Access to Medicine Index 2022 ▶ Company report cards

RA N KSCO R E8

3.47

5 (2021)

SanofiStock exchange: EPA • Ticker: SAN • HQ: Paris, France • Employees: 95,442

PERFORMANCE IN THE 2022 INDEX
8th place. Sanofi ranks among the top ten companies in the
Index. The company has strong policies governing access to
medicine and patent transparency. It leads in applying accessstrategies for supranationally procured products and engages

How score was achieved
4.43

Governance of Access
2.88

Research & Development

3.53

Product Delivery

in R&D for neglected tropical diseases.

0

1

Governance of Access: 2nd place. Sanofi has a strong per-2

3

Average

Leader4

5

formance in this area. It has an integrated access-to-medicine strategy with direct board-level responsibility foraccess-to-medicine and incentives for its senior executives,
including the CEO, and in-country and regional managers. It

Product Delivery: 8th place. Sanofi performs well in thisdiscloses outcomes of its access-to-medicine activities andarea. The company applies comprehensive access strate-

has a robust set of compliance controls to mitigate the risk ofgies for healthcare-practitioner administered products, with

non-compliance in countries in scope of the Index.

the majority covered by strategies across all country income
classifications. However, the strategies for self-adminis-

Research & Development: 8th place. Sanofi performs above

tered products tend to focus on upper-middle and lower-mid-average in this area. It has a structured access planning frame-dle income countries. The company engages in high-qual-

work and applies this to most of its late-stage pipeline candi-

ity health systems strengthening and manufacturing capacity

dates. The company has an average-sized priority pipeline andbuilding initiatives. It has strengthened its performance withperforms well in R&D capacity building.

respect to inclusive business models.

OPPORTUNITIES FOR SANOFICHANGES SINCE THE 2021 INDEX

Ensure all late-stage R&D projects have comprehensive access plans.

• Established Sanofi Global Health Unit, a non-profit unit aimed at

Sanofi has access plans in place for 81% of its late-stage projects. It can

providing access to essential medicines and care through affordable

apply plans to all late-stage candidates from Phase II onwards, including

prices and supporting local capacity building with programmes for

the Pneumococcal Conjugate Vaccine (Skypac, SP0202).

specific low and lower-middle income countries.
• Through the Global Health Unit, Sanofi has shared a commitment to

Expand registration of analogue insulins. Sanofi has six analogue insulins
in its portfolio. Insulin glargine (Toujeo®) has been filed in 30 countries
within scope of the Index. Sanofi can expand the registration of thisproduct as well as insulin lispro (Admelog®) and Insulin aspart Sanofi,
especially in countries with a high burden of diabetes such as Sri Lanka,

expand access to analogue insulins, namely glargine and glulisine, withthe target to reach 300,000 insulin-dependent patients by 2030.
• Launched a new brand of standard care medicines called Impact®. These
medicines are produced by Sanofi for non-profit distribution by the
Sanofi Global Health Unit to at-risk populations in 40 LMICs.

Guyana and Suriname.

• Integrated a new CSR strategy which places more focus on Access via its

Expand access to insulin and diabetes products. For insulin glargine• Announced the development of a global access plan for all new products,

Affordable Access and Vulnerable Communities strategic pillars.
(Lantus®), Sanofi implements access strategies considering payers' ability

with aims to make them available within two years post first launch

to pay in at least one upper-middle income country and one lower-middle

wherever this can make an impact for patients (including in countries

income country. The company can apply access and pricing strategies

within scope of the Index).

in low-income countries (LICs) to improve the affordability of diabetes• Sought regulatory authorisation alongside GSK for its COVID-19 vaccine.

medicines such as glimepiride/metformin (Amaryl® M) and insulin• Renewed partnership with the World Health Organization (WHO) to fightglargine in LICs, following through on the commitments made through theneglected tropical diseases and eliminate sleeping sickness before 2030

company's Global Health Unit.

through its long-term donation programme of pentamidine eflornithine,
melarsoprol and fexinidazole.

Measure and share outcomes of Sanofi Global Health Unit. In 2021, Sanofi• Joined the Access to Oncology Medicines (ATOM) Coalition, a new global

launched its Global Health Unit, which will expand on the company’s work

initiative that aims to improve access to essential cancer medicines inwith partners to increase access to 30 of its medicines for communicableand non-communicable diseases. To scale up this initiative and support

LMICs.
• Issued EUR 1.5 billion bond linked to access to medicine.

integration into local health systems, Sanofi can track and share both
short- and long-term patient outcomes as part of its impact evaluation ofthis programme, in addition to outcomes such as patient reach and productvolumes sold.

73

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: Pharmaceuticals, Vaccines

April 2021. Additionally it acquired Translate Bio

and Consumer healthcare.

in September 2021, Kadmon Holdings, Inc. in

Net sales by segment (2021) – in EUR

Therapeutic areas: Oncology, Immunology &November 2021, Origimm Biotechnology GmbH

Pharmaceuticals

Inflammation, Neurology, Rare Blood Disorders,in December 2021 and Amunix Pharmaceuticals,

Vaccines

6.32 bn

Rare Diseases, Diabetes and Cardiovascular

Inc. in February 2022.

Consumer healthcare

4.47 bn

Diseases.

26.97 bn		Product categories: Innovative medicines,

Sanofi's products are sold in 92 out of 108

Vaccines and Consumer health products.

countries in scope of the Index. Sanofi has sales

M&A news: Sanofi acquired Kiadis Pharma N.V.,

offices in 36 countries, and sells via distributors

Kymab Group Ltd. and Tidal Therapeutics inin an additional 56 countries.

Total

Sales by geographic region40

Net sales (Bn EUR)

Sales in countries in scope

37.76 bn

30
20
10
0

In scope, has sales offices

2017

In scope, any sales

USA

In scope, no sales

2018

2019

2020

2021

EuropeOther countries

Not in scope

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

PORTFOLIO as selected for analysis by the Index

Sanofi has a total of 37 R&D projects in scope, with 16 projects targeting a

Sanofi has 65 medicines in scope, 12 of which are on patent, and 15 vaccines.

priority disease. The other 21 R&D projects target other diseases in scope.

54% of the medicines (35) are on the WHO EML. In addition, the company

Of the projects targeting priority diseases, the focus is on lower respiratory

markets four platform technologies. The off-patent medicines target com-

tract infections (seven projects). Of the projects targeting other diseases inmunicable diseases (11) such as tuberculosis (6), malaria (3) and HIV/AIDS (1);scope, the focus is on oncology (14) Twenty-one R&D projects are in late-non-communicable diseases (NCDs) (36) such as diabetes (6), cardiovascu-

stage development that target either a priority disease (8) or address alar diseases (10), mental health conditions (10); and certain neglected tropical

public health need in LMICs (13).* Evidence of access planning was in placediseases. The on-patent medicines target mainly NCDs such as cancer (3),for 81% of these projects: six targeting a priority disease and 11 addressing

diabetes (3) and kidney diseases (2). Sanofi's preventive vaccines (15) targeta public health need in LMICs.

diseases such as tetanus, meningitis and yellow fever.

37 projects in the pipeline

84 products as selected for analysis by the Index†
15

Communicable**

Maternal and neonatal 1

1850

Non-communicableMultiple categories 02

Multiple categories
0

20
30
40
50
projects in the pipeline

40
60
80
100
products on the market

Pre-clinical

Phase I

Phase II

Phase III

Registration/approval

Other***

Total

3

2

2

3

3

1

16

Contraceptives

Medicines on patent

2 10

12

off patent

33 20

53
15

Addresses needs of LMICs*

0

3

5

5

0

13

Diagnostics

Other projects in scope

5

3

0

0

0

8

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-

Total

Discovery

Vaccines

2

Targets established R&D priorities

Other

Breakdown of products
WHO EML

Breakdown of projects

20

WHO EDL

10

Non-EML

Non-communicable74

7Neglected tropical

Maternal and neonatal 0024Communicable**

4

Neglected tropical

‡

14

1

0

0

0
0

0
4

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.

4

Access to Medicine Index 2022 ▶ Company report cards

Sanofi

GOVERNANCE OF ACCESSRANK 2SCORE 4.43

Has an access-to-medicine strategy with meas-

closes commitments, measurable goals, objectives

Sanofi performs strongly, demonstrating evi-

urable objectives, integrated within its overall

and targets for improving access to medicine

dence of all components looked for by the Index:

corporate strategy. Sanofi performs strongly. Its

in countries in scope of the Index. It facilitates

fraud-specific risk assessment, country risk-based

access to healthcare strategy, recently revamped

accountability and transparency by consistently

assessment, a continuous system to monitor

in 2021, is integrated in the activities of its three

sharing the outcomes of its access-to-medicine

activities, audits (both internal and external, cov-

core global business units: Sanofi Pasteur, Sanofi

activities in a centralised manner within its Accessering third parties and in all countries where it

Genzyme and General Medicines and its stan-to Healthcare Programmes Report and in its quar-

operates) and has formal processes to ensure

dalone business unit, Consumer Healthcare. A fifth

terly results press release.

third-party compliance with company standards.

non-profit business unit was created, Sanofi Global

No breaches in countries in scope of the Index

Health. The strategy covers all therapeutic areas

Performs well in responsible promotional prac-

in which the company is involved. The highest

tices. Sanofi's Sales Incentive Plan is primarily

responsibility for access lies directly with board-

driven by sales volume, but qualitative compo-

Publicly supports the Doha Declaration onlevel members seated on the Corporate Social

nents are adjusted depending on the specific

TRIPS and Public Health. Sanofi publicly shares

Responsibility (CSR) committee.

situation. The company sets sales incentives at

support of the Doha Declaration on TRIPS andthe national level for agents in most of the coun-

Public Health, but expresses reservations on

Provides evidence of financial and non-finan-

tries that are in scope of the Index. It has a policy

its provisions, stating that compulsory licensing

cial access-related incentives at the executive

on service engagement with scientific experts, butshould only be used in extraordinary and very lim-

level. Sanofi performs strongly. It incentivises

it does not publicly disclose information related toited circumstances. There is evidence of industry

its senior executives and in-country managers

transfers of values to healthcare professionals inassociation lobbying on intellectual property andto take action on access to medicine with finan-countries in scope of the Index (e.g. payments forthe usage of TRIPS flexibilities, namely of com-cial and non-financial rewards. The CEO also has

attending events or promotional activities), unlesspulsory licensing, by national governments inaccess-related incentives beyond CSR goals.

required by law or by local regulations.

some countries in scope of the Index. As a mem-

Publicly discloses outcomes of its access-to-­Has a robust set of compliance controls toother member companies in scope of the Index, ismedicine activities. Sanofi performs strongly inensure that governance efforts are not under-

by default connected to this activity.

transparency of access activities. It publicly dis-mined by non-compliant or corrupt activities.

were publicly found in the period of analysis.

ber of the industry association, Sanofi, like all

RESEARCH & DEVELOPMENT75

RANK 8SCORE 2.88

Access planning processes encompass all pro-in countries in scope of the Index. Notably, Sanofi

projects. These plans mostly relate to planningjects in the pipeline. Sanofi has a structured

partners with Drugs for Neglected Diseases initi-

registration in countries where it is conducting

process in place to develop access plans dur-

ative (DNDi) for two projects using fexinidazole

clinical trials.

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

to treat for two different types of human African

to all R&D projects (both in-house and collabora-trypanosomiasis. These access plans include

Publicly discloses disaggregated R&D invest-tive) for diseases in scope of the Index. In general,

WHO prequalification, a donation programmement data for phase of development. In

Sanofi begins developing access plans for R&D

managed by WHO and plans for registration in

addition, Sanofi also discloses fully disaggregatedprojects in Phase II of clinical development.

countries with a high burden of disease.

R&D investment data to Policy Cures Research.

An average-sized priority R&D pipeline com-Some projects address a public health need inThree of the four R&D capacity building ini-pared to its peers, with access plans in place for

LMICs,* with 85% (11/13) of late-stage projects

tiatives included meet all Good Practice

75% (6/8) of the late-stage candidates. Sanofi

covered by access plans. In this analysis, Sanofi

Standards. Sanofi's performance is above aver-has 16 projects, including eight late-stage candi-has 13 late-stage R&D projects that target a dis-age in this area. The number of initiatives meeting

dates in its pipeline that target a priority productease and/or product gap not yet established as a

all inclusion criteria is higher than average andgap. The company focuses on various priority

priority by global health stakeholders. These pro-more initiatives meet all Good Practice Standards

areas, including lower respiratory tract infec-

jects are all deemed by the Index to offer a clear

than what is average for this indicator. For exam-tions, coronaviral diseases and human African

public health benefit for people living in LMICs.*ple, through the Sanofi Global Site Partnership,

trypanosomiasis. Of Sanofi’s eight late-stage can-Primarily, these projects concern clinical trials in

Sanofi partners with over 80 institutes to build

didates targeting a priority product gap, there iscountries in scope of the Index and/or are first-

clinical trial capacity in countries in scope of theevidence of an access plan for six. These plans

in-class molecules. Most target cancer. Sanofi

Index.

prioritise WHO prequalification and registration

provides evidence of access plans for 11 of these*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 8SCORE 3.53

Publicly pledges not to enforce patents. Sanofi

for treatments. For example, Sanofi supplies its

all inclusion criteria is higher than average andpublicly pledges to neither file for nor enforce

meningitis vaccine (Menactra®) via tenders run

more initiatives meet all GPS than what is aver-patents. This commitment applies in all Least

by international and local public authorities in 23

age for this indicator. For example, the My Child

Developed Countries and LICs and in a subset ofcountries in scope of the Index, of which six are

Matters programme was initiated by the Sanofi

LMICs and UMICs.

LICs. The company offers a price that is adjusted

Espoir Foundation in 2006 in order to fight child-to local tenders' specifications and considers

hood cancer and reduce health inequalities

Publicly discloses information on patent status.

countries' ability to pay. In parallel, it supports

worldwide. This initiative meets all GPS.

Sanofi publicly discloses on its website infor-

local healthcare systems by providing training tomation relating to the status of its patents for

public managers. This training includes cold chain

Has engaged in both scaling up and piloting

products on the WHO Model List of Essential

management and vaccination surveillance. Sanofi

one inclusive business model. Sanofi per-Medicines (EML).

provides evidence of how patient reach has been

forms above average in the use of inclusive

increased through these approaches.

business models aimed at meeting the access

Performs below average in terms of sharingneeds of populations at the base of the income

intellectual property (IP) assets with third-

Has access strategies for its self-administeredpyramid (including other underserved popula-party researchers. Sanofi does not report on any

products for some countries in scope of thistions) in LMICs. The Sanofi Global Health Unit is

new IP-sharing agreements with public researchanalysis. Sanofi has an average performance ina new non-profit unit that sells and/or donates

institutions or drug discovery initiatives estab-this area. For one of the five products assessed,

30 of Sanofi's products at affordable prices tolished during the current analysis period thatthe company provides examples of access strat-

approximately 40 low and lower-middle income

meet all inclusion criteria for evaluation. The

egies in countries of all assessed income levels

countries.

company does have existing agreements of this(UMIC, LMIC, LIC), including efforts to reachnature in place that were established before theadditional patients through pricing strategies

Performs above average in terms of ensuring

current period of analysis and meet all inclusionthat consider local payers' ability to pay and dis-continuous supply of medicines in LMICs. Sanofi

criteria for evaluation.

ease management initiatives. For example, Sanofi

is involved in technology transfers with third-

ensured the inclusion of glimepiride/metformin

party manufacturers in LMICs, and has a system

No use of licensing agreements. Sanofi does

(Amaryl® Min) in Colombia’s mandatory nationalin place to work with relevant stakeholders to

not engage in voluntary licensing agreements forhealth plan which offers 100% coverage to eligible

communicate issues that may affect the supply

products in scope of the Index.

patients. The company has additional strategies

chain, works with several active pharmaceuti-

to improve disease early diagnosis, treatment

cal ingredient (API) suppliers/produces in-house

Filed to register new products in 14 countries

adherence and patient health outcomes. Sanofi

APIs, manages a buffer stock of relevant products

in scope on average. Sanofi did not disclose evi-

provides evidence of patient reach, reporting thatand is involved in supply chain capacity building

dence of filing for registration any of its new

approximately 920 patients receive the treat-

initiatives.

products in more than half of the top ten highment yearly.
Has a policy for reporting substandard and fal-burden countries. Among new products, its mostwidely filed is the booster vaccine (Tetraxim),

Four of the five manufacturing capacity build-sified (SF) medicines in countries in scope ofindicated for tetanus and pertussis prevention,

ing initiatives included meet all Good Practicethe Index in less than ten days. Sanofi has a pol-filed in 38 countries within the scope of the Index,

Standards. Sanofi's performance is above aver-icy for reporting SF medicines to national healthincluding four high burden disease countries andage in this area. The number of initiatives meeting

authorities or the WHO within seven days. It does

eight LICs.

all inclusion criteria is higher than average andnot provide evidence of shortened reporting time

more initiatives meet all Good Practice Standards

frames for cases which only require visual inspec-

Has access strategies for all supranationally(GPS) than what is average for this indicator. Fortion to be confirmed.

procured products in scope for this analy-

example, Sanofi has been working with the May

sis. Sanofi leads in securing access for products& Baker manufacturing site since 2015. The com-

Donates in response to expressed need andprocured supranationally. For the five products

pany provides training on hygiene, on-site safety

monitors delivery. Sanofi has public policies

assessed in this category, the company demon-and good manufacturing practice. This initiativeand supply processes in place to ensure ad hoc

strates strategies both in countries eligible formeets all GPS.

donations are carried out rapidly in response tosupply from such procurers and in at least one

expressed need, and it monitors the delivery of

non-eligible country. For example, the company

One of the five supply chain capacity build-offers the same terms to Brazil and Mexico foring initiatives included meets all Good Practicethe influenza trivalent vaccine (Vaxigrip® TIV) as

Standards. Sanofi's performance is average in

Publicly commits to the achievement of elim-

it does for PAHO-eligible countries. Sanofi pro-this area. The number of initiatives meeting all

ination, eradication or control goals in one

vides evidence of how patient reach has been

inclusion criteria is higher than average but fewer

structured donation programme for neglected

increased through these approaches.

initiatives meet all GPS than what is average fortropical diseases or malaria. Sanofi publicly com-this indicator. Sanofi partnered with the Vietnam

mits to contributing to the elimination of humanHas access strategies for the majority ofVaccine Joint Stock Co. to build capacity in supply

African trypanosomiasis by donating pentamidine

healthcare practitioner-administered products

chain planning. This includes improving forecast-(Pentacarinat®), eflornithine (Ornidyl®), melar-in scope of this analysis. Sanofi performs above

ing and warehouse planning to meet vaccine

soprol (Arsobal®) and fexinidazole (Fexinidazole

average in this area. For three of the five prod-

demand. This initiative meets all GPS.

Winthrop®) in 21 countries in scope of the Index

ucts assessed, the company provides examples

76

donations until they reach the patient.

until goals are reached.

of access strategies in countries of all assessed

Four of the five health systems strengthen-income levels (UMIC, LMIC, LIC), including efforts

ing initiatives included meet all Good Practice

to reach additional patients through pricing strat-

Standards. Sanofi's performance is above aver-egies considering relevant payers' ability to pay

age in this area. The number of initiatives meeting