European Commission drug shortage pilot study highlights industry, regulatory challenges

The European Commission has published results from a pilot study to understand the challenges to ensuring safe drug supply chains. While the commission said that one of the major challenges was getting information about critical medical products, it also noted the study has many shortcomings, making it hard to interpret the data.

During the COVID-19 pandemic, EU member states faced several critical drug shortages, which led the Commission and other stakeholders to investigate the underlying reasons for drug shortages and what to do about them. In December, the Commission, the Heads of Medicines Agencies (HMA), and the European Medicines Agency (EMA) published a list of 200 critical medicines facing potential shortages.

The Commission began a pilot study of 11 drugs to understand what may cause their shortage, and on 10 July, it released a preliminary technical report to communicate what challenges may cause those shortages. In particular, the Commission hopes the data can be used to inform conversations about shortages in various forums such as the Medicine Shortages Steering Group (MSSG) or Joint industrial cooperation forum of Health Emergency Preparedness and Response Authority (HERA) and within the Critical Medicine’s Alliance (CMA).

“The continued availability of medicines is key in our European Health Union. To achieve this, the Communication emphasizes that the EU needs to boost the resilience of its supply chains,” said the Commission. “This will require ensuring access to key capabilities at different levels of the supply chain, from sourcing of key input materials, active pharmaceutical ingredient (APIs), and precursor production to the actual manufacturing of finished products.”

“At the same time, the EU needs to reconsider its manufacturing dependencies and enhance its strategic autonomy in health, by exploring the potential for expansion of its internal EU manufacturing capacity, while also building on strategic relations with neighborhood [sic] countries and like-minded countries around the world,” it added.

Despite the limitations of the data collected, the study found that MAHs tended to rely on a limited number of suppliers across their supply chain tiers and described economic challenges, including cost pressures, high competition, and market unsustainability. The report also found that most companies base their manufacturing capacity and planning on three to six months short-term, two to three years mid-term, and five to 10 years long-term timeframes.

“For short-term production planning of generic medicines, MAHs appear to commonly use current sales rates for estimating the demand,” the report stated. “However, this approach was perceived to have some serious limitations in case of unexpected significant demand fluctuations, such as those observed during the pandemic and the post-pandemic period.”

“MAHs regard manufacturing and logistical issues as the main reasons for supply chain discontinuities, and in few instances, regulatory issues,” the report added. Manufacturing issues are related to the complexity of production processes and the fact that investing into new or modified production lines with a higher/more stable production volume is economically risky and takes time to get regulatory approval.”

Similarly, member state data showed an overreliance on active pharmaceutical ingredients (API) manufactured outside the EU, and some of the top challenges they have faced include manufacturing issues, quality issues, and unexpected increases in demand.

Despite the challenges, the study found that member states employed several measures to address supply chain issues, including using regulatory flexibility, controlled distribution, alternative protocols, communication with stakeholders, and export bans.

“Notably, regulatory flexibility and controlled distribution measures were the most reported measures,” the European Commission reported. “Approximately 50% of Member States have reported granting approvals for exemptions, such as foreign language package allowances and unlicensed medicines.”

Technical report

European Commission drug shortage pilot study highlights industry, regulatory challenges

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