Recurring shortages of medicines and the supply chain failures exposed during recent health crises have revealed structural vulnerabilities in the global production and distribution of medical goods. The persistent lack of visibility over essential inputs – from active pharmaceutical ingredients (APIs) and key starting materials (KSMs) to finished-dose products – blinds policymakers to emerging disruptions. Building on prior OECD work, this report strengthens the evidence base on the resilience of medical supply chains, with a focus on medical countermeasures; examines a range of international co‑operation instruments that could enhance supply security; and assesses how digital technologies can support proactive monitoring of medical product supply chains.
Three product classes were selected as case studies for their relevance to public health emergency preparedness: injectable systemic corticosteroids, seasonal influenza vaccines and influenza RT-PCR diagnostic tests.
Supply chain analysis for the three selected products reveals significant market concentration and manufacturing dependencies for two of them. While 84 companies sell injectable corticosteroids in the EU, national markets typically rely on one or two suppliers per molecule – a pattern likely driven by procurement tenders, as 76% of sales of these products belong to the hospital sector. Seasonal influenza vaccines are supplied by five main manufacturers, with one or two suppliers frequently accounting for the bulk of seasonal deliveries. For RT-PCR diagnostic kits, 85 companies hold CE marks, but no information is available to confirm that they actually sell test kits in the EU, or, if so, in what quantities.
For the three case studies, publicly available data do not allow a full mapping of upstream supply chains, and the analysis therefore relied on triangulating multiple sources, including manufacturer surveys. These surveys yielded useful insights but cannot be considered representative because of the low response rate. Only 20 companies were identified as holding certificates to supply active pharmaceutical ingredients (APIs) for injectable corticosteroids sold in the EU in 2024. Of these, six are located in the EU, two in the United States, and the remainder are distributed across China (9), India (2) and Malaysia (1). The respective contributions of each site to the EU market, however, could not be determined.
For finished-dose production of injectable corticosteroids, surveyed manufacturers identified upstream dependencies as the primary vulnerability of their supply chains and flagged sterile fill-and-finish operations and reliance on internationally sourced APIs and intermediates as the most critical bottlenecks. Influenza vaccine production is heavily concentrated in the EU and the United States, depends on tightly sequenced manufacturing steps within narrow seasonal windows and is vulnerable to delays in batch testing and release. RT-PCR test manufacturing is exposed to disruptions across multiple specialised reagents and components from dispersed suppliers, located both in and outside Europe, in proportions which are unknown.
Given the global nature of medical supply chains, no single country or region can secure supply by its own. The report therefore assesses the feasibility and expected impact of six categories of international co‑operation instruments, distinguishing between their capacity to expand supply, facilitate trade and strengthen resilience to acute shocks.
Broad trade agreements can diversify supply sources and expand manufacturing capacities, although they may also facilitate the offshoring of existing capacity. Strategic partnerships have proven more tractable than broad trade agreements. Globally, in the sector of critical raw materials (CRM), “targeted trade deals” have intensified trade between partners by 12%. Results for EU strategic partnerships on CRM, however, are not yet available. Current initiatives in Africa and Latin America aim for regional self-sufficiency rather than reinforcing EU supply security. They may nevertheless relieve pressure by addressing a share of an increasing worldwide demand for pharmaceuticals.
On trade facilitation, Mutual Recognition Agreements (MRAs) in the pharmaceutical sector have reduced inspection burdens and supported market access, but coverage remains uneven across product categories and jurisdictions. MRAs in the medical device sector are not active. Additional gains are available through digitalisation and interoperability of border processes, which are particularly valuable during crises when administrative delays compound physical bottlenecks.
Three potential co‑operation instruments have been assessed in depth. Given the legal and institutional complexity involved, the report suggests a gated approach for each, with binding feasibility reviews at pre‑committed decision points:
A multilateral market monitoring mechanism (MedMIS), modelled on the Agricultural Market Information System (AMIS), could improve situational awareness across a defined basket of critical products and support co‑ordinated crisis response. Its function would be diagnostic: classifying whether a disruption reflects physical capacity constraints, co‑ordination failures, or demand amplification – a distinction that determines the appropriate policy response. Participation by firms faces two distinct barriers that should be addressed simultaneously: commercial confidentiality concerns, addressed through a governed data‑aggregation architecture that prevents firm-level disclosure; and competition-law liability, which would require statutory antitrust safe harbours. The report proposes a proof-of-concept covering 20‑30 high-priority products, with a feasibility review at month 24, determining whether the mechanism proceeds, narrows scope, or transitions to a lighter co‑ordination forum;
A joint procurement instrument open to non-EU partners (MedPPA) could contract for security of supply through advance purchase commitments, volume guarantees, and diversification incentives. A resilience premium, estimated in the low-to-mid single digits based on comparator mechanisms, would be lower than the emergency procurement premiums, spot-market inflation, and wastage costs incurred when such measures are absent. To prevent defection when supply is scarce, the mechanism would require a dual-mode governance structure: consensus-based under normal conditions, with delegated executive authority and binding exclusivity provisions during declared crises. Procurement credibility would also depend on regulatory and logistics operability, ensuring that products can be authorised, released, and physically delivered across participating jurisdictions;
Finally, a common stockpile open to third countries (RescPool) could bridge the critical window between a localised shortage and production ramp-up. Rather than warehousing alone, it would combine physical rolling stock, keep-warm capacity reservation and surge arrangements matched to each product’s shelf-life and supply-chain profile. Cross-border deployability would require a “regulatory passport” protocol ensuring that stock held in one jurisdiction can be legally dispensed in all participating countries. To prevent crowd-out of national preparedness, access would follow a deductible principle: participants would need to demonstrate that national buffers are overwhelmed before drawing on pooled reserves.
The last part of the report assesses how new data-driven technologies can improve the monitoring of medical supply chains and strengthen preparedness for shortages of medical countermeasures (MCMs). It reviews public track-and-trace frameworks in the European Union, the United States, Türkiye and Canada, as well as innovative supply chain monitoring tools used by the private sector relying on artificial intelligence, predictive analytics, Internet of Things (IoT) sensors, Radio-Frequency Identification (RFID) and cloud platforms.
The analysis highlights that existing public track-and-trace systems provide useful traceability but were not designed for anticipatory shortage monitoring. They can improve security of supply indirectly, but they focus mainly on finished pharmaceutical products and provide limited visibility on upstream risks such as API and KSM dependencies, supplier concentration, transport bottlenecks or demand shocks.
Private sector initiatives go further in some respects. They collect more granular information and use more systematically predictive analytics and other data-driven technologies to anticipate disruptions and optimise operations. However, they are designed for firm-specific purposes and may rely on proprietary platforms, commercially sensitive data and uneven incentives. They can inform public monitoring but cannot simply be transposed to a public preparedness system.
Public systems and private initiatives demonstrate that near real-time monitoring of pharmaceutical products, shipments and selected inputs is technically possible. However, scaling such systems across countries, products and actors requires more than technology. It depends on common standards, interoperable infrastructures, high-quality data, proportionate reporting obligations, trusted governance and sustainable incentives for participation.
Current systems remain fragmented and insufficiently interoperable. Despite growing convergence around standards such as GS1 DataMatrix codes, existing public systems are not designed to exchange data internationally or to connect systematically with information on stocks, production capacity, international flows and demand. Effective monitoring would require stronger alignment between product identification, regulatory master data and supply-chain event reporting, including links between finished products and selected upstream inputs. Moreover, monitoring MCMs requires a broader scope than medicines alone.
For the EU, the key challenge is to move from regulatory shortage management towards anticipatory monitoring of MCM supply chains. Existing tools such as the ESMP, the EMVS, ATHINA, legal obligations in the EU Emergency Framework Regulation, as well as reinforced reporting obligations for manufacturers in the context of new EU regulations on pharmaceutical products, critical medicines and medical devices, all provide the institutional foundations to collect relevant information to better monitor MCM supply chains.
The report recommends a pragmatic and modular approach where progress would be incremental. First, ATHINA should be complemented with early-warning indicators covering the full supply chain of MCMs, possibly for a limited set of high-priority MCMs on a pilot basis at the beginning. Second, DG HERA should build dedicated analytical capacity in risk assessment and security of supply monitoring for MCMs, as well as demand forecasting, including through partnerships with external technology providers. Third, data sharing arrangements should be developed with the private sector, combining confidentiality-preserving routine reporting with escalation mechanisms allowing access to more granular information during crises. Fourth, the EU should promote international interoperability by aligning standards, supporting trusted data exchange with partner countries and exploring ATHINA’s role as a co‑ordination node in a broader global early-warning architecture developed with trusted partners.