What are the key changes in the new code of practice for the British pharmaceutical industry?

The UK’s Association of the British Pharmaceutical Industry (ABPI), along with the Prescription Medicines Code of Practice Authority (PMCPA), has published a new code of practice for the British pharmaceutical industry.

The new code comes into effect from July 2021. The 2021 code of practice will see the most extensive revision in 30 years, with considerable structural changes from the 2019 version.

This blog summarises the code’s key changes to help you prepare for the change in July.

1. New principles

The 2021 code includes the new ABPI principles, as follows:

• Benefitting patients
• Acting with integrity
• Ensuring transparency
• Treating everyone with respect

The APBI have stated their expectation that organisations begin to implement and embed these principles into their culture and ways of doing business.

2. A fresh structure

The largest change to the code is its overall structure. A key aim of updating the code was to modernise it, making it more accessible and user-friendly. As such, the clauses will now be assigned to six-colour coded sections, primarily relating to activities of stakeholder groups. This will make it easier to use and more accessible for those who need to refer to the code every day.

These sections are:

• Grey section: Overarching requirements
• Blue section: Promotion to healthcare professionals (HCPs) and other relevant decision makers
• Green section: Interactions with HCPs, other relevant decision makers and healthcare organisations (HCOs)
• Yellow section: Interaction with HCPs, other relevant decision makers, HCOs, patient organisations (Pos) and the public, including patients and journalists
• Pink section: Specific requirements for interactions with the public, including patients, journalists and Pos
• Teal section: Annual disclosure requirements

3. No more 'joint working'

Another key change is the new and more-inclusive language used to describe the topic of ‘joint working’. The criteria for the ‘joint working’ definition became the 2019 code’s most contested subject. The 2019 code defines ‘joint working’ as the pharma industry working together with the NHS to improve patient outcomes. However, there are many projects that are necessary and useful to the NHS, but it is not possible to demonstrate any direct benefit to the patient that come as a consequence.

To address this gap, the 2021 code replaces the term ‘joint working’ with ‘collaborative working’. The updated definition now refers to any project that:

• Enhances patient care
• Benefits patient care
• Benefits the NHS and, as a minimum, maintains patient care

This new definition allows room for the pharma industry to work with the healthcare system to relieve pressures in relevant areas and provide new benefits to the NHS.

4. Reference to contracted services

Another minor but notable tweak in terminology is that of contracted services. This definition has been similarly amended to address key players that the 2019 code’s definition excluded. Contracted services will replace ‘use of consultants’, and will now include relevant members of the public, such as patients and journalists, in relation to fee-for service arrangements.

5. New emphasis on transparency

Companies should also be aware of the new requirement to disclose payments to members of the public and journalists who write for them, rather than just HCPs as before. This is indicative of the need for transparency throughout the pharmaceutical industry.

6. Coronavirus amendments

Several clauses have been amended to include relevant coronavirus additions. Clause 3, 'Obligations', Clause 11, 'Marketing Authorisation' and the supplementary information to Clause 26, 'Relations with the Public', now accommodate requirements relating to the coronavirus pandemic.

Notably, the provisions advise that the approval of health ministers is now required in relation to the temporary supply of medicines for public health emergencies. Also, the overarching restrictions regarding the advertisement of prescription-only medicines to the public does not apply to the vaccination program, nor other campaigns carried out by companies and approved by health ministers.

Next steps

The 2021 code will become effective on 1 July 2021, so you still have a couple of months to prepare. British pharmaceutical companies should use this time to plan for the change by updating relevant policies and procedures, training staff on the code changes, and ensuring the company is ready for compliance.

Ideagen has the tools to help you ensure compliance with the new code of practice.

To learn more about how our quality management systems work in action, read our guide to pharma CAPA and quality management.

Written by

Sophie Willink

As Ideagen’s Content Marketing Executive, Sophie produces informative content to provide customers with digestible insights into the world of quality, audit, risk and compliance.

With a background in psychology, Sophie is passionate about understanding human behaviour and the role technology can play in measuring, reporting and improving behaviours to create higher quality business environments.