Rapid advances in research are delivering healthcare innovations or new methodologies that simply don’t fit in with current regulatory frameworks. As a result, their development, regulatory acceptance and evaluation is slow, and this in turn slows down patient access to them.
‘Regulatory sandboxes’ are flexible spaces where innovators and regulators can collaborate and explore the best way to regulate a new technology in such a way that end users are protected, while innovations are not held back by barriers that could be found in the existing regulatory framework. They are already used in sectors such as finance, but are still in their infancy in the health field.
BRIDGE: A unique regulatory science project
The aim of the BRIDGE project is to develop a comprehensive set of recommendations for designing and implementing regulatory sandboxes in practice for health, including flexible, fit-for-purpose methodologies.
‘This pre-competitive regulatory science project is unique,’ explained BRIDGE industry co-lead Francois Hebraud of Roche. ‘BRIDGE is about increasing the readiness of Europe to make use of effective regulatory sandboxes for innovative healthcare technologies and methodologies development.’
One of the project’s first tasks will be to review existing regulatory sandbox mechanisms, along with relevant health policies and regulatory frameworks.
Today, regulatory sandboxes are usually established reactively, once a new technology already exists. BRIDGE plans to incorporate a proactive horizon scanning process to identify early on emerging trends and technologies that fall outside existing regulatory frameworks. This will allow regulators and innovators to anticipate and address challenges and opportunities relating to new technologies while they are still under development.
A flexible, adaptable framework
A core project outcome will be the MOSAIC (Modular Operational Sandbox for Healthcare Innovation and Compliance) model. As emerging healthcare technologies are both complex and diverse, any framework for regulatory sandboxes has to be flexible and adaptable enough to cope with a wide range of stakeholders, products, and regulatory requirements.
MOSAIC will feature a modular design with ‘bricks’ (which could be the resources, tools, processes or personnel needed for a specific sandbox) and a ‘module base’ (which sets out how to configure or assemble the bricks). By combining the right bricks with the module base, users can build functional modules that perform specific tasks within the regulatory sandbox, such as modelling, technology assessment, and clinical validation. The functional modules are then assembled to create a regulatory sandbox that is tailored to the specific technology.
Putting the framework to the test
The BRIDGE team will test its system via use cases drawn from fields which are already challenging the regulatory frameworks of today. These are expected to include advanced and biological therapies, technologies based on artificial intelligence (AI) and digital health, combination and hybrid technologies, emergency preparedness, and innovations in non-clinical testing during drug development.
The use case simulations will involve all key stakeholders, including developers, regulators, payers and patients, and will take the technologies selected through the entire process from pre-submission to sandbox exit. The use cases will help the project to improve its framework, which will be validated through consultation with expert panels including experts from regulatory and health technology assessment (HTA) authorities.
Getting novel technologies to patients faster
Ultimately, BRIDGE’s flexible, modular regulatory sandbox tool will provide Europe with innovative regulatory approaches that will allow novel technologies to be brought to patients faster.
‘For industry, early regulatory alignment is essential,’ said BRIDGE industry co-lead Geert Preuveneers of MSD. ‘BRIDGE will help reduce uncertainty and support faster, responsible development of breakthrough therapies and technologies.’
Furthermore, by paving the way for a more anticipatory, adaptive and agile regulatory ecosystem in healthcare, BRIDGE’s work will contribute to key EU policies including the Competitiveness Compass, the pharmaceutical legislation, the AI act, and more.
‘BRIDGE equips Europe with a comprehensive framework to develop and assess emerging health technologies safely and efficiently,’ said project coordinator Gökhan Ertaylan of VITO, the Flemish Institute for Technological Research. ‘Through collaborative effort, we can align regulatory processes with innovation and deliver promising solutions to patients faster.’