General Access to Medicine ManagementRanking: 7 Score: 3.52
Has a strong access-to-medicine strategy with executive level responsibility. Sanofi is one of the 14 companies that performs strongly with regard to its access-to-medicine strategy, which includes access-related goals and aligns with its corporate strategies. The strategy centres around the development of new business models focused on developing medicines for unmet needs, affordability and strengthening healthcare systems. The highest level of responsibility for access sits with executive committee members.
Financial and non-financial access-related incentives to reward employees. Sanofi performs strongly in encouraging employees to work towards access-related objectives. It is one of 14 companies to have both financial and non-financial incentives in place to motivate employees to perform on access-related issues. These incentives include salary increases, bonuses and awards.
One of 16 companies working on impact measurement. Sanofi measures and monitors progress and outcomes of access-to-medicine activities. It also publicly reports on commitments, objectives, targets and performance information. For example, for its Global Polio Eradication initiative, the company is committed to adapt its production capacity based on needs, and to help provide vaccines to millions of children around the world, reporting a sustained reduction from 350,000 cases in 1988 to 22 in 2017. Furthermore, it is part of the Access Accelerated initiative, which includes a commitment to evaluate impact.
Some transparency about stakeholder engagement approach. Sanofi publicly discloses which stakeholder groups it engages with on access issues, but does not publicly share its process for selecting who to engage with, nor its policy for ensuring responsible engagement. It does incorporate local stakeholder perspectives into the development of access strategies.
Market Influence & ComplianceRanking: 5 Score: 3.05
Has measures to ensure third-party compliance with ethical marketing and anti-corruption standards. Sanofi has a code of conduct and policy relating to ethical marketing and anti-corruption. It provides regular compliance training for employees through e-learning tools. The company provides evidence of having formal processes in place to ensure compliance with standards by third parties. Yet, expected performance for sales agents is based solely on sales targets.
Internal control framework meets some Index criteria. Sanofi's internal control framework to ensure compliance meets some of the criteria looked for by the Index. Namely, it has an auditing and review mechanism, and performs regular evaluations that also apply to third parties. It reports that it regularly conducts fraud-specific risk assessments, and has procedures to segregate duties, so that decisions are checked by another party. It does not, however, demonstrate evidence of a monitoring system for compliance in place.
Above average transparency regarding access-related practices. Sanofi publicly discloses its policy positions on access-related topics (e.g., its global medicine protection strategy includes its position on counterfeit medicines). It is one of the few companies to have a global policy that prohibits political financial contributions. The company publicly discloses its financial support and membership of relevant organisations. It publicly discloses its policies for responsible engagement in its Code of Ethics. It does not, however, publicly disclose its policy approach to payments made to healthcare professionals in countries in scope.
Research & DevelopmentRanking: 5 Score: 2.83
Publicly commits to R&D to meet public health needs. Sanofi has publicly committed to R&D for diseases and countries in scope. Its R&D strategy for low- and middle-income countries is informed by an evidence-based public health rationale based on public health targets. Further, it has time-bound strategies for completing R&D projects for diseases in scope and evaluates progress toward these targets. Sanofi has a mid-sized pipeline in the Index with 56 projects. For diseases in scope where priorities exist, Sanofi is active in 38 projects; 35 of these target priority R&D gaps.
Access provisions in place for 40% (10/25) of late-stage candidates. Sanofi has a clear process in place to develop access plans during R&D. The process considers some R&D projects for diseases in scope, namely vaccines. To date, Sanofi has project-specific access provisions in place for 10 of its late-stage R&D projects, eight of which are preventive vaccine candidates. Of these, four are being conducted in partnership with organisations including the Medicines for Malaria Venture (MMV) and the Drugs for Neglected Diseases initiative (DNDi).
Policy to ensure post-trial access; commits to conduct clinical trials only where it intends to make the product available. Sanofi has a policy for ensuring post-trial access to treatments for clinical trial participants and has provided a detailed example of this policy in action in countries in scope. However, this policy is not publicly available. The policy is aligned with the standards set in the Declaration of Helsinki. Sanofi commits to only perform clinical studies in countries where it intends to make the product available.
Pricing, Manufacturing & DistributionRanking: 6 Score: 2.48
Does not publicly commit to equitable pricing or report a commitment to file to register products in scope. Sanofi does not commit to filing its newest products for registration in countries in scope within one year of first market approval. It also does not publicly commit to implementing equitable pricing strategies. However, it does have equitable pricing strategies for some products in scope of the Index.
Some new products in scope filed for registration in the majority of priority countries. Sanofi has filed 40% of its newest products for registration to date in more than half of the relevant priority countries (disease-specific subsets of countries with a particular need for access to relevant products). It also publicly shares some registration information for the minority of its products.
29% of products have equitable pricing strategies targeting priority countries. Sanofi's overall performance is below average compared to peers in equitable pricing. It demonstrates evidence of having equitable pricing strategies for 29% of its products for diseases in scope. These strategies apply to an average of 35% of priority countries. Some of these strategies apply both inter- and intra-country pricing strategies; these take into account an average of one and two socioeconomic factors, respectively. Sanofi also applies equitable pricing strategies to six further products informed by a public health rationale.
Has both globally consistent recall guidelines for countries in scope and processes to track products. Sanofi has guidelines for drug recalls that apply to all countries in scope. It has processes to track the distribution of products in countries in scope to facilitate rapid and effective recalls.
Patents & LicensingRanking: 18 Score: 0.33
Does not publicly disclose patent statuses.Unlike most of its peers, Sanofi does not disclose the status of its products for diseases and countries in scope.
No use of non-assert or licensing arrangements. Sanofi does not engage in voluntary licensing nor has it issued non-assert declarations for products in scope.
Does not report newly sharing IP assets with 3rd-party researchers beyond existing long term commitment agreements. Sanofi reported existing agreements with product development partnerships, including DNDi, MMV and TB Alliance. During the period of analysis, beyond existing agreements, the company reports no instances where it newly shares IP assets with third-party researchers developing products for diseases in scope.
No public commitment not to enforce patents in countries in scope. Sanofi does not have a public policy available that sets out its approach to filing for or enforcing patents in low- and middle-income countries. However, Sanofi shares information via the Index that it does not file or enforce patents in Least Developed Countries or low-income countries.
Capacity BuildingRanking: 8 Score: 2.29
18 initiatives included for evaluation. Sanofi has 18 capacity building initiatives that were included for analysis by the Index: i.e., the initiatives demonstrably address a specific local need and involve local partners. Companies could submit a maximum of 25 initiatives across all areas for assessment; Sanofi submitted 23.
Strong focus on local manufacturing and strengthening health systems. Sanofi has initiatives which meet inclusion criteria in all five areas of capacity building. Most of these initiatives are focused on manufacturing and health system strengthening; it performs strongest in manufacturing capacity building with multiple technology transfers.
Six initiatives meet all applicable good practice standards:
-Technology transfer to Maphar (Morocco)
-Technology transfer to Abidi (Iran) for supplying Iranian market
-Technology transfer of Tarivid in Nigeria
-Vaccines manufacturing partnerships
-ACAME capacity building
-FAST (Fighting Against STigma)
Most of its other included initiatives have good governance structures in place, but it commonly falls short on setting clear, measurable goals & objectives and monitoring progress against them.
Does not provide evidence of reporting substandard or falsified medicines within the recommended time frame. Sanofi has a policy for reporting cases of substandard or falsified medicines to relevant authorities. However, it does not require reporting to occur within the time frame of seven days looked for by the Index.*
Product DonationsRanking: 1 Score: 5.00
Responds to emergencies and humanitarian crises and tracks delivery. Sanofi donated medicines on the request of relief agencies. For example, during the period of analysis, it donated products in response to floods and landslides in Peru and heavy rains in India. The company discloses that such ad hoc donations are aligned with international guidelines (issued by WHO, PQMD), and it works, for example, with the NGOs such as Cruz Roja Peruana, Tulipe Association and Americares to ensure products are rapidly delivered. It also monitors the delivery of the product until received by end user.
One donation programme covering diseases and countries in scope. Sanofi's programme is focused on neglected tropical diseases (NTDs). The programme is carried out in partnership with WHO and has been ongoing since 2001. Its NTD programme for human african trypanosomiasis supplies eflornithine (Ornidyl®), melarsoprol (Arsobal®) and pentamidine (Pentacarinat®) reaches 17 countries, and Sanofi reported reaching more than 2000 patients in 2016.
Addresses long-term access by aiming to eliminate disease. Sanofi commits to long-term structured donation programmes by aiming to eliminate the diseases in question. Its eflornithine (Ornidyl®), melarsoprol (Arsobal®) and pentamidine (Pentacarinat®) donation programme aims to eliminate human african trypanosomiasis (HAT) in 17 countries by 2020.
*Defined as a recommended time frame through consultation with stakeholders during Index methodology development.