Inside the PMCPA: A Day in the Life of a Code of Practice Panel Member

I have been a member of the Panel since January 2025 and come from an industry background having spent 15 years working within medical affairs and medical information. My hope is that this blog will give you an insight into a typical day as a PMCPA Panel Member.

The PMCPA’s role is to administer the ABPI Code of Practice, which aims to ensure that the promotion of medicines to health professionals and other relevant decision makers is carried out within a robust framework, in order to support high quality patient care. Our job is to ensure that communications about prescription medicines are accurate and balanced and that pharmaceutical companies operate in a responsible, ethical and professional manner.

As a PMCPA Panel Member, each day brings a mix of Code interpretation, scientific understanding and pragmatic decision making. Each Panel Member works across several cases simultaneously, with each often at a difference stage in the complaints process. On average, a Panel Member is across 10-15 different cases at any one time.

Here's a glimpse into what a typical day might entail.

The Case Files

Once assigned to a case, Panel Members receive documents regarding the case, including the complaint, the company’s response and copies of any supporting material/evidence. Ahead of any panel deliberations, each Panel Member familiarises themselves with the details and intricacies of each document. For especially complex cases this can equate to hundreds of pages of material and days of detailed review so that we have a clear understanding of the complaint, evidence and company response.

Depending on the particulars of the case, some of the questions a panel member may be considering during this stage include:

·       What are the allegations being made and what is the evidence?

·       Do we have all the information we need to make an informed decision?

·       What is the company’s responsibility in relation to the material?

·       Is the material/activity promotional or non-promotional?

·       Can that claim be substantiated?

·       Is the context clear?

·       What is the impression of the material to the intended audience?

When examining the evidence, it is key that Panel Members remain impartial. It is our role to interpret the Code objectively and not let personal opinions or the origin of the complaint have any influence.

Another vital part of preparing for a Panel Meeting is to comprehensively search through case precedent. The PMCPA Panel will always take account of past cases during their deliberations to ensure consistency and fairness in its decision making. Each Panel Member has a responsibility to search through past cases prior to a Panel Meeting and take account of any established principles and learnings.

Panel Deliberations

Panels usually consist of three individuals. New Panel members join in an observational capacity to gain experience before becoming a voting member. Once all Panel Members have read all the papers in relation to the case, a Panel Meeting is held. We always seek to have a mix of individuals on a Panel, including those with industry experience, legal professionals and those with a medical/scientific background. This diversity is a strength as each member brings different experiences and perspectives to the table.

Each allegation in the complaint and the corresponding clauses are discussed in turn. Sometimes a consensus on the matter is reached quickly whereas others can warrant a lively discussion! Often the Panel will refer back to the wording of the complaint, as our considerations are restricted to the specific allegations made.

After extensive discussions, a decision is reached on whether or not a clause had been breached. Each case is different, even if on first glance it looks similar to a previous one. The conclusions drawn are based on the balance of probabilities, the exact allegations made, and the evidence provided by both parties. Every complaint that reaches the panel is dealt with fairly and justly whilst ensuring that patient safety is protected.

Drafting Decisions

Following a Panel Meeting, one of the Panel Members takes responsibility to produce the first draft of the written ruling – the panel minute – that explains how the decisions were reached.

Writing the panel minute takes careful consideration. The wording must clearly explain how each conclusion was reached and how this corresponds to the Code. It must be detailed enough to explain the Panel’s rationale so that parties are able to appeal. The Panel’s ruling must stand up to scrutiny; it creates a precedent for future cases and is an important resource for industry learning.

All Panel Members contribute to the panel minute, which means it may go through several reiterations before the final wording is agreed by all Panel Members.

Once agreed the panel minute is sent out to both parties, if contactable, who then have the opportunity to appeal the Panel’s decisions. Once any appeals process is complete, and/or a company has provided an undertaking if required, a case report is drafted. The case report largely consists of the same information within the panel minute with any personal or confidential information redacted. Both parties (where contactable) have the opportunity to review the case report before it is published. Prior to publication, all case reports are submitted to the Appeal Board for review as parts of its supervisory role in relation to the operation of the complaints process.

All case reports are published on the PMCPA website and act as public guidance to the whole industry.

Beyond the Panel

Whist the complaints procedure and panel work takes up a significant majority of our workload, it is not the only activity panel members are involved in.

The PMCPA receive many queries relating to the Code from a wide range of individuals. These are often complex and require careful consideration when providing guidance.

We are also constantly working to increase understanding and interpretation of the Code in a number of ways: 

·       Producing and reviewing FAQs on hot topics

·       Researching and producing guidance documents on particularly thorny areas of the Code such as the recent Guidance on Clause 3.1 and 11

·       Providing in-depth training on the Code such as at our upcoming Code in a Day session    

Final thoughts

After working for 15 years within the pharmaceutical industry I considered myself a Code expert when joining the PMCPA. However, this role allows you to constantly question your understanding and interpretation because you are asked to apply the Code to different, and often complex, scenarios every day.

The role demands attention to detail and excellent communication skills, but also that you are collaborative, pragmatic and willing to challenge the status quo. Serving as a PMCPA Panel Member is challenging but is a role I find both enjoyable and rewarding. I am helping to safeguard public trust in medicines and the pharmaceutical industry as a whole. Our decisions collectively improve how information about medicines reaches healthcare professionals which can directly have an impact on patients’ lives.

 

Written by Holly Withers