In setting out its proposed update, the ABPI is aiming to ensure the Code remains fit for purpose and supports clear and robust standards. Whilst many of the proposed amendments are relatively minor or clarificatory in nature, there are a number of proposed changes which are clearly aimed at tightening governance and addressing potential problems in high-risk areas. Other changes seek to address practical issues both in terms of future proofing, as well as perhaps seeking to make processes more flexible and risk appropriate.

So, what are the most significant changes which have been included?

Clause 5 – proposed changes to this clause separate out the expectations and obligations on the company and its employees to maintain high standards and the changes detail the requirements companies must put in place to deliver an appropriate compliance programme to ensure these high standards. New wording is also included making clear that companies are responsible for the actions of their personnel, including those retained by way of contract. These proposals are clearly aimed at tightening responsibilities for maintaining high standards on both companies and their personnel and removing potential loopholes.

Clause 8 – several changes have been proposed to this clause, including that representative briefing materials require certification, as they are associated with promotion. There is also an extension to the categories of materials which can be certified by a non-medical signatory. This change will certainly be welcome from a practical perspective but may not be as flexible as it first appears, since the proposed change to the supplementary information requires (unsurprisingly), non-medical signatories to have the same level of training as their medical signatory counterparts. The supplementary information goes on to clarify that whilst a non-medical signatory (e.g. a compliance officer or lawyer) may be able to certify certain materials, the decision to approve the activity must remain with the appropriate function, which inevitably will lead to further internal process to document such approval.

Clause 10 – the changes being proposed here are aimed at assisting companies better assess the appropriateness of meetings and distinguish between what is promotional and non-promotional education. This is often a high-risk area, and these changes suggest a desire to improve governance in this area, not least because the notes make clear that a guidance document is to be developed on non-promotional medical education in future.

Further changes to clause 10 include the requirement to have a written agreement in place when support is provided to healthcare professionals attending events/meetings, as well as a requirement to complete an educational needs assessment for every event/meeting.

Clause 12 – one of the most significant changes proposed is a complete update to this clause to include the use of QR codes to access prescribing information and describe how prescribing information may be appropriately presented in different formats. This is helpful clarification, especially as the supplementary information goes on to address certain problem scenarios (i.e. offline working/the use of multiple screens/use of links) and what may/may not be appropriate in these situations. It should also be noted that the provisions of the new clause 12 are not intended to be retroactive and only come into effect for material certified after the new 2024 Code comes into operation.

Other proposed changes to the Code worth mentioning are those to clause 27, regarding the different arrangements in place with patient organisations and proposed changes to clauses 28, 29 and 30 covering disclosures of transfers of value.

In addition to the changes to the Code highlighted, there are a few changes being proposed to the Constitution and Procedure which are also worth mentioning:

  •  The introduction of an abridged complaints procedure to deal with less serious infringements in a proportionate manner;
  •  An extension of the time permitted for companies to provide a response to a complaint, from ten to fifteen working days. This recognises an increase in the complexity of complaints and the time required to provide a suitable response;
  •  It should be noted that the issue of anonymous complaints has also been reviewed, but with no changes being proposed. For further information on the consultation and how to provide feedback, please see information on the consultation and table of proposed changes .

Please do not hesitate to contact us should you require assistance in addressing issues arising from this consultation or in preparation for the implementation of the proposed 2024 Code.