Interim Health Minister Cseke Attila has ordered the "urgent" launch of an audit of the entire mechanism for monitoring and overseeing the availability of medicines, including the procedure for issuing authorisations for special needs (ANS).
"It is unacceptable that Romania still does not have a digital system allowing us to track medicines 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. We need to identify problems in advance and intervene before patients are affected. The audit covers structures within the Health Ministry, hospitals, as well as the National Agency for Medicines and Medical Devices of Romania. I also believe that an audit is needed into the way the National Oncology Programme is being implemented," Cseke Attila said, according to a statement from the Health Ministry sent to AGERPRES.
He asked the National Agency for Medicines and Medical Devices of Romania to provide a comprehensive report on the monitoring and oversight of the medicines market, clearly identifying existing problems and what needs to be changed to prevent further supply disruptions.
At the same time, the report should include concrete proposals for improving IT systems, so that an alert system can flag in advance situations in which medicine stocks reach a critical level.
"We need a system that alerts us before we have a crisis, not after one occurs. We need clear, real-time data, not estimates and information that arrives late. The patient must be our primary reference point when we talk about medicine availability," Cseke Attila said.
The interim Health minister also asked the relevant department to review the procedure for issuing ANS authorisations and amend the current order.
One of the changes under consideration concerns raising the minimum stock level at which the procedure for issuing or reauthorising an ANS can be initiated. The current threshold is 10%, while the Health Ministry is considering setting it at a higher level in order to provide better protection for the availability of medicines on the Romanian market, the statement said.
"If a medicine's stock is already at a very low level, we cannot treat this situation as if there were no risk to patients. We will change the current threshold. The rules must allow us to intervene earlier and protect patients' access to treatment," the minister explained.
Cseke Attila stressed that the measures ordered are aimed at changing the way medicine availability is monitored in Romania, through a faster, more transparent and data-driven mechanism.
"I do not want us to find out that there is a problem only after a medicine has disappeared from the market. I want us to know in advance what is happening with stocks, have alerts in place and be able to intervene quickly. That is what a system that works for the patient means," Cseke Attila said.
