Regulations, Regulators and Regulatory Principles.

I will begin with a minor confession: I enjoy watching The Repair Shop on BBC One. In case you haven’t seen it, people are invited to bring much loved items into the Shop, everyday objects that have fallen into disrepair, to have them repaired by a series of highly skilled craftspeople. We see old instruments, toys, pieces of furniture – all manner of things, but usually with something in common: they offer an emotional link between this (living) generation and the lives of now deceased family members. But whilst I’m sure that the reunion between the owner and the now pristine, rejuvenated object is a moment that attracts many (most?) viewers, my own interest is not so much in the 'human interest' angle, but rather in watching the craftspeople. The close-ups of their faces as they work away, oblivious to the passing of time – their concentration, focus, absorption in the task (despite the intrusion by cameras) of lovingly restoring these valued items – all these combine to reveal a certain satisfaction (and even quiet joy) in what they do. This is surely an ideal for all of us: to work in a way that is both satisfying and important to the lives of others.

I am a (relatively) new member of the HTA Board, having joined in Spring 2022. As a board member, I exist to do a number of things, but one role is to provide challenge to the Senior Management Team (the Executive). But as a new member, how can one challenge if one doesn’t understand? I saw it (see it) as important to get to know the people working at the HTA, to understand them, their roles and the processes in which these are embedded. (I digress: two-dimensional, greyscale teleconferencing is no substitute for the technicolour of 3D human contact if one wants to get to know people rather than just things – we must not forget this). As all Board members, I often work closely with the Living Organ Donation (LOD) team. This team works to deliver one of the most important of HTA functions: to ensure that LOD occurs with consent in place and without evidence of any duress, coercion or reward. I have come to recognise and appreciate the careful attention to detail that is a noticeable feature of the LOD team. The day-to-day job of team members is to identify areas of concern. They are obviously guided by the Human Tissue Act when doing so, since compliance with the law is paramount, but it seems to me that they also use the experience and skills characteristic of their craft. The instinct that something is not quite right, the intuitive appreciation that further scrutiny (and perhaps escalation) is required: these are skills that come with practice and, as with The Repair Shop, an absorption in a familiar and everyday craft – here, of being a regulator.

We live in interesting times. All public bodies are having to deal with multiple challenges presented by our 'post-<insert preferred word>' society. And one additional challenge is how to engage with a profusion of guidelines and principles concerning how regulation should operate. I know this, since I was a contributor to one such recent report¹ , which focussed on promoting regulatory frameworks that do not unnecessarily impede technological innovation, since it is such innovation that can be so important for driving humanity’s future success and flourishing. (Clearly, a balance must be met between regulation being innovation-friendly and safety-oriented – but that is a discussion for another time). That report emphasised that principles for 'good regulation' can only go so far: it is regulation in practice where, so to speak, the rubber hits the road. So, I return to my theme: that coming to understand people and how they work when regulating, their ordinary habits, customs and practices, is so important in understanding where reform of regulation might be useful and where it may be a distraction.

Earlier, I mentioned working with sensitivity to instinct. The LOD team seeks to ensure that consent is in place and its focus on this is an important component in building public trust in the HTA. That’s not surprising, since the HTA was born out of an ethical controversy, having been established in 2005 in response to a national scandal concerning the retention of tissue and organs taken without the knowledge or consent of families. So, understanding ethical concerns that arise in respect of LOD, not least in respect of consent, is an important aspect of the team’s work. Proper training, helping to develop a sensitivity to what a particular set of circumstances requires in terms of a response, and proportionality in that response, are characteristics of the expert craftsperson. Of course, in an age of openness, it is also important to be able to account for decisions and, here, principles of good regulation can act as checks and balances, so that a regulator can calibrate its responses and processes against them. Getting the balance right, by drawing upon knowledge and evidence whilst being pragmatic and flexible are key aspects of an effective regulator.

Regulatory principles do not exist (and should not aim) to micro-manage the regulators in their everyday decisions and judgments - as if regulation was merely the operation of an algorithm in human form. At the heart of the regulatory process will be skilled and experienced craftspeople, and future regulatory reform requires us not just to review statutes and guidelines, but also to consider how best to harness their skills to help deliver regulated sectors that best serve the public whilst (or by) encouraging innovation. In that regard, I welcome the HTA’s ongoing work to refine its approach to regulation, seeking to be evermore proportionate and risk-based, by focusing on those areas that require the most attention to ensure public safety and confidence.

1. Closing the gap: getting from principles to practice for innovation-friendly regulation. A report from the Regulatory Horizons Council, June 2022