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In brief

The Aesgp (Association of the European Self-Care Industry), Efpia (The European Federation of Pharmaceutical Industries and Associations) and Medicines for Europe (hereafter the “Working Group“) have published a position paper containing a set of recommendations on how to make package leaflets for medicines more comprehensible to patients in order to ensure their appropriate, safe and effective use.


Key takeaways

Among the recommendations made by the Working Group, the following should be highlighted: (i) to create clearer and more easily understandable package leaflets that encourage the correct use of the medicine; (ii) to use simple, easily accessible and concise language, so as to minimize the volume of text and ensure the correct understanding of the relevant information for the patient; (iii) to use a layout and structure that facilitates the reading and understanding; (iv) to introduce a separate section for indications translated into other languages; and (v) to prepare a dedicated text and layout for the electronic package leaflet.

Author

Roberto Cursano has been a lawyer in Baker McKenzie since September 2007. He focuses on healthcare law and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts. Mr. Cursano is a former administrative officer in the Italian Ministry of Health and helps clients work closely with the Italian Public Administration. He is admitted to the bar before the Italian Supreme Court and the Council of State. As well as training and tutoring in the master’s degree program on clinical trials of pharmaceutical products at the University of Rome Sapienza, Mr. Cursano regularly publishes articles and scientific contributions. He also frequently hosts and participates in seminars and presentations on pharmaceutical and administrative law matters.

Author

Riccardo Ovidi is an Associate in Baker McKenzie Rome office.

Author

Francesca R. Baratta is an Associate in Baker McKenzie Rome office.