ABHI Membership

The Friday Blog: A Different Lens

Autumn, I fear, is upon us. It is getting to be increasingly dusky at a time I have come to regard as very much early evening, there is something distinctly chilly in the air, and the trees at the bottom of the garden are laden with berries as Mother Nature prepares for the winter ahead. But, most significantly for me, the season of Test Match cricket is over. Ended as it began. The last day a mirror of the first, a washout on, of all places, the supposedly sunny South Coast of England. It is a state of affairs, I can absolutely assure you, that will have raised a wry smile or two in Manchester, which, in comparison this year, has been dry, bright and blameless. Indeed, the best weather I experienced this Summer, an early hours’ storm of biblical proportions notwithstanding, was in the North West.

So then, time for one last hurrah as we head into the long weekend. I do hope you are able to make the most of it, and I do hope that some parts of our country that have had a resurgence in visitor activity, can get over themselves a bit, recognise what they have, realise it has a value and keep the lights on a bit longer. Cornwall, in my experience, is often party central on Bank Holiday Monday and all but closed on Tuesday. It is not alone. I suspect we will not be going far for the foreseeable future, so, for their sake and ours, those more out of the way visitor locations need to transition from a world where lunch is only available from 12 until 2 and dinner from 7 until 9. Some places get it. Blackpool, for example, probably because it did not really exist before the Manchester Evening News extolled the virtues of salt water bathing in 1750, and the railways arrived bringing visitors, will be as up for it next week as it was last. And actually, any other week for that matter. The town is also extending its famous illuminations until Christmas this year. It is not an uncontroversial move, and one that has been debated for as long as I can remember. We can only hope that there is something left of the displays by the time the storms sweeping in across Liverpool Bay have done their worst. I do, though, continue to be surprised by the number of people who have never visited the “Lumies.” You really must. They are not known as the greatest free show on earth without reason. Wrap up, because it will be breezy, it always is, but if it is dry, invest the two or three hours it will take to walk through. At the end of it, you will certainly have earnt your chippy tea. (That is a fish supper for those of you in the Home Counties.)

The Chief Executive of Blackpool Teaching Hospitals as it is now known, or The Vic, as I will always think of it, is Kevin McGee. Kevin and his Director of Finance, Tim Bennett, along with all their counterparts in the English NHS, got a letter on Thursday from Amanda Pritchard and Julian Kelly, COO and CFO respectively of NHSE/I. It was a follow up to the “Stage 3” letter we have detailed previously, and not particularly exciting. It outlined the financial arrangements to cover expected activity levels for the “window of opportunity” that exists before winter proper kicks in. What it did do was emphasise the focus on getting elective activity levels back up, something I am hoping you will begin to notice. Things can get in the way, inspections are one of them, and our friends at the NHS Confederation have written to Health Secretary Matt Hancock this week, asking him to call the regulators off. The letter said that there is currently “too much duplication” in regulation and performance management at NHS England regional level – which it said “is disproportionate, stifles innovation and provides false reassurance [that] hinders not aids effective and safe services”. Ouch. I do have to say that it has been a little eye opening being an NHS Non-Executive and witnessing the amount of processes that have to be in place to comply with the needs of regulators. For their part, the Care Quality Commission has said that it will make inspections “less burdensome” on providers as more visits are held from September, whilst also developing a new strategy to launch in May 2021, with a full public consultation in January.

Another reason to keep the snoopers out of hospital is that the Department for Health and Social Care has ruled  that CQC inspectors do not meet the criteria for weekly asymptomatic testing as they are not required to have “hands on” personal contact with people. The GMB Union reckons that this not only puts inspectors at risk, but potentially makes them super spreaders. It is something that has been played down by, amongst others, our members the Infection Prevention Society, but is gives me a faintly humorous segue to the next bit.

We are going to have to talk and think seriously and differently about the future of regulation. I know we have gone here before and not all of you appreciated the direction in which we took things. But I maintain that our position was misunderstood and, on occasion, wilfully or otherwise, misrepresented. Let me start with one incontrovertible truth. Developing a sovereign regulatory system for the UK is not a nice to have option, it is essential as we reach the end of the EU exit Transition Period. And here is another. Even if we were to mirror exactly another regulatory system, let us say the European one, even if we fully implement the new MDR next May and the IVDR subsequently, even if we update our regulations every time they do, they will still be different regulations. Ours will be ours, theirs will be theirs. But it seems to me we are having trouble thinking clearly and constructively about the future.

Maybe it is because we have underestimated just how seismic a change in our relationship with the rest of the world will happen at the end of the Transition Period. We have, perhaps, only ever considered regulation as a technical endeavour. Something that has to be done, and when it is done, and done at a European Union wide level, it is done. The implications of how we decide to do regulation on our relationship with the rest of the world has been very much in don’t know / don’t understand / not relevant, don’t care territory. But what I have learnt over the past year or so as I have spent more and more time thinking about international trade and the implications of new and continuity trade agreements for our sector, is that trade is about two things. Movement and regulation. How we move things, goods, services, data and people, and how we regulate the movement of those things. Trade is fundamental to our relationship with the rest of the world, and regulation is fundamental to trade. We can no longer think of regulation as simply a technical endeavour, it is the basis of our relationship with other nations. To use management speak, and you know how much I love to do that, we need to view regulation through a different lens.

There is another factor that is making it difficult for us to think clearly. In the development of trade agreements, there is a hierarchy of what might be achieved in terms of regulatory acceptance between signatories. At the very top of the hierarchy is the harmonisation of technical regulations, but achieving this is very rare in formal trade agreements, not least because it requires a surrender of sovereignty. The only real example of this in a trade agreement is, you guessed it, the European Union. If you satisfy the requirements of regulators in Italy, your product has to be accepted in France, Germany, Belgium and everywhere else. And the European Union is all we have ever known during our working lives. It seems to us that harmonisation of technical requirements should be easy, but we underestimate how complex and how rare it is in bilateral agreements. Mid-table in the hierarchy is accepting the outputs of overseas conformity assessment bodies, which is what the UK put on the table as part of the UK / EU trade negotiations, and what the EU has rejected. Below that remains only some form of regulatory cooperation, observation of principles and exchange of information. ABHI has continually advocated for alignment with EU regulatory arrangements, but formalising this through a free trade agreement will be far more difficult than we thought when we embarked on this journey. Please hold these thoughts in mind as we await details of Day One regulatory arrangements, which, as I write, are imminent. What I can assure you of, is that we are working hard to ensure that we get the most ambitious level of regulatory alignment possible in future trade agreements and that the burden imposed by new UK sovereign regulation is minimised as much as it can be. This is a conversation we are going to be having for a long time to come.

In the meantime, enjoy the long weekend, there is even, for the first time since 1999, live international cricket on BBC TV. OK, it is not the real thing, rather the bish, bash, boss stuff in coloured pyjamas, but I will take it.