Animal testing statistics for 2019 have yet to be released by the Health Products Regulatory Authority (HPRA). Amber Baxter explores what this means.
The Health Products Regulatory Authority (HPRA) is the state agency responsible for regulating human and veterinary medicines, medical devices and other health products. From 1 January 2013, an EU Directive to protect animals used for scientific purposes came into effect in Ireland. In January 2013, the HPRA became the competent authority responsible for the Directive’s implementation. The HPRA has been publishing statistical data on animals used from 2013 onwards.
The latest statistics released by the HPRA are for 2018 and previous years. It is unclear why the 2019 statistics have not yet been released, Dr Dan Lyons, CEO of Centre for Animals & Social Justice and public policy consultant for Irish Anti-Vivisection Society said “normally 2019 statistics should be out by now”.
According to the HPRA statistics, in 2018, there were a total of 199,800 uses of animals for procedures, with reuse representing less than 1% of this number. Mice were the most commonly used animal with 75% of the total animal use.
“This figure may well go up again for 2019 and 2020 because it just depends on how many botulinum toxin [Botox] producers there are in Ireland and how much they are producing each batch is tested on mice using a version of the Lethal Dose 50% test – one of the most severe,” said Lyons.
One botox producer in Ireland is Allergan. Allergan operates out of Westport Co. Mayo which has been referred to as the ‘botox capital of the world’. Dr Lyons said, “They [Allergan] might be using less animals as they have developed a non-animal alternative for some of their testing. Ipsen is another one. There are probably others but the HPRA won’t say exactly who they are, but you can work it out from whichever companies are in this sector and producing in Ireland.”
Of the total number of uses of animals in procedures (199,800), 72% were used for regulatory purposes, which refers to legal requirements to test the safety, quality and potency of medicines for example biological medicines such as vaccines. Out of the total testing, 9,814 involved genetically altered animals, which represents 5% of all animal use.
According to the HPRA the most common reported actual severity experienced by the animals during their uses in procedures was ‘mild’, at 55%, followed by ‘moderate’, at 27%.
In 2017, there were a total of 242,302 uses of animals for procedures, with reuse representing less than 1% of that number. Mice were the most used animal this year with 85% of the total animal use.
Of the total number of uses of animals in procedures (242,302), some 194,816 (80%) were used for biological purposes such as vaccines. Of the total number of uses of animals in procedures (242,302), 7,496 involved genetically altered animals, which represents 3% of all animal use.
Between 2017 and 2018, there was a decrease of approximately 42,500 in the testing. This was “largely due to a reduction in regulatory testing (-approx 51000)”, said Lyons. These statistics refer largely to testing for ‘Botox’ or similar products, many of which are used for cosmetic purposes despite the ban on animal testing for cosmetic products.
“The Govt and HPRA don’t have any strategy or intention to achieve sustained reduction in animal testing and associated animal suffering – they are led by the nose by biotech industry. However, ‘Translational and applied research’ has increased by about 8500 experiments. Much of this is down to increases in the category of research called ‘animal welfare’. In reality this is more about research into farm animal productivity than animal welfare as such.”
The HPRA works off the ‘Three R’s’: replacement, refinement, and reduction. Replacement involves the development and use of technologies that can be used to address important scientific questions without the use of animals. Reduction refers to methods that minimise the number of animals used per project. Refinement means that the animals used are provided with the best possible care and that suffering is reduced to an absolute minimum.
According to the HPRA they “aim to improve the welfare of animals used for scientific purposes and to promote the principles of the 3Rs. Every application received for a project involving animals is subject to a detailed evaluation process based on the 3Rs and requires scientific justification for the research techniques being applied. The likely impact on the animals must be minimised as far as possible by applying refinements and any harms experienced by the animals must be outweighed by the expected benefits of the work,
“The HPRA considers whether alternative (non-animal) methods are available or appropriate, as alternatives to the use of live animals must be used where possible. In fulfilment of the HPRA’s mandate to promote the 3Rs, in 2018 the HPRA continued its efforts to enhance awareness and utilisation of non-animal alternatives as well as refinements in the conduct of scientific studies in animals through its work, including the regular dissemination of pertinent information to the regulated sector”.