On 23 September 2024, the Association of the British Pharmaceutical Industry (ABPI) and the Prescription Medicines Code of Practice Authority (PMCPA) published an updated Code of Practice for the pharmaceutical industry. Following an extensive consultation with over 3,000 comments, ABPI has announced that the new “orange” 2024 Code amends the previous 2021 Code in three key areas: the PMCPA constitution and procedure; the provision of prescribing information; and certain elements of the Code moving from guidance to mandatory requirements. However, there are also interesting amendments to the requirement to maintain high standards and obligation to seek a lawful basis for disclosure of transfers of value to an individual.

ABPI has said that the new Code seeks to “raise the high standards expected of pharmaceutical companies even further while also ensuring that complaints can be resolved quicker”.

Key Changes

Constitution and Procedure

The new edition of the Code includes an updated Constitution and Procedure, which provides more detail as compared to earlier editions of the Code. The Constitution now expressly includes an overarching objective “to ensure that cases are dealt with fairly and justly while protecting patient safety”; this entails dealing with cases in a way that is proportionate to the importance of the case and complexity of the issues, enabling flexibility, ensuring parties can fully participate in proceedings and avoiding unnecessary delay.

This objective is reflected in the introduction of a new abridged complaints process, whereby certain cases will be dealt with via an expedited process. Parties cannot apply to have their case dealt with via the abridged process. Rather, it is for the case preparation manager (CPM) to determine that the abridged procedure will be followed, where:

  • the allegations fall within the Authority’s approved list for use of the abridged procedure;
  • it appears that the central facts will not be disputed; and
  • it is likely (in the CPM’s view) that there has been a breach of the Code.

Examples of allegations included on the approved list for the abridged procedure include: isolated incidents of promotion to the public, such as a small number of “likes” or “shares” on social media; poor quality digital materials, for example an isolated broken link to prescribing information or it not being made clear when the company website is being left; and isolated incidences of errors with disclosure of transfers of value, such as  a small number of missing or inaccurate disclosures.

The respondent has 15 working days to respond in writing. For the complaint to remain in the abridged procedure, the respondent must accept all the alleged breaches of the ABPI Code, provide a written undertaking that the activity will cease and confirm that, as a result of its investigation, it has not identified a systemic compliance issue. If the CPM is not satisfied that all these requirements are met, the abridged procedure will not apply and the complaint will follow the full procedure.

If the matter remains within the abridged procedure, administrative charges equal to one half of the complaint going through the full procedure are payable by the respondent. There is no right to appeal by either the respondent or the complainant under the abridged procedure.

Another notable change to the Constitution is in relation to the authority of the Appeal Board. Under the new edition of the Code, the Chair of the Appeal Board may set aside a decision of the Panel where there has been an error in complying with procedure.  Furthermore, in cases where the Appeal Board reports a company to the ABPI Board with a recommendation that the ABPI Board either suspend or expel the company from the ABPI, the ABPI Board must ratify the recommendation made by the Appeal Board, unless there was an error made by the Appeal Board or the recommendation is manifestly disproportionate.

Finally, the wording around the independence of the PMCPA has been strengthened; more details have been provided regarding appointments of the PMCPA’s Chief Executive and Directors and their reporting process. The PMCPA has noted that this is a further step towards increasing transparency and strengthening the public law principles of procedural fairness. 

Prescribing Information

Clause 12 on prescribing information has been completely re-written in consultation with the Medicines and Healthcare products Regulatory Agency (MHRA). The most significant change is the option to include prescribing information to healthcare professionals (HCPs) via a Quick Response (QR) code for printed and certain digital promotional material. The rationale is for HCPs to be able to always directly access the most recent prescribing information. This may be updated remotely by the pharmaceutical company, so that printed promotional material in the possession of HCPs would always directly link to the up-to-date prescribing information.

However, use of a QR code is only permitted on printed materials or on digital materials that are shown to a recipient in person (e.g. on a screen during a face-to-face presentation). QR codes cannot be used on digital materials that a recipient accesses on their own device, where the prescribing material must continue to be provided as text or via a prominent, single click link. The PMCPA has explained this distinction is because prescribing information should be easily accessible and therefore recipients should not be required to use two devices to access prescribing information. This means QR codes cannot be used to provide prescribing information in emails or digital advertisements or on websites etc because a recipient would need to locate another device in order to scan the QR code.

Other changes to Clause 12 include that, where not immediately apparent, all promotional material must include a clear prominent statement as to where the prescribing information can be found. This was previously only a requirement for promotional material provided on the internet.  In addition, new Clause 12 allows for the adverse event reporting statement to be provided in the same manner as the prescribing information and includes a strengthened requirement that, where not immediately apparent, the promotional material must include a clear prominent statement as to where the adverse event reporting statement can be found. However, where possible, it is preferred that the adverse event reporting statement features as text in the body of the material.

Mandatory Requirements

Certain parts of the Code are moving from guidance to mandatory requirements.

While it was formerly best practice for companies to ensure that a written agreement was in place to record support being provided to HCPs, and other relevant decision makers, to attend events or meetings, PMCPA/ABPI considered that increased governance was required in relation to this “high-risk” area. As such, under the new Code a written agreement is mandatory.  The agreement should set out what has been agreed, including costs such as registration fees, accommodation and travel (to the extent applicable). The supplementary information has also been amended to require documentation of the rationale for the decision to provide support to an individual to attend an event or meeting prior to the provision of the support.

Disclosure UK hosts two data “gateways” which are a collection of website links to take visitors from Disclosure UK to disclosure information published on individual company websites about patient organisations or members of the public.  Under the 2021 Code, submitting links to these gateways was optional, although encouraged, and not widely done.  Under the new Code, it is mandatory to submit the links.  

In addition, minor changes have been made to the template for disclosure agreed for the 2024 Code. The updated mandatory template must be used to submit the 2024 data to Disclosure UK by 2pm on 28 March 2025.

Other notable changes

High Standards

There is a new requirement at Clause 5.2 that “All company personnel must maintain a high standard of ethical conduct in the discharge of their duties and comply with all relevant requirements of the Code”. The 2021 edition of the Code already included a general requirement on companies to maintain high standards (Clause 5.1) but the addition at Clause 5.2 was deemed necessary to separate the requirements for companies and those for company employees. Previous PMCPA rulings of a breach of Clause 5.1 have shown that PMCPA considers the actions of just one individual can be enough for it to be held that high standards have not been maintained. In this regard, a requirement that companies “have policies or similar to clearly communicate corporate standards, expectations, and behaviour, and provide appropriate training” has been added to the supplementary information to Clause 5 and, in line with previous rulings, the supplementary information to Clause 5.2 makes clear that a breach of Clause 5.2 can be ruled even where an employee is “acting contrary to the instructions which they have been given”.

Value of items for patient support

The maximum value of an “inexpensive item” for patient support has been increased from an item that cost the company £10 excluding VAT, to £15 excluding VAT.

Lawful basis for disclosure of transfers of value

As regards disclosure of transfers of value to individuals HCPs and other relevant decision makers, additional wording has been added to strengthen the requirement to seek a lawful basis for individual disclosure. Companies should disclose in aggregate only where a lawful basis cannot be obtained.

Timelines for disclosure

The supplementary information to Clause 31.1 states that information to be published on Disclosure UK must be submitted in line with the operational timelines that will be stated on the Disclosure UK website itself. The link to the website is provided within the Code.

Conclusion

The 2024 Code will come into effect on 1 October 2024, although no materials or activity will be found in breach for failure to comply with any new requirements during the period from 1 October to 31 December 2024.  However, the PMCPA will start to operate under the new Constitution and Procedure from 1 October 2024, including use of the abridged complaints procedure. The new Code will come into full force on 1 January 2025.  There are separate timelines for the new requirements for Disclosure UK gateway links.

ABPI has announced three on-demand webinars to explain the changes to the ABPI Code and Constitution and Procedure and a free e-learning module targeted at individuals requiring an overview of the Code. In addition, the following materials are currently available on the ABPI website: