Why Europe is chronically running out of meds

On 15 December 2022, the European Medicines Company (EMA) introduced that the majority European Union international locations had been dealing with shortages of medicines. It was recognized that European international locations had been in for a troublesome winter, with each the Covid-19 pandemic and different seasonal viruses testing their well being programs. However what truly occurred this 12 months exceeded all predictions.

“To be trustworthy, what occurred this winter was that European international locations had been shocked by such a big hole between provide and demand, particularly for antibiotics,” Steffen Thirstrup admits to MIIR. Thirstrup is head of well being on the European Medicines Company, the physique accountable for scientific analysis, supervision and monitoring of the security of medicines within the EU.

From 2000 to 2018, there was a 20-fold enhance in recorded drug shortages in Europe. It is like a illness that will get worse yearly, with no treatment – but. The warfare in Ukraine and the power disaster have been used as handy excuses by political leaders in numerous international locations to attempt to disguise the truth. However the issue appears to produce other, timeless causes.

In accordance with the 2022 European Pharmaceutical Union (PGEU) report, all EU international locations that responded to the survey (which included pharmaceutical chambers and pharmacy associations from 29 international locations within the European area) had skilled a scarcity of medicines in pharmacies within the earlier 12 months. The vast majority of international locations reported that the scenario had worsened (75.86%) or remained the identical (24.14%) in comparison with the earlier 12 months. No nation reported an enchancment.

“Drug shortages are growing in Europe and have an enormous detrimental affect on sufferers. They happen in all healthcare settings and have an effect on each important life-saving medicines and really generally used ones. Group pharmacists are very involved about this phenomenon, which may put sufferers’ well being in danger. As well as, pharmacies and pharmacists make investments a variety of assets in coping with shortages, which isn’t solely a monetary burden, but in addition a lack of alternative to spend time on different patient-centred duties and enhance the standard of care,” Ilaria Pasarani, Secretary Basic of the PGEU, instructed MIIR. On common, every pharmacy within the European Union spends 6.3 hours per week trying to find lacking medicines. In some international locations, this determine reaches 20 hours per week.

The present scenario is that 28 of the 30 international locations of the European Financial Space report shortages. 

Inconsistent nationwide information

At a pan-European degree, there may be nonetheless no homogenised database recording drug shortages – i.e. in the identical language – with information that may be seen in actual time. There’s not even a definitive European settlement on how you can outline a scarcity. A number of European states have adopted the European Medicines Company’s definition (EMA, 2019): “A scarcity of a medicinal product for human or veterinary use happens when provide doesn’t meet demand at nationwide degree”.

It’s typically troublesome to evaluate the precise period of drug shortages, exactly due to the gaps and inconsistencies within the nationwide registries of medical associations. Many registries don’t even present an (estimated) expiry date for every scarcity. Most European international locations have solely began to gather standardised data on shortages within the final 5 years. There are additionally appreciable variations within the obligations to report shortages. For instance, in Denmark solely ‘severe’ shortages are reported, whereas in Sweden solely shortages anticipated to final greater than three weeks must be reported to the system.

Moreover, not all international locations publish their information in the identical format and there are not any widespread requirements for recording and reporting shortages, making it troublesome to share data and conduct comparative evaluation between international locations. The European Medicines Company doesn’t hold aggregated information for all EU international locations. “Some international locations have a really detailed community of gathering data from neighborhood pharmacies and hospital pharmacies. However not everybody has it to the identical extent. Some international locations have refined IT programs to have a look at provide and demand and might subsequently react way more rapidly,” explains EMA’s Steffen Thirstrup.

In an try to partially fill this data hole, MIIR, along with collaborating media groups from the European Information Journalism Community, spent three months trying to find information and managed to create an up to date database on drug shortages in Europe. We recorded 22,107 totally different entries over a five-year interval (2018-2023) in a complete of 9 European international locations (Germany, Italy, Spain, Slovenia, Czech Republic, Greece, Romania, Austria, Belgium) from which it was attainable to gather dependable information, both by extracting it from printed statistics in nationwide medical associations or by submitting information requests. In most of the above international locations, we had been capable of establish the Anatomical Therapeutic Chemical (ATC) classification, the advertising and marketing authorisation holder, the beginning and finish dates of the scarcity and the explanations for withdrawal.

Key conclusions

From the whole of the 9 international locations talked about above during the last 5 years (2018-2023), when including up the brand new shortages of every 12 months, it seems that Italy cumulatively registers probably the most shortages in absolute numbers (10,843) for human medicines, fairly removed from the second Czech Republic (2,699) and the third Germany (2,355). Lastly, Greece (389) is the nation with the fewest shortages in absolute phrases.

Nevertheless, absolutely the variety of medicines and vaccines in brief provide will not be at all times one of the simplest ways to attract agency conclusions, as not all international locations report their shares with the identical consistency and standards. As well as, there are totally different reference populations, international locations with totally different ranges of demand, and totally different import/export balances for medicines.

Probably the most dependable indicator to explain the scenario in every nation is the period of a scarcity. To seek out the common period of shortages within the European international locations we studied, we excluded excessive values by calculating the median. Of the 22,107 medicines we processed, we had information on the period of shortages for 16,945.  Based mostly on this, the European common period of a scarcity is 94 days, which implies that it takes about three months for a drugs to be again available on the market.

MIIR’s evaluation of the information collected reveals that Greece has the longest common period of shortages (130 days), adopted by Germany (120 days) and Belgium (103 days). Though the Czech Republic was second by way of absolutely the variety of shortages, it had the shortest period of shortages (41 days).

The European common for vaccine shortages, once more excluding extremes, is 84 days, lower than for medicines.

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

Probably the most complete research on drugs shortages in recent times was carried out by the Technopolis Group consultancy on behalf of the EU (Future-proofing pharmaceutical laws – research on drugs shortages). On this research, the Netherlands and Portugal emerged because the “champions” of medication shortages in 2019 (greater than 1,600 totally different drug shortages). In distinction, Austria, Croatia, Iceland and Greece recorded fewer than 100 shortages that 12 months, involving 60 or fewer totally different medicines.

The identical survey discovered that the common period of all scarcity notifications was 137 days and that 66% of all shortages had been resolved inside the first three months. The minimal period of a scarcity was sooner or later and the utmost was about 13.5 years (!) and is said to amoxicillin, which was in brief provide in Spain from September 2005 till March 2019. Amoxicillin continues to be some of the steadily lacking medicines on the European market.

Nevertheless, it ought to be famous that in all 9 international locations for which information had been collected by MIIR, very vital will increase in shortages are recorded in 2022 in comparison with the earlier 12 months, with Greece main the group – probably on account of under-reporting by the Greek Nationwide Organisation for Medicines (EOF) or failure to report precise shortages. Pharmaceutical associations in Greece complain that the true shortages are a lot greater than these reported by the EOF.

Causes for the shortages

In accordance with the MIIR evaluation, in a complete of six international locations (Germany, Spain, Greece, Austria, Slovenia, Czech Republic), the medicine with the very best variety of shortages are these associated to the nervous system (1,718 medicine, 19.03% of the whole), reminiscent of anaesthetics, psychotropic medicine, antidepressants, anxiolytics, antiepileptics, antiparkinsonian medicine, and many others.). 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). Quite the opposite, nearly no shortages are recorded in the identical pattern within the class of antiparasiticides, pesticides and bug repellents.

Τhe most up-to-date report of the European Pharmaceutical Union PGEU (2022) for all European international locations confirmed related outcomes: cardiovascular medicines had been lacking in most international locations (82.76%), adopted by medicines for the nervous system and anti-infectives for systemic use – antibiotics (79.31%) and medicines for the respiratory system (75.86%).

On this survey, nearly all responding international locations reported that drug shortages result in affected person misery and struggling (93.10%), discontinuation of remedy (89.66% of nations), elevated out-of-pocket funds on account of costlier and different options not reimbursed by the federal government (72.41%), but in addition to much less efficient therapies (58.62%).

The affect of Covid-19

All of the research agree that the issue is rising and impacts hundreds of thousands of sufferers in Europe. “In the course of the pandemic, but in addition within the post-pandemic interval, when a big a part of the inhabitants was affected by the post-COVID syndrome, the necessity for medicines and coverings elevated. This reality led, to a sure extent, to a rise in drug shortages,” underlined Ioulia Tseti, CEO of the Tsetis Pharmaceutical Group of Corporations and Secretary Basic of the Hellenic Confederation of Enterprises (SEV).

“The issues of the availability chain and the dependence of European Union international locations on uncooked supplies from third international locations have made the issue much more explosive. The truth that international locations reminiscent of India and China have banned the export of uncooked supplies for their very own wants has additionally exacerbated the issue. And it’s well-known that when uncooked supplies are scarce, the value is excessive,” provides Tseti. “We must always not overlook that the scarcity of uncooked supplies and the rise in power prices have been exacerbated by the warfare in Ukraine, which can also be a uncooked materials for the manufacturing of medicines exporter.”

Warfare will not be the one wrongdoer

“Drug shortages are typically the results of totally different financial, structural or regulatory causes”, stresses Ilaria Passarani, Basic Secretary of the PGEU. These embrace:

The more and more globalised nature of pharmaceutical manufacturing, together with energetic pharmaceutical substances (APIs), with manufacturing concentrated in fewer websites unfold internationally;

Shifts in demand, ensuing from longer-term components reminiscent of demographic change, but in addition short-term components reminiscent of tendering of medicines, resulting in difficulties in offering enough portions of medicines for some markets;

Pricing methods, each high and low, and regulatory adjustments, which in some circumstances can have an effect on provide;

The imposition of fastened quotas of medicines by the pharmaceutical trade, which are sometimes inadequate in relation to the precise wants of sufferers;

The elimination of the normal position of full-line wholesalers on account of Direct to Pharmacy (DTP) schemes in some markets;

The elimination and ineffectiveness of public service obligations/nationwide minimal inventory holding necessities in some international locations;

The dearth of precedence given to smaller markets;

The affect of European single market dynamics (e.g. exports).

Dependence and friction

On the European degree, over-dependence on a small variety of suppliers of energetic pharmaceutical substances and different uncooked supplies has made it troublesome for producers to fulfill present demand. China and India collectively account for greater than 60% of the worldwide provide of energetic pharmaceutical substances in 2020. Parallel exports are sometimes seen by pharmacists and the pharmaceutical trade as a part of the issue.

“It’s a proven fact that parallel exports exacerbate the issue, as the upper costs of the identical merchandise in European international locations push pharmacies to export in an effort to benefit from the value distinction and thus enhance their profitability,” says Ioulia Tseti of Tsetis Pharmaceutical.

On the identical time, pharmaceutical firms at European degree appear to have lowered their shares. Which means that if there’s a downside in a producing plant, there may be not sufficient inventory to fulfill demand till the issue is solved and drug manufacturing returns to regular.

“Parallel exports” are a degree of competition between pharmaceutical producers and drug distributors. They happen when drug distributors promote medicine with out the permission of the producer and out of doors the authorised channels. For that reason, multinational pharmaceutical firms strictly management the portions they offer to native pharmacies in an effort to restrict the possibilities of exporting their merchandise and the lack of income in developed markets with excessive drug costs. All this encourages any pharmacist who can get hold of medicines immediately from the businesses to take action, even when this can be very gradual.

However what’s Europe doing to deal with what appears to be like like a troublesome balancing resolution in an trade with big competing pursuits? Within the coming weeks, EU Well being Commissioner Stella Kyriakides is anticipated to current some long-awaited proposals to revise the pharmaceutical laws, following a protracted dialogue with the pharmaceutical trade, related authorities authorities, well being professionals, lecturers and affected person representatives.

“This dialogue and the ensuing coverage evaluation confirmed that the scarcity of medicines has develop into a systemic problem with quite a few weaknesses, together with the growing complexity and specialisation of provide chains, the shortage of geographical diversification of sourcing for sure merchandise and the perceived complexity of the regulatory framework,” an EU Fee spokesperson instructed MIIR, including that the forthcoming proposal will embrace “stricter procurement obligations, well timed notification of shortages and withdrawals and elevated transparency of shares”.

This cross-border data-driven investigation was organised and coordinated by the Mediterranean Institute for Investigative Journalism (MIIR) inside the framework of the European Information Journalism Community (EDJNet). Information evaluation and visualisations had been carried out by Corina Petridi.The analysis was carried out between January and March 2023 and 7 extra 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).