Romania continues to have the most difficult access to innovative treatments in the European Union, shows the latest report of the European Federation of Pharmaceutical Industries and Associations (EFPIA). Romanian patients wait, on average, 1,110 days for a new medicine approved in Europe to be compensated through the public health system. In many cases, delays can mean worsening of the disease or loss of important treatment opportunities.
Romania, Europe’s backbone for access to medical innovation
The EFPIA data, presented by the Romanian Association of International Medicines Manufacturers (ARPIM), show that of the 168 innovative medicines approved at European level in the period 2021-2024, only 28 were compensated in Romania at the beginning of 2026. Therefore, Romanian patients have access to only 17% of the innovative treatments available in Europe, while the European average is 45%.
At the same time, the average waiting period for access to new treatments is approximately 1,110 days, almost double the European average, estimated at 597 days.
The report shows that other countries in the region are also managing to provide faster access to innovative medicines. In the Czech Republic, patients wait approximately 659 days for compensation for a new treatment, in Poland approximately 714 days, and in Croatia approximately 734 days.
The situation is critical in oncology and rare diseases
The differences translate directly into lower chances of treatment and, by implication, survival.
“1,110 days means over three years in which a cancer patient, a child with a rare disease or a person with a severe chronic condition sees how the treatment they need exists in other European countries, but not in Romania”,
says Rozalina Lăpădatu, president of the Association of Patients with Autoimmune Diseases (APAA)
According to the EFPIA report, Romania reimburses only 20% of oncology drugs approved at European level between 2021 and 2024. In comparison, the EU average is 51%.
In the case of medicines intended for rare diseases, only 13 of the 66 treatments approved in the analyzed period are compensated in Romania, which means a percentage of approximately 20%, compared to the European average of 43%.
“The data of the WAIT 2025 report show, once again, that Romania remains at the bottom of the European Union in terms of patients’ access to innovative medicines, this time occupying the last place. This gap is felt even more in the areas with the greatest impact on survival and quality of life. We are talking about a gap documented for years, which continues to deepen, with direct effects on patients”. draws the attention of Dr. Ioana Bianchi, Director of External Relations ARPIM.
Underfunding of the health system, one of the main causes
Representatives of the pharmaceutical industry say that the delays are directly related to the reduced level of investment in health.
Romania spends approximately 1,354 euros per capita on health, and the net public expenditure on medicines is only 138 euros per capita. The level is almost 40% below the Central and Eastern European average and more than three times lower than the European Union average.
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According to ARPIM, the effects are visible both in life expectancy, lower than the European average, and in the late diagnosis of many diseases.
“For the health system, the pressure is moving towards hospitalizations and other more expensive interventions, in a context already marked by underfunding. We need a strategic dialogue with the authorities and concrete solutions that will structurally change the access to innovation in Romania”, says Dr. Radu Rășinar, president of ARPIM.
What solutions do the representatives of the pharmaceutical industry propose?
Among the measures considered priority are the creation of a predictable financing mechanism for the introduction of new compensated drugs, the modernization of the treatment evaluation process and the reform of the clawback tax (that mechanism by which the state recovers from the pharmaceutical companies a part of the costs of compensated and free drugs).
Also, the representatives of ARPIM propose the use of some type mechanisms “horizon scanning”which would allow for the early estimation of the drugs to be included in the compensation list and the necessary budgets.
Europe is losing ground in the global competition for innovation
The report also draws attention to the fact that access to innovative treatments is becoming more difficult at European level. The share of medicines fully compensated through public systems decreased from 42% in 2019 to 28% in 2025, and the average waiting time for patients increased.
At the same time, Europe is losing ground in the global competition for pharmaceutical research and development, while investments are increasing rapidly in the US and China.
For Romania, this context means the risk of falling even further behind if health reforms and investments in access to innovation are not accelerated in the coming years.
