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.

Inability to provide curative treatment or delaying chemotherapy as a result of shortages can have significant consequences for patient outcomes, including survival rates.

At various levels, in Europe, there have been and are ongoing discussions and commissions on how to overcome this new needs which require an effort to ensure compliance with European social and environmental standards are complied with in pharmaceutical production.

Solutions to the problem are believed to entail collaboration and joint action, as well as the involvement of multiple stakeholders, including regulators, industry, patients, healthcare professionals, and international players. The Organization for Economic Co-operation and Development and the World Health Organization, in particular, ...