As a global company, we work across many diverse cultures where concepts of appropriate business conduct can vary widely. We believe ethical business conduct is about values and integrity as well as compliance and risk mitigation. Taking a proactive approach in ethical business conduct increases trust in our company and improves relationships with key stakeholders.
In the Novo Nordisk Way, we outline
expectations for employee behaviour by stating that ‘we never
compromise on quality and business ethics’ (Essential 10). This is
supported by our OneCode and The Ethics
Navigator (TEN) for internal requirements on how to operate.
We focus on complying with all local and international anti-corruption laws, principles, standards and codes (including codes developed by patient organisations) and ensuring transparency in all interactions.
We have a Global Business Ethics Compliance programme to ensure compliance with all relevant anti-corruption laws and to work against corruption. The programme has seven elements:
Personal data protection and privacy
As a healthcare
company, we handle large volumes of personal data, including
information on participants in clinical trials,
human biosample donors, patients and healthcare providers reporting
safety concerns, and our employees. We store and transfer personal
data in and across different jurisdictions on a global level. Our
OneCode and The Ethics Navigator (TEN) for internal requirements on
how to operate are the basis for our global Personal Data protection
Compliance Programme. Together, they set the minimum global standards
for how we handle and protect personal data.
We always comply with any stricter local legal requirements for protecting personal data. We recognise that domestic law may not adequately protect the right to privacy in some jurisdictions. Where there is a conflict between the national law and the internationally recognised human rights principle of privacy, we always seek to make a responsible decision about how to handle personal data.
Our global Personal Data Protection Compliance Programme, including policies, training, and oversight mechanisms, is developed and maintained centrally, but each business area and its management are responsible for ensuring that their operations are in compliance with our internal requirements and applicable law.
Our Personal Data Protection Compliance Programme conducts cross-organisational reviews of risk to privacy in key functional areas to identify where we can reduce data collection and mitigate the highest risk to data subjects. The Personal Data Protection compliance programme continuously assesses risks and trends and monitors national and international laws to ensure continued compliance.
Our actions under the Personal Data Protection Compliance Programme include:
Performance
In 2023, Group Internal Audit performed 40
business ethics reviews, compared to 35 in 2022, which was in line
with the number of planned reviews for the year.
Annual training on business ethics is mandatory for all employees, including all new hires. In 2023, 99% of employees completed and documented their training, in line with 2022. The completion and documentation rate represents the emphasis of Novo Nordisk diligently following up on employees to ensure completion of the annual training. The remaining 1% is mainly due to employees being on leave.
We maintain a Compliance Hotline to enable employees, stakeholders and external parties to report potential violations of our policies or applicable laws and regulations. The Compliance Hotline is an important component of our commitment to ethical conduct and transparency.
Performance
The increase in number of
substantiated cases in the period from 2021 to 2023 is driven by the
increased business growth, including development in number of employees.
Our Responsible Sourcing programme aims to ensure that our social and environmental responsibility is reflected throughout the supply chain.
The programme is based on our commitment to the UN Global Compact and the UN
Guiding Principles on Business and Human Rights in our
supply chain.
With more than 60,000 suppliers across the globe, our expenses with
suppliers accounts for more than a third of our total sales
revenue. It is vital that we understand potential risks to responsible
business conduct across our global supply chain and take necessary
steps to mitigate risks.
Our Responsible Sourcing Standards for business partners have been
implemented globally. Our Standards articulate what we mean by
responsible sourcing and make clear our expectations to our suppliers
on responsible business conduct within human rights, labour, health
& safety, environment and anti-corruption. Our Standards build on
international standards and are aligned with the Pharmaceutical
Industry Principles for Responsible Supply Chain Management.
Novo Nordisk's Responsible Sourcing Standards for business partners
are available in the following languages:
Our other declarations, disclosures and statements include:
For our declaration on the California Transparency in the Supply Chain Act, visit our US website.
Read our Conflict Minerals Disclosure 2024
Read our Conflict Minerals Disclosure 2023
Read our Conflict Minerals Disclosure 2022
Read our Conflict Minerals Disclosure 2021
Read our statement on the UK Modern Slavery Act
Performance
The 30% increase in the number of supplier audits from 2022 to
2023 reflects the general increased activity level in Novo Nordisk.
Two critical findings on responsible sourcing were issued during 2023, both related to wages, benefits and working hours.
Three critical findings were issued during quality audits, related to reprocessing, certificates of analysis (COAs) and cross-contamination control.
Agreements regarding actions to address all critical findings have been made with the affected suppliers. Of the two critical findings issued and reported in 2022, one was addressed in the same year, and remediation for the second critical finding regarding environmental reporting was still ongoing. An agreement with the supplier has subsequently been reached during 2023.
Every day, millions of people rely on the quality and safety of our products.
All medicines have potential side effects as well as benefits. We routinely monitor the safety and quality of all our products. This includes review of safety data from clinical studies and review of side effects and technical complaints received on marketed products. By monitoring quality and safety information on our products we can take due and appropriate actions to safeguard patient safety if needed.
We have in place a Quality Management System to ensure that we adhere to international and local legislation and that safety information is handled in the same way no matter in which country the patient lives.
Our Global Safety team has a pharmacovigilance system in place ensuring that the necessary means for collection and notification of any safety data are in place.
Prior to any clinical investigation of a new pharmaceutical product or medical device, a safety committee with members from all relevant functional areas is established. This committee will exist throughout the product or device’s life cycle. It is a multi-disciplinary team providing assessments of safety data, for a pharmaceutical product or medical device in development or on the market.
Further procedures ensure we can react promptly and adequately if one of our products on the market, or used in clinical trials, is suspected of being affected by a significant product defect, such as recalling affected products.
We are committed to patient safety and want to make it easy for patients to get in contact with us, if they have a complaint or want to report a side effect. Therefore, we have established easily accessible online complaint reporting directions with contact information in local language.
Counterfeit products
Counterfeit products pose
significant and potentially life-threatening risks to the health of
patients. Such products may lack active ingredients so patients do not
receive the treatment they expect and need, or they may contain other
ingredients that could pose a safety risk.
To ensure patient safety, we have been implementing a comprehensive anti-counterfeit programme. A cross functional Anti-Counterfeit Working Group, chaired by the head of our Customer Complaint Centre, ensures vigilant risk assessment and implementation of an Anti-Counterfeit Product strategy.
We have an ongoing international collaboration with regulatory bodies, scientific and trade organisations, law enforcement agencies and other stakeholders to investigate counterfeit products and to influence legislation regarding new anti-counterfeit measures.
Those found guilty of producing or/and distributing counterfeit Novo Nordisk products are given fines and/or custodial sentences. China, as a result of lobbying and official intervention, has increased the length of sentences for counterfeiting.
We are a member of the Pharmaceutical Security Institute (PSI), which on behalf of the approximately 30 largest pharmaceutical companies, collects information and coordinates investigations into counterfeit products worldwide.
We conduct regular reviews of risks through information exchange with external collaborators. The investigation of suspected counterfeit cases is reported via our affiliates or authorities. Monthly internal counterfeit surveillance reports are reviewed by key specialists and management.
Our Quality Management System identifies and investigates alleged occurrences of counterfeited Novo Nordisk products. In China, we work with local investigation firms to perform market searches to help health authorities track down and seize counterfeit products. Outside China, we conduct investigations of suspected counterfeit products based on risk analysis and take legal action against those involved in the counterfeiting of our products.
Recognising that low awareness and under-reporting are known issues in many countries, we provide internal video training for our affiliates globally.
In China, our proactive approach including collaboration with and training of local authorities, and scouting for counterfeit products and reporting these to local authorities has enabled us to keep counterfeit products at a relatively lower level.
Currently, the main products being counterfeited are GLP-1 analogues e.g. Saxenda® in Brazil, Human insulin in vials in Bangladesh and Norditropin® sold via the internet or in fitness centres.
Performance
In 2023, Novo Nordisk had two product
recalls. In Libya, the recall was due to a labelling error on the
sales carton. In Spain, the recall was due to cracked cartridges in
FlexTouch® pens.
In 2023, Novo Nordisk had not failed any inspection among those that were resolved at year-end. During 2023, 152 inspections were conducted. At year-end, 117 inspections were passed and 35 were unresolved, as final inspection reports had not been received, or the final authority’s acceptance was pending. This is normal practice. Follow-up on unresolved inspections will continue in 2024.
The Novo Nordisk Way is a set of guiding principles which underpins every decision we make. We use a unique, systematic approach known as facilitation to ensure that everyone lives up to the Novo Nordisk Way. Any issues identified during a facilitation are addressed locally, and consolidated insights are shared with Executive Management and the Board of Directors. The Novo Nordisk Way also underpins our performance management and incentive programmes.
Performance
In 2023, a total of 42 units were facilitated and approximately
2,300 employees were individually interviewed. In addition, feedback
on those units was collected from approximately 550 stakeholders. Out
of the 42 units, one unit was assessed not to be working in accordance
with the Novo Nordisk Way, and for five units immediate actions were
required, which if not taken would lead to breaches of the Novo
Nordisk Way.
Across all units facilitated, the accelerated growth and supply-demand challenges are the two main factors which consistently impact the organisation and drive most improvement opportunities from the facilitations conducted.
The most frequent observations raised to management teams for action are associated with five out of our ten Essentials: 2) We set ambitious goals and are empowered to achieve them, 5) We build and maintain good relations with our stakeholders, 7) We focus on performance and personal development, 8) We have a healthy and engaging work environment, and 9) We strive for agility and simplicity in everything we do.
As a leading global healthcare company, we engage with a variety of stakeholders, including public officials, healthcare professionals, patient organisations and business partners. In all our interactions, our first priority is to live up to our responsibilities and all regulatory requirements.
Our policy on transparency is clear - we will be transparent and accountable for how we operate and the transactions that take place when and where we work.
This is a part of Novo Nordisk’s company values expressed in the Novo Nordisk Way and in our Business Ethics Compliance Framework, and how we earn and retain trust and confidence.
The Novo Nordisk reputation score among key stakeholders (i.e., the informed general public, people with diabetes, people with obesity, healthcare professionals and diabetes specialists) is an indicator of the extent to which we live up to society’s expectations. It is the emotional bond that stakeholders feel towards Novo Nordisk and it is measured across Esteem, Admiration, Trust and Feeling dimensions.
Performance
We achieved a strong reputation score of 82.1
points in 2023 measured on a scale of 0-100. Novo Nordisk’s excellent
reputation score is driven by positive perceptions of products and
services and by growing appreciation from the informed general public.
Currently, it is not possible to examine the complex interactions in a living organism solely through the use of cell cultures and tissues. Hence, research using living animals is essential for all pharmaceutical companies in the discovery, development and production of new pharmaceutical and medical products.
We recognise that not all research using animals can be replaced in the foreseeable future and consider it our responsibility to actively support the principles of the 3Rs (Reduce, Refine and Replace research using animals, Professor William Russell and Rex Burch, 1959) internally and externally.
Animal welfare is our highest priority. We have a centralised strategic department that contributes to internal awareness and education as well as ensure continued integration of the 3R considerations in our decision-making processes. Furthermore, the department engages in dialogues and partnerships with our key stakeholders.
When animals are necessary for research, their welfare is given high priority and attention in several ways. Not only when they are being tested, but also when they are housed.
Our state-of-the-art housing standards consider the physiological and ethological (behavioural) needs of the animals. We have successfully been able to implement the standards for all animals housed at our facilities.
The design of our renovated facilities was made in close collaboration with The Danish Animal Welfare Society and with valuable input from many internationally recognised experts within animal welfare, as well as input from the employees working every day with the animals, especially the animal caretakers.
For additional information about animal ethics, click here.
To read about our commitment to the Marseille Declaration on animal housing and use, click here
Performance
The number of animals purchased for research
in 2023 decreased by 29% compared to 2022. 96% of the animals
purchased were rodents. The significant decrease in the number of fish
and rodents in 2023 is attributable, respectively, to specific
research projects using fish larvae that have been discontinued in the
year, and to our continuous efforts to reduce the number of animals
used for research.