The BUAV has welcomed the announcement of further progress to reduce animal testing by the UK’s regulatory bodies for veterinary medicines, the Veterinary Medicines Directorate (VMD) and Veterinary Products Committee (VPC), following their annual meeting for stakeholders at the end of November. In response to a request from the BUAV for an update on their efforts to reduce animal testing for veterinary medicines, the VMD announced that it was now adopting a more proactive approach to the issue.
The VMD has recently set up a database containing a list of products for which it believes a specific batch test involving animals can now be removed. It is writing to companies to formally remind them that the animal test must now be removed from their licences (1). Already this year, the VMD has successfully requested the removal of nine such tests for vaccines that previously had to undergo repeated batch testing. This action will save the lives of hundreds of animals including horses, cats, dogs and cows.
Animals are currently used to test every single vaccine batch produced before it can be released onto the market. According to regulations, this ‘target animal batch safety test’ must be conducted on the animals of the species for which the product is designed, necessitating tests on dogs, cats, horses, cows, sheep and pigs every time a new batch of the medicine is made. Not only does this kind of repeat testing consume hundreds of animals depending on the frequency of batches (2 mammals, 10 fish or 10 birds each time) but the volumes of the vaccine that are injected can be too large and cause pain and distress (2).
In Europe, there have been moves to delete this test from regulatory requirements since at least 1996, beginning with an initial recommendation from the UK Authorities that it should be possible to instead determine safety through good manufacturing practice and quality assurance processes (3). It was not until 2005 that the European Medicines Agency agreed that the test could be waived (4), following reviews conducted in Europe (5,6) and a statement by the European Centre for the Validation of Alternative Methods (ECVAM) (7). And it was not until April this year that the European Pharmacopoeia, which is the EU-wide rule book on medicines, deleted the need for the test from most of the veterinary vaccines it lists (8). By the 1st of April 2013 products for which there are already safety data available no longer need to be repeatedly tested, thereby saving thousands of animals across Europe. Nonetheless this comes some 17 years since the original recommendation.
However, due to the way drugs are licensed it is still up to companies involved to update their procedures and stop commissioning the animal test. Companies may not realise that they have a moral and legal obligation to do this. That is why proactive action by the VMD is so important.
In 2011, the BUAV was instrumental in saving thousands of animals from being subjected to cruel toxicity tests that were no longer required by international regulations, when we brought to light the need for VMD action to prevent unnecessary abnormal toxicity and pyrogenicity tests being conducted for veterinary products. We uncovered the use of these tests at the contract testing facility, Wickham Laboratories in Hampshire, even though the tests had been deleted from the European Pharmacopeia years ago. The Laboratory was carrying out the tests for a number of companies across the EU and North America and the Home Office was doing nothing about it. Prompt action by the VMD not only stopped these tests but others being conducted in other laboratories. For further information: http://www.buav.org/article/785/buav-investigation-stops-cruel-animal-tests
The VMD is hopeful that over the next year we will see a significant decrease in the number of animals used in vaccine batch testing as companies update their licences to remove the test for their products. The VMD expressed its enthusiasm in promoting this strategy and stressed that companies need to know they have a legal obligation to use alternative approaches if they are available. We welcome this change in direction as at previous meetings with BUAV representatives the VMD had said that it did not have resources to take such a proactive approach. The BUAV now wants to see other EU countries follow this lead and check that companies keep up to date with EU requirements
2. Batch safety testing of veterinary vaccines-potential welfare implications of injection volumes. ATLA 36 (2008):685-694.
3. Reducing the use of the target animal batch safety test for veterinary vaccines. Developments in Biological Standardisation 86 (1996):97-102.
8. Vaccines for Veterinary Use Adopted by the European Pharmacopoeia Commission at the 142nd Session: International Harmonisation With VICH Guidelines 41 And 44, Deletion of the TABST and 3Rs. 17 April 2012, Strasbourg, France. See also their website on animal testing