General Access to Medicine ManagementRanking: 2 Score: 4.52
Has a strong access-to-medicine strategy with board-level responsibility. Roche 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 identifying access-related issues with local stakeholders and developing country-specific plans using its Access Planning Framework. This framework is focused on four areas: awareness; diagnosis; healthcare capacity; and funding. The highest level of responsibility for access sits with a board-level committee.
Financial and non-financial access-related incentives to reward employees. Roche 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 annual performance-related goals, and internal recognition and awards. Senior management has a separate incentive that supports the company's long-term access-oriented objectives.
One of 16 companies working on impact measurement. Roche measures and monitors progress and outcomes of access-to-medicine activities. It also publicly reports on commitments and performance information. For example, for its Patient Access Dashboard initiative, Roche reports having increased access to standard of care treatment for blood cancers and breast cancer in 14 low- and middle-income countries. 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. Roche publicly discloses which stakeholder groups it engages with on access issues, as well as its process for selecting who to engage with. It selects by conducting a materiality assessment and an engagement activity. Local stakeholder perspectives are incorporated into the development of its access strategies. However, it does not publicly share its policy for ensuring responsible engagement.
Market Influence & ComplianceRanking: 4 Score: 3.11
Has measures to ensure third-party compliance with ethical marketing and anti-corruption standards. Roche has a code of conduct relating to ethical marketing and anti-corruption, and provides continuous compliance training 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 relating to diversity, sustainability and the environment.
Internal control framework meets some Index criteria. Roche's internal control framework to ensure compliance meets some of the criteria looked for by the Index. Namely, it has a monitoring system in place to track compliance, and auditing processes. It also has procedures to segregate duties, so that decisions are checked by another party. It does not, however, demonstrate evidence of having fraud-specific risk assessment.
Above average transparency regarding access-related practices. Roche publicly discloses its policy positions on access-related topics (e.g., its position on counterfeit medicine and human rights). It does not disclose its political contributions in countries in scope. It publicly discloses its financial support and membership of relevant organisations to access, and is the only company in scope to disclose its policy for managing conflicts of interest with these institutions. The company also discloses its policies for responsible engagement. It does not, however, publicly disclose its policy approach to payments made to healthcare professionals in countries in scope.
Research & DevelopmentRanking: 14 Score: 1.84
Publicly commits to R&D to meet public health needs. Roche 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 data from external sources like WHO related to global disease burden. It lacks time-bound strategies for completing R&D projects for diseases in scope. Roche has one of the largest pipelines in the Index with 100 projects. For diseases in scope where priorities exist, Roche is active in five projects; three of these target priority R&D gaps.
Access provisions in place for 5% (2/44) of late-stage candidates. Roche does not have a clear process in place to develop access plans during R&D. Instead, Roche considers access on a case-by-case basis. In general, Roche develops access plans for these R&D projects in Phase I or II of clinical development. To date, Roche has project-specific access provisions in place for two of its late-stage R&D projects. Of these, one is being conducted in partnership with Shionogi Inc.
Public policy to ensure post-trial access; commits to registering trialed products. Roche has a publicly available policy for ensuring post-trial access to treatments for clinical trial participants and has provided a detailed example of this policy in action in countries in scope. The policy is aligned with the standards set in the Declaration of Helsinki. Once a product is approved, Roche commits to registering it in all countries where clinical trials for the product have taken place.
Pricing, Manufacturing & DistributionRanking: 8 Score: 2.39
Commits publicly to equitable pricing but does not report a commitment to file to register new products in scope. Roche 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 implement inter-country equitable pricing strategies for a minority of its products for diseases in scope, including for future products. This does not explicitly apply to future products. It also commits to implementing intra-country pricing strategies, albeit to only some of its products.
Many new products in scope filed for registration in the majority of relevant priority countries. Roche has filed 70% 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.
5% of products have equitable pricing strategies targeting priority countries. Roche's overall performance is below average compared to peers in equitable pricing. It demonstrates evidence of having equitable pricing strategies for 5% of its products for diseases in scope. These strategies apply to an average of 84% of priority countries. Some of these strategies apply both inter- and intra-country pricing; these take into account an average of one and three socioeconomic factors, respectively.
Has both globally consistent recall guidelines for countries in scope and processes to track products. Roche 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: 17 Score: 1.17
Publicly discloses detailed information on patent statuses. Like most of its peers, Roche 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. Roche does not engage in voluntary licensing nor has it issued non-assert declarations for products in scope.
Does not report newly sharing IP assets with 3rd-party researchers beyond existing agreements. Roche reported existing agreements with product development partnerships, such as the TB Alliance. 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.
Public commitment not to enforce patents in countries in scope. Roche commits publicly to neither file for nor enforce patents related to diseases within the scope of the Index. This commitment applies in Least Developed Countries and low-income countries. The company also do not file or enforce patents for any of its antiretroviral HIV medicines in sub-Saharan African countries.
Capacity BuildingRanking: 9 Score: 2.24
10 initiatives included for evaluation. Roche has 10 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; Roche submitted 21.
Focused on supporting pharmacovigilance and strengthening health systems. Roche has initiatives that meet inclusion criteria in all five areas of capacity building. Most of these initiatives are focused on pharmacovigilance and health system strengthening. These initiatives are most active in Africa.
Two initiatives meet all applicable good practice standards:
-Strengthening the Supply Chain in sub-Saharan Africa
-Partnership to Improve Breast Cancer Care in Kenya
Roche's remaining included initiatives typically have goals in place, but fall short on monitoring progress and outcomes.
Timely approach to reporting substandard or falsified medicines to relevant authorities. Roche provides evidence that it systematically reports confirmed cases of substandard or falsified medicines to relevant authorities or WHO Rapid Alert within the period recommended by stakeholders (maximum seven days).
Product DonationsRanking: 11 Score: 2.87
Has policy for responding to emergencies or humanitarian crises. While Roche did not make any ad hoc donations during the period of analysis, it has policies in place to respond directly to need, which are aligned with international guidelines. It has plans in place to ensure products are rapidly made accessible and to track the delivery of the product until received by end user.
Three donation programmes covering diseases and countries in scope. Roche's programmes are focused on non-communicable diseases (NCDs), namely cancer. All three programmes are carried out in collaboration with partners such as local ministries of health. Its breast cancer programmes supply trastuzumab (Herceptin®) in China, Pakistan and the Philippines. The programme in China began in 2011 with Roche reporting that nearly 20,000 breast cancer patients benefited from the trastuzumab Herceptin®) in 2016.
Ensures long-term access through transition planning. Roche has transition plans in place for its trastuzumab (Herceptin®) donation programme to ensure ongoing access for patients once the programme ends. The company will work with both national and local government units, health institutions and other stakeholders to ensure public reimbursement for trastuzumab (Herceptin®) so that patients can obtain it via the public health system. This will involve mobilising alternative sources of funding for cancer patients, such as the development of private health insurance for cancer.