Implementation of the ABPI Code of Practice 12 months on:

What have been the implications for Pharmaceutical marketing?

Over 130 delegates packed the Church house Conference Centre in Westminster on 8th March for a PM Society half day workshop entitled Implementation of the ABPI Code of Practice 12 months on - What have been the implications for Pharmaceutical marketing?

Chaired by PM Society Chairman Sandy Thomson, the workshop set out to review the practical implementation of the code and the nature of the complaints that have been considered in breach (or not) over the past year - as well as looking at the perceived impact on marketing practices in the industry from both industry and PMCPA/ABPI perspectives.

A distinguished panel of speakers brought viewpoints from every direction, enabling those present to hear first-hand the views and experiences of key people who have been instrumental in implementing the new Code.

Back row (l-r): Jane Marshall, Heather Simmonds, Sandy Thomson
Front row (l-r): Anne Fairey, Beryle Keeley, Niamh McMahan, Steve Gray

An Overview of the Code
After an introduction from Sandy Thomson, the first speaker was Heather Simmonds, Director of the Prescription Medicines Code of Practice Authority (PMCPA), which was established by the ABPI in 1993 to administer the ABPI Code of Practice for the Pharmaceutical Industry.

Giving an overview of the 2006 Code - Heather said it could no longer be called the 'new' Code, being more than 12 months old - she reminded delegates that it was only the latest incarnation of the Code from the ABPI. The Code will celebrate its 50th birthday next year (although she joked that the celebration might not be much of a party because of the rules on hospitality!).

The Code applies to all members of the ABPI, as well as non-members who have agreed to comply with it and accept the jurisdiction of the PMCPA. It reflects and extends beyond UK law, and also reflects a European and an international perspective through the EFPIA and IFPMA Codes.

Heather outlined the principal changes introduced by the 2006 Code. These included increased engagement with health professionals, patient groups, agencies etc something she maintained was vital for the reputation of the industry as a whole. She suggested that some agency delegates might have been asked to attend the workshop by their clients, as part of an industry-wide push to engage with every organisation which takes part in industry marketing, and which might affect the wider reputation of the industry. She cited the creation of a new Communications Manager post by the PMCPA as evidence of this intent.

In addition, a new EFPIA Code had influenced the 2006 ABPI Code. On top of this, MHRA prevetting of marketing activity for new chemical entities (NCEs) created a backdrop for change. The IFPMA Cod had been updated in 2007.

One of the major impacts has been increased transparency, coupled with enhanced training for companies, individuals and third party agencies. There had been an increase in complaints (reflecting a greater awareness of the Code), and more voluntary admissions, which Heather suggested showed more commitment to, and engagement with, the Code than before.

There has also been more complaints from employees and ex-employees, which although potentially a cause for concern, again did at least show they were aware of the Code.

A wider range of sanctions have impacted on how the Code is viewed, and the appointment of additional independent members - including a nurse practitioner and a lay member to the Appeal Board.

Heather suggested that there have been three areas which have caused most debate: hospitality, venues and meetings; medical and educational goods and services; and working with patient groups and providing information to the public. She said that there were some common themes linking these, especially the need for complete transparency in all industry dealings.

Getting into specifics, Heather talked about the changes to Clauses 18, 19 and 20, which have perhaps caused most comment both within the industry and more widely.

The issue of promotional aids has raised many queries, particularly the concept of a 'perceived' value of no more than £6 (+VAT). Heather explained that this related to what a recipient might reasonably expect to pay for the item in a shop, and was worded in this way to get around the problem of the actual cost to the pharmaceutical company often being much lower - due to bulk buying - than its retail value.

The issue of prescribing information not being needed on a promotional aid which had no more than the brand or non-proprietary name and company name on it had been controversial, but Heather pointed out that this particular restriction had come from European legislation and hence UK law and not the ABPI.

Also contained in Clause 18 is new guidance about what is acceptable in the provision of medical and educational services, which must enhance patient care or benefit the NHS whilst maintaining patient care. Heather said that this had been helpful over the past 12 months, clarifying what is and isn't acceptable, and helping marketers and representatives remain within the Code.

One long-running hot potato has been the issue of entertaining of HCPs during meetings, often abroad. The new Code's restrictions on such hospitality was perhaps the change which was most widely reported when the new Code was published, and Heather revealed representations from unlikely sources about it, including letters from providers of 'lavish or deluxe venues', which are now unacceptable for hosting meetings.

Despite this - and some complaints from disgruntled HCPs - she said that many pharma companies had taken the opportunity to review meetings arrangements on a wider scale than that dictated by the Code, with some changing their own policies beyond what is required.

On communicating with patients, the new Code now only covers information to the public about prescription only medicines. But within this group, the onus is on the industry to ensure that information is of good quality - including what is published on (for example) patient group websites where the pharma company has a link.

The new rules set out the differences between proactive information and reference information. In addition, meetings attended by public and journalists have to comply with Clause 19, limiting lavish entertainment. Heather suggested that this had not caused too many problems.

When it comes to working with patient organisations, the Code sets out a clear framework, with companies now obliged to make public a list of all such organisations to which they provide financial support. In fact, some companies have exceeded this requirement, publishing more information than required.

There has, however, been some concerns from patient groups about the requirement to have written agreements setting out agreed activities, the level of funding and the approval process for certain activities. Proforma templates are available on the ABPI website.

The procedure for dealing with complaints is in the spirit of the new Code, now more transparent than ever, with brief details about ongoing cases on the PMCPA website. Although the Panel can require the suspension of certain materials and/or activities, in fact this sanction has not so far been used.

However, other sanctions, including advertising of certain breaches, public reprimands, and the requirement of corrective statements, all point to a more public stance, with more frequent publication of case reports, and ongoing cases made public. This increased level of public scrutiny is vital if the Code is to work and be seen to be working, said Heather.

Her conclusion was that overall, the net effect of the 2006 Code has been to demonstrate that the industry commitment to robust self-regulation is working.


Communicating the Code
If the Code is to achieve its aim of building public confidence in the industry, its communication is key, and that is why the new post of PMCPA Communications Manager was created in 2006. Its holder, Niamh MacMahon, joined the PMCPA in July 2006 from the General Social Care Council, where she was Head of Public Affairs.

Explaining to the workshop why the communications role was created, Niamh said that the aim was to build confidence amongst health professionals and the public in the industry's commitment to effective and robust self-regulation, building on the momentum created by the publication of the 2006 Code. If this was achieved, she said, it would raise the opinion of the industry as a whole externally.

There has been an avalanche of communications activity since the role was created, aimed at diverse audiences. With the intention of widening the HCP audience to include nurse prescribers and pharmacists in 2007, initiatives such as Code Awareness Day (15th May) will be high-profile, and Niamh called on the industry to throw its weight behind the campaign.

The PMCPA is already working hard at building relationships with key stakeholder organisations, as well as building links with the Royal Colleges - "get them young", commented Niamh. Of course, the media plays a crucial role, and a proactive PR campaign is securing coverage in relevant media, as well as securing speaker slots at relevant conferences.

Guidance notes for health professionals on the Code and its operation have been updated and widely circulated. Guidance for patients and the public will follow soon.

In the political sphere, the PMCPA has held a follow-up meeting with the Health Select Committee, which was supportive of the action taken and impressed with the industry's commitment to robust self regulation.

Niamh was keen to impress that improving the reputation of the industry had to be a joint effort, and that the PMCPA/ABPI couldn't do it alone. She urged delegates to read the case reports and keep up-to-date on the latest advice.

More importantly, she said that the industry had to comply not just with the letter of the Code, but with its spirit. It shouldn't be a question of finding ways around the Code's provisions, but rather of looking for constructive ways to work within it. She suggested that a good test was to put yourself in your competitor's shoes: how would you react if your competitor was doing what you are doing?

Above all, she said, it was everyone's responsibility to defend the industry. "People will only see the value of the industry if we tell them about it, and are proud of it ourselves" she said.

The net result of this openness and proactive communication has been a big increase in awareness and understanding of the Code. 73% of doctors are now aware of it compared with 52% last year - and that figure jumps to 89% in primary care.

This has brought more complaints to the Authority (134 in 2006 compared with 101 in 2005). Niamh said that the ideal situation might be to see a greater number of complaints filed, indicating increased vigilance, but with a smaller proportion upheld, indicating increased compliance.

She concluded by saying, "The industry is well-regulated, and we should have confidence in the Code."


The View of the MHRA
A particular viewpoint about the Code is provided by the MHRA, the body responsible, amongst other things, for prevetting of pharmaceutical advertising when necessary. Beryl Keeley, the agency's Advertising Standards Unit Manager, provided an overview of how the Code had affected the industry from the MHRA's perspective.

She introduced three key messages: that regulation must be seen to be effective; that the statutory backdrop protects the concept of self-regulation; and that working in harmony is in the best interests of all stakeholders in the industry.

The concerns of these stakeholders had been largely met by the new provisions in the Code, according to Beryl. New sanctions available to regulators had been welcomed, and the greater transparency inherent in many of the changes had improved confidence that regulation is seen to be effective.

Beryl suggested that awareness of the Code prior to the changes had been very low amongst professionals, especially in advertising and marketing agencies, and that an increase in complaints pointed to a generally raised level of awareness. The two-thirds ratio of complaints upheld is historically consistent, even given the increased number of complaints.

The 2006 Code came in the context of a shift in emphasis by the MHRA, towards prevetting of advertising, especially for high-risk products, particularly new chemical entities (NCEs). The aim is to ensure as far as possible that the industry gets it right first time, rather than waiting for complaints after the event to provide a judgement.

All new active substances authorised after 1st November 2005 have fallen under the new prevetting regime. The result has been a big increase in the number of products where material has been vetted, by a factor of around two and a half.

However, NCEs do not form the biggest sector of those products being vetted. They account for approximately 41% of the 2005/6 figure, whilst around 46% is accounted for by products where there are major safety concerns, or where there is a major new indication. A small proportion are products where there has been a previous breach, and where the agency has decided that this means that prevetting should take place to prevent further breaches.

Beryl explained how the vetting process works, saying that the target is to respond to submission within five working days. Because of this ambitious target, she urged the industry to keep the agency informed of when submissions were planned, so that vetting 'slots' could be kept clear. Telling delegates that there was a dedicated MHRA advertising assessor working with the agency, she emphasised their wish to help rather than get in the way of marketers.

She stressed that the vetting process was not intended to delay any launch - nor should it be viewed as an opportunity to test where the boundaries lie. She said that the process is not rocket science, and offered some tips to help marketers get through the process simply and smoothly.

The first was to state the indication clearly - it's perhaps surprising how many advertisements going for prevetting don't do this.. Secondly, it's important that any claim is backed up by proper evidence, not simply on in vitro or animal data. Next, key safety messages should not be exaggerated, neither should tolerability claims - these have to be seen to be credible.

Finally, Beryl advised thinking about the appropriateness of any imagery. Do the age of models use reflect the target patient group? Is what they are doing in any picture reasonable for the particular patient group? The key here, said Beryl, is relevance.

The five-day target is largely being met: across 2006 the average was 85%, but this included an admitted crisis at the start of the year, when staffing problems meant that the figure dropped to below 50%. By the end of the year it was consistently above 90%, and the agency even achieved 100% in December.

The MHRA is concerned that its industry customers are satisfied with performance, and to this end a satisfaction survey was carried out among 30 companies involved in vetting in 2006, from which they received 21 replies. The results were significantly better than 12 months ago, with high scores being given on such performance indicators as helpfulness of the assessor, constructiveness of comments, and quality of response letters.

Looking forward, Beryl said that the key was maintaining high standards, and continuing to ensure that regulation is seen to be effective. With an increased reliance on vetting, she said that complaints should drop.

One plea for the future was that the industry relied less on safety in its advertising. To do this, you need to be totally sure that the data backs up any claim, and she suggested that a more holistic approach would be less likely to mislead doctors.

In Europe, the attention is falling on Information provision, and the Commission is consulting with stakeholders in order to present a report on current practice with regard to this, especially on the internet, together with its risks and benefits for patients. If appropriate, what will follow will be an information strategy to ensure good quality, objective, reliable and non-promotional information is made available.

Overall, Beryl said that the industry and its regulators needed to collaborate to help improve both the way things were done, but also the way the industry was viewed externally. "We're strongest when we work together to promote high standards," she said.


An Industry Overview
Presenting the industry view was Steven Gray of Steven Gray Consulting, a company he recently established - after spending 17 years in the industry, latterly as Compliance Officer for AstraZeneca's UK Marketing Company.

Steven comes at the Code with the attitude that he wants to make compliance a "positive experience". He says that few people outside the PMCPA and the MHRA thought it could be, despite comments like those made by Kent Woods, MHRA Chief Executive: "Regulation of medicines advertising is a partnership with long-established systems of self-regulation underpinned by the statutory role of the MHRA. Working together helps to ensure high standards and a 'level playing field', and protects public health."

But that message wasn't perhaps getting across, as the profile of the MHRA was not high amongst pharma marketers, according to Steven. Pre-vetting has changed all that (even if initially the industry didn't want it), however the challenges of launch deadlines means that the relationship between companies and the MHRA is never going to be easy.

The initial experience of pre-vetting did little to change this preconception, said Steven. During the period when the MHRA was gearing up, it was 'painful', with a credibility gap caused by a feeling that the agency was being pedantic, had a poor knowledge of marketing terminology - and was slow.

But once through those initial teething problems, Steven said there has been a 'significant improvement': "The MHRA deserve credit for having climbed up the learning curve remarkably fast," he commented.

Success, he believes, is dependent on marketers getting closer to regulatory people within their own organisations.

There are some simple underlying principles behind the Code, which Steven suggested there was little to argue with, let alone breach: promoting within the licence, protecting patient safety, honest marketing and protecting the reputation of the industry. But perhaps achieving the detail of these worthy aims in the real world is more difficult.

Steven said that some of the 2006 changes were not unexpected, and relatively easy to implement, including rules on the number of promotional mailings and advertisements, promotional items with a low perceived value which didn't carry the generic drug name, and restrictions on air travel, lavish hospitality and deluxe meeting venues.

Others ended up being less clear, and/or more tricky to comply with. Steven outlined these: for example, if no competitions or prizes are allowed, what about scientific awards? What can reps say when introducing a 'medical service'? And given the national jurisdiction of the Code, how does this fit in in a multi-national world?

Overall, though, the biggest problems have occurred in areas where people didn't realise what the impact of the Code would be, according to Steven. The all-embracing Clause 18 has caused particular problems, especially in definition - is sponsorship a 'medical education service', for example - but despite this Steven said that the industry generally supports Clause 18, saying it was something "we can be truly proud of".

His reaction to the new Clause 20 was even more positive: "Some of the changes were absolutely fantastic," he gushed. "It gave us a phenomenal chance to really communicate with our end users."

On the down side, the new Code has meant that interactions with Patient Groups have become more confusing, with terminology such as 'Agreement' and 'Sponsorship' becoming ambiguous. As a result some agreements between pharmacos and PAGs have become formal legal documents - something which Steven suggested did not need to be the case. There is still lots of work to do on better communications with PAGs, he said.

Relationships with journalists have become more complicated, with the need to treat them in the same regards as HCPs, according to Steven (a point which was raised later in the syndicate discussions). Is there a need to certify journalists' articles? This seemed unclear (some guidance was later given - see below).

There is little doubt that some of the changes have been controversial, with some employees finding it difficult to do their job, and scared of being fired if they get things wrong. At the same time, said Steven, customers were concerned for different reasons, often playing one company off against another in an attempt to secure advantage.

Despite this, Steve was positive about the impact of the Code. "When you sit down with people and explain why, the reaction has been very positive, " he said. "Some doctors are now willing to engage with the industry, whereas before they might have been embarrassed to be associated with us."

It's clear the environment has shifted, and that compliance is here to stay. The UK is one of the few countries in Europe still allowed to operate without a statutory code. So when the next revision comes - probably in 2008 - the industry must engage with it, said Steven. "When 2008 happens, we need to remember it's our Code, therefore compliance should be a positive experience."


What constitutes a breach
At this stage, Heather Simmonds took to the podium once more, to explain what constitutes a breach. Joking that she felt a certain nervousness in the audience at this, she started by listing some of the rules which could trip up marketers, in particular those contained in Clause 3 (Marketing Authorisation) and Clause 7 (Information, Claims and Comparisons).

Clause 3 prohibits promotion prior to the grant of the marketing authorisation, and any such promotion must be in accordance with it, and must not be inconsistent with the summary of product characteristics (SPC).

Heather described Clause 7 as the heart of the Code, saying: "If you can crack Clause 7, you'll probably be OK".

Specifically, the Clause says that information on medicines has to be made available, and that such information, claims and comparisons must be accurate, balanced, fair, objective and unambiguous, based on an up-to-date evaluation of all the evidence. All of this has to be capable of substantiation, and this must be provided on request. Information must not use exaggerated or all-embracing claims, superlatives are discouraged, and it must encourage rational use.

It goes further: references must be given when referring to published studies, and these references must be on file, and provided on request. Artwork has to comply with the Code, and references must be given when taken from published studies. Uses of words such as 'safe' and 'new' are carefully regulated.

So 'dos' for promotion include recognising the special nature of medicines and the professional standing of the audience; being of a high standard and not likely to cause offence; and being tailored to the audience it is directed at.

Amongst the 'dont's' are bringing discredit on or reducing confidence in the industry; disparaging competitors or health professionals; and disguised promotion.

Heather gave some actual examples of cases where there had been breaches. These included:

• Cost comparisons, where it was not clear where branded and generic products were being compared
• Procedural errors, resulting in sanctions such as reprimands, corrective statements and even suspension
• Financial inducements to journalists from a PR agency to attend meetings
• An advertisement which was itself correct, but included the address of a patient group website which contained material that in effect promoted an unlicensed medicine

Examples where no breach of the Code was ruled were also given. These included:

• A meeting with patient groups and others which included attendance at an European meeting, visits to hospital as well as discussions with health professionals
• Company disclosure of support to patient groups

Discussion Groups
Delegate them broke into three discussion groups, to examine three scenarios to see how they would ensure they remained within the confines of the Code. Whilst it is impossible to capture every aspect of each discussion, we offer a summary of the main points which were raised during the subsequent feedback session.


Group one: Pre-launch parameters
This group looked at pre-launch materials, symposia activities, medical liaison teams and links to other organisations' websites.

Points raised included:

• If a donation to a PAG is used for leaflets for example, what about checking those leaflets for factual accuracy - does the pharmaco have to certify it? (Answer - it depends on each individual case)
• The question of colour in branding: to what extent can you carry pre-launch liveries into post-licence material? (Answer - as clinical trial material is very targeted, this shouldn't be a problem, as the patient won't see the original material) or even use of licences for HCP advertising in material for patients (Answer as long as not promotion of a prescription only medicine to the public the use of similar colour/design is not necessarily a breach of the Code or UK law)
• One for the Medical Liaison Team: what if a customer asks about a product in the context of disease awareness? (Answer - this again depends on the case, and referring such questions to Medical information is the safest route - disease awareness might be seen as encouraging questions)
• Press releases destined for a lay audience: there's little you can say if they must be non-promotional. Do they need certification under Clause 14? (Answer - Heather Simmonds said that the ABPI Code exempted business press releases from formal certification but advised such material is examined for compliance before release. Beryl Keeley stated that the MHRA need to approve everything whilst products are undergoing pre-vetting)

Group two: Electronic media
This group looked at websites, e-marketing, what can and cannot be done (e.g. e-mailing doctors), and links to other organisations' websites.

Points raised included:

• The issue of controlling targeting and prior consent where a third party website provider offers the opportunity to send an e-detail to subscribers.
• The issue of formatting - although information might leave the sender in one format, it may not appear on the recipient's screen in the same format. This was regarded as OK, as long as the original information sent was in a reasonable format.
• Where a general information support website for patients includes general disease area information as well as product-specific information, there are several issues:
  • Whether the website is aimed at all sufferers or just those using the prescribed medicine - if it is open access website you have to assume it's everybody
  • Where to draw the line between what is information and what is promotion - the website must be information only
  • Whether you can use the site to collect data - in general no, as data collection has to be more robust than that
• Whether you could include a patient chatroom - no, as you can't manage the content
• The website must consider access by disabled people
• The use of colour must be sensible and balanced

Group three: Medical Education and PR
This group looked at meetings, hospitality, media relations, editorial control and liaison with patient groups.

Points raised included:

• Events for UK health professionals should only be held abroad where there and valid and cogent reasons for doing so, for example where the meeting is an add-on to an existing conference, or where it includes seeing a specific R&D or production site
• The question of what material is legitimate to have on an exhibition stand at a meeting was raised, particularly where that meeting has a mixed audience. The answer is that it should be at the 'lowest common denominator' - so if there are patients at the event, then HCP material should not be on display, although it would be permissible to have such material on request. All materials must comply with Clause 20 of the Code.
• The thorny issue of sponsoring journalists to attend meetings was raised and discussed widely. Where journalists are being paid to attend, then clearly their material needs to be vetted - but where do you draw the line? What about journalists whose flights are paid (for instance), but their time is not? This point caused some debate, with disagreement about whether in this instance the copy should be seen before publication - and whether journalists would be prepared to do that. Heather Simmonds said that transparency was a key consideration. It was not necessarily a problem to support journalists to attend meetings but this should be made clear. Comparisons were made with the sponsorship of health professionals. This was an issue which needed to be discussed further.

Conclusion
Summing up, Sandy Thomson thanked all of the speakers, as well as discussion group facilitators Steve Clark, Anne Fairey and Jane Marshall, for driving so much helpful discussion into the four hours of the workshop. Discussion continued well after the end of the event over a glass of wine, proving that this is an issue which has huge relevance for the industry, and which has finally gained the awareness that it needs.

Held on: 08/03/2007