Astellas Pharma: Protopic “whole British summer” leavepiece found inconsistent with SPC sun-exposure warning (AUTH/2418/7/11)

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Key facts

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Case number	AUTH/2418/7/11
Parties	Pharmacist v Astellas Pharma Ltd
Product	Protopic (tacrolimus)
Material	Leavepiece (ref: PRO11003UK)
Main claim/theme	“142 days without a major eczema flare? That’s a whole British summer” with outdoor imagery
Core issue	Overall impression considered inconsistent with SPC warning to minimise skin exposure to sunlight and advise sun protection methods
Complaint received	24 June 2011
Case completed	10 October 2011
Applicable Code year	2011
Breach clauses	Clause 3.2
No breach clauses	Clause 7.2; Clause 9.1
Sanctions	Undertaking received; Additional sanctions: Not stated

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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A pharmacist complained about a Protopic (tacrolimus) promotional leavepiece (ref: PRO11003UK) issued by Astellas Pharma Ltd.
The front cover headline stated: “142 days without a major eczema flare? That’s a whole British summer” alongside imagery of a woman outdoors with exposed skin (sandals, knee-length shorts, vest top).
The complainant alleged the leavepiece implied Protopic could be used in summer with sun-exposed skin and was inconsistent with the Protopic SPC warning about minimising skin exposure to sunlight.
The Panel noted the leavepiece implied use on visible/delicate areas (including face/neck) and that images elsewhere in the piece appeared to reflect sunlight.
The SPC (Section 4.4) stated exposure of the skin to sunlight should be minimised and physicians should advise sun protection methods (minimise time in sun, sunscreen, covering skin with appropriate clothing).
Astellas argued the scene was intentionally overcast (no overt sunshine) and that the SPC did not say sunlight must be avoided, only minimised; it also argued it was not practical to depict all precautions in imagery.
Both the complainant and Astellas appealed aspects of the decision.

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Breach upheld: Clause 3.2 (promotion inconsistent with the SPC).
No breach upheld: Clause 7.2 (not misleading on the narrow allegation that it implied Protopic could be used in summer on sun-exposed skin).
No breach upheld: Clause 9.1 (no additional ruling; Clause 3.2 breach considered sufficient to cover concerns).
The Appeal Board was concerned that Astellas research suggested prescribers would not ordinarily advise Protopic patients about sun protection, and said companies should ensure correct use and acknowledge relevant SPC warnings in context.

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