Access to Medicine Index 2022 ▶ Company report cards

RA N KSCO R E53.72

8 (2021)

Merck KGaA
Stock exchange: XFRA • Ticker: MRK • HQ: Darmstadt, Germany • Employees: 60,334

PERFORMANCE IN THE 2022 INDEX
5th place. Merck performs strongly and is now in the top fiveof the Index. Merck excels in R&D access planning and it
performs well in its approach to patent transparency. It also
engages in high-quality capacity building initiatives across

How score was achieved
4.14

Governance of Access
3.40

Research & Development

3.78

Product Delivery

all fields and has an average performance in Governance of0

1

Access.

2

3

Average

Leader4

5

Governance of Access: 10th place. Merck has an average performance in this area. It has a clear access-to-medicine strategy that is integrated into its overall corporate strategy, butframework in place and has access plans for all late-stage

it does not extend across its pipeline and portfolio. It dis-candidates. The company excels in R&D capacity building.

closes the outcomes of its access-to-medicine activities andhas a robust set of compliance controls to mitigate the risk

Product Delivery: 5th place. Merck performs well in thisof non-compliance in countries in scope of the Index, but it

area. Merck performs strongly in sharing intellectual prop-

provides limited evidence on access-related incentives forerty assets with third-party researchers. It has improved in

its CEO and no evidence of access-related incentives for

its approach to equitable access strategies, yet the focus isin-country and regional managers.

mostly on upper-middle and lower-middle income countries.
Merck engages in high-quality capacity building initiatives

Research & Development: 4th place. Merck performs strongly

across all fields (i.e., manufacturing, supply and health sys-in this area. The company has a structured access planningtems strengthening).

OPPORTUNITIES FOR MERCK KGaA

CHANGES SINCE THE 2021 INDEX

Improve the quality of access plans for R&D projects for cancer. Merck has access• Added “country segmentation” to compliance risk

plans in place for all late-stage R&D candidates. Most of these plans, focus solely
on registration in countries in scope of the Index. Merck can expand its access plans
beyond registration to consider more access components such as equitable pricing andlicensing.

management in all countries where Merck actively operates
to classify countries in terms of their risk exposure.
• Donated research instruments and materials to the Eijkman
Institute for Molecular Biology to support in its efforts inaccelerating COVID-19 vaccine development research in

Expand manufacturing capacity building efforts beyond vaccines. Merck started the
Merck Africa Biologics and Vaccine Initiative (MABVI), which aims to develop integrated

Indonesia.
• The Merck Family Foundation donated EUR 100,000 tosolutions to deploy innovative manufacturing technologies that enable local biologics

Business for Health Solutions (BHS), an initiative in which

manufacturing across Africa. The initiative is currently active in eight countries in scope

Merck employees dedicate time to build capacity in the localof the Index and focuses on vaccines. Merck can expand this initiative to focus on further

African healthcare sector. The initiative will be expanded to

products such as biological treatments. The company can also regularly monitor and

up to six healthcare companies in western Africa.

share impact.

• Expanded its long-term donation programme to adult

Expand access to cancer treatments. Merck implemented access strategies for• Successfully completed the clinical development oftreatment for the elimination of schistosomiasis in Rwanda.
avelumab (Bavencio®) in at least one upper-middle income country and one lowermiddle income country. The company can increase patient reach through registration,

the potential new medication (arpraziquantel) to treat
schistosomiasis in children as of 6 years of age and below.

equitable pricing and/or non-exclusive voluntary licensing, especially in countries where• Submitted the WHO prequalification dossier of an

the burden of bladder cancer is the highest such as Egypt, Armenia and the Republic of

optimised praziquantel (Cesol® 600) formulation.

Moldova.

200

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.

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.

Access to Medicine Index 2022 ▶ Company report cards

SALES AND OPERATIONSBusiness segments: Electronics, healthcare andMerck's products are sold in 89 out of 108

life sciences.

countries in scope of the Index. Merck has sales

Net sales by segment (2021) – in EUR

Therapeutic areas: Endocrinology, fertility,

offices in 20 countries, and sells via suppliersLife sciences

8.99 bngeneral medicine, immunology, immuno-

and/or pooled procurement in an additional 69

Healthcare

7.09 bnoncology and neurology.

countries.

Electronics

3.61 bn

Product categories: Diagnostics, innovative		

medicines and medical devices.

Total

19.69 bn

M&A news: Merck KGaA acquired Exelead in
February 2022 for approximately USD 780
million.
Sales by geographic region
25

Net sales (Bn EUR)

Sales in countries in scope

20
15
10
5
0

In scope, has sales offices
In scope, any sales

2017

2018

Middle East/Africa

In scope, no sales

Latin America

Not in scope

2019

2020

2021

Asia-Pacific
EuropeNorth America

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

PORTFOLIO as selected for analysis by the Index

Merck has a total of 68 R&D projects in scope with 33 of these projects

Merck has 13 medicines in scope, two of which are on patent. 38% of thesetargeting priority diseases. The other 35 R&D projects target other dis-

medicines (5) are on the WHO EML. In addition, the company markets twoeases in scope. Of the projects targeting priority diseases, the focus is on

diagnostics for HIV/AIDS. The off-patent medicines target non-communica-

schistosomiasis (13 projects) and malaria (11). Of the projects targetingble diseases (9) such as cardiovascular diseases (5), cancer (1) and diabetes

other diseases, the focus is on oncology (34).

(3). Furthermore, the company markets chloroquine for malaria and prazi-

Thirteen R&D projects are in late-stage development that target either aquantel for parasitic worm infections. The on-patent medicines target

priority disease (3) or address a public health need in LMICs (10).* Evidence

cancer (2).

of access planning was in place for 100% of these projects.

68 projects in the pipeline

15 products as selected for analysis by the Index†
18

Communicable**

Maternal and neonatal 032

Non-communicable11

Non-communicable

5

Multiple categories 0
0

20
30
40
50
projects in the pipeline

Phase II

Phase III

Registration/approval

Other***

1

1

0

2

12 33

Addresses needs of LMICs*

13

7

1

2

0 23

Other projects in scope

4

4

0

0

4

*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 in12

the 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-

Total

Phase I

0

Other

Pre-clinical

17

Total

Discovery

Targets established R&D priorities

20
30
40
50
products on the market

Breakdown of products
WHO EML

Breakdown of projects

10

WHO EDL

10

Non-EML

0

201

1

Neglected tropical

Maternal and neonatal 0
Multiple categories

3

Communicable**

13

Neglected tropical

Medicines on patent

0

2

2

off patent

5

6

11
0

Vaccines

00Contraceptives

00

Diagnostics
Other

‡

0
2

2
0

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.

0

Access to Medicine Index 2022 ▶ Company report cards

Merck KGaA

GOVERNANCE OF ACCESSRANK 10SCORE 4.14

Has an access-to-medicine strategy with meas-strongly in transparency of access activities. It

dence of all components looked for by the Index:

urable objectives, integrated within the overallpublicly discloses commitments, including on

fraud-specific risk assessment, country risk-based

corporate strategy. Merck performs well. It has

combating NCDs, measurable goals, objectives

assessment, a continuous system to monitora Global Health strategy focused on availabil-

and targets for improving access to medicine

activities, audits (both internal and external, cov-

ity, affordability, awareness and accessibility. The

in countries in scope of the Index. It facilitatesering third parties and in all countries where it

strategy covers some of the therapeutic areas inaccountability and transparency by consistently

operates) and has formal processes to ensure

which the company is involved, with a focus on

sharing the outcomes of its access-to-medi-

third-party compliance with company standards.

the elimination of schistosomiasis, malaria, andcine activities in a centralised manner within its

No breaches in countries in scope of the Index

the prevention and control of non-communicable

Sustainability Report.

were publicly found in the period of analysis.

sibility for access lies directly with the CEO of

Has an average performance in responsible

Publicly supports the Doha Declaration on

Healthcare at Merck, who manages Global Healthpromotional practices. Merck’s sales agents are

TRIPS and Public Health. Merck publicly shareson behalf of the Executive Board.

not solely incentivised on sales volume targets.

support of the Doha Declaration on TRIPS andHowever, additional details on how the company

Public Health, but expresses reservations on

Provides evidence of financial and non-financial

addresses sales incentives for sales agents are

the implementation of its provisions. That is, it

access-related incentives at the executive level.

unavailable. It does not publicly disclose informa-

highlights compulsory licensing as a risk of under-

Merck performs well. It incentivises the CEO andtion related to transfers of values to healthcare

mining innovation. There is evidence of industry

other senior executives with objectives related

professionals in countries in scope of the Index

association lobbying on IP and the usage ofto sustainability. It publicly states that the CEO's(e.g. payments for attending events or promo-

TRIPS flexibilities, namely of compulsory licens-Long-Term Incentive Plan (LTIP) is connected to ational activities), unless required by law or by local

ing, by national governments in some countries in

Sustainability Factor consisting of three sustaina-

regulations, though it has policies and procedures

scope of the Index. As a member of the industry

bility indicators, and the goal of the first indicatorin place limiting transfers of values to healthcare

association, Merck, like all other member compa-

is to achieve human progress for more than one

professionals.

nies in scope of the Index, is by default connecteddiseases (NCDs) in LMICs. The highest respon-billion people by 2030 through sustainable sci-to this activity.
Has a robust set of compliance controls toence and technology.

ensure that governance efforts are not underPublicly discloses outcomes of its

mined by non-compliant or corrupt activities.

access-to-medicine activities. Merck performs

Merck performs strongly, demonstrating evi-

RESEARCH & DEVELOPMENTRANK 4SCORE 3.40

Access planning processes encompass all pro-

WHO prequalification, priority registration in

Does not publicly disclose R&D investment

jects in the pipeline. Merck has a structured

high burden African countries, engagement withdata disaggregated by disease category, prod-

process in place to develop access plans during

access-oriented funding organisations and local

uct type or phase of development. Merck does

R&D. The process is intended to be applied to all

manufacturing arrangements to ensure equitable

not disclose disaggregated R&D investment data

R&D projects (both in-house and collaborative) forand sustainable access and supply.

to global health organisations.

begins developing access plans for R&D projects in

Many projects address a public health need in

All five R&D capacity building initiatives

Phase II or earlier of clinical development.

LMICs,* with 100% (10/10) of late-stage candi-

included for analysis meet all Good Practicedates covered by access plans. In this analysis,

Standards. Merck leads in this area. The num-

An average-sized priority R&D pipeline com-

Merck has ten late-stage R&D projects that target

ber of initiatives meeting all inclusion criteria ispared to its peers, with evidence of accessa disease and/or product gap not yet designatedhigher than average and more initiatives meet allplans in place for 100% (3/3) of late-stage can-as a priority by global health stakeholders. These

Good Practice Standards than what is average fordidates. Merck has 33 projects, including threeprojects are all deemed by the Index to offer athis indicator. For example, Merck partners withlate-stage candidates that target a priority prod-

clear public health benefit for people living in

Seeding Labs, to improve access to lab equip-

uct gap. The priority pipeline focuses mainly

LMICs.* Primarily, these projects are first-in-classment for the scientific community in countries

on schistosomiasis and malaria. There is evi-molecules. All target cancer. Merck provides evi-in scope of the Index. Additionally, Merck is thedence of access plans for all three of Merck's

dence of access plans for all ten of these projects.

founding sponsor of the TeleScience platform, anlate-stage candidates. Notably, the access plan

These plans focus mainly on registration prepara-

online platform that provides teaching and train-

for the potential new treatment option for schis-tion in countries in scope of the Index.

ing to scientists in LMICs.

diseases in scope of the Index. In general, Merck

tosomiasis (arpraziquantel) includes plans for202*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 5SCORE 3.78

Public commitment not to enforce patents in

Has access strategies for its self-administered

The company has engaged in both scaling up

countries in scope. Merck publicly pledges to

products for some countries in scope of thisand piloting one inclusive business model.

neither file for nor enforce patents. This commit-

analysis. Merck performs below average in thisMerck performs above average in the use ofment applies to all Least Developed Countries

area. The company provides examples of accessinclusive business models aimed at meeting theand LICs as well as in a subset of LMICs andstrategies which consider affordability in UMIC

access needs of populations at the base of the

UMICs, a total of 90 countries in scope of theand LMIC contexts for three of the five products

income pyramid (including other underserved

Index.

assessed. Evidence of access strategies in LICs

populations) in LMICs. CURAFA™ points of care

was not provided. Merck makes efforts to reachfor integrated healthcare services, piloted in

Publicly discloses detailed information on pat-

additional patients using pricing strategies that

Kenya, aim to provide primary healthcare accessent status. Like most of its peers, Merck publicly

consider relevant payers' ability to pay. For exam-

to underserved populations in low-income com-discloses the patent statuses for small mole-ple, in Egypt, the company participates in tenders

munities in emerging economies.

cules in scope via the Pat-INFORMED database.

to supply the diabetes medicine metformin/glib-

Additionally, Merck discloses the type of patents

enclamide (Glucovance®) and it has initiatives to

Performs above average in terms of ensuring

and their expiry dates on its website for a subset

assist patients in disease management. The com-continuous supply of medicines in LMICs.

of products in scope of the Index.

pany provides evidence of the number of patients

Merck is involved in technology transfers withreached by this product in Egypt and Mexico.

third-party manufacturers in LMICs, and has a sys-

Performs above average in terms of sharing

tem in place to work with relevant stakeholders

intellectual property (IP) assets with third-

Three of the five manufacturing capacity build-to communicate issues that may affect the supply

party researchers. Merck engaged in 17 newing initiatives included meet all Good Practicechain, works with several active pharmaceuti-

IP-sharing agreements with third-party researchStandards. Merck's performance is above aver-cal ingredient (API) suppliers/produces in-house

institutions or drug discovery initiatives estab-

age in this area. The number of initiatives meeting

APIs, manages a buffer stock of relevant products

lished during the current analysis period that

all inclusion criteria is higher than average andand is involved in supply chain capacity building

meet all inclusion criteria for evaluation. The

more initiatives meet all Good Practice Standards

initiatives.

company does have existing agreements of this(GPS) than what is average for this indicator. For

nature in place that were established before theexample, the Pediatric Praziquantel Consortium

Has a policy for reporting substandard and fal-current period of analysis and meet all inclusionaims to reduce the global disease burden of schis-sified (SF) medicines in countries in scope of

criteria for evaluation.

tosomiasis by addressing the medical need of

the Index in less than ten days. Merck provides

infected children aged six and below. One of theevidence of reporting confirmed SF medicines to

No use of licensing agreements. Merck does

goals of this program, led by Merck, is to establish

the relevant national health authorities within ten

not engage in voluntary licensing for products ina sustainable and affordable manufacturing anddays. When authorities request a visual assess-scope of the Index. It publicly states it would con-supply chain that involves sites in LMICs. This ini-

ment of an obvious counterfeit product (e.g.,sider granting non-exclusive voluntary licences intiative meets all GPS.

obvious artwork errors or a non-existing batchcertain circumstances.

number), Merck commits to provide conclusions
Three of the five supply chain capacity build-of the assessment to the relevant health authori-

Filed to register new products in six countries

ing initiatives included meet all Good Practiceties in less than ten days.

in scope on average. Merck did not disclose evi-

Standards. Merck's performance is above aver-dence of filing for registration any of its newage in this area. The number of initiatives meeting

Donates in response to expressed need andproducts in more than half of the top ten highall inclusion criteria is higher than average andmonitors delivery. Merck has public policies

burden countries. Among old products, its most

more initiatives meet all GPS than what is aver-and supply processes in place to ensure ad hoc

widely registered is bisoprolol (Concor®/Concor®

age for this indicator. Merck has been a member

donations are carried out rapidly in response toCOR), indicated for cardiovascular diseases, filedof CAMP-N Supply Chain Technical Working

expressed need, and it monitors the delivery ofin 63 countries relevant to the Index, includingGroup since its launch in 2017. This coalition of

donations.

four high burden countries (Republic of Moldova,

government agencies, private sector entities,

Syrian Arab Republic, Ukraine and Uzbekistan)

non-governmental organisations, philanthropic

Publicly commits to the achievement of elim-

and ten LICs.

foundations and academic institutions is ded-

ination, eradication or control goals in one

icated to increasing access to medicines andstructured donation programme for neglected

Merck is not eligible for assessment of supra-

health products for NCDs. This initiative meetstropical diseases or malaria. Since 2007, Merck

nationally procured products.

all GPS.

has publicly committed to supporting the elimina-

Has access strategies for some healthcare

Two of the five health systems strengthen-(Cesol®) in 43 countries in scope of the Index

practioner-administered products in scopeing initiatives included meet all Good Practice

until goals are reached.

of this analysis. Merck's performance is above

Standards. Merck's performance is average

average in this area.* For one of the two prod-in this area. The number of initiatives meetingucts assessed, the company provides examples

all inclusion criteria is higher than average butof access strategies in countries of all assessed

fewer initiatives meet all GPS than what is aver-income levels (UMIC, LMIC, LIC). The company

age for this indicator. For example, Merck andmakes efforts to reach additional patients using

the NALA Foundation Partnership to Eliminate

pricing mechanisms that consider payers' abil-

Schistosomiasis combines treatment, research

ity to pay and has implemented strategies toand development and health education andensure patients' access to a product not availa-

WASH (water, sanitation and hygiene) to support

ble on the market yet. Merck provides evidence

the elimination of this neglected tropical diseaseof how patient reach has been increased throughin Ethiopia. This initiative meets all GPS.

tion of schistosomiasis by donating praziquantel

the approaches used in the UMIC and LMIC country examples.

203* The description of Merck’s performancein PP4 (HCP-administered products) was
corrected from "average" to "above average" on 1 Dec 2022. This typographicalerror did not impact the underlying analysis or scoring.