Novo Nordisk A/S

Places 5th, scores 4.12

Has an access-to-medicine strategy with measurable objectives, integrated within its overall corporate strategy. Novo Nordisk performs strongly. The Defeat Diabetes strategy, focused on prevention, innovation, access and affordability, covers all therapeutic areas in which the company is involved for diseases in scope. The highest responsibility for access lies directly with the board, namely with the CEO, under the supervision of the Board of Directors. 

Provides evidence of financial and non-financial access-related incentives at the executive level. Novo Nordisk also performs strongly here. It incentivises its senior executives and in-country leaders for delivering on its access to care objectives. The CEO also has access-related incentives, linked to long-term social targets.

Publicly discloses outcomes of its access-to-medicine activities. Novo Nordisk performs strongly in transparency of access activities. It publicly discloses commitments including Access to Insulin, measurable goals, objectives and targets for improving access in countries in scope. It consistently shares outcomes of its access-to-medicine activities, including on the number people treated with insulin based on targets set and for its Changing Diabetes in Children programme. 

Has an average performance in responsible promotional practices. Novo Nordisk’s sales agents are not solely incentivised on sales volume targets. The company sets sales incentives at the individual level for agents. Novo Nordisk 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 industry association commitments e.g. in Brazil and in the Philippines.

Has a robust set of compliance controls to ensure that governance efforts are not undermined by non-compliant or corrupt activities. Novo Nordisk performs strongly here, demonstrating all components looked for by the Index: Fraud-specific risk assessment, country risk-based assessment, a continuous system to monitor activities, audits (both internal and external, covering third parties and in all countries where it operates) and has formal processes to ensure compliance with company standards by third parties.

Publicly supports international agreements. Novo Nordisk states that health emergencies requiring exceptions to IP rights can and should be accomodated under the international legal framework. It expresses reservations on the use of compulsory licensing. It states that its positions are generally aligned with its industry associations.

Places 18th, scores 0.98

No structured process for access planning disclosed. Novo Nordisk does not have a structured process in place to develop access plans during R&D. The company did not disclose a structured timeline for the development of access plans for its R&D projects. 

Novo Nordisk has no priority R&D projects in its pipeline. The company’s R&D projects focus mostly on diabetes mellitus (Type 1 and 2).

Some projects address a public health need in LMICs*, with 33% of the late-stage projects covered by access plans. In this analysis, Novo Nordisk has three late-stage R&D projects that target a disease and/or product gap not yet designated 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 diabetes mellitus. Novo Nordisk provides evidence of access plans for one of these projects. 

Public policy to ensure post-trial access; commits itself to registering trialled products. Novo Nordisk has a policy for ensuring post-trial access to treatments for clinical trial participants. This policy covers a subset of clinical trial participants on a case-by-case basis. Once a product is approved, Novo Nordisk commits to seek registration 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. Novo Nordisk performs poorly in this area. The company submitted two R&D capacity building initiatives, but none met all criteria for inclusion.

Places 4th, scores 3.81

Public commitment not to enforce patents in countries in scope. Novo Nordisk publicly pledges to neither file for nor enforce patents. This commitment applies in Least Developed Countries and low-income countries.

Publicly discloses detailed information on patent status. Novo Nordisk both publicly discloses on its website the patent statuses for biologics and for small molecules in scope via the Pat-INFORMED database. Novo Nordisk’s disclosure includes detailed information about patents, including expiry date, patent number and jurisdiction. 

Does not share IP assets with third-party researchers. Novo Nordisk reports no instances where it shares IP assets with third-party researchers developing products for diseases in scope during the period of analysis.

No use of non-assert or licensing arrangements. Novo Nordisk 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. Novo Nordisk did not disclose evidence of filing any of its most recently registered products in more than half of the relevant top 10 high burden countries (disease-specific subset of countries with the highest burden of disease). Its most widely registered product, insulin human (rDNA) (Actrapid®) for diabetes mellitus is registered/has been filed for registration in 76 countries in scope, including Guyana and Central African Republic.

No supranationally procured products. Novo Nordisk has no products eligible for scoring in this indicator.

No healthcare practitioner-administered products. Novo Nordisk has no products eligible for scoring in this indicator.

Has access strategies for its self-administered products for some countries in scope of this analysis. Novo Nordisk performs above average in this area. The company provides examples of access strategies which consider affordability in countries of all assessed income levels (UMIC, LMIC, LIC) for three of the five products assessed. It makes efforts to reach additional patients through the use of equitable pricing strategies and donation. For example, in Kenya, the human insulin (rDNA) (Actrapid®) is covered by the Access to Insulin Commitment, an inter- and intra-country equitable pricing strategy. The company guarantees a price ceiling of 3 USD per vial under this the commitment. Novo Nordisk also runs a programme that covers capacity building, patient education and provision of insulin at a low price in faith-based health facilities for patients at the base of the economic pyramid. In addition, the company donates human insulin for children with Type 1 diabetes mellitus through the Changing Diabetes® in Children programme. Novo Nordisk is able to provide evidence of how patient reach has been increased.

Two manufacturing capacity building initiatives meet all Good Practice Standards. Novo Nordisk has an average performance in this area. The company submitted two initiatives, which were both included for analysis and met all Good Practice Standards.‡ Both initiatives support partner manufacturing sites in India and Bangladesh in meeting Good Manufacturing Practic (GMP) standards, the qualification of equipment and the validation of manufacturing processes.

Three supply chain capacity building initiatives meet all Good Practice Standards. Novo Nordisk performs above average in this area. The company submitted four initiatives, which all met all criteria for inclusion. Three of them met all Good Practice Standards.‡ Examples include:
- The Defeat-NCD Partnership, strengthening the supply and procurement of non-communicable disease (NCD) treatments. 
- The Base of the Pyramid, improving diabetes care for people living at the base of the economic pyramid in Kenya
For the partnership initiative with the Africa Resource Centre in Kenya to support the National AIDS and STD Control Program, Novo Nordisk did not sufficiently demonstrate how the initiative aims for sustainability.

Five health system strengthening initiatives meet all Good Practice Standards. Novo Nordisk is one of the leaders in this area. The company submitted the maximum of five initiatives, which were all included for analysis and met all Good Practice Standards: i.e., they address local needs, have local partners, mitigate risk of conflict of interest, have defined goals and objectives, (plan to) measure outcomes, have a governance structure in place and aim for sustainability/integration in the local health system. For example, the Changing Diabetes in Children (CDiC) initiative aims to improve diabetes care for children by establishing clinics for Type 1 diabetes care, training healthcare workers, supporting patient education and donating free-of-charge human insulin. To date, the initiative has established 208 clinics in 14 countries, enrolled over 26,500 children and has been extended until 2030. 

Has engaged in the development and implementation of a scaled up inclusive business model. Novo Nordisk performs well when it comes to implementing scalable inclusive business models that aim to meet the access needs of populations at the base of the pyramid in countries in scope. It has scaled up its model Base of the Pyramid addressing diabetes-related access issues including awareness and health infrastructures in five African countries. 

The company has multiple mechanisms in place to ensure continuous supply in countries in scope of the Index. Novo Nordisk performs well in this area, disclosing multiple strategies to ensure the continuous supply in countries in the scope of the Index. In January 2020, Novo Nordisk rolled out a new demand planning platform ‘Demand Planning 4 Future’, which covers all markets and products and includes both commercial sales and humanitarian organisations sales. In February 2020, Novo Nordisk started a mapping project in 15 sub-Saharan African countries and India, identifying key agents in the value chain with the aim to improve processes and enhance availability. 

Has a policy for reporting substandard and falsified (SF) medicines in countries in scope in less than 10 days. Novo Nordisk has a policy for reporting SF medicines to the relevant health authorities, including the FDA, within 7 days. It does not distinguish reporting time frames for cases which only require visual inspection to be confirmed. 

Donates in response to an expressed need, and monitors delivery to end user. Novo Nordisk has a 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. For example, it donated insulin and glucagon for diabetes mellitus to at least 50 countries in 2020 in response to the COVID-19 pandemic.

Is not engaged in structured donation programmes for NTDs where elimination, eradication or control goals are possible. Novo Nordisk is not engaged in structured donation programmes for NTDs where elimination, eradication or control goals are possible. However, it is engaged in another structured donation programme: the Changing Diabetes in Children programme where it donates human insulin (Actrapid®, Insulatard® and Mixtard®) to 14 countries since 2009