Package leaflets for medication in the EU: The possibility of integrating patients’ perspectives in a regulated genre?

Abstract

Package leaflets (PLs) have been legally required to accompany medicines in the EU since 1999. Despite the best intentions and efforts, however, they are generally not well-received by the public for whom they are intended. This paper picks up on the challenges that medical regulatory writers face in producing quality PLs using the official PL template when research indicates that patients would prefer a more personalised genre that incorporated their experiences and knowledge. This paper advocates greater inclusion of patients’ perspectives, as this is currently achievable given the current legislation. The paper also notes the tantalising prospect of replacing the template with a set of recommendations that draws on knowledge of what works best for patients.

Keywords:

• Package leaflets
• Regulatory writers
• Template
• Patients’ perspectives
• Semi-expert patients

Additional information

Notes on contributors

Antoinette Fage-Butler

Antoinette Fage-Butler gained her PhD at the Department of Business Communication, Aarhus University Denmark, where she is currently an associate professor. Her primary research interests are within written health communication (offline and online; mass communication and one-to-one), ethical aspects of health communication, and poststructuralist approaches to discourse and genre.