What can you learn from the PMCPA annual reports?
The PMCPA (Prescription Medicines Code of Practice Authority) have recently published two annual reports for 2019 and 2020. What can we learn from them and why do they seem to be so late?
On the surface of it, publishing the 2019 and 2020 annual reports in summer 2022 appears to be way overdue. People have been asking me, what have they been up to? How come they are this behind?
The reason is that the annual reports include all the cases and their outcomes that are submitted to the PMCPA in a calendar year. So if a 2019 case takes a long time to reach a conclusion, maybe because the case is complex or they are waiting for audit findings, this delays the annual report being published.
How long do cases take to process?
Put simply, it is not a quick process. Evidence needs to be gathered from all sides, then assessed and a ruling is made. Then there is an option for appeal. So it can take years to reach a conclusion. The 2020 report shows the average time to complete a case is around 28 weeks, increasing to 40 weeks if it is taken to appeal.
But there are extreme cases, for example case 3285 against Daiichi-Sankyo. The complaint was made on 30th November 2019. An interim ruling was made quickly on 13th February 2020, but then the case has been considered by the appeal board six times, the latest on 28th April 2022. One report found ‘a systemic lack of governance in the UK’ resulting in multiple re-audits. The case is still ongoing and the Appeal Board will consider further sanctions after another audit in Oct/Nov 2022. An eye watering three years after the initial complaint.
The number of cases remains pretty static with around 140 cases per year for 2019 and 2020. But there has been a sharp upturn in the complexity of the cases, with more matters per case for the PMCPA to consider (694 in 2018, 597 in 2019 and 736 matters in 2020). A lot of complaints now have multiple aspects to them with multiple clause allegations for each. But a lot of allegations were unfounded or lacked supporting evidence and in 2020 only 34% (249/736) were actually found in breach of the Code.
A prolific complainant
The reports show a new trend – a prolific complainant. The Code is a self-policing system allowing anyone to make complaints. But complaints between companies should be discussed during inter-company dialogue with an attempt of resolution before contacting the PMCPA.
But a significant number of complaints were received from the same individual. From the numbers in the report and reading the individual cases this person is most likely a ‘concerned anonymous healthcare professional’, but evidently with Code knowledge. Their complaints accounted for 27% (36/132) of complaints in 2019 and 37% (55/148) in 2020. The PMCPA have not commented further.
Employees making complaints
2019 and 2020 continued to see around 15 cases per year from ex or current employees. It is a reminder that companies need to have a complaints process in an attempt to resolve internal concerns before staff feel compelled to go to the PMCPA.
Increase in appeals and clause 2 breaches
There was a significant increase in matters which were appealed – 78 in 2020 vs 40 in 2019. Both the complainant or defendant can appeal if they disagree with the panel’s ruling.
And the PMCPA flagged their concern over an increase of clause 2 breaches (30 cases in 2020, 25 in 2019 and 13 in 2018) which reflect serious matters. In 2020, 43 companies breached the Code and 23 (53%) of these had a breach of clause 2. Watch out for this upward trend, particularly if senior employees are involved in Code breaches.
How can you stop making the same mistakes?
Firstly, make sure staff (in pharmaceutical companies and third parties) involved in creating, reviewing or approving materials or doing activities covered by the Code are properly trained and undertake annual refresher sessions. Keep up to date with the published Code cases as these set precedence and give a great understanding of how the Code is interpreted.
We are expert Code trainers, providing eLearning, live zoom sessions and bespoke in-house courses for all levels. We also run monthly Code case updates which can save hours of case reading and fast-tracks the key learning points. Do get in touch if we can help or you can read more on our Code training course page.
Written 25th August 2022