European Union (EU) officials are moving to address recent shortages of  antibiotics, particularly amoxicillin, in the EU and outlined recent action to address manufacturing and supply issues.  

“Shortages of medicines have been an ongoing public health concern, and the situation in the EU has been exacerbated by geopolitical events or trends such as the war in Ukraine, the energy crisis, and high inflation rates,” said the European Medicines Agency (EMA), the European Commission, and the Heads of Medicines Agencies (HMA), through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), in a January 20, 2023 joint statement.   

These groups reported that a recent surge in respiratory infections has led to increased demand for antibiotics  such as amoxicillin (alone and in combination with clavulanic acid), especially in pediatric formulations. In addition, manufacturing delays and production capacity issues have led to supply problems affecting the majority of EU member states. The supply issues also affect countries outside the EU, and the EMA has exchanged information with other international regulators. In addition, various measures have been implemented at the EU member state level to address the situation.  

The MSSG, which is responsible for responding to medicine supply issues caused by major events or public-health emergencies, and the Medicines Shortages Single Point of Contact (SPOC) Working Party, which is responsible for monitoring and reporting events that could affect the supply of medicines in the EU, have been monitoring the situation since November 2022. They say they have been further engaging with key players in the supply chain of amoxicillin for possible supply-mitigation measures, such as increasing manufacturing capacity.  

In addition, the MSSG is encouraging national regulatory authorities in the EU to make use of available regulatory flexibilities, such as allowing the exceptional supply of certain medicines or presentations that may not be authorized in a particular EU member state or granting full or partial exemptions to  certain labelling and packaging requirements. In addition, the MSSG says it supports temporary national measures such as unit-dose dispensing and compounding. 

The European Commission, the EMA, and the HMA are further cooperating to investigate whether additional measures could be undertaken to mitigate the impact of these shortages. The MSSG says it will continue to cooperate with  stakeholders, and the SPOC Working Party will continue to engage with  companies to provide regulatory support to increase supplies. 

Based on current information from companies and stakeholders, EU officials say it is expected that the situation will improve in the coming months (as reported on January 20, 2023).  

Source: European Medicines Agency