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UK Government confirms no legal requirement for animal testing in medical research

Published on November 13, 2023

In response to a recent question to the Department of Health and Social Care (DHSC), the UK Government has categorically stated that animal testing in medical research is not a legal requirement.

This remarkable new response debunks the commonly held belief that animal testing is a legal requirement. Up until now, clarity on the Government’s position has been difficult to point to.

The written question, posed by MP Giles Watling – Chair of the All-Party Parliamentary Group on Animal Welfare – sought to understand whether the UK regulator considered approval of new therapies on a case-by-case basis, or whether they would always ask for a standard set of animal test results. Health Minister Will Quince affirmed in response that whilst there is no UK legislation mandating animal testing for this purpose, international regulatory guidelines are followed that suggest using animal data in the drug evaluation process.

So, what are these international regulatory guidelines that the UK follows exactly? They are a set of standards established by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) – a body formed by the US, Europe and Japan back in 1990. The ICH brings together regulators and members of the pharmaceutical industry to write guidelines on the development of medicines. The guidelines are then implemented by countries at a local level.

Within their guidelines, the ICH strongly suggest that a new drug should normally be tested on two species of animal (one rodent such as mice, and one non-rodent such as dogs or monkeys) before it can proceed to human clinical trials. However, in this recent response, the DHSC state that assessors will accept data from a “suitably validated model that has been demonstrated to be predictive […] in lieu of animal data.” With this in mind, surely human-specific models such as organ-on-a-chip technology which has proven to be more predictive than animal tests could be submitted instead. This assertion of a more flexible approach from the Government is entirely welcomed by those wishing to see progress for patients and animals.

And the UK can progress in this area because, critically, the ICH’s guidelines are not legislation. This idea had previously been confirmed in evidence given to the All-Party Parliamentary Group (APPG) on Human Relevant Science by an employee of the Medicines and Healthcare Products Regulatory Agency (MHRA) in 2021. (Simply put, the MHRA regulates medicines in the UK, approving new drugs and ensuring they are safe to use and in good supply). The MHRA employee stated that “there is no legal requirement that animal studies be used”, something that was backed-up by an expert in EU and international animal law at a subsequent meeting.

The same employee also confirmed that the MHRA accepted alternatives to animal studies, that animal studies should not be default, and that it made this clear to all sponsors of clinical trials. Up until this point, it had been difficult to clarify the MHRA’s position on the requirement for animal tests. While the employee made it clear that they were speaking in a personal capacity, rather than officially representing the Agency, their evidence did provide confidence that the regulator is open to taking a more flexible and evidence-based approach.

In fact, we know that there is already a case in which the MHRA has been more progressive regarding the data it requires. In January 2019, the regulator approved in-human clinical trials for a cancer therapy developed by Achilles Therapeutics whose application had not been supported by animal data. The therapy involved using a patients’ own immune cells to treat the cancer, rendering animal data particularly irrelevant.

In addition, development of the COVID-19 vaccines saw a global regulator depart from the usual requirement that animal tests must be completed before a therapy can move to human clinical trials. Specifically, the International Coalition of Medicines Regulatory Authorities (ICMRA) stated that ‘it is not required to demonstrate the efficacy of the SARS-CoV-2 vaccine candidate in animal challenge models prior to proceeding to [first in human] FIH clinical trials’. Moderna Therapeutics then carried out animal tests at the same time as human trials. Usually, the data from animal tests determines whether human trials go ahead, but in this instance, the two types of testing were carried out in parallel.

Around the world, policymakers are increasingly acknowledging the effectiveness of human-specific methodologies to get safer medicines to market quicker and more ethically. Examples include the USA’s FDA Modernization Act 2.0  which explicitly states that it will accept data from human-specific sources in place of animal tests, and the European Parliament’s 2021 resolution to phase out animal use by adopting an action plan. If it is to realize its vision of making the UK a Science Superpower, the UK Government must keep pace and take concrete policy action.

Nevertheless, whilst the response from the DHSC is a key development and cause for optimism, it is also important to note that animal tests that are carried out to satisfy such regulatory requirements make up only a small proportion of the animal experimentation that takes place in Britain – less than one quarter in 2022, in fact. But of course, behind every statistic is an animal in a laboratory, and when broken down, the sheer number of animals that make up this portion is difficult to digest. In total last year, to satisfy the ICH guidelines, over 145,000 animals were used in experiments including over 86,000 mice, over 1,700 cynomolgus monkeys, and almost 2,500 beagles.

So, while we do now have more clarity on the Government’s current position in this area, it is important that we keep the pressure on policymakers to speed up the transition to human-specific, animal-free methodologies. Backing up this assertion with supportive action such as appointing a Minister for Human-Specific Technologies and developing an action plan will kickstart much-needed progress in this area.

Our vision is for a future where medical research breakthroughs are made using new technologies – not animals – and the Government must play a central role in accelerating the UK’s adoption of them. We hope that this is a sign that policymakers are listening.

Have you contacted your MP to encourage them to support the transition to human-specific medical research?

Keen to learn more about human-specific technologies? Read our briefing here

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