Eli Lilly & Co.

Places 13th, scores 2.85

Has an access-to-medicine strategy with measurable objectives and a business rationale. Eli Lilly has an average performance. It has an access strategy, centered around the Lilly 30x30 programme, which goes beyond philanthropy. The strategy covers some of the therapeutic areas in which the company is involved, for example some non-communicable diseases (NCDs) including diabetes. While the board oversees access, the highest responsibility lies with the CEO and the executive team. A new Steering Committee oversees progress on Lilly 30x30.

Provides evidence of financial access-related incentives at the executive level. The CEO has access-related incentives linked to its ability to drive the 30x30 strategy and ensure progress. Eli Lilly does not disclose, however, whether senior executives and in-country managers are also incentivised toward access goals. 

Does not publicly disclose outcomes of its access-to-medicine activities. Eli Lilly performs below average on transparency regarding access initiatives. It publicly discloses its commitments, objectives and targets related to improving access to medicine in countries in scope, also via the IFPMA Global Health Progress platform, namely with its Lilly 30x30 Programme initiatives. It does not, however, share the outcomes of its individual access activities during the period of analysis, but reports having reached 7.2 million patients in 2019, compared to 2015 through Lilly 30x30. 

Performs comparatively poorly in responsible promotional practices. Eli Lilly does not disclose whether sales agents are incentivised on other measures than sales volume. There is evidence that the company sets incentives based on sales targets at the individual level for agents. It does not publicly disclose information related to transfers of values to healthcare professionals in countries in scope (e.g. payments for attending events or promotional activities), unless required by local regulations or trade associations. 

Has some compliance controls to ensure that governance efforts are not undermined by non-compliant or corrupt activities. Eli Lilly has an average performance, with evidence of some of the components looked for by the Index: A continuous system to monitor activities, audits and formal processes to ensure third-party compliance with company standards. There is no evidence, publicly found or disclosed to the Index, of fraud-specific risk assessment or country risk-based assessment.

Does not publicly support the Doha Declaration on TRIPS and Public Health. Eli Lilly does not publicly share any support of or statement on the Doha Declaration on TRIPS and Public Health, but states that its position aligns with IFPMA. There is no evidence of a policy to dissent from industry association positions on these.

Places 19th, scores 0.88

No structured process for access planning reported. Eli Lilly does not report a structured process to develop access plans during R&D. The company did not report a structured timeline for the development of access plans for its R&D projects.

A small-sized priority R&D pipeline compared to peers, with access plans in place for 33% of the late-stage candidates. Eli Lilly has six projects including three late-stage candidates in its pipeline that target a priority product gap. The company focuses mostly on coronaviral diseases and tuberculosis. Of Eli Lilly‘s three late-stage candidates targeting a priority product gap, one has evidence of an access plan in place, which is for the TBA-7371 / DprE1 Inhibitor. This project runs in partnership with the TB alliance.

Some projects address a public health need in LMICs*. The company does not disclose evidence of access plans for the late-stage projects. In this analysis, Eli Lilly has 14 late-stage R&D projects that target a disease and/or product gap not yet established as a priority by global health stakeholders. These projects are all deemed by the Index to offer a clear public health benefit for people living in LMICs.* Primarily, these projects concern clinical trials in countries in scope and/or are first-in-class molecules. Most target cancer. 

Public policy to ensure post-trial access; commits itself to registering trialled products. Eli Lilly has a publicly available policy for ensuring post-trial access to treatments for clinical trial participants. This policy covers a subset of clinical trial participants with a serious condition and no alternative treatments are available. Once a product is approved, Eli Lilly commits itself to registering it in all countries where clinical trials for the product have taken place. The policy does not consider affordability for the wider population in the country where the trial(s) took place.

No R&D capacity building initiatives included for evaluation. Eli Lilly has no initiatives included for analysis aimed at building supply chain capacity. Companies could submit a maximum of five initiatives in this capacity building area. The company reported no information to the Index about building R&D capacity in countries in scope of the Index. No initiatives were identified for selection based on publicly available information.

Places 18th, scores 1.25

Public commitment not to enforce patents in countries in scope. Eli Lilly publicly pledges to neither file for nor enforce patents. This commitment applies to all Least Developed Countries.

Publicly discloses detailed information on patent status. Like most of its peers, Eli Lilly publicly discloses the patent statuses for small molecules in scope via the Pat-INFORMED database. This information is periodically updated and includes detailed information about patents, including filing date, grant number, grant date and jurisdiction.

In addition to the older assets, Eli Lilly newly shared one IP asset with third-party researchers developing products for diseases in scope during the period of analysis. During the period of analysis Eli Lilly newly shared one IP asset with third-party researchers developing products for diseases in scope. It shares this asset with the drug discovery initiative COVID-19 Therapeutics Accelerator launched by the Bill and Melinda Gates Foundation, Wellcome and Mastercard. The asset shared is molecule libraries. The new agreement is in addition to previously agreed IP sharing agreement with the product development partnership TB Alliance.

No use of non-assert or licensing arrangements. Eli Lilly does not engage in voluntary licensing nor has it issued non-assert declarations for products in scope.

No evidence of new products in scope filed for registration in the majority of high burden countries. Eli Lilly did not disclose evidence of filing any of its most recently registered products in more than half of the top 10 high burden countries (disease-specific subset of countries with the highest burden of disease). Its most widely registered product dulaglutide (Trulicity®) for diabetes mellitus is registered in seven countries in scope, including El Salvador and India. 

No supranationally procured products. Eli Lilly has no products eligible for scoring in this indicator.

No evidence of access strategies for any of its healthcare practitioner-administered products in scope of this analysis. Eli Lilly has not disclosed, either publicly or to the Index, access strategies for any of the four products (three oncology medicines and a treatment for ischaemic heart disease) assessed by the Index in this category. 

No evidence of access strategies for any of its self-administered products in scope for this analysis. Eli Lilly has not disclosed, either publicly or to the Index, access strategies for any of the five products, assessed by the Index in this category. Four products in this category are indicated for diabetes mellitus treatment. 

No manufacturing capacity building initiatives included for evaluation. Eli Lilly has no initiatives included for analysis aimed at building manufacturing capacity. Companies could submit a maximum of five initiatives in this capacity building area. The company reported no information to the Index about building manufacturing capacity in countries in scope of the Index. No initiatives were identified for selection based on publicly available information.

No supply chain capacity building initiatives included for evaluation. Eli Lilly has no initiatives included for analysis aimed at building supply chain capacity. Companies could submit a maximum of five initiatives in this capacity building area. The company reported no information to the Index about building supply chain capacity in countries in scope of the Index. No initiatives were identified for selection based on publicly available information.

Two health system strengthening initiatives meet all Good Practice Standards. Eli Lilly has average performance in this area. The company reported no information to the Index about health system strengthening initiatives in countries in scope of the Index. Three initiatives were identified for selection based on publicly available information, of which two meet all Good Practice Standards: i.e., they address local needs, have local partners, mitigate risk of conflict of interest, are guided by clear goals and objectives, (plan to) measure outcomes, have a governance structure in place and aim for sustainability/integration in the local health system. These include:
- The HOPE Centre in South Africa, educating communities about diabetes mellitus and hypertension and providing clinical services. To date, 14,000 people have been screened. 
- Health Worker Training Initiative, a multi-company partershipwith Last Mile Health, Living Goods and the Bill & Melinda Gates Foundation, training and deploying 2,500 digitally enabled community health workers by 2022 in six sub-Saharan African countries. 

Has not engaged in the development and implementation of inclusive business models. Compared to peers, Eli Lilly performs relatively poorly when it comes to implementing scalable inclusive business models that aim to meet the access needs of populations at the base of the pyramid (which may include vulnerable populations) in countries in scope, with a long-term horizon. No initiatives were disclosed to the Index and no current status of any ongoing initiative was publicly available.

Some mechanisms identified to ensure continuous supply in countries in scope of the Index. Eli Lilly has average performance in this area, with limited information identified by the Index on the steps it takes to ensure the continuous supply of its medicine in countries in scope of the Index. Eli Lilly has policies and processes in place to align demand and supply, working together with local manufacturing and distribution sites. Eli Lilly reports having a global Product Shortage Prevention Strategy and a monitoring and reporting process for shortages in place. However, no details have been identified as to what these strategies and processes include. 

Does not have a policy for reporting substandard and falsified (SF) medicines in countries in scope within the recommended time frame. Eli Lilly does not disclose, publicly or to the Index, evidence of a policy in place to report SF medicines to relevant health authorities. It has a public policy on tackling counterfeit products. 

Donates in response to an expressed need and monitors delivery to end user. Eli Lilly has a public policy in place to ensure ad hoc donations are carried out in response to an expressed need, and it monitors the delivery until the end user.

Is not engaged in structured donation programmes for NTDs where elimination, eradication or control goals are possible. Eli Lilly is not engaged in structured donation programmes for NTDs where elimination, eradication or control goals are possible. However, the company is engaged in other structured donation programmes, such as the Life for a Child programme where it donates insulin lispro, human insulin analogue (Humalog®) for Type 1 diabetes mellitus in 37 countries since 2009.