1. July 2002 EU Conference on 3Rs Animal Experimentation - a controversial issue

2. July 2002 EU Conference on 3Rs A need for stakeholder engagement … and be out there Open your doors

3. July 2002 EU Conference on 3Rs Inform me (90) Involve me (00) New direction for stakeholder engagement Show me (95)

4. 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 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

5. 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

6. 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

7. July 2002 EU Conference on 3Rs Triple Bottom Line Commitments Economically viable Socially responsible Environmentally sound

8. 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

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. 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

11. 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

12. 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

13. July 2002 EU Conference on 3Rs Improving Animal Welfare Why keep rabbits like this? … when it can be done like this?

14. 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

15. July 2002 EU Conference on 3Rs More Focus on The Three Rs Drivers for implementation Common sense Commitment Communication Reduction Refinement Replacement

16. 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

17. July 2002 EU Conference on 3Rs Total Number of Animals Used by Novo Nordisk 9798 99 00 01

18. 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

19. 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

20. July 2002 EU Conference on 3Rs Animal Ethics Committee External Contractors Non-Human Primates Biological Product Control Animal Welfare Standards Ethical Review Committee Research Ethical Review Committee Safety

21. July 2002 EU Conference on 3Rs The European Contact European Federation of Pharmaceutical Industries and Associations EFPIA Animal Research and Welfare Group

22. 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 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. 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)

24. 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

25. Looking into the future