#EAPM – Stalled #HTA needs to move up a gear

| January 9, 2019

Stop, start, stop…It may seem to everyone that the whole debate on the European Commission’s proposals for enhancing EU-wide cooperation on health technology assessment has been like sitting in a traffic jam – HTA appears to be going nowhere fast after almost a year since ‘hit the streets’, writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan.

Hopefully, now that we are into 2019, there will be some movement. Although don’t expect the green light required to fully unblock the road in respect of mandatory elements of joint clinical assessments.

Despite positivity from the European Economic and Social Committee, and the backing of the European Parliament for the mandatory parts of the proposal, several member states have objected, some raising subsidiarity concerns in an area, health care, that comes down to closely guarded national competence.

Meetings have been organised, discussions have been held – not least by the European Alliance for Personalised Medicine (EAPM), which successfully gathered stakeholders for a key roundtable in Brussels recently – but the lights remain on amber at best and the debate rumbles on.

For its part, EAPM will hold another round table to discuss progress on the issue in the first quarter of this year and will support the rotating presidencies – Romania and Finland – throughout 2019 as the plans hopefully begin to nudge forward.

The recent background…

During the latter part of 2018, the rotating presidency of the EU, Austria, worked hard to make progress, tabling a revised text, based on written and oral contributions by delegations.

A particularly important addition to the text was suggested by some delegations. This sought to define an assessment’s scope.

Austria responded quickly by introducing provisions that require definitions of the content of the joint clinical assessment, or JCA, be defined. This was in respect of interventions, comparators, patient population and patient-relevant health outcomes.

On top of this, Austriaworked to clarify the selection of experts to carry out JCA, transparency and confidentiality rules for participating in the joint EU work, the information to be submitted by the industry, plus the procedural steps and timelines.

But in the end, despite its best efforts, Vienna was forced to acknowledge that disagreements could not be overcome during the Austrian presidency. So now all eyes have turned to its successor Romania, which has taken on the presidency for the first time.

What are Romania’s plans?

The Romanian presidency, already under pressure from some observers who say it is not yet fully prepared for the role, has said it is keen to avoid the political battle over mandatory versus voluntary aspects of the CommissionHTA plans.

number of member states are against any mandatory element on HTA (more of that later) while a larger number, plus the European Parliament, think it is necessary.

A compromise seems a long way off there is concern that it may actually be left to the Finnish presidency, which takes over in July after the May elections, to finish the job. At the very least, the hope is that all will be done-and-dusted before Croatia takes over the reins on 1 January, 2020…

Romanias health attaché Stefan Staicu has already said that his country wants to side-step tackling the relevant section in Article 8, and movon to Article 9 instead, which is more concerned with timelines.

Romania has essentially set its sights on a technical compromise first, followed by a political one at the end of its presidency.

It remains to be seen how much progress Romania will make before the next Health Council meeting on June 14in Luxembourg.

Key points for Austria’s progress report

Towards the end of its presidency, Austria published a progress report on HTA (30 November) ahead of an EU Health Council meeting.

Vienna had aimed to secure at least a partial general approach by the end of its tenure.

It’s fair to say that the country made great efforts to address concerns about mandatory uptake of JCA, but the attempt largely failed, according to its own report.

Austrian health attaché Philipp Tillich was quoted as saying: “As it turned out we had to adapt our objectives to the reality.”

He described as “unfortunate” the fact that Austrian could ultimately only release a progress report, adding that there was “a very strong political resistance from a couple of member states”.

Tillich went on to advise Romania to “simply ignore” the heated political debate for the time being and backed the country dedicating itself to “those less tricky but also technically very important parts of the text”.

The report pointed out that member states have already agreed that technical discussions on the Commissions proposal will continue this year.

In what is sure to be a busy period already, not least due to the May European Parliament elections and, of course, Brexit, further discussion is crucial to find a way to ensure high-speed and quality assessments for the benefit of all patients and potential patients across the EU.

Of course, this all relies on data, and also up for discussion at the moment are the consequences for developers that dont provide needed data on time.

So, where next on HTA?

Having admitted that it will effectively hold a “transitory” presidency as we head towards the May Parliamentary elections, Romania is however aimingto reach a political agreement among member states on HTA, according toSorina Pintea, the country’s health minister.

“Romanias presidency aims at continuing negotiations in order to make as much headway as possible in order to reach a general approach at Council level,” shesaid, while talking about a “realistic” approach and relyingon collective efforts “and a strong political will.

More plans from Romania on health

Pintea has also spoken about Romanias other plans on health.

These include a plan to produce Council Conclusions on upping vaccination coverage and tackling antimicrobial resistance.

Access to medicines and patient mobility are also top priorities, the health ministersaid.

An informal meeting involving the EU’shealth ministers is scheduled for15-15 April in Bucharest, during which access to medicines (with an emphasis on hepatitis treatments) and cross-border health care will be high on the agenda, according to Pinea.

The Romanian presidency has also announced that it is planning a workshop on9-10 May, covering the topic of vaccines and a further meeting to discuss early diagnosis of cancer on 29-30 May.

On top of these activities, an e-health conference is planned for late June, Minister Pintea said.

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Category: A Frontpage, EU, European Alliance for Personalised Medicine, Health, Personalised medicine