#EAPM: Patient access must be key to new HTA plans

With the European Commission’s call for mandatory joint clinical assessment in HTA being debated at the moment, the whole issue absolutely has to revolve around patient access, writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan. 

As the European Parliament debates the Commission proposal in meetings, and EAPM does the same, politicians and policymakers need to unite and retain a focus for the benefit of those needing innovative drugs and treatments.

An Employment, Social Policy, Health and Consumer Affairs Council session will take place, on 22 June, to discuss the proposal.

Meanwhile, the Working Party on Pharmaceuticals and Medical Devices has already examined the proposal in three meetings under the Bulgarian Presidency of the EU. The Council has since been invited to hold a public exchange of views to ensure transparency.  Problems have already arisen in that, while the Commission has justified the choice of mandatory cooperation on HTA as being the most efficient option for harmonizing clinical assessments and streamlining the functioning of the internal market, not all Member States see the mandatory element as the way forward.

Germany is one such nay-sayer, alongside France, the Czech Republic and Poland, with these potentially forming a qualified minority to block the proposal. They say that it could lead to a lowering of HTA standards and force poorer member states into having to buy expensive drugs.  The proposal has a strong focus on overcoming impeded and distorted market access, but some critics have pointed out that HTA is aimed at ensuring patient access to necessary, effective and timely treatment, and not at addressing issues caused by duplication of requests for data from national authorities.

The Bulgarian Presidency has concluded that there is a need to explore possibilities other than the proposed mandatory system. Continuing to explore only the mandatory option could minimise the chances of reaching an agreement among member states, the Presidency says.

The institutions are aiming to reach agreement by December 2018, with Parliament scheduled to adopt its position prior to that in October.  EAPM will host a two-hour meeting at the Strasbourg seat of Parliament on 3 July which will involve MEPs and key stakeholders on the subject, and will address the potential impact of the Commission’s strategy.

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 resistance in certain member states, given that they have a jealously guarded competence in the arena of health and argue that the EU executive is over-stepping its remit.

The arguments rumble on and Ortwin Schulte, the health attaché from Germany, speaking at EAPM’s recent roundtable on the topic, claimed: “It’s better to have an emotional debate than a boring debate about a boring text.”

As stated above, it’s the ‘mandatory’ call that has caused division. On top of this, Cabezón Ruiz and others have called for medical devices to be included in any new legislation, while industry has strongly said that it wants them left out.

A meeting of health ministers on 22 June in Luxembourg will be key, this because there is a need for consensus before the European Parliament elections in May of 2019, and the arrival of a new Commission a few months later.

Despite certain objections, most member states do agree that there is room for common ground, (there has been a degree of cross-EU HTA cooperation for two decades), but the details need to be agreed before the new Parliament intake and the new Commission. Therefore stakeholders such as EAPM’s members, and of course patients, are emphasizing that there is no time to waste.  The Alliance agrees that the Commission’s plan would avoid unnecessary HTA repetition, and enhanced cross-state cooperation should lead to the swifter introduction of innovation for the good of all Europe’s patients.

Of course, the EU has already dipped its toe into the health-care water with initiatives on clinical trials, cross-border healthcare, IVDs and the newly enforced General Data Protection Regulation, so many would see co-operation on HTA as a sensible next step.

So, it is fair to say that EAPM and its stakeholders are broadly in favour of the Commission proposals, but any amendments must be geared towards more equitable access for EU citizens and the process cannot be allowed to drag on.

Member states need to be convinced that co-operation needs to 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.

EAPM also broadly believes that future HTA cooperation (after a three-year transition period) will lead to a much-more level playing field. So policy- and law-makers must find a way to make the initiative work.  The speedy access to innovative health care is vital to so many patients and must be the number-one priority for lawmakers.

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. Let’s get it right, and let’s do it quickly.

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