Novo Nordisk diabetes supplement in The Times ruled to be pre-licence promotion of liraglutide to the public

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Key facts

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Case number	AUTH/2202/1/09
Case reference	Lilly v Novo Nordisk
Complainant	Eli Lilly and Company Limited
Respondent/company	Novo Nordisk Limited
Product(s)	Liraglutide
Material/channel	Diabetes supplement distributed with The Times newspaper (“Changing the Future of Diabetes”); article “Gut protein drug expected to help improve control”
Key issue	Pre-licence promotion of liraglutide to the public in a sponsored supplement; company responsibility due to editorial control/influence
Dates (received/completed if stated)	Complaint received 23 January 2009; case completed 10 March 2009
Appeal	Not stated
Code year	Not stated
Breaches/clauses	Clauses 22.2, 22.1, 3.1, 9.1, 2
Sanctions	No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

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

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Eli Lilly complained about an article, “Gut protein drug expected to help improve control”, in a 16-page diabetes supplement (“Changing the Future of Diabetes”) distributed with The Times on 14 November 2008.
The supplement was sponsored/fully funded by Novo Nordisk and distributed to coincide with World Diabetes Day.
The article was based on an interview with Novo Nordisk’s chief science officer and referred to clinical trials of liraglutide, including claims of “better blood glucose control” and that it “has also helped people reduce weight”, and mentioned a “single daily injection”.
The article stated liraglutide was unapproved / lodged with authorities in Europe and the US and, if approved, expected to be available from mid 2009.
Novo Nordisk argued the supplement was disease-awareness/educational, that the article presented research findings and made clear the product was not yet approved.
The Panel noted the order confirmation/sponsorship arrangement showed Novo Nordisk had full editorial control, owned the copyright and was part of the editorial team; there was no strictly arm’s length arrangement.
The Panel considered Novo Nordisk responsible for the supplement’s content for Code compliance and that patients could be encouraged to ask a health professional to prescribe liraglutide, regardless of it being unavailable to prescribe at the time.

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The Panel ruled the article breached the Code as it promoted liraglutide to the public and amounted to pre-licence promotion prior to marketing authorisation.
The Panel ruled that high standards had not been maintained.
The Panel ruled Novo Nordisk failed to exercise due diligence in public-facing material, bringing discredit upon and reducing confidence in the pharmaceutical industry.
Complaint received: 23 January 2009.
Case completed: 10 March 2009.

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Clause 22.2 – Breach ruled (information to the public; considered likely to encourage patients to ask a health professional to prescribe a specific medicine).
Clause 22.1 – Breach ruled (promotion/advertising of a prescription only medicine to the public).
Clause 3.1 – Breach ruled (promotion prior to the grant of a marketing authorisation).
Clause 9.1 – Breach ruled (high standards not maintained).
Clause 2 – Breach ruled (failure to exercise due diligence; brought discredit upon/reduced confidence in the industry).

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