The case for CSR/ Sustainability Reporting Done Responsibly


Insights on how you can protect the environment, maintain and increase the value of your company, through a structured process.

Insights on how you can protect the environment, maintain and increase the value of your company, through a structured process.

Home / case studies / Case study: How Sanofi protects patient safety

Case study: How Sanofi protects patient safety

As a global healthcare leader committed to preventing 
and treating diseases and to supporting people around the globe through their health challenges, with a presence in over 100 countries worldwide, Sanofi focuses on protecting patient safety, guaranteeing quality at every phase of a product’s
 life cycle, from the earliest stages of development to distribution.

This case study is based on the 2016 Integrated Report by Sanofi published on the Global Reporting Initiative Sustainability Disclosure Database that can be found at this link. Through all case studies we aim to demonstrate what CSR/ ESG/ sustainability reporting done responsibly means. Essentially, it means: a) identifying a company’s most important impacts on the environment, economy and society, and b) measuring, managing and changing.

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Patient safety is a top priority for Sanofi  Tweet This! and the main focus of its Global Pharmacovigilance and Epidemiology (GPE), quality and anti-counterfeiting teams, with GPE continuously monitoring the safety of Sanofi’s products to determine their best conditions of use. In order to protect patient safety Sanofi took action to:
  • promote effective quality management
  • enhance product security
  • monitor product safety

What are the material issues the company has identified?

In its 2016 Integrated Report Sanofi identified a range of material issues, such as carbon emissions, waste management, talent development, business ethics, medicine pricing and innovation. Among these, protecting patient safety stands out as a key material issue for Sanofi.

Stakeholder engagement in accordance with the GRI Standards

The Global Reporting Initiative (GRI) defines the Principle of Stakeholder Inclusiveness when identifying material issues (or a company’s most important impacts) as follows:

“The reporting organization shall identify its stakeholders, and explain how it has responded to their reasonable expectations and interests.”

Stakeholders must be consulted in the process of identifying a company’s most important impacts and their reasonable expectations and interests must be taken into account. This is an important cornerstone for CSR / sustainability reporting done responsibly.

Key stakeholder groups Sanofi engages with:  

Stakeholder Group
Healthcare professionals
Authorities and payers
Business partners
International and local organisations
Local communities

How stakeholder engagement was made to identify material issues

To identify and prioritise material topics Sanofi organised an international stakeholder panel, gathering more than 40 external stakeholders from around the globe, and also set up internal working groups.

What actions were taken by Sanofi to protect patient safety?

In its 2016 Integrated Report Sanofi reports that it took the following actions for protecting patient safety:

  • Promoting effective quality management
  • Sanofi’s Global Quality vision involves five key areas: quality systems, inspection readiness, quality risk management, quality performance and quality culture. The company’s quality team is dedicated to making sure that products and services provided are fully compliant with all requirements, effective, safe and easy to use. Sanofi uses a mature risk management process, handling quality issues including recalls when necessary, and identifying emerging quality risks, taking measures to avoid them or mitigate their consequences. Sanofi also monitors the quality performance of its own entities and key suppliers or subcontractors through audits, taking appropriate corrective and preventive measures if needed.
  • Enhancing product security
  • Sanofi seeks to ensure optimal product security through a number of initiatives. These include controlled transport conditions and anti-counterfeit measures, such as tamper evidence, authentication technologies, and serialisation. In addition, Sanofi makes sure it adapts to evolutions in the regulatory environment and supports digital health software development, while at the same time making sure all applications are compliant with applicable legal requirements. 
  • Monitoring product safety
  • Sanofi’s Global Pharmacovigilance and Epidemiology (GPE) organisation monitors the safety of its products around the globe: prescription medicines and vaccines, consumer health products, generics and medical devices. GPE constantly assesses the benefit-risk profile of Sanofi’s products at every stage of their life cycle to determine, together with the health authorities, the best conditions of their use. GPE also provides physicians, healthcare professionals and patients with complete, up-to-date safety information, including possible risks associated with a product. Additionally, Sanofi’s GPE Department collects pharmacovigilance data from all sources of information, building strong interactions with patients and healthcare professionals globally, during both clinical development and product life cycle management. In this way, it ensures the completeness of the safety data collection process and the effectiveness of Sanofi’s safety evaluations, in compliance with all applicable regulations and policies. Sanofi also makes safety information on its products available through its websites.

Which GRI Standards and corresponding Sustainable Development Goals (SDGs) have been addressed?

The GRI Standards addressed in this case are:

1) Disclosure 416-1 Assessment of the health and safety impacts of product and service categories

2) Disclosure 417-1 Requirements for product and service information and labeling


Disclosure 416-1 Assessment of the health and safety impacts of product and service categories does not correspond to any SDG.

Disclosure 417-1 Requirements for product and service information and labeling corresponds to:

  • Sustainable Development Goal (SDG) 12: Ensure sustainable consumption and production patterns
  • Business theme: Product and service information and labeling
  • Sustainable Development Goal (SDG) 16: Promote peaceful and inclusive societies for sustainable development, provide access to justice for all and build effective, accountable and inclusive institutions at all levels
  • Business theme: Compliance with laws and regulations


80% of the world’s 250 largest companies report in accordance with the GRI Standards

SustainCase was primarily created to demonstrate, through case studies, the importance of dealing with a company’s most important impacts in a structured way, with use of the GRI Standards. To show how today’s best-run companies are achieving economic, social and environmental success – and how you can too.

Research by well-recognised institutions is clearly proving that responsible companies can look to the future with optimism.

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1) This case study is based on published information by Sanofi, located at the link below. For the sake of readability, we did not use brackets or ellipses. However, we made sure that the extra or missing words did not change the report’s meaning. If you would like to quote these written sources from the original, please revert to the original on the Global Reporting Initiative’s Sustainability Disclosure Database at the link:




Note to Sanofi: With each case study we send out an email requesting a comment on this case study. If you have not received such an email please contact us.