Brexit and the waning days of the United Kingdom

[The Minsky Moment]

if he'd been advising WeWork

Also a big softbank client.  Mr. Son's judgment has been questionable as of late.

[Sheilbh]

The sheltered life of people on this island my goodness. 

I wonder how many know the meat they eat must first be slaughtered

Incidentally - one of the few things in British politics that I think might be genuinely exceptional (at least in a European context): lack of peasantry or agricultural labour as a significant bloc of voters in the democratic age.

[Zanza]

MEDICAL DEVICES AND THE LIMITS OF UK REGULATORY AUTONOMY
Insight
Sam Lowe , Derek Hill
05 August 2021
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Medical devices illustrate the limited scope for post-Brexit UK divergence from EU rules, and the trade-offs the UK must face.

In his negotiations with the EU, Boris Johnson prioritised the UK's ability to set its own rules and regulations (at least in respect of Great Britain). Yet more than five years after the UK voted to leave the EU, Johnson's government is still struggling to articulate its vision for what it wants the UK to do differently from the EU and, more importantly, why. Medical device regulation provides an instructive example of both the opportunities now open to the UK, but also the constraints it will find itself under.

Medical devices are technologies that help diagnose or treat patients, or prevent illness without the use of drugs. They include everything from MRI scanners, hip implants and scalpel blades to smartphone apps that treat depression. The EU is currently struggling to implement a wide-ranging change in how medical devices are regulated – from the 1993 Medical Device Directive (MDD) to the 2017 Medical Device Regulation (MDR). Phased introduction of the MDR was due to be completed by May 2020, but was extended until this year due to COVID-19 pressures. This new regulatory framework is designed to ensure more thorough testing of devices before they can be used on patients, and more rigorous monitoring of performance of devices once on the market. The MDR's implementation, however, has not gone smoothly.

Many of the medical devices already on the market in the EU and UK now require recertification.

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There is an argument for UK divergence from the EU's rules for these devices. Many of the devices already on the market in the EU and UK now require recertification. This recertification does not just mean repeating the same tests that were previously passed, such as for electrical safety and biocompatibility. For many devices, MDR compliance requires performing more thorough testing on patients (which can cost millions of pounds per device) than was required when the device was originally put on the market. At the same time there is a lack of clarity on how novel devices – like those containing artificial intelligence algorithms – should be tested.

Unlike for medicines, Europe does not have a central regulatory agency for medical devices. Instead the process of checking whether devices can be given the medical device CE mark falls to 'notified bodies'. These are public or private organisations that an EU member-state (and the UK) authorises to approve products before they are put on the market. The best known in the UK is the British Standards Institution (BSI). The notified bodies are struggling to equip themselves with the necessary skills and capacity to cope with the workload arising from the new MDR. Manufacturers are now incurring higher costs and longer timelines to have devices certified or recertified. This is not just because they need to repeat testing, but also because the notified bodies can now take over a year to review the associated technical documentation, when it used to take a few months.

The higher costs and longer timelines create two significant problems. Firstly, some medical devices will be taken off the European market because their manufacturers (often small and medium-sized companies) have decided recertification is not worth it. Secondly, many novel devices developed by European companies are being introduced in the US first rather than in Europe – because the United States Food and Drug Administration (FDA) provides greater clarity and better ways of getting feedback about necessary testing than European regulators. For example, if a manufacturer is developing a novel digital device to help diagnose or treat patients, they can request a meeting with the FDA before they start testing on patients to ensure that the tests they plan address regulatory concerns about the safety and effectiveness of the device. This dramatically reduces the chance that expensive and time-consuming testing will be performed but then found inadequate when the results are submitted for regulatory review. European medical device experts are increasingly talking about a crisis in medical devices that could prevent European patients from accessing medical technologies that are available across the Atlantic.

Many manufacturers have suggested they will not bother with the additional cost and complexity of putting their devices through the UKCA processes on top of the updated European process.

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The UK is in a particularly challenging position as a result of Brexit. Had the MDR been implemented as planned in 2020, the UK would have adopted the new European regulations before the end of the Brexit transition period. But because MDR implementation was delayed due to COVID-19, the UK has maintained the old MDD until a new domestic regulatory framework is put in place. As an interim position, the UK is allowing medical devices tagged with the EU's CE mark to be used until June 2023. After that, all medical devices sold in the UK will need to have been reviewed by UK approved bodies and given a UK Conformity Assessed marking (UKCA). There is not currently any mutual recognition of the necessary medical device testing (conformity assessments) between the EU and UK, so manufacturers selling on both markets will need to go through the testing process twice. Many manufacturers have suggested they will not bother with the additional cost and complexity of putting their devices through the UKCA processes on top of the updated European process: the UK market is simply not large enough for many non-British companies to make the effort worthwhile.

It is therefore possible that UK patients will suffer the fallout of two changes to the medical device regulatory framework in quick succession. This could lead to both a loss of access to some medical technologies that are currently available, and the slow introduction of innovative new technologies. But these challenges also create a window of opportunity for the UK to alter its approach to medical device regulation.

The UK has four potential options. It could:

1. Continue with a unique UK regulatory framework for medical devices, requiring the recertification of all medical devices by June 2023. This is the approach which sits most comfortably with the UK government's desire for regulatory autonomy. But there is a risk that the UK market will be considered too small for some manufacturers to justify the costs, especially if such recertification requires a different type of testing because regulations are different in the UK from elsewhere. Where they do bother, additional certification costs might also be passed on to UK purchasers.

2. Pursue option one, but attempt to supplement it with strengthened and new mutual recognition agreements with some other regulatory jurisdictions (Canada, Australia, New Zealand and Singapore are sometimes mentioned). This approach would be more global in nature and could potentially reduce the compliance burden for medical device companies. But it would place some constraints on the UK's regulatory autonomy, as it would probably require some harmonisation of approach. It would also probably be slow to implement, and require renegotiation when the UK or another country updates its own regulations: it is hard to imagine deep mutual recognition agreements with multiple jurisdictions in place in time for the current 2023 deadline.

3. Continue to allow EU CE marked medical devices to be marketed in the UK for a much longer period of time and de-prioritise the implementation of its own regime. The UK could try to negotiate access to the new European database on medical devices (EUDAMED) to assist in this, or require manufactures to use a similar UK database. This approach would offer greatest continuity for businesses, and ensure ongoing alignment between Great Britain and Northern Ireland (where Northern Ireland's special status under the Northern Ireland protocol means CE marking still applies). But it would also see the UK inherit the challenges arising from messy MDR implementation in the EU, without the means to influence EU attempts to address them.

4. Open up its market by unilaterally allowing medical devices that are in use in other trusted jurisdictions such as the US, EU, Canada and Australia to be sold in the UK, subject to a registration requirement. This approach is arguably most appealing from a patient's point of view. It would allow UK patients to access innovative medical devices that are already on the market in other countries – most importantly, those available in the USA. This might even be labelled an "Australian-style" medical device regulation, as it could be designed to copy the approach of the Australian medical regulator, the Therapeutic Goods Administration (TGA). The TGA allows a fast-track approval process for medical devices that have undergone overseas assessments or approvals, with obligations on manufacturers to monitor and take responsibility for any safety issues. But there is a downside: the UK should not expect reciprocity from these foreign regulators – especially the USA. This would give foreign manufacturers an advantage over UK ones: for example a US company would have easy access to the UK market but UK companies would not enjoy similar easy access to the US market. In addition, unilateral recognition of foreign certification would mean other countries determined the rules used to ensure medical devices are safe and effective, leaving the UK as a rule taker – and not just from the EU. 

Of course, the divide between the different options is not clear cut in practice. An amalgamation of aspects of the four approaches listed is possible – for example the unilateral recognition of the testing regimes of other countries does not preclude the negotiation of subsequent mutual recognition agreements. And the unilateral recognition of foreign certification does not prevent the UK from attempting to carve out a regulatory niche for itself. For example, leveraging the NHS, the UK could seek to provide an innovation-friendly framework for new medical devices, such as AI powered medical devices and drug-device combinations such as surgical implants that slowly release a drug. (Although companies producing these innovative products would still have one eye on eventual US and EU authorisations.) But the issues associated with a new UK approach to regulating medical devices illustrate the trade-offs the UK will need to navigate.

With its relatively small market size, the UK will struggle to break free entirely from the regulatory pull of larger economies – particularly when it comes to highly regulated products.

Opportunities to diverge from EU rules and approaches, and deliver better outcomes for companies, consumers and patients do exist. However, with its relatively small market size, the UK will struggle to break free entirely from the regulatory pull of larger economies – particularly when it comes to highly regulated products. In the case of medical devices, British patients are more likely to benefit if the UK systematically embraces its position as an Australian-style rule taker, and free-rides on the regulatory innovation and capacity of others. UK companies might also benefit from such an approach, as their device development could be focused on the requirements of large export markets (perhaps especially the US) in the knowledge that doing so would also ensure access to their home market. 

Sam Lowe is a senior research fellow at the Centre for European Reform and Derek Hill is a professor of medical imaging science at University College London.

https://www.cer.eu/insights/medical-devices-and-limits-uk-regulatory-autonomy

Interesting piece on the policy choices Britain faces after Brexit and the trade-offs. These choices will determine how Brexit is seen longer term. But it is not clear that the current British government is actually willing to make choices and trade-offs.

[Sheilbh]

Yeah - I think the argument over divergence is not going to be over existing regulations and rules. It will be things like this about implementing new systems, regimes, regulations.

My own preference is that the UK's regulatory approach should be based on the idea of making the UK the most attractive place it can be to innovate - largely through regulatory certainty. But also leveraging our current advantages. So if it was up to me I'd look at the things the UK does well (strong tech sector, finance, good research universities, culture and in the NHS some of the largest health datasets in the world) and then how can we shape regulation to favour innovation in those areas and get at least some of the benefit ourselves.

I'd focus relentlessly and fairly ruthlessly in terms of regulation but also funding, government time/support, planning and development decisions, R&D investment etc on those sectors - and I'd add energy just because I think it's essential for the world that every country is really focused on that. I don't think our goal should be regulatory autonomy or not, setting regulatory standards or not - but just fostering innovation, based on areas we currently have some competitive advantage/playing to our strengths. For the rest I'd probably minimise changes, align or unilaterally recognise other standards - whichever is easiest, but that requires a joined up strategy/approach.

I've mentioned before the challenges for European companies working on AI around the lack of clarity around what will and won't be the legal framework for AI. It is technology that is already being developed in America and China, but in Europe I'd be telling companies that there wasn't much legal certainty around future regulation. I think last time I advised on this there were three separate committees I was aware of working on building an "ethical framework" for AI - I admire the rigour but I think it's partly to avoid making choices and I think in practice it means that we'll be relying on American and Chinese developed solutions and getting them to follow our law. Just like we can trust Chinese and American big tech companies to be following GDPR scrupulously

I can't remember the context at all but I weirdly did have to help a client once on whether or not their software qualified as a medical device - it was, from memory, very complicated

For what it's worth legislation has now passed on this point that gives lots of powers to the Health Secretary to make regulations/secondary legislation. I think this would have been a focus for Hancock - he's a former digital minister and he did a lot of promo stuff and speaking at Health Tech conferences about using regulation to promote innovation. From someone who works in the NHS he was very, very keen on NHSX which he established which is a unit within the NHS responsible for developing policy and best practice on the use of tech, data etc in the NHS.

I'm not sure what Javid's priorities will be - my guess would be that it'll be very pro-business because he is a bone-dry Tory and aside from that I'm not sure what his priorities will be and I doubt we'll hear much about it until the pandemic is more "over". At the minute the focus of the Health Department is probably just on covid and probably will be for a while

Edit: And as I've mentioned before I think the choices will be easier for a Tory government to make because they all think and want Brexit to be permanent. There is no #FBRE faction on the right. The challenge will be on the left - not just on regulation but in other policy areas too. I think there is going to be an almighty fight at some point between people whose priority/ultimate policy goal is to rejoin the EU (the Lib Dems+ coalition) who will want to minimise divergence and those who are willing to accept Brexit as at least probably permanent who will be willing to diverge if they think there's benefits from it.

I think some of the rejoiner will consolidate in the Lib Dems, but I think this will probably be an issue for Labour and it's a question of when that is.

[Sheilbh]

A thought from Duncan Weldon - as he puts it a mega hot take, but sort of linked to my thought/fear that Labour's a zombie party being propped up by FPTP:

Duncan Weldon
@DuncanWeldon
Fancy a mega-hot take?
The problem facing 21st century European Social Democrats is the same problem that faced late 20th century Western European Liberals: they won.
Issues that were hugely contentious dividing lines are now simply cross-party consensus.
I mean, just look at the extent of state provision of services and benefits and redistribution in 2021 *after* the austerity of the 2010s or the market turn of the 1980s and compare it to the 1920/1930s. A different world.

Perhaps as Europe took a turn from liberal to social democrat once the great liberal achievements (secularisation, equal treatment for all citizens, rule of law etc) were kind of complete. Now all of Europe, even the UK, has reasonably strong employment rights and a welfare state. Perhaps having achieved the core objectives of the social democrats there's now a turn to the Greens as the next progressive/disruptive party (which will have a different electoral base) while the social democrats will linger, as the liberals have in their heartlands but at around 5-15% of the vote?

[crazy canuck]

I am not sure it can be claimed that liberal democracy won.  It is was certainly near the finish line, but has stumbled badly when it looked back to watch its rival communism collapse and be carried off the track.  And it is not certain the once strong favourite will actually finish the race.

[Sheilbh]

I am not sure it can be claimed that liberal democracy won.  It is was certainly near the finish line, but has stumbled badly when it looked back to watch its rival communism collapse and be carried off the track.  And it is not certain the once strong favourite will actually finish the race.

Yeah it's not a claim about liberal democracies as a system or globally but liberal parties within European politics. The European liberal parties project I think was primarily tied up with equality before law (Catholic emancipation, Jewish emancipation, the end of artistocratic/guild etc privileges), secularism or at least religious tolerance for groups outside a state church, suffrage, rule of law - and arguably in some case national identity (again a universal principle over the particular) etc.

It sort of has made those achievements and there aren't - as there were in Europe's past - conservative or reactionary forcesin politics that want to unwind any of that. To an extent their race was run - they had nothing left to fight for so fractured as mass politics brought primarily economic questions to front of European politics. Some joined (and moderated) the social democratic tradition; others turned to a strong pro-market/centre-right liberalism primarily allied with conservatives or christian democrats. But their role in mass politics was hugely diminished by the post-war period. The great liberal battles of the 19th century were baked into all of Europe's democracies.

[crazy canuck]

I am not so sure about your view that conservatives in Europe are not trying to role back what progress liberal democracy did make.

[Jacob]

I am not so sure about your view that conservatives in Europe are not trying to role back what progress liberal democracy did make.

No argument about Eastern Europe (Hungary and Poland). Do you see it happening in Western Europe?

[crazy canuck]

I am not so sure about your view that conservatives in Europe are not trying to role back what progress liberal democracy did make.

No argument about Eastern Europe (Hungary and Poland). Do you see it happening in Western Europe?

Sure the UK is already doing that.  France could do that if the elections go wrong.  Spain - well you just need to read that thread to get a sense of the risks.  Italy - the eternal clusterfuck.  Etc. 

The notion that liberal democracy somehow won and the gains are somehow immutable is a nonsense.  The institutions of liberal democracy don't just stand on their own and in fact are beginning to fail.

[Zanza]

I broadly agree with the idea that social democrats "won" in Western Europe and consider social democracy as one of the greatest achievements of our civilization. It lifted millions from poverty, which is the root cause for most human misery.

But I still hope that liberal parties make a comeback to protect our democratic institutions from reactionary/neo-fascist parties and our civil rights from ever-growing state surveillance (which often has wide consensus in the political mainstream) and that social-democrats make a comeback to fight the growing wealth divide in our societies.

But right now, liberals seem to tend libertarian only favoring the strong and social-democrats do not seem to focus on the economic well-being of the masses anymore, but focus on identity politics and the like.

The Greens are indeed in a similar position, maybe without ever reaching political supremacy. They already "won" in the sense that every party but the most reactionary parties now claims environmental protection and climate change as core topics of their policies.

[garbon]

https://www.theguardian.com/business/2021/aug/11/gower-lamb-is-first-british-food-to-get-protection-under-post-brexit-scheme

Gower lamb is first British food to get protection under post-Brexit scheme

Lamb grazed on samphire, sorrel and sea lavender on the Gower peninsular in Wales is the first UK food to receive protection under the post-Brexit regime.

The UK's independent geographical indication scheme, which marks out products from a particular region to prevent them being undermined by copycats from elsewhere, was set up to replace a previous EU-wide scheme.

Produced using knowledge and skills dating back to medieval times, Gower salt marsh lamb comes from lamb born, reared and slaughtered in south Wales. About 3,500 lambs a year are reared on the marshes.

Dan and Will Pritchard from Weobley Castle Farm, who produce Gower salt marsh lamb, said: "We are the third generation of Pritchards to farm in this amazing location, meaning that we've perfected our way of rearing lamb over the years. We currently produce around 1,000 lambs per year – taking care of the whole process to create meat with a unique local flavour of samphire and sea lavender.

"This recognition means that the reputation of our regional product is protected, and it helps us promote traditional agricultural practices and eliminate non-genuine products."

The UK protection regime – which includes speciality products such as traditional Bramley apple pie filling, as well as products linked to a particular region – already includes more than 5,000 products from across Europe originally given protection under the EU scheme, such as Melton Mowbray pies, Jersey Royal potatoes, and champagne.

However, Gower salt marsh lamb, and any future products listed under the new UK scheme, will only be protected from copycats in England, Wales and Scotland. Producers of the lamb, and any other products wanting to join the list in England, Wales and Scotland, will have to apply for separate protection in the EU, involving further costs and paperwork.

...

[garbon]

I am not sure it can be claimed that liberal democracy won.  It is was certainly near the finish line, but has stumbled badly when it looked back to watch its rival communism collapse and be carried off the track.  And it is not certain the once strong favourite will actually finish the race.

Yeah it's not a claim about liberal democracies as a system or globally but liberal parties within European politics. The European liberal parties project I think was primarily tied up with equality before law (Catholic emancipation, Jewish emancipation, the end of artistocratic/guild etc privileges), secularism or at least religious tolerance for groups outside a state church, suffrage, rule of law - and arguably in some case national identity (again a universal principle over the particular) etc.

It sort of has made those achievements and there aren't - as there were in Europe's past - conservative or reactionary forcesin politics that want to unwind any of that. To an extent their race was run - they had nothing left to fight for so fractured as mass politics brought primarily economic questions to front of European politics. Some joined (and moderated) the social democratic tradition; others turned to a strong pro-market/centre-right liberalism primarily allied with conservatives or christian democrats. But their role in mass politics was hugely diminished by the post-war period. The great liberal battles of the 19th century were baked into all of Europe's democracies.

Even if we focus just on Western Europe, does everyone actually have a lived experience of equality before the law? I suppose laws can no longer be explicitly discriminatory (for the most part) but I'd wager that justice isn't equally applied.

[Sheilbh]

Even if we focus just on Western Europe, does everyone actually have a lived experience of equality before the law? I suppose laws can no longer be explicitly discriminatory (for the most part) but I'd wager that justice isn't equally applied.

Of course not but I don't think that's ever really been a concern of liberalism or liberal movements. Perhaps especially in Europe where the other wing of the liberal project was often nationalism and nation building - and with it defining the nation so who, precisely, had equality before law. They might extend rights (in theory) to, say, Jews of that nation, but it might not work if you spoke another language or belonged to a different "nation". It was, I think, about a formal and legal conception of inequality/equality rather than a social or economic one, or one that looks at actual ability in practice to access those rights.

It was about formal equality before law - so sweeping away archaic, traditional or customary laws that apply to diferent groups or the availability of different courts in a sort of patchwork of jurisdictions. Instead you have a single code of law that applies to all and a single court system available to all, even if that means some groups have lost old protections and have no experience in dealing with the new court. From a left-wing perspective you would probably say that's exactly the point as liberalism is sort of the revolutionary force of the middle class and the people who were often people who could benefit from others losing the loss of special rights or protections, or the ability to plead at a special court.

The Greens are indeed in a similar position, maybe without ever reaching political supremacy. They already "won" in the sense that every party but the most reactionary parties now claims environmental protection and climate change as core topics of their policies.

But I don't think they have won except in rhetoric. The liberals achieved their goals in law and that was broadly accepted by both conservative forces and the left (I wonder if liberalism would have survived if the left had stuck to a revolutionary tradition?); similarly the social democrats have basically achieved their goals and have build the programs, social services and rights that are now broadly accepted by conservatives and liberals.

I don't think the Greens have yet actually got their goals embedded in law and policy. Although everyone accepts the issue and the rhetoric of the Green movement now.

Sure the UK is already doing that.  France could do that if the elections go wrong.  Spain - well you just need to read that thread to get a sense of the risks.  Italy - the eternal clusterfuck.  Etc.

I don't think the UK is doing that.

Also France if elections go wrong means Le Pen - and I wouldn't identify Le Pen or RN, or for that matter Salvini and Lega or the FdI in Italy, as parts of the mainstream conservative/christian democratic current. They have been more successful in those countries and have replaced the traditional party of the right (in France - only at Presidential elections; and in Italy the 20th century party system exploded - perhaps less a clusterfuck than a foreshadowing for the rest of Europe). But it's the same on the left - I think liberal victories have buy-in from social democrats, I wouldn't say they have the same from the communist or the radical left traditions who often have a different conception of equality before law or rule of law looks like. The difference is that those parties haven't ever really replaced the social democrats (with Italy as an exception because the PCI was the main party of the left) - though there were points in the post-war era when the communist current was the strongest on the left.

The notion that liberal democracy somehow won and the gains are somehow immutable is a nonsense.  The institutions of liberal democracy don't just stand on their own and in fact are beginning to fail.

But again you're conflating liberal democracy with liberalism as a political movement in Europe and they're not the same.

I'm not sure contemporary liberals are essential to liberal democracy and I think those sort of broader principles are diffused on the left and right - at least within mainstream conservative/christian democratic traditions.

[Josquius]

FPTP is the big problem. The UK just isn't a democracy by modern standards.
Really what needs to happen is the Greens join the grand coalition of Labour... but that ship has sailed, its much too late for that now. If only Labour had really firmly adapted green politics early on.