Reducing the burden on medical signatories
The ABPI Code of Practice has always included strict requirements for the certification of promotional and some non-promotional activities and materials. The Prescription Medicines Code of Practice Authority (PMCPA) state in their Guidance on Certification that, “certification is often the final step in a process that involves review by a range of staff prior to final approval”.
Although necessary, the copy approval process – from origination, uploading, review and certification through to archiving – can often be a lengthy, complex and painful part of everyday pharma operations. Basic errors in this copy approval process however, can lead to breaches of the Code and serious sanctions imposed on companies.
For example, Pfizer complained about a number of AstraZeneca promotional items (Case AUTH/1977/3/07). In one instance, guidelines had been entered into AstraZeneca’s copy approval system in such a way that the intent of the originator had either not been apparent or had been misinterpreted by the signatories. The subsequent case ruling stated that such flaws in the copy approval system were unacceptable and high standards had not been maintained.
One of the most significant amends in the new ABPI Code of Practice 2019 is the introduction of “Appropriately Qualified Persons” (AQPs). Medical signatories across the industry are now asking within their individual companies how and if such staff can help reduce the approval burden that largely still sways heavily towards signatories.
What can AQPs do?
Printed material: In the past a medical signatory has had to check printed material against the final certified electronic version.
“It has long been argued that this was never a ‘compliance’ check, only an identity one, and therefore could be performed by those trained to do this,” says Jean Woolcock, managing consultant and medical signatory, CompliMed.
In a positive and pragmatic move, the new ABPI Code now allows AQPs to do this check and does not require their names to be notified to the PMCPA and MHRA (as is the practice for signatories).
Overseas meetings: Medical signatories were required to certify the meeting arrangements (such as accommodation and flights) for UK health professionals travelling to overseas meetings. However, the new ABPI Code allows AQPs to do this instead.
In terms of who these AQPs could be, it is left to individual companies to make this judgement based on “relevant experience both within and outwith the industry, length of service and seniority”. The ABPI Code reminds us however, that “such a person must have an up-to-date and detailed knowledge of the Code”.
Unfortunately the language used in the new ABPI Code may cause some confusion, as the names of these AQPs must be notified to the PMCPA and MHRA AND the process for checking overseas meeting arrangements is referred to as “certification”.
Implementing AQPs in your companies
It is abundantly clear that the advent of AQPs represents an opportunity for companies to reduce the approval burden placed on medical signatories, which in turn could positively impact on their workload and therefore the quality and compliance of all items.
Many questions remain though:
- Will companies actively embrace and implement this change, given that it would require amends to existing approval SOPs, training of AQPs and all those involved in copy approval, as well as amends to approval systems?
- Will companies consider implementing 2 different types of AQPs, given the obvious confusion around the associations with the terms ‘signatories’ and ‘certification’?
- How can companies mitigate the risk of AQPs accidentally certifying promotional and other material?
- Can approval systems help companies who want to change their processes?
Emma Hyland, VP, commercial strategy, Veeva, believes companies can quickly adapt technology to adopt this change. “It’s all a matter of reviewing your current workflows, mapping on the suggested workflow changes, and considering the right permissions for your new AQPs,” she says. “The technology can be changed swiftly, it’s the processes around it that need to be carefully considered and can take time to implement.”
There is of course a broader question of which pharmaceutical companies actually implement ABPI Code changes and what factors prevent full implementation.
In a CompliMed survey of seven companies at the end of 2018, only one had fully implemented the 2016 ABPI Code amend which saw the requirement of two signatories fall to one medical signatory. Those that continued to use two signatories cited their reasons as maintaining joint accountability with commercial, internal attitudes to risk and change, external compliance scrutiny and so on.
The adoption of AQPs is yet to be seen, but watch this space for further updates.
About the author:
Dr Rina Newton is managing director of CompliMed. Rina has more than 20 years’ experience working with the ABPI Code of Practice – as originator, reviewer, medical & non-medical final signatory and auditor – so is well-versed with the practical challenges in applying the Code to everyday situations.