General Access to Medicine ManagementRanking: 16 Score: 2.79
Has an access-to-medicine strategy with board-level responsibility. Bayer has an access-to-medicine strategy with a business rationale. Bayer's access approach has as a key focus on family planning and maternal and neonatal health. The highest level of responsibility for access sits with a board-level committee.
Financial and non-financial access-related incentives to reward employees. Bayer 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 variable performance-related compensations. Bayer's senior management has a separate incentive that supports the company's long-term access oriented objectives.
One of 16 companies working on impact measurement. Bayer measures and monitors progress and outcomes of access-to-medicine activities. It also publicly reports on commitments, for example, it reports to commit to supply medicines to fight African sleeping sickness to WHO. 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. Bayer publicly discloses which stakeholder groups it engages with on access issues, as well as its process for selecting who to engage with. It selects by a process based on expertise, activity and geographic coverage. Local stakeholder perspectives are incorporated into the development of its access strategies. It publicly shares its policy for ensuring responsible engagement; namely with its principles of responsible lobbying.
Market Influence & ComplianceRanking: 10 Score: 2.61
Has measures to ensure third-party compliance with ethical marketing and anti-corruption standards. Bayer has a policy relating to ethical marketing and anti-corruption, and provides regular compliance training for employees. 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. Bayer's internal control framework to ensure compliance meets some of the criteria looked for by the Index. Namely, it audits compliance following an annual audit plan. It does not report conducting fraud-specific risk assessments, nor does it demonstrate evidence of a monitoring system in place to track compliance in the workplace. However, Bayer does not demonstrate evidence of having procedures to segregate duties, so that decisions are checked by another party.
Average transparency regarding access-related practices. Bayer publicly discloses its policy positions on access-related topics (e.g., its positions on intellectual property, and TRIPS). It also publicly discloses political contributions in countries in scope. Bayer publicly discloses its memberships of relevant organisations to access in countries in scope, but not the financial contributions it provides. It discloses its policies for responsible engagement within its code of conduct. However, the company does not publicly disclose its policy approach to payments made to healthcare professionals in countries in scope.
Research & DevelopmentRanking: 8 Score: 2.14
Commits to R&D to meet public health needs. Bayer has made a specific commitment to R&D for diseases and countries in scope, but it is not publicly available. Its R&D strategy for low- and middle-income countries is informed by an evidence-based public health rationale based on goals published by external sources like WHO. Further, it has time-bound strategies for completing R&D projects for diseases in scope and evaluates progress toward these targets. Bayer has one of the smallest pipelines in the Index with 11 projects. For diseases in scope where priorities exist, Bayer is active in four projects; three of these target priority R&D gaps.
Access provisions in place for 11% (1/9) of late-stage candidates. Bayer does not have a clear process in place to develop access plans during R&D. It does, however, consider access for some R&D projects for diseases in scope, namely for collaborative projects. To date, Bayer has project-specific access provisions in place for one of its late-stage R&D projects. This project, to develop a paediatric formulation of nifurtimox (Lampit®) for the treatment of Chagas disease, is being conducted in-house and includes a registration strategy and plan to apply for WHO prequalification.
No policy for post-trial access. Bayer does not have a policy for ensuring post-trial access to treatments for clinical trial participants. Additionally, it does not disclose a commitment to registering newly approved products in all countries where clinical trials for these products have taken place.
Pricing, Manufacturing & DistributionRanking: 15 Score: 2.07
Does not publicly commit to equitable pricing or report a commitment to file to register new products in scope. Bayer does not commit to filing its newest products for registration in countries in scope within one year of first market approval. Neither does the company publicly commit to implement equitable pricing strategies. However, it does have equitable pricing strategies for some products in scope of the Index.
Many new products in scope filed for registration in the majority of relevant priority countries. Bayer has filed 70% 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). However, it does not publicly share registration information for any of its products.
12% of products have equitable pricing strategies targeting priority countries. Bayer's overall performance is below average compared to peers in equitable pricing. It demonstrates evidence of having equitable pricing strategies for 12% of its products for diseases in scope. These strategies apply to an average of 9% of priority countries. One of these strategies applies inter-country pricing; this strategy, for contraceptive methods, takes into account one socioeconomic factor. Bayer also applies an equitable pricing strategy to one further product informed by a public health rationale.
Globally consistent recall guidelines for countries in scope but no processes to track products. Bayer 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: 18 Score: 0.33
Does not publicly disclose patent statuses. Unlike most of its peers, Bayer does not disclose the status of its products for diseases and countries in scope.
No use of non-assert or licensing arrangements. Bayer 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 agreements. Bayer reported existing agreements with product development partnerships such as the Drugs for Neglected Diseases initiative (DNDi). 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. Bayer does not have a public policy available that sets out its approach to filing for or enforcing patents in low- and middle-income countries.
Capacity BuildingRanking: 14 Score: 1.22
Six initiatives included for evaluation. Bayer has six 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; Bayer submitted 21.
Focused on supporting pharmacovigilance systems. Bayer has initiatives which meet inclusion criteria in two areas of capacity building: pharmacovigilance and health system strengthening. Most of these initiatives are focused on pharmacovigilance capacity building in sub-Saharan Africa.
Some initiatives meet some good practice standards. None of Bayer's included initiatives meet all the good practice standards looked for by the Index. Most of its initiatives have goals in place, but it commonly falls short on monitoring progress and outcomes.
Does not provide evidence of reporting substandard or falsified medicines within the recommended timeframe. Bayer has a policy for reporting cases of substandard or falsified medicines to local regulatory authorities. However, it does not require reporting to occur within the time frame of seven days looked for by the Index.*
Product DonationsRanking: 8 Score: 3.33
Responds to emergencies and humanitarian crises and tracks delivery. Bayer donated medicines on the request of relief agencies. For example, during the period of analysis, it donated products in response to the 2017 Mexico earthquake. The company discloses that such ad hoc donations are aligned with international guidelines (issued by WHO), and it works, for example, with Direct Relief and Health Partners International to ensure products are rapidly delivered. It also monitors the delivery of the product until received by end user.
Three donation programmes covering diseases and countries in scope. Bayer's programmes are focused on neglected tropical diseases (NTDs), namely Chagas disease and human African trypanosomiasis (HAT) of the type T. b. gambiense and T. b. rhodesiense. All three programmes are carried out in partnership with its long-term partner, WHO. Its NTD programme for Chagas disease supplies nifurtimox (Lampit®) in 14 countries in scope and has been ongoing since 2004. During the period of analysis, Bayer reports that this has reached almost 8,000 patients.
Addresses longer-term needs by committing to eliminate disease. Bayer's structured donation programmes aim to eliminate the diseases targeted. For example, its nifurtimox (Lampit®) donation programme aims to support control and elimination of Chagas disease in 14 countries in scope. For its three neglected tropical diseases programmes, Bayer commits to supplying the drug as long as WHO requires it; i.e., until elimination of the disease.
*Defined as a recommended time frame through consultation with stakeholders during Index methodology development.