Regulatory sandboxes should be able to experiment and draw on several relevant healthcare innovation related frameworks other than pharmaceutical products (i.e. medical devices, in-vitro diagnostics, AI, digital health technologies, and substances of human origin among others).

The proposal should:

1. Scan the horizon for potential sandbox candidates including how sandboxes provide an additional tool to existing frameworks, and use the examples identified to model the process.

To this end, a key objective is to identify a number of healthcare innovation case studies to better understand how a regulatory sandbox could be used to solve further-defined challenges at an existing regulation level and inform recommendations for end-to-end operations. These cases could draw from the past, present and from horizon scanning activities (the EMA’s work in this area already provides a hint) to anticipate future innovations, looking across their development value chain.

2. Analyse how regulatory sandboxes can drive science and health technology innovation in an evolving environment.

The proposal should do this by:

• anticipating consequences for health technology development under a regulatory sandbox mechanism, acknowledging its time-limited scope and the consequences (considering the technical particularities of healthcare innovation) for other downstream activities e.g., standardisation, health technology assessment;
• proactively identifying any guardrails and mitigation measures.

3. Develop recommendations for end-to-end operations of regulatory sandboxes to inform healthcare innovation developers, regulators and downstream decision makers.

The proposal should do this by:

• mapping out conceptual elements and operationalisation features of future sandbox mechanisms based on existing experiences in other fields such as governance, conditions fostering dialogue and collaboration, access to the right type of expertise, support, regulatory customisation, sharing/communicating lessons learned and their translation via the appropriate frameworks into new standards, among other elements to be further defined;
• modelling how to operationalise the sandbox(es) (including governance, operations, principles) and how they could be used in healthcare innovation development and evaluation in conjunction with existing regulatory mechanisms to advance innovation at European and national levels.

Part of the topic entails modelling a regulatory sandbox. The proposal should therefore consider good practices for designing and evaluating the necessary operating models to ensure the robustness and future applicability of the output of the project.

The project outcomes could also offer directions for the translation of the resulting recommendations into digital tools and systems deemed necessary for the functioning of regulatory sandboxes (e.g. ensuring collaboration between different health authorities’ triage mechanisms, horizon scanning, fitness check evaluations), as relevant.

When developing a comprehensive and shared understanding of the value of regulatory sandboxes, applicants will have to explore key aspects across the life-cycle of healthcare innovations with the objective of accompanying their ultimate adoption, which could include as appropriate R&D, regulatory authorities, HTA bodies, payers, governments, clinicians and patients. Ethical considerations would also have to be considered as some innovations could trigger questions in this field. A shared objective should include to develop a regulatory strategy and interaction plan for generating appropriate evidence, enabling engagement across all the different decision makers in a timely manner (e.g. national competent authorities, EMA and the respective Innovation Task Force, qualification advice) and identifying aspects that can be leveraged by existing regulatory tools, as well as the limiting aspects and the flexibilities that would be required under a regulatory sandbox to achieve the timely development and access of healthcare innovations.