17 / 05 / 2022
Developments In EU Animal Research Policies
And what do they mean for the UK post-Brexit?
2021 saw several developments in the European Union surrounding how animals are currently used in research, and how the 3Rs could be implemented further.
Some of the most significant developments within the EU were the introduction of the ALURES (Animal Use Reporting – EU System) database, the development of the European Medicines Agencies Innovation Task Force, and the call for an EU action plan within European Parliament.
FRAME Policy and Projects Intern Jessie Hellier provides an overview of the recent changes to EU policies, explains the implications for UK research following Brexit, and outlines the opportunity the UK government now has to make positive changes to animal research, testing and welfare legislation.
Last summer, the EU Commission published its first statistical database on the use of animals for scientific purposes across all EU states.
The ALURES database is the most comprehensive database of animal use statistics in the world and contains information on the following three areas:
- The number of animals (conventional and genetically altered) used for the first time for research, testing, routine production, and education and training.
- The uses and reuses of animals, reasons for their use, severity level, genetic status, and use of animals to meet legislative requirements.
- The numbers, uses, and reuses of animals for the creation and maintenance of genetically altered animals.
Having a database as detailed and thorough as the ALURES database allows for a complete overview of how animals are being used in science in the EU. It also allows us to see the areas and specific procedures in which animals are being used the most, which can aid in identifying areas the 3Rs should focus on, and where human-relevant methods can be utilised. The ALURES database is also open access to all, allowing maximum transparency. As a new tool, data from every year and every country is not yet available, but all national data will be accessible from 2023.
Innovation Task Force
The Innovation Task Force (ITF) is a multidisciplinary group within the European Medicines Agency (EMA), that includes scientific, regulatory, and legal representation. It was set up to ensure coordination across the medicines agency and establish a platform for applicants to discuss innovative aspects in medicines development. The tasks force aims to:
- Proactively identify scientific, regulatory, and legal issues that emerge from innovative technologies.
- Address the impact of emerging technologies on scientific, legal, and regulatory requirements, and review their implications in conjunction with other committees.
- Identify the need for specialised expertise.
- Provide advice on the eligibility of Agency procedures that relate to research and development in conjunction with other relevant committees and authorities. This can include where there are uncertainties on the inclusion of a medicinal substance, substances that may or may not class as medicinal, and substances used in medical devices.
- Increase awareness of emerging technologies at the Agency.
The ITF has been around for many years as part of the EMA, however, in September 2021, the EMA announced that, through the IFT, it would be putting special support in place for developers to reduce, replace and refine their use of animals in drug development. This announcement will encourage the development and implementation of New Approach Methodologies (NAMs) in place of using animal models, and will provide a multidisciplinary platform for discussion and integration of NAMs in drug development and medicinal products. This new service is free of charge, and any NAMs that follow the principles of the 3Rs and fulfil testing requirements are eligible for consideration within the platform.
EU action plan
On 15 September 2021, the European Parliament adopted a resolution asking for an action plan to accelerate a transition to innovation without the use of animals in research, regulatory testing, and education. The resolution asked for ambitious yet achievable objectives and targets that would lead to an active reduction in animal use. The votes stood at 667 votes to 4 in favour of the resolution.
The resolution was put forward to parliament to highlight the lack of progress made in the past decade with regards to reducing the use of animals in science. In 2011, 11.5 million animals were used in research, compared to 9.4 million in 2017 (the most recent figure available). Furthermore, there remains a lack of transparency surrounding animal use in science and inadequate funding for more human-relevant methods. The resolution also highlighted that the ban on animal testing of cosmetics within the EU was successful, and proves that phasing out animal testing is feasible, without jeopardising scientific innovation.
Whilst the vote was not legally binding, it has placed significant pressure on the European Commission to respond to the objectives of the resolution, and MEPs are calling for an action plan to be drawn up and presented to parliament by the end of 2022.
What do the changes mean for the UK?
As of 31 January 2020, the UK was no longer a member of the European Union. This means the UK will not be affected by any of the developments within the EU with regards to animal use in research.
The UK already publishes detailed annual statistics on its use of animals in research and testing, however, will not benefit from being published in the ALURES database. Due to this, UK research will not be included when identifying areas where the 3Rs should focus and NAMs can be developed, as well as being left out of focused funding opportunities. The UK will also be unable to use the extra support provided through the Innovation Task Force, potentially falling behind in the uptake and development of new approach methodologies as a result. The same can be said with regards to the EU action plan, which will only affect EU member states.
All of this has the potential to present a significant issue for scientific research in the UK. The developments within the EU show a commitment to reducing the use of animals in science, but with the UK no longer included in these developments, there is a risk that the UK could fall behind and continue to use animals when human-relevant methods are available elsewhere. At the same time, the EU will also not benefit from any progress made within the UK and will not have the UK statistics included in its national data. The UK is one of the largest users of animals in research in Europe, so a significant amount of animal use data will be missed out in the ALURES database, and therefore not factored into discussions on 3Rs focus areas.
There is definitely an opportunity for the UK to step up and introduce its own developments to match, or even surpass, those of the EU. The introduction of the Animal Welfare (Sentience) Bill is already a great example of where the UK has developed legislation to show its commitment to animal welfare. The EU Directive 2010/63 has also already been transposed into UK legislation post-Brexit which shows a commitment to the welfare and protection of animals used for scientific purposes. The ‘working to reduce the use of animals in scientific research’ delivery plan, published in 2014, also needs to be re-addressed in order to show a commitment to the 3Rs, and, in particular, focusing on replacement at the same level as reduction and refinement.
The UK is at the forefront of scientific innovation, evidenced by the fast development and uptake of the COVID-19 vaccine, and continually aims for higher standards of animal welfare on all fronts. This stance can only be taken further by the UK taking the long-overdue step of ensuring the development and uptake of NAMs are the focus of conversations surrounding the use of animals in research and testing.
Committing to the reduction, and eventual replacement, of animals in research will not only benefit animals, but also humans, in allowing for more relevant, human-based science.
To find out more about the legislation the UK and other countries across the world have in place regarding the use of animals in testing and research, visit our dedicated Legislation & Regulation page.
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