The off-label use of drugs is currently not regulated in Romania. Rather, it is up to physicians to decide on the off-label use of a product based on their independent medical assessment. According to a draft legislative initiative, this is about to change in Romania and off-label use should therefore be pre-approved by the National Medicines Agency, based on existing evidence of effectiveness.
The bill refers to the following circumstances: (i) use for life-threatening conditions that are not covered by approved products; (ii) use for conditions for which approved therapies are unsatisfactory; (iii) use for the treatment of diseases for which there is no approved drug. It is unclear whether the bill intends to limit off-label use to just these situations.
In addition, there is uncertainty as to the type of existing evidence against which off-label use is assessed, as the bill is silent on this.
Requests for off-label use can only be made by healthcare professionals (PSS), to whom the National Medicines Agency must respond within 15 days. In the absence of a response, the request is considered tacitly accepted.
The legislative process was launched in 2021 and is ongoing. The bill has been approved by the Senate and is awaiting debate in the Chamber of Deputies, as the judicial parliamentary chamber.
There have been two previous initiatives to regulate off-label prescribing, which were not adopted as no alignment was achieved due to the medical-scientific complexity of the issue. This time, the bill has strong political support and is seen as a necessity in situations like the COVID-19 pandemic. The practical impact on business is difficult to assess at this stage, as the draft provision is very brief (it only has 2 paragraphs). Therefore, we believe that the project will most likely require additional implementation standards which will be proposed later this year.