Zagreb: A national reimbursement agency here has spent eighteen months trying to work out which incoming medicines will arrive with a European clinical dossier attached and which will not. On 19 August the Commission published a tool intended to answer that question before a company files anything.
The eligibility tool and the accompanying updated guidance sit inside the health technology assessment regulation, which since January 2025 has required joint clinical assessments for new oncology medicines and advanced therapy medicinal products. From January 2028 the scope widens to all orphan medicines, and from 2030 to every centrally authorised medicine.
The regulation solved a duplication problem. Before it, twenty-seven national bodies each appraised the same clinical evidence for the same medicine, asked the developer for broadly the same data in slightly different formats, and reached conclusions that diverged more from differing methods than from differing evidence. A joint assessment produces one clinical analysis that all member states use.
It deliberately did not solve the pricing problem. Member states keep full control over whether they reimburse a medicine and at what price, because health system financing remains national competence. The joint assessment answers whether a medicine works better than the comparator. It says nothing about whether a given country can afford it.
That division sounds clean and creates friction in practice. National agencies have complained that joint assessments sometimes select comparators that do not reflect their national standard of care, which leaves them redoing work the regulation was meant to eliminate. Developers have complained about the opposite problem, that the scoping process demands evidence across every plausible national comparator and inflates dossiers accordingly.
Hence the eligibility tool. Its practical value is timing. A developer that knows early whether its product falls in scope can design the evidence package around the joint requirements rather than retrofitting a national dossier. The Commission’s health service has framed the update as removing uncertainty, which is a modest claim and probably an accurate one.
Small developers benefit most. A large pharmaceutical company employs people whose entire job is regulatory strategy across European markets. A biotech with one asset and forty staff does not, and has been the group most likely to discover its obligations late. The orphan medicines expansion in 2028 will hit exactly that cohort, since rare disease development skews heavily towards small firms.
The 2030 endpoint is where the system faces its real test. Assessing every centrally authorised medicine means a volume of joint work far beyond current capacity, drawing on assessors seconded from national bodies that are themselves short-staffed. If capacity does not scale, the coordination group faces a choice between slower assessments and thinner ones, and neither serves patients waiting for access decisions.
For the agency in Zagreb, the immediate change is smaller and welcome. It can now see what is coming. Whether a European assessment shortens the gap between authorisation and reimbursement in Croatia depends on a budget conversation that no tool will resolve.
