Since 2023, the pharmaceutical industry operating in Europe has faced an unprecedented challenge related to drug shortages. Previously, shortages were dictated by production capacity and changing market conditions. However, the largely inflationary-driven negative impact on pharmaceutical developers seen in 2023 has continued into 2024 as manufacturers battle with high operating costs while governments continue to curb price growth through cost-containment policies. The rigidity of certain pricing and reimbursement systems has meant that there is limited room to facilitate price increases. However, some markets are starting to loosen restrictions in order to address drug shortages. GlobalData reviews the current drug shortage landscape across several European markets (Austria, Belgium, Italy, Norway, Slovenia, Spain, and Portugal) while looking at key trends for these shortages such as geographic distribution, generic and reimbursement status, and multi-brand impact. Acknowledgement will also be given to various government responses to alleviating these drug shortages.
Of the assessed markets, Norway reports the greatest number of packs currently out of stock.
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Drug shortages occur every so often and are typically linked to factors including manufacturing issues, distribution problems, and fluctuating market dynamics. In the past, these shortages have mainly been limited to specific affected products and emerging markets. Post-pandemic surges in demand, inflation, currency devaluation, and a rise in the cost of active pharmaceutical ingredient (API) production and import have caused shortages to expand to more advanced economies where parallel trade is also being leveraged to obtain medicines from markets with lower prices within the EU. Additionally, the volume of drug shortages being reported has reached new levels in response to pricing pressures that are testing a manufacturer’s willingness and ability to supply certain medicines in certain markets. Of the seven European markets that were assessed (Belgium, Austria, Italy, Norway, Portugal, Slovenia, and Spain), the majority of packs reporting shortages are in Norway (58%), followed by Slovenia (20%) and Italy (10%).
Most shortages apply to the same active ingredient across multiple markets while generics see the greatest difficulties.
A total of 17,250 packs are reporting shortages and account for 1,278 active ingredients. The frequency of the same active ingredient reporting a shortage across these markets was taken into account and shows that 11% of these active ingredients underwent a shortage in at least four or more of the markets, while 1% are currently out of stock in six of the seven assessed markets. In each of these assessed markets, the most common drug type undergoing shortages are generics. The president of the Medicines for Europe trade association, Elisabeth Stampa, has discussed the ongoing shortages in the EU with news sources, and has stated that generics will continue to suffer unless prices are revised upwards and realigned to account for inflation-driven cost increases. However, in Norway, a significant number of branded (on-patent) medicines (31%) also undergo shortages. The three on-patent brands reporting the greatest number of pack types with shortages in Norway are Aranesp, Minirin, and Oxis. Overall, prices tend to be lower in Norway than in comparable markets such as Denmark and Sweden, alongside an unfavourable exchange rate. As the cost of manufacturing increased in 2023, Norway’s restrictive pricing made it untenable for products to remain in the market, likely triggering these shortages. Furthermore, the increased uptake of drugs, such as Novo Nordisk’s Ozempic (semaglutide) upon its expansion into weight management, have led to shortages of semaglutide and triggered the reimbursement of Novo Nordisk’s Rybelsus (semaglutide) for type 2 diabetes to help alleviate shortages. This is most clearly seen in Belgium where all packs currently reporting shortages are for semaglutide.
Furthermore, in each of these assessed markets, a significant number of active ingredients reporting shortages have reported being out of stock for more than one brand name of the same active ingredient. Portugal has seen the greatest percentages of shortages affecting more than one brand of the same active ingredient (50%), followed by Italy (44%) and Slovenia (29%). Of those packs undergoing shortages, 51% are not reimbursed by a national health authority. However, this distribution does vary by market. While overall there is a slight majority towards non-reimbursed packs being out of stock, more packs that are reporting shortages are reimbursed in Italy and Norway.
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By GlobalDataAnalgesic and psycholeptic drugs were the most commonly reported drug type undergoing shortages.
GlobalData also considered the Anatomical Therapeutic Chemical (ATC) code classification of these packs. Overall, most packs suffering from shortages (25%) are categorized under the nervous system ATC class. More specifically, analgesics (N02)and psycholeptics (N05) are impacted, including treatments for pain relief, schizophrenia, and epilepsy. Shortages within this space have been predominantly led by manufacturing issues and the requirement to import from other markets, triggering shortages in their own market.
The increasing number of drug shortages, especially in 2023 and 2024, has become a driver for pricing and reimbursement policy changes. Advanced economies are commonly adding greater pricing flexibility to address these shortages, but a market’s response to these shortages is predominantly dictated by the perceived threat of shortages, the strength of their domestic pharma industry, the ability to pay for medicines, and high inflation. As such, responses have varied, but flexible approaches have included increasing price caps, exchange rate adjustments (such as in Turkey), relaxation of procurement rules, and greater use of risk-sharing agreements.
This article is produced as part of GlobalData’s Price Intelligence (POLI) service, the world’s leading resource for global pharmaceutical pricing, HTA and market access intelligence integrated with the broader epidemiology, disease, clinical trials and manufacturing expertise of GlobalData’s Pharmaceutical Intelligence Center. Our unparalleled team of in-house experts monitor P&R policy developments, outcomes and data analytics around the world every day to give our clients the edge by providing critical early warning signals and insights. For a demo or further information, please contact us here.
