By Penny Bouloutza
Recommendations to pharmaceutical companies to increase their production capacity of antibiotics for the treatment of respiratory infections, and to EU member states not to stockpile them at the expense of their general availability in Europe, were addressed by the European Health Emergency Preparedness and Response Authority (HERA) ahead of the winter. This effort aims to prevent a recurrence of shortages in critical antibiotics, especially amoxicillin and amoxicillin/clavulanic acid, which many countries faced last year.
During HERA's latest session at the end of July, attended by representatives from EU countries, the European Medicines Agency, pharmaceutical companies, and the European Centre for Disease Prevention and Control, the focus was on the availability of antibiotics for the upcoming autumn and winter. Shortages were deemed unacceptable, even if limited to one member state.
The current list of temporary export bans encompasses 228 pharmaceutical formulations, involving 117 different active substances.
The meeting discussed supply and demand for different antibiotics and their formulations, with recommendations for actions to facilitate the specific market. The industry was asked to increase production capacity for antibiotics in areas that might face issues. National authorities were urged not to stockpile antibiotics to avoid potential exacerbation of the situation and to take measures to promote their responsible use. Notably, in our country, recent large-scale meetings with relevant national authorities requested pharmaceutical companies to ensure full market coverage by increasing quantities of broad-spectrum antibiotics, both domestically produced and imported.
During the HERA session, pharmaceutical industry representatives raised the issue of low antibiotic prices, which render production unprofitable. The idea of a common procurement of antibiotics at the same price for all member states, suggested during the meeting, was not universally embraced as it would mean higher acquisition costs for some countries, including Greece.
Nevertheless, the European Centre for Disease Prevention and Control (ECDC) offered a tentative positive outlook for the intensity of respiratory infections in the upcoming winter. Based on the current flu season in the southern hemisphere and SARS-CoV-2 trends, there are no indications of a "severe" winter regarding respiratory illnesses.
"HERA, along with the European Medicines Regulatory Authority, is devising a strategy to prevent and address the complex issue of antibiotic shortages, a phenomenon strongly observed last winter. It is significant that pharmaceutical industry representatives maintain constant communication with competent authorities to predict antibiotic demand with utmost precision and take all measures to ensure its coverage," said Vasilis Kontozamanis, Greece's representative on HERA's Board of Directors. He added, "Continuous monitoring of the situation is imperative. So far, considering the flu season's progression in the southern hemisphere, there are no signs of a respiratory disease surge, which makes us optimistic that this winter's situation will improve."
The problem of inadequate coverage of antibiotic demand was acute last winter in our country and persists today for certain formulations. Manolis Katsarakis, General Secretary of the Panhellenic Pharmaceutical Association, mentioned that "we faced difficulties last winter due to shortages in respiratory formulations and some antibiotics, such as clarithromycin, amoxicillin, and amoxicillin/clavulanic acid. Currently, the market for respiratory formulations has been restored, and for antibiotics, we are beginning to have sufficiency. Although there are limitations on how much we can order, the flow from pharmaceutical warehouses to pharmacies remains constant. However, for antibiotic syrups, which are worth noting are not available in generic form, procurement remains a challenging endeavor."
Mr. Katsarakis is hopeful that the problem won't be severe this year. "Very recently, the National Organization for Medicines (EOF) decided to update the list of medicines prohibited from being exported, adding antibiotics and respiratory formulations that were not on the previous list. This strengthens the Greek market against the outflow of medications planned to be distributed for the country's residents. This removes any argument for pharmaceutical companies not to supply sufficient quantities of drugs to the Greek market," he points out.
The current list of temporary export bans encompasses 228 pharmaceutical formulations, involving 117 different active substances. This includes 11 formulations of orally administered broad-spectrum antibiotics, including amoxicillin and azithromycin, and 12 topically used antibiotics, such as ophthalmological and dermatological formulations, or combinations of antibiotics with other active substances. According to Diomidis Lyberis, Vice President of EOF, the temporary export ban on medications is one of the measures taken to address shortages. "We must examine the reason for each shortage. For example, last year, in some cases, shortages were linked to changes in companies' production plans. Due to COVID-19 and the measures taken to address it, there was no surge in respiratory infections in previous years, so companies had reduced production in related formulations," Lyberis notes.
Additionally, since late July, the EOF platform has been operational, requiring pharmaceutical warehouses to report real-time sales and inventory of scarce drugs. This is a measure to prevent hoarding of medications with the prospect of selling them abroad once the export ban is lifted. "And of course, we have reminded pharmaceutical companies of their obligation to adequately supply the Greek market with quantities of formulations," emphasizes Lyberis.
[This article was translated from its Greek original]
