#EAPM – Spahn caution on HTA, while #vdL faces ‘EU way of life’ grilling

| September 18, 2019

Greetings, colleagues. It’s Strasbourg week for MEPs, which usually means plenty going on. But before that…

The whole issue over health technology assessment continues. As you may recall, the European Commission’s amended plans are now at Council level, and Germany’s Health Minister Jens Spahnhas had a couple of things to say about progress, writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan.

Spahn was talking to Politico and revealed that, despite objections to perceived Commission over-reach led by his country and the other big-hitters France (Berlin and Paris object to mandatory uptake of HTA, emphasizing member state competence) he feels that a solution is possible.

He added and that Germany still has “good talks with our EU partners”.

In more detail, Spahn was reported as saying: “Im convinced that science should not lead to different results in Madrid, Warsaw or Copenhagen. Thats why we can make health technology evaluation more European. 

But we have to answer at the national level the question of what consequences this evaluation has for each respective national health system.

The health minister wants to “proceed cautiously”. He said that: “All sides still have to learn about European benefit assessment. Its about building confidence in this new method. So why not evaluate only ten medicinal products per year using the new method? Then we can look ahead.

One thing remains clear to me: Each EU country must draw its own conclusions from a European benefit assessment. Social security is a national competence. I dont want to give up on this principle.

Spahn added that he hopes: “The new Commission will be a little more willing to compromise.

German health priorities

Lest we forget, Germany takes over the rotating EU Presidency in mid-2020, and Berlin’s health supremo highlighted digitization, Big Data and artificial intelligence as core priorities for his portfolio.

He said during an interview that “we should concentrate on those areas that actually generate added benefit for Europe. These are cross-border issues such as infectious diseases, patient mobility and the supply of medicines”.

Spahn is, of course, a compatriot of Commission President-elect Ursula von der Leyen, and one of a bunch of hopefuls vying to succeed Angela Merkel as German chancellor.

His message for the incoming European Commission runs thus: “Instead of just we should do it’ speeches, it should be we are doing it,’ less describing problems, more solving problems.” 

He said he wants von der Leyen – whom he calls “fast, structured and ambitious” – to have a big effect on the way the EU goes about its business. 

Europe needs ambition and ideas, but Europeans also want solutions that improve their everyday lives,” Spahn said.

Meanwhile, in the rest of Europe…

Over in The Netherlands, the elderly are urgently queuing up for care home slots in ever-increasing numbers. The country’s ‘oldies but goldies’ formed a waiting list 14,000 strong in July, as they look for a spot near their homes.

The country’s National Health Care Institute says that number shows an increase of around 1,000 since February, with some 4,000 having been on the list for more than six months. 

The Institute points to a shortage of nursing staff and, of course,a growing elderly population as key reasons.

Good news on cancer

Cancer survival rates appear to have improved over the past 20 years in some developed countries, including some in the EU.

The report from the International Agency for Research on Cancer, which collected data on 3.9 million patients in Denmark, Ireland, the UK, Norway, Australia, Canada and New Zealand for seven types of cancerlooked at oneyear and fiveyear survival rates acrosstwo intervals, 1995-99 and 2010-14.

The cancers studied were oesophagus, stomach, colon, rectum, pancreas, lung, and ovary.

The report states that: “Over 1995-2014, oneyear and fiveyear net survival increased in each country across almost all cancer types,” and adds that five-year rectal cancer survival increased more than 13%in Denmark, Ireland and the UK. 

The research agency said that the improvements probably resulted from major health-care reforms and technological advances that have enabled earlier diagnosis, plus more effective and tailored treatment, as well as better patient management than before.

In the wake of the report, Ireland’s Health Minister Simon Harris said that cancer prevention is the most cost-effective way to control the disease, adding that hes set to put forwardnew tobacco controlsin the not-to-distant future.

Medical device manoeuvres

The EUMedical Device Regulation enters into force on 26 May 2020, although there have been well-documented concerns over readiness in certain quarters. Now we have the case of so-called Class 1 medical devices that will, for the first time, require their own safety checks.

Apparently, such devices were overlooked by the Commission when the regulation was written– oops! – but the EU’s executive has given the go ahead to include them, with the Council expected to initiate the procedure this month. It must also be agreed by Parliament.

The incoming regulation already permits certain medical devices to stayon the market until 2024,if certified under the previous rules. Now, this could be extended to devices that have been up-classified” for the first time. 

Germany and Ireland have led the line in wanting to address concerns that widely used products would become unavailable.

The US wants the Commission to change the deadline, but it says it won’t. 

One official, who played-down fears about the fact that, under the new regs, there will be fewer notified bodies that test devices, said: “This is the purpose of the regulation, even if we get less [notified bodies designated, that] is because we want only notified bodies which are up to standards.

This is why we have the new regulation in place, because we want to provide better reliability and protection of safety.

Some notified bodies have said they will not look to become compliant under the new regulation, with the official conceding that more may still withdraw.

Despite this, the Commission still plans to have 20 notified bodies approved to operate this year.

Over to Strasbourg…

So, how about that ‘European Way of Life’ Commission portfolio? It’s caused a split among MEPs and we’ll see more of that this week.

Incoming President-elect Ursula von der Leyen is at the Stras plenary as this update goes out to you, partly to explain her portfolio assignmentto political group leaders meeting asthe Conference of Presidents.

Officially, VdL can call her portfolios anything she wants, but this one’s causing a few issues, having been dubbed ‘racist’ apart from anything else. Spare a thought for poor old vice president-designate Margaritis Schinas, who has the brief.

Renew Europe want Ursula to change the title, while the Socialists’ leader Iratxe García is keeping her power dry for the moment, saying simply shes “pleased” that vdLwill explain her thinking.

We will be looking for her to clarify some of the confusion that has been created by allocation of portfolios and titles,” Garcia added.

EPP group leader Manfred Weber, from the same group, of course, as the incoming Commission president, has said: “We should not allow right extremists to hijack the European way of life debate. It’s our debate.” 

The title is crystal clear and we defend it,” the former EPP Spitzenkandidat added.


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