#EAPM: Building consensus is way forward in health care

The European Commission’s recent proposal on health technology assessment aims to introduce joint clinical assessment of health technologies at EU level, in a bid to (among other things) boost integration in the area of health, writes European Alliance for Personalised Medicine Executive Director Denis Horgan. 

The European Parliament has drafted a response, up for debate in early June, in which it praises the Commission’s proposal as ‘timely’, saying it represents high-added value.    Individual member states, which hold their health-care competency under the Treaties dear, have been cooperating on health technology assessment, or HTA, for two decades.

But the Commission feels that this needs to be reinforced via joint clinical assessment.  EAPM agrees, and is of the opinion that what it calls ‘consensus building’ is a key aspect of any new moves.

The Alliance believes that alignment between member states and stakeholders is absolutely required in order to ensure that innovation is getting into Europe’s health-care systems.  This may, of course, be easier said that done given that several member states have already objected to the Commission’s proposal on the grounds that it steps too far into their own competences.

Meanwhile, Ireland has asked for a greater emphasis on medical devices; so nothing is certain just yet.  Parliament’s draft report, plus the Commission plans, will be the topic of a key EAPM meeting on 6 June. The Brussels seat of Parliament will host the meeting being held to scrutinise the report distributed by rapporteur Soledad Cabezon Ruiz, MEP. One day later (7 June) Parliament’s own lead committee on the issue (Environment, Public Health and Food Safety) will itself meet to consider the draft.

Parliament states in its draft that any policies regulating health and healthcare provision must have the aim of guaranteeing access to medicines for patients. Yet there is a great deal of concern regarding the reality of the situation.

It argues that Europe needs more and better clinical evidence, to determine the efficacy and therapeutic advantage of medicines. Until now, member states have made decisions on efficacy and value on an individual basis, but the Commission and now Parliament believes that joint clinical assessment is the way forward. They base this partly on a need to avoid duplication across member states, caused by a lack of clinical evidence across the EU and sub-optimal communication.

Other areas need improvement, the draft says, such as clinical evidence in respect of medical devices.  Meanwhile, Parliament feels that the proposal may bring about more collaboration in fields such as personalised medicine. EAPM agrees on these necessary basics.

A little recent history: Since 2006, member states have been working together on HTA under the EUnetHTA support framework on a voluntary basis. Currently, more than 50 HTA bodies are operating in the EU, conducting assessments using different methodologies in different HTA capacities.

As it stands, within the EU, HTAs are fragmented with different systems, different procedures and different requirements regarding the type of clinical evidence. This contributes to distorted market access, which constitutes an impediment to the rapid uptake of innovations in the field of health.

Basically, that’s bad news for Europe’s patients. Parliament is of the view that, with a reinforced cooperation system for certain HTA, “all EU countries can benefit from efficiency gains and make better use of their resources, thus maximizing the EU-added value”.

But it also notes that the methodologies within the Commission’s legislative proposal “are not clearly defined and should be further developed in the future” urging the Commission to act in “a supportive capacity in the execution and choice of methodologies”. On a more positive note, rapporteur Cabezon Ruiz, on the subject of a planned steering/co-ordination group tasked with overseeing changes and their implementation, welcomes what would be its core tasks.

These include: joint clinical assessments focusing on the most innovative health technologies with the most potential impact for patients; joint scientific consultations whereby developers can seek advice from HTA authorities; identification of emerging health technologies to identify promising technologies at an early stage, and; voluntary cooperation in other areas.

As noted above, EAPM is heavily focused on consensus building generally across the EU and stakeholders, not least in the realm of HTA.  Innovation, it says, is a major pillar in bringing new, targeted medicines to patients. In the health arena, this means the translation of knowledge into what we can call “value”.

The latter covers the value to patients but must also take into account value to healthcare systems, society and, of course, manufacturers.   Early dialogue between technology developers, regulators, HTA and, where relevant, pricing bodies will promote innovation and quicker access to medicines at affordable prices, for the benefit of patients. Yet we need agreement, or ‘consensus.’

As it stands, there is uncertainty in certain quarters and this uncertainty results in what the Alliance has called a sort of legislative schizophrenia, characterized by strident demands for more harmonization and controls, yet accompanied by equally vigorous rejection of any of the centralization that such developments would clearly require.

It’s a fine line, and here’s some more history: In the EU, it was only with the most recent treaty, the Treaty of Lisbon, that came into effect in 2009, that the EU stipulated that “a high level of human health protection shall be ensured in the definition and implementation of all Community policies and activities”.

This was complemented by the Charter on Fundamental Rights (which stated that “Everyone has the right of access to preventive health care and the right to benefit from medical treatment” - but still qualified that right as “under the conditions established by national laws and practices”).  So despite the 20-year voluntary cooperation of HTAs, the EU’s direct involvement in overall healthcare is still relatively new.  Which then leaves us with the fact that a high degree of trust is necessary across all healthcare expert bodies and the individual member states of the EU. It’s not there, yet.

However, the need for better collaboration and consensus building is widely established as a prerequisite to giving innovation a better chance, in Europe, and around the developed world.

Therefore it is a key goal of EAPM and its multi-stakeholders and affiliates to take down silos, build consensus and work harder and closer together for the benefit of all patients.  Cross-border HTA collaboration, despite all its potential difficulties, would represent a dramatic move forwards.

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