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EU to revise pharmaceuticals law amid antibiotic shortages

The early upsurge in respiratory infections has led to a sudden increase in demand for antibiotics

Stella Kyriakides

Proposed revisions to the EU pharmaceuticals law have been made amid a growing number of antibiotic shortages across Europe.

Speaking at a session of the European Parliament, EU health commissioner Stella Kyriakides said the revisions could include stronger obligations for supply of medicines, earlier notifications of shortages and enhanced transparency of stocks.

Other, non-legislative measures are also being taken to keep medicine supplies for EU patients going.

The new strategy, planned for March this year, is set to “secure access to medicines for all patients in need and to avoid disruptions of medicines in the EU”, Kyriakides told the session.

She added: “Patients across the EU must always have access to the medicines they need at affordable prices. We have the ambition to achieve this with a new pharmaceutical strategy for Europe.

“As this is a global issue, we are in close contact with our international counterparts, while also supporting member states and industry.”

The root causes of the shortages have already been identified as the sudden increase in demand for antibiotics because of more respiratory infections, along with insufficient production capacity.

Kyriakides also explained that the early upsurge in respiratory infections in Europe this winter has been earlier than usual and was putting pressure on the “already pressed” health systems and workers.

“The lockdown measures that have been in place because of COVID-19 have understandably made people less exposed to respiratory viruses,” she said.

Member states have already reported high transmission rates of respiratory viruses in all population groups and shortages of antibiotics have been reported in 26 European countries, the European Medicines Agency (EMA) said.

“Together with the EMA, we are doing our best to support and coordinate the member states and industry in facing this challenge,” Kyriakides said. “We are deploying all existing regulatory flexibilities and seeking ways with industrial partners to rapidly increase production and prevent and mitigate shortages.”

It was also outlined that, if needed, the Health Emergency Preparedness and Response Authority (HERA) – the health crisis body created to prepare the EU for a future pandemic – could step in and coordinate the procurement of medical countermeasures on behalf of member states.

Article by
Emily Kimber

19th January 2023

From: Regulatory, Healthcare



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