Novartis, Camurus, Pfizer and Boehringer Ingelheim have been named in advertisements for breaches of the ABPI Code

Novartis – Case AUTH/3400/10/20

For promoting inclisiran (Leqvio) prior to the grant of the marketing authorisation, Novartis was ruled in breach of the following clauses of the Code:

Clause 2 - Bringing discredit upon, and reducing confidence in, the pharmaceutical
industry
Clause 3.1 - Promoting an unlicensed medicine
Clause 9.1 - Failing to maintain high standards
Clause 9.10 - Failing to be sufficiently clear as to the company’s role and involvement
Clause 12.1 - Disguising promotional material
Clause 14.1 - Failing to certify promotional material
Clause 28.1 - Failing to comply with all relevant requirements of the Code

Camurus – Case AUTH/3404/10/20

For failing to include obligatory information and certify promotional materials for Buvidal (buprenorphine) and for failing to fairly reflect Camurus’ role and responsibility in relation to two promotional webinars which were, in addition, not restricted to health professionals and other relevant decision makers and were thus considered to be promoting Buvidal to the public, Camurus was ruled in breach of the following clauses of the Code:

Clause 2 - Bringing discredit upon, and reducing confidence in, the pharmaceutical
industry
Clause 4.1 - Failing to include prescribing information
Clause 4.3 - Failing to include the non-proprietary name immediately adjacent to the most prominent display of the brand name
Clause 4.9 - Failing to include information about how to report adverse events
Clause 9.1 - Failing to maintain high standards
Clause 9.10 - Failing to clearly indicate its role and responsibility in relation to two
promotional webinars
Clause 12.1 - Disguising promotional material
Clause 14.1 - Failing to certify promotional material
Clause 26.1 - Promoting a prescription only medicine to the public
Clause 26.2 - Encouraging members of the public to ask for a specific prescription
only medicine
Clause 28.1 - Failing to restrict access to promotional material to health professionals and
other relevant decision makers

Pfizer – Case AUTH/3437/12/20

For a senior employee placing an uncertified promotional post on his/her personal LinkedIn account which linked to an article about the company’s vaccine prior to the grant of its marketing authorisation which was ‘liked’ by another employee, Pfizer was ruled in breach of the following clauses of the Code:

Clause 2 - Bringing discredit upon, and reducing confidence in, the pharmaceutical
industry
Clause 9.1 - Failing to maintain high standards

Pfizer – Case AUTH/3438/12/20

For a senior employee placing an uncertified promotional post on his/her personal LinkedIn account about the Pfizer/BioNTech vaccine on LinkedIn which linked to an article about the vaccine which described the vaccine as being judged as safe for use in the UK without qualification, prior to the grant of its marketing authorisation, Pfizer was ruled in breach of the following clauses of the Code:

Clause 2 - Bringing discredit upon, and reducing confidence in, the pharmaceutical
industry
Clause 7.9 - Using the word ‘safe’ without qualification
Clause 9.1 - Failing to maintain high standards

Boehringer Ingelheim – Case AUTH/3462/1/21

For providing a flow diagram for Pradaxa (dabigatran) which directed health professionals to select the most appropriate dose for their patient, taking into account age, concomitant verapamil and bleeding risk, without clearly bringing to their attention that Pradaxa was contraindicated in severe renal impairment, which put patient safety at risk, Boehringer Ingelheim was ruled in breach of the following clauses of the Code:

Clause 2 - Bringing discredit upon, and reducing confidence in, the pharmaceutical
industry
Clause 7.2 - Providing a misleading diagram
Clause 9.1 - Failing to maintain high standards

The case reports are available at www.pmcpa.org.uk.