AAALAC International in Europe: Approaches to an Ethical Review Successful approaches to the ethical review by accredited units in Europe

Transcription

1 AAALAC International in Europe: Approaches to an Ethical Review Successful approaches to the ethical review by accredited units in Europe THE GSK EUROPE EXPERIENCE May , Rome Italy A Tamellini, A Ferrara, D. Markovic, A Martinez

2 Presentation outline Introduction: GSK as a multinational company GSK approach to care and ethical treatment of animals in research The Ethical Review Process in: Italy Croatia Spain Conclusions

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4 GSK Care and Ethical Treatment of Animals in Research GSK has a corporate responsibility as regards care and ethical treatment of animals Public policy This is supported by an Internal Policy which applies to: All GSK employees and complementary workers WW All breeding, handling or research involving animals financially supported by GSK independent of location

5 GSK Care and Ethical Treatment of Animals in Research GSK s Commitment Using animals in research only where there are no alternatives or when required by regulatory authorities Implementing Replacement, Reduction, Refinement Meeting all applicable laws, rules, and regulations pertaining to care and welfare of animals used in research. Seek voluntary accreditation of its animal care and use facilities and programs by independent bodies (e.g. AAALACi)

6 GSK Care and Ethical Treatment of Animals in Research GSK s Ethical Review Animal Care and Use Committees regularly review animal practices at all sites Animal-based research is allowed to begin only after approval of scientific proposals or protocols by these groups Audits to external institutions conducting animal work on behalf of GSK

7 Different legislative environments EEC directive 86/609 but, national regulations All the sites are AAALACi accredited

8 Research & Development at GlaxoSmithKline The Medicines Research Centre in Verona In Italy Verona is one of the CEDDs* of GSK, centre of excellence for Neurosciences In Italy since 1970 Integrated research site: all key pharmaceutical research disciplines 580 scientists 15 nationalities More than 5000 m 2 animal facilities First R&D center AAALACi accredited in Italy since * Centres of Excellence for Drug Discovery

9 Legal Framework in Italy European Directive 86/609 Italian Legislative Decree 116/1992 covers all scientific procedures involving the use of live animals Central control on lab animal use by Italian Ministry of Health (MoH) Specific legal requirements for breeding, supplier and user establishments ( authorizations, recording of activities etc) Main staff roles and competences identified (e.g. scientist in charge for experimental conduction, vet responsible for animal welfare, person responsible for user establishment) Proposed use of animals must be notified or submitted for authorisation to MoH.

10 Project Project/protocol review Anaesthetised rodents/rabbits Non anesthetised rodents/rabbits Dogs, cats. NHP Notification to MoH Request of autorisation to MoH Release of authorisation Italian NIH Start of experimental procedure

11 Research Scientist + CARE Dept. Rep. Institutional Vet CARE Committee Project Anaesthetised rodents/rabbits Non anesthetised rodents/rabbits Dogs, cats. NHP Notification to MoH Request of autorisation to MoH Release of authorisation Italian NIH Start of experimental procedure

12 Ethical Review Process in GSK Verona The internal Ethical Committee CARE plays a key role in the ERP Not required by law CARE membership: 11 members different expertise Bimonthly meetings Main CARE activities performed in order to guarantee an ethical review of experimental activities Guarantee Institutional Oversight Animal welfare and 3Rs Review and approval of experimental protocols before submission to MoH Issue and approval of internal guidelines Approval of training program for staff involved Audits of facilities and procedures on animals

13 Research & Development at GlaxoSmithKline In Croatia Facility completed in 2002 GSK Research Centre Zagreb (since 2006) occupies approx. 50% of overall facility (8900 m 2 ) 4800 m 2 of laboratory space (incl. support laboratories, write-ups, and corridors) 2320 m 2 of animal research facility (with energy plant and corridors) 950 m 2 of technical space 830 m 2 of offices Fully equipped with instruments needed for modern discovery and development in pharmaceutical R&D

14 GSK Research Centre Zagreb Ltd. (Organisation Units, R&D Partnership and Support Functions ) Macrolide DPU (Discovery Performance Unit) Novel Anti-Inflammatory Macrolides IRU (Integrated Research Unit) Internal Contract Research Organisation (CRO) LAS (Laboratory Animal Science) Key Interfaces DPU LAS IRU LAS WW

15 Zagreb Legal framework Permissions for animal experimentation (PfAE): allignment with regional legislation Obtaining import permits for shipments of SPF laboratory animals from breeders (every 2 months) Obtaining Permission for the Quarantine housing of the imported animals from the Ministry of Agriculture, Fisheries and Rural Development, Department for Veterinary science (once, valid until the conditions change) Obtaining all necessary permissions for the animal experimentation according to the Croatian law on animal welfare (Official gazette 135/06), and the corresponding rules: Rule on conditions and quarantine duration for the imported animals Rule on the evidence of experimental animals and types of experiments Rule on experimental animals housing conditions, special conditions for the animal facilities and type of experiments

16 Zagreb Legal framework Positive opinion on the experimentation with the laboratory animals (Ministry of Agriculture, Fisheries and Rural Development) Permissions for the experimentation on the experimental animals (vertebrates) (Ministry of Agriculture, Fisheries and Rural Development, Department for Veterinary science) (quarterly/semi-annually) Reporting about the number of animals and type of experiments used during the each year (annul reports to the Ministry of agriculture, forestry and water management, Department for Veterinary science (once a year)

17 Ethical Review process: Committee on Animal Research Ethics - Zagreb Animal welfare and implementation of 3R s Assessment of experimental procedures (periodic meetings to review protocols for conduct of animal related experiments submitted by institutional staff) Facilities (dealing with program review and facility inspection) Health and Safety (dealing with occupational hazards, risk assessment, security assessment and supervision of hazardous agents and animal projects) Training (periodic meetings to discuss issues that arise relating to animal care and use including appropriate training of the animal research staff) Laws and regulations relevant to the use of laboratory animals monitoring and consistent application thereof

18 Research & Development at GlaxoSmithKline In Spain Diseases of the Developing World Drug Discovery Center Tres Cantos, Madrid Opened in 1995 Infectious Diseases Malaria Tuberculosis DDW 8,500 m2 Chemistry, Biology Animal facilities, 2000m2 ABSL3 facilities with 18 independent animal rooms First R&D center AAALAC accredited in Spain

19 Spain Legal Framework and Ethical Committe Regulation European Regulation (Council Directive 86/09) Spanish Regulation (Royal Decree 1201/2005) Central Government Research Centers (25) Mandatory Local Ethical Committee Central Research Committee on Animal Experimentation Regional Regulation Regions have the authority to implement their own regulations Universities, Hospitals, etc Private Research Centers Mandatory Local Ethical Committee Only 6 out of 17 regions

20 Ethical Review Process in GSK Spain CEEA, is our local Ethical Committee on Animal Experimentation Not required by legislation in force (regional regulation) CEEA memberships include vets, animal welfare, scientist and non-scientist people. Activities performed in order to guarantee an ethical review of experimental activities: Review and approval of experimental protocols Animal welfare and implementation of 3R s Issue and approval of internal guidelines Approval of training program for staff involved Semianual inspection of animal facilities Revision of procedures with animals Assure compliance with GSK policies and legal requirements

21 Our experience with AAALAC accreditation GSK R&D Tres Cantos was accredited in No legal obligation to have an ethical review process in place. Ethical Committee was established in Composed by four members Chairperson and attending veterinarian was the same person One member was responsible for several protocols The composition and leadership of the Ethical Committee may present a conflict of interest. The Council recommends modifiying the composition and leadership of the Ethical Committee to avoid the perception of a conflict of interest. GSK R&D Tres Cantos was re-accredited in 2007 with no SFIs.

22 Ethical Review Process in GSK- conclusions Ethical review in animal research is a complex process that requires the commitment of the institution Cannot be limited to compliance with regulations An effective ethical review is needed to achieve and to maintain performance and quality standards required A driver for implementing best scientific practices in a world-wide R&D organisation GOOD WELFARE = GOOD SCIENCE = GOOD BUSINESS