The Monday Morning Quote #417

“Every nation gets the politicians it deserves.”

Joseph de Maistre

Playing the “What If” game.

I delivered my presentation, “Is Dentistry Making You Sick?” in Gloucestershire a couple of days ago and introduced a game that I suggest participants play with their teams and partners. It’s called “What If” and the rules are simple in the extreme, you come up with the most unlikely thing that you can imagine and make plans on how you will deal with it on a personal and business level. Then move on to the second most unlikely and so on – I think you get the drift.

Visualise scenarios, research, plan and rehearse.

The example I used was of the owner of a 95% NHS dental practice who had been planning for the new NHS contract to replace the shameful 2006 edition, it has been promised over and over by successive governments. The contract will emphasise prevention and have a level of capitation payments. It will have been trialled and tested and approved by the BDA.

The What If game when played on Monday at 9am would have had them wake up one day and discover that the government had called a general election in order to concentrate on Brexit. The side effects of the likely victory would be to railroad their austerity programme through until 2022 and also enable them to kick any positive change in the dental contract into the the longest of long grass until who knows when.

Now what would you do if that happened – apart from ringing Lily Head?

What If – what’s next?

NHS urged to share data so patients can be deported

If an NHS doctor divulged personal information about a patient, they could be struck off. But the government pays the NHS to do just this. A patient’s name, date of birth and address are among the data which are passed on to the Home Office. If you are in the UK illegally, they can find you and force you onto a secret chartered plane before your lawyer has even had breakfast.

Buried in the recent constitutional uproar over the triggering of Article 50 and President Donald Trump’s flurry of objectionable executive orders, was the news that the NHS has been passing on data to the Home Office so it can track down people who are living in the country illegally and deport them.

From The Conversation Continues here

I am reminded of Martin Niemöller’s words which start, “First they came for…”


“This year 6 US citizens won Nobel prizes. And every one of them was an immigrant….

2016-nobel-laureates“This year 6 US citizens won Nobel prizes. And every one of them was an immigrant. Every one of them.”

via Memex

And some of them have started pointing this out – while politicians on both side of the Atlantic trade in anti-immigrant rhetoric.

Continues here.

My mother was an immigrant, the vast majority of boys in my school had parents or grandparents who were immigrants or names that reflected origins outside the UK as it stood then.

I read Robert Winder’s book, Bloody Foreigners, when it was first released and I have re-read much of it over the past 6 months, here’s what the Sunday Times said about it:

The story of the way Britain has been settled and influenced by foreign people and ideas is as old as the land itself. In this original, important and inspiring book, Robert Winder tells of the remarkable migrations that have founded and defined a nation.

‘Our aristocracy was created by a Frenchman, William the Conqueror, who also created our medieval architecture, our greatest artistic glory. Our royal family is German, our language a bizarre confection of Latin, Saxon and, latterly, Indian and American. Our shops and banks were created by Jews. We did not stand alone against Hitler; the empire stood beside us. And our food is, of course, anything but British . . . Winder has a thousand stories to tell and he tells them well’ Sunday Times.


The Monday Morning Quote #394

You can fool all the people some of the time,

and some of the people all the time,

but you cannot fool all the people all the time.


Worth a read. Brexit – its impact on regulatory aspects of health and life sciences.

From Eversheds LLP via Lexology

Much UK regulatory law originates from the EU. Most of it comes from EU Directives which the UK has implemented into our national law. Examples are Directive 2001/83/EC on the Community code relating to medicinal products for human use (as amended) and Directive 89/105/EEC, regulating the pricing of medicinal products for human use and their inclusion in national health insurance schemes. Some of it is derived from EU Regulations which are directly applicable in the UK, without the need for any implementing legislation here. An example is Regulation 726/2004 on the authorisation and supervision of medicinal products and establishing the European Medicines Agency.

This briefing considers some potential impacts of a vote to leave the EU (“Brexit”) on regulatory aspects of healthcare and life sciences.

What would happen immediately after a Brexit?

It is likely to be business as usual immediately after a vote to leave the EU.

The general consensus is that two years is the likely minimum period before the UK would actually leave the EU. The complex issues involved suggest that a longer period may be necessary. There is a mechanism in the EU treaty for a Member State to withdraw from the EU (Article 50 of the Treaty on European Union). Under this, the UK would give notice to leave followed by a period of negotiation to agree terms of withdrawal. Exit would take place at the earliest on signing the withdrawal agreement or two years after notice is given. David Cameron has stated that he would give notice to the EU the day after a vote to leave, though there is debate as to whether notice is served automatically in those circumstances.

Uncertainty therefore is likely to prevail for some years, with the status quo broadly expected to continue in the meantime.

What type of relationship might the UK have with the EU if it leaves?

Different model examples for a future UK/EU relationship are being touted.

One example is the Norway arrangement, in which the UK could leave the EU but have a relationship with it through remaining part of the European Economic Area (EEA). In those circumstances, the UK would remain bound to implement and apply much of EU law, including regulations such as REACH, but would have lost its ability to influence it. Reports suggest Norway adopts as much as three quarters of all EU legislation.

In other circumstances, the UK would not be bound by EU law unless it agreed otherwise, maybe as part of a deal to secure continued access to the European Single Market. Other models include the Swiss model with the UK re-joining the European Free Trade Association (EFTA) and entering into a bilateral trade agreement with the EU. A further model is the WTO (World Trade Organisation) alternative, in which the UK would leave the EU and (like China and the US) rely on its membership of the WTO as a basis for trade with the EU.

The bottom line is that no-one knows, and it seems likely that a bespoke arrangement would be negotiated to provide for the terms of the UK’s continuing relationship with the EU upon leaving.

How would UK regulatory law be affected by exit from the EU?

A comprehensive review of all law, including relating to healthcare and life sciences, will be needed to identify what is derived from the EU, and what should be repealed in whole or in part or changed. The UK’s scope for this will depend on the nature of the post-Brexit UK/EU relationship. This is likely to be a significant task.

EU Directives

Exit from the EU would not automatically undo UK laws which have been put in place to implement EU Directives. Those laws would remain in place until the UK decides otherwise, but without any opportunity to influence any changes at EU level going forward.

Careful consideration will be needed as to what the UK’s position should be in relation to the requirements under these Directives.

EU Regulations

Because Regulations work directly at EU level, not UK national level, there would be a regulatory gap following exit. This might look like an appealing opportunity to be rid of some burdensome regulation. However, UK companies exporting to the EU and their EU customers would still have to ensure that their products comply with existing EU regimes.

Any gaps in UK legislation due to EU requirements no longer being applicable are likely to be “plugged” as soon as possible.

What about rulings of the CJEU (Court of Justice of the European Union)?

Pre exit CJEU case law will remain part of UK law post exit, unless Parliament legislates otherwise. Post exit CJEU decisions will remain persuasive where decided on equivalent law. Any material difference between the interpretation of EU based laws by UK courts from interpretations of similar laws in EU jurisdictions could present challenges. This will be particularly relevant to businesses operating on a pan-European basis.

Some potential impacts of a Brexit on healthcare and life sciences

If the UK leaves the EU, businesses operating across the EU will not be able to include the UK in any centralised procedure for obtaining EU-wide marketing authorisation from the European Medicines Agency. A separate national authorisation for the UK would be needed. Any UK business supplying medicines into the EU will still need to be mindful of the EU regulatory framework to ensure compliant supplies into the EU.
Any marketing authorisation already obtained through the centralised procedure from the European Medicines Agency will need to be reviewed and separate national authorisation obtained. However, a sensible transitional arrangement to minimise disruption and safeguard patient safety is likely to be put in place by UK regulators, working with industry.
A different regulatory approach in the UK from the EU could present challenges, for example for companies wishing to carry out clinical trials in both the UK and EU. A Brexit would come at a time when the EU is looking to simplify the application process for the conduct of trials in the EU and ensure greater harmonisation, through the imminent introduction of the EU Clinical Trials Regulation (536/2014). Separate procedures for the UK would be likely to increase the administrative burden.
Maintaining quality assurance of medicinal products in line with EU principles of good manufacturing practice would in any event be a pre-condition for sales into the EU market. From a practical perspective, any reduction in standards could seriously affect the competitiveness of UK products, given the global drive to higher standards.
There are concerns that the UK will have access to less data than previously. Currently the EU pharmacovigilence system is coordinated by the European Medical Agency, which ensures effective analysis, risk evaluation and information sharing.
For UK manufacturers of medical devices, Brexit will mean that there will be additional hurdles to overcome in relation to the conformity assessment and CE Marking process. As a non-Member State, UK businesses will need to appoint a European authorised representative to enable the devices to be sold in Europe. Industry has raised concerns about whether representatives have the immediate resources to service all UK companies. The appointment of a representative will also trigger labelling changes. Both management time and capital expenditure will be required to deal with the administrative changes that will follow.

One impact of a Brexit would be significant legal uncertainty, resulting from lack of precedent and the complexity of the UK and EU’s intertwined legal regimes. A Brexit would not result in change overnight. The negotiation of the UK’s relationship outside the EU would commence and could last for years. In the meantime, the UK may come under pressure to abide by EU regulation in return for ongoing access to the European Single Market.

We are committed to giving clear, straightforward and objective advice on what the EU referendum and, in the event the UK votes to leave, any exit may mean for your business. The issues are not the same for every business and we will ensure that our advice is tailored to your needs.

Elections – little changes from Heath to Trump via the Dáil Éireann

The US election campaign and subsequent coronation will grind on for another 10 months and appears from here to be more show biz than content. This time round Donald Trump has given us something to wonder about, marvel at or just shake our heads over.

In Ireland the general election was called last week, the election posters appeared overnight on telegraph poles, lamp posts and street signs the length and breadth of the land all bearing a candidate’s mug shot like nothing more than a nationwide hunt for a gang of serial killers.

Thank goodness for The Peoples’ Republic of Cork and their take on election promises and cliches.

If he is elected to Dáil Éireann he will deliver for the people of Cork and will deliver it on time. He can prove this because he once worked as a pizza delivery driver and when most customers’ got their food it was at the very least luke warm.

On one condition: he will speak up for Cork when speaking to the local media only. When it comes to a minister in his party announcing a another €20 billion upgrade to the M50 motorway around The Pale he will be only too glad to stand in the background of the press shots and nod approvingly. Any spare change for Cork there, lads? Thought not.

The opinion poll that says he has as much chance of being elected as the Father Mathew statue is completely wrong because he says the reaction he is getting on the doorsteps is completely different and he is very confident of topping the poll. Sorry, they’re all lying to you, bud.

Even though he will be almost completely powerless and his party not in government he wants to make it clear that he will gladly fight anybody if it means even one extra job for Cork. And by fight, he wants it known that he will joyfully take off his top in the middle of Daunt Square at 2.30am and go at it with some langball from the IDA – even if that means spilling his curry chips all over the ground. That’s how committed he is. He’s amazing really, isn’t he?

At this point in his career he has yet to be given a brown envelope or have a big extension put on to his house in exchange for political favours so it is important to note the use of present tense here. His declaration that he is a man of integrity is by no means a guarantee of his future standards. A politician’s honesty is like a tax clearance certificate – it is only a statement about the present.

That’s quite impressive because we’ve never met, you’ve never met us and we’ve never heard of you. But look, we appreciate the offer and there’s a load of soggy leaves blocking a drain around the side of the house – as you say you work for us, would you mind tending to it please?

This is always a good opportunity for government election candidates to drop in some off-the-shelf mind numbing clichés like “we intend to work with the stakeholders” and “set ambitious targets with our strategic partners”. It’s important to create a bland and boring statement so people don’t realise that
you have as much influence in adding new routes out of Cork as Rory the seal who lives under the Shandon Bridge. And to be fair Rory is pulling his fair share of tourists.

For opposition candidates on Leeside it is very unhelpful that Cork is one of the safest counties to live in and that violent crime is very low. But statistics can be sidestepped by shouting that robberies, murders and assaults are all “getting out of hand” and sentencing “needs to be seriously looked at”. He’ll build loads more prisons, double the number of Gardaí, give them machine guns, put CCTV on every street and put electronic tags on everyone called Majella and Darren.

He says all the right things but the wobbly flesh dangling from the bottom of his chin that flops around when he moves his head and the big belly wobbling out through his blazer speaks a lot louder than the phrases his party whip handed him to learn off before the interview.

He will never ever suggest that the people who have mounds of litter blowing up against their front doors and all around their estates should perhaps, put down the remote control and the chicken suppers and waddle outside to clean it up themselves. He’ll sheepishly agree with them it’s a disgrace that the council only clean it three times a week and should be “doing more”.

The condition of your grandmother on the trolley in CUH is stable. Your dole payment is stable. The walls of the hotel room you and your family live in are stable. Why would you want things to change?

Oh dear God, spare us.

What they really mean…