Bioethics at Novo Nordisk

1
Animal Experimentation
- a controversial issue
2
A need for stakeholder engagement
and be out there
Open your doors
3
New direction for stakeholder engagement
Inform me (90)
Show me (95)
Involve me (00)
4
New Ways of Dealing with Regulatory Requirements
Do only what is necessary to avoid problems
with the authorities Try to live in accordance
with the values and principles underlying
regulatory requirements Making extra internal
requirements on top of those made by the
authorities

• Minimum compliance

Active compliance
Positive compliance
5
Improving the welfare and perception of
experimental animals
working together
Users
Protectors

• Better housing
• Ethical limits
• Improved procedures
• More open communication

6
The Way Forward

• creating a
  positive atmosphere
• More respect
• sensitive creatures, not just scientific tools
• Better welfare
• considering the needs of the animals
• A change in attitudes
• overcoming the barriers to animal welfare
• New ways of thinking
• need to know, not just nice to know
• More responsibility
• positive compliance, putting values into action

7
Triple Bottom Line Commitments
Economically viable
Socially responsible
Environmentally sound
8
Bioethics at Novo Nordisk
Ethical welfare aspects of experimental animals
Ethical aspects of experiments on humans and
human material
Ethical aspects of gene technology and access to
genetic resources
9
Bioethics Policy

• Novo Nordisk will continuously improve our
  bioethical performance.
• This means that we will
• Promote bioethical awareness throughout the
  company
• Ensure high ethical standards for
• Animal experimentation and testing
• Clinical trials and the use of human material
• Gene technology  
• Set high ethical standards for our external
  contractors and monitor performance
• Engage in stakeholder dialogue and
  partnerships, and report on our performance
• Live up to the spirit, values and principles
  of relevant conventions, laws and
  requirements.

10
Policy on animal experimentation

• We will continuously improve our ethical
  performance by
• Fully supporting the principles of The Three Rs
• Setting high ethical standards in relation to
  animal testing and experimentation
• Requiring that the welfare of the animals is
  considered and their needs fulfilled as best
  possible
• Providing appropriate training and education of
  employees and animals
• Engaging in dialogue with key stakeholders
• Reporting annually on our performance in terms
  of animal testing

11
Strategy on animal experimentation

• Set high ethical standards in relation to animal
  experimentation
• Perform internal ethical review of experiments
• Thoroughly evaluate experiments on primates
• Develop and implement new measures and standards
  in relation to CROs

12
Strategy on animal experimentation

• Set high animal welfare standards in relation to
  housing and care of experimental animals
• House animals according to their needs
• Provide appropriate training and socialisation of
  the animals
• Provide appropriate training and education of all
  employees handling and working with experimental
  animals

13
Improving Animal Welfare
Why keep rabbits like this?
when it can be done like this?
14
Strategy on animal experimentation

• Continuously work towards implementation of the
  Three Rs
• Replace animal tests by alternative methods
  wherever possible
• Refine methods to reduce pain and distress
• Reduce the number of animals wherever possible
• Abolish all biological product control tests
  within a three year period

15
More Focus on The Three Rs
Drivers for implementation
Common sense Commitment Communication
Reduction Refinement Replacement
16
Implementation of the Three Rs

• Integrate the Three Rs in all RD processes and
  procedures
• Review animal models on a continuous basis for
  replacement with alternatives
• Use human cells and tissues instead of living
  animals whereever possible
• Participate in or support external initiatives on
  the development of alternatives to animal testing

17
Total Number of Animals Used by Novo Nordisk
01
97
98
00
99
18
Strategy on animal experimentation

• Ensure high awareness and adherence to the the
  Novo Nordisk ethical standards
• Improve internal awareness of animal ethics
• Improve adherence by conducting reviews and
  audits
• Influence authorities and other external bodies
  by setting new trends and standards

19
Strategy on animal experimentation

• Ensure transparency and openness
• Report on our performance annually in our TBL
  report
• Create an interactive website for communication
  with stakeholders internally and externally
• Provide information on the ethical and scientific
  rationale behind our experiments
• Support national and international initiatives to
  make applications for animal experiments
  available to the public

20
Animal Ethics Committee
Ethical Review Committee Research
Ethical Review Committee Safety
External Contractors
Non-Human Primates
Biological Product Control
Animal Welfare Standards
21

• The European Contact
• European Federation of Pharmaceutical Industries
  and Associations
• EFPIA
• Animal Research and Welfare Group

22
Objectives of the EFPIA Group

• Elaborate a European industry position on issues
  at stake
• Promote the principle that good science and the
  use of alternatives (3 Rs) leads to the ethical
  use of animals in research
• Further develop industry initiatives to show our
  dedication to animal welfare and our willingness
  to contribute to new developments, e.g. research
  into environmental enrichment

23
Objectives of the EFPIA Group

• Maintain dialogue with politicians and regulators
  dealing with the issue in Europe
• European Parliament
• European Commission bodies (DG Environment, DG
  Health and Consumer Protection, DG Enterprises,
  DG Research and EMEA)
• Council of Europe
• Pharmacopoeia and OECD
• Maintain dialogue with key stakeholders e.g.
  NGOs (science, patients and animal welfare
  organizations)

24
IVTIP (In Vitro Testing Industrial Platform)

• 16 industrial member companies
• Promotes development of in vitro testing and
  their use in industry
• Follows progress in EU and other research
  projects since 1993
• Active in technology transfer (Technology
  Transfer Project)
• Provides positions about industrial requirements
  for in vitro tests
• Through meetings, interface between academic
  researchers, SMEs and industry
• Has an extensive network in industry

25
Looking into the future