The Friday Blog: How Far Do You Need to Be Able to See?
I am going to start this week with a sporting anecdote. For those of you who do not follow cricket, and I suppose that there must be one or two of you out there, probably reading this in the United States, some brief context may be helpful. Cricket, ordinarily, is a game that needs to be played in the daytime. The ball is small, dark in colour and travels at high velocity. The players, therefore, need a reasonable amount of brightness to have a sporting chance of being able to see the thing. Even for those who only ever hear of cricket occasionally on the evening news, the phrase “bad light stopped play,” will not be entirely unfamiliar. It can, of course, be enormously frustrating for players and followers alike, but it can also add a significant element of drama to the already wonderful theatre that is our national game. A case in point is a classic, light affected encounter that took place in 1971, yet is still talked about regularly today.
It featured my native county, Lancashire, playing against Gloucestershire in the semi-final of the Gillette Cup competition. Proceedings had gone on a lot longer than anticipated, so much so that by the time the game was entering its closing stages, it had not so much gone a bit dark, as become night-time. The lights of Manchester shone bright and gay in the distance and the pavilion clock rolled inexorably towards nine. Batting, in near impossible conditions, was the Lancashire captain and absolute legend, Jackie Bond. Eventually, exasperated, Bond approached the umpire.
“Come on Ump,” he said, “we are going to have to go off here. I can’t see the boundary, I can’t see the fielders, I can’t even see the length of the pitch.”
The umpire was the veteran, Arthur Jepson, equally as colourful a character as Bond himself. Jepson looked at the Lancashire skipper, looked at the sky and pointed. “What’s that up there, Jack?” he asked.
“It’s the moon umpire,” replied Bond.
“Well how far do you need to be able to see? Play on.”
And so they did, and happily for me and a crowd so large it spilled, unruly onto the outfield, youths actually sitting amongst the players, Lancashire prevailed, as they did six weeks later in the final at Lords, another nail biter, this time against Kent.
It made me happy thinking about that game, and, in particular, the Lancashire players involved. Their names, unknown to most of you, are forever famous to me, having been indelibly imprinted onto my boyhood brain. Saying them aloud again now, evaporates the intervening 50 summers and brings back countless memories. I can tell you stories about all of them. At the other end from Bond at the moment of victory was a future captain and coach, David Hughes, and opening the batting was another David who would follow the same route. “Bumble” Lloyd is now a popular TV commentator. There was Peter Lever, delivering Exocets from the Warwick Road End, “Flat” Jack Simmons, particularly partial to a pie and a pint, and the pugnacious Harry Pilling. Despite standing not much more than five feet tall, Pilling’s great passion in life, alongside playing cricket, was brawling in Public Houses. And he was good at that too. And there were our overseas players. The West Indian icon, Clive Lloyd and the brilliant Indian wicketkeeper, Farokh Engineer, now well into his 80s, but still a regular and revered visitor to his adopted county.
The point, however, being, is that conditions on that feted Manchester evening were far from ideal, but they were good enough to get a result. I think that is where we find ourselves with regard to key elements of Brexit and what will happen on 1st January.
You will, I hope, have noticed that on Tuesday, the MHRA published what is being called its “standstill guidance,” outlining the arrangements for the regulation of medical devices after 1st January. In his communication to you, Peter described it as practical and pragmatic, which I think is right. Once these things have been announced, there is a tendency to forget what the alternatives might have been. In this case we were told a couple of years ago by our then Minister, Lord O’Shaughnessy, that the UK would continue to accept the CE Mark for a time limited period, something that felt like the only sensible approach. But that commitment was withdrawn by Michael Gove in February, not that I would not criticise him for doing so. The UK had published its legal text for the negotiations and in it, as part of an Annex covering all New Approach regulated goods, called for the mutual recognition of the outputs of third-party conformity assessment bodies. It was a request that was rejected by the EU. Continuing to guarantee unilateral recognition of the CE Mark would have taken that negotiating position off the table. That it is now been confirmed should be considered as a major victory for those of us that lobbied hard for alignment with the EU in the short to medium term. Furthermore, medical devices have two and a half years of continuity, more than any other sector. Now, it may seem that it was the obvious thing to do, but others close to this, have told me that walking away from anything with Europe written on it, was an option in play very late in the day. We might now be looking at emergency measures from Day One, something that does not bear thinking about.
I told you last time that we would need to start talking and thinking seriously about the future of regulation, well here we are. And first things first, and you will get bored of hearing this long before I get bored of telling you it, but simply unilaterally accepting the CE Mark, or indeed any other form of approval, is not going to be a long-term option for the UK. Unilateral acceptance, as I said last time, requires the surrender of sovereignty. It is something that has been achieved within the EU, but not so completely in any other international trade agreement. I cannot tell you why we voted to leave the EU, there are probably 17 and a half million reasons, but when someone does the word cloud as part of a thesis on why we got where we got to, “sovereignty,” I am guessing, will be one of the ones you will be able to see, to continue my cricketing theme, off the bat. Add to this that some senior people in our government have convinced themselves that the reason they won a big majority at the last election, was the promise to “get Brexit done,” and you can see the political issues with unilaterally accepting someone else’s rules.
But let us just suppose we can get over the S thing. A few years ago, we wrote a Green Paper that set out some options for the future of regulation, and, for completeness, we explored them all. We were told that it was a paper that would make people’s heads explode, but, for completeness, we explored all the options anyway. One was to get out of the business of actually doing regulation itself. Others do it well, Europe, the US, Japan, so why not just accept their regulations and employ a simple registration system? It is something other countries do, albeit typically ones with emerging economies and little in the way of an indigenous HealthTech industry. It is not an approach entirely without merit, not least as it is inexpensive. But is it really an approach for a country such as ours, where the political arguments and rhetoric surrounding Brexit have been about the UK taking its place on the world stage as a newly independent coastal state? I think not.
Regulation is a central, indispensable assurance, something in which everybody needs to have confidence. There are examples the world over of industries being decimated when consumers have lost faith in the regulatory systems that were supposed to protect them. In the UK, and thanks, in no small part to its relationship with the NHS, our industry has played a major role in setting global standards for quality, not only in design and manufacture, but also in outcomes. The UK, therefore, needs to be an accomplished regulator. Furthermore, it is highly desirable that we are able to influence the development of the global regulatory framework. The UK Industry and Regulators have played a significant role in the development of European legislation over the last 30 years, and can again take the lead in developing a sovereign regulatory system which will be compatible with other jurisdictions. And, like it or not, beyond 2020, the UK will need its own, sovereign regulation for HealthTech. It is not an option. We need to work now to ensure that our new system fulfils certain criteria. First and foremost, to avoid any terminal loss in confidence, it needs to provide the continuing assurance of patient safety. It should also be recognisable by Competent Authorities internationally, which might include recognition of research and mechanisms that ensure compliance. A new UK Conformity Assessment process should further promote this, and be compatible with initiatives such as the Medical Device Single Audit Program (MDSAP). MDSAP allows recognised organisations to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of all the regulatory authorities participating (Australia, Brazil, Canada, Japan and the United States). It is potentially an enormous prize. Audits are time consuming and expensive, and the vast majority of what is required by individual jurisdictions is the same.
Our Regulator should also contribute to global regulatory development by becoming a member of the International Medical Device Regulators Forum (IMDRF) in its own right. IMDRF is a global forum that exists to accelerate harmonisation in medical device regulation and includes all major markets (Australia, Brazil, Canada, China, European Union, Japan, Russia, Singapore, South Korea and the United States). The UK should draw on the principles developed by IMDRF when creating regulations for HealthTech, which will further support global harmonisation.
One thing we will strive tirelessly to ensure, is that any sovereign UK regulation should not contain unnecessary, costly or burdensome additional requirements from those of other, established global Regulators. Data compatibility between Regulators will ensure patient access to technologies internationally, as well as maintaining the attractiveness of the UK as a market for HealthTech. The Regulator should work closely with our industry and other stakeholders, to provide transparent, collaborative and innovative approaches to regulation. Lessons can be learned from the swift and pragmatic approach of the MHRA to make products available during the COVID-19 pandemic, and risk-based methodologies that incorporate ethical business practise into the regulatory process. The latter will be particularly relevant to rapidly iterating digital health technologies. Establishing the UK Regulator as innovation friendly, and linking the regulatory process to the adoption and spread of technologies, could make our country a first choice market for new clinical developments.
We would also like to see the Regulator lead on the development of an educational programme in Regulatory Science, fulfilling the substantial requirements of both industry and Regulators themselves, for a consistent supply of appropriately qualified professionals. And, of course, the Regulator needs to be adequately resourced to fulfil its expanded functions, funding coming from central government to maintain independence from the sector it regulates.
Many of these thoughts are captured in our newly published paper on the requirements of a sovereign UK regulatory system, whilst other issues will be explored in our Access and Patient Safety conference later this month.
Elsewhere, you will have also noticed a ramping up in the advice to ensure trader readiness by the end of the Transition Period. Conditions are far from ideal, and we can have no absolute certainty on what the future looks like, but we can see how the immediate term is shaping up and have no choice but to be ready for the end of the year. In terms of what has to be done now, how far do you need to be able to see?
Richard Phillips, Director, Policy and Communications