Access to Medicine Index 2022 ▶ Company report cards

RA N KSCO R E9

3.36

13 (2021)

Bayer AG
Stock exchange: XFRA • Ticker: BAYN • HQ: Leverkusen, Germany • Employees: 99,637

PERFORMANCE IN THE 2022 INDEX
9th place. Bayer ranks among the top ten companies of theIndex. It performs strongly in access strategies for healthcare
practitioner-administered products. The company has also
strengthened its performance in inclusive business models

How score was achieved
4.29

Governance of Access
2.65

Research & Development

3.49

Product Delivery

and in access planning during R&D.

0

1

Governance of Access: 8th place. Bayer performs well in this2

3

Average

Leader4

5

area. It has an access-to-medicine strategy integrated into
its overall corporate strategy, although the strategy covers
only some of its therapeutic areas. It incentivises senior executives and in-country and regional managers to perform on

the Index compared to its peers. However, the company’s per-access-to-medicine goals and has a robust set of complianceformance in R&D capacity building is below average.

controls to mitigate the risk of non-compliance in countries in
Product Delivery: 9th place. Bayer has an above average per-scope of the Index.

formance. The company has comprehensive access strategies
Research & Development: 10th place. Bayer's performance isfor some of its products but lacks access strategy examples

average in this area. It now has a structured access planningin low-income countries for its self-administered products.

process in place and applies this to most late-stage pipeline

Bayer has also both scaled-up and piloted inclusive businesscandidates. Although it has a small-sized priority R&D pipe-

models and performs well in supply chain capacity building.

line, its access plans include the most countries in scope of

OPPORTUNITIES FOR BAYERCHANGES SINCE THE 2021 INDEX

Ensure all late-stage R&D projects have comprehensive access plans. Bayer has• Established an ESG committee in January 2022 at the

introduced a structured process for access planning beginning in Phase II of clinicaldevelopment. It has access plans in place for 80% of late-stage candidates analysed. The
company can expand its access plans to all R&D projects from Phase II onwards.

supervisory board level.
• Invests over EUR 400 million to construct a production site
for contraceptives in Costa Rica and expand a production
site in Finland, both of which will supply to LMICs.

Expand access to on-patent cancer products in lower-middle and low-income• Introduced a structured framework to include accesscountries, such as darolutamide (Nubeqa®). Bayer has access strategies in UMICs
for darolutamide, indicated for prostate cancer. The company can provide evidenceof expanding access to the product via equitable access strategies and registration inlower-middle income countries, low-income countries and countries with a high burdenof disease such as Guyana and Suriname. In addition, the company can expand accessto sorafenib (Nexavar®), indicated for thyroid and liver cancer, via equitable accessstrategies and registration in LICs and in countries with a high burden of disease such as
Bolivia, Guinea and Gambia.

planning in the development process early on for all its
pipeline projects (both in-house and collaborative).
• Received first approval for nifurtimox (Lampit®) indicatedfor paediatric Chagas disease.
• Began to report disaggregated R&D investment data to
Policy Cures Research.
• Opened two new hubs in Pakistan and the Philippines
for The Challenge Initiative (TCI), a platform that enables
governments to scale up family planning approaches for the

Expand technology transfer initiatives for reproductive health commodities toadditional countries. Bayer has previously transferred technology for its hormonal

urban poor.
• Extended its commitment with the World Healthcontraceptive products to manufacturers in LMICs such as Algeria and Morocco. Bayer

Organization (WHO) for an additional five years to

can expand the geographic scope of these technology transfers to build manufacturing

accelerate control and elimination of neglected tropicalcapacity and improve regional availability in countries or regions with specific accessdiseases including the donation of medicines for treatment

gaps.

of chagas disease and African trypanosomiasis (sleeping
sickness), estimated at USD 8 million.
• Donated over USD 3.8 million in products to the UNFPA
as well as USD 1 million for logistical supply chain support
during the COVID-19 pandemic.
• Received WHO Prequalification (PQ) (RH100) for
levonorgestrel-releasing intrauterine system (Mirena®).
All contraceptive products sold under supranational
programmes have now received WHO PQ.

160

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: Consumer health, crop

Bayer's products are sold in 95 out of 108

science and pharmaceutical.

countries in scope of the Index. Bayer has sales

Net sales by segment (2021) – in EUR

Therapeutic areas: Cardiology, oncology,

offices in 38 countries, and sells via suppliers

Crop science

20.21 bn

ophtalmology, radiology and women's health.

and/or pooled procurement in an additional 57

Pharmaceutical

18.35 bn

Product categories: Innovative medicines.

countries.

Consumer health5.29 bn

M&A news: Bayer acquired Vividion

		Therapeutics in August 2021 for USD 1.5 billion.

Total

Sales in countries in scope

Sales by geographic region

43.85 bn

Net sales (Bn EUR)

50
40
30
20
10
0

In scope, has sales offices
In scope, any sales

2017

2018

2019

Europe/Middle East/Africa

In scope, no sales

Latin America

Not in scope

2020

2021

Asia-PacificNorth America

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

PORTFOLIO as selected for analysis by the Index

Bayer has a total of 29 R&D projects in scope with ten of these pro-

Bayer has 13 medicines in scope and seven contraceptive methods andjects targeting priority diseases. The other 19 R&D projects target otherdevices. Of the medicines, eight are on patent. Of the 20 medicines anddiseases in scope. Six projects concern vector control products. Of the pro-contraceptive products, 55% (11) are on the WHO EML. In addition, thejects targeting priority diseases, the focus is on malaria (three projects). Of

company markets 13 vector control products. The off-patent medicines

the projects targeting other diseases, the focus is on kidney diseases (4)target mainly women health, these include contraceptive methods (5) andand oncology (10).

target neglected tropical diseases, such as human African trypanosomia-

Ten R&D projects are in late-stage development that target either a prior-sis (3). The on-patent medicines mainly target non-communicable diseases

ity disease (4) or address a public health need in LMICs (6).* Evidence ofsuch as cancer (5) and kidney diseases (2). The vector control products

access planning was in place for 80% of these projects: four targeting a pri-target communicable diseases such as dengue and chikungunya (8) andority disease and four addressing a public health need in LMICs.

malaria (12).

29 projects in the pipeline

33 products as selected for analysis by the Index†

Communicable**5

Communicable**

6

Neglected tropical5

Neglected tropical4

Maternal and neonatal

6

Non-communicable

8

Maternal and neonatal 0

19

Multiple categories 0

10

20
30
40
50
products on the market

Pre-clinical

Phase I

Phase II

Phase III

Registration/approval

Other***

0

0

1

1

2

4 10

Total

Discovery

2

Targets established R&D priorities

Addresses needs of LMICs*

4

2

0

4

0 10

Other projects in scope

3

3

2

1

0

*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 in9

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

Breakdown of products
WHO EML

Breakdown of projects

161

9
0

20
30
40
50
projects in the pipeline

Other

10

Non-EML0

Multiple categories

WHO EDL

Non-communicable

8

Medicines on patent2

6

off patent

5

0

5

Vaccines000Contraceptives

43

Diagnostics
Other‡

7
0

0

13 13

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.

Access to Medicine Index 2022 ▶ Company report cards

Bayer AG

GOVERNANCE OF ACCESSRANK 8SCORE 4.29

Has an access-to-medicine strategy with meas-

publicly discloses its commitments, measura-dence of all components looked for by the Index:

urable objectives, integrated within the overall

ble goals, objectives and targets for sustainability

fraud-specific risk assessment, country risk-based

corporate strategy. Bayer performs strongly. It

and improving access to medicine in countries

assessment, a continuous system to monitor

has an access strategy aiming at increasing thein scope of the Index. It facilitates accountabil-

activities, audits (both internal and external, cov-

societal impact of its business activities. The

ity and transparency by consistently sharing theering third parties and in all countries where it

strategy covers most therapeutic areas in which

outcomes of its access-to-medicine activities inoperates) and has formal processes to ensure

the company is involved, mainly focusing on wom-a centralised manner within its Patient Accesscompliance with company standards by third

en’s health and access to contraceptives. The

Charter and ESG Report.

parties. No breaches in countries in scope ofhighest responsibility for access lies directly with

the Index were publicly found in the period of

the board, with the Chief Sustainability Officer.

Performs above average in responsible pro-Furthermore, in 2022 Bayer established an ESG

motional practices. Bayer’s sales agents arecommittee at supervisory board level to oversee

not solely incentivised on sales volume targets.

Publicly supports the Doha Declaration onaccess-related goals.

However, Bayer sets sales incentives at the indi-

TRIPS and Public Health. Bayer publicly sharesvidual level for agents. The company does notsupport of intellectual property rights in line with

Provides evidence of financial and non-financial

publicly disclose information related to transfers

the TRIPS Agreement, while highlighting a needaccess-related incentives at the executive level.

of values to healthcare professionals in countries

for appropriate measures in place for the devel-

Bayer performs strongly. It incentivises its seniorin scope of the Index (e.g. payments for attending

opment of innovative products. There is evidence

executives and in-country managers to take action

events or promotional activities) unless requiredof industry association lobbying on intellectualon access to medicine with financial and non-fi-

by law, but it does have a Fair Market Value policy

property and the usage of TRIPS flexibilities,

nancial rewards. The CEO also has access-related

to facilitate appropriate transfers.

namely of compulsory licensing, by national gov-

incentives linked to sustainability goals.

ernments in some countries in scope of the Index.
Has a robust set of compliance controls to

As a member of the industry association, Bayer,

Publicly discloses outcomes of its

ensure that governance efforts are not under-

like all other member companies in scope of theaccess-to-medicine activities. Bayer performs

mined by non-compliant or corrupt activities.

Index, is by default connected to this activity.

strongly in transparency of access activities. It

Bayer performs strongly, demonstrating evi-

RESEARCH & DEVELOPMENTRANK 10SCORE 2.65

Access planning processes encompass all pro-notable example is the development of paediat-

jects in the pipeline. Bayer has a structured

ric nifurtimox (Lampit®) to treat Chagas disease.

Does not publicly disclose R&D investment

process in place to develop access plans during

Registration in additional endemic high dis-data disaggregated by disease category, prod-

R&D. The process is intended to be applied to allease-burden countries is planned for this project.

uct type or phase of development. However,R&D projects (both in-house and collaborative)

162

analysis.

Bayer does disclose fully disaggregated R&D

for diseases in scope of the Index. Bayer begins

Some projects address a public health need indeveloping access plans for R&D projects no later

LMICs,* with 67% (4/6) of late-stage projects

than Phase II of clinical development.

covered by access plans. In this analysis, Bayer

Two R&D capacity building initiatives included

has six late-stage R&D projects that target a dis-for evaluation. Neither initiative included for

A small-sized priority R&D pipeline comparedease and/or product gap not yet established as aanalysis meet all Good Practice Standards. Bayer's

to its peers, with access plans in place for 100%priority by global health stakeholders. These pro-performance is below average in this area. The(4/4) of the late-stage candidates analysed.

jects are all deemed by the Index to offer a clear

number of initiatives meeting all inclusion criteria

Bayer has ten projects, including four late-stage

public health benefit for people living in LMICs.*

is lower than average and fewer initiatives meetcandidates, in its pipeline that target a prior-Primarily, these projects concern clinical trials in

all Good Practice Standards than what is aver-ity product gap. These focus on various disease

countries in scope of the Index and/or are first-

age for this indicator. Bayer builds R&D capacity

areas including malaria, Chagas disease, Zika,

in-class molecules. The projects mainly focus on

in Vietnam, by providing technical assistance todengue and chikungunya. Of Bayer's four late-cancer and kidney diseases. Bayer provides evi-

PATH in developing an affordable and sustainablestage candidates targeting a priority product gap,

dence of access plans for four of these projects.

COVID-19 vaccine.

all have evidence of access plans. These plans

These access plans mainly focus on plans forrange from registration to a partnership with theregistration in countries in scope and the devel-

Drugs for Neglected Diseases initiative (DNDi). A

opment of an equitable pricing strategy.

*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.

investment data to Policy Cures Research.

Access to Medicine Index 2022 ▶ Company report cards

PRODUCT DELIVERYRANK 9SCORE 3.49

Public commitment not to enforce patents inegies in countries of all assessed income levels

ments in countries in scope of the Index to scalecountries in scope. Bayer publicly pledges to(UMIC, LMIC, LIC). It also makes efforts to reachup high-impact family planning approaches forneither file for nor enforce patents. This commit-

additional patients through donations, suprana-

the urban poor. This initiative meets all GPS.

ment applies in LICs only, for all its products intional agreements and tenders. For example, in

scope of the Index.

Brazil, Bayer has donated this product throughHas engaged in scaling up three and piloting

the International Contraceptive Access (ICA)

two inclusive business models. Bayer performs

Publicly discloses information on patent status.

Foundation. In Egypt, Bayer reached an agree-

above average in the use of inclusive business

Like most of its peers, Bayer discloses the pat-ment with the Ministry of Health to include

models aimed at meeting the access needs ofent statuses for small molecules in scope via thethe contraceptive in the government’s Family

populations at the base of the income pyra-

Pat-INFORMED database. Bayer discloses pat-

Planning sector, and it will be provided for freemid (including other underserved populations) in

ent information such as filing date, grant number,to patients that cannot afford the contracep-

LMICs. Through the Bayer Foundation's Women

grant date and jurisdiction.

tive price while strengthening the health system

Empowerment Award, Bayer annually awards

via healthcare practitioner training and aware-

EUR 25,000 to scale the social enterprises of five

Performs below average in terms of sharing

ness campaigns. Bayer provides evidence of an

female entrepreneurs across sub-Saharan Africa.

intellectual property (IP) assets with third-

increase in patient reach.

An example from this cycle is Whispa health, aparty researchers. Bayer does not report on any

platform that connects users to local medical

new IP-sharing agreements with public research

Has access strategies for its self-administeredcentres, with the aim to be Africa's preferred sex-

institutions or drug discovery initiatives estab-

products for some countries in scope for thisual and reproductive health access provider.

lished during the current analysis period thatanalysis. Bayer performs below average in thismeet all inclusion criteria for evaluation. The

area. For three of the five products assessed,

Performs above average in terms of ensuring

company does have existing agreements of thisthe company provides evidence of pricing strat-

continuous supply of medicines in LMICs. Bayernature in place that were established before theegies considering payers' ability to pay in UMIC

is involved in technology transfers with third-

current period of analysis and meet all inclusionand LMIC country examples. Bayer was able toparty manufacturers in LMICs, and has a systemcriteria for evaluation.

secure rivaroxaban (Xarelto®) full reimbursementin place to work with relevant stakeholders toin Colombia in January 2022. In addition, it intro-

communicate issues that may affect the sup-No use of licensing agreements. Bayer does

duced a new patient programme that offers theply chain, has established multi-source networks

not engage in voluntary licensing for products infirst treatment cycle free of charge and supports

for active pharmaceutical ingredients in addition

scope of the Index.

patients in obtaining reimbursement coverage.

to in-house production and is involved in supply

Evidence that about 500 patients have been

chain capacity building initiatives. The company

Filed to register new products in six countries

included in the programme since December 2021

also manages a buffer stock of relevant products

in scope on average. Bayer did not disclose evi-is provided.

based on local medical needs assessments that

dence of filing for registration any of its new

inform supply risk management.

products in more than half of the top ten high

One of the three manufacturing capacity build-burden countries. Among old products, its mosting initiatives included meets all Good PracticeHas a policy for reporting substandard and fal-

widely registered is rivaroxaban (Xarelto®), an

Standards. Bayer's performance is average insified (SF) medicines in countries in scope of

antithrombotic medicine for several indications,this area. The number of initiatives meeting all

the Index in less than ten days. Bayer has a pol-including prevention of stroke. It has been filed

inclusion criteria is average but fewer initiatives

icy for reporting SF medicines to national healthin 68 countries within scope of the Index, includ-

meet all Good Practice Standards (GPS) thanauthorities within seven days for the most severeing 12 LICs. Bayer has filed rivaroxaban andwhat is average for this indicator. For the initia-

risk category. It does not provide evidence ofsorafenib (Nexavar), indicated for liver and thy-

tive that met all GPS, since 2019, Bayer has built

shortened time frames for reporting cases whichroid cancer, in more than half of the top ten highmanufacturing capacity of its partners by mak-only require visual inspection to be confirmed.

burden countries. sorafenib has been filed ining it mandatory for all contract manufacturing

Ecuador, Ethiopia, Honduras, Mongolia, Thailand

organisation sites to be audited according to

Donates in response to expressed need andand Vietnam.

the industry-wide Pharmaceutical Supply Chain

monitors delivery. Bayer has public policies

Initiative (PSCI) standards.

and supply processes in place to ensure ad hoc

Has access strategies for all its supranation-

donations are carried out rapidly in response toally procured products in scope of this analysis.

All three supply chain capacity building ini-

expressed need, and it monitors the delivery ofBayer has an average performance in securing

tiatives included for analysis meet all Good

donations.

access for products procured supranationally. For

Practice Standards. Bayer's performance isthree of the four products assessed in this cate-above average in this area. The number of initia-

Publicly commits to the achievement of elim-

gory, the company demonstrates that it applies

tives meeting all inclusion criteria is average, but

ination, eradication or control goals in two

the same pricing strategies both in UNFPA coun-more initiatives meet all GPS than what is average

structured donation programmes for neglected

tries eligible for supply from such procurers andfor this indicator. For example, Bayer is a partner

tropical diseases or malaria. In one programme,

in at least one country not eligible. The company

in the PSCI where it helps suppliers meet PSCI

Bayer publicly commits to controlling Chagas

provides evidence of patient reach, reporting

standards in several LMICs including India, China,

disease in endemic countries in Latin America

that between 24 and 25 million women received

Kenya and Nigeria.

as well as eliminating human African trypano-access to modern contraception annually during163

somiasis in endemic countries in Africa. The
Three of the four health systems strengthen-company publicly commits to donating nifurtimox

ing initiatives included meet all Good Practice(Lampit®) and suramin (Germanin®) for as long as

Has access strategies for the healthcare prac-

Standards. Bayer's performance is average inneeded until goals are reached.

titioner-administered product in scope of this

this area. The number of initiatives meeting all

analysis. Bayer performs above average in thisinclusion criteria is average and an average num-area. For the product assessed, levonorgestrel-re-

ber of initiatives meet all GPS for this indicator.

leasing intrauterine system (Mirena®/LNG-IUS),

For example, Bayer is a partner in The Challenge

the company provides examples of access strat-

Initiative (TCI) — a platform that enables govern-

the reporting period.