In the rapidly evolving landscape of the pharmaceutical industry, the updated 2024 ABPI (Association of the British Pharmaceutical Industry) Code of Practice represents a significant step forward in raising the bar for ethical and transparent practices. This comprehensive code, which governs the conduct of pharmaceutical companies in the United Kingdom, has undergone a series of strategic revisions to further enhance patient care, strengthen public trust, and promote responsible innovation.

The 2024 ABPI Code of Practice, which comes into effect on October 1, 2024, introduces three key sets of changes that aim to elevate the industry’s standards and streamline the complaints resolution process.

Prescribing Information: A Modernized Approach

One of the notable updates in the 2024 ABPI Code is the revised approach to providing prescribing information. Recognizing the changing landscape of information dissemination, the code now offers pharmaceutical companies greater flexibility in how they present this crucial data to healthcare professionals and the public.

Clause 12 of the updated code outlines the new requirements for prescribing information, which can now be delivered through a range of options, including:

1. Inclusion as text within the promotional material
2. Provision of a clear and prominent Quick Response (QR) code with instructions to scan for the prescribing information
3. Accessibility via a clear and prominent, direct, single-click link in digital materials

This modernized approach aims to ensure that prescribing information is easily accessible and integrated seamlessly into the promotional content, making it more convenient for healthcare professionals and patients to access the necessary details.

The updated requirements for prescribing information reflect the evolving digital landscape and the need to provide healthcare professionals and the public with easy access to essential product details.

The change will ensure that promotional items should not have an outdated PI associated with them, therfore improving patient safety. To further bolster patient safety, it would have been helpful if the code had been changed, dissolving the need for the company created prescribing information and all promotional items were required to connect to the summary of product characteristics – a legal and regulated document. Howver this would have required an amendment to the medicines act in England and Wales.

The PMCPA: A New Constitution and Procedure

Another significant change in the 2024 ABPI Code is the introduction of a new “Constitution and Procedure” for the Prescription Medicines Code of Practice Authority (PMCPA), the independent body responsible for administering the code.

The revised constitution and procedures aim to streamline the complaints process, ensuring that cases are handled efficiently and fairly while upholding the overriding objective of protecting patient safety. Key updates include:

1. Strengthened case management: The PMCPA now has the authority to issue case management directions, such as setting deadlines, redacting confidential information, and determining the format of hearings (remote or in-person).

2. Abridged complaints procedure: For certain types of complaints, the PMCPA can now follow an abridged process, allowing for faster resolution of cases where the central facts are not disputed and a breach of the code is likely.

3. Independent referees: The PMCPA can now refer specific decisions to independent referees, providing an additional layer of oversight and ensuring impartiality.

4. Compliance and non-compliance: The new constitution emphasizes the importance of all parties complying with the PMCPA’s requirements and directions, with the Chair of the Appeal Board empowered to take appropriate action, including restricting a party’s participation or determining that a case should not proceed.

In latter times the PMCPA has been accussed of takign too long investigating and adjudicating on complaints. This new streamlined process should speed up the processing of complaints.

From Guidance to Mandatory Requirements

The 2024 ABPI Code of Practice also sees the transition of several elements from guidance to mandatory requirements, further strengthening the industry’s commitment to ethical and responsible practices.

One notable change is the requirement for pharmaceutical companies to publicly disclose their relationships with patient organizations and members of the public, including patients and journalists. This move towards greater transparency aligns with the industry’s broader efforts to build trust and demonstrate its accountability to stakeholders.

Another key change is the introduction of mandatory requirements for collaborative working between the pharmaceutical industry, healthcare organizations, and other stakeholders. The updated code emphasizes the need for these collaborations to enhance patient care, benefit the National Health Service (NHS), and maintain or improve patient outcomes.

Collaborative working between healthacre companies and healthcare providers is a powerful tool for driving innovation and improving healthcare, when used correctly. The 2024 ABPI Code of Practice further strengthens that these partnerships are conducted in an open and transparent manner, with a clear focus on patient-centric outcomes.

Upholding High Standards

The overarching goal of the 2024 ABPI Code of Practice is to maintain and elevate the pharmaceutical industry’s commitment to ethical and responsible practices. By introducing these strategic changes, the code aims to strengthen the industry’s relationship with healthcare professionals, patients, and the general public, while also enhancing patient safety and the appropriate use of medicines.

The life sciences and healthcare enviroment is changing at pace. This iteration of the code has no discussion on AI generated interactions with healthacre professionals. With AI technology branches being very distinct and on the whole their outputs being different from items currently being defined as digital, the ABPI may need to assess the rate at which the code is evolved.

The 2024 ABPI Code of Practice comes into effect on October 1, 2024, with a transitional period until the end of the year to allow companies to adapt to the new requirements. From January 1, 2025, the full force of the updated code will be in place, ushering in a new era of heightened accountability and transparency for the pharmaceutical industry in the United Kingdom.