Innovation in regulation – the start of a critical conversation
- Bone marrow and PBSC donations
- Human application
- Living organ donation approvals
- Organ donation and transplantation
- Post mortem
- Public display
- Transplant approvals
Earlier this year the Minister for Innovation laid out a challenge to health regulators, the Professional Standards Authority, NICE and NHSX during an unprecedented roundtable. If the post-Brexit ambition, as outlined in the government’s Life Sciences Vision, is to provide a world-class regulatory environment that benefits patients and the public while also promoting jobs, growth, and investment, how do we collectively map out the principles and practices needed to achieve these goals? There was a high degree of commitment amongst the participants to working closely and learning from the COVID-19 pandemic. But this was only kicking off a much more far-reaching conversation that we need to have.
We are at the start of an ongoing dialogue with all our stakeholders about how we can achieve the goal stated in the Life Sciences Vision “to deliver a progressive UK regulatory offer with the capacity to unleash innovation in regulatory processes.” This conversation is critical for the future of health care and life sciences in the UK. It’s also critical in another sense: challenging us to constructively question our regulatory model and tools, asking how our regulation can develop to improve outcomes for patients and the public.
The HTA, like many organisations, is looking to the future in a post-Covid world. Over the last couple of years, our vision has centred on achieving greater sustainability, agility, and resilience across our activities.
While this will continue in the coming year, we also need to sharpen our focus on regulatory innovation from an HTA perspective and consider how we can contribute to a system-wide approach that will promote the UK’s regulatory environment as an enabler for innovation in the life sciences.
The HTA has already started to introduce new regulatory tools and approaches, some of which were given impetus by COVID-19, such as the rolling out of Virtual Regulatory Assessments. Several of our stakeholders also have seen changes to licensing, aimed at making the process more effective and efficient.
Our next step is to better target regulatory interventions by exploiting advances in technology and data analytics. We are also in discussions about joining trusted partners to share data that offers greater insight into regulatory risk and reduces data collection burdens. Data and intelligence-driven insights will strengthen our ability to identify sector trends and issues and respond in a more proportionate and targeted way.
By collaborating with key partners, we aim to ensure that regulatory considerations are baked into innovation and do not become a barrier or an afterthought. Productive dialogue is essential to ensure effective regulation is hard-wired into innovation from the start. Therefore, the HTA is convening roundtables this autumn that address specific challenges and opportunities on the horizon.
We are delighted to be joined in the first roundtable of the series by colleagues from Anthony Nolan and NHS Blood and Transplant. The discussion will explore how the use of tissues and cells for patient treatment is likely to evolve in the coming three to five years and consider the questions this might pose for regulation that will support innovation in the sector.
This critical dialogue is not an endpoint but the stimulus for the longer-term conversation we need to have with as many stakeholders as possible to make sure that the right regulation is in place to build public trust in, and enable, future innovation.