Rethinking the project licence application and assessment processes to maximise 3Rs impacts

In the UK, researchers must hold a project licence (PPL) from the Home Office if their work involves a regulated procedure on protected animals¹. Over recent years various reports (e.g. the Rawle report) have highlighted opportunities to strengthen the application of the 3Rs within this process.

To address these, we were commissioned by the Home Office’s Animals in Science Regulation Policy Unit to undertake a comprehensive review of how the principles of the 3Rs are incorporated into the PPL application and assessment process. The review, supported by extensive consultations with stakeholders, examined the structure, content and function of the current PPL form, how it is currently used and how effectively it supports the harm-benefit analysis that sits at the heart of UK legislation and the practical implementation of the 3Rs.

Our findings led to the development of a set of recommendations that outline significant changes to the PPL form, that would represent one of the most substantial evolutions of the licencing process in the last decade. The 12 recommendations strengthen the protection of animals and the application of the 3Rs, improve the clarity and efficiency of the licence assessment process, and support researchers, Animal Welfare Ethical Review Body (AWERBs) and Animals in Science Regulation Unit (ASRU) with their responsibilities.

Our recommendations enable greater flexibility to implement refinements, encourage the use of more relevant indicators of animal suffering, and promote the harmonisation of severity limits and humane endpoints. Alongside these benefits, the proposed changes offer operational gains by reducing the length of a typical PPL application by around a quarter, streamlining the review process for AWERBs and ASRU and facilitating compliance monitoring, while freeing-up capacity to focus on other responsibilities, including the implementation of the 3Rs in practice.

The report published today sets out the review methodology, key findings and the rationale underpinning each recommendation. Successful delivery of the recommendations will require close collaboration between the Home Office and the regulated community to develop a detailed implementation plan, enable a smooth transition and bring the intended benefits of our proposed changes to the licencing system and how the 3Rs are embedded within it.