Access to Medicine Index 2022 ▶ Company report cards

RA N KSCO R E10

3.23

9 (2021)

Roche Holding AG
Stock exchange: SIX • Ticker: ROG.SW • HQ: Basel, Switzerland • Employees: 100,920

PERFORMANCE IN THE 2022 INDEX
10th place. Roche ranks among the top ten companiesof the Index. The company performs well in Research &Development, strengthening its performance in R&D accessplanning. The company has an average performance inHow score was achieved
4.00

Governance of Access
2.88

Research & Development

3.22

Product Delivery

Governance of Access, but its strategies for equitable access0

1

are below average for some products.

2

3

Average

Leader4

5

Governance of Access: 12th place. Roche has an average performance in this area. It has an access-to-medicine strategy

stage pipeline candidates. The company has a small-sized pri-integrated into its corporate strategy and publicly discloses

ority pipeline and has an average performance in R&D capac-

outcomes of its access-to-medicine activities. However, it

ity building.

lacks a fraud-specific risk assessment as part of its compliance framework to mitigate the risk of non-compliance in

Product Delivery: 11th place. Roche has an average perfor-

countries in scope of the Index and a formal policy to limit

mance in this area. The company provides evidence of com-transfers of values to healthcare professionals in countries inprehensive access strategies for a subset of products, yet thescope of the Index.

focus is mostly on upper-middle and lower-middle income
countries. Roche engages in high-quality supply chain capac-

Research & Development: 8th place. Roche performs above

ity building and health systems strengthening initiatives, but

average in this area. Roche has a structured access planning

its involvement in manufacturing capacity building is compar-

framework, with access plans in place for the majority of late-

atively poor.

OPPORTUNITIES FOR ROCHECHANGES SINCE THE 2021 INDEX

Ensure all late-stage R&D projects have comprehensive access plans. Roche has access• Expanded the Global Access Program in 2021 to include

plans in place for 90% of late-stage R&D projects. These predominantly focus on plansmolecular PCR diagnostic tests for COVID-19.

for registration filings. The company can expand existing plans beyond commitments• Expanded the proportion of access plans in its pipeline.

to register in countries where it is conducting clinical trials to include more access• Roche initiated a clinical trials framework, activating thecomponents such as equitable pricing and licensing.

first pharma sponsored oncology trial in East Africa.
• Suspended patents on tocilizumab (Actemra®/

Expand access strategies for oncology products. Roche has seven on-patent medicines

RoActemra®) in LMICs after the World Health Organization

listed on the WHO Model List of Essential Medicines, including erlotinib (Tarceva®),(WHO) recommended it as a treatment for severe

a first-line treatment for lung cancer, and atezolizumab (Tecentriq®), indicated for
multiple cancer types. Roche applies access strategies for erlotinib in upper-middle
income countries, including an intra-country pricing strategy in Peru. It can apply similarequitable access strategies and non-exclusive voluntary licensing in lower-middle

COVID-19.
• Entered a partnership with The Global Fund to support
LMICs in strengthening critical diagnostics infrastructure.
• Received WHO prequalification for HIV and HCV tests, andincome countries and low-income countries with high burden of lung cancer such as

WHO guidelines now include cobas® MTB and cobas® MTB-

Tunisia and Vietnam.

RIF/INH tests.
• Launched a human papillomavirus (HPV) self-sampling

Expand manufacturing capacity building activities to additional countries. Roche isinvolved in technology transfer initiatives to regional manufacturers in Bangladesh,
China and Algeria to improve availability of the company’s oncology products. Throughsolution, expanding cervical cancer screening options forpatients living in areas with limited healthcare resources.
• Joined the Access to Oncology Medicines (ATOM) Coalition,

partnerships to build local manufacturing capacity, including technology transfers,

a new global initiative that aims to improve access to

Roche can improve availability of its products in more countries, such as Nigeria, Ghana

essential cancer medicines in LMICs.

and South Africa.

216

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: Diagnostics andRoche's products are sold in 93 out of 108

pharmaceuticals.

countries in scope of the Index. Roche has sales

Sales by segment (2021) – in CHF

Therapeutic areas: Diabetes care,

offices in 31 countries, and sells via suppliers

Pharmaceuticals

45.04 bnhaemophilia A, immunology, infectious diseases,

and/or pooled procurement in an additional 62

Diagnostics

17.76 bn

neuroscience, oncology and ophtalmology.

countries.

		

M&A news: Roche acquired GenMark

Total

62.80 bn

Diagnostics in March 2021 for USD 1.8 billion.

Sales by geographic region
80

Sales (Bn CHF)

Sales in countries in scope

60
40
20
0

In scope, has sales offices
In scope, any sales

2017

2018

2019

Africa/Australia/Oceania

In scope, no sales

EuropeNot in scope

2020

2021

Asia

Latin America

North America

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

PORTFOLIO as selected for analysis by the Index

Roche has a total of 87 R&D projects in scope, with 17 of these projects

Roche has 29 medicines in scope, 23 of which are on patent, and 81 diag-targeting priority diseases. The other 70 R&D projects target other dis-nostics. 41% of the medicines (12) are on the WHO EML. In addition, theeases in scope. In total, 14 of the 87 projects are diagnostic R&D projects.

company markets 13 platform technologies. The off-patent medicines tar-

Of the projects targeting priority diseases the focus is on hepatitis B (fiveget communicable diseases (CDs) (3) such as hepatitis C, malaria and lower

projects). Of the projects targeting other diseases in scope, the focus is on

respiratory infections and non-communicable diseases (NCDs) (4) such as

oncology (53).

cancer (2) and cardiovascular diseases (2). The on-patent medicines tar-

Twenty R&D projects are in late-stage development that target either a

get NCDs such as cancer (15) and kidney diseases (2), and CDs such as HIV/priority disease (5) or address a public health need in LMICs (15).* Evidence

AIDS and coronaviral diseases. The platform technologies target respira-of access planning was in place for 90% of these projects: five targeting a

tory infections, diabetes, cancer and other diseases in scope of the Index.

priority disease and 13 addressing a public health need in LMICs.
87 projects in the pipeline

123 products as selected for analysis by the Index†

17

Maternal and neonatal 174

Non-communicableMultiple categories 1

4

Multiple categories
0

40
60
80
100
projects in the pipeline

20

40
60
80
100
products on the market

0

17

Vaccines

0

0

4

3

0

2

8

17

Contraceptives

Targets established R&D priorities

Addresses needs of LMICs*

1

9

1

1

Other projects in scope

23 11 141

4 53

*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 in5

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-

Other‡

Total

Non-EML0

Diagnostics

Total

0

Other***

0Registration/approval

60Phase III1

Phase II

16

5

Phase I7

off patent

Pre-clinical

Medicines on patent

Discovery

WHO EML

Breakdown of products

Other

20

Breakdown of projects

217

4

Maternal and neonatal

68

Non-communicable
038Communicable**
Neglected tropical 0

WHO EDL

Communicable**
Neglected tropical 0

23

0
81

81

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

Roche Holding AG

GOVERNANCE OF ACCESSRANK 12SCORE 4.00

Has an access-to-medicine strategy with meas-

access-to-medicine activities, including its Global

uous system to monitor activities, audits (bothurable objectives, integrated within its overall

Access Programme, in a centralised mannerinternal and external, covering third parties andcorporate strategy. Roche performs strongly. Its

within its Annual Report.

in all countries where it operates) and has formal

strategy is focused on understanding local barri-processes to ensure third-party compliance withers to access and covers all therapeutic areas theHas an average performance in responsible

company standards. There is no evidence, publicly

company is involved in. The highest responsibil-

promotional practices. Roche’s sales agents arefound or disclosed to the Index, of fraud-spe-

ity for access lies directly with the board, namely

not solely incentivised on sales volume targets.

cific risk assessment. No breaches in countries

with the Corporate Governance and Sustainability

However, the company sets sales incentives atin scope of the Index were publicly found in theCommittee.

the individual level for agents. Roche has an inter-

period of analysis.

nal tracking mechanism but does not publicly
Provides evidence of financial and non-finan-disclose information related to transfers of values

Publicly supports the Doha Declaration on

cial access-related incentives at the executive

to healthcare professionals in countries in scope

TRIPS and Public Health. Roche publicly shareslevel. Roche performs well. It incentivises its CEO,of the Index (e.g. payments for attending events

support of the Doha Declaration on TRIPS andsenior executives and in-country managers toor promotional activities), unless required by law

Public Health, but expresses reservations on its

perform on access to medicine with financial andor by local regulations. The company does notprovisions, namely on the effectiveness of com-

non-financial rewards.

place limits on transfers of value to healthcare

pulsory licensing to lower drug prices. Thereprofessionals, but reports setting remuneration inis evidence of industry association lobbying online with fair market value.

intellectual property (IP) and the usage of TRIPS

Publicly discloses outcomes of its
access-to-medicine activities. Roche performs

flexibilities, namely of compulsory licensing, bystrongly in transparency of access activities. It

Has some compliance controls to ensure thatnational governments in some countries in scope

publicly discloses its commitments, measura-

governance efforts are not undermined byof the Index. As a member of the industry asso-

ble goals, objectives and targets for improving

non-compliant or corrupt activities. Roche has

ciation, Roche, like all other member companies

access to medicine in countries in scope of the

an average performance, demonstrating evi-in scope of the Index, is by default connected to

Index. It facilitates accountability and transpar-

dence of some components looked for by thethis activity.

ency by consistently sharing the outcomes of its

Index: country risk-based assessment, a contin-

RESEARCH & DEVELOPMENTRANK 8SCORE 2.88

Access planning processes encompass all pro-the Index, a new pricing policy, WHO prequalifica-

Does not publicly disclose R&D investment

jects in the pipeline. Roche has a structured

tion, patent waivers in LMICs, product donations

data disaggregated by disease category, prod-

process in place to develop access plans during

and scaling up production capacity to meet

uct type or phase of development. Roche does

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

demands.

not disclose disaggregated R&D investment data

R&D projects for diseases in scope of the Index.

to global health organisations.
Many projects address a public health need in

An average-sized priority R&D pipeline com-

LMICs,* with 87% (13/15) of late-stage projects

Two of the three R&D capacity building ini-pared to its peers, with access plans in place

covered by access plans. In this analysis, Roche

tiatives included meet all Good Practicefor 100% (5/5) of the late-stage candidates.

has 15 late-stage R&D projects that target a dis-Standards. Roche's performance is average

Roche has 17 projects including five late-stage

ease and/or product gap not yet established as ain this area. The number of initiatives meeting

candidates in its pipeline that target a priority

priority by global health stakeholders. These pro-

all inclusion criteria is average and an average

product gap. These focus mostly on hepatitis B

jects are all deemed by the Index to offer a clear

number of initiatives meet all Good Practiceand coronaviral diseases. Roche has access planspublic health benefit for people living in LMICs.*

Standards (GPS) for this indicator. For exam-in place for all five late-stage priority candidates.

Primarily, these projects concern clinical trials

ple, Roche builds R&D capacity by educating

These plans mainly concern registration prepa-

in countries in scope of the Index. Most target

lab researchers through its Fondation Roche

ration in countries in scope of the Index. Notably,

cancer or Alzheimer's disease. Roche provides

Recherche en Afrique scholarship programme.

the access plan for tocilizumab (Actemra®/

evidence of access plans for 13 of these projects.

This initiative provides scholarships to students

RoActemra®) for the treatment of COVID-19 uses

These plans mostly relate to an intention to reg-in Côte d'Ivoire to increase the number of skilled

a multifaceted approach that considers availa-

ister in countries where Roche is carrying out

medical laboratory technicians and meets all GPS.

bility, affordability and supply. The plan includes

clinical trials.

registration preparation in countries in scope of218*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 11SCORE 3.22

Public commitment not to enforce patents inassessed. Examples of access strategies in LICs

area. The number of initiatives meeting all inclu-

countries in scope. Roche publicly pledges towere not provided. Roche makes efforts to reachsion criteria is higher than average and moreneither file for nor enforce patents in all Least

additional patients using patient assistance pro-initiatives meet all GPS than what is average

Developed Countries and LICs within the scope

grammes (PAPs). For example, Roche applies

for this indicator. For example, Project ECHO®

of the Index. Roche does not file nor enforce

differential pricing for pertuzumab (Perjeta®) in(Extension for Community Health Outcomes)

patents for its antiretroviral HIV medicines in

Egypt based on the patients' ability to pay, and itaims to help broaden access to best practice can-sub-Saharan Africa.

implements both pricing and non-pricing support

cer treatment in LMICs by training and mentoring

to out-of-pocket patients through a PAP while

healthcare personnel in underserved areas.

Publicly discloses information on patent status.

strengthening the health systems with capac-

Like most of its peers, Roche discloses the patent

ity building initiatives. Roche provides evidence

Has engaged in scaling up three inclusive busi-

statuses for small molecules in scope via the Pat-of how patient reach has been increased throughness models but has not shown evidence of its

INFORMED database. Roche’s disclosure includes

the approaches used, reporting that patient reachinvolvement in piloting any new inclusive busi-

information about patents, patent number andhas more than doubled in 2021.

ness models that meet all inclusion criteria.

jurisdiction.

Roche performs average in the use of inclusive
Has access strategies for its self-adminis-

business models aimed at meeting the access

Performs below average in terms of sharing

tered products for few countries in scope ofneeds of populations at the base of the income

intellectual property (IP) assets with third-

this analysis. Roche performs below averagepyramid (including other underserved popula-party researchers. Roche does not report on any

in this area. The company provides examples oftions) in LMICs. Project TRACMA aims to solve

new IP-sharing agreements with public researchaccess strategies which consider payers’ afforda-

access hurdles of breast cancer patients in Angola

institutions or drug discovery initiatives estab-bility in UMICs and LMICs for one of the fourand provide therapies to the patients who canlished during the current analysis period that

products assessed: alectinib (Alecensa®), a can-benefit from them.

meet all inclusion criteria for evaluation. The

cer drug. This included efforts to reach additional

company does have existing agreements of thispatients using pricing strategies that consider

Performs above average in terms of ensuring

nature in place that were established before therelevant payers’ ability to pay. For example, thecontinuous supply of medicines in LMICs. Roche

current period of analysis and meet all inclusioncompany has implemented a four-tiered pricing

is involved in technology transfers with third-

criteria for evaluation.

strategy for alectinib in the Philippines, the ALIVE

party manufacturers in LMICs, and has a system

programme, based on the country's profile andin place to work with relevant stakeholders to

No use of licensing agreements. Roche does

patients' economic status. In addition, the com-

communicate issues that may affect the supply

not engage in voluntary licensing agreements forpany created a PAP to reduce the out-of-pocket

chain, works with several active pharmaceuti-

products in scope of the Index.

costs for patients. Roche has further initiatives tocal ingredient (API) suppliers/produces in-housesupport medicine access such as deferred pay-

APIs, manages a buffer stock of relevant products

Filed to register new products in 22 countries

ment schemes and capacity building initiatives toand is involved in supply chain capacity buildingin scope on average. Roche has filed for registra-

strengthen the healthcare system. Evidence ofinitiatives.

tion one of its newest products in eight of the top

patient reach increase is provided.
Has a policy for reporting substandard and fal-ten high burden countries. This product, Elecsys®
Chagas, used for diagnosis and screening ofNone of the manufacturing capacity build-sified (SF) medicines in countries in scope of

Chagas disease, has been filed for registration ining initiatives included for analysis meet all

the Index. Roche has a policy for reporting SF

15 countries in scope of the Index. The majority ofGood Practice Standards. Roche's performance

medicines to relevant health authorities, but

Roche's products considered for analysis have notis below average in this area. The number of ini-does not strictly specify the reporting timeframe.

been filed for registration in LICs.

tiatives meeting all inclusion criteria is lower

Roche, however, states that reporting typicallythan average and fewer initiatives meet all Goodoccurs within 24 hours once a case is confirmed.

Has access strategies for its supranationally

Practice Standards (GPS) than what is average

Earlier reporting prior to the end of the investiga-

procured products in scope of this analysis.

for this indicator. In one of the included initia-

tion is possible when visual inspection is sufficientRoche performs below average in securing accesstives starting in 2018, Roche built manufacturing

for confirmation.

for products procured supranationally. The com-capacity by transferring technology for secondarypany supplies three products assessed via its

packaging of bevacizumab (Avastin), trastu-

Donates in response to expressed need andGlobal Access Program (GAP), developed in con-zumab (Herceptin®) and rituximab (MabThera®)

monitors delivery. Roche has public policies

sultation with international partners includingin Algeria.

and supply processes in place to ensure ad hoc

CHAI, PEPFAR, USAID, UNITAID and the Global

donations are carried out rapidly in response toFund. Roche did not provide examples of how

Three of the four supply chain capacity build-

expressed need, and it monitors the delivery ofaccess was secured for countries not eligible foring initiatives included meet all Good Practice

donations until they reach the patient.

the GAP. However, Roche has been expanding theStandards. Roche's performance is above aver-

GAP by including new diagnostics for HPV-related

age in this area. The number of initiatives meeting

Has no long-term donation programmes for

cervical cancer, tuberculosis and hepatitis in 2019all inclusion criteria is higher than average andneglected tropical diseases (NTDs) or malaria

and molecular PCR diagnostic tests for COVID-19

more initiatives meet all GPS than what is aver-that are eligible for analysis under this indi-

in 2021. The company demonstrated expansion

age for this indicator. For example, the Global

cator. Roche is not engaged in any structuredof patient reach: to date over 11 million children

Philanthropic Secondment Program provides

donation programmes for NTDs or malaria where

have been tested for HIV with Roche tests.

the mechanism to share Roche employee exper-

elimination, eradication or control goals are pos-tise with NGOs that are helping to improve global

sible and that are eligible for analysis under thisHas access strategies for the majority ofhealth and education, including the topic of sup-indicator.

healthcare practitioner-administered products

ply chain, logistics and project management.

in scope of this analysis. Roche's performance219

is above average in this area.* The company pro-All five health systems strengthening initiatives

vides examples of access strategies in bothincluded for analysis meet all Good Practice

UMICs and LMICs for four of the five productsStandards. Roche is one of the leaders in this

* The description of Roche’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.