As a result of Brexit, there have been necessary adjustments made to legislation and the regulatory bodies responsible for the evaluation and registration of medicines, as well as the protection of animals used in research and testing.
FRAME outlines these changes and explains why Brexit could be an opportunity for the UK government to positively influence the legislation governing animal research and testing.
Following the UK’s decision to leave the EU, the European Medicines Agency, which evaluates medicines throughout the EU, was moved from London to Amsterdam. The UK’s Medicines and Healthcare Regulatory Agency (MHRA) is solely responsible for approving medicines for use in the UK from March 2019.
The regulation of live animal experiments in the UK will be upheld post-Brexit, as all ASPA (Animals [Scientific Procedures] Act 1986) requirements are being retained as part of the EU Withdrawal Act (2018). A new Animal Sentience Bill has also been promised which will signal the government’s intention to explicitly recognise animal sentience in domestic law and to take account of the welfare needs of animals when formulating and implementing policies.
On the 2nd March 2020, the Medicines and Medical Devices Bill was passed at second reading. If the Bill becomes an Act of Parliament, it will ensure the UK has the power to amend and update laws on medicine regulations after Brexit.
Along with regulating the legislation included in this Bill after Brexit, the MHRA can apply for the UK to join the ICH (The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use). The ICH brings together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines. These guidelines are generally followed by members to achieve greater harmonisation worldwide and ensure that safe, effective and high-quality medicines are developed and registered. Previously, the UK was signed up through the European Commission.
Post-Brexit, the UK will have more ownership of regulations for developing and testing new medicines in this country. Moving forward, this could potentially include changes that impact on the number of animals and species required in certain areas of safety testing.
The UK is currently still aligned with EU Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation (REACH), which requires chemical companies to provide information on the health effects and environmental hazards of chemicals.
FRAME strongly advocates that the UK stays within the REACH regulations to facilitate data sharing and ensure animal testing is only carried out as a last resort when information on a substance is not available elsewhere.
Brexit presents the UK government with a unique opportunity to improve and positively influence global standards of animal welfare, for example by encouraging compliance with the principles of replacement, reduction and refinement. When forming new trade deals, the UK can set out what is expected of other countries in terms of their standards of animal welfare and ways of proving the safety of medicines, chemicals and food.
FRAME will continue to work and collaborate with others in the field to ensure high standards of animal welfare are maintained and unlock the potential of non-animal approaches that can provide more scientifically valid and human-relevant outcomes, for the benefit of human health.