The Association of European Medicines Distributors (ADEM) contests the measure proposed by the Ministry of Health regarding the temporary suspension of the distribution outside the territory of Romania, for a period of 6 months, of certain oral antibiotic and antipyretic medicines.
In the context of the increasing spread of the respiratory syncytial virus (RSV) in the EU/EEA and implicitly the establishment of the state of epidemiological alert in Romania on January 7, the Ministry of Health published, on December 29, 2022, the draft order regarding the approval of the List of Antibiotic Medicines and antipyretics with oral administration, whose distribution outside the territory of Romania is to be temporarily suspended, for a period of 6 months.
“ADEM believes that the export suspension measure is redundant and unjustified, creating unnecessary turbulence in the Single Market. We do not understand the measure, we do not understand why medicines that are not exported are proposed for export suspension, we do not agree with this measure and we would like to get some clarifications on this matter,” says ADEM.
ADEM maintains that the measure does not solve the “already known” problems that cause “shortages and that affect the producers” and budgets allocated to medicines, such as: manufacturing related reasons, high demand and consumption, delays or unavailability of raw materials necessary for packaging or for making the active substances and mainly the commercial reasons caused by the increase in the prices of utilities against the background of the energy crisis and implicitly the increase in the prices of all the components on the entire manufacturing chain.
“Romania ranks first in Europe in terms of consumption of antibiotics, with an extremely high level of bacterial resistance, and in the last ten years it has not been possible to take measures to limit the excessive consumption of antibiotics, neither in the case of outpatients nor in hospitals. Generic medicines, affordable for the already poor population due to the very high inflation, have been and are being permanently withdrawn from Romania. These are real and effective solutions, while the authorities are overly concerned with suspending exports, which wouldn’t be a problem in the first place had the fundamental problems of the pharma market been regulated,” the ADEM press release also states.