General Access to Medicine ManagementRanking: 15 Score: 2.86
Lacks overarching access-to-medicine strategy; responsibility for access lies at board-level. AbbVie does not have an overarching access-to-medicine strategy, but shows evidence of some activities guided by access-related goals. For example, it conducts research to develop new medicines for neglected diseases, supported by its Executive Council on Neglected Tropical Diseases and its corporate responsibility commitments to access to medicine. The highest level of responsibility for access sits with a board-level committee.
Financial access-related incentives in place for employees. AbbVie has financial incentives in place to motivate employees to perform on access-related issues. These incentives include awards based on access efforts.
Measures and monitors outcomes and progress; not impact. AbbVie 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 Foundation’s partnership with Direct Relief International, AbbVie reports having established a data management and order tracking system to ensure effective monitoring of its HIV testing programmes in Least Developed Countries. However, it does not report measuring the impact of its initiatives.
Stakeholder engagement: incorporates local perspectives into strategies. AbbVie 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.
Market Influence & ComplianceRanking: 17 Score: 1.59
Does not report processes for ensuring third-party compliance with standards. AbbVie has a code of conduct relating to ethical marketing and anti-corruption. It provides regular 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, its incentives for sales agents are based solely on sales targets.
Internal control framework lacks Index criteria. AbbVie's internal control framework for ensuring compliance meets one of the criteria looked for by the Index. This is an auditing and review mechanism, however, it does not report that this mechanism involves both internal and external resources, nor that it applies to all third parties in countries where AbbVie operates. The company does not report conducting fraud-specific risk assessments, nor does it demonstrate evidence of having a monitoring system in place to track compliance, or having procedures to segregate duties to ensure decisions are checked by another party.
Below average transparency regarding access-related practices. AbbVie does not publicly disclose policy positions that impact access to medicine. Neither does it disclose political contributions in countries in scope. AbbVie publicly discloses its financial support and membership of relevant organisations for access. It does not, however, publish its policies for responsible engagement. Neither does it publicly disclose its its policy approach to payments made to healthcare professionals in countries in scope.
Research & DevelopmentRanking: 12 Score: 1.98
Publicly commits to R&D to meet public health needs. AbbVie 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 external guidance including the United Nations Sustainable Development Goals. Further, it has time-bound strategies for completing R&D projects for diseases in scope and evaluates progress toward these targets. AbbVie has a mid-sized pipeline in the Index with 49 projects. For diseases in scope where priorities exist, AbbVie is active in 13 projects; 11 of these target priority R&D gaps.
Access provisions in place for 10% (2/21) of late-stage candidates. AbbVie has a general 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 and tuberculosis. Information is publicly available on project-specific access provisions for two of AbbVie's late-stage R&D projects. Both projects are being conducted in partnership with the Medicines for Malaria Venture (MMV).
No public disclosure of post-trial access policy. AbbVie does not have a publicly available policy for ensuring post-trial access to treatments for clinical trial participants, and it does not provide an internal policy that can be evaluated.
Pricing, Manufacturing & DistributionRanking: 18 Score: 1.70
Commits publicly to equitable pricing but does not report a commitment to file to register new products in scope. AbbVie does not commit to filing its newest products for registration in countries in scope within one year of first market approval. However, it does publicly commit to implementing inter-country equitable pricing strategies for a minority of its products for diseases in scope. This does not explicitly apply to future products. Its public commitments also apply to intra-country equitable pricing strategies, albeit to only some of its products.
A third of new products in scope filed for registration in the majority of priority countries. AbbVie has filed 33% 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 the registration status for any of its products.
25% of products have equitable pricing strategies targeting priority countries. AbbVie's overall performance is average compared to peers in equitable pricing. It demonstrates evidence of having equitable pricing strategies for 25% of its products for diseases in scope. These strategies apply to an average of 76% of the relevant priority countries and take an average of three socioeconomic factor into account.
Globally consistent recall guidelines for countries in scope but no processes to track products. AbbVie 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: 8 Score: 2.34
Publicly discloses detailed information on patent statuses. Like most of its peers, AbbVie 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.
Uses licensing to enable generic supply. AbbVie has non-exclusive voluntary licensing agreements in place for two compounds (for diseases in scope). Its broadest licence, for paediatric iopinavir/ritonavir (LPV/r) (Aluvia®/Kaletra®), encompasses 93 countries, including 62 middle-income countries in scope. It has not issued any non-assert declarations for products in scope.
Does not report newly sharing IP assets with 3rd-party researchers beyond existing agreements. AbbVie reported existing agreements with product development partnerships such as the Drugs for Neglected Diseases initiative (DNDi) and the Medicines for Malaria Venture (MMV). 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. AbbVie 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: 16 Score: 0.86
One initiative included for evaluation. AbbVie has one capacity building initiative that was included for analysis by the Index: i.e., the initiative demonstrably addresses a specific local need and involves local partners. Companies could submit a maximum of 25 initiatives across all areas for assessment. AbbVie's initiatives were identified for selection based on publicly available information.
Initiative aimed at building local R&D capacity. AbbVie has one initiative which meets inclusion criteria in R&D capacity building. It provides scholarships for students to study science at The Asian University for Women in Bangladesh. AbbVie does not publicly disclose initiatives which meet inclusion criteria in any of the other areas of capacity building.
Limited publicly available data on initiatives. AbbVie's included initiative meets the criteria for inclusion, but no additional good practice standards looked for by the Index. The company reported no information to the Index about its R&D capacity building initiative, and publicly available information is limited.
Timely approach to confirming and reporting substandard or falsified medicines. AbbVie 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: 13 Score: 2.60
Responds to emergencies, humanitarian crises and tracks delivery. AbbVie 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 with independent organisations, such as Americares, to ensure products are rapidly delivered. It also monitors the delivery of the product until received by end user.
Four donation programmes covering diseases and countries in scope. AbbVie's programmes are focused on communicable and non-communicable diseases. All four programmes are carried out in partnership with independent partners. Its programme for respiratory distress in newborns supplies the treatment beractant (Survanta®) in four countries and has been ongoing since 2015. Meenakshi Medical Mission Hospital in India reports that beractant (Survanta®) has already helped to treat over 400 infants and preterm babies a year.
Ensures long-term access through transition planning. AbbVie has transition plans in place for one of its programmes to ensure ongoing access for patients once the programme ends. It commits to continuing this programme and fulfilling local product needs as identified by its partner Americares.