General Access to Medicine ManagementRanking: 12 Score: 3.08
Has a strong access-to-medicine strategy with executive-level responsibility. Eisai is one of 14 companies that performs strongly with regards to its access-to-medicine strategy which includes access-related goals, and aligns with its corporate strategies. The strategy is focused on long-term sustainable solutions, that explicitly views young emerging markets as opportunities for long-term investments. The highest level of responsibility for access sits with an executive manager.
Financial and non-financial access-related incentives to reward employees. Eisai 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 bonuses rewarding performance and non-financial awards.
One of 16 companies working on impact measurement. Eisai measures and monitors progress and outcomes of access-to-medicine activities. It also publicly reports on commitments, objectives, and targets. For example, for its partnership with WHO on eliminating lymphatic filariasis, the company reports committing to provide 2.2 billion tablets free of charge to WHO by 2020. Furthermore, it is part of the Access Accelerated initiative, which includes a commitment to evaluate impact.
Some transparency about stakeholder engagement approach. Eisai publicly discloses which stakeholder groups it engages with on access issues, but does not publicly share its process for selecting who to engage with. Neither does it report incorporating local stakeholder perspectives into the development of access strategies. However, Eisai publicly shares a specific policy for ensuring responsible engagement — in order to deal with stakeholders in a responsible way, with respect and trust and which includes a no tolerance policy for bribery or corrupt behaviour.
Market Influence & ComplianceRanking: 3 Score: 3.19
Has measures to ensure third-party compliance with ethical marketing and anti-corruption standards. Eisai has a code of conduct and policy relating to ethical marketing and anti-corruption, and provides regular compliance training for employees. The company provides evidence of formal processes in place to ensure compliance with standards by third parties. Sales agents' rewards are not solely based on sales targets, but rather on the uptake of patient screening and treatment.
Internal control framework meets some Index criteria. Eisai'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 in place, and performs ad hoc evaluations that also apply to third parties. It reports that it regularly conducts fraud-specific risk assessments. It also has procedures to segregate duties, so that decisions are checked by another party. It does not, however, demonstrate evidence of a monitoring system in place to track compliance in the workplace.
Below average transparency regarding access-related practices. Eisai publicly discloses its policy positions on access-related topics (e.g., its position on intellectual property). It does not disclose political contributions in countries in scope. Eisai publicly discloses its membership of relevant organisations for access, but not its financial contributions. The company also discloses its policies for responsible engagement within its code of conduct. It does not, however, publicly disclose its policy approach to payments made to healthcare professionals in countries in scope.
Research & DevelopmentRanking: 6 Score: 2.80
Publicly commits to R&D to meet public health needs. Eisai 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 by following external targets including the United Nations Sustainable Development Goals. Further, it has time-bound strategies for completing R&D projects conducted in partnership for diseases in scope and evaluates progress toward these targets. Eisai has a mid-sized pipeline in the Index, with 41 projects. For diseases in scope where priorities exist, Eisai is active in 19 projects; 17 of these target priority R&D gaps.
Access provisions in place for 30% (3/10) of late-stage candidates. Eisai 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 projects for neglected tropical diseases. In general, Eisai develops access plans for R&D projects for neglected tropical diseases in early-stage development but does not have such clear timelines for other diseases. To date, Eisai has project-specific access provisions in place for three of its late-stage R&D projects. All three are being conducted in partnership with the Drugs for Neglected Diseases initiative (DNDi). The Global Health Innovative Technology Fund (GHIT) is also involved in one of the projects.
Policy to ensure post-trial access; commits to registering trialed products. Eisai has a policy for ensuring post-trial access to treatments for clinical trial participants. However, this policy is not publicly available. The policy is aligned with the standards set in the Declaration of Helsinki. Eisai commits to registering newly approved products in all countries where clinical trials for these products have taken place.
Pricing, Manufacturing & DistributionRanking: 14 Score: 2.07
Does not commit publicly to equitable pricing or report a commitment to file to register new products in scope. Eisai does not commit to filing its newest products for registration in countries in scope within one year of first market approval. Neither does it publicly commit to implementing equitable pricing strategies. However, it does have equitable pricing strategies for some products in scope of the Index.
No new products in scope filed for registration in the majority of priority countries. Eisai has not filed any 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). Its most widely registered product, for epilepsy, is registered in three out of 11 possible priority countries. However, it publicly shares detailed registration information for a minority of its products.
20% of products have equitable pricing strategies targeting priority countries. Eisai's overall performance is average compared to peers in equitable pricing. It demonstrates evidence of having equitable pricing strategies for 20% of its products for diseases in scope. These strategies apply to an average of 14% of priority countries. All of these strategies apply inter- and intra-country pricing; these take into account an average of six and four socioeconomic factors, respectively.
Globally consistent recall guidelines for countries in scope but no processes to track products. Eisai has guidelines for drug recalls that apply to all countries in scope. It does not demonstrate evidence of having processes to track the distribution of products in countries in scope to facilitate rapid and effective recalls.
Patents & LicensingRanking: 11 Score: 1.84
Publicly discloses detailed information on patent statuses. Like most of its peers, Eisai publicly discloses the patent statuses for small molecules in scope via the Pat-INFORMED platform. This will be periodically updated and includes detailed information about patents, including filing date, grant number, grant date and jurisdiction.
No use of non-assert or licensing arrangements. Eisai does not engage in voluntary licensing nor has it issued non-assert declarations for products in scope. It publicly states it would consider granting non-exclusive voluntary licences in certain circumstances.
Shares many IP assets with 3rd-party researchers. Compared to its peers, Eisai shares many IP assets with third-party researchers developing products for diseases in scope. This includes ten shared with research institutions and neglected disease drug discovery initiatives, such as the Medicines for Malaria Venture (MMV) and the TB Alliance. The assets shared include molecule libraries and performing assays for drug discovery.
Public commitment not to enforce patents in countries in scope. Eisai commits publicly to neither file for nor enforce patents related to diseases within the scope of the Index. This commitment applies in Least Developed Countries, low-income countries and Low Human Development Countries.
Capacity BuildingRanking: 11 Score: 2.00
Eight initiatives included for evaluation. Eisai has eight 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; Eisai submitted 22.
Strong focus on strengthening local R&D capacity and health systems. Eisai has initiatives which meet inclusion criteria in all areas of capacity building, except pharmacovigilance. Most of these initiatives are focused on R&D capacity building and health system strengthening. Most of its health system strengthening initiatives are active in East Asia.
Most initiatives meet most good practice standards. None of Eisai's included initiatives meet all the good practice standards looked for by the Index. While most of its initiatives have good governance structures in place, the standard it most commonly falls short on is monitoring the progress and outcomes of its initiatives.
Timely approach to confirming and reporting substandard or falsified medicines. Eisai provides evidence that it systematically confirms suspected cases of substandard or falsified medicines and then reports confirmed cases to relevant authorities or WHO Rapid Alert within the period recommended by stakeholders (maximum seven days for each, confirmation and reporting).
Product DonationsRanking: 4 Score: 4.04
Has policy for responding to emergencies or humanitarian crises. While Eisai did not make any ad hoc donations during the period of analysis, it has policies in place to respond directly to need. The company discloses that such ad hoc donations are aligned with international guidelines (issued by WHO). The company tracks the delivery of the product until received by end user.
One donation programmes covering diseases and countries in scope. Eisai's programme is focused on neglected tropical diseases (NTDs). The programme is carried out in partnership with WHO and has been ongoing since 2013. Its NTD programme for lymphatic filariasis supplies diethylcarbamazine citrate (DEC) in 24 countries. As of June 2017, Eisai reports that over 1.1 billion tablets have been provided through WHO’s elimination programme.
Addresses long-term access by aiming to eliminate disease. Eisai commits to long-term structured donation programmes by aiming to eliminate the diseases targeted. For example, its DEC donation programme aims to eliminate lymphatic filariasis in 24 countries. It plans to supply DEC tablets continuously after 2020, until lymphatic filariasis is completely eliminated in all endemic countries where the treatment is needed.