSD has sales

Therapeutic areas: Cardiovascular, diabetes,

offices in 15 countries and sells via suppliers and/Animal health4.70 bnhospital acute care, immunology, neuroscience,or pooled procurement in 66* countries.

Pharmaceuticals

43.02 bn

Other segment sales

0.02 bnoncology and virology.

Net sales by segment (2020) – in USD*In 2016, MSD reported sales in 81 countries.

Product categories: Animal health, innovative		

medicines and vaccines.

Total

47.75 bn

M&A news: MSD acquired Acceleron Pharma Inc.
in November 2021 for USD 11.5 billion.
Sales by geographic region
50

Net sales (Bn USD)

Sales in countries in scope

40
30
20
10
0

2017

In scope, has sales offices
In scope, sales unknown
Not in scope

2018

2019

2020

2021

USA

Europe, Middle East and Africa

Japan

Asia Pacific (other than China and Japan)

Latin America

China

Other

SAMPLE OF PIPELINE AND PORTFOLIO ASSESSED BY THE INDEXPIPELINE for diseases in scope

PORTFOLIO as selected for analysis by the Index

MSD has a total of 47 R&D projects in scope with 13 of these projects targeting priority diseases. The other 34 R&D projects target other diseases
in scope. Of the projects targeting priority diseases, the focus is on HIV/AIDS (five projects). Of the projects targeting other diseases in scope, thefocus is on oncology (29).
Twenty-eight R&D projects are in late-stage development that target
either a priority disease (10) or address a public health need in LMICs(18).* Evidence of access planning was reported in these sections for 43%of these projects: three targeting a priority disease and nine addressing apublic health need in LMICs.

MSD has 37 medicines in scope, 23 of which are on patent, and 13 vaccines. 32%of the medicines (12) are on the WHO EML. In addition, the company markets
one vector control product and four contraceptive methods and devices. The
off-patent medicines target mainly non-communicable diseases (NCDs) (12) suchas mental health (1) and cardiovascular diseases (4), cancer (2), asthma (2) andmigraine (1); communicable diseases (CD) (3) such as HIV/AIDS, tuberculosis andhepatitis C. The on-patent medicines target CDs such as HIV/AIDS (5), hepatitis C (3), respiratory and other prioritised infections; and NCDs such as diabetes(6), cancer (3) and mental health (1). MSD's preventative vaccines (10) target CDs
such as measles (2) and lower respiratory infections, and NCDs such as cancer(2). One vaccine is indicated for immunisation against HPV-related cervical cancer.

47 projects in the pipeline

55 products as selected for analysis by the Index†
13

1

Multiple categories
0

20
30
40
50
projects in the pipeline

10

20
30
40
50
products on the market

Discovery

Pre-clinical

Phase I

Phase II

Phase III

Registration/approval

Other***

Total

Breakdown of products

Vaccines

0

0

3

3

5

2

0

13

Contraceptives

Targets established R&D priorities

Medicines on patentoff patent

Addresses needs of LMICs*

0

8

5

5

0 18

Diagnostics

Other projects in scope

0 14

1

1

0 16

Other‡*50 diseases and 243 product gaps inscope have been established as a priority by global health stakeholders. For
other diseases, the Index used a set of criteria to determine which projects in thepipeline offer a clear public health benefit to patients in LMICs. Only projects inthe clinical phase of development were
included for this analysis.
**Neglected tropical diseases, while also
communicable, are highlighted separately
throughout the Index.
***Other includes projects that have atechnical lifecycle and projects that fol-

2

21

23

10 4

14

12

1

13

2

2

Total

10

Breakdown of projects

5024

Non-communicableMultiple categories 004Maternal and neonatal

32

Non-communicable

Other

1

1

Non-EML

Maternal and neonatal

25

Communicable**
Neglected tropical

WHO EML1

WHO EDL

Communicable**
Neglected tropical

4
0

0
1

low a different development cycle (e.g.
diagnostics).
†Products included in the analysis wereselected using a set of criteria determinedby stakeholder consensus.
‡Other includes vector control products.

1

Access to Medicine Index 2022 ▶ Company report cards

Merck & Co, Inc

GOVERNANCE OF ACCESSRANK 20SCORE 3.14

Has an access-to-medicine strategy with meas-ency by consistently sharing the outcomes of its

third parties and in all countries where it oper-

urable objectives, integrated within its overall

MSD for Mothers initiatives in a centralised man-ates) and formal processes to ensure third-party

corporate strategy. MSD performs strongly. It

ner directly on its website.

compliance with company standards. There ishas an access strategy, guided by its Access tono evidence, publicly found or disclosed to the

Health Statement of Guiding Principles, which

Performs comparatively poorly in responsible

Index, of fraud-specific risk assessment, country

covers all therapeutic areas in which the company

promotional practices. MSD does not disclose

risk-based assessment, or a continuous system

is involved. The highest responsibility for access

whether its sales agents are not solely incentiv-

to monitor activities. No breaches in countries

lies indirectly with the board, namely with theised on sales volume targets. There is evidencein scope of the Index were publicly found in the

Public Policy and Responsibility Council reportingthat the company sets incentives based on sales

period of analysis.

to the Executive Committee.

targets at the individual level for agents. It has
Guiding Principles for ethical business practices

Publicly supports the Doha Declaration on

Does not provide evidence of financial or

involving the medical and scientific community

TRIPS and Public Health. MSD publicly shares

non-financial access-related incentives atand discloses information related to transfers of

support of the Doha Declaration on TRIPS andthe managerial level. Merck's performance isvalues to healthcare professionals in countries

Public Health but expresses reservations on

below average. The company does not disclosein scope of the Index in accordance with law andits provisions. That is, it challenges compulsory

access-related incentives for senior executives or

local regulations and association guidance (e.g.

licensing, stating it should only be used in very

in-country managers.

payments for attending events or promotional

limited circumstances. There is evidence of indus-

activities).

try association lobbying on IP and the usage of

Publicly discloses outcomes of its

TRIPS flexibilities, namely of compulsory licens-

access-to-medicine activities. MSD performs

Has some compliance controls to ensure that

ing, by national governments in some countries instrongly in transparency of access activities.

governance efforts are not undermined byscope of the Index. As a member of the industry

It publicly discloses commitments, measura-

non-compliant or corrupt activities. MSD per-association, MSD, like all other member compa-

ble goals, objectives, and targets for improving

forms relatively poorly, demonstrating evidence

nies in scope of the Index, is by default connected

access to medicine in countries in scope of theof some components looked for by the Index:

to this activity.

Index. It facilitates accountability and transpar-

audits (both internal and external, covering

RESEARCH & DEVELOPMENTRANK 11SCORE 2.38

Access planning processes encompass all pro-For example, MSD agreed a non-exclusive vol-register in countries in scope apply to nine ofjects in the pipeline. The company reported nountary licensing agreement with the Medicines

these projects.

information to the Index about its access planning

Patient Pool for its COVID-19 antiviral molnupira-processes. However, evidence of this was identi-vir (MK-4482 and EIDD-2801) before it received

Does not publicly disclose R&D investment

fied in the public domain. MSD has a structured

emergency regulatory authorisation.

data disaggregated by disease category, product type or phase of development. However,process to develop access plans during R&D. The

51

process is intended to be applied to all R&D pro-

Many projects address a public health need in

MSD does disclose fully disaggregated R&D

jects for diseases in scope of the Index. In general,

LMICs*, with 50% (9/18) of late-stage projects

investment data to Policy Cures Research.

MSD begins developing access plans for R&D pro-supported by access plans. In this analysis, MSD

jects in Phase II of clinical development.

has 18 late-stage R&D projects that target a

One R&D capacity building initiative included

disease and/or product gap not yet established

for analysis meets all Good Practice Standards.

A small-sized priority R&D pipeline compared

as a priority by global health stakeholders. These

MSD's performance is average in this area. The

to peers, with evidence of access plans for

projects are all deemed by the Index to offer

number of initiatives meeting all inclusion criteria

30% (3/10) of the late-stage candidates. MSD

a clear public health benefit for people living

is lower than average and fewer initiatives meethas 13 projects, including ten late-stage candi-

in LMICs.* Primarily, these projects concern

all Good Practice Standards than what is averagedates in its pipeline, that target a priority productclinical trials in countries in scope of the Index

for this indicator. The company did not participate

gap. These projects focus mostly on HIV/AIDS.

or are first-in-class projects. Most target cancer.

in the Access to Medicine Index data submis-

Of MSD's ten late-stage candidates targeting a

The company did not participate in the Accesssion. However, based on information in the publicpriority product gap, three have evidence of an

to Medicine Index data submission. However,domain, one initiative could be included for anal-

access plan in place. The company did not par-MSD has a policy whereby once a product isysis. In this initiative, MSD partners with Seeding

ticipate in the Access to Medicine Index dataapproved, it commits to registering it in all

Labs to improve access to laboratory equipment

submission. However, evidence of access planscountries where clinical trials for the productfor the scientific community in LMICs.

for three projects was found in the public domain.

have taken place. Therefore, commitments to*50 diseases and 243 product gaps inscope have been established as a priority
by global health stakeholders. For otherdiseases, the Index used a set of criteria
to determine which projects in the pipeline offer a clear public health benefit topatients in LMICs. Projects in the clinicalphase of development were included forthis analysis.

Access to Medicine Index 2022 ▶ Company report cards

PRODUCT DELIVERYRANK 19SCORE 1.75

Public commitment not to enforce patents

Has an access strategy for its healthcare prac-

Has engaged in scaling up two inclusive busi-

in countries in scope. MSD publicly pledges totitioner-administered products in scope of thisness models but has not shown evidence ofneither file for nor enforce patents. This commit-

analysis. MSD performs below average in securing

its involvement in piloting any new inclusive

ment applies in LICs.

access for healthcare practitioner-administeredbusiness models that meet all inclusion crite-

products. Evidence of an access strategy that con-ria. MSD performs average in the use of inclusive

Publicly discloses information on patent sta-siders some affordability factors was found in

business models aimed at meeting the accesstus. Like most of its peers, MSD discloses the

China for pembrolizumab (Keytruda®), an oncol-

needs of populations at the base of the income

patent statuses for small molecules in scope via

ogy product. No evidence of access strategies forpyramid (including other underserved popula-

the Pat-INFORMED database. MSD discloses

the remaining products were found in the public

tions) in LMICs. In Kenya, MSD is supporting thepatent information such as filing date, grant num-domain, nor was evidence regarding patient reach,expansion of M-TIBA to include maternal healthber, grant date and jurisdiction. Additionally, iteither publicly or to the Index. The products are anservices through Mom Care, a new platform that

discloses US patent numbers for its entire US

oncology treatment, antibiotics and a product tar-links patients, providers and payers to improve

portfolio of vaccines and biologics.

geting ischaemic heart disease.

the financing and delivery of maternity care.

Performs below average in terms of sharing

No evidence of access strategies for any of

Performs below average in terms of ensuring

intellectual property (IP) assets with third-

its self-administered products in scope of thiscontinuous supply of medicines in LMICs. MSD

party researchers. MSD does not report on any

analysis. MSD has not disclosed, either publicly orshows evidence of its involvement in supply chain

new IP-sharing agreements with public research

to the Index, access strategies for any of the fivecapacity building initiatives and transfers tech-

institutions or drug discovery initiatives estab-

products assessed by the Index in this category.

nology with third-party manufacturers in LMICs.

lished during the current analysis period that

The products are diabetes treatments, a productHowever, there is no evidence that the company

meet all inclusion criteria for evaluation. The

targeting asthma and one targeting migraine.

works with relevant stakeholders to communicatecompany does have existing agreements of thisissues that may affect the supply chain, maintains

nature in place that were established before theNo manufacturing capacity building initiatives

a network of several active pharmaceutical ingre-

current period of analysis and meet all inclusion

included for analysis. There is no evidence — indient suppliers, nor manages a buffer stock of

criteria for evaluation.

the public domain or disclosed to the Index — ofrelevant products.

manufacturing capacity building initiatives active
Uses licensing to enable generic supply. MSD

during the period of analysis that met inclu-

Does not disclose a policy for reporting sub-has a non-exclusive voluntary licensing agree-sion criteria for evaluation. MSD's performance isstandard and falsified (SF) medicines inment in place for two compounds (for diseases

below average in this area.

countries in scope of the Index. MSD does notin scope). Its licence for its paediatric formulation

disclose, publicly or to the Index, evidence of aof raltegravir (Isentress®), indicated for HIV/AIDS,

Both supply chain capacity building initiatives

policy in place to report SF medicines to relevant

encompasses 89 countries within the scope ofincluded for analysis meet all Good Practice

health authorities. However, it publicly discloses

the Index including 59 middle income countries.

Standards. MSD's performance is average in thishaving a global Product Integrity Strategy on

MSD also has a licence for its COVID-19 antiviral,area. The number of initiatives meeting all inclu-

tackling counterfeit products, and reports thatmolnupiravir (Lagevrio®), agreed with 27 subli-

sion criteria is lower than average but an average

it responds in alignment with local regulatorycensees, covering 95 countries relevant to thenumber of initiatives meet all Good Practicerequirements.

Index including 68 middle income countries.

Standards (GPS) for this indicator. For example, MSD is a member of the Neglected TropicalDonates in response to expressed need andNo evidence of filing for registration new prod-

Disease (NTD) Supply Chain Forum which pro-monitors delivery. MSD has public policies

ucts in any country in scope on average. MSD

vides a common platform for all partners to comeand supply processes in place to ensure ad hoc

did not disclose evidence of filing for registration

together and explore options to manage the NTD

donations are carried out rapidly in response to

any of its analysed products.

drug supply chain.

expressed need, and it monitors the delivery of

Has access strategies for all its supranation-

One of the two health systems strengthen-ally procured products in scope of this analysis.

ing initiatives included meets all Good Practice

Publicly commits to the achievement of elim-

MSD performs below average in securing accessStandards. MSD's performance is below average

ination, eradication or control goals in twofor products procured supranationally. For all

in this area. The number of initiatives meeting all

structured donation programmes for neglectedof the three products assessed in this category,inclusion criteria is lower than average and fewer

tropical diseases or malaria. In one programme,

examples of strategies both in countries eligi-

initiatives meet all GPS than what is average forfor over 15 years MSD has publicly committed

ble for supply from such procurers and in at least

this indicator. For example, MSD for Mothers is a

to supporting the elimination of onchocercia-

one non-eligible country were found publicly. For

USD 650 million global initiative, contributing thesis and lymphatic filariasis by donating ivermectin

example, the company has a tiered pricing policy

company's scientific and business expertise and(Mectizan®) in 27 countries in scope of the Index

for vaccines, including the pneumococcal vac-financial resources to address preventable mater-

until goals are achieved.

cine polyvalent (23-valent) (Pneumovax®23).

nal deaths through supporting quality maternity

Information regarding patient reach was notcare and access to modern contraception. This

found in the public domain.

initiative meets all GPS.

donations.

52