Romania: 1,110 days to reimburse an innovative medicine, compared to the EU average of 597

The Romanian Association of International Medicine Producers (ARPIM) highlights that the issues discussed in recent weeks within the healthcare system — funding sustainability, medicine availability, the use of generics and biosimilars, continuity of treatment, and delays in reimbursing innovative therapies — are in fact all part of the same journey: whether the right treatment reaches the patient, and whether it does so in time.

Over 1,100 days of waiting for an innovative medicine

According to data cited by ARPIM, a patient in Romania waits an average of 1,110 days — more than three years — from the European approval of an innovative medicine to its reimbursement in the country. The European average is 597 days.

Of the 168 innovative medicines granted centralised European approval between 2021 and 2024, only 28 were reimbursed in Romania as of 5 January 2026 — representing 17%, compared to a European average of 45%.

The disparities are particularly striking in therapeutic areas where timing is critical. In oncology, Romania reimburses only 20% of medicines approved at European level between 2021 and 2024, against a European average of 51%. For rare diseases (orphan medicines), the figure is also 20%, compared to the European average of 43%. For patients, these delays can mean disease progression, the onset of complications, and a reduction in available treatment options.

Generics, biosimilars, and innovation — part of the same solution

ARPIM emphasises that generic, biosimilar, and innovative medicines should not be viewed as competing solutions. Generics and biosimilars can help make more efficient use of resources where alternatives already exist, freeing up funds to address other system needs. At the same time, for many recent therapies — including those in oncology and rare diseases — no generic equivalent yet exists.

The cost of delayed treatment

The Association notes that the efficiency of a healthcare system cannot be assessed on the basis of medicine prices alone. When treatment does not arrive in time, the costs do not disappear — they simply shift towards complications, hospitalisations, sick leave, productivity losses, and the time families dedicate to caregiving.

A report produced by the WifOR Institute for EFPIA, based on data from 29 European countries, shows that the use of newer medicines between 2014 and 2022 was associated with the avoidance of 20.9 million hospital bed-days and approximately 1.83 million years of life lost prematurely.

For Romania specifically, the same analysis estimates that every euro invested in innovative medicines generates 8 euros in socioeconomic benefit — above the European average of 5.67 euros.

What ARPIM is calling for

The organisation argues that faster and more predictable mechanisms for assessment, pricing, and reimbursement are needed, alongside a pricing policy that supports medicine availability and tools that enable the system to anticipate and plan the financing of new therapies in advance.

ARPIM supports updating the list of reimbursed medicines within the existing legal framework, in parallel with modernising the assessment, pricing, and reimbursement mechanisms. For therapies that have already been assessed, it calls for a clear and predictable pathway between a positive opinion and patients' effective access to treatment.

According to ARPIM, the recent public debate has seen different actors within the system — CNAS, the Romanian College of Physicians, patient organisations, and the pharmaceutical industry — essentially addressing the same issue, albeit from different perspectives: CNAS focuses on funding sustainability, the College of Physicians on access and continuity of treatment, patient organisations on the consequences of treatment disruptions, and the pharmaceutical industry on the entire medicine pathway, from availability through to rapid access to new therapies.

The Association states that it is ready to engage in dialogue, bringing data, expertise, and proposed solutions towards a medicines policy built collaboratively by all stakeholders involved.

Article supported by the Romanian Association of International Medicine Producers (ARPIM).