The Romanian legal landscape is buzzing with changes in the life sciences sectors. With the presence of global pharmaceutical companies and a push for innovative therapies, the country is solidifying its position as a key market, while advancing toward economic stability, according to Musat & Asociatii Deputy Managing Partner Dan Minoiu.
"As Romania grapples with unprecedented high temperature levels, its legal landscape is also heated with significant developments in life sciences," Minoiu points out. "These days the pharmaceutical and healthcare industry in Romania is robustly represented in the market. Many of the top 100 global pharmaceutical companies have a presence here, engaging in various projects – some have even established factories. Romania is considered a key market due to its sizable population and growing healthcare market."
Minoiu highlights that the Romanian healthcare system is quite unique. "Consider the scenario where individuals are suffering from certain diseases that are currently treatable with new medicines and medical devices. Sometimes these treatments are available globally, yet their market access path can be lengthy. In Romania, bureaucratic hurdles often slow this down, and the inclusion of new therapies for patients in the national health insurance system depends on limited state funding." Consequently, Minoiu says, "significant delays can occur before these new therapies benefit communities or specific patient groups."
"Although we have transposed EU pharmaceutical legislation, there are certain pricing and reimbursement issues specific to the Romanian market," Minoiu continues. "Innovations are anticipated across the pharmaceutical sector and the broader market, including involvement from financial institutions. These advancements could greatly benefit both the state budget and mitigate financial risks while promoting access to advanced therapies."
In terms of legislation, "a pressing topic that’s gaining significant attention in other jurisdictions is the implementation of new financial instruments to enhance patients' access to treatment while maintaining a sustainable state budget," Minoiu adds. "These instruments, referred to as 'managed entry agreements' are already regulated across most EU countries. They serve two main purposes: balancing budgetary constraints and promoting innovation. Depending on the situation, they might involve cost-reduction mechanisms, discounts or rebates, or performance-based agreements where the reimbursement levels are tied to achieving specific clinical outcomes."
Additionally, Minoiu comments on the current state of the Romanian economy. "According to data published by Romanian institutions, the economy is performing well, particularly in certain sectors," he notes. "While there is still significant progress to be made to catch up with other EU countries, the current economic environment in Romania is benefiting from an increase in the confidence in Romania as a rather exceptional island of stability in the region. With the expected efforts to lower the inflation rate and to increase revenues to the state budget, the economy is likely to be on a promising trajectory."
Finally, another recurring theme, according to Minoiu, is how to integrate new technologies into the legal profession and keep pace with increasingly sophisticated client demands. "The key question we’re grappling with is how to quickly adapt to the evolving legal landscape and make effective use of the latest tools," he stresses. "While some of these technologies prove highly beneficial for certain aspects of our work, others may be less so. Nonetheless, they provide a valuable starting point for navigating these changes."
