International Integrated Reporting Framework, Social and Environmental reports

 

Novo Nordisk A/S – Annual report – 31 December 2018

Industry: pharmaceuticals

CONSOLIDATED SOCIAL STATEMENT – SUPPLEMENTARY INFORMATION
Statement of social performance
for the year ended 31 December

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Notes to the consolidated social statement
In the consolidated social statement, Novo Nordisk reports on three dimensions of performance: patients, employees and responsible business. Progress is reported on two long-term targets, namely employee engagement and company reputation (see pp 15, 16, 19 and note 9.6).

The consolidated social statement contains material performance information of strategic importance, such as patients reached with diabetes care products, employee turnover, gender diversity, training of employees in business ethics, supplier audits and product quality.

Section 6
Basis of preparation
General reporting standards and principles
Novo Nordisk’s annual reporting complies with the Danish Financial Statements Act. Section 99a and b specifies the requirements of the EU Directive on disclosure of non-financial and diversity information to report on management of risks related to environment, climate, human rights, labour and social conditions, anti-corruption and gender distribution. This requirement is addressed in the Management Review. Novo Nordisk also adheres to the following internationally recognised voluntary reporting
standards and principles:
• The International Integrated Reporting Framework, <IR>, developed by the International Integrated Reporting Council. The framework consists of a set of content elements and guiding principles intended to improve the quality of information available to providers of financial capital.
• The UN Guiding Principles Reporting Framework, the only comprehensive guidance for companies to report on how they respect human rights. Novo Nordisk’s implementation of the Guiding Principles on Business and Human Rights is reported at novonordisk.com/sustainable-business/performance-on-tbl.html
• The UK Modern Slavery Act, adopted in 2015, requires commercial organizations operating in the UK to publish an annual slavery and human trafficking statement. Novo Nordisk’s annual statement is available at novonordisk.com/sustainablebusiness/performance-on-tbl.html
• Recommendations of the Financial Standards Board’s Task Force on Climate-related Financial Disclosures (TCFD). TCFD aims to develop voluntary, consistent climate-related financial risk disclosures for use by companies in providing information to investors, lenders, insurers, and other stakeholders. Novo Nordisk’s actions taken in line with the TCFD recommendations are reported at novonordisk.com/sustainable-business/performance-on-tbl/environmentalresponsibility.
• The AA1000APS(2008) and AA1000AS(2008) framework, which states that reporting must provide a complete, accurate, relevant and balanced picture of the organisation’s approach to and impact on society.
• The UN Global Compact, a strategic policy initiative for businesses that are committed to aligning their operations and strategies with 10 universally accepted principles in the areas of human rights, labour, environment, anti-corruption and broader UN Goals. Novo Nordisk’s obligation as a participant in the UN Global Compact to provide a Communication on Progress is met by inclusion of material information in the Annual Report and additional information at novonordisk.com/annualreport and submitted to the UN Global Compact database unglobalcompact.org.

Novo Nordisk applies AA1000APS(2008) as a component in creating a generally applicable approach to assessing and strengthening the credibility of the Group’s public reporting of social and environmental information. Novo Nordisk has designed processes to ensure that the qualitative and quantitative information that documents the social and environmental dimensions of performance is assured, as well as the systems that underpin the data and performance. The principles outlined in AA1000APS(2008) have been applied as described below.

Inclusivity
As a pharmaceutical business with global reach, Novo Nordisk is committed to being accountable to those stakeholders who are impacted by the organisation. From a social responsibility perspective, the key stakeholder groups are patients who rely on Novo Nordisk products, employees at Novo Nordisk and throughout the Group’s value chain, business partners and local communities. Novo Nordisk maps its stakeholders and has processes in place to ensure inclusion of stakeholder concerns and expectations. In addition, Novo Nordisk continuously develops its stakeholder engagement and capacity to be a sustainable business at corporate, regional and affiliate levels. See how Novo Nordisk defines what is meant by sustainable business on p 5.

Materiality
Key issues are identified through ongoing stakeholder engagement and trendspotting, informed by data-driven analysis and addressed by programmes or action plans with clear and measurable targets. Long-term targets are set to guide performance in strategic areas. The issues presented in the Annual Report are deemed to have a significant impact on the Group’s future business performance and may support stakeholders in their decision-making.

Responsiveness
The Annual Report reflects how the company is managing operations in ways that respond to and consider stakeholder concerns and interests. The report reaches out to a wide range of stakeholders, each with specific needs and interests. The management report is prepared with the retail investors in mind. To these stakeholders, however, as well as to the many other groups who may seek information in the Annual Report, this is just one element of interaction and communication with the company.

Applying materiality
The consolidated social statement is a result of assessing legal requirements and disclosure commitments applicable to Novo Nordisk. Whether information is tied directly or indirectly to Novo Nordisk’s ability to create value over the short, medium and long term is also assessed.

When assessing whether a disclosure is material to include in the consolidated social statement, Management considers whether the matter is of such relevance and importance that it could substantively influence the assessment by providers of financial capital of Novo Nordisk’s ability to create value over the short, medium and long term. See more at novonordisk.com/sustainable-business/performance-on-tbl/more-abouthow-we-work-and-report.

The conclusion from the external assurance provider is available in the Independent limited assurance report on p 109.

Principles of consolidation
The consolidated social statement and disclosures cover the Novo Nordisk Group comprising Novo Nordisk A/S and entities controlled by Novo Nordisk A/S.

Social accounting policies
The accounting policies set out below and in the notes have been applied consistently in the preparation of the consolidated social statement for all the years presented.

Changes to accounting policies and disclosures
The following disclosure changes have been made:
• ‘New patent families (first filings)’ is no longer reported, as it no longer adequately reflects progress in research activities, cf new research and development strategy (see p 22). Information on patent expiries has been moved to p 20.
• Total tax contribution has been added to provide an overview of the tax contribution to society generated by Novo Nordisk. The taxes can be either borne or collected by Novo Nordisk. Data collected for 2018 only.

Other accounting policies
Employee engagement
Employee engagement is measured on a scale of 1–5 and based on questions in the annual employee survey, OurVoice, related to employee engagement. The score is calculated as the proportion of employees who responded favourably (4 or 5) to relevant questions. For 2018, the response rate was 91% compared with 94% in 2017.

Relevant employees trained in business ethics
The mandatory business ethics training is based on the Business Ethics Code of Conduct in the form of globally applicable e-learning, and related tests released annually by the Novo Nordisk Business Ethics Compliance Office. The target groups for the individual tests vary in size and are defined by Novo Nordisk. The target groups are all employees of Novo Nordisk at the end of the reporting period except employees on leave, student assistants, PhDs and postdocs. The percentage of employees completing the training is calculated as the percentage of completion of training in both the Code of Conduct
and related tests, based on internal registrations.

Section 7
Patients
7.1 Patients reached with Novo Nordisks diabetes products (estimate)
Accounting policies
The number of full-year patients reached with Novo Nordisk diabetes products, excluding devices and PrandiMet®, is estimated by dividing Novo Nordisk’s annual sales volume by the annual usage dose per patient for each product class as defined by the World Health Organization (WHO). PrandiMet® is not included as no WHO-defined dosage exists.

The number of full-year patients reached with Novo Nordisk diabetes products via the Access to Insulin Commitment is estimated by dividing Novo Nordisk’s annual sales volume in the least developed countries as defined by the United Nations and other low-income countries as defined by the World Bank as well as selected organisations providing relief in humanitarian situations, by the annual usage dose per patient for human insulin in vials as defined by WHO.

The WHO-defined daily dosage has not changed since 1982 and may not reflect the recommended or prescribed daily dose accurately. Actual doses are based on individual characteristics (eg age and weight) and pharmacokinetic considerations. Despite this uncertainty, Novo Nordisk assesses this to be the most consistent way of reporting.

Development
The estimated number of full-year patients reached with Novo Nordisk’s diabetes care products increased from 27.7 million in 2017 to 29.2 million in 2018. This 5% increase was primarily driven by sales of human insulin (0.6 million people) and long-acting, premix and fast-acting modern and new-generation insulin (0.6 million people).

In 2018, as in 2017, the estimated number of patients reached via the Access to Insulin Commitment was 0.3 million, and Novo Nordisk sold insulin according to this commitment in 20 countries. Beyond this scheme, Novo Nordisk also sold human insulin below the ceiling price in other countries, as well, reaching an estimated 5 million patients in 2018, as in 2017.

7.2 Donations
Accounting policies
Donations by Novo Nordisk to the World Diabetes Foundation (WDF) and the Novo Nordisk Haemophilia Foundation are recognised as an expense when the donation is paid out or when an unconditional commitment to donate has been made.

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WDF, an independent trust, supports sustainable partnerships and acts as a catalyst to help others do more. In 2018, WDF provided funding to 30 partnership projects in 27 countries. The projects focus on awareness, education and capacity building at local, regional and global levels. See note 5.2 in the consolidated financial statements and worlddiabetesfoundation.org.

Novo Nordisk also provides financial support for improving global access to haemophilia care. NNHF supports programmes in developing and emerging countries. Initiatives focus on capacity building, diagnosis and registry, education and empowerment. Since 2005, NNHF has provided funding for 268 programmes in 73 countries. See nnhf.org.

7.3 Animals purchased for research
Accounting policies
The record of animals purchased for research comprises the number of animals purchased for all research undertaken by Novo Nordisk either in-house or by external contractors. The number of animals purchased is based on internal registration of purchased animals and yearly reports from external contractors.

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The number of animals purchased for research in 2018 decreased by 3% compared with 2017 and reflect the changes in stages of the different research projects. In all, 97% of the animals purchased were rodents. The variation in the purchase of large animals from year to year reflects the development phases the research projects have reached.

Section 8
Employees
8.1 Employees
Accounting policies
The number of employees is recorded as all employees except externals, employees on unpaid leave, interns, bachelor and master thesis employees and substitutes at year-end.

Employees are attributed to geographical regions according to their primary workplace across the commercial units, research and development, production and support functions. Employees in corporate functions are included in Region Europe and employees in the global service centre in Bangalore, India are included in Region AAMEO.

The rate of turnover is measured as the number of employees, excluding temporary employees, who left the Group during the financial year divided by the average number of employees, excluding temporary employees.

Diversity at Novo Nordisk is reported as the percentage split by gender in all managerial positions and for newly appointed managers. Managerial positions are defined as all managers at Novo Nordisk (global job level incl EVP, SVP, CVP, VP, General Manager, Director, Manager and Team Leader). New managers are defined as all employees who have moved to a managerial position within the last 12 months – both promoted and externally hired.

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The development in employees was mainly driven by Region China, Region Europe, the global service centre in Bangalore, India and expansions of production facilities in Algeria, China and the US. Employee turnover increased from 11.0% in 2017 to 11.7% in 2018.

The decreasing share of women among newly appointed managers was driven by fewer women appointed to entry level positions (manager and team leader). At the same time a higher share of women were appointed to senior management positions (SVP, CVP, VP and GM), especially among external hires.

All management teams, from entry level upwards, are encouraged to focus on enhanced diversity, with the aim of ensuring a robust pipeline of talent for management positions.

Among employees as a whole, the gender split was 49% women and 51% men in 2018, same as in 2017.

The graph below shows the gender split among managers for the last three years.

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8.2 Frequency of occupational accidents
Accounting policies
The frequency of occupational accidents with absence is measured as the internally reported number of accidents using full-time employees, excluding externals, employees on unpaid leave, interns, bachelor and master thesis employees, and substitutes, per million nominal working hours. An occupational accident with absence is any work-related accident causing at least one day of absence in addition to the day of the accident.

Development
The average frequency rate of occupational accidents with absence was 2.4 per million working hours in 2018, compared with 2.7 in 2017 due to a 8% decrease in the number of accidents. The decrease is mainly attributed to improved performance in the commercial units. In 2018, as in 2017, there were no work-related fatalities. Novo Nordisk works with a zero-injury mindset and has a long-term commitment to continuously improving safety performance.

Section 9
Responsible business
9.1 Business ethics reviews
Accounting policies
The number of business ethics reviews is recorded as the number of business ethics reviews performed by Group Internal Audit in subsidiaries, production sites and headquarter areas. Group Internal Audit will during a business ethics review, examine procedures and processes in place to ensure ethical behaviour. Any identified gaps in procedures, processes or behaviour are presented to Management and the Board of Directors as findings. An action plan to mitigate findings is agreed between Management and Group Internal Audit, and Group Internal Audit follows up on the implementation of the agreed actions before closing the findings.

Development
A total of 33 business ethics reviews were completed in 2018 with 113 findings, compared to 34 reviews with 130 findings in 2017. Based on the completed business ethics reviews, it is Group Internal Audit’s assessment that the business ethics compliance level, in 2018 as in 2017, continued to be sound. Management action plans and closure of findings has progressed as planned, and there were no overdue management actions or findings at the end of the year.

9.2 Fulfilment of action points from facilitations of the Novo Nordisk Way
Accounting policies
Facilitation is the internal audit process for assessing compliance with the Novo Nordisk Way. The assessment is based on review of documentation and feedback from stakeholders followed by an on-site visit where randomly selected employees and management are interviewed. Any identified gaps related to the Novo Nordisk Way are presented to management as findings. The facilitators and management agree on an action plan to close the findings. The percentage of fulfilment of action points is measured as an average of timely closure of action points issued in the current year and the two previous years. The reason for using a three-year average as the basis for the calculation is that action lead times typically vary from a few months to more than a year.

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A total of 63 units were facilitated covering approximately 17,000 employees, of whom almost 2,200 were interviewed. In addition, feedback on those units was collected from almost 700 stakeholders. Overall, the facilitations in 2018, as in 2017, showed a ‘high level’ of compliance with the Novo Nordisk Way. Corrective actions and corresponding deadlines were agreed with local management for all actions. The main areas of improvement that were identified, covering approximately 60% of all findings, concerned Essential 5 ‘We build and maintain good relations with our key stakeholders’, Essential 7 ‘We focus on personal performance and development’ and Essential 9 ‘We strive for agility and simplicity in everything we do’. The 10 Essentials are part of the Novo Nordisk Way. See pp 6–7 for additional information.

9.3 Supplier audits
Accounting policies
The number of supplier audits concluded by Novo Nordisk’s Corporate Quality function includes the number of responsible sourcing audits and quality audits conducted among suppliers.

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The number of audits concluded in 2018 increased by 20% compared with 2017. The increase in quality audits was related to projects, notably the expansion of the production facilities in Clayton, North Carolina. Responsible sourcing audits decreased due to a reduced need for audits of new suppliers to production, a majority of which were categorised as low risk suppliers. There were no critical findings in 2018.

9.4 Product recalls
Accounting policies
The number of product recalls is recorded as the number of times Novo Nordisk has instituted a recall and includes recalls in connection with clinical trials. A recall can affect various countries.

Development
Novo Nordisk had three product recalls from the market in 2018, compared with six in 2017. None of these recalls were critical. Local health authorities were informed in all instances to ensure that distributors, pharmacies, doctors and patients received appropriate information.

9.5 Failed inspections
Accounting policies
The number of failed inspections is measured in relation to the US Food & Drug Administration (USFDA), the European Medicines Agency (EMA), EU notified bodies (Lloyd’s Register Quality Assurance) and domestic authorities for strategic manufacturing sites. Failed inspections are defined as inspections where Warning Letters or EMA non-compliance letters related to GMP inspections are received, GMP/ISO certificates for strategic sites are lost, pre-approval inspections result in a Warning Letter, study conclusions are changed due to GCP/GLP inspection issues, or marketing or import authorisations are withdrawn due to inspection issues. Strategic sites are defined as the manufacturing sites in Brazil, China, Denmark, France and the US.

Development
In 2018, as in 2017, there were no failed inspections among those resolved at year-end. 75 inspections were conducted in 2018 compared with 83 in 2017. At year-end, 55 inspections were passed and 20 were unresolved, as final inspection reports had not been received or the final authority acceptance was pending, which is normal. Follow-up on unresolved inspections continues in 2019.

9.6 Company reputation
Accounting policies
Company reputation is measured annually using the RepTrak® methodology developed by Reputation Institute. The total score is measured as the mean company reputation score among people with diabetes, general practitioners and diabetes specialists across key markets. Reputation is measured on a scale of 0–100, with 100 being the best possible score. A score above 80 is considered excellent; a score between 70 and 80 is considered strong. Data were collected between June and September 2018.

The data are collected through annual surveys carried out by external consultancy firms.

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9.7 Total tax contribution
Accounting policies
Novo Nordisk’s total tax contribution is measured as the taxes borne or collected by Novo Nordisk, which have been paid in the respective year. Taxes borne are defined as taxes where Novo Nordisk carries the cost. Taxes collected are defined as taxes Novo Nordisk collect on behalf of others, e.g. employee income taxes deducted from the employee salary and paid on to the government.

Tax on company income
Tax on company income primarily consists of corporate income taxes and withholding taxes on company dividends.

Employment taxes
Employment taxes primarily consist of taxes collected from the employees on behalf of the government and social security costs.

Indirect taxes
Indirect taxes consist of non-refundable VAT, net VAT collections, custom duties, environmental taxes and property taxes.

Other taxes
Other taxes consist of country specific taxes not linked to one of the categories above, e.g. the US branded prescription drug (BPD) fee.

The total tax contribution in 2018 amounted to DKK 25,825 million split into 53% on taxes borne and 47% on taxes collected.

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Notes to the consolidated environmental statement
In the consolidated environmental statement, Novo Nordisk reports on performance in terms of resources, emissions and waste. Progress is reported against two long-term targets; to have all power at production sites sourced from renewable energy by 2020 and to have zero CO2 emissions from operations and transportation by 2030. See p 17 and notes 11.1 and 12.1.

The statement of environmental performance contains material performance information of strategic importance, such as energy and water consumption, CO2 emissions, waste and breaches of regulatory limit values.

Section 10
Basis of preparation
General reporting standards and principles
The consolidated environmental statement has been prepared in accordance with the same standards as those for the consolidated social statement. See section 1 ‘Basis of preparation’ of the consolidated social statement on p 98.

Principles of consolidation
The consolidated environmental statement covers the production sites, laboratories and offices with significant activities. CO2 emissions related to transportation cover cars leased or owned by Novo Nordisk, business flights and suppliers distributing Novo Nordisk products.

Environmental accounting policies
The accounting policies set out below have been consistently applied in the preparation of the consolidated environmental statement for all the years presented.

Changes to accounting policies and disclosures
The following disclosure change have been made:
• ‘CO2 emissions from energy consumption’ and ‘CO2 emissions from product distribution’ are reported as one disclosure ‘CO2 emissions from production sites and product distribution’. Historical data has been updated accordingly.
• ‘CO2 emissions from operations and transportation’ has been added as a new long-term target, to drive the new environmental strategy in alignment with management priorities. Historical data does not exist. See note 12.1 for information about the scope.

Section 11
Resources
11.1 Energy consumption and share of renewable power
Accounting policies
Energy consumption is measured as consumption of power, steam, heat and fuel. The fuel is mainly from natural gas, biogas and wood. Energy consumption is based on meter readings and invoices. Energy consumption covers all energy types at production sites and also covers laboratories and office buildings at the production sites.

Share of renewable power used at production sites is reported according to the Greenhouse Gas (GHG) Protocol Scope 2 Guideline. It is calculated as the sum of power in each country that comes from 100% renewable sources, either sourced or self-produced.

Development
In 2018, energy consumption at the production sites remained stable at 2.9 million GJ compared with 2017. Energy consumption for the production of biopharmaceuticals increased by 3% due to new API production facilities, while energy consumption for production of diabetes and obesity treatment remained stable in line with planned production. To support the new long-term environmental target, Novo Nordisk will expand the scope of reporting energy consumption to also cover global offices and laboratories.

In 2018, 77% of the power used at the production sites was based on renewable energy compared with 79% in 2017. The decrease was due to decreased production in Kalundborg, Denmark, which uses wind power for electricity. Novo Nordisk remains well on track to reach its target of 100% power from renewable sources at production sites by 2020.

11.2 Water consumption
Accounting policies
Water consumption is measured based on meter readings and invoices. It includes drinking water, industrial water and steam used at production sites.

Development
In 2018, water consumption decreased overall by 5% to 3.1 million m3. Water consumption for production of diabetes and obesity treatment decreased by 7% in line with planned production while water consumption for the production of biopharmaceuticals increased by 5% due to new API facilities.

Three facilities, in Algeria, Brazil and China, are in regions subject to high water stress or large seasonal variations and consumed 14% of the total water used at the production sites. There have been no water shortage incidents in 2018 and overall, water consumption at these facilities decreased by 5% in 2018.

Section 12
Emissions and waste
12.1 CO2 emissions
Accounting policies
CO2 emissions from energy consumption at production sites
CO2 emissions from energy consumption cover consumption of power, fuel, heat and steam from all buildings at production sites. Emissions are measured in metric tons, calculated according to the GHG Protocol and based on emission factors from the previous year.

CO2 emissions from product distribution
CO2 emissions from product distribution are calculated by external transportation suppliers as the estimated emissions from product distribution in metric tons. CO2 emissions are calculated based on the worldwide distribution of semi-finished and finished products, raw materials and components by air, sea and road between production sites and from production sites to subsidiaries, direct customers and importing distributors. CO2 emissions from product distribution from subsidiaries to pharmacies, hospitals and wholesalers are not included.

CO2 emissions from operations and transportation
CO2 emissions from operations and transportation comprises the components set out below.

CO2 emissions from operations cover consumption of power, fuel, heat and steam at production sites, laboratories, office buildings in Denmark and consumption of power in office buildings outside of Denmark. Emissions are measured in metric tons, calculated according to the GHG Protocol and based on emission factors from the previous year.

CO2 emissions from business flights are estimated based on mileage and emission factors for short, medium and long-haul flights obtained from travel agencies.

CO2 emissions from company cars cover cars leased or owned by Novo Nordisk. Emissions are calculated by multiplying emission factors by the volumes of diesel and gasoline used.

For CO2 emissions from product distribution – see ‘CO2 emissions from product distribution’ above.

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In 2018, CO2 emissions from production sites and product distribution decreased by 2%. CO2 emissions from production decreased slightly primarily due to lower energy consumption in Kalundborg, Denmark.

Novo Nordisk has a new long-term target to have zero CO2 emissions from operations and transportation by 2030. This includes all CO2 emissions from production, global offices and laboratories, product distribution, business flights and company cars. In 2018, the total CO2 emissions from operations and transportation were 269,000 tons – see p 17 for additional information.

12.2 Waste
Accounting policies
Waste is measured as the sum of all the waste disposed of at production sites based on weight receipts.

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  1. Organic residues for recycling is waste from the production of the active pharmaceutical ingredients, where the energy is recovered in biogas plants and the digested slurry is used on local farmland as fertiliser.
  2. Energy recovery is waste disposed of at waste-to-energy plants and at a biogas plant.
  3. Ethanol is used in purification of diabetes and biopharmaceutical products. The ethanol is recovered in own regeneration plants and re-used many times. The ethanol waste reported here is from production with no regeneration or residues from the regeneration process.
  4. Water waste and other waste not suitable for other disposal methods, such as hazardous waste for incineration and various other types of waste.

In 2018, the total waste volume from production sites decreased by 10% compared with 2017. This is mainly due to a decrease in the organic residues from the fermentation of insulin.

Two one-off occurrences caused increases within the categories ‘Other’, ‘Recycling’ and ‘No energy recovery.’ The increase within ‘Recycling’ (other) came from the clean-up of old renovation waste at the production facility in Brazil, where the waste could be used in cement production. The increase in ‘No energy recovery’ was a result of organic residues used directly as fertiliser without prior energy recovery in the biogas plant.

At Novo Nordisk, it is a priority to recycle as much waste as possible, and secondarily to ensure energy recovery when recycling is not possible. 94% of the total waste is recycled, used for biogas production or incinerated at plants where the energy is used for heat and power production.

21% of the waste is categorised as hazardous waste, an increase from 18% in 2017. This is mainly due to increasing volumes of ethanol waste due to less ethanol regeneration.

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Section 13
Responsible business
13.1 Breaches of regulatory limit values
Accounting policies
Breaches of regulatory limit values cover all breaches reported to the environmental authorities.

Development
Incidents with breaches of regulatory limit values increased from 23 in 2017 to 27 in 2018; however four of these breaches were caused by the same incident. The breaches were mainly related to wastewater, and all had minimal impact on the environment.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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