General Access to Medicine ManagementRanking: 1 Score: 4.56
Has a strong access-to-medicine strategy with board-level responsibility. Novartis 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 has three objectives focused on low-income markets: the control and elimination of disease; piloting new business approaches and engaging in R&D for unmet needs. The highest level of responsibility for access sits with a board-level committee.
Financial and non-financial access-related incentives to reward employees. Novartis 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. Non-financial incentives include a global programme recognising associates making significant contributions towards corporate responsibility initiatives. Senior management achievement of access objectives is linked to compensation.
One of 16 companies working on impact measurement. Novartis measures and monitors progress and outcomes of access-to-medicine activities. It also publicly reports on its commitments, objectives, targets and performance information. For example, for its Malaria Initiative, Novartis reports having provided more than 850 million treatments on a non-profit basis, to more than 60 countries since 2001, contributing to a significant reduction of malaria-related deaths. Furthermore, it is one of the companies that is measuring impact, with Boston University Metrics Framework, for at least one access initiative, e.g. Novartis Access.
Clear and transparent engagement approach that includes local stakeholders. Novartis 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 corporate responsibility materiality analysis, including research and surveys with internal and external stakeholders. Local stakeholder perspectives are incorporated into the development of its access strategies. It has some policies covering responsible interactions with stakeholders; namely on prioritising access to healthcare, innovation, patient health and safety, and ethical business practices.
Market Influence & ComplianceRanking: 2 Score: 3.34
Has measures to ensure third-party compliance with ethical marketing and anti-corruption standards. Novartis has a code of conduct relating to ethical marketing and anti-corruption, and provides regular 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, Novartis newly rewards other aspects such as performance, innovation, collaboration, courage and integrity.
Internal control framework meets all Index criteria. Novartis has all the components looked for by the Index for an effective internal control framework to ensure compliance. Namely, it reports that it regularly conducts fraud-specific risk assessments. It has a global risk assessment, and a monitoring system to track compliance. It also has an auditing and review mechanism in place, which apply to third parties. Novartis demonstrates evidence of having procedures to segregate duties, so that decisions are checked by another party.
Above average transparency regarding access-related practices. Novartis publicly discloses its policy positions on access-related topics (e.g., its perspective on corporate responsibility including quality and safety of medicines, intellectual property, and its Access to Healthcare Perspective). The company discloses political contributions in countries in scope. It discloses its membership of relevant institutions and whether it provides financial support. Novartis discloses its policy for responsible engagement through its global policies for Responsible Lobbying and Anti-Bribery; its policies also include access perspective, intellectual property and quality and safety. It does not, however, publicly disclose its policy approach to payments made to healthcare professionals in countries in scope.
Research & DevelopmentRanking: 3 Score: 3.55
Publicly commits to R&D to meet public health needs. Novartis 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. Novartis has one of the largest pipelines in the Index with 117 projects. For diseases in scope where priorities exist, Novartis is active in 28 projects; 26 target priority R&D gaps.
Access provisions in place for 25% (9/36) of late-stage candidates. Novartis has a clear process in place to develop access plans during R&D through its Novartis Access Principles. This process considers all R&D projects for diseases in scope. In general, Novartis develops access plans for R&D projects in Phase II of clinical development. To date, Novartis has project-specific access provisions in place for nine of its late-stage R&D projects. Of these, four are being conducted in partnership.
Public policy to ensure post-trial access; commits to registering trialed products. Novartis 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, Novartis commits to registering it in all countries where clinical trials for the product have taken place.
Pricing, Manufacturing & DistributionRanking: 3 Score: 2.95
Commits publicly to equitable pricing but does not report a commitment to file to register new products in scope. Novartis 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 equitable pricing strategies for the majority of its products for diseases in scope.
Many new products in scope filed for registration in the majority of relevant priority countries. Novartis has filed 50% of its newest products for registration to date in more than half of the 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.
57% of products have equitable pricing strategies targeting priority countries. Novartis' overall performance is average compared to peers in equitable pricing. It demonstrates evidence of having equitable pricing strategies for 57% of its products for diseases in scope. These strategies apply to an average of 20% of priority countries. Almost all of these strategies apply inter- and intra-country pricing; these take into account an average of six and one socioeconomic factors, respectively. Novartis also applies equitable pricing strategies to three further products informed by a public health rationale.
Globally consistent recall guidelines for countries in scope but no processes to track products. Novartis 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: 16 Score: 1.29
Publicly discloses detailed information on patent statuses. Like most of its peers, Novartis 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. Novartis 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 few IP assets with 3rd-party researchers. Novartis shares one IP asset with third-party researchers developing products for diseases in scope. It shares this asset with the University of Cape Town. The assets shared include a molecule library.
Public commitment not to enforce patents in countries in scope. Novartis 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.
Capacity BuildingRanking: 3 Score: 3.75
22 initiatives included for evaluation. Novartis has 22 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; Novartis submitted the maximum.
Strong focus on strengthening capacity of local R&D, manufacturing and health systems. Novartis has initiatives which meet inclusion criteria in all five areas of capacity building. It has at least one initiative in all areas which meet all good practice standards, except pharmacovigilance capacity building. Novartis performs strongest in manufacturing capacity building, R&D capacity building and health system strengthening.
12 initiatives meet all applicable good practice standards:
-Partnership with local third-party manufacturers in Iran
-Technical transfer for local manufacturing in China
-India local manufacturing for the Healthy Families (Arogya Parivar) programme
-Bangladesh Alternative distributor project
-Novartis Memorandum of Understanding with South African Department of Science and Technology and South African Research Council
-Skills-building for research writing
-SMS for Life 2.0
-Novartis Malaria Initiative
-Better Hearts Better Cities
-Strengthening care at the community level
-Partnerships to develop capabilities in oncology
-Novartis Foundation leprosy initiative (LEARNS & LPEP)
Novartis's remaining included initiatives typically fall short on just one good practice standard. For example, two of its pharmacovigilance initiatives did not show evidence of good governance structures and process for mitigating conflicts of interest.
Does not provide evidence of reporting substandard or falsified medicines within the recommended time frame.* Novartis has a policy of reporting cases of substandard or falsified medicines to relevant authorities and in some cases to WHO Rapid Alert. For example, Novartis reported a case of falsified arthemeter/lumefantrine (Coartem®) to WHO Rapid Alert in the period of analysis. However, it does not require reporting to occur within the time frame of seven days looked for by the Index.*
Product DonationsRanking: 3 Score: 4.43
Responds to emergencies and humanitarian crises and tracks delivery. Novartis donated medicines on the request of relief agencies. For example, during the period of analysis, it donated medicines in response to Hurricane Harvey in Haiti in 2017. The company discloses that such ad hoc donations are aligned with international guidelines (issued by WHO, PQMD), and it works, for example, with the Swiss Red Cross and the International Committee of the Red Cross to ensure products are rapidly delivered. It also monitors the delivery of the product until received by end user.
Three donation programmes covering diseases and countries in scope. Novartis' programmes are focused on neglected tropical diseases (NTDs) and non-communicable diseases. All three programmes are carried out in collaboration with partners such as WHO and the Max Foundation. Its programme for chronic myeloid leukemia supplies imatinib (Glivec®) and nilotinib (Tasigna®) in 57 countries and has been ongoing since 2002. Novartis reports that almost 71,000 patients have been reached in Index Countries during the period of analysis.
Addresses long-term access by aiming to eliminate disease. Novartis commits to long-term structured donation programmes by aiming to eliminate the diseases targeted. For example, its multi-drug therapy donation programme aims to eliminate leprosy in 49 countries.
*Defined as a recommended time frame through consultation with stakeholders during Index methodology development.