Why Europe is chronically running out of meds

On 15 December 2022, the European Medicines Agency (EMA) announced that almost all European Union countries were facing shortages of medicines. It was known that European countries were in for a tough winter, with both the Covid-19 pandemic and other seasonal viruses testing their health systems. But what actually happened this year exceeded all predictions.

"To be honest, what happened this winter was that European countries were surprised by such a large gap between supply and demand, especially for antibiotics," Steffen Thirstrup admits to MIIR. Thirstrup is head of health at the European Medicines Agency, the body responsible for scientific evaluation, supervision and monitoring of the safety of medicines in the EU.

From 2000 to 2018, there has been a 20-fold increase in recorded drug shortages in Europe. It's like a disease that gets worse every year, with no cure – yet. The war in Ukraine and the energy crisis have been used as convenient excuses by political leaders in various countries to try to hide the reality. But the problem seems to have other, timeless causes.

According to the 2022 European Pharmaceutical Union (PGEU) report, all EU countries that responded to the survey (which included pharmaceutical chambers and pharmacy associations from 29 countries in the European region) had experienced a shortage of medicines in pharmacies in the previous 12 months. The majority of countries reported that the situation had worsened (75.86%) or remained the same (24.14%) compared to the previous 12 months. No country reported an improvement.

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"Drug shortages are increasing in Europe and have a huge negative impact on patients. They occur in all healthcare settings and affect both essential life-saving medicines and very commonly used ones. Community pharmacists are very concerned about this phenomenon, which can put patients' health at risk. In addition, pharmacies and pharmacists invest a lot of resources in dealing with shortages, which is not only a financial burden, but also a loss of opportunity to spend time on other patient-centred tasks and improve the quality of care," Ilaria Pasarani, Secretary General of the PGEU, told MIIR. On average, each pharmacy in the European Union spends 6.3 hours per week searching for missing medicines. In some countries, this figure reaches 20 hours a week.

The current situation is that 28 of the 30 countries of the European Economic Area report shortages. 

Inconsistent national data

At a pan-European level, there is still no homogenised database recording drug shortages – i.e. in the same language – with data that can be viewed in real time. There is not even a definitive European agreement on how to define a shortage. Several European states have adopted the European Medicines Agency's definition (EMA, 2019): "A shortage of a medicinal product for human or veterinary use occurs when supply does not meet demand at national level".

It is often difficult to assess the actual duration of drug shortages, precisely because of the gaps and inconsistencies in the national registries of medical associations. Many registries do not even provide an (estimated) expiry date for each shortage. Most European countries have only started to collect standardised information on shortages in the last five years. There are also considerable differences in the obligations to report shortages. For example, in Denmark only 'serious' shortages are reported, while in Sweden only shortages expected to last more than three weeks have to be reported to the system.

Furthermore, not all countries publish their data in the same format and there are no common standards for recording and reporting shortages, making it difficult to share information and conduct comparative analysis between countries. The European Medicines Agency does not keep aggregated data for all EU countries. “Some countries have a very detailed network of collecting information from community pharmacies and hospital pharmacies. But not everyone has it to the same extent. Some countries have sophisticated IT systems to look at supply and demand and can therefore react much more quickly,'' explains EMA's Steffen Thirstrup.

In an attempt to partially fill this information gap, MIIR, together with collaborating media teams from the European Data Journalism Network, spent three months searching for data and managed to create an updated database on drug shortages in Europe. We recorded 22,107 different entries over a five-year period (2018-2023) in a total of nine European countries (Germany, Italy, Spain, Slovenia, Czech Republic, Greece, Romania, Austria, Belgium) from which it was possible to collect reliable data, either by extracting it from published statistics in national medical associations or by submitting data requests. In many of the above countries, we were able to identify the Anatomical Therapeutic Chemical (ATC) classification, the marketing authorisation holder, the start and end dates of the shortage and the reasons for withdrawal.

Key conclusions

From the total of the nine countries mentioned above over the last five years (2018-2023), when adding up the new shortages of each year, it appears that Italy cumulatively registers the most shortages in absolute numbers (10,843) for human medicines, quite far from the second Czech Republic (2,699) and the third Germany (2,355). Finally, Greece (389) is the country with the fewest shortages in absolute terms.

However, the absolute number of medicines and vaccines in short supply is not always the best way to draw firm conclusions, as not all countries record their stocks with the same consistency and criteria. In addition, there are different reference populations, countries with different levels of demand, and different import/export balances for medicines.

The most reliable indicator to describe the situation in each country is the duration of a shortage. To find the average duration of shortages in the European countries we studied, we excluded extreme values by calculating the median. Of the 22,107 medicines we processed, we had data on the duration of shortages for 16,945.  Based on this, the European average duration of a shortage is 94 days, which means that it takes about three months for a medicine to be back on the market.

MIIR's analysis of the data collected shows that Greece has the longest average duration of shortages (130 days), followed by Germany (120 days) and Belgium (103 days). Although the Czech Republic was second in terms of the absolute number of shortages, it had the shortest duration of shortages (41 days).

The European average for vaccine shortages, again excluding extremes, is 84 days, less than for medicines.

For vaccines, the longest median shortages were recorded in Italy (111 days), Germany (68 days) and the Czech Republic (66 days).

The most comprehensive study on medicine shortages in recent years was carried out by the Technopolis Group consultancy on behalf of the EU (Future-proofing pharmaceutical legislation – study on medicine shortages). In this study, the Netherlands and Portugal emerged as the "champions" of medicine shortages in 2019 (more than 1,600 different drug shortages). In contrast, Austria, Croatia, Iceland and Greece recorded fewer than 100 shortages that year, involving 60 or fewer different medicines.

The same survey found that the average duration of all shortage notifications was 137 days and that 66% of all shortages were resolved within the first three months. The minimum duration of a shortage was one day and the maximum was about 13.5 years (!) and is related to amoxicillin, which was in short supply in Spain from September 2005 until March 2019. Amoxicillin is still one of the most frequently missing medicines on the European market.

However, it should be noted that in all nine countries for which data were collected by MIIR, very significant increases in shortages are recorded in 2022 compared to the previous year, with Greece leading the group – possibly due to under-reporting by the Greek National Organisation for Medicines (EOF) or failure to report actual shortages. Pharmaceutical associations in Greece complain that the real shortages are much higher than those reported by the EOF.

Reasons for the shortages

According to the MIIR analysis, in a total of six countries (Germany, Spain, Greece, Austria, Slovenia, Czech Republic), the drugs with the highest number of shortages are those related to the nervous system (1,718 drugs, 19.03% of the total), such as anaesthetics, psychotropic drugs, antidepressants, anxiolytics, antiepileptics, antiparkinsonian drugs, etc.). In second place are cardiovascular medicines (1,307, 14.48% of all shortages) and in third place anti-infectives for systemic use - antibiotics (1,126 medicines, 12.47% of all shortages). On the contrary, almost no shortages are recorded in the same sample in the category of antiparasiticides, insecticides and insect repellents.

Τhe most recent report of the European Pharmaceutical Union PGEU (2022) for all European countries showed similar results: cardiovascular medicines were missing in most countries (82.76%), followed by medicines for the nervous system and anti-infectives for systemic use - antibiotics (79.31%) and medicines for the respiratory system (75.86%).

In this survey, almost all responding countries reported that drug shortages lead to patient distress and suffering (93.10%), discontinuation of treatment (89.66% of countries), increased out-of-pocket payments due to more expensive and alternative solutions not reimbursed by the government (72.41%), but also to less effective treatments (58.62%).

The impact of Covid-19

All the studies agree that the problem is growing and affects millions of patients in Europe. "During the pandemic, but also in the post-pandemic period, when a large part of the population was affected by the post-COVID syndrome, the need for medicines and treatments increased. This fact led, to a certain extent, to an increase in drug shortages," underlined Ioulia Tseti, CEO of the Tsetis Pharmaceutical Group of Companies and Secretary General of the Hellenic Confederation of Enterprises (SEV).

"The problems of the supply chain and the dependence of European Union countries on raw materials from third countries have made the problem even more explosive. The fact that countries such as India and China have banned the export of raw materials for their own needs has also exacerbated the problem. And it is well known that when raw materials are scarce, the price is high," adds Tseti. "We should not forget that the shortage of raw materials and the increase in energy costs have been exacerbated by the war in Ukraine, which is also a raw material for the production of medicines exporter.”

War is not the only culprit

"Drug shortages are generally the result of different economic, structural or regulatory causes”, stresses Ilaria Passarani, General Secretary of the PGEU. Those include:

• The increasingly globalised nature of pharmaceutical manufacturing, including active pharmaceutical ingredients (APIs), with production concentrated in fewer sites spread across the world;
• Shifts in demand, resulting from longer-term factors such as demographic change, but also short-term factors such as tendering of medicines, leading to difficulties in providing sufficient quantities of medicines for some markets;
• Pricing strategies, both low and high, and regulatory changes, which in some cases can have an impact on supply;
• The imposition of fixed quotas of medicines by the pharmaceutical industry, which are often insufficient in relation to the actual needs of patients;
• The elimination of the traditional role of full-line wholesalers as a result of Direct to Pharmacy (DTP) schemes in some markets;
• The removal and ineffectiveness of public service obligations/national minimum stock holding requirements in some countries;
• The lack of priority given to smaller markets;
• The impact of European single market dynamics (e.g. exports).

Dependence and friction

At the European level, over-dependence on a small number of suppliers of active pharmaceutical ingredients and other raw materials has made it difficult for manufacturers to meet current demand. China and India together account for more than 60% of the global supply of active pharmaceutical ingredients in 2020. Parallel exports are often seen by pharmacists and the pharmaceutical industry as part of the problem.

"It is a fact that parallel exports exacerbate the problem, as the higher prices of the same products in European countries push pharmacies to export in order to take advantage of the price difference and thus increase their profitability," says Ioulia Tseti of Tsetis Pharmaceutical.

At the same time, pharmaceutical companies at European level seem to have reduced their stocks. This means that if there is a problem in a manufacturing plant, there is not enough stock to meet demand until the problem is solved and drug production returns to normal.

"Parallel exports” are a point of contention between pharmaceutical manufacturers and drug distributors. They occur when drug distributors sell drugs without the permission of the manufacturer and outside the authorised channels. For this reason, multinational pharmaceutical companies strictly control the quantities they give to local pharmacies in order to limit the chances of exporting their products and the loss of profits in developed markets with high drug prices. All this encourages any pharmacist who can obtain medicines directly from the companies to do so, even if it is extremely slow.

But what is Europe doing to tackle what looks like a difficult balancing decision in an industry with huge competing interests? In the coming weeks, EU Health Commissioner Stella Kyriakides is expected to present some long-awaited proposals to revise the pharmaceutical legislation, following a long discussion with the pharmaceutical industry, relevant government authorities, health professionals, academics and patient representatives.

"This dialogue and the resulting policy analysis showed that the shortage of medicines has become a systemic challenge with numerous weaknesses, including the increasing complexity and specialisation of supply chains, the lack of geographical diversification of sourcing for certain products and the perceived complexity of the regulatory framework," an EU Commission spokesperson told MIIR, adding that the forthcoming proposal will include "stricter procurement obligations, timely notification of shortages and withdrawals and increased transparency of stocks".

👉 Original article on MIIR

This cross-border data-driven investigation was organised and coordinated by the Mediterranean Institute for Investigative Journalism (MIIR) within the framework of the European Data Journalism Network (EDJNet). Data analysis and visualisations were conducted by Corina Petridi.The research was implemented between January and March 2023 and seven more EDJNET members participated: Deutsche Welle (Germany), Il Sole 24 Ore (Italy), PressOne (Romania), Deník Referendum (Czech Republic), El Orden Mundial (Spain), Pod črto (Slovenia), BIQdata (Poland).

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