Romania is experiencing significant pressure in pharmaceutical reimbursement and increasingly heavy FDI scrutiny, creating uncertainty and added complexity across the market, according to DLA Piper Romania Partner Alina Lacatus.
“One theme has dominated much of the recent legal work: the reimbursement of new, innovative medicines,” Lacatus explains. “Even after a medicine is scientifically assessed through the healthcare technology assessment and approved by the National Drug Agency for inclusion in the reimbursement list, it cannot reach patients unless the state also has the budget to pay for it. This tight connection between technical approval and annual budget availability has made the system particularly fragile.”
According to Lacatus, the biggest disruptions came from “Romania’s mechanism for reimbursing certain innovative medicines under cost-sharing agreements. These agreements require companies to contribute financially to the state budget in exchange for the state reimbursing the product. Because the 2025 budget law left too little money for renewing the existing agreements and concluding new agreements for new molecules, around twenty medicines that had already been reimbursed and were under such agreements could not enter into new negotiations.”
At the same time, “the pathway for medicines that do not require cost-sharing agreements also stalled,” Lacatus adds. “These products only need to be added to the reimbursement list once they are approved for unconditional inclusion in the reimbursement list, but the list was not updated. Several draft updates were circulated for public consultation, yet none were adopted, meaning that no new medicines were included despite having completed the healthcare technology assessment process with the outcome of unconditional reimbursement. This left patients waiting and companies uncertain about timelines.”
A legislative change in early October added even more pressure. “For the purpose of a medicine being included in the reimbursement list, it introduced extended donation obligations for certain medicines, requiring companies to donate products for longer periods and in larger quantities.” According to Lacatus, “the state introduced these measures as a way to secure free access to treatment for specific patient groups in the absence of sufficient funding. This meant for companies revisiting market strategies and finding new ways to comply with the law.”
“A draft update to the reimbursement list was supposed to enter into force on December 1, but it still has not been adopted, leaving predictability extremely low,” Lacatus points out. “Some medicines have been waiting more than three years for reimbursement. As delays continue, more patients are turning to the courts to force the state to provide treatments free of charge, a trend that has noticeably increased. There is cautious hope that upcoming adjustments to the healthcare tax may bring more funds into the system and improve stability.”
Parallel to the challenges in healthcare, “lawyers have experienced Romania’s FDI screening regime that has become one of the broadest and most demanding in the region,” Lacatus adds. “Romania reviews investments not only from non-EU countries but also from EU and even Romanian investors. Approval is required for traditional M&A deals but also for greenfield projects, internal restructurings, capital increases, and certain loans. With a low EUR 2 million threshold of the investment and an unusually wide definition of sensitive sectors, the number of filings has surged.” Last year, she adds, “the national security authority reviewed around 500 cases – double the year before and far higher than in neighboring CEE countries. As volumes grow, review times are slowing, affecting transactions in sectors from energy and IT to real estate and manufacturing. Without simplification, even straightforward deals will continue to require lengthy approvals, adding another layer of conservatism to the market.”
