On 13 January 2025, having first attempted inter-company dialogue, Opella raised formal concerns with PAGB regarding claims for Movicol Ease in consumer and professional advertising.

The complainant raised a number of challenges:

• Claims that the product had a “triple-effect formula that draws water into the stool to hydrate, to soften and to restore a natural, more regular, bowel movement’ [consumer facing website] and had “a natural action that works in two ways: hydrates & bulks, softens & lubricates” [healthcare professional facing website] were misleading regarding the mechanism of action and effect of the drug.
• A description of steps for use on the consumer facing website suggested one sachet of Movicol Ease was sufficient to return the patient to their natural routine, which was misleading.
• The claim “To restore your natural bowel movement”, featured in point of sale and on the consumer facing website, suggested one sachet of Movicol Ease was sufficient to return the patient to their natural routine and implied a guaranteed effect.
• A table on the healthcare professional facing website, comparing Movicol with stimulant laxatives, indicated that Movicol was suitable for use in pregnancy, while stimulant laxatives were not which was misleading.

The complaint was considered under the following rules:

PAGB Consumer Code for Medicines

4. Advertising shall be true and shall not mislead. It shall not contain any exaggerated claims, either direct or implied.

17. Advertising shall not claim or imply, that a product’s effects are guaranteed.

PAGB Professional Code for Medicines

4. Advertising shall be true and shall not mislead. It shall not contain any exaggerated claims, either direct or implied.

22. All comparisons shall be balanced, fair and supportable.

The PAGB Senior Management Team reviewed the materials and considered the arguments set out in both the complaint and response to assess whether the content breached the Consumer Code for Medicines or Professional Code for Medicines, as applicable.

• PAGB considered whether the wording “triple-effect formula that draws water into the stool to hydrate, to soften and to restore a natural, more regular, bowel movement” misrepresented how Movicol works, and was likely to mislead consumers to their detriment. We considered, on balance, that within this context consumers would understand the meaning of triple effect in relation to the actions of hydrating the stool, softening the stool and restoring normal bowel movement. We did not consider this description to be in conflict with the way of working described in the product SPC, and did not consider that consumers would be misled as to how the medicine works, or the effects it has on stools or bowel function.
• PAGB considered whether the wording “a natural action that works in two ways: hydrates & bulks, softens & lubricates” misrepresented how Movicol works, and whether the description was likely to mislead heath care professionals. We considered that the claims that the product hydrates, bulks, softens and lubricates were aligned with product SPC and general medical understanding of how macrogol works, and that healthcare professionals would understand the wording as expanding on the action of the product. We did not believe healthcare professionals would be misled as to how the medicine works, or the effects it has on stools or bowel function.
• When reviewing the steps for use on the consumer website, PAGB considered whether the material implied that only one dose was required to return to a natural routine, and whether it implied this effect was guaranteed. We considered that there was a risk of consumers interpreting the phrasing as suggesting that only one sachet was required, which would not be the case for all consumers. However, during intercompany dialogue Norgine indicated that while they did not consider the claim misleading, they would be amending this section of the website to remove any ambiguity. The website now includes the line “Use up to 3 times a day for up to 5 days”. In light of this we did not consider further investigation is required on this point.
• PAGB considered the claim “To restore your natural bowel movement” to be a simple statement of the product indication. We did not consider the content likely to be interpreted as a guarantee of efficacy by consumers, nor did we consider it to be a claim relating to dosing that could imply only one sachet was needed for the product to take effect.
• PAGB noted that rule 18 of the Professional Code states that advertising of a product for use in pregnancy is acceptable only if there is a positive pregnancy statement in section 4.1 or 4.6 of the SPC. Movicol Ease contains a positive pregnancy statement in section 4.6; ‘Movicol Ease can be used during pregnancy.’ The stimulant laxatives referenced in the complaint did not contain a positive pregnancy statement in their SPCs. As such, it would be a breach of this rule to promote these stimulant laxatives for use during pregnancy. We therefore considered that the comparison followed the rules of the Professional Code in relation to claims for use in pregnancy and that the table did not unfairly represent other treatments and was balanced, fair and supportable.

Conclusion

No breach of the Code.