Animal Experimentation

- a controversial issue

July 2002 EU Conference on 3Rs

A need for stakeholder engagement

and be out there

Open your doors

July 2002 EU Conference on 3Rs

New direction for stakeholder engagement

Inform me (90)

Show me (95)

Involve me (00)
July 2002 EU Conference on 3Rs

New Ways of Dealing with Regulatory Requirements

Minimum compliance

Do only what is necessary to avoid problems with the authorities

Active compliance

Try to live in accordance with the values and principles underlying regulatory requirements

Positive compliance

Making extra internal requirements on top of those made by the authorities

July 2002 EU Conference on 3Rs

Improving the welfare and perception of experimental animals

Users & Protectors

working together

July 2002 EU Conference on 3Rs

Better housing Ethical limits Improved procedures More open communication

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
July 2002 EU Conference on 3Rs

Triple Bottom Line Commitments

Economically viable

Socially responsible

Environmentally sound

July 2002 EU Conference on 3Rs

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

July 2002 EU Conference on 3Rs

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.

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
July 2002 EU Conference on 3Rs

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

July 2002 EU Conference on 3Rs

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

July 2002 EU Conference on 3Rs

Improving Animal Welfare

Why keep rabbits like this?

when it can be done like this?

July 2002 EU Conference on 3Rs

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

July 2002 EU Conference on 3Rs

More Focus on The Three Rs

Drivers for implementation
Common sense Commitment Communication Reduction Refinement Replacement

July 2002 EU Conference on 3Rs

Implementation of the Three Rs

Integrate the Three Rs in all R&D 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

July 2002 EU Conference on 3Rs

Total Number of Animals Used by Novo Nordisk

150000 125000 100000 75000 50000 25000 0

97 98 99 00 01
Novo Nordisk outside Denmark Novo Nordisk in Denmark Contract research organizations

July 2002 EU Conference on 3Rs

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

July 2002 EU Conference on 3Rs

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

July 2002 EU Conference on 3Rs

Animal Ethics Committee

Ethical Review Committee Research Ethical Review Committee Safety

External Contractors

Non-Human Primates

Biological Product Control

Animal Welfare Standards

July 2002 EU Conference on 3Rs

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

July 2002 EU Conference on 3Rs

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 dedication to animal welfare and our willingness to contribute to new developments, e.g. research into environmental enrichment

Further develop industry initiatives to show our

July 2002 EU Conference on 3Rs

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)

July 2002 EU Conference on 3Rs

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

July 2002 EU Conference on 3Rs

Looking into the future