Many people in Europe face drug shortages in the dead of winter when viruses attack us. This is what “Politico” writes.
EU countries are reporting serious problems in the supply of important medicines from the end of 2022. How bad is the situation and what has been done?
A study shows that almost a quarter of 29 European countries – from the EU, Turkey, Kosovo, Norway and the CIS – are experiencing shortages of 600 medicines. 20 percent reported shortages of 200-300 drugs. Three-quarters of countries said shortages were greater this winter than a year ago. In 4 countries, the shortage is also linked to deaths.
The picture becomes clear from the data of the regulators. Belgian authorities report nearly 300 medicines in short supply, Germany 408, Austria 600. Italy has the largest number of medicines that cannot be found in pharmacies – 3,000, many of which are different variants of one and also medicine.
Which medications have disappeared?
Antibiotics – especially amoxicillin, which is used for respiratory infections – have reduced supplies. It is also difficult to find other types of medicine – cough syrup, children’s paracetamol or for high blood pressure.
What is happening?
The shortage is the result of increased demand and reduced supply.
Seasonal infections – flu and respiratory virus – started earlier and are more severe than usual. In addition, there is an unusual prevalence of throat diseases in children. Experts believe it is related to the weak immune system, because due to the lockdown it does not recognize everyday viruses. This took pharmaceutical companies by surprise.
Inflation and the energy crisis also had an impact.
Last year, Centrient Pharmaceuticals, a Dutch maker 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 Dutch manufacturer, received government help to keep its factory afloat after declaring bankruptcy.
Other factors are the shortage of raw materials or limitations in production capacity.
How are governments responding?
Some countries freeze exports to protect domestic supplies. In November, the Greek drug regulator expanded the list of drugs banned for resale in other countries. Romania has temporarily suspended the export of certain antibiotics and painkillers for children. Last week, Belgium published a decree allowing authorities to stop exports in the event of a crisis.
These measures can have side effects. A letter from European Health Commissioner Stella Kyriakides to Greece’s Health Minister Thanos Pleuris asked him to consider how the bans would affect third countries. “Member States must refrain from taking measures at national level that could affect the EU’s internal market and prevent access to medicines for those in need in other Member States,” Kyriakides wrote.
Germany’s government is considering changing the law to ease public procurement requirements that currently force health insurers to buy drugs where they are cheapest, concentrating supplies in the hands of a few of the most competitive manufacturers. The new law will force drugs to be bought from multiple suppliers, including more expensive ones, to ensure reliability of supply. The Netherlands recently introduced a law requiring sellers to keep stock for six weeks to overcome shortages. Similar rules were proposed by the Swedish government.
A panel of the European Medicines Agency (EMA) has recommended that the rules be liberalized to allow pharmacies to sell pills or individual doses of drugs. In Germany, the president of the German Medical Association has even called for the creation of unofficial drug banks, where people could give away unwanted medication to those in need. And in France and Germany, pharmacists have begun to produce their own drugs, although this is unlikely to help given the scale of the shortage.
In Bulgaria, it was decided to export medicines only if there is 100 percent availability. The list of drugs prohibited for export will include all those whose market availability falls below 100%. Until now, an export ban was imposed when stocks fell below 65%.
The Ministry of Health also proposes to double the period of drug monitoring from six months to a year.
“There are seven recommendations in the audit of “Information Service”, made last year at the insistence of Prof. Asena Serbezova. Of all of them, she implemented only one – she changed the formula in the Specialized Electronic System for the Tracking and Analysis of Medicinal Products (SESPA).” Thus, Medzhidiev again blamed his predecessor, Prof. Asena Serbezova, for the drug crisis. Already months ago, the minister hinted that the formula used to monitor drug availability was wrong and legal changes were needed. Last week, Dr. Medzhidiev for the first time directly accused Serbezova of “wrong actions”.
“Out of 400 drugs monitored for a possible shortage, they have been reduced to 60. And at the moment we are wondering how to restore control,” Medzhidiev said then. A reply from the former Minister of Health was not long in coming, who stated in writing that the decision to change the formula was not the result of a momentary mood, a mistake, but based on the findings of the “Information Service” report.
“There is no country in the EU where it is so unambiguous, tendentious and populist at “convenient” moments to play on the thin thread of people’s nerves, using the problem of drug shortages, creating “culprits” to offer themselves for a pacifier while it hides the intellectual and administrative weakness (or maybe interest) for a comprehensive solution to the problem that would be sustainable over time,” Serbezova also wrote.
Can the EU handle this crisis?
In theory, the EU should be more ready than ever to deal with a crisis in the entire bloc, commented “Politico”. It has recently improved its legislation to address health threats, including the lack of pharmaceuticals. The EMA has been given extended powers to monitor drug shortages. An entirely new unit, the Health Preparedness and Emergency Response Authority (HERA), has also been created, with the power to buy drugs for the entire bloc.
But so far this is not happening. For HERA to work, at least four EU countries must join a buying programme, but no country has yet asked to activate the procedure, an EU spokesman said. This is perhaps not surprising. Attempts to coordinate purchases of cheaper drugs during the pandemic have been so slow and bureaucratic that countries have all but given up, preferring to buy on the open market themselves.
The European Medicines Agency’s working group on shortages may decide on Thursday whether to recommend that the Commission declare drug shortages a “major event” — a term that will trigger some (limited) EU-wide action. EMA’s shortages group will have the power to request data on drug stocks and manufacturing capacity from suppliers and issue recommendations on how to reduce shortages.
But still not everyone agrees that the situation is that bad.
Speaking to the European Parliament’s health committee, the Commission’s top health official Sandra Galina said she rejected the notion of a huge shortage and that there were alternative medicines that could be used.
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