02-07-2025
Europe's new health assessment system could be a game-changer
EU countries have begun jointly assessing new medicines under a landmark EU regulation aimed at speeding access to treatments and strengthening cross-border health cooperation.
To see the new approach – in effect since January – in action, look no further than a modest but revealing spreadsheet on the European Commission's webpage. It lists the joint clinical assessments (JCAs) now underway. Currently, three new cancer drugs are being evaluated by national health authorities, with their assessments soon to be shared across all EU countries.
At present, each EU member state maintains its own evaluation committees and criteria. For smaller or less affluent countries, it remains a resource-heavy challenge to assess how a new product performs compared to existing alternatives – and whether it justifies the potential cost.
On Wednesday, a conference organised by the Commission's health department marked the implementation of the Health Technology Assessment Regulation (HTA) – which governs this approach – as the start of 'a new era of collaboration.' HTA typically begins after a medicine or device has been approved and provides national decision-makers with evidence on whether – and how - to offer it to their populations.
While the regulation stops short of harmonising the full HTA process, it introduces a major innovation: joint clinical assessments. These evaluations review existing research on a product's clinical effectiveness. Roisin Adams, Chair of the Member State Coordination Group on HTA, underscored their importance in helping countries rein in spiraling healthcare costs.
'Many countries are still recovering from global events, not least the pandemic. We need to make smart decisions – and for that, we need solid information,' she said.
In this initial phase, only new cancer drugs and advanced therapy medicinal products will trigger a joint assessment, coordinated by the Member State Coordination Group and supported by HTA experts at the European Commission. According to Adams, around 25 medicines are expected to undergo assessment in 2025. High-risk medical devices, such as implantable cardiac defibrillators, will be added in 2026, orphan drugs in 2028, and by 2030, all new medicinal products will be covered by the regulation. Hope for cancer patients Patient organisations are hopeful the new approach will deliver.
'It's meant to accelerate access and increase transparency,' said Antonella Cardone of Cancer Patients Europe. Once a joint assessment is published, patient advocates hope to put more pressure on national systems that are slow to make new treatments available.
For now, though, the regulation is creating additional work for national HTA bodies.
Pedro Facon, General Manager of Belgium's National Health Institute and head of the EU-wide consortium streamlining HTA procedures, likened the situation to parenting a toddler: 'As a national HTA institution, we're faced with new, complex procedures – all while continuing our regular work.' He also noted that agencies leading assessments are only reimbursed two years later – a practical hurdle for already stretched institutions.
Still, many experts say the long-term gains outweigh the short-term strain.
Sabine Vogler, Head of Pharmacoeconomics at Austria's National Public Health Institute, acknowledged the difficulty of aligning diverse systems, but called the initiative 'an important step forward,' especially for smaller and less resourced countries.
'Ultimately, this should save time, since countries can adapt joint assessments to fit their national context,' she said.
Maya Matthews, Deputy Director and Head of HTA at the European Commission's DG SANTE, highlighted the broader potential. Her team, she stressed, is doing far more than 'niche work.' HTA could be 'the key to some of the big discussions we're having – about access, unmet needs, and reducing complexity.'
One thing is certain: the future of EU health cooperation may well be built, at least in part, on carefully crafted Excel sheets.
(de)
