Performance by Technical Area

Lacks overarching access-to-medicine strategy; responsibility for access lies at the executive level. Astellas does not have an overarching access-to-medicine strategy, but shows evidence of some activities guided by access-related goals. For example, it aims to discover, develop and provide innovative medicines for patients, supported by its goal to improve access to health.The highest level of responsibility for access sits with its Corporate Social Responsibility Committee, which reports to a board-level committee.

No evidence of access-related incentives for employees. Astellas does not disclose details of how it incentivises employees (financially and non-financially) to perform on access-related issues. It is one of only two companies which do not demonstrate evidence of such incentives.

One of 16 companies working on impact measurement. Astellas measures and monitors progress and outcomes of access-to-medicine activities, for example its Action on Fistula initiative. It also publicly reports on its commitments and performance information. Furthermore, it is part of the Access Accelerated initiative, which includes a commitment to evaluate impact. 

Discloses who it engages with, incorporates local perspectives into strategies. Astellas publicly discloses which stakeholder groups it engages with on access issues, but does not publicly share its process for selecting who to engage with, or its policy for ensuring responsible engagement. It does incorporate local stakeholder perspectives into the development of access strategies.

Does not report processes for ensuring third-party compliance with standards. Astellas has a code of conduct relating to ethical marketing and anti-corruption, that is aligned with WHO Guidelines. It provides compliance training for employees. The company performs relatively poorly when it comes to enforcing compliance measures and non-sales incentives. It does not provide evidence of having formal processes in place to ensure compliance with standards by third parties. Further, expected performance for sales agents is based solely on sales targets. 

Internal control framework meets all Index criteria. Astellas has all the components looked for by the Index for an effective internal control framework to ensure compliance. Namely, it reports that it regularly conducts fraud-specific risk assessments. It also has a monitoring system in place to track compliance, it conducts audits involving both internal and external resources—which also apply to third parties. Astellas also demonstrates evidence of having procedures to segregate duties, so that decisions are checked by another party.

Below average transparency regarding access-related practices. Astellas publicly discloses its policy positions on access-related topics (e.g., its policy statement on access to healthcare, which includes its position on intellectual property). The company does not disclose political contributions in countries in scope. It publicly discloses its memberships of relevant organisations but does not disclose whether it provides financial support. It publicly discloses its position on Patient Organisation Engagement. It does not, however, publicly disclose its policy approach to payments made to healthcare professionals in countries in scope.

Publicly commits to R&D to meet public health needs. Astellas 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. Astellas has one of the smallest pipelines in the Index with 25 projects. For diseases in scope where priorities exist, Astellas is active in four projects; all four target priority R&D gaps.

Access provisions in place for 6% (1/17) of late-stage candidates. Astellas does not have a clear process in place to develop access plans during R&D. Instead, it considers access on a case-by-case basis. To date, Astellas has project-specific access provisions in place for one of its late-stage R&D projects. This project is being conducted in partnership as part of the Pediatric Praziquantel Consortium.

No policy for post-trial access. Astellas does not have a policy for ensuring post-trial access to treatments for clinical trial participants. Instead, it takes a case-by-case approach to post-trial access, mostly for participants on clinical trials for cancer products. Astellas does not disclose a commitment to registering newly approved products in all countries where clinical trials for these products have taken place.