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How Drug Preparations Undermine Europe’s Regulatory System

Genevieve Michaux and Luca Salernitano examine the complexities and concerns surrounding the flourishing practice of preparing medicines for patients by pharmacies and hospitals in the EU. They say it undermines the very essence of the EU drug evaluation system and the regimes adopted to incentivize the development of medicinal products for rare diseases and pediatric patients.

Pharmacist
There are concerns that preparations are undermining the EU drug approval system • Source: Shutterstock

Medicines prepared for patients by pharmacies or hospitals are becoming more and more common but they undermine the European drug review system and are detrimental to drug development for the smaller populations – rare disease and pediatric patients – in whom they have traditionally been used. 

About The Authors

Genevieve Michaux is a partner at the Brussels, Belgium, office of law firm Mayer Brown LLP, and Luca Salernitano is an associate at the same office. Email: gmichaux@mayerbrown.com.

Certain pharmacies can produce preparations in large quantities. This may not be a big threat to authorized prescription-only medicines designed...

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