Tag: Safety

When you’re feeling under the weather, the last thing you want to do is trek from pharmacy to pharmacy searching for basic medicines like cough syrup and antibiotics. Yet many people across Europe — faced with a particularly harsh winter bug season — are having to do just that.

Since late 2022, EU countries have been reporting serious problems trying to source certain important drugs, with a majority now experiencing shortages. So just how bad is the situation and, crucially, what’s being done about it? POLITICO walks you through the main points.

How bad are the shortages?

In a survey of groups representing pharmacies in 29 European countries, including EU members as well as Turkey, Kosovo, Norway and North Macedonia, almost a quarter of countries reported more than 600 drugs in short supply, and 20 percent reported 200-300 drug shortages. Three-quarters of the countries said shortages were worse this winter than a year ago. Groups in four countries said that shortages had been linked to deaths.

It’s a portrait backed by data from regulators. Belgian authorities report nearly 300 medicines in short supply. In Germany that number is 408, while in Austria more than 600 medicines can’t be bought in pharmacies at the moment. Italy’s list is even longer — with over 3,000 drugs included, though many are different formulations of the same medicine.

Which medicines are affected?

Antibiotics — particularly amoxicillin, which is used to treat respiratory infections — are in short supply. Other classes of drugs, including cough syrup, children’s paracetamol, and blood pressure medicine, are also scarce.

Why is this happening?

It’s a mix of increased demand and reduced supply.

Seasonal infections — influenza and respiratory syncytial virus (RSV) first and foremost — started early and are stronger than usual. There’s also an unusual outbreak of throat disease Strep A in children. Experts think the unusually high level of disease activity is linked to weaker immune systems that are no longer familiar with the soup of germs surrounding us in daily life, due to lockdowns. This difficult winter, after a couple of quiet years (with the exception of COVID-19), caught drugmakers unprepared.

Inflation and the energy crisis have also been weighing on pharmaceutical companies, affecting supply.

Last year, Centrient Pharmaceuticals, a Dutch producer of active pharmaceutical ingredients, said its plant was producing a quarter less output than in 2021 due to high energy costs. In December, InnoGenerics, another manufacturer from the Netherlands, was bailed out by the government after declaring bankruptcy to keep its factory open.

The result, according to Sandoz, one of the largest producers on the European generics market, is an especially “tight supply situation.” A spokesperson told POLITICO that other culprits include scarcity of raw materials and manufacturing capacity constraints. They added that Sandoz is able to meet demand at the moment, but is “facing challenges.”

How are governments reacting?

Some countries are slamming the brakes on exports to protect domestic supplies. In November, Greece’s drugs regulator expanded the list of medicine whose resale to other countries — known as parallel trade — is banned. Romania has temporarily stopped exports of certain antibiotics and kids’ painkillers. Earlier in January, Belgium published a decree that allows the authorities to halt exports in case of a crisis.

These freezes can have knock-on effects. A letter from European Health Commissioner Stella Kyriakides addressed to Greece’s Health Minister Thanos Plevris asked him to take into consideration the effects of bans on third countries. “Member States must refrain from taking national measures that could affect the EU internal market and prevent access to medicines for those in need in other Member States,” wrote Kyriakides.

Germany’s government is considering changing the law to ease procurement requirements, which currently force health insurers to buy medicines where they are cheapest, concentrating the supply into the hands of a few of the most price-competitive producers. The new law would have buyers purchase medicines from multiple suppliers, including more expensive ones, to make supply more reliable. The Netherlands recently introduced a law requiring vendors to keep six weeks of stockpiles to bridge shortages, and in Sweden the government is proposing similar rules.

At a more granular level, a committee led by the EU’s drugs regulator, the European Medicines Agency (EMA), has recommended that rules be loosened to allow pharmacies to dispense pills or medicine doses individually, among other measures. In Germany, the president of the German Medical Association went so far as to call for the creation of informal “flea markets” for medicines, where people could give their unused drugs to patients who needed them. And in France and Germany, pharmacists have started producing their own medicines — though this is unlikely to make a big difference, given the extent of the shortfall.

Can the EU fix it?

In theory, the EU should be more ready than ever to tackle a bloc-wide crisis. It has recently upgraded its legislation to deal with health threats, including a lack of pharmaceuticals. The EMA has been given expanded powers to monitor drug shortages. And a whole new body, the Health Emergency Preparedness and Response Authority (HERA) has been set up, with the power to go on the market and purchase drugs for the entire bloc.

But not everyone agrees that it’s that bad yet.

Last Thursday, the EMA decided not to ask the Commission to declare the amoxycillin shortage a “major event” — an official label that would have triggered some (limited) EU-wide action— saying that current measures are improving the situation.

A European Medicines Agency’s working group on shortages could decide on Thursday whether to recommend that the Commission declares the drug shortages a “major event” — an official label that would trigger some (limited) EU-wide action. An EMA steering group for shortages would have the power to request data on drug stocks of the drugs and production capacity from suppliers, and issue recommendations on how to mitigate shortages.

At an appearance before the European Parliament’s health committee, the Commission’s top health official, Sandra Gallina, said she wanted to “dismiss a bit the idea that there is a huge shortage,” and said that alternative medications are available to use.

And others believe the situation will get better with time. “I think it will sort itself out, but that depends on the peak of infections,” said Adrian van den Hoven, director general of generics medicines lobby Medicines for Europe. “If we have reached the peak, supply will catch up quickly. If not, probably not a good scenario.”

Helen Collis and Sarah-Taïssir Bencharif contributed reporting.