Rank 9 in 2016
Falls from 9th to 17th place. AbbVie continues to lack evidence of a clear access-to-medicine strategy, despite having key products in scope for the treatment of hepatitis C.
Rises 2 places to 15th, but remains in the last quartile with no evidence of an access-to-medicine strategy, and no public intention to measure impact.
Falls 9 places to 17th for failing to disclose how company associates are held accountable, and does not report several expected components of an internal control framework.
Falls 6 places to 12th as it lacks a public policy for post-trial access, and has access plans in place for a comparatively small proportion of late-stage projects.
Falls 8 to places 18th for failing to disclose data concerning volume of sales and price disclosures.
Holds 8th place. Has licensed key HIV products through the MPP, and publicly discloses patent statuses via Pat-INFORMED.
Falls 4 places to 16th, with limited information on its activity in capacity building.
Falls 4 places to 13th. Despite having four structured programmes, these reach a comparatively small number of countries.
Establish an overarching access strategy. AbbVie can consolidate its access approaches into an overall strategy and clearly align it with its corporate strategy.
Expand process to establish more access plans for R&D projects. While AbbVie has a process in place to establish access provisions for R&D projects during development, it appears to cover R&D projects for only a subset of the diseases in scope. Further, it does not have a clear timeline in place to develop these provisions as early as possible. By refining its process to include the consideration of all projects for diseases in scope and to establish access plans earlier in the development process, AbbVie can ensure that products are available to more patients as soon as possible following market approval.
Strengthen internal controls against non-compliance. AbbVie can incorporate additional processes to mitigate the risk of non-compliance with ethical standards. For example, it can establish formal processes that hold third-parties accountable to the companies’ standards. It can develop fraud-specific risk assessments, processes for continuous monitoring of compliance and procedures to segregate duties. The company can also expand its auditing mechanism to incorporate both internal and external resources, and apply these standards to third parties that it engages with in countries in scope.
Expand access further by maximising effectiveness of licensing approach. In order to improve availability of the essential medicines which AbbVie has agreed voluntary licences for (glecaprevir/pibrentasvir [Mavyret™] and lopinavir/ritonavir [Aluvia®/Kaletra®]), AbbVie can: boost the geographic scope of these licences further, incorporating further countries with a high prevalence of HIV/AIDS and hepatitis C. AbbVie can also maximise the effectiveness of its licensing approach to access by reviewing future generic company activity in countries within the scope of agreed licences where AbbVie itself does not have sales. In cases where generic company activity remains absent/limited, AbbVie can consider proactively registering and pricing equitably within these countries to facilitate competition and access, or by identifying mechanisms within licences to incentivise generic market entry.
Change since 2016
- Discloses publicly the patent statuses for small molecules in scope via the Pat-INFORMED platform.
- Received FDA approval for the pangenotypic viral hepatitis C treatment glecaprevir/pibrentasvir (Mavyret™) in August 2017; it is the third pangenotypic treatment to market but the first eight-week treatment.
- Joined the Drugs for Neglected Diseases initiative’s NTD Drug Discovery Booster to accelerate the development of early-stage projects for Chagas disease and leishmaniasis through compound library sharing.
- Partnered with the Philippines Society of Newborn Medicine to reduce the prevalence of respiratory distress syndrome (RDS).
- Partnered with the Medicines Patent Pool in fall of 2018 to provide a non-exclusive voluntary licence for glecaprevir/pibrentasvir (Mavyret™), increasing access to the important 8 week treatment for hepatitis C by enabling generic production of the pangenotypic medicine.
Pipeline and Portfolio
for diseases and countries in scope
Mid-sized pipeline: 49 R&D projects (all medicines) for diseases in scope.
Clinical candidates: 37, including two Phase II clinical candidates that are part of two potential single-exposure cures for malaria.
Regulatory approvals: 4, including glecaprevir/pibrentasvir (Mavyret®) for the treatment of hepatitis C virus (pangenotypic).
R&D focus: medicines: non-communicable diseases (cancer), communicable diseases (malaria) and neglected tropical diseases (Chagas disease and leishmaniasis).
Access provisions: for 11 projects, all applied through access-oriented partnerships.
Comparatively small portfolio: 16 products (all medicines) for diseases in scope.
Portfolio focus: medicines: non-communicable diseases (hypertensive heart disease and epilepsy) and communicable diseases (viral hepatitis C).
Essential medicines: 69% of AbbVie's medicines are currently listed on the 2017 WHO Model List of Essential Medicines (WHO EML).
First-line treatments: 44% of AbbVie's medicines have first-line indications for diseases in scope.
One business unit: Pharmaceuticals, with four main therapeutic areas (immunology, oncology, virology and neuroscience).
M&A news: 2016 acquisition of Stemcentrx, specialising in developing oncology medicines targeting small cell lung cancer and other solid tumours.
Presence in emerging markets: In 2016, AbbVie reported sales in 81 countries in scope. Data for 2018 not available.
*Neglected Tropical Diseases, while also communicable, are highlighted separately throughout the Index. See Appendix II.
**See Appendix IV for definition.