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• July 2002 • EU Conference on 3Rs
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
Inform me (’90)
Involve me (’00)
New direction for stakeholder engagement
Show me (’95)
• July 2002 • EU Conference on 3Rs
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
• July 2002 • EU Conference on 3Rs
working together
• Better housing
• Ethical limits
• Improved procedures
• More open communication
Users &
Improving the welfare and perception of experimental animals
Protectors
• July 2002 • EU Conference on 3Rs
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
Economicallyviable
Sociallyresponsible
Environmentallysound
• 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
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.
• July 2002 • EU Conference on 3Rs
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
0
25000
50000
75000
100000
125000
150000
Contract researchorganizations
Novo Nordiskoutside Denmark
Novo Nordisk inDenmark
97
98
99
00
01
• 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
External Contractors
Non-Human Primates
Biological Product Control
Animal WelfareStandards
Ethical Review CommitteeResearch
Ethical Review CommitteeSafety
• 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 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
• 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. NGO’s (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