#EAPM – EU heavyweights show Commission #HTA proposal yellow card

| June 26, 2018

France and Germany have speedily published their views on the European Commission’s proposals for mandatory joint clinical assessment (JCA) on Health Technology Assessment (HTA). The latter were widely discussed by the larger member states at a meeting of EU health ministers in Luxembourg last week.  The two big nations have kicked the mandatory option well-and-truly into touch, although they do say that, in principle, they support a more profound, co-operation at EU level in the area of HTA, writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan. 

They add that “well-organised and high-quality co-operation can assist member states in preparing their healthcare decisions, in particular regarding pricing and reimbursement”. But they say that conditions must be right and retain the room for manoeuvre at national level, in implementing health-care decisions, as well as in pricing and reimbursement.

“It should only be required that EU-level clinical assessments be taken into consideration at national level, instead of having them obligatorily applied”, the two countries say. They suggest other amendments to the Commission proposal, arguing that the summary assessment of the existing scientific analysis must continue to be a task incumbent on member states.

They add that JCA would inform countries regarding HTA but that individual member states would not have to fall into line if JCA “is inadequate in the context of the national health-care system”. Also, they say that, as a general rule, any newly set-up coordination group overseeing co-operation “should make its best efforts to reach consensus through in-depth negotiations. If this is not possible, voting by qualified majority should be the rule.”  That’s a full tackle to the EU Executive’s proposal.

It remains to be seen what will happen next, as we are only at half-time and not yet into the final stages. Some countries may back the Franco-German proposal, while others in favour of mandatory JCA may offer their own ideas. At last Friday’s meeting (22 June), several member states complained that the Commission is over-stepping its remit in its bid for a mandatory solution to improve HTA co-ordination, given that health is a member state competence.

The Commission says that the proposal is aimed at improving the functioning of the internal market by harmonizing the member states’ rules on carrying out clinical assessments for health technologies at national level.

But Germany, France, Denmark, the Czech Republic, Poland, the UK, Italy and Spain gave mandatory JCA a red card, while still generally backing improved cooperation and co-ordination.  Belgium, Croatia, Cyprus, Estonia, Ireland, Lithuania, Portugal, Romania, Slovakia and Slovenia looked to back the original proposal but are now set to have a VAR-style review before coming down on one side or another. The same applies to Austria, Finland, Hungary, Latvia, Luxembourg, Malta, Sweden and The Netherlands. A major sticking point in the HTA negotiations was that member states want to keep full control over whether to offer a particular medicine and the reimbursement levels.

The Commission said that its plan would not have an impact in this area, but the EU’s super-nations disagreed.  The European Alliance for Personalised Medicine (EAPM) will soon be engaging with individual countries, the Commission and Members of the European Parliament down the line in these areas. In fact, EAPM will host a two-hour engagement meeting at the Strasbourg seat of Parliament on 4 July which will involve MEPs and key stakeholders on the subject of cooperation in HTA, and will address the potential impact of the various options.  The Alliance meeting will take place a few days before the Parliament’s ENVI committee, under rapporteur Soledad Cabezón Ruiz, also meets (9-10 July) and EAPM aims to discuss the best possible amendments to the proposed legislation in advance of that gathering.

Parliament is busy examining the options, right now, proposing detailed changes to the Commission proposal. There are already around 200 suggested amendments and that number is likely to grow. EAPM rejects the argument that mandatory JCA will undermine member-state competence and says that such a move would bring added value, for the benefit of patients.

The Alliance recognizes that while decision of healthcare delivery is a national competence, the Commission’s original proposal represented a necessary co-ordinating action at EU level.  EAPM added that mechanisms were suggested for the HTA Coordination Group to ensure that it remains member state-centric, but geared up to bring more value to decision making, reduce duplication, and aid long-term co-operation across the EU.  The Alliance also says it wants to see a pooling of expertise, better quality and faster reports, smarter use of available sources and increased transparency for patients.

Industry, meanwhile, would likely benefit from business predictability, competitiveness and innovation, as well as savings through the reduction in duplication, EAPM maintains.

While there are clearly differences in the procedural frameworks and methodologies across member states, this is not particularly desirable in the broadest sense and the Commission proposal aimed to tackle this without undermining individual country competence.

For sure, what we will see down the line is a ball-juggling act worthy of Cristiano Ronaldo, but the fact is that there really is little reason for methodologies to differ from country to country, given that they all have the same ‘goal’, as it were.

Co-ordination has taken place over the last two decades through EUnetHTA, and the Commission’s aim was to upscale this.  This could still happen, but right now it looks as though Europe is heading for a penalty shoot-out and will have to wait and see what happens at the final whistle.

Either way, more teamwork is most certainly required.

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