The ABPI Code: more to come in 2009

Is UK pharma coping with the revised Code and what changes will 2009 bring?

In theory, at least, the answer to this question must be ‘yes’. In practice, some of the requirements have taken a little while to understand and, for some aspects, full implementation may be a little way off yet. As with any set of guidelines, it is impossible to anticipate every potential scenario and so, until there are actual cases and rulings by the Prescription Medicines Code of Practice Authority (PMCPA), the meaning and implications of some changes cannot really be completely appreciated. However, this article seeks to outline some of the common views and answer some of the questions that have arisen so far.

In general, the changes in the Code have been well received and the need for them has been very well understood. Dr Stephen Huang, medical director at Trinity-Chiesi comments: “On balance, the changes in the ABPI Code seem about right and should prevent us from having to take extreme measures like those in the new US Code.”

Service contracts

One of the most significant changes is the introduction of contracts for healthcare professionals who provide a service to a pharmaceutical company (contained in Clause 20 of the revised Code).

Some companies have expressed ‘delight’ at the aspects of the new Code that deal with contracts and contracting arrangements, particularly those that already operated a system of formal contracts, because all companies are now approaching arrangements with speakers, etc in a similar fashion.

The new contract requirements have been well received in most quarters. Actelion’s medical director, Dr Bharat Karbal, voiced his approval of the shift in perception that the changes bring: “It visibly moves away from the practice of ‘developing’ KOLs [key opinion leaders]. I believe it is more comfortable for the KOL to declare that they have been paid, rather than risk being seen as having a ‘tie in’ with the company. Also, FMV [fair market value] is a great way forward to taking the guesswork and inconsistency out of fees.”

How these new contracts will work in practice, however, is yet to be seen. This is because, while some companies already operated a policy of contracting services, others did not. The short time-line between the Code being released (1 May) and the requirement for contracts to be implemented (1 July) allowed just about enough time to write the relevant policies and processes and to roll them out to field-based staff. However, few companies had time to develop supporting material to help representatives explain the changes to customers. The experience in 2006 was that when contracts for patient groups were introduced, there was a need to spend time working with the groups to help them understand the need for the written documentation. Companies would therefore be well advised to consider how best to help healthcare professionals understand the rationale behind the need for service contracts.

Some companies have asked for greater clarity about just how tightly the service and the contract need to be linked – how to manage annual contracts, for example, which might not specify the individual payment for every single activity. Others have asked for guidance on how to apply FMV to patient group representatives and whether a doctor’s private earnings potential can be taken into account when calculating FMV. In these early months, there are likely to be a great many requests for clarification. In general, it seems that consideration of NHS earnings rather than private income is the most appropriate benchmark.

Evelyn Diamond runs Essentially Medical, a company that organises educational meetings for GPs. She echoes the call for clarity in some areas of the Code: “We set up talks in general practices by local consultants who give their time for free. Then we ask pharmaceutical companies to sponsor the meeting by covering the cost of food and we charge a small administration fee. The pharmaceutical companies are not involved in selecting the speakers, yet some companies are already asking about whether they need to set up contracts in order to comply with Clause 20. Our advice is that they don’t need to, but that doesn’t stop the reps from worrying. Thankfully, once we explain our meeting arrangements to the relevant compliance team, the concerns usually fade and the local representatives are able to support our events.”

Business class travel

There is one aspect of Clause 20 for which this author needs to extend an apology and to offer a point of clarification – for providing incorrect information in the April 2008 issue of Pharmafocus. Back then I said that business class travel was banned for all healthcare professionals engaged to provide services to a pharmaceutical company. This is incorrect – business class travel is allowed for healthcare professional service providers. Much of the new ABPI Code is based on its European ‘parent’, the European Federation of Pharmaceutical Industries and Associations (EFPIA) Code, which was issued in November 2007. I had based my comment on the wording of the EFPIA Code and applied it to the 2006 ABPI Code (and sense-checked it against the draft 2008 Code, of course).

Essentially, my error stemmed from the fact that the new Clause 20 states that the relevant parts of Clause 19 apply in full to consultants. We all know that Clause 19 prohibits pharmaceutical companies from sponsoring or providing business class travel for delegates at educational meetings. Therefore, it seemed logical to conclude that travel for consultants had to be similarly restricted. The position has since been clarified (verbally) by the PMCPA in several of its lectures (though not in writing yet).

When Clause 20 refers to the need to comply with the relevant parts of Clause 19, this does not include business class travel. This is because the supplementary information to Clause 19 refers to ‘delegates’. Persons engaged by pharmaceutical companies are ‘consultants’, not delegates. But everything else applies. Presumably the aspect of the supplementary information which bans the sponsorship of travel for delegate spouses is relevant to Clause 20, however. While the current clarification of the distinction between delegate and consultant might (theoretically) allow companies to provide travel for the spouses of ‘consultants’, I really would advise against testing this position.

This is one small example of how the interaction between different sections of the Code can cause confusion – in this case, mine! However, there are other areas to be aware of as well.

Market research activities

Another aspect of Clause 20 that has caused some confusion is the fact that the requirement for consultant contracts encompasses market research activities. Trinity-Chiesi’s Dr Huang echoed the comments of many: “An agreement can be signed between the healthcare professional and the research company, but not the pharma company as it will defeat the anonymous purpose of the research.” The industry’s market research organisation, the British Healthcare Business Intelligence Association (BHBIA), is thought to have expressed similar concerns and it is understood that discussions are currently taking place between the PMCPA and BHBIA to agree a way forward. Currently, most companies appear to be continuing as normal and not mandating a requirement for their market research agencies to get all healthcare professionals to sign a contract directly with the pharmaceutical company. In practice, it is difficult to see how this is achievable, given the strict principles of confidentiality enshrined in the principles of market research.

Provision of samples

One area of the Code that raised a few eyebrows is the new rule that states that any medicine which has been on the market for more than 10 years may not be proved as a sample. Most people agree initially that a time limit is sensible. Then they are faced with the detail – does a line extension count as a ‘new medicine’; can generics be sampled; how should we consider general sale list medicines that are given to prescribers? Unfortunately the Code’s definition of medicine isn’t much help (it defines it as a ‘medicine’). It is likely that each marketing authorisation will have its own new 10-year period; however, this is not a certain position and we await the inevitable case law to guide us.

Room for interpretation

We should remember that, at 50 years old, the ABPI Code is the world’s most established and one of the most comprehensive. The evolution of the Code has led inevitably to some complexity, so it is not surprising that further explanation is needed from time to time. Yet we need to recognise that, in some areas, complete clarity may never be achieved. After all, debates still continue about what makes a venue ‘luxurious’ or ‘deluxe’, and have occured ever since the words were first introduced. The inclusion in 2008 of the word ‘extravagant’ to expand the list of unacceptable venues hasn’t, in itself, caused a ripple in any of the companies I have spoken to. However, it has been used as an example during more general pleas for clarity in some of the definitions used in the Code. It would certainly be welcomed in some camps if the Code could define the facilities that would render a hotel ‘extravagant’ (or ‘deluxe’ or ‘luxurious’).

Jeremy Clark, managing director of the Marlow office of Huntsworth Health, whose advertising, medical education and public relations business is already taking account of the changes, adds a thought from the agency perspective: “We are often asked by client pharma companies, ‘What does the Code say?’ or ‘Can we do that now?’ and we have been updating our positions on the new points in the last few months so we can give a good answer. But the real question usually turns out to be ‘What is the client’s interpretation of the new Code?’ Although one of the goals of the Code is to promote greater consistency of good practice, the differences in interpretation – sometimes subtle, sometimes not so subtle – continue to surprise us. The role of agencies in the next few months will be to have a good answer to the first questions, while remembering to ask and get a clear answer to the second.”

Donations for healthcare organisations

The new Clause 18.5 on donations is not causing too many problems, as most companies had some form of donations assessment process in place already. However, the wording of the link between Clauses 18.5 and 18.4 is a little confusing. For example, Clause 18.5 itself does not specify the need for certified written agreements for contracts, but it does say that donations must either be for research or comply with Clause 18.4 – and Clause 18.4 does require certified written agreements. However, not everyone agrees that the arrangements for donations need to be formalised to the same extent as services to medicine. In fact, there are a small number of healthcare organisations that seem to be expressing some reluctance to sign the contracts issued by pharmaceutical companies. In particular, this is where industry contracts include statements that separate the donation from any link to the company’s product – the healthcare organisations seem to be uncomfortable with such statements (perhaps offended that anyone might even conceive of such a link). The donations still happen, but one or two potential recipients are issuing their own contracts rather than use those provided by industry. There are again echoes of the situation with patient groups in 2006, and companies should be aware of the potential need for proactive communications with their applicants about the new requirements of the Code. Otherwise the support offered by pharma may actually diminish rather than enhance our reputation.

The ‘strong recommendation’ that industry publicly declares all the donations it gives to healthcare organisations has been received with something resembling apathy. No one is ruling it out, but so far there is little enthusiasm to implement it either. Many companies are including a clause in their contracts that would let them do so; however, few are making plans to publish lists of supported PCTs and hospitals on their corporate websites, despite the fact that pharma’s US marketing companies all seem to be embracing transparency.

Nor is there much enthusiasm for the recommendation to ask the recipients to publicly declare the donations they receive, and in fact there is little evidence of this consideration even being included in the written agreements that accompany the donations. To be honest, there is still resistance in some quarters to the need to include a sponsorship declaration on any documents printed using pharma money (Clause 9.10). Some healthcare and patient organisations still express concerns that such statements detract from their independence. Taking the time to explain the rationale for the declaration helps; however, it is perhaps worrying that sponsorship declarations are still an issue given that they have been a Code requirement for a long time!

What is new is the requirement to state the nature of the support provided. This is leading to some discussion about the exact wording of sponsorship declarations to be used. Some companies have invested considerable time in developing a range of declarations that can be used in various scenarios – only to have the recipient organisation then change the wording before the document is printed. This is causing consternation for some compliance officers because the final wording used might be seen as misleading from a Code perspective. Thankfully the only area of the Code where we have to ensure that appropriate declarations are made is where the activity concerns patient groups; for healthcare organisations, we tell them what they should declare – it’s up to them to do so.

Broadly speaking, the separation of patient group activities into a stand-alone clause has been seen as a cosmetic change. The new inclusions, such as the requirement to gain written permission before using a patient group’s logo or the need to comply with Clause 19 regarding the level of hospitality, do not seem to be of concern to anyone.

Provision of internet sites

Equally, the changes to (new) Clause 24 regarding the provision of internet sites do not seem to be causing too many concerns. Trinity-Chiesi, for example, already has password-controlled access to its websites for healthcare professionals. Other companies are known to be incorporating sections for patients on their healthcare professional sites. However, there are one or two concerned voices. Marketers express frustration that registering for passwords delays access to the site and reduces web traffic. Compliance teams express concern about just how much information can be provided to patients whilst staying within Clause 22 (and not crossing the line into product promotion).

Non-interventional studies

There appears to be very little evidence of significant changes being caused by the rules around enhanced monitoring and controls for non-interventional studies and the establishment of a new scientific service. Many companies are either simply allocating the task to the relevant therapy area medic, or have not specifically addressed the requirement owing to the absence of any projects that fit the criteria. One company, in particular, has a long-running review panel that scrutinises all protocols, from clinical to market research, including all activities that the global team want to undertake in the UK. This is undoubtedly working well for the company concerned, and is seen as of such high quality within the company that its subsidiaries in other companies will not comment on global proposals until the UK team have offered their opinion first!

Important dates for your diary

Any and all activities that were ongoing on 1 July should by now have been through a period of reassessment. This is because the ‘period of grace’ ended on 1 October and all ongoing activities now need to be fully compliant. The two exceptions are the enhanced reporting requirements for patient group interactions and the incorporation of the new adverse event statement. For the adverse event statement, companies have until 1 July 2009 to update their material, but it is worth making a note in the diary to remind yourself because anything still in circulation at that time will need to be withdrawn or replaced.

By the way, the new adverse event statement as detailed in the Code is different from that originally announced by the PMCPA late last year and (at the time of writing) that which is published on the PMCPA website in its ‘Guidance’ section.

It is worth pencilling in another date into the diary as well – 1 April 2009. On this date, all companies should have upgraded the sections of their websites that report on patient group activities. So far there is little indication as to how much information each company will publish about its activities. However, companies are gradually amending their contracts to ensure that they have the necessary agreement from their patient groups in order to make the declarations. It is appropriate to remember that the requirement for publishing details of the activities pre-dates the Code’s implementation – therefore, companies also need to consider obtaining agreement to publish details about retrospective activities since 1 January this year.

Omissions

For me personally, the Code is more memorable for what it didn’t contain than what it does. There is no guidance on patient support programmes or risk-sharing commercial schemes, nothing on account management or working with the new (private) NHS, and nothing comprehensive about the ever-expanding use of electronic media – just what are the rules regarding meta-tags to gain enhanced Google listings? And how does one categorise partnership working and its outputs when it comes to approving material? I have my views; others will have theirs.

Perhaps the strangest omission is any meaningful reference to individual donations to healthcare professionals. Bearing in mind the Code’s focus on contracting and transparency, why is it that the rules have tightened on contracting the provision of services from individual healthcare professionals and also on donations to institutions, but the provision of travel grants to individual healthcare professionals is subject to much looser controls? As always, some answers will be found in case law as the year progresses; others will be addressed in the next Code.

Our Code

There is no doubt, however, that the rationale for the changes that have taken place this time around is rock-solid. Dr Karbal is positive about the changes and sees the new Code as “a good step towards shifting attitudes from one of establishing a valid defence of an activity whilst trying to find ways to get around the Code, to an environment where to openly comply makes good business sense because it facilitates making commercial gains”.

Dr Karbal admits, however, that not everyone in the industry agrees: “Doubtless there will be some grumblings from those in the front-line who have to deal with increased levels of administration and who have to explain to customers why they have increased administration when they interact with industry.”

Any concerns, however, can be put neatly into perspective by remembering one thing: it’s our Code and we choose what we put in it. Now we need to implement it and comply with it. And then start on the next one¿

Steven Gray is a chartered marketer and former compliance officer who specialises in providing business-friendly compliance services to the pharmaceutical industry. For further information, visit www.stevengrayconsulting.co.uk.

Steven Gray
E: pharmafocus@wiley.com

Monday , December 15, 2008