generics. The pharmaceutical supply in Europe at the highest level of criticality

The political priorities outlined by Elisabeth Stampa (Medicam), new president of Medicines for Europe

Egualia – 7 marzo 2022

«The conflict in Ukraine following two years of the Covid-19 pandemic further highlights the need to ensure better patient access to medicines and to restore the security of pharmaceutical supplies in Europe, which is now more critical than ever ».

This was stated by Elisabeth Stampa (CEO of Medichem SA), new president of Medicines for Europe, the association that represents the industries of generic, biosimilar and value-added medicines throughout Europe, with over 400 production plants, 126 research sites and development and 190,000 employees.

«Sette medicinali su dieci dispensati in Europa non sono coperti da brevetto: il contributo del nostro settore al sistema sanitario europeo è stato e resta fondamentale – prosegue la Stampa -. Mentre i sistemi sanitari iniziano a riprendersi dalla pandemia, una nuova crisi minaccia la stabilità e la sicurezza dell’approvvigionamento di medicinali in Europa. Ciò accresce l’urgenza di coordinare l’azione dell’UE sui medicinali essenziali e sull’accesso alle cure, traducendo le dichiarazioni politiche in una vera riforma politica».

Queste – secondo il neo-presidente – le priorità politiche chiave, che richiedono un’azione urgente dell’UE nell’anno che dovrebbe vedere la messa a terra della pharma strategy:

1. Facilitate the sustainable production of active pharmaceutical ingredients and medicines in the EU to secure supplies to patients and healthcare systems in Europe;

2. ensure the competitiveness of the European medicines and off-patent active ingredients sector and a flexible and digital regulatory system that facilitates timely access for patients;

3. support the green transformation of manufacturing industry.

Note:

I recenti “incidenti” di qualità riguardanti le API (principi attivi e intermedi) provenienti dalla Cina e dall’India (cases of nitrosamine contamination) have raised questions as to whether the system of self-certification or written country of origin certification provides guarantees sufficient that the imported APIs are manufactured in compliance with GMP regulations.