Living with the Code of Practice
The 2008 edition of the ABPI Code of Practice came into force on 1 July and the industry is fairly humming with debate over its interpretation.
Heather Simmonds, director of the Prescription Medicines Code of Practice Authority (PMCPA), has a straightforward and comforting message to share. To her, the 2008 Code represents relatively few generally small changes. Only a few organisations will come into the Code's ambit for the first time in 2008, and many of the issues can be covered by adopting new contracts. She would also add that opinions expressed by people outside the PMCPA are just that, as there is no case law to provide guidance, and that she and her colleagues are happy to provide informal advice.
Simmonds knows the Code better than anyone, and many in pharma will hope things will turn out as she says. Nevertheless, some will be cautious in their interpretion of the new rules, while others are frustrated by its failure to say more about the issue of pharma's need for guidance on how to operate in the great new medium of our times – the internet.
Each new edition of the Code includes at least some areas that require interpretation, says Bayer head of medical governance, Christine Wicks. "There are always areas where there is a lack of clarity, and it's down to interpretation. There are also areas where it doesn't offer rules so much as advice," says Wicks. "In these cases you have to make sure you have a really good justification for doing whatever you decide to do."
To this, Simmonds would add that the areas where the Code gives advice should often be seen as a sign of things to come – in the next edition, they could become the rule.
Industry compliance consultant Steven Gray recently told delegates at a London workshop sponsored by the training website Wellards.co.uk that they should be aware of the subtlety of some of the language used in certain important aspects of the latest edition of the Code. One example, he said, appeared in Clause 20 on engaging consultants, which says that Clause 19 on hospitality applies.
"The use of the word 'delegates' in clause 19, in effect means that consultants can still fly business class, but that delegates attending a conference can't," he said. Another example, he added, was the expansion of a company's accountability in the new Code.
Licensee compliance and 'reasonable steps'
A new requirement of the 2008 Code is that companies must now take 'reasonable steps' to ensure that commercial partners that are not acting on the company's behalf (such as licensees and partners in joint ventures) fully understand the Code and are compliant, which extends the accountability of pharma companies beyond the normal supplier relationship.
Marketing and communications consultant Paul Dixey reports that he is starting to see contracts with clauses specifying that suppliers must act in accordance with the Code. But is a contract clause enough?
Wicks doesn't think so. "This requires a bit more from us. We need to talk with service suppliers to make sure they and their staff have full knowledge of its requirements. Some already send their staff on regular training, while others employ a specialist consultant to make sure what they do is Code compliant. Whichever route they take, they can present it as evidence of compliance."
Dixey would agree. "The way forward is for suppliers to show that their training and systems ensure compliance. They could even have their own compliance departments – we could see agencies going to a client and saying: "Here's our proposal, and it has the stamp of our internal compliance person."
"If I was a brand manager, I'd be pleased," he adds. "I wouldn't want to be presented with a proposed campaign and then be told by my compliance manager that I can't run it. It's much better to start with compliance from the point where you're discussing what the brand manager wants to achieve."
One of the most important new clauses is arguably the requirement for companies to publish short descriptions of their support for patient organisations.
Ian Hale, operations and compliance director with compliance consultancy Code in Practice, believes the new rules on declaring significant help for patient groups are a valuable step, and have largely sorted out the issue of transparency in relation to patient groups, but it does raise one question: "There's no definition of what 'significant' is – is it £100 or £10,000, and does it vary with the size of the charity?"
"A lot of people will take the cautious route and insist on declaring everything, at least until someone is found in breach and the issue becomes clearer," says Hale.
The issue of the contracts required each time a health professional is employed to speak, attend an advisory board or review data is clearly laid out in the latest edition, says Dixey.
"From now on, each time you need to have a new contract in place because you're offering them remuneration for different activities."
But an interesting nuance in this section of the Code is that, in hiring speakers, pharma is required to select people who can be shown to be qualified for the task they are asked to perform – they can't just be someone who supports a particular product. This point will require some interpretation, says Dixey.
"Companies will have to be able to prove that they had good reason to choose a particular speaker. What's more, whoever selects the speaker must have the expertise to make the choice. Situations could arise where a rep who wants a particular speaker may find his compliance colleagues will remind him he can't select a speaker, and that it has to be done by the medical team."
On payment for these services, however, Wicks argues that the new Code is an improvement. "What we pay is very much in line with day-to-day salaries of the calibre of person concerned, and if every company did the same the people concerned would be happier with what they are paid. The Code is trying to get more uniformity in this area."
Contracts for everyone else, too
The 2008 Code doesn't just require contracts for speakers, but for all services, and they have to be stored and managed so that they can be examined by the PMCPA's inspections.
Most companies keep these kinds of documents in their respective business units, but is this the right way to go in the future if pharma companies are required to keep records for audit?
Gray argues this is not a trivial task and requires careful thought – but it is also perfectly achievable for organisations well accustomed to operating management systems, such as accounting and trial data, that are often based on storing PDF files.
Dixey believes that some companies will for the first time decide they need to ensure they have standard contracts across their organisations.
In talking with pharma professionals about the 2008 Code, the topic that comes up most is how to communicate the new messages to the healthcare professionals and third-party organisations they work with.
Wicks is one who believes this is the biggest challenge inherent in the revised Code.
"Our customers haven't had to work so closely with the Code in the past, and their understanding of what we're up against is less clear.
"I think there's a low level of awareness, and the challenge is communicating the reasons why they are important and why we need a contract or an agreement in place."
Economy class air tickets
The rule that is perhaps causing more concern than any other is the interpretation of the supplementary note to Clause 20, which states that service providers are to be subject to the relevant parts of Clause 19.
It was certainly a topic of considerable debate among delegates at a Wellards-sponsored London workshop led by Gray, who shared his own interpretation: "Speakers can fly out business class – but if they present on day one and then stay for the whole conference, they fly in the back [in economy class] on the way home."
Wicks says that she has talked with various people on this issue, but would still like some more clarity on the rule on flights for speakers and service providers.
"At the moment, if you commission someone to work for you, if appropriate you can offer them business class travel; however, you couldn't justify that if your speaker was travelling to Paris.
"However, if I was asked to fly to somewhere like New Jersey to work, and then go straight back to work after a night flight in which I would have to sit bolt upright, I might think that was unreasonable.
"Happily, I don't think the new Code rules out business class travel in these situations, although I think it will require a programme and an agenda to justify the business class ticket. However, the problem will be getting it across to people that we can't offer business class travel to everybody."
Hale identifies another problem with the provision allowing health professionals to upgrade their flights from their own funds.
"If the individual's ticket is business class, how then do you reimburse the price of the economy class flight only? The audit trail would show that you had reimbursed some money on a business class flight."
This is all difficult, says Hale, but there is a way of dealing with the issue. "There is an established industry-wide view now that flights up to four hours should be economy class and those over four hours should be premium economy. No-one has been picked up on that as yet."
As Gray says: "The Code is just a guide; the job of industry is to interpret it practically to each individual situation. The changes may be small for many companies – however, implementing them in practice is not always as straightforward as we hope."
Box: Clear for take off? The economy or business class dilemma
Despite being seemingly clear, some practical questions remain about whether business class travel can be provided in some instances, and the subject remains one of the leading areas of concern.
The rules are governed by Clause 19 and 20, listed below.
From Clause 20: If a health professional attends an event in a consultant or advisory capacity, the relevant provisions of Clause 19 apply.
From Clause 19 Supplementary information: Companies should only offer or provide economy air travel to delegates sponsored to attend meetings.
Delegates may of course organise and pay at their own expense the genuine difference between economy travel and business class or first class.
Box: The Code on consultants
From Clause 20: A written contract or agreement must be agreed in advance of the commencement of the services which specifies the nature of the services to be provided and the basis for payment of those services.
A legitimate need for the services must be clearly identified in advance of requesting the services and entering into arrangements with the prospective consultants.
The criteria for selecting consultants must be directly related to the identified need and the persons responsible for selecting the consultants must have the expertise necessary to evaluate whether the particular health professionals meet those criteria.
The contracting company must maintain records concerning, and make appropriate use of, the services provided by consultants.
The Code on patient organisations
From Clause 23.2: When working with patient organisations, companies must ensure that the involvement of the company is made clear and that all of the arrangements comply with the Code.
This includes the need to declare sponsorship (Clause 23.8) and the prohibition on advertising prescription-only medicines to the public (Clause 22.1).
From Clause 23.8: Companies must ensure that their sponsorship is always clearly acknowledged from the outset.
The wording of the declaration of sponsorship must accurately reflect the nature of the company's involvement.
Box: Internet Anxiety
Arguably the greatest weakness in the current Code is the fact that it still says relatively little about the web.
"I think the Code is still playing catch-up," says Dixey. "Asking for content aimed at professionals to be clearly identified and separate from that for patients is all very well, but that was what people were doing three years ago.
"The online world has moved on, and now includes weblogging, social networking, e-detailing and e-CME – yet these issues are being left to the discretion of compliance officers.
"Of course, compliance people often take a cautious approach and simply say that a particular project is too difficult and shouldn't be attempted. The downside of this is that when patients and physicians go online to look for information, they won't find the pharma company's point of view."
Weblogging and social networking may not have been addressed, but Dixey insists commercial people in the industry are talking seriously about how pharma can use them.
Another new Code stipulation is that where the general public reader is directed to look at another site, the company has to approve the destination content.
In the circumstances, says Dixey, the best thing might be not to link to external sites or to have a contract including a clause placing the external content under the company's control – but that may not sit well with many organisations.
In the end, however, Dixey says the approach to the internet needs to change. "I'd argue that the Code needs to include new rules that reflect what's going on, and to update them more often, perhaps annually.
"There's a good case for asking companies specifically to submit suggestions for areas for the code-makers to look at."
Gavin Atkin is a freelance writer specialising in medical and pharmaceutical topics. He can be contacted at email@example.com
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