#EAPM - Halloween and Easter rolled into one. Perhaps not the best plan…

The latest news on Brexit doesn’t really make for a great deal of happy reading for, well, anybody much. But British MPs are probably not too worried as they’re already off on their Easter breaks (until 23 April, which is St George’s Day, no less), writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan.

Can’t be bad. And they’ve now got 31 October (Halloween) to, um, ’look forward to’…

On the subject of reading and Easter, the report on EAPM’s (very) recent 7th annual presidency conference will be with you next week, before you all hopefully get the chance of an Easter break, too. After such an exciting week, Brexit ’n' all that, you doubtless deserve it.

Hey, hey, it’s HTA!

It was great to see several journalists present at the Alliance event, and one-or-two almost inevitably latched on to elements of the ongoing HTA debate, which were played out between the European Commission’s Flora Giorgio and Germany’s head of the Perm Rep in Brussels, Ortwin Schulte.

The arguments over mandatory EU-wide joint action on health technology assessment haven’t changed much, despite Parliament’s backing for most of it, and Germany and others have shown no signs of budging even now it’s at Council level. 

The bottom-line remains that, for the EU Executive, there has to be some form of mandatory element in order to enhance the HTA process, while Germany is saying “hands off our member-state competence”.

The Commission’s Giorgio took the opportunity at EAPM’s conference to underline the oft-heard lines that the goal is to avoid duplication, bring about more and better consistency, and up the quality of assessments.

She stressed that, under the plans, individual countries would still make the assessments, and that the legislation would not affect national-level pricing and reimbursement decisions. 

HerrSchulte, however, was having none of the ‘mandatory’ stuff and argued that, actually,the proposal comes very close to influencing pricing and reimbursement. It’s not just Germany that feels like that, he emphasized.

He reminded attendees and the Commission that France, Spain, Poland, the Czech Republic and Bulgaria, alongside Germany, had sent a well-reported letter"explaining some red lines". The German parliament is heavily against the proposal, regardless of the European Parliament’s view, he said, so there you go. 

Schultz did concede, however, that: ”It would be a massive setback not tofind a common position eventually," adding that "It merits some efforts”.

Any bets on which is settled first, Brexit or HTA? No, we didn’t think so…

No deal and health care: The latest

Prior to Wednesday’s (10 April) special summit in Brussels, during which the EU agreed to a ‘flextension’ till Halloween in respect of the UK’s so-far disastrous attempts to leave, health care rights came up.

The day before the meeting, European Social Affairs Commissioner Marianne Thyssen said that even in the event of a no-deal scenario: “We have discussed with member states that they will continue to compensate the UKfor medical expenses incurred in the UKby European citizens who legally reside there.” 

However, tourists are not included in this, she said, adding that those traveling to a post-Brexit Britain should therefore take out health insurance.

Over in Amsterdam, meanwhile, the Netherlands’Health Minister Bruno Bruins has said the country will, at least temporarily, accept medical devices re-authorized by a technical body in the EU-27, in the event that they still do not have the proper labelling for up to six months after a no-deal UK departure.

And in Dublin, the Irish government reassured everyone listening that the country is “unlikely to face general medicines supply issues in the period immediately post-Brexit, even in a no-deal scenario”.

The hope is obviously that this will back up several strong requests from Ireland’s Health Minister Simon Harris askingpeople not to stockpile medicines. The government added that it is “confident there are enough stocks of medicines in the country to manage any potential supply issues at ports”. 

Over in London, the UK’s Health Secretary Matt Hancock was last month effectively saying the opposite when he warned that a no-deal Brexit could disrupt supplies in Ireland as well as in Britain.

Romania robust on health

An informal meeting of health ministers is set tobe held in Bucharest on 14-15 April under the Romanian EU presidency, during which the "main objective" will be "to guarantee access to health for all European citizens". 

Romania’s Health Minister Sorina Pintea said that the emphasis will be on"access to new medications that are affordable and sustainable for all, and high quality and safe treatments for all” andwill involve "an integrated approach and multi-step action", covering "topics of interest, such as universal patient access to medicines, hepatitis and patient mobility". 

At the same meeting, attendees will see a focus on improving cross-border health-care access and ideas on how to improve patients’ awareness of their rights to get reimbursement for treatments in member states other than their own. 

The European Parliament earlier this year called for, among other items, national guidelines to help patients compare costs.Despite excellent intentions, the 2011 directive on cross-border healthcare has, quite frankly, never worked optimally and efforts clearly need to be stepped up.

Meanwhile, Romania is also putting pressure on EU health ministers by asking them to figure out how individual countries can integrate the European Reference Networks, or ERNs, into their own health systems.

“It is important to use the momentum and address this fundamental issue before the enlargement process of the networks is launched,” says Bucharest.

Later, on 9-10 May, Cluj-Napoca will host an expert-level workshop on vaccination programmes in the EU, looking at ensuring optimal coverage for vaccines. Apparently, the presidency will be seeking agreement to set up an EU-wide vaccination register.

Minister Pintea is also keen to bring down the levels of vaccination denial. Well, there’s certainly no denying her efforts.

At the end of the same month (29-30 May) a further expert meeting will take place, this time on cancer screening with a view to instigating the creation of a European cancer prevention alliance. 

Looking even further ahead, in the last month of the Bucharest presidency (11-14 June), EU Health Week will be held in the capital, hosting a conference on e-health and a meeting of the EU's e-Health Network. 

Croatia busy ahead of presidency 

Once Romania has handed over the baton to Finland on 1 July, the next in line for the EU’s rotating presidency will be Croatia (1 January 2020).

In an encouraging early sign, it will soon become the fifth EU member state able to send and receive e-prescriptions across borders and get patient summaries from other countries. 

Already doing this are Finland and Estonia, swapping e-prescriptions since January, plus the Czech Republic and Luxembourg. The latter pair will, in the next few months, begin exchanging patient summaries. 

The e-prescription programme is being gradually rolled out across all EU member states, with patient summaries offering background info on the likes of allergies, medications, previous illness and surgeries.

Data and trials

The European Commission recently tried to clarify in a document what it calls the “interplay” between the clinical trial regulation and data privacy laws.

The head of the European Medicines Agency Guido Rasi is already on record as worrying that the General Data Protection Regulation (GDPR) could threaten medical research in some cases, such as secondary use of medical data harvested from a particular and specific trial.

Under GDPR, there must be a “valid legal ground” if a researcher wants to use the personal health data “for any other purposes than the one defined by the clinical trial protocol”.

The “valid legal ground” covers a public interest in safeguarding public health, the legitimate interest of the organisation or the person’s explicit consent. 

The document states that it would be possible for the secondary use to fall under the same legal basis used for the original processing of the data, but that this is not guaranteed.

Under GDPR it transpires that obtaining informed consent for a citizen to participate in a clinical trial is also distinct from the requirements of getting the person’s consent to process their personal data.

There. It’s all very simple. Just like Brexit…

Have a good break.

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