Romania’s acting Health Minister Cseke Attila has ordered an urgent audit of the entire mechanism for monitoring and overseeing the availability of medicines, the Health Ministry announced on Wednesday, 26 August. The decision comes as Romania still lacks a digital system capable of showing, in real time, when a drug stock reaches a critical level.
🖥️ A digital early-warning system
„It is inadmissible that Romania still lacks a digital system to track medicine traceability and know in real time when a stock reaches a critical level. We cannot wait for a medicine to disappear from the market and only then look for solutions”, Cseke said. „We need a system that alerts us before a crisis occurs, not after it appears. We need clear, real-time data, not estimates and information that arrive late. The patient must be our first reference point when we talk about medicine availability.”
The minister stressed that Romania must be able to see in advance where problems arise and intervene before patients are affected, rather than discovering that a medicine has disappeared from the market only when it is too late.
🏥 Audit across the entire health system
The audit targets structures within the Health Ministry, hospitals, as well as the National Agency for Medicines and Medical Devices of Romania (ANMDMR). Cseke also said he believes an audit is necessary on how the National Oncology Programme is being run, in the context of repeated signals about the availability of oncology treatments, including cytostatics.
The review also covers the procedure for issuing Special Needs Authorizations (ANS) — the mechanism through which medicines that are missing from the Romanian market can be brought in for individual patients. The ministry is also analysing raising the minimum stock threshold from which the authorization procedure can start, currently set at 10 percent. „If a medicine is already at a very low stock level, we cannot treat this situation as if there were no risk for patients. We will change the current threshold. The rules must allow us to intervene earlier and protect patients’ access to treatment”, the minister added.
💊 Why now: supply warning signals
The measures come after several signals of supply problems for certain medicines, including epilepsy treatments. In recent months, pharmacies and patient organisations have repeatedly drawn attention to the risk of shortages, arguing that the current monitoring tools provide information too late, when stocks have already reached dangerously low levels.
According to the ministry, the goal is to move from a reactive approach to a preventive one: alerts should be triggered long before a medicine disappears from shelves, so that authorities can intervene, redirect stocks or accelerate imports in time.
🔍 What’s next
- Complete report from ANMDMR — the National Agency for Medicines is expected to deliver a full report on market monitoring, with concrete data on stocks and supply bottlenecks.
- Concrete IT proposals — the ministry wants concrete solutions to improve the digital systems used to track medicine traceability and availability in real time.
- Revised stock threshold — the current 10-percent threshold for triggering the special authorization procedure is expected to be raised so that interventions start earlier, before a crisis develops.
Source: Mediafax
