I am repeating the following written ministerial statement made today in the other place by the Minister of State for Science, Innovation, Research and Nuclear, my noble Friend Lord Vallance of Balham:
Today, the Government are laying before Parliament a strategy to support the development, validation and uptake of alternative methods to the use of animals in science.
The Government are proud to lead a new era in advancing innovative and effective approaches to scientific research and development. We are committed to delivering on our manifesto pledge to “partner with scientists, industry and civil society as we work towards the phasing out of animal testing”. Not only that, but we aim to establish the UK as a world leader in developing and adopting alternatives to animal testing. This reflects not only our deep commitment to animal welfare, but our belief in the economic, scientific and societal benefits that come from investing in and phasing in modern alternatives. The Government recognise the urgency of this transition and are determined to drive meaningful change through co-ordinated, cross-governmental action.
Our vision is for a world where the use of animals in research and development is eliminated in all but exceptional circumstances, achieved by creating a research and innovation system that replaces animals with alternative methods where scientifically possible. This will include a wide range of new and validated alternatives used in discovery and translational research, and new methodologies for chemical and environmental testing, and safety and toxicity testing of potential novel human and veterinary medicines. This strategy lays out the steps that we, the Government, will take over the next five years towards achieving this vision across the whole of the UK. We also highlight specific instances of animal use where we will take immediate and near-future action to ensure alternative methods are applied going forward.
The use of animals in science at present provides an important insight into human and animal biology and disease. Animals are also used in many sectors to test the safety and efficacy of chemicals in consumer products, and in new human and veterinary vaccines, medicines and medical devices before they are trialled in their intended populations or marketed. Enabling the properly regulated use of animals, while we move away from animal testing, is essential to improving the health and lives of humans and animals and to the safety and sustainability of our environment. We will continue to support the appropriate use of animals where reliable and effective alternatives are not yet available. But we will not accept a slow pace of change when and where scientific and technical advances mean that a faster transition away from animal use is possible.
Recent scientific advances have provided new impetus to the development of alternative methods that replace, reduce and refine the use of animals in research—the three R’s. There is also a rapidly accelerating global movement to adopt alternative methods in the life sciences, which we not only welcome but aim to accelerate further and seek to be a world leader in. The maturity of these methods differs across scientific and regulatory sectors, but alternative methods are being applied in a wide range of contexts across discovery research, veterinary science, drug and chemical discovery, toxicity testing and clinical investigations. We are at a tipping point where international regulatory and political commitment, technological capabilities and scientific advances are converging to create a system capable of delivering the scientific, commercial, societal, economic and animal welfare benefits offered by alternative methods.
The term “alternative methods” describes a broad range of tools and technologies that can reduce or replace animal use across the whole of the bioscience landscape. They are being applied in a wide range of contexts and have benefits including specificity, sensitivity, species relevance and speed, but also disadvantages, such as a current inability to fully replicate testing on a living animal. Only a few of these methods have, to date, been fully validated or qualified to replace animals for specific purposes, with insufficient funding to advance research from Government over the past decade, and therefore adoption for discovery research and uptake into policy and regulatory use has been patchy, with slower progress than many have desired. That is why more research and investment is urgently needed, and this Government, in our new strategy, are committing fully to both. This strategy covers the whole range of uses of animals in science and has been developed to accelerate the development, validation and adoption of scientifically evidenced alternative methods in discovery, applied, translational and regulatory research and testing.
The strategy will build on the UK’s well-established life sciences research system, enabling it to respond with greater agility to opportunities in the rapidly evolving alternative methods landscape. It has six objectives:
Accelerate the replacement of animals in science to phase out their use;
Achieve equal or better research and testing outcomes using alternative methods;
Drive private investment in alternative methods to boost innovation and growth;
Improve regulatory confidence and acceptance of alternative methods;
Create infrastructure and partnerships to unlock value from UK data; and
Position the UK as a global leader in alternative methods.
We, the Government, will deliver this by focusing on five key commitments:
Driving alternative method development and uptake in discovery research: We will incentivise the development and adoption of alternative methods. This will be delivered through (i) increased and sustained investment focused on animal replacement; (ii) better animal research approval and dissemination mechanisms to assess whether animal use is required or whether alternatives could be used; and (iii) a workforce with the necessary skills set to implement the uptake of new alternative methods quickly and effectively. We will establish a new pre-clinical translational research hub to bring together data, cell engineering, genomic technology and expertise to create a pipeline of novel translational medicine models. This will be an exciting step forward that will create more jobs in the alternative methods industry and help to position the UK as a world leader in developing alternatives and moving away from animal testing.
Accelerating alternative methods validation and uptake for regulatory decision making: We will establish a national approach to accelerating the validation and regulatory acceptance of alternative methods. At its core will be a new UK centre for the validation of alternative methods that will co-ordinate a cross-sector network of public and private laboratories and facilitate engagement between policy makers, regulators, industry end users and alternative method developers.
Delivering the transformative potential of our data assets: We will create national infrastructure, collaborations and regulatory frameworks to expedite equitable and secure access to high-quality datasets to enable data-driven innovation that reduces animal use and enables the use of alternative methods. This will include increasing investment in data-driven biology, establishing data sharing platforms to facilitate access to public and private data repositories, setting clear standards for data quality and interoperability, widespread adoption of AI methods to assess potential safety and toxicity profiles, and developing regulatory guidance to support data-driven and AI-informed decision making. We will be working with industry and regulators to make their historical data sets available for use.
International leadership and co-operation: We will establish the UK as a global leader in the regulation and science of alternative methods, ensuring our participation on key forums and international committees in this space. We will also expand existing and establish new partnerships with international regulators to identify internationally agreed priorities of mutual importance, explore data sharing possibilities and AI projects to assess toxicity, safety and efficacy from existing data sets, and accelerate the global acceptance of validated alternative methods.
Effective governance culture: We will establish governance structures with diverse stakeholder representation to oversee progress and delivery of the actions described in this strategy. This will include a set of key performance indicators with which to assess delivery of the strategy and forming a cross-governmental ministerial group on alternative methods, chaired by the Science Minister. We will have a publicly available dashboard of progress against key deliverables.
This strategy has been developed involving stakeholders from industry and regulatory agencies representing chemicals, agriculture, food and pharmaceutical sectors, and many of the actions and commitments we pledge are applicable across multiple sectors.
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