#EAPM – Backstop…and back to square one?

| August 9, 2019

Greetings, colleagues, and welcome to the first update of August, writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan.

If you’re already on holiday, here’s hoping it’s proving to be an enjoyable one. And we promise not to keep you for too long.

The UK is due to leave the EU on the 31 October, as you will doubtless remember, and as we make our way through the summer months, that date looms ever larger.

Halloween is really not too far away – and the pumpkins and toffee apples are already popping up on the horizon.

Britain’s new prime minister Boris Johnson has not so much as popped up on the horizon, though, as stuck his head above a parapet. Tin hats anyone? We might all need one as the prospect of a no-deal departure is becoming ever-more likely.

Boris and co are demanding the removal of the Irish backstop as a precursor to any further talks. But this surely won’t happen, will it

Jonathan Powell was the UK’s chief negotiator on Northern Ireland from 1997-2007 and, in a recent article for the Financial Times, he made the following key point regarding Prime Minister Johnson: “There is no chance of the EU dropping the backstop as a precondition for meeting him, even if they were prepared to discuss it face to face.

“And, as long as the British government does not put forward a convincing alternative to deal with the threat posed to the Good Friday Agreement by Britain leaving the single market and the customs union and thereby recreating a hard border, the EU cannot back down.”

All seems quiet in Brussels. maybe too quiet. But there is currently no real sense of panic. Indeed, many feel that Boris will be thwarted in his do-or-die no-deal threat, possibly by a no-confidence vote that will force an election.

Meanwhile, the departure of one more Tory will leave him with no majority (it is currently just one, including Northern Ireland’s DUP).

In Wales, the sitting Conservative was last week deposed by a pro-remain Liberal Democrat, while in Scotland the latest opinion poll suggests that most Scots now favour independence, many of them because of the mess over Brexit.

On the other hand, in a no-deal departure, almost everything that the EU-27 doesn’t want to see happen on the island of Ireland probably will. But still no obvious jitters.

The main issue, of course, is the re-establishment of a hard border, although the UK says it won’t the ones to create one.

A British spokesman recently said: “Under no circumstances will we create a hard border in Northern Ireland or impose physical checks or infrastructure of any kind at the Northern Irish border.

“We are fully committed to upholding and protecting the Good Friday Agreement.”

The spokesman added: “The fact is the Withdrawal Agreement has been rejected three times and will not pass in its current form, so if the EU wants a deal, it needs to change its stance.”

The EU, at least on Monday (5 August), was unmoved, with the European Commission’s chief spokeswoman, Mina Andreeva, telling journalists that no one in Brussels envisages any positional change.

Andreeva added that: “In a no-deal scenario, the UK will become a third country very concretely without any transition arrangements.

“And that very obviously causes a significant disruption not only for citizens and businesses but also would have a serious economic impact, which would…have a proportionately higher impact in the United Kingdom than in the EU-27 member states.”

If no deal does go through, Irish officials will presumably be obliged to impose border inspections and customs duties on UK goods, as a direct result of WTO rules as well as the safeguarding of the integrity of the EU’s single market.

Medical supplies to Brits could suffer badly. As Politico has pointed out, France gets a lot of pharmaceuticals from the Netherlands, which could halt exports if there were doubts about the new interpretation of the single market in Ireland. So the goods wouldn’t reach Calais and the Channel Tunnel.

More than three years down the line and the situation is, if anything, becoming more rather than less complex. Halloween really could be a horror story for all concerned.

My body is a temple

Another Eurobarometer poll is just out and sees EU citizens citing “health and social security” as one of the three “most important issues” being faced in their particular country. The other two are unemployment and the rising cost of living.

Health and social security concerns top the charts in six nations, namely Finland (48%); Slovenia (47%); Hungary (45%); Portugal (34%); Latvia (32%); and, wait for it… the UK at 29%.

Ten countries rank health and social security in second place, with the highest proportions in Sweden (42%), Ireland (41%) and Denmark (40%).

Are you listening, politicians? Well let’s hope so as a further poll from Eurobarometer shows that, after this year’s European Parliament election, EU citizens have a rising trust in the bloc and increasing optimism about the EU’s future.

A record-busting number (56%) said they believed their “voice counts” in the EU. If ever there were a call to duty for MEPs, then that’s surely it.

As it turns out, the Brits have less faith in the EU than respondents from any other member state, with just 29% saying they tend to trust it. Meanwhile, generally, trust in the EU beats trust in national governments by about 10 percentage points.

The EU has bigged-up the poll results, saying: “Overall, the EU is seen in a more positive light than at any time over the past 10 years.”

HTA news

The EUnetHTA Executive Board has been busy and recently adopted the following “Understanding of EUnetHTA HTA”. Don’t you just love these terms? “Understanding.” OK…

This text was worked out over several months of consultation with the project’s board, and it explains that the EUnetHTA Executive Board agreed that HTA in the context of EUnetHTA activities is understood to be composed of the following elements:

• Assessments should inform decision-making

• Assessments are not decision-making processes themselves

• Information should be of relevance to a decision-maker or user of the assessment. Wording which is overly exclusionary has the potential to predetermine decision-making, and formulations such as “no conclusions can be drawn” should be avoided

• Assessments should include the  best available evidence at a specific given time point

• Assessments should specifically formulate a ‘summary of findings’

• Summaries should endeavour to use clear and concise  scientific language

So now you know.

Meanwhile, the Commission has followed up on the European Parliament’s legislative resolution on the proposal for a regulation on HTA and amending Directive 2011/24/EU.

In essence it says that it welcomes the overall positive approach set out in the resolution, adding that while waiting for the Council position, it reserves its position on the amendments of the European Parliament.

On that note, the Commission did express concerns over certain amendments. For those of you who are really keen, the issues arise in amendments 45, 49, 115, 116, 117, and 118. The Commission is also, it seems, a bit worried about Amendment 153.

And so the HTA proposals rumble on…

Europe needs to toughen up

A recent policy brief put together by Carl Bildt and Mark Leonard has the title: “From plaything to player: How Europe can stand up for itself in the next five years.”

In it, the authors point out that the last five years have not been kind to the European Union’s foreign policy.

“The EU has been less relevant, less active, and less united than was hoped in the heady days after the Lisbon Treaty came into force in 2010,” they write.

They add that the next five years “might be harder still”. This is because “the world is well on its way towards a new order based on geopolitical competition and the weaponization of global economic, cultural, and even climate linkages.”

“As the international situation descends into a miasma of geopolitical competition, Europeans are in danger of becoming hapless playthings in a tussle for pre-eminence between China, Russia, and the United States,” they add.

Just to really cheer us all up, Bildt and Leonard state that the EU’s foreign policy is inadequate to the task of keeping Europe safe in today’s world of great power politics and uncertainty.

They add that trust between Brussels and member states dwindled, and policy came to reflect the lowest common denominator of popular opinion.

Looking ahead, they feel that the next five years “herald acute pressure on Europe, particularly as Russia, China, and the US undermine multilateral institutions and treat trade, finance data, and security guarantees as instruments of power rather than global public goods”.

They suggest that the new high representative should move quickly to rewire European foreign policymaking to exercise strategic sovereignty, noting that the high representative needs more support on this strategy.

In a clear message to Ursula von der Leyen’s incoming Commission, Bildt and Leonard say that the new leadership team in Brussels needs to re-operationalise European defence, build Europe’s self-sufficiency through a strong European pillar in NATO, and consider innovations such as a European Security Council.

“Europe will only build greater unity by tackling controversial issues head on in the European Council and the Foreign Affairs Council. The high representative needs to play a much more active role in these debates,” they say.

All of that should certainly keep von der Leyen, the former German defence minister, pretty busy going forward.

Meanwhile, we wish you good health and happy holidays.

About EAPM

The European Alliance for Personalised Medicine brings together Europe’s leading healthcare experts and patient advocates to improve patient care by accelerating the development, delivery and uptake of personalised medicine and diagnostics.

It is calling for the European Commission, the European Parliament and EU member states to help improve the regulatory environment so that patients can have early access to personalised medicine, and so that research is boosted.


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