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

Facilitate the sustainable production of active pharmaceutical ingredients and medicines in the EU

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

Egualia – 7 March 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.

«Seven out of ten medicines dispensed in Europe are not covered by a patent: the contribution of our sector to the European healthcare system has been and remains fundamental – continues La Stampa -. As healthcare systems begin to recover from the pandemic, a new crisis threatens the stability and security of medicines supply in Europe. This adds to the urgency of coordinating EU action on essential medicines and access to treatment, translating political statements into real political reform."

These - according to the new president - are the key political priorities, which require urgent action by the EU in the year that should see the grounding of the 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:

Recent quality incidents involving APIs (active and intermediate ingredients) from China and 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.

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