European Doctors and Pharmacists wants stronger laws to prevent medicine shortages
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As patients throughout the content struggling to find antibiotics and other medicines, particularly for children, doctors and pharmacists have called on the European Commission to deliver stronger legislation to prevent future drug shortages after the European Medicines Agency (EMA) declined to declare the current severe restrictions on antibiotics a “major event.”
Infections, including Strep A and RSV, have surged particularly following the complete removal of Covid-related restrictions, with pharmacists say the shortage is a test bed for the EMA’s expanded mandate to monitor medicine shortages, which was brought in following the severe shortages and desperate hoarding witnessed in the pandemic — and one that has demonstrated its inadequacy.
In comments to Politico, Ilaria Passarani, secretary-general of pharmacists’ lobby, PGEU said that this crisis has shown that the “current regulatory tools in place, including the new regulation on the extended mandate of EMA, are not fit for purpose and are not sufficient to guarantee continued treatment for all patients across Europe.”
A large part of this boils down to a lack of transparency, she said, as the current rules do not ensure that the EMA and national medicines regulators have sufficient information on available stocks. For example, six EU countries don’t have systems in place that allow pharmacies to flag shortages, instead relying solely on manufacturers to report what’s available, she said.
The new EU rules also provide for the creation of a European shortages monitoring platform, which would allow for centralized data collection of the supply and demand of medicines — however, she pointed out it’s only scheduled to be fully operational in 2025.
EMA, Europe’s drug regulator has decided not to label the ongoing shortage of antibiotics in the continent a “major event”. The declaration of a “major event”, would have allowed the European Medicines Agency (EMA) to coordinate action at a pan-European level and increase the reporting obligations of manufacturers.
Ancel·la Santos, senior health policy officer at the European consumer organization BEUC, said the EMA’s decision not to initiate a major event was a missed opportunity to show the EU takes the issue seriously. “[It] would have sent a strong political message that this issue is a priority,” and provided the EMA with more detailed information and the competence to coordinate actions at the EU level, she said.
The EMA said, however, that its processes provided “clear and up-to-date understanding of the current situation.”
EU officials have asked drug suppliers to increase production capacity and have made recommendations, including encouraging EU states to allow the use of medicines that may not be authorised domestically.
There has been a spike in demand for certain drugs linked to the resurgence of respiratory infections after two years of COVID restrictions, which has put additional pressure on global supplies, and made obtaining imports from elsewhere unlikely. Drugmakers had also cut output when demand dipped at the height of the pandemic.
Europe is in a difficult position given the migration of generic ingredient and drug manufacturing to places like India and China where costs are lower.
Meanwhile, local producers have faced large hikes in input costs due to the war in Ukraine.
