2026-06-06 13:45

EU Medicine Shortages 2025–2026: Strategy Guide for B2B Pharma & Distributors

A Record No One Wanted to Set

In 2023 and 2024, EU medicine shortages reached the highest levels ever recorded. Not in a developing economy without infrastructure. In the European Union — one of the world's most sophisticated pharmaceutical markets, with over 4,000 approved marketing authorisations processed annually and GDP health expenditure averaging 8.2% across member states.

Between 2022 and October 2024, national authorities reported 136 critical shortages to the European Medicines Agency (EMA). By March 2025, 34 medicines were simultaneously in shortage across the EU — 16 of them on the European Commission's own list of essential medicines. These included thrombolytics used in stroke emergencies, amoxicillin — the world's most prescribed antibiotic — and cyanide poisoning antidotes.

The European Court of Auditors, in its Special Report 19/2025 published in September 2025, concluded bluntly: medicine shortages remain a 'chronic headache' for the EU, and the situation is not improving. For pharmaceutical business development managers, distributors and health startups operating in Central and Eastern Europe, this is not a peripheral regulatory story. It is the defining supply chain risk of the next three to five years — and a commercial opportunity for those prepared to act strategically.

▶ Key stat: 46% of critical generic medicines in the EU rely on a single supplier. 83% depend on a single major manufacturer. (Teva Research / IQVIA MIDAS, 2025)

Why Is This Happening? The Structural Roots of the Shortage Crisis

Medicine shortages are not a logistics failure. They are the predictable result of three converging structural problems that have built up over decades:

1. Price competition has made generic manufacturing economically unsustainable in Europe

Generic medicines account for 70% of treatment volume across the EU and represent 9 out of 10 products on the EU's critical medicines list. Yet relentless price compression through national procurement tenders has driven profit margins for generic manufacturers to levels that no longer justify maintaining European production capacity. The result: manufacturing of active pharmaceutical ingredients (APIs) has concentrated in India and China, where 80–90% of EU-consumed APIs are now produced.

When a quality issue, geopolitical disruption, or logistics shock hits a single Indian or Chinese plant, the downstream effect is a shortage across 27 EU member states simultaneously — because there is no alternative supplier.

2. Data fragmentation prevents coordinated EU response

Each EU member state sets its own rules for shortage notification. In Belgium, a manufacturer can wait until the day a drug becomes unavailable. In the Netherlands, notification must be given at least two months before expected supply failure. This means the EMA — responsible for EU-level coordination — frequently receives data that is late, incomplete, or absent entirely.

The European Court of Auditors found that 'reporting does not always work well in practice, is late or absent.' Without reliable early-warning data, neither regulators nor market participants can plan effectively.

3. Enforcement mechanisms are absent

Despite years of political attention and multiple regulatory proposals, the EU still lacks binding enforcement tools. The EMA can coordinate and recommend — but cannot sanction manufacturers for late reporting or failure to implement shortage prevention plans. As ECA auditors noted: the EU's proposals 'lack enforcement mechanisms such as sanctions.' This is the structural gap the Critical Medicines Act is designed to address.

The Regulatory Response: ESMP and the Critical Medicines Act

European Shortages Monitoring Platform (ESMP): Mandatory Since February 2025

The ESMP went fully operational on 29 January 2025 — three days ahead of its statutory deadline of 2 February 2025. All marketing authorisation holders (MAHs) are now legally obligated to use the platform as the sole channel for reporting shortages of centrally authorised medicines. National reporting obligations remain in parallel at member state level.

The platform enables EMA to monitor supply, demand and availability of medicines under three scenarios: normal conditions, crisis preparedness, and active crisis response. MAHs must also register an Industry Single Point of Contact (i-SPOC) — a specific named individual responsible for shortage reporting within their organisation.

▶ Action item for MAHs & distributors: If your company holds a EU centralised MA and has not yet registered your i-SPOC in ESMP, this is a compliance gap. Non-compliance creates regulatory risk and reputational exposure with national competent authorities.

Shortage Prevention Plans (SPP) and Shortage Mitigation Plans (SMP)

EMA published templates for SPPs and SMPs in June 2024. While currently recommended rather than mandated for all products, the revised EU Pharmaceutical Legislation — currently in legislative process — is expected to make SPPs obligatory for all marketed products. MAHs should treat SPP preparation as an immediate business priority, not a future compliance exercise.

Document	Purpose	Status (2025)	Who Needs It
Shortage Prevention Plan (SPP)	Map supply chain vulnerabilities; define minimum stock levels; identify risks	Recommended; will become mandatory under revised pharma legislation	All MAHs with EU/EEA-marketed products
Shortage Mitigation Plan (SMP)	Define response procedures when shortage occurs; roles, escalation, NCA notification	Recommended; will become mandatory	All MAHs with EU/EEA-marketed products
ESMP Reporting	Real-time shortage notification to EMA	MANDATORY since 2 Feb 2025	MAHs of centrally authorized products
i-SPOC Registration	Named contact for shortage reporting in ESMP platform	MANDATORY since 2 Feb 2025	All MAHs using ESMP

The Critical Medicines Act: A Structural Shift in EU Supply Policy

In March 2025, the European Commission proposed the Critical Medicines Act (CMA) — a legislative framework designed to reduce medicine shortages by strengthening supply chains for products on the Union List of Critical Medicines. The CMA introduces four main instruments:

Strategic Projects. Designated projects for critical medicine or API production receive streamlined access to EU funding (STEP, EU4Health) and fast-tracked regulatory procedures.

Public Procurement Reform. The CMA mandates use of Most Economically Advantageous Tender (MEAT) criteria in procurement, explicitly incorporating supply chain resilience, sustainability, and reliability alongside price. This is a fundamental shift from the current race-to-the-bottom pricing dynamic.

Collaborative Procurement. Member states can request Commission support for joint cross-border procurement of critical medicines — reducing fragmentation and improving negotiating leverage.

International Partnerships. The CMA envisions partnerships with like-minded countries to diversify API and finished-dose supply chains — including relevant for CEE markets' access to EAEU-sourced raw materials.

▶ Strategic implication: The shift from price-only to MEAT criteria in public tenders creates a commercial advantage for suppliers who can demonstrate supply chain resilience documentation — exactly what SPPs and SMPs provide.

What This Means for CEE Pharmaceutical Markets — and for Slovakia

Central and Eastern European markets, including Slovakia, are disproportionately affected by medicine shortages for three structural reasons. First, CEE markets are typically at the end of manufacturer allocation sequences — when a shortage hits, markets with the lowest prices or smallest volumes are deprioritised first. Second, national health budgets in CEE constrain the price adjustments that might incentivise manufacturers to maintain supply. Third, generic substitution rules vary significantly across CEE, limiting pharmacists' ability to substitute discontinued products.

Slovakia's State Institute for Drug Control (ŠÚKL) publishes daily updates on supply interruptions, cancellations and resumptions. The Institute has limited legal tools to compel manufacturers to maintain availability — it can facilitate extraordinary imports of foreign-language packages and generic substitution, but cannot mandate supply. This structural gap makes proactive supply chain management by distributors critical.

The PGEU Medicine Shortages Report 2025 found that in 96% of responding countries, shortages persist at sustained levels — and in at least one member state, 36.7% of all shortages concerned medicines on the Union List of Critical Medicines. GLP-1 receptor agonists (including semaglutide — the subject of Investpharm's previous analysis) featured prominently on the shortage list, alongside insulins and essential cardiovascular drugs.

▶ Opportunity signal: Companies that can demonstrate reliable supply continuity — particularly through diversified supplier portfolios and GDP-compliant logistics — are positioned to win B2B tenders where MEAT criteria apply.

B2B Strategy: Five Actions for Distributors and Manufacturers in 2026

1. Register your i-SPOC in ESMP — immediately

If your company markets centrally authorised products in the EU and has not completed i-SPOC registration in ESMP, this is the highest-priority compliance action. Non-registration means non-compliance with mandatory EMA requirements, and it creates exposure in any regulatory inspection or tender evaluation process.

2. Prepare Shortage Prevention Plans for your top-10 products by revenue

EMA's SPP template requires a supply chain map, risk assessment, historical shortage data, minimum stock level commitments, and root-cause analysis. This is not a box-ticking exercise — it is the foundation of supply chain intelligence. Companies that have invested in SPP preparation will have a significant advantage when SPPs become mandatory under revised pharmaceutical legislation.

3. Diversify your API and finished-dose supplier base

The single-supplier concentration risk (46% of critical generics with one EU supplier, per IQVIA MIDAS/Teva data) is quantifiable and manageable. Building relationships with secondary API suppliers — including from EAEU markets where quality-compliant manufacturers exist — creates a documented resilience advantage that can be cited in MEAT-based tenders and partner negotiations.

4. Monitor the EU Critical Medicines List — and build your portfolio accordingly

The Union List of Critical Medicines identifies products where shortage risk is highest. For distributors, this list is an investment signal: products on it face the most severe shortage-driven demand spikes, and suppliers who can guarantee availability at those moments command premium terms.

5. Leverage GDP-certified logistics as a differentiator

In a market increasingly focused on supply chain documentation and resilience, GDP-certified warehouse and distribution infrastructure is no longer a baseline requirement — it is a commercial differentiator. When a national health authority or hospital procurement department evaluates two offers of equal product quality, documented GDP compliance and supply continuity capability tips the evaluation.

How Investpharm Addresses the Supply Continuity Challenge

Investpharm was built around the reality that market access in CEE and EAEU markets is not simply a regulatory task — it is a supply chain management challenge requiring local expertise, GDP-compliant infrastructure, and relationships that sustain availability when global supply chains fracture.

GDP-certified warehouse in Bratislava. Investpharm operates a GDP-compliant warehouse in Bratislava with full cold-chain capability, batch traceability, and documented handling procedures aligned with EU Good Distribution Practice guidelines. For manufacturers seeking a reliable EU entry point for multi-market distribution — Slovakia, Moldova, and CEE — this infrastructure provides both regulatory compliance and operational continuity.

Multi-market supply network. Through affiliate Semastar in Moldova and established relationships in Kazakhstan and the UAE (Afar Trade), Investpharm can structure supply routes that diversify single-point-of-failure risks. For manufacturers, this means a single partnership that spans four market geographies with differentiated regulatory expertise — and a supply continuity narrative that strengthens tender bids in all of them.

Regulatory support for shortage compliance. Investpharm's regulatory team assists partners in preparing ESMP-compliant shortage reporting frameworks, SPP/SMP documentation, and local NCA communication — including ŠÚKL in Slovakia and AMDM in Moldova — for both centrally and nationally authorised products.

▶ Partnership enquiries: info@investpharm.eu | investpharm.eu | Bratislava, Slovakia

Frequently Asked Questions

Question	Answer
What is the ESMP and who must use it?	The European Shortages Monitoring Platform (ESMP) is the mandatory EU-wide platform for reporting medicine shortages. Since 2 February 2025, all MAHs of centrally authorised products must use ESMP to report supply interruptions. National reporting obligations remain separately.
What is a Shortage Prevention Plan (SPP)?	An SPP is a structured document mapping a product's supply chain vulnerabilities, minimum stock levels, historical shortage data, and risk mitigation measures. EMA published templates in June 2024. SPPs are currently recommended but are expected to become mandatory under revised EU pharmaceutical legislation.
What is the Critical Medicines Act?	Proposed by the European Commission in March 2025, the Critical Medicines Act aims to reduce EU medicine shortages by incentivising resilient supply chains through MEAT procurement criteria, strategic project designation, collaborative procurement, and international supply partnerships.
How do medicine shortages affect CEE markets like Slovakia?	CEE markets are typically deprioritised in manufacturer allocation sequences during shortages due to lower price points and smaller market volumes. Slovakia's ŠÚKL has limited legal enforcement tools. Proactive distributor supply chain management and GDP-certified logistics are critical differentiators.
What percentage of critical generics in the EU rely on a single supplier?	According to IQVIA MIDAS data and Teva research (2025), 46% of critical generic medicines in the EU have only one supplier, and 83% depend on a single major manufacturer — primarily in India or China.

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