Title: Europe's Critical Medicines List Guarantees No Supply
Author: Arthur Harmash
Published: 2026-09-16
Source: https://lymyvoyage.com/articles/europe-s-critical-medicines-list-guarantees-no-supply
Citations:
- https://www.europarl.europa.eu/topics/en/article/20200709STO83006/medicine-shortages-in-europe-how-the-eu-is-responding
- https://www.ema.europa.eu/en/news/first-version-union-list-critical-medicines-agreed-help-avoid-potential-shortages-eu
- https://www.ema.europa.eu/en/news/ema-welcomes-political-agreement-critical-medicines-act
- https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/medicine-shortages-availability-issues/availability-medicines-during-crises/union-list-critical-medicines
- https://europe.noharm.org/news/can-eu-have-sustainable-antibiotic-supply-chain
- https://chinaobservers.eu/how-to-address-europes-dependence-on-medicine-imports-from-china/
- https://www.pgeu.eu/publications/pgeu-press-release-medicine-shortages-persist-across-europe-as-pharmacies-absorb-growing-pressure-new-pgeu-report-shows/
- https://health.ec.europa.eu/medicinal-products/critical-medicines-act_en
- https://healthpolicy-watch.news/eu-parliament-backs-critical-medicines-act/
- https://www.mccannfitzgerald.com/knowledge/pharma-and-life-sciences/eu-critical-medicines-act-political-agreement-reached-what-life-sciences-companies-need-to-know
---
The European Union keeps a list of the medicines it cannot afford to run out of. The striking thing about it is how unremarkable the contents are: amoxicillin, insulin, vaccines, painkillers, medicines for chronic and rare diseases.[^1] These are not experimental therapies. They are the drugs a pharmacy expects to have in a drawer.
That inversion — the fragile medicines being the cheap and ordinary ones rather than the exotic ones — is the point of the list, and it has a concrete explanation in where the raw ingredients are made. But there is a second thing worth knowing before treating the list as reassurance. The European Medicines Agency says so itself: being on it does not guarantee supply.[^2]
Amoxicillin. Paracetamol. Insulin. Measles vaccine. All on the EU's official list of medicines Europe cannot afford to run out of.
A list of critical medicines sounds like a safety net, and it is natural to assume that naming a drug protects it. So what does being on the list actually oblige anyone to do? According to the agency that publishes it: nothing. Inclusion does not guarantee supply.
The reason ordinary drugs are the fragile ones is geography. Around 80% of the active ingredients imported into Europe come from just five countries, and China alone supplies about 45% of them.
Pharmacists feel this weekly, not theoretically. Across 27 European countries, 96% report shortages, and pharmacies now spend roughly 12 hours a week working around them — more than double five years ago.
Europe is acting, and the fix has costs of its own. A new law will reward medicines made in Europe, but health groups warn that European stockpiling and "made in Europe" preferences could push prices up and pull supply away from lower-income countries.
What none of this proves is that a shortage is coming for any particular drug. The list measures how much harm a shortage would cause, not how likely one is. And the law meant to change that is still not in force.
So the list is an honest diagnosis rather than a remedy. It tells you which medicines Europe would most regret losing. Whether Europe keeps them is a question the list was never designed to answer.
## What is actually on the list
The Union list of critical medicines was first agreed on 12 December 2023, after the European Medicines Agency, the European Commission and the Heads of Medicines Agencies reviewed 600 active substances drawn from six existing national lists.[^2] It has been updated annually since.
Its size depends entirely on what you count. The first version covered more than 200 active substances.[^2] The European Parliament's briefing, updated in March 2026, puts the current list at more than 270 active substances, including antibiotics, insulin, vaccines and medicines for chronic and rare diseases.[^1] The EMA, writing in May 2026, described it as "over 200 active substances."[^3] Because a single active substance appears in many authorised products, the same list is also reported as covering more than 300 medicines. All of these figures can be correct at once; none of them are interchangeable.
The criteria are narrow and worth stating precisely. A medicine qualifies if it treats a serious disease, has limited alternatives, and meets criticality thresholds in more than one third of EU and EEA countries.[^2] Note what is absent: nothing about how likely a shortage is, or how concentrated its supply chain happens to be. The list ranks consequences, not probabilities.
The latest revision, version 2.1, was published on 12 December 2025 and last updated on 19 January 2026. In the 2025 annual review the network assessed 61 active substance groups and combinations and added nine of them.[^4] The second version was reported to account for roughly 75% of all authorised medicinal products in the EU.[^4]
## Why the cheapest drugs are the fragile ones
The explanation is manufacturing concentration, and the headline figure comes from a European Commission assessment published in 2021: around 80% of the active pharmaceutical ingredients imported into Europe originate in just five countries — China, India, Indonesia, the United States and the United Kingdom — with China supplying about 45% of the total.[^5]
For antibiotics specifically the concentration is sharper still: China accounts for an estimated 80–90% of global antibiotic active-ingredient production.[^5]
Product-level dependencies reported from 2021 EU trade data run higher than the aggregate suggests. Roughly 95% of the vitamin B1 and derivatives imported into the EU came from China, over 96% of a class of heterocyclic compounds used in many antibiotics, and over 98% of chloramphenicol and its derivatives.[^6] The same analysis notes that India — the EU's other major supplier — itself imports around 70% of its own active ingredients from China, so supplier diversification on paper can be less diversification than it appears.[^6]
This is where the economics bite. Off-patent generics such as amoxicillin and paracetamol sell at very low margins, which is precisely why their production consolidated into a handful of large-scale plants in a handful of countries. The medicines most likely to be in short supply are cheap *because* their supply chains are concentrated, and concentrated *because* they are cheap. The European Parliament reports that over 50% of reported shortfalls stem from manufacturing issues, and that EU countries ran critically short of 136 medicines between January 2022 and October 2024.[^1]
## What a shortage looks like in a pharmacy
The Pharmaceutical Group of the European Union surveys pharmacists across 27 EU and EFTA countries. Its 2025 report found 96% of responding countries experiencing shortages, with the situation stagnating at what it calls an unacceptably high level in 70% of them, and more than 600 medicines in shortage in over a third of countries.[^7]
The workload figure is the one that makes the abstraction concrete: pharmacies now spend around 12 hours a week managing shortages — sourcing alternatives, contacting prescribers, counselling patients and preventing medication errors — more than double the level recorded five years earlier.[^7] Nearly nine in ten responding member states reported treatment interruptions, and for the first time reduced patient trust was the single most frequently reported consequence.[^7] The categories most affected — cardiovascular medicines, antibiotics, oncology treatments, insulins, GLP-1 receptor agonists and nervous system medicines[^7] — overlap closely with the critical list itself.
## The law meant to fix it, and where it actually stands
The European Commission proposed the Critical Medicines Act in March 2025, to improve the availability, supply and production of critical medicines through strategic project designation, procurement incentives, collaborative member state purchasing, international partnerships and state aid guidelines.[^8]
The legislative sequence matters, because the Act is frequently described as though it were already in force. The European Parliament backed it on 21 January 2026 by 503 votes to 57, with 108 abstentions.[^9] Parliament and the Council then reached a provisional political agreement in the early hours of 12 May 2026.[^10] The EMA welcomed it the same day.[^3] That text still requires formal endorsement by both institutions, with publication in the Official Journal expected towards the end of 2026 and the date of application still to be confirmed.[^10] As of September 2026, the Act is agreed, not applied.
The content also changed between those two stages, in a direction worth noting. Health Policy Watch, reporting on Parliament's January position, described a requirement that companies have at least 50% of production of the medicine or its active ingredient in Europe to receive preferential treatment in public tenders.[^9] The provisional agreement of May describes something looser: contracting authorities may incentivise EU manufacturing by rewarding suppliers *in proportion to* the share of the medicine and its active ingredients made in the EU.[^10] A proportional reward and a 50% threshold are materially different instruments, and the shift from one to the other softened the "buy European" mechanism.
Two other provisions are concrete. The threshold for triggering joint Commission procurement drops from nine member states to five, and orphan medicines become eligible for strategic projects and collaborative procurement.[^10] Stockpiling, however, remains voluntary: information-sharing is not mandatory, and reallocation between member states runs through an existing voluntary solidarity mechanism.[^10]
## What the list and the Act leave out
**Listing is a diagnosis, not a remedy.** The EMA is explicit that inclusion does not guarantee supply security; it signals that preventing a shortage is particularly important because one would cause significant harm.[^2] No manufacturer is obliged to keep producing a listed medicine.
**The dependency figures are five years old.** The 80%/45% concentration figures rest on a European Commission assessment from 2021, as do the product-level percentages.[^5][^6] They are the best public numbers available and they are widely cited, but trade patterns since 2021 are not captured by them.
**The fix has costs, and they fall partly outside Europe.** Amref Health Africa warned that EU stockpiling mandates could drain global supplies, that increased EU demand for active ingredients could raise global prices and make medicines less affordable in lower-income countries, and that "made in Europe" incentives could undercut African pharmaceutical manufacturing.[^9] The European Federation of Pharmaceutical Industries and Associations argued from the opposite direction that local-content preference risks weakening global supply diversification and reducing flexibility.[^9] Price increases of 20% to 40% have been estimated for some critical medicines.[^9]
**Voluntary stockpiling limits both the benefit and the harm.** Because the agreed text keeps stockpiling information-sharing voluntary,[^10] the Amref concern about EU hoarding is softened — and so is the Act's own capacity to prevent a shortage.
## How to use this
If you want to know whether a specific medicine is at risk, the Union list is the wrong instrument. It tells you how badly a shortage would hurt, not how likely one is; for likelihood, the EMA's separate supply-chain vulnerability assessments and the European Shortages Monitoring Platform are the relevant tools.[^3]
If you are quoting the list's size, say which unit you mean. "More than 270 active substances"[^1] and "more than 300 medicines" describe the same list; "300+ drugs" and "200+ substances" are not a contradiction to be resolved but two counts of different things.
And if you are reading that Europe has solved this, check the date and the stage. A political agreement in May 2026 is not a law in force, the "buy European" requirement in the agreed text is weaker than the one Parliament voted for in January, and stockpiling remains voluntary.[^10] The list has been accurate about the problem since 2023. The remedy is still arriving.
[^1]: https://www.europarl.europa.eu/topics/en/article/20200709STO83006/medicine-shortages-in-europe-how-the-eu-is-responding — European Parliament, "Medicine shortages in Europe: how the EU is responding" (published Jul 16, 2020; last updated Mar 30, 2026). Accessed Sep 16, 2026.
[^2]: https://www.ema.europa.eu/en/news/first-version-union-list-critical-medicines-agreed-help-avoid-potential-shortages-eu — European Medicines Agency, "First version of the Union list of critical medicines agreed to help avoid potential shortages in the EU" (published Dec 12, 2023). Accessed Sep 16, 2026.
[^3]: https://www.ema.europa.eu/en/news/ema-welcomes-political-agreement-critical-medicines-act — European Medicines Agency, "EMA welcomes political agreement on Critical Medicines Act" (published May 12, 2026). Accessed Sep 16, 2026.
[^4]: https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/medicine-shortages-availability-issues/availability-medicines-during-crises/union-list-critical-medicines — European Medicines Agency, "Union list of critical medicines" (version 2.1 published Dec 12, 2025; page last updated Jan 19, 2026). Accessed Sep 16, 2026.
[^5]: https://europe.noharm.org/news/can-eu-have-sustainable-antibiotic-supply-chain — Health Care Without Harm Europe, "Can the EU have a sustainable antibiotic supply chain?" (published Jun 11, 2024), citing a European Commission assessment published in 2021. Accessed Sep 16, 2026.
[^6]: https://chinaobservers.eu/how-to-address-europes-dependence-on-medicine-imports-from-china/ — Veronika Blablová, "How to Address Europe's Dependence on Medicine Imports from China", China Observers in Central and Eastern Europe (CHOICE) (published Jul 18, 2023), citing 2021 EU trade data. Accessed Sep 16, 2026.
[^7]: https://www.pgeu.eu/publications/pgeu-press-release-medicine-shortages-persist-across-europe-as-pharmacies-absorb-growing-pressure-new-pgeu-report-shows/ — Pharmaceutical Group of the European Union, "Medicine shortages persist across Europe as pharmacies absorb growing pressure, new PGEU report shows", reporting the PGEU Medicine Shortages Report 2025 covering 27 EU and EFTA countries. Accessed Sep 16, 2026.
[^8]: https://health.ec.europa.eu/medicinal-products/critical-medicines-act_en — European Commission, Directorate-General for Health and Food Safety, "Critical Medicines Act". Accessed Sep 16, 2026.
[^9]: https://healthpolicy-watch.news/eu-parliament-backs-critical-medicines-act/ — Felix Sassmannshausen, "EU Parliament Backs Critical Medicines Act, Sparking Supply Concerns In Africa", Health Policy Watch (published Jan 21, 2026). Accessed Sep 16, 2026.
[^10]: https://www.mccannfitzgerald.com/knowledge/pharma-and-life-sciences/eu-critical-medicines-act-political-agreement-reached-what-life-sciences-companies-need-to-know — McCann FitzGerald LLP, "EU Critical Medicines Act: Political agreement reached – what life sciences companies need to know" (published May 15, 2026). Accessed Sep 16, 2026.