Stay calm and carry on: How to implement the updated ABPI code
Don’t panic – that’s the message from one ABPI code expert who tells Amanda Barrell it’s time to take stock and prioritise.
Compliance managers have less than six months to rewrite processes and procedures in line with the updated ABPI code of practice before it becomes enforceable in July. But it doesn’t all have to be done at once, says Dr Rina Newton, managing director at code consultancy firm, CompliMed.
The updated Association of the British Pharmaceutical Industry (ABPI) Code of Practice was agreed at the body’s general meeting in January, following months of public consultation.
While the foundations remain the same, the updated code, which comes into force on 1 July, is structured differently to the 2019 version. It also incorporates a new set of “ABPI principles”, which state the industry’s commitment to benefiting patients, acting with integrity, ensuring transparency, and treating everyone with respect.
Dr Newton told pharmaphorum that this was “probably the biggest change we will ever see”, explaining that the new structure closely aligned to the European Federation of Pharmaceutical Industries and Associations (EFPIA) code.
“The layout is completely different, and it is now colour coded,” she said. “In theory, that means it should be much easier to map what we do against the European code.”
While the basis of the rules has not changed, the updated code reorganises them into the four “buckets” of people, processes, activities, and systems.
It also introduces the overarching concept of collaborative working, which includes joint working, donations, and grants, while breaking the medical and educational goods and services (MEGS) umbrella down into its constituent elements.
Many organisations will now need to “reconfigure” their processes to suit the newly arranged code, said Dr Newton.
“There are entire agencies out there that only do MEGS,” she said. “That work isn’t going away but they will need to rebrand because the term has been striped out.”
Pharmaceutical companies will need new standard operating procedures (SOP) to cover activities such as collaborative working, and new documentation to reflect changes in language.
The next few months will be a huge change management exercise for organisations, said Dr Newton. But while amending processes and documentation to suit the 2021 code won’t be easy, the task doesn’t have to be as overwhelming as it first appears, she said.
“Stay calm and break it down into manageable, bite-size pieces. Let’s start at the beginning and let’s have a plan.
“You don’t need to turn the whole organisation around in five months and you don’t need to do it all in one go.”
Dr Newton advised compliance managers to rely on the “usual pillars of a healthcare compliance programme”.
“Look very carefully at those four areas – people, process, activities, and systems – and think about everything you need to change to comply.
“It’s important to adopt a position. There is no point spending weeks and weeks creating a SOP to support collaborative working, for example, if the company doesn’t plan to go down that route.”
Other examples centre on the new code’s provision for the addition of appropriately qualified person (AQP) signatories, and the removal of the long-standing two-page journal advert limit.
“There are lots of things have been written into this version of the code, that, practically speaking, a lot of companies will want to avoid implementing.
“I can imagine many will decide to stick with their normal signatories and to the two-page rule, for distance.”
Once organisations have decided which changes make sense to implement, prioritisation is the next step. Not everything, Dr Newton said, needs to be done by July.
The Prescription Medicines Code of Practice Authority (PMCPA), which administers the code, has granted a grace period, of until the end of the year, for organisations realigning their MEGS activities.
Other changes, such as introducing AQPs, for example, can be built into next year’s recruitment plans.
“Not every change is practical or pragmatic. And those that are should be prioritised,” said Dr Newton.
Looking at how the updated code may impact on working practices, Dr Newton said there was a danger it could place additional pressure on signatories in the short term.
“Our analogy for signatories is to describe them as the goalkeeper. When they are surrounded by good reviewers – a good defence line – only a few balls come their way. That makes it less likely that any will get past them to cause a breach.
“But this code increases the number of balls they need to save,” she said.
Everything that falls within collaborative working, for example, must be certified, and non-interventional study protocols are among the activities that will now need a signatory for the first time.
While the 2021 version makes provision for support from AQPs, it will take time for these people to be recruited, trained, and monitored. “In the interim, the workload on signatories is going to go up,” Dr Newton said.
Guardians of the code
Ultimately, adopting the new code will be a long process – one that organisations will need to plan carefully.
There may be a bit of a frenzy over the next few months as teams adapt to new concepts, language, new documents, SOPs, and clause numbers.
“But I think it will be interesting to see which companies decide to implement all the changes and become the guardians of the new code,” Dr Newton said.
About the author
Amanda Barrell is a freelance health and medical education journalist, editor and copywriter. She has worked on projects for pharma, charities and agencies, and has written extensively for patients, healthcare professionals and the general public.