july 2002 eu conference on 3rs animal experimentation - a controversial issue

• July 2002 • EU Conference on 3Rs

Animal Experimentation- a controversial issue


A need for stakeholder engagement

… and be out there

Open your doors


Inform me (’90)

Involve me (’00)

New direction for stakeholder engagement

Show me (’95)


New Ways of Dealing with Regulatory Requirements

Minimum complianceDo 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

Active compliance

Positive compliance


working together

• Better housing

• Ethical limits

• Improved procedures

• More open communication

Users &

Improving the welfare and perception of experimental animals

Protectors


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


Triple Bottom Line Commitments

Economicallyviable

Sociallyresponsible

Environmentallysound


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

Bioethics PolicyNovo 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


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



• 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


Improving Animal Welfare

Why keep rabbits like this?

… when it can be done like this?



• 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


More Focus on The Three Rs

Drivers for implementation

Common sense

Commitment

Communication

Reduction

Refinement

Replacement


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


Total Number of Animals Used by Novo Nordisk

0

25000

50000

75000

100000

125000

150000

Contract researchorganizations

Novo Nordiskoutside Denmark

Novo Nordisk inDenmark

97

98

99

00

01



• 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


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


Animal Ethics Committee

External Contractors

Non-Human Primates

Biological Product Control

Animal WelfareStandards

Ethical Review CommitteeResearch

Ethical Review CommitteeSafety


The European Contact

European Federation of Pharmaceutical Industries and Associations

EFPIA

Animal Research and Welfare Group


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 R’s) 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


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. NGO’s (science, patients and animal welfare organizations)


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


Looking into the future

july 2002 eu conference on 3rs animal experimentation - a controversial issue

Documents

eu conference

rs animal experimentation

rs strategy

rs implementation

rs bioethics

rs policy

rs drivers

rs triple