Performance by Technical Area

Has a strong access-to-medicine strategy with executive-level responsibility. Merck KGaA is one of 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 ensuring its products are accessible through four approaches: availability; affordability; awareness; and accessibility. The highest level of responsibility for access sits with an executive manager.

Financial and non-financial access-related incentives to reward employees. Merck KGaA 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 grants and ad hoc awards. 

One of 16 companies working on impact measurement. Merck KGaA 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 charter on access to health in developing countries, Merck KGaA reports on its activities to achieve targets aligned with United Nations Sustainable Development Goals (SDGs).  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. Merck KGaA publicly discloses which stakeholder groups it engages with on access issues, as well as its process for selecting who to engage with in its 2017 Corporate Responsibility Report; e.g., it adopts a needs-based approach to establish partnerships which can promote access. It does not publicly share its policy for ensuring responsible engagement. It does incorporate local stakeholder perspectives into the development of access strategies.

Has measures to ensure third-party compliance with ethical marketing and anti-corruption standards. Merck KGaA has a code of conduct relating to ethical marketing and anti-corruption, and provides regular compliance training via online classes for employees. The company provides evidence of having formal processes in place to ensure compliance with standards by third parties. Sales agents' rewards are not solely based on sales targets. Instead, it rewards other qualities such as ethical behaviour in the workplace.

Internal control framework meets some Index criteria.  Merck KGaA'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, involving internal resources, applying to all third parties and all countries where they operate. It does not, however, report fraud-specific risk assessments, nor does it demonstrate evidence of a monitoring system for non-compliance in the workplace, or procedures to segregate duties, to ensure decisions are checked by another party. 

Above average transparency regarding access-related practices. Merck KGaA publicly discloses its policy positions on access-related topics. For example, it publishes its position on drug shortages, ethical business practices, intellectual property rights, and it publicly supports the Doha Declaration. It is one of the few companies in scope to have a policy that prohibits political financial contributions, and it shares its position on responsible engagement in its code of conduct. It publicly discloses its membership and financial support of relevant organisations to access. 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. Merck KGaA 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. Merck KGaA has a mid-sized pipeline in the Index with 74 projects. For diseases in scope where priorities exist, Merck KGaA is active in 32 projects; all 32 of these target priority R&D gaps.

Access provisions in place for 26% (5/19) of late-stage candidates. Merck KGaA has a clear process in place to develop access plans during R&D. The process considers all R&D projects for diseases in scope. In general, Merck KGaA develops access plans for R&D projects when entering clinical development. To date, Merck KGaA has project-specific access provisions in place for six of its late-stage R&D projects. Five are being conducted in partnership.

Policy to ensure post-trial access; commits to registering trialed products. Merck KGaA 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. Once a product is approved, Merck KGaA commits to registering it in all countries where clinical trials for the product have taken place.

*Defined as a recommended time frame through consultation with stakeholders during Index methodology development.