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#EAPM- Commission’s HTA proposals need level playing field

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The World Cup is now well under way in Russia, but in Brussels another kind of football, this one political, is being kicked around. Ahead of an EU health council meeting on 22 June, the Bulgarian Presidency has cast doubt on the mandatory aspects of the Commission’s proposal for joint clinical assessment (JCA) in respect of HTA, writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan.

Already several member states have highlight issues 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.  They could end up giving the whole deal a ‘red card’.

In a paper, the presidency noted 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, and at establishing a framework for mandatory joint clinical assessment at European Union level.

It added that, currently, the legal basis for co-operation on health technology assessment is Directive 2011/24/EU. Article 15 of the Directive contains an obligation for the EU to support a voluntary network of national authorities or bodies responsible for HTA.

The Commission’s original proposal, unveiled in late January, has a strong focus on overcoming impeded and distorted market access, with the institutions aiming to reach agreement by December 2018, and the European Parliament scheduled to adopt its position prior to that in October.

The presidential discussion paper is framed in such a way that it asks member states whether they would prefer a voluntary agreement, (hopefully an improved one, in EAPM’s view) which would obviously allow some countries to opt out.  EAPM is strongly of the opinion that what is necessary here is improved coordination on EU-wide HTA, within a clearly defined framework, which may be difficult to achieve without some kind of mandatory element. What that would be remains a moot point.

Under the European Union’s social pillar each citizen across all member states should be able to have the same access to the best health care, often through earlier diagnosis. This is evidently not the case at the moment.  The Alliance believes that a truly constructive framework for JCA between individual HTA bodies is clearly required to cut down on unnecessary duplication.

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Striking a balance between a mandatory JCA and a voluntary one looks to be the only option at this stage, and it is up to the health council and its members to solve this issue.

Currently there are delays in HTA decisions which inevitably lead to unacceptable delays in access. The key to the Commission proposal is ensuring that member states pool their expertise with the help of a facilitating framework and mechanism.  However, the Bulgarian Presidency paper said that jointly assessing the added value of new medicines and medical devices through mandatory means,“could minimize the chances of reaching an agreement”.

This could well prove to be ‘a game of two halves’ as some (mainly smaller) countries are actually in favour of a mandatory methodology. Notably, Germany and France have raised concerns, as well as Czech Republic & Poland at this stage.  EAPM has already had a meeting on the subject earlier this month and will follow up with Member States in the wake of the upcoming council meeting on 22 June.  The word on the street is that many countries believe that the Bulgarian Presidency paper is somewhat biased in favour of retaining voluntary cooperation on HTA, with 13 countries already objecting to its phrasing in meetings.

Nobody is arguing that “the current voluntary cooperation has been perceived positively” but the fact that the presidency asked ministers if they “support discussion on alternative ways to ensuring its long-term sustainability, other than the proposed mandatory participation and/or uptake,” seems to be putting the mandatory option out of play.  The Bulgarian paper calls it “a key concern repeatedly raised in all previous discussions” so clearly there is a long way to go.

Kiril Ananiev, the Bulgarian health minister, also appeared to try to kick the ball into touch regarding a mandatory arrangement some time ago when he told the European Parliament’s Environment, Public Health and Food Safety (ENVI) committee that “to have an advancement on the issue, we need to have less sensitive issues in it”.

The presidency organized three rounds of discussions at preparatory level in the Council, and its paper goes on to state that: “While the Commission has justified the choice of policy option (mandatory cooperation on HTA) as being the most efficient option for harmonizing clinical assessments and hence streamlining the functioning of the internal market, member states have not identified mandatory uptake of joint HTA as a necessary solution.

“Key aspects have been questioned, including the problem identified (fragmentation of the internal market), the adequacy of the solution proposed (harmonization of HTA assessments), scope, mechanism and other aspects,” it adds.  Clearly, much discussion lies ahead and could well go into ‘added time’, if not quite a penalty shoot-out.  Regardless of the final score, EAPM believes that the whole issue absolutely has to revolve around patient access.  EAPM will host a two-hour meeting at the Strasbourg seat of Parliament on 4 July which will involve MEPs and key stakeholders on the subject, and will address the potential impact of the Commission’s strategy, as well as the meeting of health ministers.

The 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.   Cabezón Ruiz has already stated that the Commission’s initiative could strengthen the EU, despite the aforementioned resistance in certain member states.

She and others have also called for medical devices to be included in any new legislation, while industry has strongly said that it wants them left out.

As mentioned, most member states do agree that there is room for common ground, (there has been a degree of cross-EU HTA co-operation for two decades), but the details need to be thrashed out for the benefit of the EU’s patients. Therefore stakeholders such as EAPM’s members are emphasizing that there is no time to waste.

Whatever way it happens, member states need to be convinced that co-operation must be stepped-up regarding HTA to avoid repetition, while patients (especially with rare diseases) could also benefit from enhanced cooperation in respect of clinical trials.

Austria takes over the EU rotating presidency on 1 July and plans to hold eight meetings on the subject over six months, before leaving the final touches to the Romanian Presidency early next year. It seems that it will be some time into the future before the final whistle blows.

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