The new proposal for an EU HTA Regulation is out. We take a look at what is at stake and what to expect over the coming months and years.

Getting medicines to patients faster while making better use of available resources and avoiding duplication – this is the proclaimed goal of the new Health Technology Assessments (HTA) proposal that the European Commission published on 31 January. Long-awaited, leaked and already heavily debated, the draft bill on how to better coordinate European processes around the assessment of the added therapeutic value of new medicines and certain medical devices will now make its way through the Brussels legislative jungle.

But what is actually at stake and what we can expect to happen over the coming months and years?

The claims for the proposal are ambitious. Apart from accelerating access to medicines and saving money, the bill is intended to insert some predictability as well as transparency into the increasingly complex value assessment procedures that we find across Europe. This is hailed as good news for industry as well as for patients: industry can hope to get life-saving medicines and medical devices out onto European markets faster, while patients will be able to access those products earlier and more easily across Europe.

The proposal appears to have backing from many sides. It was not only praised by EU Health Commissioner Vytenis Andriukaitisbut also welcomed by EFPIA, the European Federation of Pharmaceutical Industries and Associations. European patient and consumer organisations also warmly received the draft regulation, albeit warning policymakers to safeguard the high existing standards that can be found in certain – usually big – Member States.

On this point, patient group concerns echo, at least partially, Member States’ concerns. The latter are divided, however, with countries with well-established HTA bodies such as Germany and France not amused, as illustrated by the reaction of Germany’s Federal Joint Committee (G-BA) which warned of the imminent destruction of  functioning Member State procedures pointing to differential needs and the shortcoming of a one-size-fits-all approach. Accusations of an attempted ‘power grab’ by the EU over national competences were only one of the many arguments Europe’s capitals brought forward in the heated debate that preceded the publication of the draft text – and certainly one of the reasons why it was published with such a delay. Given that health constitutes a clear competence of Member States, the European Commission of course needed to put forward fairly good reasons for proposing a regulation that touches on these very competences.

For smaller EU countries, the new bill comes as a welcome boost, for example in Croatia, where HTA processes are still in their infancy. The Netherlands is also among those who are backing more EU-wide coordination, whereas the UK can be expected to be somewhere in-between, seeing the advantages of greater alignment while hesitating to make joint clinical assessments mandatory. However, in light of their dwindling influence, they will take a backseat.

So how good, or bad, can it get? And for whom?

The proposal foresees the use of common HTA tools, methodologies and procedures in mandatory joint clinical assessments, joint scientific consultations (‘early dialogue’), collaboration on the identification of emerging health technologies (‘horizon scanning’) as well as further voluntary cooperation in other areas, such as on surgical procedures or on economic aspects of health technologies. Its scope is clearly restricted to the clinical aspects of HTA, ie problem definition and relative safety and effectiveness assessments, whereas non-clinical (economic, social, and ethical) aspects remain in the hands of national governments, including those highly contested decisions on pricing and reimbursement.

The draft text also includes a safeguard clause, whereby Member States can refuse to participate in mandatory joint clinical assessments on grounds related to the need to protect public health. And, last but not least, a review clause leaves the door wide open for all sorts of subsequent changes. Among other things, this could also include modifications to the role foreseen for the European Medicines Agency (EMA). Some patient groups and Member States had voiced their concern over the possibility of turning the Agency into a coordination body, thereby moving national competences further into EU waters. The current proposal thus foresees the EMA facilitating cooperation rather than coordinating HTA activities across Europe, but this could still change, depending on the current appetite of policymakers.

As legislators get ready for the upcoming negotiations, they will have to address a number of questions that remain unanswered and which affect some stakeholders more than others. For example, in cases where disease prevalence differs significantly across Europe, a one-size-fits-all approach could indeed make market access more complex, to the detriment of patients. It should also be kept in mind that while the proposal purposefully leaves out pricing and reimbursement, HTA assessments do still affect decisions related to pricing and reimbursement in national contexts in different ways.

An area in which we can expect heated debate will be just how mandatory, and how close, the collaboration should be in the end. The European Parliament has already expressed its preference for a higher degree of collaboration in its own initiative report on access to medicines from 2017. It’s Rapporteur, MEP Soledad Cabezón Ruiz, is among those who would be a likely candidate to steer the HTA proposal through the house. But the EPP also seems interested and, in the end, it will depend on whether her political group (S&D) can – and wants to – secure the file, or whether another group will win the bid in the end. We should find out more this month, when coordinators are expected to discuss the issue.

Timelines are another part of the proposal that will probably be contested. As it stands, the new law would become applicable three years after entering into force. Following the date of application, a further three-year period is envisaged to allow for a phase-in approach for Member States to adapt to the new system. According to the perhaps too optimistic view of the Commission, we could expect a final deal in 2019. Three years on, we would then see a phase-in starting with ten pilot projects overseen by the new coordination group, with a view to extending assessments to all new medicines and high risk medical devices in the first three years. The aim is to have sixty to sixty-five joint clinical assessments done at EU level six years after the regulation comes into force. At that point, EU countries would be requested to undertake joint assessments.

But all of this is open for discussion, and just how smoothly the proposal will pass through the house remains to be seen. MEPs would need to make it a priority in order to get Parliament to agree on a final version before the great majority of Members turn towards more pressing issues: their home campaigns for the upcoming 2019 European Elections.

At Member State level, the debate is expected to be even more challenging, with all eyes on the upcoming Austrian Presidency of the EU, who would really have to push this dossier in order to close it before the 2019 elections. This means that the entire process could be delayed significantly, maybe for years.

Publication of the proposal may be an important milestone, but it is only one of many before joint assessment becomes a reality.