General Access to Medicine ManagementRanking: 13 Score: 3.06
Has an access-to-medicine strategy with executive-level responsibility. Bristol-Myers Squibb has an access-to-medicine strategy with a business rationale. The strategy includes measures such as equitable pricing, licensing, philanthropy and capacity building. The highest level of responsibility for access sits with its Worldwide Access Council, at the executive level.
Financial and non-financial access-related incentives to reward employees. Bristol-Myers Squibb 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 awards for performance and public recognition by senior company leaders in internal meetings and through internal social media for objectives reached.
One of 16 companies working on impact measurement. Bristol-Myers Squibb measures and monitors progress and outcomes of access-to-medicine activities. It also publicly reports on commitments, targets, objectives and performance information. For its HIV and hepatitis C medicines that are available in countries in scope, the company reports tracking the number of patients benefiting from its medicines. 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. Bristol-Myers Squibb publicly discloses which stakeholder groups it engages with on access issues, but does not publicly share its process for selecting who to engage with, nor its policy for ensuring responsible engagement. It does incorporate local stakeholder perspectives into the development of access strategies.
Market Influence & ComplianceRanking: 7 Score: 2.71
Has measures to ensure third-party compliance with ethical marketing and anti-corruption standards. Bristol-Myers Squibb has a code of conduct relating to ethical marketing and anti-corruption and provides biannual compliance training for employees and third parties. 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. Bristol-Myers Squibb's internal control framework to ensure compliance meets some of the criteria looked for by the Index. Namely, it has an internal auditing department for the whole company, involving both internal and external resources and applying to all third parties. 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. Bristol-Myers Squibb publicly discloses its policy positions on access-related topics (e.g., its policy committing to provide appropriate patient access to medicines). It is one of the few companies in scope to have a policy that prohibits political financial contributions outside the USA. The company publicly discloses its membership of patient organisations, including the financial support it provides. It discloses policies for responsible engagement within its Principles of Integrity. It does not publicly disclose its policy approach to payments made to healthcare professionals in countries in scope.
Research & DevelopmentRanking: 17 Score: 1.56
Publicly commits to R&D to meet public health needs. Bristol-Myers Squibb 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 linked to sources 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. Bristol-Myers Squibb has one of the smallest pipelines in the Index with 25 projects. For diseases in scope where priorities exist, Bristol-Myers Squibb is active in two projects; both of these target priority R&D gaps.
No clear process to consider access during development. Bristol-Myers Squibb does not have a clear process in place to develop access plans during R&D. Instead, Bristol-Myers Squibb considers access on a case-by-case basis. In general, Bristol-Myers Squibb develops access plans for R&D projects late in the development process and close to submission for market approval. To date, Bristol-Myers Squibb does not have any project-specific access provisions in place for its eight late-stage R&D projects. Five of these projects were approved during the period of analysis.
Public policy to ensure post-trial access; commits to registering trialed products. Bristol-Myers Squibb has a publicly available policy for ensuring post-trial access to treatments for clinical trial participants. The policy is aligned with the standards set in the Declaration of Helsinki. Once a product is approved, Bristol-Myers Squibb commits to registering it in all countries where clinical trials for the product have taken place.
Pricing, Manufacturing & DistributionRanking: 16 Score: 2.00
Commits publicly to equitable pricing but does not report a commitment to file to register new products in scope. Bristol-Myers Squibb does not commit to filing its newest products for registration in countries in scope within one year of first market approval. However, 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.
Some new products in scope filed for registration in the majority of priority countries. Bristol-Myers Squibb has filed 10% 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.
20% of products have equitable pricing strategies targeting priority countries. Bristol-Myers Squibb's overall performance is average compared to peers in equitable pricing. It demonstrates evidence of having equitable pricing strategies for 20% of its products for diseases in scope. These strategies apply to an average of 65% of priority countries. Most of these strategies apply inter-country pricing; these take into account an average of three socioeconomic factors. Bristol Myers Squibb 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. Bristol-Myers Squibb 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: 4 Score: 2.54
Publicly discloses detailed information on patent statuses. Like most of its peers, Bristol-Myers Squibb 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. Bristol-Myers Squibb has non-exclusive voluntary licensing agreements in place for two compounds (for diseases in scope). Its broadest licence, for atazanavir sulfate (Reyataz®), encompasses 97 countries including 66 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. Bristol-Myers Squibb 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. Bristol-Myers Squibb 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: 18 Score: 0.74
Eight initiatives included for evaluation. Bristol-Myers Squibb has eight 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; Bristo-Myers Squibb submitted 22.
Focused on strengthening health systems. Bristol-Myers Squibb has initiatives that meet inclusion criteria in three areas of capacity building: manufacturing, R&D, and health system strengthening. Most of these initiatives are focused on health system strengthening in the disease areas of HIV/AIDS, viral hepatitis (B and C) and cancer.
Most initiatives meet most good practice standards. None of Bristol-Myers Squibb's included initiatives meet all the good practice standards looked for by the Index. While its health system strengthening projects have good governance structures in place, some initiatives fall short on setting clear, measurable goals and objectives.
Does not provide evidence of reporting substandard or falsified medicines to relevant authorities. Bristol-Myers Squibb has a policy for the prevention and handling of counterfeit medicines. However, it does not provide evidence that it systematically reports cases of substandard or falsified medicines to relevant authorities and/or WHO Rapid Alert.
Product DonationsRanking: 10 Score: 3.05
Responds to emergencies and humanitarian crises and tracks delivery. Bristol-Myers Squibb 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, PQMD), and it works, for example, with Americares and Direct Relief 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. Bristol-Myers Squibb's ongoing donation programme is focused on cancer. The programme is carried out in partnership with the the Max Foundation and has been ongoing since 2016. The company's cancer programme for chronic myeloid leukemia supplies dasatinib (Sprycel®) in 15 countries. In 2017, Bristol-Myers Squibb reports to have reached 118 patients. During the period of analysis Bristol-Myers Squibb also donated products for the treatment of hepatitis C in a demonstration project with several partners.
Ensures long-term access through transition planning. Bristol-Myers Squibb has transition plans in place for its dasatinib (Sprycel®) donation programme, to ensure ongoing access for patients once the programme ends. It commits to contractually agree to continue providing the product to patients once the programme has ended, as long as patients meet certain eligibility criteria (e.g., recommendation from physician, there are no other means available to access the product, etc.).