Parliamentary Intergroup on Animal Welfare and Conservation of Animals. European Parliament, Strasbourg, 23 May 2013

Transcription

1 Parliamentary Intergroup on Animal Welfare and Conservation of Animals European Parliament, Strasbourg, 23 May 2013

2 At a glance A Public-Private Partnership launched in COMPANIES 7 SECTORS OF ACTIVITY 5 DGS OF THE EUROPEAN COMMISSION 1 ADVISORY BODY : EPAA MIRROR GROUP Our vision The vision of EPAA is the replacement, reduction and refinement (3Rs) of animal use for meeting regulatory requirements through better and more predictive science.

3 THE CONSISTENCY APPROACH : A VEHICLE FOR WIDER IMPLEMENTATION OF NON-ANIMAL METHODS IN VACCINE MANUFACTURE Dr Ian Ragan Project Co-ordinator

4 The European vaccines industry Vaccines for human use Most of world production is in Europe 50% of world vaccine R&D is in Europe 2-3 million lives saved per annum Vaccines for veterinary use Protection of livestock & companion animals and prevention of zoonotic disease Market smaller and highly fragmented by species and disease Higher burden of animal use and cost

5 Vaccine production and animal use LICENSING LOT RELEASE RESEARCH CLINICAL TESTING PRODUCTION QUALITY CONTROL (20%) (80%) 15% of all animal use for biomedical research and testing in Europe 80% of this is for quality control (QC) of lot release Is it safe? Does it work? QC of each vaccine lot produced is a statutory requirement. Animal use for vaccine QC is extensive, and pain and distress can be severe.

6 What is the consistency approach? The composition of many modern vaccines is well defined quality assurance can be provided without use of animal tests Traditional vaccines are complex and their composition is less well defined the consistency approach aims to combine rigorous manufacturing quality with non-animal tests to assure safety and potency without use of animals

7 Where are we now? Several alternatives to current standard tests have already been developed and validated for use BUT: Not all the alternatives avoid use of animals completely Validated alternatives are not universally used Assurance of the potency of the final lot remains a challenge HOWEVER: The Directive 2010/63/EU (protection of animals used for scientific purposes) requires manufacturers and testing laboratories in the EU to use non-animal tests in preference The consistency approach is a vehicle for wider implementation of non-animal methods

8 Consistency testing how would it work? Test first few lots thoroughly in non-animal tests, in laboratory animals and finally in clinical studies Specify the profile of a safe and potent vaccine based on clinical, manufacturing and non-animal testing criteria Examine subsequent lots against these criteria If the profile is within agreed parameters, the vaccine lot is released.

9 Consistency approach: what makes it attractive? Quality is linked to a well characterised clinical/historical lot (scientific benefit) Quality control is quicker (a few days instead of 2 months) (economic benefit) NO further animal use is required for lot release testing (animal welfare benefit)

10 Aims of the project Priorities from both vet and human vaccines e.g. rabies, diphtheria, tetanus, pertussis Gaps in data needed to remove animal tests Collaboration and transparency Funding for further research Validation by EURL ECVAM* and EDQM* Communication to increase uptake conferences, workshops, publications *EU Reference Laboratory for alternatives to animal testing European Directorate for the Quality of Medicines and HealthCare

11 EPAA Vaccine Project December 2010 September 2011 Vaccine Project Committee Manufacturers Intravacc ECVAM EDQM Launch Meeting April 2011 Technical Committee VPC OMCLs EMA International Observers February 2012 Expert Working Groups Human Rabies DTaP* Vet Rabies Clostridials EWG workshops *Diphtheria, tetanus and pertussis

12 Composition of expert working groups: manufacturers AND regulators Manufacturers are reluctant to invest in an alternative test without assurance of regulatory acceptance Regulators are reluctant to assure acceptance in the absence of data (Potency test of veterinary vaccines: The way from in vivo to in vitro, 2010 workshop, PEI, GE)

13 Workshop reports

14 Future needs Research funding to fill the scientific gaps Regulatory involvement for validation and approval of alternatives Harmonisation of global regulatory requirements Global campaigns to encourage adoption of the consistency approach

15 Strategic investment in key technologies (inc. biotechnology) Attracting private investment in research and innovation Encouraging creation of innovative SMEs

16 CONCLUSIONS - EPAA is a unique platform for cross-sector collaboration on alternative approaches to animal testing. - Gathers more than 100 high-level experts on 3Rs - 12 ongoing projects focusing on the most advanced alternative approaches to animal testing, including: - Vaccines Consistency Approach - Stem Cells - Skin Sensitization alternatives - International cooperation on 3Rs with private and public partners, including foreign regulators (incl. US FDA)

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