Governments’ “stupid” strategies to stockpile medicines will lead to drug shortages in other EU countries this winter, Czechia’s Deputy Health Minister Jakub Dvořáček warned, as he called out Germany over its requirement.
Berlin announced last year that pharmaceutical companies must hold six months worth of supplies of certain off-patent medicines in a bid to tackle chronic and growing drug shortage problems.
Throughout Europe, countries have been beset by severe drug shortages, especially during winter when rates of disease surge. Several countries have now imposed their own measures including mandatory stockpiles, with Germany’s required stocks being the highest.
But Dvořáček says these kinds of national measures will have a knock-on effect on the availability of drugs in other European countries and undermine EU-wide measures aimed at plugging medicine gaps.
“My winter will probably be tough again,” he said in an interview with POLITICO.
He argues that such strong measures from larger countries mean that drug companies will prioritize those markets, even if it means drugs are left “lying there in the warehouse.”
“Imagine the situation: We have Czech pharmacies, Slovak pharmacies, which are empty and German pharmacies which are full. Every patient will say ‘oh, the stupid government, you are not able to protect us, we have to go to German pharmacies to get pharmaceuticals,’” he said.
The EU introduced new measures last year to make it easier for countries to share medicines when they experience critical drug shortages.
But Dvořáček says that recent national moves taken by countries including Austria and France could undermine the EU-wide solidarity plan.
Medicines for Europe, which represents the off-patent, generic drugs sector that supplies around 70 percent of the therapies used in Europe, says that a six-month reserve of the average demand of antibiotics for Germany would mean that a quarter of the total EU supply is ring-fenced for the German market only.
Pushing for change
Czechia, alongside Romania, Cyprus, Malta, Slovenia and Slovakia, will use a meeting of health ministers on Friday to push for countries to reconsider their national strategies and ask the European Commission to analyze whether the measures are compliant with EU law.
A paper, to be shared at the meeting, is “against stupidity,” Dvořáček said. “It’s about being clever, about planning, thinking and sharing,” he said.
He also called for countries to be more open with each other. “It’s also about informing each other that you are going to [change legislation] — so we are not finding out based on information from someone else,” he said, adding: “We were warned by producers.”
Dvořáček argues that it’s not just smaller countries which oppose stockpiling measures. The European Commission recommended that Austria’s proposed four-month stockpiling obligation should allow a release clause “in case of urgent demand” in another EU country.
The Commission also called for a common EU-wide approach to be developed with EU countries this year.
Responding to Czechia’s criticism, Berlin played down the impact its mandatory stockpiles will have.
The obligation “does not apply to all medicinal products, but only to off-patent medicines and only within the framework of discount agreements concluded between the pharmaceutical entrepreneur and the health insurance companies,” Sebastian Gülde, a spokesperson for the German health ministry, told POLITICO in a written response.
“The companies would only be allowed to conclude contracts with the German health insurance companies if they can fulfil the contractual obligation to stockpile the prescribed quantity of medicinal products,” which “does not affect existing obligations in other countries,” Gülde said.
“As we understand it, the companies remain obliged to fulfil their obligations from the previous contracts in other countries. German law does not stand in the way of this.”
This article has been updated to add Slovakia to the countries that co-signed the paper.