Taking the pain out of regulatory engagement in healthcare
Getting a new healthcare product from idea to widespread use involves clearing a series of regulatory hurdles. So many, in fact, that the National Institute for Health and Care Excellence (NICE) recently set up a pathbreaking Office for Market Access, charged with helping new businesses navigate through these processes. Where NICE has led, other regulators should follow: improving and innovating in how they engage with healthcare innovators should be a major priority.
One challenge regulators face is simply how to deal with one another. Healthcare organisations of all sizes frequently find themselves caught between regulatory regimes, or being pushed in different directions.
Take the Early Access to Medicines Scheme, which since 2014 has offered an accelerated pathway to approval and patient access for medicines with significant potential for high impact. While the licensing at the front-end of the process by the Medicines and Healthcare products Regulatory Agency (MHRA) can run very smoothly, breaks in the handoffs to other agencies (e.g., NICE), for cost effectiveness review and onward to local commissioning decisions, can inject major delays into the uptake, slowing down patient access and impacting outcomes. (Although as the new Accelerated Access Pathway comes into operation, some of these frictions will likely be mitigated for qualifying innovations.)
In areas where technology is moving rapidly, such as telemedicine, even getting a consistent definition of what it is that regulators are trying to regulate, let alone a consistent regulatory stance, can be difficult.
There is even greater complexity when market participants need to comply with additional devolved regulators such as Welsh and Scottish (SMC) bodies, not only with regulations from UK-wide bodies.
While some might find a root-and-branch reform of the regulatory system desirable in the long term, there is a lot that regulators can do to improve coordination, communication, and shared priority-setting in the near term.
Regulators could develop more comprehensive and detailed joint strategies or statements of intent, covering how they engage each other and their approach to resolving overlaps and inconsistencies. They could increase the number of roundtables they host to listen and respond to organisations’ concerns, with particular focus on new and small businesses, many of which will lack the resources to afford legal counsel, other external advisers, or even the not-for-profit fees of a body like NICE’s Office of Market Access. And as inconsistencies in approach or novel regulatory issues are surfaced, naturally guidance documents should be updated, and new guidance published, following consultation with all stakeholders.
Beyond synchronising their efforts, innovation for regulators should also mean taking a flexible and open approach to new areas coming under regulatory scrutiny. In FinTech, the Financial Conduct Authority led the world in creating the first regulatory “sandbox”, which helps firms to build new products to comply with regulations and test them in a “live market environment”.
This kind of setting is particularly important for firms with products that do not easily fit into existing rules. The model has proven extremely successful in the financial sector, being adopted by many other financial regulators.
Though this model was partly inspired by the clinical trials model in the life sciences, only now are UK healthcare regulators catching up with the FCA in using this approach for healthcare organisations.
The CQC was just awarded £500,000 from BEIS’s Regulators’ Pioneer Fund to “test out new ways of engaging with innovative providers, such as regulatory sandboxing.” If the CQC is to take this model forward successfully, it should focus on the lessons learned from implementing this model in finance, the lessons from nascent efforts to adapt it by healthcare regulators abroad, and, of course, how to tailor it for the challenges posed by healthcare in the UK (from the sensitivity of the personal data through to how to engage the greater range of stakeholders involved).
This may mean focusing efforts initially on particularly pressing healthcare subsectors, like telemedicine. It will likely also require coordination with other regulators, to give firms a broad regulatory perspective and a single point of testing, as the FCA is now considering. The Department for Health and Social Care itself also recently proposed introducing a healthtech regulatory sandbox, incorporating the input of other healthcare regulators (alongside bodies with adjacent concerns, like the Information Commissioner’s Office). The Department’s recognition of the importance of creating new modes of engagement with, and collaboration between, healthcare regulators, is certainly welcome. However, when it comes to setting up a shared, multi-regulator testing environment of the kind they propose, two is not twice as good as one — indeed, having two threatens to undermine the purpose of having a unified sandbox in the first place. As such, it is critical at this stage of planning and development for the CQC, the Department, and other regulators, to ensure that high-minded commitments to collaboration are met with a corresponding alignment of efforts behind a single sandbox approach.
More generally, the regulator might want to take a proactive stance in helping applicants, particularly smaller firms, through the application process to maximise their chance of acceptance for a year’s cohort. Initiating a regular review process, giving participants the opportunity to give feedback, and focusing on helping participants that have successfully completed their testing to scale up from the sandbox could also really enhance the success of this approach in healthcare.
As well as providing these kinds of environments, there’s also scope for further support for firms that are particularly aligned with the regulators’ own responsibilities. Companies are beginning to find ways to automate and enhance compliance with health regulations — such as Protenus, which detects inappropriate activity in electronic medical records. Regulators in other sectors have played an important part in growing their own RegTech ecosystem, such as by facilitating events like RegTech hackathons. As healthcare regulators consider how to support such businesses, these are useful models to learn from.
Our regulators rightly say they want to promote innovation, and appear to want to burnish their own reputations for innovation as they consider selling their expertise abroad. If that is the case, a key task will be to constantly rethink the ways in which they engage with and support people and organisations working within our healthcare ecosystem. And in particular, this should encompass the thriving startup scene, with its promise to revolutionise the way care is delivered in this country.
