The current antibiotic shortage remains a ‘big alarm bell’ for Europe but it does not require special measures as alternatives to cope with are available to member states, the  European Commission’s health policy ‘number-two’ said.

Shortages of certain medicinal products – and in particular antibiotics for pediatric care – are causing a lot of headaches for EU governments and their regulatory institutions.

Recently, the demand for amoxicillin, an antibiotic used to treat bacterial infections, markedly increased due to a surge of cases of respiratory viruses combined with continued COVID-19 infections.

However, according to the head of the Commission’s health services (DG SANTE) Sandra Gallina, the situation in Europe is not as dramatic as it has often been described.

“Let me dismiss a bit the idea that there is a huge shortage,” she told MEPs in the European Parliament’s environment and health committee on Monday evening (23 January).

She added that it is still possible, at the current stage of the shortage, to fend off some scarce medicine products with other options. In particular, she pointed out that both the EU’s medicine agency (EMA) and the Commission are offering regulatory flexibility to member states to allow the use of different formulations to replace the drugs that are in short supply.

“We need to say this so that people don’t become completely distressed,” she continued. However, she acknowledged that for patients it is already “very distressing not to find the medicine that he or she is expecting to find”.

However, some MEPs criticised the Commission’s new approach to the matter.

“I don’t think we should create the impression that everything is OK. People are struggling to access medicines, and there are no alternatives in place,” replied German socialist MEP Tiemo Wölken.

Likewise, German Christian democrat Peter Liese raised his own experience of working in paediatrics before becoming an MEP, saying that his former hospital sounded an alarm bell regarding the lack available of antibiotics.

“They told me it was the most horrible Christmas that they ever had. And this was not due to COVID: it was due to the RS [respiratory syncytial] virus,” he said.

Costly options

In a statement released on Friday (20 January), the EMA said that 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.

In particular, some paediatric medical formulations are no longer available in Europe because of an explosion of respiratory infections among children of a very young age, likely linked to the reduced circulation of respiratory viruses over the past three years, as a consequence of the COVID-19 lockdown.

For Gallina, the primary root cause is “a wrong calculation in terms of the demand” by pharmaceutical companies, as did not anticipate a simultaneous surge in respiratory infections across Europe, the US and Latin America.

“Production for antibiotics is not at the snap of your fingers, you need at least 45 days,” she said, adding that it is important to be aware that this demand crisis for amoxicillin is also linked to industrial choices.

During the hearing, some MEPs suggested the Commission consider activating the EU joint procurement crisis response mechanism for medicines, whose rules were lately improved when it comes to better security of supply.

Gallina replied that this remains a possibility, but not a good one since the shortage is already started.

“You need to be doing joint procurement much before because now you will be buying at the highest price”, she said, adding that the affordability of medicines is also an important element of supply issues.

Other MEPs hinted at the option to resort to the recently extended mandate of the EMA which can be triggered in case of ‘major events’ in relation to shortages.

But not even this possibility seems viable for the head of DG SANTE. “Whenever there are alternatives – and in this case, there are alternatives, we cannot be just going for a major event as it triggers a whole set of elements, including the increase of prices,” she concluded.

Source: Euractiv.com