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MORE DETAILS
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EVENING BRIEFING - 5 JUNE 2008 - OXFORD
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Steven Gray provided us with an excellent and in-depth review of the new ABPI Code of Practice 2008, details of which have just now been published. A short overview of the meeting is published here below, meantime the PMCPA has published some material on their web site, but it's not easily found so here are the direct links.
listing of changes included in the new ABPI Code of Practice 2008
the "Printer's Proof" of the new ABPI Code of Practice 2008
PowerPoint presentation of the main changes of the new ABPI Code of Practice 2008
To make sure you're included in announcements about future events just email Peter Llewellyn, if you haven't already done so, to register your interest.
The new ABPI code explained
Overview written by Marian East of MedSense.
Background
On 5 June, Oxford, an excellent and informative meeting, kindly sponsored by Wellards, the company who can answer anything you ever needed to know about the NHS, took place.
The aim of the meeting was to update the attendees on what the 2008 update to the ABPI Code of Practice will include. Is the code a new shade of grey?
No-one who is associated with the pharmaceutical industry can have failed to notice the anticipation of the revised 2008 ABPI Code of Practice. The 2006 update code threw up many queries and grey areas on what was or was not acceptable behaviour in working practices.
Steve Gray (from Steven Gray Consulting Limited) gave an informative and detailed overview of the changes in 2008. Many of the changes are harmonised across all European codes under the EFPIA umbrella.
One key change of concept is the focus away from ‘promotion’ to ‘interaction’ with Healthcare Provides (HCP). This means that increased openness and transparency for all activities, whether promotional or operational.
Contracts
Contracts will now feature heavily in most activities. Whether the activities include speakers, trainers, market researchers*, media spokespersons or individuals, contracts are mandatory. In addition, the requirements for recording and documenting any grants made to healthcare institutions mean that many companies are likely to issue contracts for grants and donations as well. The jury is still out on the type of contracts that will be needed – a simple one page document or an extensive manuscript, drafted by lawyers - it will depend on each circumstance and is likely to develop in time, resulting in an accepted format as the code is absorbed into everyday practice.
* One –off remote telephone or email questionnaires will not need a contract, especially if payment is nominal.
Engagement of HCPs as service providers
Each contract must specify the service provided and the basis for the fee. Companies will be ‘encouraged’ to include a clause requiring the service providers to make appropriate declarations as well. It is already common in the USA for speakers to make declarations of commercial and research interest before slide presentations.
Companies must be able to prove have to prove that the services provided by the HCPs are legitimate, and records will need to detail the service being provided and the rationale for using that specific provider.
Due to data protection issues, permission to store the service provider’s details should also be obtained. Payment should be according to Fair Market Value – similar service = similar payment.
Travel
The emotive words, ‘business class’ were raised. When can HCPs turn left on the plane or when to travel stowage? Business travel should still be acceptable for speakers crossing the pond to give a presentation and then to return immediately after the meeting. However, if the speaker decides to stay a few more days to attend a congress, then economy travel will adhere to the code. Try explaining that to some of your more precocious KOLs!
Institutions
Companies can only engage the services of healthcare institutions, e.g. PCTs, Medical societies etc, solely for the purpose of enhancing patient care, benefiting the NHS or conducting research.
Donations, grants and benefits in kind, must comply with the existing 18.4. Which means they must also now be certified, documentation kept on record and declarations on materials should indicate the nature of the support. Each company must also consider whether it declares the donations publicly and whether it should ask the receiving institution to make a similar declaration.
Of note: If KOLs need help as an individual (e.g travel grants), then no declaration is required. However if they seek help on behalf of an institution, then the new clause 18.5 requires that companies consider declaring the payment.
Meetings
As to be expected, the shades of grey are becoming blacker. Meetings must not be held at luxurious, extravagant or deluxe venues, especially those associated with sporting facilities. Sponsorship of entertainment is unacceptable, so ‘Gala’ dinners may not only have to be renamed, but also have to take place with only the sound of clinking plates and jovial banter to pass the time. All meetings, whether connected to planning, training, investigator, clinical or non-interventional studies will be included.
Visits to research or manufacturing facilities must be appropriate and educational.
You’ll be pleased to know that quizzes are back in! This is good news for those struggling to constantly find novel ways to share data in an interactive and innovative way. However, there must be no prizes (what? No little chocolate bottle of Fizz?).
International events
International events, whether in the UK or elsewhere will have to explain and declare where exhibited products are licensed and (if held in the UK) promotional material can only be displayed if the product is licensed in a ‘major’ country and if a significant proportion of the delegates are from countries where the product is licensed.
There is no change to International advisory boards – as now, these should comply to Code of the country of location, plus each attendees country, plus the country of the organising company. This is where organising a simple meeting could become complex.
Gifts
The value of the usual give-aways and gifts are still kept at £6.00. Bulk buying will make no difference as it is still the perceived’ value that is taken into account. But at least books can contain brand names!
Mailings
The limit of how frequently mailings can be sent to doctors, remains at eight, however this does exclude safety statements and also now price changes, as long as no promotional claims accompany the communication. Emails don’t count, which raises the question of how many hyperlinks can you fit in an email alert?
Patient groups
The code for working with patient groups has tightened further to avoid any question of bias, lack of transparency or perceived imbalance. Sole sponsorship cannot be assumed or requested. Sponsorship must be fully declared and publicised by 31st March 2009 – but its no longer just a list of names; now its the nature of the support too!
Clinical trials
Clinical trials will now have to be publicly recorded within 21 days of the first patient recruitment. The results should be published ‘within a reasonable time’ and sent to all HCPS who participated.
Conclusion
The new code will no doubt clarify the historical grey areas, without creating too many new ones. It should now tighten up even further the code to demonstrate transparency, ethical credibility and fair balance. Hopefully it will be welcomed by the industry and the first few months of uncertainty will diminish with time and experience.
The timeline to change to the new code depends on the activity. (see box)
Links
www.wellards.co.uk
www.stevengrayconsulting.co.uk
www.abpi.org.uk
www.clinicaltrials.ifpma.org
www.pmcpa.org.uk
www.efpia.org
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