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

Employees

Healthcare professionals

Authorities and payers

Business partners

Patients

International and local organisations

Investors

Local communities

Media

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

 

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References:

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:

http://database.globalreporting.org/

2) http://www.fbrh.co.uk/en/global-reporting-initiative-gri-g4-guidelines-download-page

3) https://g4.globalreporting.org/Pages/default.aspx

4) https://www.globalreporting.org/standards/gri-standards-download-center/

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.

What are the material issues the company has identified?

In its 2014 Corporate Social Responsibility Report Sanofi identified a range of material issues, such as access to healthcare, patient safety, ethics in Research & Development, business ethics, people development. Among these, reducing the environmental impact of pharmaceuticals stands out as a key material issue, as addressing pharmaceuticals in the environment is one of the priority focuses of Sanofi’s environmental strategy.

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 organization should identify its stakeholders, and explain how it has responded to their reasonable expectations.”

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

Employees

Healthcare professionals

Authorities and payers

Business partners

Patients

International and local organizations

Investors

Local communities

Media

How stakeholder engagement was made to identify material issues

After developing an exhaustive list of sustainability issues, Sanofi performed a mapping of both internal and external stakeholders to engage in the materiality analysis. Sanofi first secured the participation of 33 internal business leaders and decision-makers, including members of the Executive Committee and the senior leadership team (Sanofi’s top 200-plus), across its business units and in all of its major regions of operation. Sanofi then worked with BSR to identify more than 270 external stakeholders across the company’s diverse stakeholder groups. Sanofi and BSR then prioritized these stakeholders using three criteria – expertise, willingness to engage and level of influence – with the intention of replicating as closely as possible the stakeholder spread across categories and locations. Finally Sanofi examined the list for duplication and produced a shortlist of 110 stakeholders to invite.

Sanofi’s desire was to engage with the maximum of stakeholders from this shortlist, yet the company was met with a number of difficulties. Certain stakeholders were unable to participate because of time constraints and others were uncomfortable participating, despite Sanofi’s pedagogical efforts to explain the purpose and process of materiality. Despite these difficulties, Sanofi was very happy to engage with 69 external stakeholders, including 36 through interviews and 33 via an online survey. This division was intentional, as each type of input provides different benefits – the external stakeholder survey allows for rapid gathering of data from a broad set of stakeholders and interviews probe more deeply on topics where survey data is inconclusive or where open-ended responses are critical to developing an in-depth understanding of stakeholder expectations. In total Sanofi engaged with more than 100 internal and external stakeholders spread across all regions in which Sanofi does business, providing for a large sample size that Sanofi believes represents its diverse stakeholder landscape.

Acting as an impartial third party, BSR interviewed both the internal and external stakeholders. Interviewees were asked to review the exhaustive list of issues and identify the most and least important. They assessed the issues based on their experience and perspective, as well as criteria chosen carefully by Sanofi, such as potential impact on revenue generation or potential regulatory or reputational risk. Interviewees were additionally asked to note risks or opportunities related to the most important issues, to identify trending issues (that is, those issues that might not yet be viewed as material, but that were thought to have increasing importance) and to provide and discuss any issues they felt were missing from the list. It is important to note that Sanofi did not ask the participants to assess the company’s performance for each issue. Survey respondents performed the same exercise via a secure online survey tool using the same questions and selection criteria as those used in the external interviews, with dedicated space for additional comments and consideration.

What actions were taken by Sanofi to reduce the environmental impact of pharmaceuticals?

In its 2014 Corporate Social Responsibility Report Sanofi set the following targets for reducing the environmental impact of pharmaceuticals, based on the company’s approach to materiality – on taking action on what matters, where it matters:

• Analyzing wastewater effluents at Sanofi sites

Sanofi has established a program at eight Sanofi chemical manufacturing sites to develop analytical methods for detecting and quantifying pharmaceutical substances in wastewater from its treatment plants. The program will also determine maximum target concentrations. Sanofi identified 30 active pharmaceutical ingredients (APIs) from Sanofi’s product port­folio based on environmental proprieties (tonnage, toxicity, bioaccumulation and persistence) and began to quantify their trace amounts in wastewater effluents. By late 2014, 44% of the APIs in wastewater from Sanofi’s sites had been assigned a target value. Sanofi’s in-house experts would use the company’s cutting-edge facilities at the Sanofi Chemistry & Biotechnology Development Laboratory to determine such values for the remaining 56% by the end of 2015.

• Using state-of-the-art technologies to treat wastewater discharge from Sanofi’s sites

Sanofi is committed to making its processes safer and more environmentally friendly. Industrial effluents (wastewater) are treated either in the sites’ wastewater treatment facilities and/or at municipal treatment sta­tions in accordance with operating permits. The choice and performances of technolo­gies for effluent treatments are adapted to site specific conditions. Specific additional treatments may be implemented either at the workshop level or at site discharge, when required and appropriate. The Group’s manufacturing sites want to reach “the best practices.” In 2014, the Sanofi Chemistry & Biotechnol­ogy Development Laboratory received NF EN ISO/CEI 17025 accreditation, positioning Sanofi as a major player in micropollutant monitoring. Located in Aramon, France, the facility is Sanofi’s internal reference laboratory for the analysis of effluents from industrial sites, giving Sanofi’s in-house specialists access to the latest technology to identify, monitor and quantify micropollutants in wastewater discharge. This official accreditation recog­nizes Sanofi’s high-quality quantification expertise as well as the excellence of its methods, processes and equipment as a support to its facilities.

• Carrying out environmental risk assessments

Sanofi’s commitment to preventing environ­mental risks is central to its CSR and HSE (Health, Safety and Environmental) policies. Guided by Sanofi’s Ecoval committee of in-house experts, Sanofi has established a sound governance system for assessing the potential impact of its products on the envi­ronment. The committee also coordinates Sanofi’s Environmental Risk Assessments (ERA) in line with regulations for all new drugs in the United States, Europe and other countries. It also oversees the voluntary environmental studies of APIs used in Sanofi products already on the market.

• Encouraging and supporting the proper use of medicines

Medicines are not ordinary consumer goods. At each link in the healthcare chain, professionals, public authorities, patients and the public must be informed about the proper use of medicines, to ensure their safety and efficacy. Specialists in the field of pharma­ceutical residues in the environment recom­mend an ongoing program of public educa­tion so that medicines are used properly and pharmaceutical waste is limited. In recent years, Sanofi has increased its initiatives to encourage the proper use of medicines, in particular by pro­moting information and education for health­care professionals and patients. Sanofi cooperated with local stakeholders to train doctors, nurses and pharmacists in the PACA region of France (Provence-Alpes-Côte d’Azur) about the proper use of medicines. In 2014, more than 150 people were trained and the program was set to continue in 2015. Additionally, a patient education program in Brittany, France, organized in cooperation with local healthcare professionals, enrolled more than 1,000 patients in 2014.

• Supporting take-back programs for the collection and safe disposal of unused medicines

To protect local ecosystems, Sanofi supports take-back programs that collect unused drugs from patients and informs consumers about their safe disposal. Sanofi has sup­ported such programs in Belgium, Brazil, Colombia, Czech Republic, France, Japan, Mexico, Philippines, Portugal, Saudi Arabia, Spain, Taiwan, Turkey, North America and Venezuela.

Which GRI indicators/Standards have been addressed?

The GRI indicator addressed in this case is: G4-EN27: Extent of impact mitigation of environmental impacts of products and services

 

References:

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:

http://database.globalreporting.org/

2) http://www.fbrh.co.uk/en/global-reporting-initiative-gri-g4-guidelines-download-page

3) https://g4.globalreporting.org/Pages/default.aspx

4) https://www.globalreporting.org/standards/gri-standards-download-center/

Note to Sanofi: With each case study we send out an email to your listed address in request for a comment on this case study. If you have not received such an email please contact us.