PMCPA consults on changes to its Constitution and Procedure

PMCPA consults on changes to its Constitution and Procedure

The Prescription Medicines Code of Practice Authority has today launched a public consultation on proposed amendments to its Constitution and Procedure.

Alongside the ABPI Code, the Constitution and Procedure (C&P) sets out how the system of self-regulation for the UK pharmaceutical industry operates and how the Prescription Medicines Code of Practice Authority (PMCPA) administers it. [1]

This consultation is open from 3 August until 21 September 2026 and the PMCPA is inviting comments from pharmaceutical companies, health professionals, patient organisations, members of the public and any other interested party [2].

The proposed amendments are targeted, rather than wholesale. They have been developed through a working group of ABPI members that met throughout 2025, from feedback received directly from complainants and companies about their experience of the complaints procedure, and from the PMCPA's own experience of applying the 2024 C&P in practice. They also reflect input from the Code of Practice Appeal Board, the ABPI Board and the Medicines and Healthcare products Regulatory Agency (MHRA).

The overall objective of the amendments is to create a modern, robust, and proportionate complaints process while safeguarding its transparency, ensuring all parties can participate fully, and giving effect to the overriding objective that cases are dealt with fairly and justly while protecting patient safety [3].

An expanded abridged complaints procedure

The abridged complaints procedure (ACP) was introduced in the 2024 C&P, to allow simpler complaints to be resolved proportionately, while more complex complaints continue to be considered in full by the Code of Practice Panel. The PMCPA is proposing to expand the ACP so that it can be used in a greater proportion of cases. The same safeguards would apply, in that more complex and serious cases would continue to be considered in full.

A limitation period for complaints

The PMCPA has been piloting a limitation period policy since 1 June 2025 and now proposes to formalise it in the C&P. Under the proposal, a complaint would not proceed if it is received more than two years after the activity complained about took place or the material complained about was last used or appeared. A shorter period of six months would apply to complaints about the personal social media activity of company personnel, reflecting the fast-moving nature of that medium. The PMCPA would retain a discretion to proceed cases where there are exceptional circumstances, such as where patient safety concerns arise. The Appeal Board's existing supervisory role over the operation of the complaints procedure would continue to apply to all cases to which the limitation period is applied.

Companies joining and leaving self-regulation

The PMCPA is proposing two changes to strengthen accountability in relation to companies that join and leave self-regulation.

To avoid holding companies retrospectively to standards that previously did not apply to them, a company that joins self-regulation would be held accountable under the Code for activities predating its acceptance of the PMCPA's jurisdiction only where the relevant Code clause mirrors the Human Medicines Regulations 2012. This sits alongside a wider programme of tailored training and guidance for new members.

In relation to companies that choose to leave self-regulation, the proposals clarify that they remain liable for Code breaches, related administrative charges and any other costs associated with sanctions in respect of any complaint received before that notice was given.

Other proposals

The consultation document sets out a further range of more minor amendments and clarifications, including the Appeal Board's ability to require a specific scope audit and enhancing the PMCPA’s scrutiny powers. Views are also sought on where the PMCPA should advertise details of cases involving a breach of Clause 2, a corrective statement, or a public reprimand.

How to respond

After reading the consultation proposals [Public consultation on proposed amendments to the PMCPA Constitution and Procedure], comments on each proposal can be provided via this MS Forms Survey [PMCPA Constitution and Procedure – Public Consultation]. The survey also includes an open question inviting views on any aspect of the C&P, whether covered by the consultation or not. Responses should be submitted by 21 September 2026 [4].

Post-consultation next steps

The PMCPA will review all responses received and seek input from the Code of Practice Appeal Board and the ABPI Board in the final quarter of 2026. Subject to those approvals, and formal approval at an ABPI General Meeting, the PMCPA intends to implement a new C&P in early 2027.

The new C&P would supersede the version published within the 2024 ABPI Code, would be published electronically on the PMCPA website, and would in due course become a publication separate from the ABPI Code itself.

This consultation is separate from any proposed update to the ABPI Code of Practice, on which we expect to begin industry engagement later in 2026 [5].

PMCPA Chief Executive Alex Fell said: “Self-regulation requires not only high standards but also a commitment to transparency, proportionality and continuous improvement. Nearly two years on from the introduction of the current Constitution and Procedure, we have reflected on our experience and the feedback we have received.

“These targeted proposals are about resolving complaints more efficiently, giving complainants and companies a clearer and quicker route through the process, and making sure that companies remain accountable for their conduct under self-regulation. We encourage everyone with an interest in the administration of the Code to share their views through the consultation.”

ABPI President Russell Abberley said: “The UK pharmaceutical industry's system of self-regulation plays a vital role in maintaining high standards, transparency, and trust. The ABPI remains fully committed to a strong, independent, and effective system of self-regulation that underpins high standards across our industry.

This consultation provides an important opportunity to review and strengthen the PMCPA's constitution and procedures, ensuring they continue to meet the needs of patients and the wider healthcare community. We encourage everyone with an interest in these arrangements to contribute their views and help shape their future development.”

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