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Survey: Only 17% accessibility rate for Romanians to new medicines approved at European level in 2019-2022
Romanians have access to only 17% of the medicines approved at European level in the period 2019-2022, in 2023, no new medicines were unconditionally subsidised in our country, and in 2024 only 28 new medicines were included in the list of those subsidised, according to data from the study of the European Federation of Pharmaceutical Industries and Associations (EFPIA) on the Indicator of Access to Innovative Medicines Patients W.A.I.T. (Waiting to Access Innovative Therapies) for 2023.
The Romanian Association of International Manufacturers of Medicines (ARPIM) made public on Thursday a series of data from three reports published in June 2024 by EFPIA, data collected from 36 countries (27 from the EU and 9 from outside the EU) that provide information on the 167 innovative medicines with centralized marketing authorization in the period 2019-2022.
Dr. Ioana Bianchi, Director of Foreign Affairs at ARPIM, said that, according to the study data, in Romania, the availability rate of oncological drugs was 19% (out of the 48 that received European approval between 2019 and 2022, only 9 were available in Romania on January 5, 2024) as well as in the case of "orphan" drugs (drugs dedicated to the treatment of rare diseases) which was also 19%.
Out of 167 innovative medicines that received approval from the European Medicines Agency (EMA) between 2019 and 2022, only 29 medicines were available in Romania on 5 January 2024. No medicine approved at European level in 2022 was subsidised in Romania on January 5, 2024.
The drop is dramatic compared to last year's similar study, which showed an availability rate of 30% (51 drugs), the study data also highlights.
As for the access time, i.e. the time from approval by the European Medicines Agency (EMA) to availability in Romania, it is 778 days, while German patients, for instance, have access to state-of-the-art medicines in just 126 days, according to the data presented by Dr. Bianchi.
In our country, the main reasons why pharmaceutical companies have to wait to submit their evaluation files are: the evaluation criteria, the technical and human infrastructure necessary for diagnosing diseases, so the average time for submitting files is 86 days, but the average time for a reimbursement decision is 563 days, the data of the said study reads.