Issue: January /February 2023

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.

Life Sciences organisations have had to rapidly adapt to a new landscape of operations. The challenges of the pandemic have put an urgent focus on enhancing patient outcomes by improving products delivery processes. In 2023 Life Sciences companies must develop strategies to capitalise on the opportunities that data-driven technologies offer. Frits Stulp of Iperion – a Deloitte business – predicts a new wave of data-based transformation as the drive to reduce time to market and address product shortages continues.

Competition, complex new science and regulatory changes have been compounded by economic tightening. In 2023 and beyond, smaller biopharma companies in particular will need to rethink their strategies to attract investors, carefully plan how and with whom they outsource and ensure they understand the finer nuances of the regulations when they seek to globalize. Mark Lane and Rami Scharf of PharmaLex describe the challenges ahead.