Novo Nordisk Annual Report 2021
Contents
Introducing Novo Nordisk
Strategic Aspirations
Key risks Management
Consolidated statements
Additional information
Novo Nordisk Annual Report 2021 91
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.
9.3 Product recalls
Novo Nordisk had one product recall in the US in 2021 due to disbursement
of product samples without proper temperature monitoring.
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.
9.4 Failed inspections
In 2021, as in 2020, Novo Nordisk had no failed inspections among those
resolved at year-end. However, a contract manufacturer filling syringes for
WegovyⓇ failed an inspection causing disruption in the supply of WegovyⓇ.
During 2021, 97 inspections of Novo Nordisk were conducted, compared
with 77 in 2020. At year-end, 86 inspections were passed and 11 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 2022.
Accounting policies
The number of failed inspections is measured in relation to inspections
by the US Food & Drug Administration (USFDA), the European Medicines
Agency (EMA), the Notified Body (TÜV SUD) 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authorisations are withdrawn due to inspection issues.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.
9.5 Facilitations of the Novo Nordisk Way
In 2021, a total of 34 units were facilitated and more than 1,600 employees
were individually interviewed. In addition, feedback on those units was
collected from approximately 500 stakeholders.
Overall, the 2021 process continues to show a good level of adherence to
the Novo Nordisk Way. 5 units were found to be in breach of one or more of
the Novo Nordisk Essentials. The Essential with the strongest performance
continues to be Essential 1 (We create value by having a patient-centred
business approach) and Essential 10 (We never compromise on quality and
business ethics. In 2021, partly driven by the focus on strengthening the
culture journey, significantly more findings were issued related to Essential 2
(We set ambitious goals and strive for excellence) and Essential 7 (We focus
on personal performance and development).
Accounting policies
Facilitations of the Novo Nordisk Way is measured as the number of
facilitations completed. It is an internal process for assessing adherence
to the Novo Nordisk Way. The assessments are based on review of
documentation and feedback from stakeholders followed by an on-site
visit during which randomly selected employees and management are
interviewed. Identified gaps and improvement opportunities related to the
Novo Nordisk Way are presented to and discussed with management. The
facilitators and management agree on an action plan to address those gaps
and improvement opportunities.
9.6 Company reputation
Company reputation
Scale 0-100
2021
2020
2019
People with diabetes
77.1
N/A
N/A
People with obesity
79.4
N/A
N/A
General practitioners
81.5
N/A
N/A
Diabetes specialists
84.8
N/A
N/A
Informed general public
90.3
N/A
N/A
Total score (average)
82.6
N/A
N/A
Company reputation is replacing the previous disclosure of company trust.
A new and more comprehensive approach to reputational intelligence was
launched in 2021 to cover more markets and stakeholders.
Accounting policies
The reputation score is based on four factors measuring esteem, admiration,
trust, and feeling of the stakeholders towards Novo Nordisk across ten key
markets: USA, Canada, Brazil, China, Japan, Germany, Italy, UK, France, and
Denmark. The data are collected through online surveys carried out by an
external consultancy firm. Responses are aggregated to produce an overall
score on a Likert scale of 1-7 which is rebased on a 0-100 scale.
9.7 Animals purchased for research
Rabbits
Animals purchased
Number
2021
2020
2019
Mice, rats and other rodents
Pigs
35,675
38,850
48,081
759
783
880
184
239
349
Dogs
114
91
157
Non-human primates
495
264
168
Fish
10,638
9,804
Other vertebrates
14
5
2
Total animals purchased
47,879
50,036
49,637
The number of animals purchased for research in 2021 decreased by 4.3%
compared with 2020 due to reduced usage of mice, rats and other rodents.
The overall development reflects the changes in stages of the different
research projects. The reduction in the number of rodents purchased
reflects Novo Nordisk's continuous focus on reducing the number of animals
per research project. 75% of the animals purchased were rodents and 22%
were fish.
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.View entire presentation