It has long been communicated to the UK pharmaceutical industry that the Prescription Medicines Code of Practice Authority (PMCPA) welcomes all input and feedback on the ABPI Code of Practice. But what does this actually mean, what does the PMCPA do with such feedback, and what motivates feedback or prevents it from being given?
As experts on the ABPI Code, our client base allows us to have a comprehensive view in relation to its administration and, in particular, the frustrations felt by pharmaceutical companies. We consider it highly constructive and a positive step to be able to provide healthy challenges of PMCPA decisions and/or seek clarification on their rulings.
We’ve documented frustrations and suggested solutions to help the wider industry improve its understanding of the way that the ABPI Code is administered.
What is the PMCPA?
“The Prescription Medicines Code of Practice Authority was established by The Association of the British Pharmaceutical Industry to operate the ABPI Code of Practice for the Pharmaceutical Industry, independently of the ABPI.”
In other words, the ABPI owns the Code and since 1993, the PMCPA has administered it. According to the PMCPA website, it:
• Operates the complaints procedure
• Provides advice and guidance on the Code
• Provides training on the Code
• Arranges conciliation between pharmaceutical companies when requested to do so
• Scrutinises samples of advertising and meetings to check their compliance with the Code.
The role of the PMCPA appears to have expanded over the years to managing Compliance Network Meetings as well as any updates to the Code. Unsurprisingly, decreased resources at the PMCPA and increases in other work have meant frustrations have been expressed about PMCPA operations and processes around the handling of complaints.
Some of this feedback has been provided to the PMCPA, but some individuals and companies choose not to disclose this directly but rather express it to us.
Content of the Code
The public consultation on suggested proposals to amend the Code is a critical step in ensuring everyone (inside and outside the industry) has a chance to have a say on the content of the Code. However, this process has, in the past, been owned and managed by the PMCPA with varying degrees of oversight from the Appeal Board and the ABPI Board. Although bodies such as the ABPI Code Working Group (made up of industry representatives that work with the Code) met throughout 2018 to consider ways to streamline and simplify the Code, it is unclear how their outputs were further considered and the criteria that were met for some of their comments to make it through to public consultation.
The ABPI has an opportunity to re-establish its ownership of the Code moving forward, by managing the public consultation in a transparent and consultative manner.
The public consultation on the 2020 ABPI Code and PMCPA Constitution is expected to open at the end of this summer.
Compliance Network Meetings
Since 2012, the PMCPA has hosted quarterly meetings at their offices with compliance managers. These PMCPA Compliance Network Meetings were intended to be a forum whereby company attendees could discuss topics of interest, share experiences and best practice with one another, as well as allow discussions with the PMCPA, so that their case rulings could be better understood and therefore adhered to.
Given the PMCPA only administer the Code and that the ABPI’s own expert networks are already established under their ownership, it is unsurprising that the ABPI has decided that it will, in future, run these meetings – the PMCPA will continue to participate and share its thoughts on recent cases and developments.
The first ABPI Compliance Network meeting took place at the ABPI’s offices on 15 March 2019.
There has been concern for some time about the time taken for the PMCPA to notify a company of its ruling, and the lack of transparency overall in the complaints process. In addition, frustrations have been expressed about complex and lengthy case reports and the ability for an average reader to understand fully the key learning points in order to remain Code-compliant.
With this in mind, a standard operating procedure (SOP) for complaints was developed to provide standardisation, transparency and oversight. Many companies asked in 2018 for this SOP to be incorporated into the PMCPA Constitution. Whilst the ABPI acknowledged the pressures on the PMCPA and suggested the SOP is considered for implementation, this isn’t likely to occur until 2020.
Through clear timelines, case ruling forms and tabulated summaries of case rulings, this SOP will bring the industry much-needed clarity, as well as help the PMCPA to manage complaints more quickly and effectively, producing rulings that are easier to understand.
It is clear that appropriate feedback mechanisms must exist to allow the PMCPA to fully understand these frustrations. Although this article describes four ways in which compliance with the Code may be improved, it is valuable for all involved, if feedback is constructive, action is taken, and improvements are carefully measured.
Dr Rina Newton is Managing Director of CompliMed. Contact CompliMed at email@example.com
Read the full magazine here: April Pf Magazine