Inactive ingredients added to medicines, such as capsule shells, fillers and coatings, are often a serious ethical issue for millions of EU citizens.
Medicine packaging and leaflets may list the excipient name, but they do not disclose species origin. As a result, patients and clinicians often cannot tell whether a capsule’s gelatine is from cows, pigs or fish, or whether ingredients like stearates and glycerol are from animals or plants.
For many people, that origin matters. This includes vegans and vegetarians, and people with religious dietary rules, including halal and kosher, and some Hindu, Buddhist and other faith-based or cultural restrictions. It also matters for clinicians and pharmacists, because they cannot reliably advise patients or choose alternatives when origin is not shown.
EU law (Directive 2001/83/EC) requires excipients to be listed in the leaflet, and sometimes on the box. But it does not require the species origin to be stated. Even when “gelatine” is listed, the origin stays unknown.
A UK audit of the 100 most commonly prescribed medicines found 74% contained at least one potentially animal-derived excipient (lactose, gelatine, or magnesium stearate) and 20% contained gelatine. There is no comparable EU-wide audit identified in the cited literature.
Other studies report that many healthcare professionals are unsure which medicines contain these ingredients. Ethics papers argue that not disclosing animal-derived ingredients can undermine informed choice for patients who would object.
Make origin disclosure part of regulated product information. Companies already record excipient origin in internal specifications and supplier documentation.
Add simple origin labels in the medicine’s professional info (SmPC) and patient leaflet, and where there’s space, on the box too. For example: “gelatine (pig/cow/fish)”, “glycerol (plant/animal/synthetic)”, “magnesium stearate (plant/animal/synthetic)”.
Use a standard symbol or short note to flag the presence of animal-derived excipients, explained in the leaflet.
Create an EU database where marketing authorisation holders record species origin for relevant excipients, accessible via QR code or search.
Download: Brief + Evidence summary (PDF)