The 2008 ABPI Code of Practice – the impact for representatives

The 2008 ABPI Code of Practice – the impact for representatives

How will the changes to the Code affect your daily role? Steven Gray breaks down the 2008 version.

There seems to be a fair amount of noise at present about the new ABPI Code of Practice. So, what has actually changed – from a representative’s perspective?

The main change you might see is an increase in documentation (yes, that does mean paperwork). But it’s for a good reason, honest. Essentially, the industry has taken steps to address some of the concerns in the external environment about the way that all corporations are seen to behave – not just those in the pharmaceutical industry.

All of us are aware of the growing expectation of the public that corporations should behave responsibly and ethically. No industry and no corporation can ignore the need to operate in a transparent way or to have tight business practices. And the scrutiny of the pharmaceutical industry is particularly acute.

“No industry and no corporation can ignore the need to operate in a transparent way or to have tight business practices”

For example, in the US a combined group of high-ranking pharmaceutical executives developed some joint proposals with senior academics about the right way for industry to interact with US medical colleges. The answer – they shouldn’t! The working group actually concluded that pharma should not provide sponsorship for medical education because the prescriber would be influenced inappropriately. The final report also included a recommendation that pharma should not even engage the services of physicians as speakers at educational meetings organised by the industry!

The enforcement of the US (PhRMA) Code is very, very different from the way we apply the ABPI Code in the UK. And the market is of course very different. However, it is an interesting development and gives some insight into the kind of rationale driving the changes in our own Code – and indeed in Codes across the world.

The main change in the ABPI Code, in common with the rest of Europe, is a further shift from simply providing guidance about the way we promote to healthcare professionals (HCPs) to an increase in guidance about the way we interact with HCPs. Combined with this shift in emphasis is an unwritten recognition that corporations need to be aware of an increasing range of regulations and legislation that is impacting our business. For example, the US Foreign Corrupts Practices Act is anti-bribery legislation that definitely affects businesses listed on the US stock exchange and probably affects any company that does business in the US. The legislation is very wide-ranging and basically means that the US operation can be fined if any part of the global business falls foul of its requirements – or can’t prove that it doesn’t! And the fines are based on a percentage of turnover…

So, into the Code comes contracts and enhanced record keeping. In comes a recommendation that everyone makes a declaration when money changes hands. There are other peripheral changes too, but we’ll come back to those. Let’s start with contracts.

Contracts with HCPs

Drawing up a contract with an HCP • A legitimate need for the service must be clearly identified • Selection of service provider must be directly related to the need • Service provider must be selected by the relevant company expert • Number of service providers must be appropriate to the identified need • Written contract signed before service commences • Contract to specify the nature of the service and the payment • Records must be kept by the company about the services provided • Engagement must not be an inducement to prescribe, buy, sell etc • Payment must be at FMV

Every time a pharmaceutical company wants to engage the services of a healthcare professional, the details of the arrangement need to be captured in a written agreement. For most companies, this will mean a formal contract that the healthcare professional has to sign.

So what are the implications of this for representatives? Every speaker will need to be working under a contract every time they speak at a company meeting. Or act in the capacity of chairperson.

The contract will include details about the service that the HCP is providing and the basis for the payment. In other words, how much they are being paid and how they will earn it. The payment must be at Fair Market Value. This essentially means that two HCPs with an equivalent seniority providing roughly the same service should be paid roughly the same amount of money. Seems fair enough.

Of course, there is no actual formally published list of Fair Market Values, so each company will have to create their own – or, at the very least, they will review their existing honoraria tables.

The details of the arrangement need to documented and recorded – so there will need to be a system for storing the contracts somewhere. Some companies will make full use of electronic technology; others will establish fi ling cabinets at Head Office.

There are a few things that are also likely to be included in the contracts even though the Code doesn’t specify that they need to be. In order to comply with Data Protection laws, most companies will include clauses in the contracts stating that the HCP’s details will be stored and what the details will be used for. Many contracts are also likely to include references to the Code itself, which remind HCPs that they are acting on the company’s behalf whilst performing the service. Which means that anything the HCP says and does is subject to the Code.

There is another clause that might be included as well. It is suggested in the Code that companies might like to ask their service providers to make declarations of interest. Effectively this means that when your speaker gets up to the podium, they need to declare that they have been paid by the company to be there. And they will need to declare when they speak at a competitor’s meeting. And when they are writing a protocol in a related disease area. And if they are part of a committee that is deciding whether to include your product (or the competitor product) on the formulary.

Actually, they don’t have to declare it. The Code only suggests that it would be a good idea for companies to ask them to. Each company must decide whether it wants to incorporate the request into a clause in the contract.

Multiple contracts

By now you are probably working out how many times you ask certain individuals to speak and are starting to worry about the number of documents those HCPs will have to sign. Don’t worry. Since everyone in the industry will be doing this, HCPs will get used to it very quickly – in fact many companies already insist that contracts are signed, so most HCPs will already be used to the idea.

However, there is another piece of good news. The wording of the contract theoretically allows for the establishment of annual contracts. This would mean that regular speakers could sign a single document that details all their services. Well, all their speaking engagements anyway. And even then, the company will need to have some form of recording system that links each engagement back to the original contract. It is worth remembering that the company will also engage the services of certain HCPs for a number of different purposes. For example, advisory boards, international speaking engagements, training representatives, acting as company spokespeople for media interviews, etc. Because it is very difficult to write a contract that is all-encompassing, most companies will initiate a new contract for each type of service – and probably for each occasion on which the service is performed.

Still with me? We are almost done with contracts. Three more things.

The service that is being performed must be ‘legitimate’. In other words, there has to be a real need for the service so that we can’t be accused of making up a service just to pay an HCP some money. In practical terms, this means that you should not automatically engage a chairperson for every meeting – you need to think about whether you actually need one.

The second-to-last point is that the selection of service providers must be done by someone with appropriate ‘expertise’. Now, as the company representative in the local area, it could be reasonably argued that you know your local KOLs better than anyone else in the company and so you are the person with that ‘expertise’. However, some companies might feel that it is appropriate to escalate the decision to first line managers – or even to approve every speaker centrally. The reason for escalating the decision will probably be to make sure that the company cannot be accused of making selections based on business potential rather than the skill of the service provider.

Finally – the contract has to be signed before the service is performed. Bearing in mind that most speakers prepare their slides the day before the talk, getting them to sign their contract on the actual day they present would be a breach of the Code…

You may or may not be interested to know that all of these points are captured in the brand new Clause 20.

But the fun with contracts doesn’t stop there. Oh no.

Contracting with institutions

Companies can also contract the services of institutions. So, for example, a company might contract with a PCT to provide lecturers to the company on a regular basis. Or contract with a hospital department to conduct research on behalf of the company. The purpose of the service must be to enhance patient care, to conduct research or to help the NHS, however.

Grants to institutions

There is also a change that impacts the way the company must react whenever a healthcare organisation asks for money or non-financial support. It is perfectly okay for the company to help the healthcare organisation – though again, the support must be of benefit to patient care or the NHS or for research.

The details of the grant must be documented and recorded. Like the contracting of services from HCPs and institutions, the grant must not be seen as an inducement to prescribe, recommend, administer, buy or sell a product. Most companies will capture this wording in a written document, which the applicant might then have to sign – again, the company will need to tell the institution that they will be keeping the details of the grant on file.

The Code also suggests that the company might like to declare publicly when it makes grants. It doesn’t say how, or where, or what information to include. Nor is it compulsory, but you might start to see lists of donations appearing on company websites. It is also suggested that the company asks the healthcare organisation to make a declaration about the support it has received. Again, this is not compulsory, but it is possible that you will start to see lists of donors appearing on hospital and PCT websites.

Other changes

Obviously, there are a number of changes to the Code that will not impact directly on your role as a representative. We will not cover those in this article. Suffice to say that there are new rules on Non-Interventional Studies (NIS – sometimes called ‘post-licence clinical experience programmes’). There is also a requirement for greater transparency whenever any form of research is started or finished. And you will see a slightly revised Adverse Event reporting statement starting to appear on your promotional material.

There are a couple of other areas that might impact you more directly, however.

There are already tight rules around what a representative can and cannot do when discussing Therapy Reviews with customers. There is another new restriction. There has been significant concern about the way in which some Therapy Reviews have been offered and whether they might be seen as ‘switch services’, whereby patients are simply moved from one product to another. To address this concern, representatives may not offer a Therapy Review at the end of any visit where the HCP has agreed a change to the company’s products. In other words, if your promotional discussion is really successful you should not then mention the existence of a Therapy Review.

Quizzes are now allowed at promotional meetings – as long as they are non-promotional in nature and test the learning gained at the meeting, and as long as there is no prize.

The last point that will affect the role of a representative regarding samples. There is a new limit on the length of time that samples can be made available. After a medicine has been on the market for 10 years, a company must stop providing samples. This is based on the thinking that the reason samples are provided is to allow the HCP to become familiar with the product. Once a product has been on the market for 10 years it seems reasonable to assume that most HCPs have got to grips with it!

So that’s the 2008 Code. (Or some of it anyway.)

And we should celebrate too. The ABPI Code of Practice has reached its half-century. Time to start taking bets on what will be in the Code in another 50 years?

Steven Gray is the author of ‘Tightening Regulations and Raising Standards in UK Marketing Communications: the new ABPI Code of Practice (2008) explained’ – available for download at www.KeywordPharma.com. Written by pharmaceutical industry specialists, KeywordPharma publications provide authoritative and succinct information for pharma executives. Available to purchase individually as e-documents, they build into a specialist knowledge library for everyone working in and around the pharmaceutical industry.

Information about resources, training courses and training material connected with the Code can be found at www.stevengrayconsulting.co.uk or or contact Steven on 07984 59 8585.