Regulating what comes next

The uncertainty inherent to innovation can be challenging from a regulatory perspective as healthcare moves towards solutions that combine medicines, devices and digital technology. How to regulate future discoveries that we cannot yet imagine?

Twenty five (25): this is the number of technological trends in healthcare that the EMA identified in partnership with the World Health Organization (WHO) and the European Commission’s Joint Research Centre’s (DG JRC) in an horizon scanning exercise published in Frontiers in Medicine journal1, December 2022.

When we think about the healthcare of the future we imagine patients having access to life-saving innovations such as functional 3D printed replacement organs and tissues, or gene sequencing technology applied to diagnostics to guide the choice of more personalised and targeted treatments. We imagine people living longer, healthier, and more active lives supported by scientific and technological advancements that will improve the whole patient journey, from diagnosis to treatment and monitoring. We imagine a more sustainable, efficient and advanced healthcare system that will be able to respond to the evolving needs of European citizens. The question is: how do we get there? 2

As inspiring and exciting as this might sound, the uncertainty that surrounds the development of innovation can be challenging from a regulatory perspective, particularly, as healthcare moves towards solutions that cut across the traditional boundaries that separate medicines, devices and digital technology. How can we regulate these products and the ones that are yet to emerge? How can the regulatory processes be fast and agile to adapt and push innovation forward without compromising the safety and efficacy of novel products?

Technology and science often advance at a speed that can create a gap with the mechanisms of regulation. Regulators can find it challenging to follow every breakthrough product and often don’t have a regulatory box in which to put truly novel innovations. While safety concerns are legitimate in every regulatory field, these are even more justified when it comes to healthcare. At Roche, we propose new regulatory solutions, such as the regulatory sandbox, that ease this process and help regulators and innovators work together toward the best – and safest – possible means of bridging this innovation-regulation gap.

The world of healthcare is not alone in facing this issue. If we look at the rapid development of digital technologies in recent years we see that similar issues have come up in different fields. In the financial technology sector (Fintech), disruptive innovation started to result not only in new methods for business but also consumer fraud and exploitation. Hence, the need to mitigate the risks with fast and fit-for-purpose regulatory responses. Inspired by the pharmaceutical sector, Fintech regulators shaped their new toolbox around a similar concept to that of clinical trials, allowing for them to monitor new technologies in a limited, safe, and controlled environment. And so appeared the regulatory sandbox.

Today, these tools are widely used in the financial services sector for designing new services e.g. testing digital wallets and digital ID technologies. Similarly, regulatory sandboxes have emerged as testbeds in transport e.g. for autonomous cars and drones, energy e.g. for smart meters, and telecommunications e.g. for 5G deployment. The European Union (EU)is not new to the sandbox concept either, with the European Commission introducing this approach as a part of its proposal to lay down harmonised rules for artificial intelligence.

In practice, a regulatory sandbox is a legal framework that provides structure to a prototype and allows, for a limited period of time, the testing of new approaches in a controlled environment under reduced or more flexible regulatory constraints. The sandboxes that exist to date have a few things in common. First of all, to participate in a sandbox, the innovative product needs to meet a set of eligibility criteria. For example, participants are often required to demonstrate that their idea constitutes a genuine innovation, whether this is a new and emerging technology or the innovative use of an existing one. The sandbox also exists for a limited timeframe at the end of which both regulators and innovators are able to draw their respective learnings. Finally, most regulatory sandboxes include safeguard mechanisms to align with overarching regulatory objectives, like consumer protection, safety and data governance.

Therefore, not only do regulatory sandboxes promote constructive collaboration between innovators and regulators but also have the potential to pilot individual innovative approaches for real life solutions before adjusting the regulatory frameworks for scaled up use. This will address any gaps in the short term and at the same time pave the way for mid- to longer term assessment solutions. This lowers the risk of inappropriately regulating novel solutions. The main idea behind this tool is to develop mechanisms that allow regulation to support responsible innovation, creating opportunities to test in the real world how the innovation might interact with and affect existing regulation within a controlled scope and timeframe.

A regulatory sandbox would complement existing regulatory tools and provide regulators with a piloting environment. Sandboxes can help address the rising challenges that come with the complex interplay between medicines and devices, e.g. across data usage, drugs, diagnostics and integrated solutions at the interface of different regulatory frameworks. Science is evolving faster than ever and around 20% of the approved products are now combination products, composed of a medicine and a medical device3. This figure is only going to increase in the future, as new technologies come into play and others, like artificial intelligence, keep advancing at an increasing pace.

Although regulatory sandboxes have the potential to introduce several benefits, being aware of their potential pitfalls can help regulators set them up in the most appropriate way.

Sandboxes ultimately aim to speed and simplify patient access to innovation. However, the set-up and implementation of this regulatory experiment can be quite time consuming. In the absence of clear objectives and expected outcomes, we face the risk of not drawing any useful conclusion from the exercise, while wasting resources that, in most cases, are already scarce.

With clear goals comes the definition of clear admissibility criteria. With the right participant line-up, complemented by thorough and comprehensive horizon scanning, regulators can already have a clear view on the approaches and solutions that are emerging and need to be tested.

Finally, in the form that we see today, regulatory sandboxes are small-scale programmes that target relatively few firms that receive personalised advice, assistance and monitoring. When scaling up these programmes we need to plan adequately and avoid placing additional pressure on the already burdened regulatory authorities.

At Roche, we believe that if we keep these principles in mind, regulatory sandboxes represent an important approach to address complexities in the European ecosystem for innovative products. As such, it is an important piece of the puzzle in the comprehensive reform of the European pharmaceutical regulatory framework.

With the revision of the European Pharmaceutical Legislation coming for the first time in 20 years we are presented with a clear opportunity to advance a modern regulatory framework. At Roche we welcome the introduction of a sandbox mechanism to test highly innovative products. This will help future-proof the EU regulatory system and its competitiveness in anticipating and accompanying the uptake of innovation. It can also help attract and retain highly innovative businesses that may otherwise consider regulatory hurdles as a barrier to investment in their complex product.

At the same time, we call on the EC to be more ambitious, and have the role of the EMA be a true orchestrator between highly complex, siloed and multi-governance-based EU regulatory frameworks, e.g. the medicinal products and IVDR/MDR regulatory frameworks.

Such a modern framework is needed to fit the purpose of regulating not only today’s novel discoveries, but also those of tomorrow. And to keep pace with what is around the corner. A framework that recognises the need for adaptability and flexibility to assess the astonishing and accelerating cycle of innovation, and support it.

At Roche, we work tirelessly to develop what patients need next and are committed to working with regulators and policymakers to ensure that our innovations reach and meet the unmet needs of the patient communities waiting for them.


  1. Health horizons:Frontiers in Medicine journal, December 2022.


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