Industry Insights MedComms: 30/05/25
In this round of insights in medical communications, we discuss three articles published in the latest edition of Medical Writing, a journal series published by the European Medical Writers Association (EMWA). This edition focusses on communicating about rare diseases.
Regulatory writing for rare diseases
In an interview published in Medical Writing, Kelley Hill reflected on the challenges of regulatory writing for rare diseases. As they often draw on small patient populations, rare disease reports often include unconventional evidence. Hill emphasises that writers must account for scientific uncertainty when writing about rare diseases and adapt global templates to regional regulatory expectations. She also stresses the importance of emotional intelligence for creating narratives. This involves dedicating time to understanding the patients’ journeys as they discover their diagnoses.
Interview link: https://shorturl.at/DbhY0
Understanding regional requirements when writing for orphan drugs
An article by Katie Brooks et al. published in Medical Writing aimed to provide a guide for navigating document types and regulatory pathways for orphan drugs across the US, European Union and Japan. The article outlines how writing requirements can differ substantially between regions. According to the article, it is important to have an early engagement with regulators, regular input and messaging for each market to understand the existing differences. Medical writers play a key role in maintaining consistency in their writing, thus ensuring that efficient communication reaches patients living with rare diseases.
Article link: https://shorturl.at/xujIa
The impact of medical writing in rare disease communication
Dr Christian J. Hendriksz’s contribution to Medical Writing, Penning Hope, delivered a reminder of the human dimension of medical writing. In his article, Dr Hendriksz reflected on his personal experience as both a clinician and a parent of a child with a rare disease and shared how medical writers bridge gaps between scientific data and lived experience. He called on the profession to adopt a sense of social responsibility, particularly when supporting populations in low- and middle-income countries. Dr Hendriksz encouraged writers to embrace inclusive, patient-first language in any form of writing, from clinical study protocols to lay summaries. In this way, writers ultimately become partners in improving patient care and hope.
Article link: https://shorturl.at/gtCZ1
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