| 1. Sanofi-aventis holds animal welfare as fundamental. Team experts in veterinary medicine, animal science, and animal welfare ensure the highest possible standard of treatment and care practices. Programs and facilities are designed to meet or exceed local and national laws and regulations. Global standards are maintained that meet those used by international laboratory animal care accrediting associations. | Number of sites accredited by AAALAC (the Association for Assessment and Accreditation of Laboratory Animal Care) versus total number of sites.
| 20 sanofi-aventis sites are affected
Sanofi-aventis Pharma (16 sites affected):
10 sanofi-aventis sites accredited
(2012 goal: 16 R&D sanofi-aventis sites will be accredited)
Sanofi Pasteur (4 sites affected):
1 sanofi pasteur site accredited by AAALAC
1 sanofi pasteur site accredited by Canadian Council on Animal Care
(2011 goal: all 4 sanofi pasteur sites will be accredited) |
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| Number of sites visited in 2008. | 3 sites visited ► 2 granted continued accreditation, 1 newly accredited. |
| 2. Internal Ethics Committees are monitoring and supervising all aspects of animal welfare. All use of animals is reviewed and must be approved by these committees prior to any use. | % of protocols reviewed by internal Ethics Committee. | 100% of protocols (regulatory and non-regulatory) are reviewed and approved prior to animal use. |
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| % of protocols following committee recommendations. | Ethics Committee position is decisive. 100% of protocols follow the committee’s decision. |
| Functions represented in the Ethics Committees. | R&D has a quality document in development which defines membership of the Ethics Committees as follows: senior animal researchers, attending veterinarian, non-affiliated member, biostatistician. |
| 3. Animals are used only where there is a firm expectation that the results will contribute to the protection and/or improvement of human health and safety. | % of research protocols approved. | 100% of research protocols are validated by The Ethics Committees that ensures each of these conditions:
• 100% of animals are used only where there is a firm expectation that the results will contribute to the protection and/or improvement of human health and safety for to the quality medicines;
• 100% of animals are used because no suitable alternative exists. |
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| 4. Animals are used only when valid non-animal alternatives do not exist, and in the case where the alternatives are not yet recognized by regulatory authorities. |
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5. Those animals used are the fewest in number and “lowest” phylogenetically necessary to achieve the scientific and/or regulatory objective.
All are specifically supplied for use by qualified and licensed breeders or suppliers. | % of Ethics Committees having a biostatistician. | 100% of the committees have a biostatistician who ensures the lowest number of animals for each species is used to have significant results. |
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| % of rodents species. | 95% of animals used are rodents. Sanofi-aventis is committed to reduce where possible the use of non-human primates (e.g., sanofi pasteur significantly reduced the use of primates over the past five years). |
% of breeders audited.
Measures taken in case of non-compliance. | • 100% of the breeders are audited internally on a three-year cycle (sanofi-aventis or sanofi pasteur). The breeders are also audited externally by AAALAC and/or by national authorities.
• In case of non compliance, measures are taken according to the degree of importance of the failure, it can be a warning or the partnership can be stopped until the problem is corrected. |
| 6. Animals are treated humanely, with housing and care complying with internationally accepted guidelines and environmental enrichment consistent with sound scientific principles. | Which guidelines are followed? | Sanofi-aventis adheres to these guidelines/regulations:
• European Directive 1986/609/EC
• European Convention 1986; ETS/123 (higher standard)
Sites comply with the guidelines of their country and, at a minimum, the ILAR Guide, NRC, 1996 which is followed in all countries. |
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| 7. All personnel caring for and using animals are adequately trained and competent, and retrained regularly. | % of employees trained. | Specific training on animal welfare and use were implemented in several sites in addition to mandatory training.
• 30% of employees were trained in 2009. |
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| 8. Animals never experience unnecessary pain or distress. Anesthetics and analgesics are used wherever necessary and feasible. Prolonged physical restraint is used only when alternative procedures are inadequate. Humane endpoints are defined. Finally, euthanasia is always by a recommended or approved humane method. | Use of pain index relevant for each country (in compliance with local/global regulation). | Animal pain is assessed by researchers, veterinarians and is reviewed by Ethics Committees using a pain index such as the Canadian, UK, US or Swiss for sanofi pasteur index:
• sites in Canada ► Canadian index;
• sites in the United-States ► US specific pain index;
• sites in the UK ► UK specific index;
• sites in France ► Swiss index or Canadian index for sanofi pasteur. |
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| Pain evaluation. | Humane endpoints are defined before starting the study protocol, and pain is evaluated throughout the study. If something unexpected happens, the humane endpoints are immediately reevaluated in order to minimize the pain. |
| 9. External studies are contracted only where these principles are met. | % of CROs audited. | • 100% of toxicology CROs are audited at least every three-years to assure that they comply with sanofi-aventis quality principles. Moreover animal welfare audits are conducted when establishing a contract with a CRO. |
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