Investor Presentaiton
Novo Nordisk Annual Report 2023
Introducing Novo Nordisk
Strategic Aspirations
Risks
Management
Consolidated statements
Additional information
Section 9
Governance performance.
9.1 Business ethics reviews and training
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.
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, vendors
and headquarter areas.
The mandatory ethics and compliance training is based on the principles for ethics
and compliance for employees working at Novo Nordisk. The training is provided
in the form of globally applicable e-learning and related tests. The percentage of
employees trained in business ethics is calculated as the number of employees that
have completed the training divided by the total number of employees at year-end.
9.2 Compliance Hotline
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. 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.
ACCOUNTING POLICIES
Number of substantiated cases reported via the Compliance Hotline includes the number
of cases where reported allegations of suspected misconduct have been substantiated or
partially substantiated. When a case has been substantiated or partially substantiated,
corrective actions are initiated.
Convictions for violation of anti-corruption and anti-bribery laws include convictions
where a Novo Nordisk legal entity (parent or any affiliate) has been found in violation
by a court of law.
9.3 Supplier audits
Number
2023
2022
2021
Responsible sourcing audits
Quality audits
24
14
16
358
280
237
Total supplier audits
382
294
253
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.
ACCOUNTING POLICIES
The number of supplier audits concluded by Novo Nordisk's Corporate Quality
function consists of the number of responsible sourcing audits and quality audits
conducted at suppliers.
9.4 Product recalls
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.
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.
9.5 Failed inspections
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.
ACCOUNTING POLICIES
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 Complete Response 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. Acquired companies
inspections are defined as inspections run by the acquired company. Inspections at
acquired companies run by Novo Nordisk are reported as Novo Nordisk inspections.
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