Since the end of 2022, EU countries have been reporting serious supply problems with some important medicines, many of which are now in short supply.. POLITICO spoke about how serious this problem is and what is being done to solve it.
How serious is the deficit
In a survey of groups representing pharmacies in 29 European countries, including the EU, as well as Turkey, Kosovo, Norway and North Macedonia, about a quarter of the countries reported shortages of more than 600 drugs, and 20 percent reported shortages of 200-300 drugs. Three-quarters of countries said deficits were worse this winter than a year ago. Groups in four countries reported drug shortages were associated with deaths.
This picture is supported by data from regulators.. Belgian authorities reported a shortage of almost 300 medicines. In Germany - 408, and in Austria at present more than 600 drugs cannot be bought in pharmacies. In Italy, the list is even longer - more than three thousand drugs, although many of them are different forms of the same drug..
What medicines are in short supply?
Antibiotics, particularly amoxicillin used to treat respiratory infections, are in short supply in European countries. Other drug classes, including cough syrups, paracetamol for children, and blood pressure medications, are also in short supply..
Why is this happening?
It is a combination of increased demand and reduced supply.. Seasonal infections - flu and respiratory syncytial virus (RSV) in the first place, started earlier and are more severe than usual. There has also been an unusual outbreak of streptococcus A throat disease in children.. Experts believe the unusually high infection rate is linked to a weakened immune system that, due to lockdowns, is no longer familiar with some of the microbes that surround people in everyday life.. This tough winter, after several quiet years (with the exception of COVID-19), caught drug manufacturers by surprise and they were unprepared.
Inflation and the energy crisis have also put pressure on pharmaceutical companies, affecting supply.
Last year, Centrient Pharmaceuticals, a Dutch manufacturer of active pharmaceutical ingredients, said its plant was producing a quarter less than in 2021 due to high energy costs.. In December, InnoGenerics, another manufacturer from the Netherlands, received government bailouts after declaring bankruptcy to keep its factory running.. According to Sandoz, one of the largest generic drug manufacturers on the European market, this has led to a particularly tight supply situation.. A company representative told POLITICO that, among other reasons, there is a shortage of raw materials and limited production capacity..
How do governments react
Some countries slow down exports to protect domestic supplies. In November last year, the drug regulator in Greece expanded the list of drugs whose resale to other countries - the so-called parallel trade - will be prohibited.. Romania temporarily halted the export of some antibiotics and children's painkillers. Earlier in January, Belgium published a decree allowing authorities to halt exports in the event of a crisis..
These export freezes could backfire. Letter from European Commissioner for Health Stella Kyriakides to Greek Minister of Health Thanos Pleuris asks to take into account the implications of the bans for third countries.
The German government is considering changes to legislation to ease procurement requirements that force health insurers to buy medicines where they are cheapest, concentrating supply in the hands of a few of the most cost-competitive manufacturers.. The new law will require you to buy medicines from several suppliers, including more expensive ones, to make supplies more reliable.. The Netherlands recently introduced a law requiring suppliers to keep a six-week supply of drugs in case of a shortage, in Sweden the government is proposing similar rules.
At a more detailed level, a committee led by the EU medicines regulator, the European Medicines Agency (EMA), has recommended loosening the rules to allow pharmacies, among other measures, to dispense pills or doses of medicines on an individual basis.. In France and Germany, pharmacists have begun to produce their own medicines - although this is unlikely to significantly affect the situation, given the scale of the shortage.
Can the EU fix this
In theory, the EU should be more prepared than ever to deal with a pan-European crisis. The bloc recently updated its legislation to counter health threats, including a shortage of pharmaceuticals.. EMA has been given expanded powers to monitor drug shortages. A new body has also been created, the Health Emergency Preparedness and Response Authority (HERA), which has the right to enter the market and purchase medicines for the entire block.
But not everyone agrees that everything is so bad. The EMA has decided not to ask the Commission to declare an amoxicillin shortage a "
European Medicines Agency's working group on shortages may decide whether to recommend to the Commission that a drug shortage be declared a 'major event'. The EMA Steering Group on Shortfalls will have the authority to request data from suppliers on drug stocks and production capacity, and provide recommendations on how to reduce shortages..
Speaking before the European Parliament's health committee, Sandra Gallina, the chief health commission official, said she wants to "
Others believe that the situation will improve over time.
“I think it will resolve itself, but it depends on the peak of infections. If we peak, supply will quickly recover. If not, then this is probably not the best scenario,” said Adrian van den Hoven, CEO of Medicines for Europe..
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