Vlad Voiculescu on the new pharmaceutical legislation: "Romania can use this law to become much stricter with manufacturers"

The new European pharmaceutical reform promises to provide Romania with the necessary levers to stop the chronic drug crisis and to prevent the exodus of innovative companies, warns MEP Vlad Voiculescu.

Brussels, December 15, 2025 — In an analysis of the recent provisional agreement on EU pharmaceutical legislation, MEP Vlad Voiculescu explained how the new rules will change the way Romanian patients access treatments. The reform aims not only to accelerate innovation but also to ensure an equitable distribution of medicines, so that Eastern states are no longer disadvantaged compared to those in the West.

In short

Romania will be able to access a European mechanism for redistributing stocks in case of crisis.

The definition of "unmet medical needs" will be strict to avoid unjustified extensions of monopolies on expensive medicines.

Romanian companies risk migrating fiscally to other EU states not because of the new legislation, but due to internal unpredictability.

One of the most serious problems of the Romanian healthcare system – the periodic disappearance of essential medicines – could be alleviated by the new obligations imposed at the community level. Voiculescu emphasizes that the authorities in Bucharest will no longer be alone in facing large producers.

"Romania can use this legislation to become much stricter with producers and quicker in response. Our country will have access to a European mechanism that allows the redistribution of stocks between states in crisis situations," said the MEP.

He added that producers will be required to have clear plans to prevent shortages, and if the Romanian authorities firmly implement these rules, they can avoid critical situations and obtain emergency solutions directly from the EU.

Regarding the extension of patent protection periods, a sensitive subject for the CNAS budget, Voiculescu insists that incentives should go only towards real innovation, not towards minor modifications of old medicines ("evergreening").

"Authorities must reject extensions of protection for medicines that only bring minor improvements, without real clinical benefits. This way, abuses are avoided and incentives remain directed only towards authentic innovations," he explained.

To protect vulnerable patients, the MEP supports a definition of "unmet medical needs" that includes serious diseases in poor regions, validated by independent experts.

Regarding the impact on IT and HealthTech entrepreneurs, Voiculescu draws attention to the fact that European tools for reducing bureaucracy, such as the Unified European Company (S.EU), are useful, but cannot compensate for the fiscal instability at home.

"Some companies may choose to register in another member state for a more stable fiscal environment, but this phenomenon is not determined by the new pharmaceutical legislation, but by the internal economic situation. (...) Romania needs to reduce its own bureaucracy if it wants to maintain added value in the country," warned Vlad Voiculescu.

The implementation of the new directives will fall to the National Agency for Medicines (ANMDMR) and the Ministry of Health, institutions that will need to quickly integrate the new rules to benefit from European solidarity mechanisms.

https://2eu.brussels/ro/stiri/vlad-voiculescu-despre-noua-legislatie-farmaceutica-romania-poate-folosi-aceasta-lege-ca-sa-devina-mult-mai-stricta-cu-producatorii