2023 | January /February 2023

Drugs and APIs shortage put EU patients at risk

by cyb2025

CARLO LUSSO
Custom Synthesis Manager, Chemical Development and Manufacturing, Angelini Pharma S.p.A. | Fine Chemicals Business Unit, Milan, Italy

ABSTRACT

Drugs & APIs shortage is a global issue with an evident impact affecting all the people independently of their geographic or economic position. A complex problem never has a single motivation but there are different factors that cause this trouble: supply issues, demand issues, regulatory issues, procurement, unavailability of raw materials, logistics and finally even trade disputes. In this long list we cannot forget to mention the heavy impact that has accelerated all of these difficulties in the last 3 years: the effects of the Coronavirus on the global drug supply chain.
Finally, let’s not forget Medicine shortages harm patients and push up costs: surveys conducted by the European Medicines Agency (EMA) and others regulatory Associations in Europe report that medicines shortages have a significant impact on patient care.
Shortages can lead to failure to treat, delayed treatment, the use of less desirable, often expensive, alternative products, an increased potential for errors or adverse events related to using alternative medicines or dosages, and exclusion from treatment, to list just a few of the reported outcomes.
Only by bringing some pharmaceutical products back to Europe, which have been managed elsewhere for too long, will be possible to keep these issues under control. All this will be possible through economic investments and by evaluating the product not only on the basis of the most advantageous cost, but also on the basis of the quality, safety, traceability and certifications provided. For these reasons will be difficult to maintain the same current prices which will inevitably increase but with some important guarantees which will protect us from the current problems which we have to face and manage today.

IMPACT OF COVID-19 ON GLOBAL PHARMACEUTICAL PRODUCTION AND TRADE
The coronavirus crisis has brought to the fore the geopolitical dimension of these shortages, that is, the EU’s dependency on countries beyond its boundaries, especially China and India, for the production of many active pharmaceutical ingredients and medicines.

ABOUT THE AUTHOR

Carlo Lusso is the responsible CDMO business development & project portfolio management of Angelini Fine Chemicals about Europe & Asia – business unit of Angelini Pharma S.p.A.
He is currently tasked of coordinate chemical development programs and technology transfer in/out of new Angelini’s in-licensing and custom small molecule APIs / HPAPIs.

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