2023/24 review: Maintaining public trust and confidence

We are an effective regulator that maintains public confidence through our licensing, inspection and authorisation processes and by being open and transparent. We believe that patients and families should be confident that their tissue will be used in line with their wishes and handled with care.

We continue to adopt a regulatory approach that seeks to deter or prevent criminal breaches of human tissue legislation. This includes referring cases to the police for investigation where we consider there to have been a potential breach. While police referrals are more commonplace in relation to living organ donation, referrals are made across our sectors when necessary. 

Last year, one of our referrals to the police resulted in a healthcare group being fined £100,000 after pleading guilty to the unlawful storage of human tissue. This marked a key milestone for us as it was the first criminal conviction originating from a direct referral and involved close working with the police. It was a stark reminder of the reason we were setup as a regulator¹ and that it is still pertinent today. Following the conviction, we proactively engaged with the independent healthcare sector and relevant organisations (such as professional regulators and bodies) to promote good practice among health professionals. We will continue to raise awareness of our legislation across sectors and work to amplify our message in 2024/25.

We have also taken steps to maintain trust and confidence by increasing our transparency as a regulator and ensuring that we act in accordance with our values. One way this has been achieved is by publishing more data about our operations, policies and procedures. 

We published two data instalments last year. This included datasets relating to licensing, inspection, shortfalls and enquiries data from April 2017 to March 2022, as well as 2022/23. Our commitment to release this data in an accessible format will continue and builds on other data we routinely publish, such as our quarterly publication of closed incidents.

Given 2023/24 was the last year of our corporate strategy, we took steps to proactively assess our impact as an independent regulator. Understanding our impact on the sectors we regulate and the wider health system was essential in understanding how effectively we deliver our core function. It also helped inform how we respond to and manage the challenges that we face. 

We appointed an external contractor to engage with our workforce, licensed establishments and other key stakeholders to determine our impact. The work showed that our oversight of the safe and ethical use of human tissue continues to be relevant in a modern world as our sectors keep pace with innovation and developments. The findings also identified how we make an impact, for example by using our expert voice, maintaining the trust of licensed establishments, and facilitating collaboration to deliver a common goal.

My relationship with the HTA as a DI is very different to the relationship [with another regulator]. Lots more collaborative approach with the HTA and more proactive interaction between the two.

Certainly what they have been doing through the sector-wide collaboration is reaching out to other organisations both to gain information and to influence practice in those settings.

These findings and opportunities for us to increase our impact have been used to inform our approach, such as the development of our 2024 to 2027 corporate strategy. They will continue to inform our work over the coming year.