Germany gears up to avert winter drug shortages

Amid warnings of potential shortages for key medicines this winter, German health minister Karl Lauterbach presented a five-step plan and reassured the public that the country is “much better prepared” than one year ago.

Like several European countries, Germany was faced with shortages of key medicines last winter, including antibiotics, fever drugs, and painkillers, with children’s drugs especially affected.

At the time, a high number of respiratory infections, including COVID-19 as well as the common cold and flu, pushed the supply of common drugs beyond its limits – a situation many fear could return this year.

After meeting with key stakeholders in Berlin, Lauterbach on Thursday (14 September) tabled a national five-step plan to tackle potential shortages.

“This fall and winter, we will do everything we can to make sure children get the medicines they need,” the health minister stressed in a statement.

Among the factors destabilising the medicine supply across the EU are a lack of geographical diversification when sourcing key ingredients and medicines, perceived regulatory complexity, and the increased specialisation of the supply chains.

“The reason we have shortages is due to many different variables. It’s not one,” Health Commissioner Stella Kyriakides said in spring 2023, when presenting the pharmaceutical strategy proposal, a part of which aims to address drug shortages.

The proposal, however, is still a way away from a political agreement, as the Parliament and Council still have to form and agree on their positions.

Counting on a concerted effort

For the majority of the five measures set out in the new plan, the ministry counts on the cooperation of doctors, producers, and pharmacies.

With the pharmaceutical companies, Lauterbach agreed to a “regular exchange of situational analyses” meant to help pre-empt any risk of shortage.

Meanwhile, doctors are set to “appeal to parents” so that they do not “unnecessarily” hoard large quantities of drugs at home, while the government will help promote a “sober” assessment of the situation to avoid panic buys.

“If panic buys are avoided, the supply of pediatric drugs is largely assured in the fall-winter,” the ministry statement stressed.

The pharmacists’ umbrella association ABDA, for its part, committed to working towards a level distribution of the drugs in question and is set to extend efforts to exchange stocks with each other where needed – something the government will ensure is possible legally.

“Much better” situation than last year

Meanwhile, as the only major new legislative measure presented as part of the plan, the suspension of fixed sums for critical drugs will be prolonged. Fixed sums usually set out the maximum price producers can charge health insurance companies for their drugs. Their suspension is meant to ensure production is financially attractive for pharma companies.

The new plan comes on the back of an anti-shortage law, which was passed in April and came into force in July, which included the loosening of certain price rules for drugs as well as stricter obligations on the stockpiling of key medicines.

However, Lauterbach said on Thursday the law will need more warm-up time before its effects will be fully seen.

Still, the minister is optimistic that Germany is prepared for the upcoming winter. “We are in a much better position than last year,” he stressed.

Pharmacists, industry sceptical

But pharmacists are less convinced. In an interview with public TV station ARD, Thomas Preis, head of the pharmacists’ association of the Northern Rhine region, said more than 1.5 million people are currently already affected by drug shortages every day.

Especially for antibiotics and generics – drugs that are not patented any more – supply is at risk, he warned.

Generics association ProGenerika also criticised Lauterbach’s new measures as not going far enough.

“Individual steps are helpful as acute symptom treatment. They do not change the root problem,” the association’s chairman, Andreas Burkhardt, said.

According to Burkhardt, generics companies are already producing at full capacity and would “urgently” need to invest in expanding their production capacities but are lacking the “economic foundation” to do so.

“This is not going to be changed by the ALBVVG [the new law] either,” he stressed.

[Edited by Nathalie Weatherald]