novo nordisk OneCode Principles for Working User Guide

novo nordisk OneCode Principles for Working

OneCode – Principles for working at Novo Nordisk applies to everyone employed by or working on behalf of Novo Nordisk. The purpose of OneCode is to guide us on how we act as a company and as individuals, empowering each of us with the principles and requirements to make the right decisions across our business.

Our Purpose

A message from our CEO

Every day, thousands of people worldwide go to work at Novo Nordisk. Each of us is committed to our shared purpose of driving change to defeat serious chronic diseases, built upon our heritage in diabetes. By discovering and developing new and innovative medicines, we address diseases that affect hundreds of millions of people around the world. I am proud to be part of this ambitious journey with you.

Patients are essential to our purpose and have been so since the day Novo Nordisk was founded in 1923. They are our neighbours, families and friends. We work tirelessly to improve patients’ lives, enhance access to care and collaborate with partners to enable affordable care for more people worldwide. Our decisions are based on what is best for patients and, thereby, for Novo Nordisk.

We operate in a highly regulated environment and following applicable rules and regulations is critical to safeguarding our license to operate. Our values are expressed in the Novo Nordisk Way. OneCode supports us in living up to the Novo Nordisk Way, especially essential 10 ‘We never compromise on quality and ethics’.

The purpose of OneCode is to guide us on how we act as a company and as individuals. It empowers each of us with the principles and requirements to make the right decisions across our business. OneCode applies to everyone employed by or working on behalf of Novo Nordisk. OneCode helps us do the right thing, so that we can fulfil our purpose in an ethical and compliant way.

OneCode is not an exhaustive list of every principle or policy you may need to know, but it is a good roadmap and directs you to additional resources. Therefore, use the Novo Nordisk Way, OneCode and relevant Standard Operating Procedures (SOPs) to guide your actions and decisions.

We all share the responsibility to live by OneCode.

Sincerely,

Lars Fruergaard Jørgensen
President and CEO of Novo Nordisk

Our Healthy Workspace

We foster a safe and respectful work environment

Health & Safety

We care about your well-being while you are at work, and when you are going to work and returning home. We foster a healthy and safe working environment and care for each other. Well-being at Novo Nordisk is feeling safe and knowing that you’ve been given the trust and tools to do your job at the highest level, whether working on-site, remotely or in the field. We support an environment which allows you to perform at your best and to experience a balanced life.

What does it mean for me?

• Take action when you see risks at the workplace. Remove the risk or reach out to your manager or local Health and Safety Representative/Coordinator.
• We all play part to ensure a healthy and engaging working environment – see more here

Diversity & Inclusion

At Novo Nordisk, we bring together people of diverse backgrounds, perspectives and thoughts. Each of our colleagues is unique, and we work together to create an inclusive culture where all employees are respected, have a sense of belonging and equitable opportunities to realise their potential.

Human Rights

Human rights are a set of fundamental rights and freedoms that are inherent to all human beings, regardless of their race, gender, nationality, religion, or any other status. Everyone is entitled to human rights without distinction. We respect all human rights and are committed to fulfilling the UN Guiding Principles on Business and Human Rights. We do not tolerate discrimination or harassment in any shape or form – either at Novo Nordisk or by business partners. That is how we build a safe and respectful work environment.

What does it mean for me?

• Treat everyone with respect
• Do not engage in or tolerate harassment, discrimination or retaliation
• Avoid negative impacts on people and address such impacts when they occur
• Agree on Human Rights expectations with business partners

Read our Anti-Harassment Framework here, and see how to report an actual or potential violation here.
To learn more, read about our human right commitment here.

Our Treatments & Stakeholders

We provide medicines in a responsible way

Ethical research & development

Medicines from Novo Nordisk are subjected to high quality and safety standards throughout the life cycle. From early research to clinical trials to when our medicines are available to patients, we never compromise on applying high standards. We respect all human and animal subjects’ rights, integrity, and dignity to ensure their safety and well-being.

Bioethics is embedded in our research and is fundamental to our decision- making processes and aligned with our sustainability principles. Our research activities and clinical trials fulfil international and national ethical and human rights principles. We are committed to transparency and share our results openly.

What does it mean for me?

Apply the following principles for any research and clinical trials activity:

• Ensure accountability through a governance framework
• Act in accordance with ethical, legal, quality, and regulatory standards
• Assess compatibility for data use
• Ensure a fair balance of interests
• Apply a sound scientific approach
• Protect privacy & confidentiality
• Demonstrate oversight & compatibility
• Always ensure free, prior and informed consent of any participant

For more information, read Novo Nordisk Principles of Clinical Research here and Global Bioethics standards here.

Safety information reporting

You must inform your local safety department of any safety information involving Novo Nordisk products that is reported directly to you. This includes information received outside working hours, and it applies whether the Novo Nordisk product is a drug or a medical device, including Software as a Medical Device (SaMD). Safety information may be reported to you by patients, customers, healthcare professionals or others, but regardless of the source, you must forward the information within 24 hours (in Japan within the same day). If you are not sure whether to forward the information, forward it anyway.

What constitutes safety information?| ·         Side effects: any healthcare problem or symptom experienced by a user of our products where there is a suspected connection to the product

·         Serious outcomes, e.g., hospitalization or death

·         Use of a Novo Nordisk drug during pregnancy

·         Overdose, drug abuse, and drug misuse

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·         Medication errors: e.g., administration of the wrong drug

·         Lack of efficacy: the drug does not give the expected beneficial effect

·         Occupational exposure: exposure to a Novo Nordisk product as a result of one’s occupation. E.g., accidental needle stick due to occupation as a nurse.

·         Technical Complaints: any information that claims product (drug or medical device) defects

·         Suspected counterfeit, diverted or stolen products

What information must be obtained for the report?

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·         Patient details (age/age group, gender)

·         Name of the Novo Nordisk product and the batch number

·         Details about the reported safety information (when occurred, recovery status)

·         Details about the reporting person (e.g., phone number or email). Novo Nordisk will probably need to follow up for more information, if the person has agreed to be contacted.

How to report safety information?

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Report the safety information to your local department – type localsafety/ in your browser. For example, employees in Denmark must report to the Danish affiliate’s safety department. If you are unable to do it, then report to your direct manager within the same timeframe. As a last option, you can report directly to Global Safety in HQ via email: [email protected]

Let the person reporting the safety information know that…

| ·         You need to forward the information to the safety department for the sake of patient safety and to comply with current legislation

·         The data will be treated confidentially and stored permanently in the Novo Nordisk global safety database

·         Novo Nordisk is obliged to report information on product complaints and side effects to health authorities in accordance with local legislation

·         The full information on how we process personal data in Novo Nordisk can be found on the Novo Nordisk global company website under “Report a side effect” or on the local affiliate company website

Our stakeholders

We interact with external stakeholders in various ways to advance quality of care. We ensure that our interactions with stakeholders are justified by a valid business purpose and are fully compliant, as we never compromise on ethics. We treat all stakeholders fairly and honestly, respect their independence and we expect our partners to act with integrity.

Patients and Patient Organisations

| Our business approach is patient-centred, and we believe that regular and systematic patient involvement and dialogue are vital to improving our products, treatments and care.
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Healthcare Professionals and Healthcare Organisations

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We interact with Healthcare Professionals (HCPs) and Healthcare Organisations (HCOs ) in many ways, including for our research and development activities, medical information communications, educational efforts and promotional activities , in order to provide, exchange or obtain scientific or educational input.

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Public Officials

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We interact with Public Officials, (POs) like politicians, governmental employees, and similar, for the purpose of discussing legitimate Novo Nordisk business, to participate in events organised or sponsored by Novo Nordisk or to provide bona fide services.

Third Party Representatives

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We partner with Third Party Representatives (TPRs) like distributors and marketing agencies, to help develop innovative solutions and make them available to patients.

What does it mean for me? Interacting with patients

• Focus on patients’ best interests
• Treat patient information with respect and protect confidentiality
• Follow the established contracting or engagement process
• Report any side effects or serious outcomes of our medicines

What does it mean for me? Working with HCPs, HCOs, POs and TPRs

When interacting with HCPs, HCOs, POs and TPRs:

• Ensure the interaction is based on a valid scientific and/or business purpose
• Ensure fair market value
• Be responsible, ethical, and transparent
• Disclose any potential conflict of interest
• Follow the established contracting or engagement process
• Never engage with these stakeholders in order to gain an inappropriate advantage for yourself or Novo Nordisk
• Do not offer, give or receive gifts, or bribes
• Do not seek to inappropriately influence them

Responsible Sales & Marketing

We communicate to HCPs about our products to encourage their informed use so they can make the best treatment choices for the benefit of patients’ health. The main purpose of the rules on promotion of medicinal products is to safeguard the health of patients.

We only promote Novo Nordisk products for approved uses in a manner that is truthful, accurate, non-misleading and balanced. We do not initiate or engage in conversations around the use of any Novo Nordisk products in private social settings, or on social media. This information should only be provided by HCPs or medical colleagues.

We share scientific information about our products to ensure that the medical community is fully informed, including providing information about new developments, product safety, and to follow laws and regulations. If you receive a question that is inconsistent with an approved product label or relates to a non-approved product, refer the request to the local medical department.

Our Quality Culture

We adhere to high quality standards

In Novo Nordisk, we have a Quality Mission that clearly states our obligation to ensure ‘quality to patients’. In Novo Nordisk, ‘Quality to patients’ is defined as all activities that ensure effective and safe treatment to our patients. At Novo Nordisk, our Quality Mission is our Quality Policy.

You are responsible for pursuing this mission every day at work. To do so, comply with the requirements related to your job and actively take responsibility for quality in everything you do.

The Quality Management System (QMS) helps you with this

The QMS is a framework for managing quality in our everyday work. It contains our processes described in procedures and helps us as employees to be competent to do our work in compliance.

Training and competencies

It is important that you are competent and sufficiently trained to perform your job tasks before you do them. This ensures stable processes and working in compliance with requirements securing product quality. Therefore, you must always complete the training assigned to you before you start working with the task and no later than the due date. Your manager ensures you have a current training plan that shows the training activities you need to complete.

What does it mean for me?

• Make sure you are trained before you do your tasks
• Check ISOtrain on a regular basis
• When your responsibilities change, you must discuss with you manager the need for additional training or removal of training
• If you have worked out of compliance, you must contact your manager immediately.

For more information type training/ in your browser or read Training Q174772. If in doubt, contact your manager or your Training Responsible Person.

Q&A

• Q: Why is Quality important for me?
  • A: We need to ensure quality to protect our patients and to keep our license to operate to stay in business. Therefore, it is important that you as a Novo Nordisk employee understand both why and how to ensure quality in your daily work.
• Q: What is GxP?
  • A: GxP is the regulatory requirements within healthcare. These are health authority regulations to the different activities that we do throughout the product life cycle – from developing the drug and device to delivering it to patients. Complying with these requirements is a pre-requisite to obtain and maintain a marketing authorization.
• Q: How can I support Product Quality?
  • A: Report any error or change in our products so it can be corrected or eliminated (see ‘Report Customer Complaints’ and ‘React to deviations’ sections).
• Q: What does quality mindset mean?
  • A: Quality mindset means that you live by the Novo Nordisk quality mission. An example could be that you react and bring up quality issues to management attention.

Further information and guidance:

• Novo Nordisk Quality Manual – Q166087
• Quality Manual eLearning (iSOtrain course 74255)
• Type quality/ in your browser

If you are in doubt, contact your manager, QA or the local Quality Responsible Person.

Our Safeguards & Integrity

We protect ourselves, Novo Nordisk and society

Systems and technology

Technology connects and empowers us and allows us to work efficiently. Our devices, platforms, and tools enable effective collaboration and communication with our colleagues, customers and patients. Remember all the good that technology gives us, but also be aware of digital risks such as fake emails, scams, and unauthorised software and online services.

What does it mean for me? Systems and technology

Follow the 7 principles of IT Code of Conduct to protect yourself and Novo Nordisk.

1. Only use Novo Nordisk equipment
2. Connect securely
3. Work securely
4. Don’t download
5. Don’t upload
6. Protect information
7. Act on security incidents

For more information, including Q&A, type ITsecurity/ in your browser or read IT Code of Conduct [Q127938].

Information and data use

We work to solve global health challenges. That requires innovative approaches, including digital health and data-driven solutions. Our data ethics standards help us build a trustful relationship with colleagues, partners and patients. We take seriously the responsibility of safeguarding personal data and confidential information.

We respect intellectual property rights, including third parties’ rights, as well as data and information related to our business activities, our products and our patients. Since many of us have access to confidential information, we must ensure it remains confidential by only using approved, company-provided solutions in alignment with our policies and procedures.

What does it mean for me? Personal data protection

When working with personal data, you must follow Novo Nordisk’s 5 principles for handling personal data:

1. Use the least amount of data needed
2. Inform people how we use their data
3. Only share data with those who need to know, or by consent where required
4. Store data securely
5. Delete data when no longer needed.

For more information and support go here. If you suspect a data breach, contact the Compliance Hotline immediately.

Security

Each of us plays a role in ensuring that we have a secure workplace by complying with security procedures and guidance. It is important not only at our sites, but also during travel and events. Make sure you are aware of all applicable security protocols and follow the relevant security requirements. If it is safe for you to do so, then you are expected to challenge unsecure behaviour or situations that may pose a threat (For product safety – see section 3).

What does it mean for me? Security

All employees are expected to:

• Visibly wear you NN ID Card whilst on a NN site. Present your access card if requested to. Immediately notify your manager is you lose your access card.
• Only enter areas you’re approved for and never allow access to Novo Nordisk sites to unauthorised individuals
• Report any suspicious behaviour, security concern, and opportunity for improvement to your local Security Champion or, if unable to so, to Global Security
• Support security investigations in a transparent and timely manner

When you travel:

• Ensure you have downloaded the International SOS App and have fully read all guidance relating to your destination – available here
• Contact your Regional Security Adviser should you have any queries surrounding travel security, or have any concerns about your destination country

If you need a security advice, contact your local Security Champion or [email protected]. In case of an urgency or a serious situation or crisis, contact the Alarm Response Centre (+45 44 42 00 00) available 24/7. The latest Global Security guidelines and recommendations can be found here.

Record keeping

We record, report and retain all information accurately and completely in order to protect our credibility. We never falsify company records. We document and record information in harmony with laws, requirements, and company policy – locally and globally.

Fair Competition

We value our relationships with suppliers, customers and competitors, and we respect and comply with laws that govern those relationships. We value competition and never restrict it, and we do not fix prices or terms for our competitor products. We compete fairly and do not speak badly about our competitors or make unfounded claims.

What does it mean for me? Fair Competition

• Do not share confidential business information with competitors
• Speak up, inform your manager, and involve Legal Compliance, if you receive or become aware of competitor information that was obtained unethically

Sanctions & Export Controls

Novo Nordisk provides essential medicines and medical devices to patients worldwide, including in countries that are subject to certain sanctions and export controls. We are committed to complying with all applicable sanctions and export controls in order to ensure access to patients and sustainable operations. We are all responsible for sanctions and export controls compliance at Novo Nordisk and we do not ignore “red flags” or indicators of non-compliance.

What does it mean for me? Sanctions & Export Controls 

• Read the Sanctions & Export Controls SOP and resources on SharePoint.
• Do not engage in transactions with sanctioned parties. If you identify a potential or current transaction that may involve a sanctioned party, you must stop interactions and immediately contact Legal & Compliance.
• Contact Legal & Compliance if you have concerns regarding sanctions or export controls risks.

Communication and media

We let our professional colleagues from Media Relations and Investor Relations communicate on our behalf. We only use channels that are approved by Novo Nordisk and only communicate when we are allowed by relevant stakeholders. Social media, such as Facebook, LinkedIn and X, has changed the way we interact and communicate with the world. At Novo Nordisk, we apply the same ethical mindset to social media and digital communication as to everything else. We never use social media – or any other media channel – to improperly promote Novo Nordisk products.

Most of us have social media presence of our own. When using social media privately, we must act and behave in accordance with our shared values, laws and regulations. Remember not to promote our products on social media. Our brand, image and reputation are dependent on how we are perceived by our patients, employees, customers, and the public. We are confident that all of us at Novo Nordisk act and behave in alignment with OneCode.

What does it mean for me? Communication and media

• Contact Media Relations or Investor Relations if you receive a request for information or comment on behalf of Novo Nordisk
• Never speak ‘off the record’
• Do not promote Novo Nordisk products on social media or any other media where it is not permitted

Sustainability

We want to play a leadership role in helping solve environmental and climate challenges, and to ensure compliance with external requirements. We will continuously minimise our use of resources, such as energy, water and raw materials used in Novo Nordisk. We are on a mission towards zero environmental impact, despite globally increasing production. To get there, we embrace a circular mindset – eliminating waste and pollution, designing and producing our products so that the materials can be recovered and reused, and reshaping our business to minimise consumption and eliminate waste by turning it into new resources. Actions are key to our success and we act daily in accordance with the ambition of having zero environmental impact.

What does it mean for me? Sustainability

• Integrate environmental considerations in your daily operation
• Make sure you sort out waste
• Eliminate waste of energy, water & materials in our daily operations
• When contributing to the design of our products and production facilities – design for sustainability and circularity
• Educate yourself via the Circular for Zero Academy

Ethics & Compliance

Novo Nordisk follows laws, regulations, industry codes, and strictly prohibits any form of bribery and corruption by both its own employees and business partners. We never offer, give or receive incentives to improperly influence others or to undermine their independence. We ensure the integrity of our business transactions by keeping documents and records organised, accurate and complete. To ensure this, we conduct internal audits providing objective assurance of financial processes, IT security, ethics and compliance, quality and ESG processes.

We make decisions based solely on objective criteria and professional judgement, and are never improperly influenced by our personal, social, financial or political interests. Our decisions are based on what is best for Novo Nordisk and our patients, rather than any personal advantage.

What does it mean for me? Ethics & Compliance 

• Ensure that business-related documents are accurate, truthful and complete
• Ensure that business decisions are free of personal interest
• Disclose any potential conflict of interest to your manager
• Do not provide or receive bribes or improper advantages
• Do not steal funds, inventory or assets from Novo Nordisk
• Do not falsify, misuse, manipulate expenses or financial information
• Follow our ethics & compliance requirements (Type TEN/ in your browser) and educate yourself via the Ethics & Compliance Academy

Insider trading

We operate in accordance with insider trading laws and regulations, and never trade stocks or securities based on non-public information or material. We trust employees to do the right thing and help us prevent fraud against Novo Nordisk, our business partners or government entities.

What does it mean for me? Insider trading

• Keep material non-public Novo Nordisk information confidential
• Do not use, share, or make trading decisions based on non-public, confidential information.

Our Speak-up Culture

We rely on you to do the right thing and never compromise on ethics. That is an important way for you to contribute to Novo Nordisk in driving change to defeat serious chronic diseases. We share Novo Nordisk’s purpose, and the ambition to make it real.
How Novo Nordisk performs is the sum of how each of us acts. Your actions are within your control, and how you behave is crucial to how we succeed as a team at Novo Nordisk. These actions define high-level the behaviours we want to lead with, see and support.

Ethical decision making is a skill, that we continuously train and improve at Novo Nordisk. OneCode is a part of that, but success is determined by how we act every day and how we help each other develop. Speak up when you need help, help when others speak up.
Our culture is rooted in openness, accountability and respect. When you speak up or listen, it strengthens our culture. You must speak up whenever you have questions, doubts, ideas or concerns. Speaking up helps us grow.

Violating relevant laws, regulations, or OneCode, or encouraging other to do so, puts both you and Novo Nordisk at risk. Appropriate disciplinary actions will be taken against any employee or business partner whose actions violate this Code, our values or any policies of Novo Nordisk.

Your actions lead the way, and if you report a concern in good faith, you will find support and trust. All reports remain confidential when possible. All reports are investigated, and appropriate action taken, for example training or disciplinary sanctions. Refuse to do anything that violates OneCode, even if it means loss of business for Novo Nordisk. That is how your actions are a key part of defining the behaviour of Novo Nordisk.

What does it mean for me? Speak-up

Report any actual or possible violation of law or behaviour inconsistent with OneCode, our values, or our policies.

• You report concerns by either:
  • Talking to your manager
  • Reaching out to Legal, Ethics & Compliance or People & Organisation
  • Reporting to the Compliance Hotline or ombudsman

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