The 2008 ABPI Code of Practice – what is the impact for Med Ed? Written by Steven Gray
The overall impact of the changes in 2008 is that agencies should consult with clients about changes to internal processes and the resultant need for additional or alternative documentation.
Given the size of the code, reviewing and absorbing all the changes is no small task. Some clauses contain very minor teaks; others have extensive additions. Thankfully not every clause has been subjected to change! Those clauses that have changed are covered comprehensively in a KeywordPharma Expert Review issued by Network Pharma and freely available to download at www.keywordpharma.com/abpi2008.
A summary set of slides for delegates is also now available here.
Certain clarifications were provided regarding activities that fall within the scope of the Code. These include disease awareness campaigns, market expansion activities and Joint Working with health organisations. International journals fall within scope if the journal is produced in English within the UK. ’Produced’ means compilation, editing, typesetting, printing and binding – but not factors such as where the head office of the publisher is located.
The code now mandates the use of a specific new statement on all promotional material: “Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.gov.uk. Adverse events should also be reported to (name of pharma company).”
Companies are now required to declare the “nature” of the company’s involvement. In other words, companies must clearly distinguish between hands-off grants and those events that they organise themselves; and whether they paid for the lunch or for the speakers’ travel costs.
A complete set of rules has been introduced across Europe regarding non-interventional studies. Ostensibly, they are designed to prevent companies inappropriately using the guise of “research” to pay for prescriptions.
Full electronic approval systems are now permissible thanks to a key change in the code. Previously, companies have been able to certify material electronically, but have had to complete hard-copy certificates prior to archiving. Now companies may use electronic certificates to meet the requirements of clause 14.
The practice of providing donations and grants to institutions is now clearly represented in the Code – donations are allowed so long as they are for the purposes of enhancing patient care, maintaining patient care whilst benefiting the NHS, or to support research. The grants must be documented and ”kept on record” and must not be an inducement to prescribe, supply, administer, recommend, buy or sell any medicine.
The supplementary information to clause 18 makes it clear that this clause relates only to grants to institutions; grants to individuals (travel grants, etc.) are covered in clause 19.
The definition of unacceptable venues has been expanded to include extravagant (as well as deluxe and luxurious). This change is likely to have little impact in practice and is driven by revised wording in the European (EFPIA) code.
Clause 20 is a brand new clause. The requirements are significant and, in summary, require every payment to a HCP for services provided to the company to be contracted in writing. The clause applies broadly to speakers, advisory board consultants, chairpersons, trainers and those individuals undertaking clinical trials. There is a long list of criteria that must be applied in order to engage the services of HCPs. These include identifying a legitimate need for the service and choosing service providers that relate to that need.
Detailed guidance is now provided about the content of the written agreements that must be in place for all significant activities and ongoing relationships with Patient Groups. And by 31 March 2009, the list of supported patient groups must include short descriptions of the nature of the support.
All promotional websites must now be password-controlled – unless the site also contains information suitable for the public. Essentially, the intention is that the public should not need to enter the site (and be exposed to promotional claims) in order to get information about company products.
Steven can be contacted by phone on 07984 59 8585 or email at enquiries@stevengrayconsulting.co.uk on on the web at www.stevengrayconsulting.co.uk
