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UK pharma Code of Practice to change with digital times

Changes proposed on the Code’s 60th anniversary

ABPI

UK pharma industry organisation the ABPI has unveiled proposed changes to its Code of Practice, aimed at reflecting changes industry practices and relations with healthcare professionals.

There are 45 proposed amendments to the Code in total in the consultation, covering a wide range of industry practices. These include the growth of conditional marketing licences, discussions with the NHS about 'service redesign', the certification of digital materials, the provision of services and genetic tests to the NHS, as well as updates to how healthcare professionals are asked to disclosure payments from pharma.

Mike Thompson, chief executive of the ABPI, said: “In the 60th anniversary year of the ABPI Code, the 70th anniversary of the ABPI and the 25th anniversary year of the PMCPA, we are proud to launch this open-to-all consultation.

Mike Thompson

The ABPI's Mike Thompson

“The views of those we work with are very important to us - including the NHS, health professionals, patient organisations, regulators and government as well as the pharmaceutical industry.

“We look forward to receiving contributions and comments on this important consultation.”

One notable amendment aims to clarify the marketing of medicines granted a conditional licence, an increasingly common occurrence, especially in cancer therapies. The proposed changes clarify that a conditionally approved treatment can be promoted, but that it must be clearly communicated that it is approved on a conditional licence.

Another amendments is looking to free-up the compliance process within pharmaceutical companies.

The current code of practice states that printed promotional material based off an already-certified digital version still requires a subsequent signatory.

However, the new amendment proposes removing this rule, to allow the printed material to be checked by an appropriately qualified person, rather than a signatory.

Speeding up the compliance process was also tried and tested following the Code’s 2016 amendment, which only required one suitably qualified person to sign off on promotional materials, abolishing the previous two-signatories rule.

Despite the close attention paid to complying with Code, some major transgressions still regularly occur. Earlier this year, Martindale Pharma, Pierre Fabre, Janssen and Pharmasure were all named in adverts following serious breaches the Code. These cases included instances of promoting an unapproved medicine and providing healthcare professionals with a hamper of chocolates.

Heather Simmonds, director of the PMCPA, said: “The ABPI Code of Practice is a living document, which is regularly updated. It reflects UK law and other requirements, such as international and European Codes to support high quality patient care. We always welcome views on its content and operation to ensure high standards and that confidence in self-regulation is maintained."

Once the consultation closes, the ABPI Board will agree on final proposals, which will be voted on by the ABPI and member companies. The code is also expected to see further changes next year to remain in line with changes from the IFPMA and EFPIA codes.

The updated code is expected to come into operation at the beginning of January 2019, with a proposed transition period until the end of April 2019.

Read the full consultation here : Consultation on proposals to change ABPI Code of Practice for the Pharmaceutical Industry

30th August 2018

From: Regulatory

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