Sustainability Accounting Standards Board (SASB) index - Sanofi
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REPORTING FRAMEWORK AND INDICATORS
Sustainability Accounting Standards
Board (SASB) index
Code Metrics Sanofi's Disclosures Comments
Safety of Clinical Trial Participants
Post-Trial Access Policy
Incidental Findings
Access to clinical trial data
Clinical Study Transparency Policy All our clinical trials are run in
accordance with the Principles of
Discussion, by world
Clinical Trial results Good Clinical Practice (GCP) and
region, of management
HC-BP-210a.1 process for ensuring
Patient support international ethical standards, in
quality and patient safety
during clinical trials
particular the Helsinki Declaration on
Policy Position on Minority Diversity in ethical principles regarding human
Human Clinical Trials experimentation.
Medical Ethics, Bioethics and Clinical
Trials Chapter 4 p.29-30
Integrated Report
Number of FDA Sponsor
Inspections related to
clinical trial management Sanofi systematically aligns on the
and
Pharmacovigilance most exacting standards of Good
pharmacovigilance that
HC-BP-210a.2
resulted in: (1) Pharmacovigilance Practices. In 2020,
Voluntary Action Indicated Chapter 4 p.27 33 audits and 5 inspections have been
(VAI) and (2) conducted on Pharmacovigilance.
Official Action Indicated
(OAI)
Total amount of monetary
losses as a result of
Sanofi and its subsidiaries disclose
legal proceedings their involvement in litigation,
HC-BP-210a.3 Form 20-F p135-138
associated with clinical arbitration and other legal
trials
in developing countries proceedings.
SASB Index
1
Published May 2021Access to Medicines
Sanofi’s strategy of improving access
to healthcare for the underserved is as
much about ending global epidemics
of infectious diseases and avoiding
their resurgence, as it is about
meeting the growing needs of patients
Access to Healthcare (Factsheet) suffering from non-communicable
Description of actions and Access to Healthcare for the most diseases. Sanofi Genzyme helps
initiatives to
vulnerable (Factsheet) patients access unique therapies,
promote access to health
care products for regardless of their location and
HC-BP-240a.1
priority diseases and in Addressing the Needs of Rare Disease financial situation, by working closely
priority countries as Patients around the World with national health services,
defined by the Access to
Medicine Index Chapter 4 p.18 government agencies and private
insurers, as well as patient
Integrated Report associations.
Sanofi Global Health will operate in
the 40 countries with some of the
lowest gross domestic product (GDP)
per capita, and will offer 30 of our
most essential medicines.
Sanofi and the World Health
Fighting Malaria Organization (WHO) have joined
List of products on the
WHO List of Fighting Neglected Tropical Diseases forces in the fight against NTDs since
Prequalified Medicinal 2001. Sanofi is also at the forefront by
HC-BP-240a.2 Products as part of its Fighting Tuberculosis developing new treatment options for
Prequalification of
Medicines Programme Chapter 4 p.21 Tuberculosis and Malaria diseases.
(PQP)
Integrated Report The list is of medicines and vaccines is
available here
Affordability & Pricing
Number of settlements of
Abbreviated New
Drug Application (ANDA)
litigation that
involved payments and/or
HC-BP-240b.1
provisions to delay Form 20-F p136 Patent litigation of Cerdelga®
bringing an authorized
generic product to
market for a defined time
period
Percentage change in: (1)
average list price
and (2) average net price Chapter 4 p. 22-23
HC-BP-240b.2
across U.S. product
portfolio compared to Prescription Medicine Pricing Principles
previous year
SASB Index
2
Published May 2021Percentage change in: (1)
list price and (2) net
HC-BP-240b.3 price of product with Not reported
largest increase
compared to previous year
Drug Safety
List of products listed in FDA's MedWatch Safety Alerts for
the Food and Drug Human Medical
Administration’s (FDA)
HC-BP-250a.1 Zantac OTC recall
MedWatch Safety Products database
Alerts for Human Medical
Products database Form 20-F 2020 p.67-68
Number of fatalities
associated with products
HC-BP-250a.2 as reported in the FDA FDA Adverse Event Reporting System
Adverse Event
Reporting System
Number of recalls issued, In 2020, Sanofi conducted 39 recalls
HC-BP-250a.3 Chapter 4 p.27
total units recalled (45 in 2019 and 44 in 2018).
Sanofi focuses particular attention on
the challenge of preventing
Pharmaceuticals in the environment
Total amount of product pharmaceuticals from entering the
HC-BP-250a.4 accepted for takeback, Chapter 4 p.44 to 47 environment. Sanofi is committed to
reuse, or disposal
minimize the potential environmental
Planet Mobilization
impacts of our medicines through its
Planet Mobilization Program.
Number of FDA
enforcement actions taken
in In 2020, Sanofi has received 177
HC-BP-250a.5 response to violations of Chapter 4 p.27 regulatory inspections, of which 22
current Good
Manufacturing Practices
were conducted by the US FDA.
(cGMP), by type
Counterfeit Drugs
Description of methods
and technologies used
Fighting Falsified Medical Products
to maintain traceability of
HC-BP-260a.1 products
Serialization : Medicine Identification,
throughout the supply
chain and prevent Authentication & Traceability
counterfeiting
Sanofi has training programs for
employees, public health agents,
Discussion of process for customs officials and police officers
alerting customers from around the world. There has
and business partners of
HC-BP-260a.2
potential or known Fighting Falsified Medical Products been a focus on internal awareness
risks associated with among sales forces as well as quality
counterfeit products and supply chain representatives to
better detect malicious acts (theft,
falsification, illicit diversion) involving
SASB Index
3
Published May 2021Sanofi products, and to put in place
mitigation measures within the
framework of an end-to-end product
security program.
Number of actions that led
to raids, seizure, Sanofi cooperates for instance with
arrests, and/or filing of
HC-BP-260a.3
criminal charges Fighting Falsified Medical Products Interpol Operation Pangea and
related to counterfeit Europol Operation Shield
products
Ethical Marketing
Total amount of monetary Sanofi and its subsidiaries disclose
losses as a result of Promotional Practices (Factsheet) their involvement in litigation,
HC-BP-270a.1 legal proceedings
associated with false Form 20-F p135-138 arbitration and other legal
marketing claims proceedings.
The core mission of our promotional
activities is to provide quality
Description of code of
information about the product
ethics governing Promotional Practices (Factsheet) presented in compliance with the
HC-BP-270a.2
promotion of off-label use
Code of Ethics marketing authorization for that
of products
product, and to promote correct use
of the product among healthcare
professionals.
Employee Recruitment,
Development & Retention
Discussion of talent
recruitment and retention Chapter 4 p. 9-10
HC-BP-330a.1 efforts for scientists and
research and Integrated Report
development personnel
(1) Voluntary and (2)
Chapter 4 p.17
involuntary turnover rate
for: (a) executives/senior
Integrated Report
HC-BP-330a.2 managers, (b) midlevel
managers, (c) CSR Indicators Evolution and Auditors’
professionals, and (d) all
others Report (Factsheet) p.10-11
Supply Chain Management
Percentage of (1) entity's
facilities and (2) Tier I
suppliers' facilities
For all manufacturing, supply and
participating in the Rx-360 distribution of our pharmaceutical
International products and vaccines, our facilities
Pharmaceutical Supply
HC-BP-430a.1
Chain Chapter 4 p.25-28 hold the manufacturing licenses and
Consortium audit program GxP certificates issued by the
or equivalent third-party appropriate health authorities (FDA,
audit programs for
integrity of supply EMEA, WHO…)
chain and ingredients
SASB Index
4
Published May 2021Business Ethics
Total amount of monetary Sanofi and its subsidiaries disclose
losses as a result of
their involvement in litigation,
HC-BP-510a.1 legal proceedings Form 20-F p135-138
associated with corruption arbitration and other legal
and bribery proceedings.
Description of code of Relations with Healthcare professionals
ethics governing
HC-BP-510a.2
interactions with health Service Engagements with Scientific
care professionals Experts
Activity Metric
Access to Healthcare (Factsheet)
Our access to healthcare reached 124
Number of patients CSR Indicators Evolution and Auditors’
HC-BP-000.A million of patients in more than 170
treated report (Factsheet)
countries in 2020.
Integrated report
Number of drugs (1) in (1) Form 20-F p15-24
portfolio and (2) in
HC-BP-000.B
research and (2) Research and Development
development (Phases 1-3)
Integrated Report
Smart links :
- Sanofi Website
- Document Center
- Integrated Report 2020 Live
- Integrated Report 2020 pdf
- Annual Report on Form 20-F 2020
- Universal Registration Document (in French)
- Declaration of Extra-Financial Performance (Chapter 4 of the Universal Registration Document)
SASB Index
5
Published May 2021You can also read
