General Access to Medicine ManagementRanking: 8 Score: 3.42
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.
Market Influence & ComplianceRanking: 2 Score: 3.34
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.
Research & DevelopmentRanking: 2 Score: 3.69
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.
Pricing, Manufacturing & DistributionRanking: 11 Score: 2.27
Commits publicly to equitable pricing but does not report a commitment to file to register new products in scope. Merck KGaA does not commit to filing its newest products for registration in countries in scope within one year of first market approval. It publicly commits to implement inter-country equitable pricing strategies for a minority of its products for diseases in scope, including for future products. Its public commitments also apply to intra-country equitable pricing strategies, albeit to only some of its products.
No new products in scope filed for registration in the majority of priority countries. Merck KGaA 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 diabetes mellitus, is registered in four out of 12 possible priority countries. It also does not publicly share registration information for any of its products.
30% of products have equitable pricing strategies targeting priority countries. Merck KGaA's overall performance is average compared to peers in equitable pricing. It demonstrates evidence of equitable pricing strategies for 30% of its products for diseases in scope. These strategies apply to an average of 23% of priority countries. Some of these strategies apply inter-country pricing; these take into account an average of four socioeconomic factors. However, all of its equitable pricing strategies apply intra-country pricing; these take an average of three socioeconomic factors into account. Merck KGaA also applies equitable pricing strategies to 9 further products informed by a public health rationale.
Has both globally consistent recall guidelines for countries in scope and processes to track products. Merck KGaA 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: 7 Score: 2.42
Publicly discloses detailed information on patent statuses. Like most of its peers, Merck KGaA 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. Merck KGaA 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 some IP assets with 3rd-party researchers. Compared to its peers, Merck KGaA shares some IP assets with third-party researchers developing products for diseases in scope. It shares four in total with research institutions and neglected disease drug discovery initiatives, such as the Medicines for Malaria Venture (MMV) and the Drugs for Neglected Diseases initiative (DNDi). The assets shared include molecule libraries and performing assays for drug discovery.
Public commitment not to enforce patents in countries in scope. Merck KGaA commits publicly to neither file for nor enforce patents related to diseases within the scope of the Index. This commitment applies to most Least Developed Countries, low-income countries, and in a subset of lower-middle income countries and upper-middle income countries.
Capacity BuildingRanking: 6 Score: 2.43
14 initiatives included for evaluation. Merck KGaA has 14 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; Merck KGaA submitted the maximum.
Strong focus on enhancing local manufacturing. Merck KGaA has initiatives which meet inclusion criteria in all five areas of capacity building. It performs strongest in manufacturing capacity building, including initiatives for training third-party manufacturers and technology transfers.
Two initiatives meet all applicable good practice standards:
-Virtual plant teams
-Product Development Partnerships in Brazil
Merck KGaA's remaining included initiatives typically have goals in place, but fall short on monitoring their progress and outcomes.
Does not provide evidence of reporting substandard or falsified medicines within the recommended timeframe. Merck KGaA has a policy for reporting cases of substandard or falsified medicines to relevant authorities or WHO Rapid Alert. However, it does not require reporting to occur within the time frame of seven days looked for by the Index.*
Product DonationsRanking: 5 Score: 3.91
Responds to emergencies and humanitarian crises and tracks delivery. Merck KGaA donated medicines on the request of relief agencies. For example, during the period of analysis, it donated products in Yemen. The company discloses that such ad hoc donations are aligned with international guidelines (issued by WHO), and it works, for example, with the German Red Cross 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. Merck KGaA's programmes are focused on neglected tropical diseases (NTDs). The programme is carried out in collaboration with WHO. Its programme for schistosomiasis supplies praziquantel (Cesol®) in 37 countries and has been ongoing since 2007. In 2016, Merck KGaA reported donating more than 200 million praziquantel (Cesol®) tablets to WHO.
Addresses long-term access by aiming to eliminate disease. Merck KGaA commits to long-term structured donation programmes by aiming to eliminate the diseases targeted. For example, its praziquantel (Cesol®) programme aims to eliminate schistosomiasis in 37 countries.
*Defined as a recommended time frame through consultation with stakeholders during Index methodology development.