“You don’t sell anything to anybody unless you think they are going to come back for more.”
Sam Rogers / Kevin Spacey
The Monday Morning Quote #371
All of creation,
Like a book and a picture,
Is a mirror for us.
Of our life, of our state;
Of our death, of our fate
A faithful symbol.
From: The Name of the Rose by Umberto Eco
Omnis mundi creatura
Quasi liber et pictura
Nobis est speculum.
Nostrae vitae, nostrae mortis
Nostrae status, nostrae mortis
Fidele signaculum.
The Symbolic Nature of the Universe
BY JAMES MARCHAND
Sidney Toledano on numbers.
I have recently worked with a couple of clients who have been obsessing about and dominated by numbers – it turns out that a previous adviser had insisted that they use systems where everything is counted, measured and future performance is predicted. The problem is that many of the predictions were unrealistically optimistic and the subsequent counting and comparing has produced a sense of failure in the management team. Add in a feeling of overwhelm where the counting takes over from the doing and there is a feeling of inertia. I love numbers as much as, if not more than, the next man or woman but by no means are they the be-all and end-all of a business. So the Key Performance Indicators (KPIs) should be decided and monitored but they need to be realistic, easy to see and part of a system where changes can be made in response to stimulus.
I read the interview from which this is an excerpt whilst on a flight over the Irish Sea, and I was thinking that at the front of the ‘plane there were a couple of pilots with a bank of instruments in front of them which they were monitoring but not obsessing about. In the same way that when you drive a car you are subconsciously scanning speedometer, fuel gauge, temperature, sat-nav, rev-counter, rear mirrors and it’s only when one of these shows something for concern that you take action.
It’s the doing that is most important, not the counting – that’s just a tool.
Sidney Toledano has been the President & Chief Executive of Dior Couture since 1998. During his time in charge the group have opened another 200 stores and both turnover has risen from €134 million to €5 billion. In his interview in the FT recently I was struck by the former mathematician’s attitude to numbers and business.
“We already had the culture at Dior, but we had to be more agile and reactive. That is why I always say, ‘If business is not good, don’t stay in the office’. Some people try to find out what’s wrong through the numbers. But if you stay in the office nothing will change.”
“My Father taught me it’s better to have no explanation for success than to have a lot of explanations for a failure. Success is intuition, action, decision and take some risks. Frankly, numbers; I see them every day when I get the worldwide update. I can see every single figure for every single piece. But I don’t spend more than 10-15 minutes on it because I follow them every day.”
“It’s like a good doctor. They see the numbers very quickly – temperature, whatever – but they talk to the patient. I’ve never seen a doctor fixing a problem with a thermometer. And you never fix a problem with the numbers. Don’t look and you miss everything.”
Summer soft patch significant? – from RBS Chief Economist’s Weekly Brief
Here are a some of the stats that leapt out at me. The full report is here.
Italics are mine.
Weak signal. The soft patch for British business continues, according to the latest Purchasing Manager’s Index, with activity remaining subdued in each of the UK’s three main sectors in May. Manufacturing output, at 50.1, just about scraped above the 50-mark that separates expansion from contraction. But orders are weak and come mainly from domestic demand. Meanwhile output in construction is the weakest in three years, although true to form construction firms remain optimistic. Lastly, activity in the dominant service sector, at 53.5, remains below its long run average of 55.2.
Re-writing history. Once a year the Office for National Statistics makes new estimates for GDP growth over the past few decades. These revisions are normally small but sometimes they are meaningful. Take the first two years of this recovery. The original data showed that 2010 was a year of fairly slow growth (1.5%) before the recovery speeded up to a sprightlier 2% in 2011. But the revised statistics have now reversed that, with 2010 being the year of 2% growth before a slowdown in 2011. What hasn’t changed is the fact that this is one of the slowest recoveries the UK has ever experienced.
Comeback kids. Ireland and Spain were amongst the economies hit hardest by the Euro crisis, but their growth is now the envy of the rest. Business confidence, as measured by the PMI, is highest in Ireland (59.1) with Spain in second place on 54.8. But current concerns are concentrated on two big economies that aren’t doing very well. France and Italy are hovering close to the stagnation point of 50. That’s unfortunate for France, but at least the GDP of the Euro 2016 hosts is 3% above its pre-crisis peak. But it is disastrous for Italy whose economy is still 7% smaller than it was in 2008.
More of the same? Surveys suggest the US growth slowdown might be more than a passing phase. The Institute for Supply Management’s service sector index slipped from 55.7 in April to 52.9. That was the lowest level since February 2014. Especially notable was the fall from 59.9 to 54.2 in the new orders gauge. The manufacturing report was more encouraging. It rose by 0.5 points but a reading of 51.3 hardly signalled runaway growth.
The Monday Morning Quote #370
“If a man looks at the world when he is 50 the same way he looked at it when he was 20 and it hasn’t changed, then be has wasted 30 years of his life,”
Speaking in London 1974
The Monday Morning Quote #369
“And I won’t sit down
And I won’t shut up
And most of all I will not grow up”
Frank Turner excerpt from Photosynthesis
– thanks to Colin Campbell whose superb presentation “My Fitness to Practice (FtP) case and other more important matters” was one of the highlights of the BDA Conference in Manchester this weekend. Colin quoted Frank Turner’s lyrics during the conclusion of his presentation.
To read more about Colin’s case and presentation take a look here, here and here and subscribe to his blog.
Whilst you’re reading enjoy Frank’s song.
The Monday Morning Quote #368
May I have the courage today
To live the life that I would love,
To postpone my dream no longer
But do at last what I came here for
And waste my heart on fear no more.
from “A Morning Offering” by
Tony Cozier RIP
Never presume.
One of the wonderful things about radio is that you make your own mind up about the person whose voice you can hear and it’s rare that you get it right.
I first heard Tony Cozier’s voice commentating on cricket during the Headingly Test in August 1966, England were defeated by an innings and 55 runs despite a dogged partnership by Basil D’Olviera and Ken Higgs. I was at scout camp in the Vale of Glamorgan and I remember one of the older boys making a comment about the West Indian commentator that these days would be considered downright racist.
Tony Cozier was from Barbados and had the accent to prove it. It wasn’t until I went to Bristol to watch the WI v Pakistan match in the World Cup in 1999 and was able to see into the commentary box with binoculars whilst listening to Test Match Special with an earpiece that I realised that the man I presumed looked like Sobers, Hall or Lara was white.
He came to cricket comentary from journalism and it showed in his approach. His wonderful voice was part of the coverage of every West Indian tour, a knowledgable, informative and entertaining commentator who was able to see and acknowledge faults in his own team and deeply regretted their fall from the pinacle of world cricket. He also knew that was the way with sport.
Another part of the sound of summers has left us RIP Tony Cozier, a full obituary here.
The Monday Morning Quote #367
Three this morning:
“I attribute my success to this – I never gave, nor took excuses…”
“… very little can be done under the spirit of fear.”
“… the first requirement in a hospitals is that it should do the sick no harm.”
are you listening Jeremy?
…no I thought not.
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.
Conclusions
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.
The Incisal Edge 