Animal Welfare in Practice
Scientists from the Paul-Ehrlich-Institut have helped to revise 43 monographs in the European Pharmacopoeia – making many animal tests superfluous.
For many years, scientists at the Paul-Ehrlich-Institut have been working on the revision of monographs in the European Pharmacopoeia. This is where the requirements on the testing of medicinal products – including animal tests – are laid down. Dr Ingun Lemke and Dr Beate Krämer from the Veterinary Medicine division are members of the 15 V expert group of the European Pharmacopoeia, based at the European Directorate of the Quality of Medicines & Healthcare (EDQM). One of the central objectives of Group 15 V is the implementation of the 3R principle: avoiding animal testing (Replacement), reducing the number of experimental animals (Reduction) and limiting animal suffering to the absolute minimum (Refinement).
The previous requirements for the testing of extraneous pathogens such as viruses, bacteria or fungi, were looked at carefully, as well as the methods used for this testing. On the initiative of the Paul-Ehrlich-Institut, Group 15 V subjected all the relevant monographs for animals to a revision. The results were collated, tests were checked to see if they were necessary and alternatives to animal testing were demonstrated. Two monographs that specified in vivo tests with embryonated chicken eggs for the testing of poultry vaccines were deleted. The revision also led to the deletion, without replacement, of in vivo tests for extraneous viruses in cattle and pigs for inactivated vaccines. A new monograph now describes the principles for the detection of extraneous viruses in immunological veterinary medicinal products exclusively by means of in vitro tests. In total, 43 revised monographs finally came into force on 1 July 2020.
With a risk-based testing approach, by weighing the benefits and risks, we were able to delete unnecessary animal tests and replace others with in vitro test methods. In this way, we are saving a large number of animals from distressing tests.
Dr Ingun Lemke , Deputy Head of the Assessment of Immunological Medicinal Products for Veterinary Use Section
Tetanus vaccines contain attenuated toxins (toxoids) of the tetanus bacterium as antigens – and these must not become toxic again. Research findings by Dr Krämer and Dr Heike Behrensdorf-Nicol from the Veterinary Medicine division showed that there is no evidence of any such reversal process. As a result, the European Pharmacopoeia Commission deleted, without replacement, the prescribed irreversibility tests on guinea pigs from the monographs for tetanus vaccines for human and veterinary use. The changes came into force on 1 January 2021. The withdrawal of the irreversibility test sends out a signal, as the European Pharmacopoeia serves as a model worldwide.
Committees
- Dr Ingun Lemke, Dr Beate Krämer; Pharmacopoeia Expert Group 15 V (Veterinary Sera and Vaccines) - EDQM
Literature
Behrensdorf-Nicol HA, Krämer B (2019): Is the test for irreversibility of tetanus toxoids still relevant?.
Vaccine 37: 1721-1724.