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January 2019

The Prescription Medicines Code of Practice Authority (PMCPA) has announced the publication of the 2019 ABPI Code of Practice, which updates and amends the previous ABPI Code of Practice 2016 and the PMCPA Constitution and Procedure.

The ABPI Code is a self-regulatory code, first established by the ABPI in 1958. It sets standards for pharmaceutical companies which aim to ensure that they operate in a responsible, ethical and professional manner when promoting medicines, providing information to patients and working with healthcare professionals and patient organisations. It is administered by the PMCPA independently of the Association of the British Pharmaceutical Industry (ABPI). The Code reflects UK law, as well as incorporating requirements from equivalent international and European codes and the principles set out in World Health Organisation (WHO) ethical criteria for medicinal drug promotion.

The changes to the Code of Practice came into operation on 1 January 2019, following an open-to-all consultation process and approval by ABPI members on 4 December 2018. However, there is a transitional period until 30 April 2019, to allow pharmaceutical companies to familiarise themselves with the updated provisions. During this transitional period, no material or activity will be regarded as being in breach of the Code if it fails to comply with its provisions only because of requirements which this edition of the Code newly introduces.

The 2019 Code includes a new introductory section setting out the main principles and overview of self-regulation. It states that:

"The aim of the Code is to ensure that the promotion of medicines to health professionals and other relevant decision makers and other activities are carried out within a robust framework to support high quality patient care" and that "Whilst the industry has a legitimate right to promote medicines to health professionals, the Code recognises and seeks to balance the needs of patients, health professionals and the public, bearing in mind the environment within which the industry operates and the statutory controls governing medicines".

Other key changes include:

• Updates to better reflect the central role of digital marketing, including online communications.
• Changes to arrangements for the certification of materials and activities within companies.
• Updates to reflect regulatory changes, such as the introduction of conditional licences.
• Updates following changes to codes of conduct and guidance for health professionals.
• Pharmaceutical companies are also required to use the 2019 Disclosure Template in order to submit their 2018 data to Disclosure UK in March 2019.

The 2019 ABPI Code of Practice is available for download from the PMCPA website.

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