A few thoughts on the New Code

The results are in, and once again, we have a split decision much like our last poll

on social media use. This time, we asked which of the PMCPA’s recent constitutional

changes surprised you the most. The majority selected the PMCPA’s new power to

add or remove clauses from a complaint, with the elimination of appeals in the

abridged process following closely behind.

For context, the other two options were the encouragement for complainants to

contact companies first, and the extended response time for companies now 15

working days instead of 10. Both changes seem sensible. The additional time could

ease the pressure on companies addressing complaints, and encouraging

complainants to reach out to the company initially might reduce the number of

complaints.

Let’s delve into the two main topics, starting with the most popular answer: the

PMCPA’s new power to add or remove clauses.

This shift could have positive implications.

Here’s why: until now, the Panel could only assess the specific allegations referred to

the pharmaceutical company for response. In recent cases, we’ve seen that if an incorrect allegation was made, the Panel couldn’t examine related issues more broadly. With this new rule, the Case Preparation Manager can now “interpret” the complainant’s words. We welcome this for its potential to improve accountability and strengthen self regulation.

However, there are some potential downsides. We’ve seen that the PMCPA occasionally misapplies clause numbers. Take case AUTH/3734/2/23 (Complainant v Valneva) as an example: the Case Preparation Manager initially missed citing clause 12.1 for missing PI, which was later addressed under clause 5.1. Mistakes like these raise questions about the potential consequences if an erroneous clause were added to a case.

Now, onto the second hot topic: no appeals in the abridged process. This change

could bring unexpected challenges. While it remains to be seen how it will play out in

practice, one possible scenario could arise if a case manager overlooks issues like

patient safety or broader compliance gaps. For instance, if a missing black triangle is

the main issue and was ruled upon, would there be any recourse to challenge

unnoticed incomplete safety data afterwards?

These are considerations worth pondering.

So, how is your organisation preparing for these changes?

Are you planning to designate someone to oversee public code complaints, or will

these changes be integrated into your existing complaint handling process?

If you’d like some guidance on navigating these updates, feel free to reach out Compliance Hub is always here to help.

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