Clearing or Deepening the HTA Mist?

The European Union's bid to get a clearer view on how new medicines should be valued took another twist in late October with a formal meeting in Brussels to discuss health technology assessment. This brought the key players together in a formal inception of the consultation process – already outlined in ACT – on defining the way ahead in this delicate task. 

Delicate, because there are differing objectives for each of the key players – the European Commission, the multiple health system regulators in the individual member states that make up the EU, the drug and devices industries that supply health technology, the doctors that prescribe products and procedures, and the patients that seek treatment.

While the Commission promotes coordination, national bodies hesitate to surrender their autonomy to tackle their local conditions. Companies are conscious of the waste that current incoherence can imply, but nervous about the prospect of a simplistic leveling up of criteria for approval. Doctors resent excessive intrusion into their freedom to make clinical decisions, and patients are suspicious of what they see as bureaucratic controls that could limit their access to innovative care.

Delicate, too, because the EU is itself in a phase of self-doubt, something akin to a crisis of confidence in the merits of working more closely together. The strains of coping with recent financial and economic turmoil have set member state against member state, and member states against the Commission. The current migratory pressures have exposed additional divisions over how to respond, and have led even to the partial closure of  borders between member states reversing decades of progressive opening up. And the rise of populism – reflected in the growing success of fringe parties surfing on a tide of anti-establishment disenchantment in many member states - is making national governments and the EU institutions increasingly nervous of interventions that might further provoke public backlashes.

Add to that the anxieties over the existential threat to the EU posed by Britain's move to leave, and the atmosphere is anything but propitious for warm entente over something that goes to the hearts of citizens so directly as access to healthcare.

EU health commissioner Vytenis Andriukaitis trod carefully as he addressed the HTA meeting last week. He opened with an acknowledgement that it was taking place "in times of challenges for the European Union". His claim was that HTA cooperation can nonetheless "have big advantages both for people and healthcare systems", bringing "social added value", "better access to treatments at sociably acceptable prices," "more transparency and fairness." And to foster industry acceptance, he added that it can help "sustainable growth and jobs by investing in science, research and industry."

On this basis, he argued that cooperation on HTA "must unite" – and more widely than just the EU. HTA is "an important tool used worldwide," he went on, explicitly urging closer links between the EU and the US too. But he also recognized that this new step in the process will have to be careful and inclusive to win the support it needs. This meeting was, he made clear, not for making decisions, but merely to launch "the first public consultation on a future initiative to strengthen EU cooperation on HTA beyond 2020." His emphasis was on "understanding what your needs and expectations are," and "to examine the best way to shape the future." He said it was "a key ingredient for success" to maintain "continuous and constructive dialogue with all member states and stakeholders."

The choice of a "softly-softly" approach, of a search for progress via consensus, is understandable. Indeed, political realities make it a necessity, since neither the commissioner himself nor the Commission as a whole has any mandate to impose anything at all in this field - as the limited nature of Andriukaitis' own promises of aid revealed: "You can certainly count on my support and that of my services. We stand ready to help, where we can." So weak is the Commission's power that conciliatory concessions have to be offered even before any real discussions take place. "We recognize that a 'one-size-fits all' approach is not applicable," he stated.

What is understandable is not necessarily right, or enough. Because the reality is – as again Andriukaitis conceded, and as on-the-ground facts have long demonstrated – that "significant discrepancies between national procedures and methodologies remain," and "leads to different requirements and ultimately different outcomes." This tentative approach to HTA coordination may not manage to dispel the surrounding mist, and risks turning into yet another unfortunate EU venture in which optimism triumphs over experience.