Organising meetings has always been a time-consuming aspect of the representative’s role,but since the 2006 changes to the Code it has also become one of the most frustrating, particularly with regard to the choice of venue. Are you having trouble keeping up with what’s allowed and what you can get away with? Steven Gray provides some clarity on these issues.

The 2006 version of the ABPI Code of Practice brought tightened restrictions on meetings and hospitality, and since its launch there have been numerous questions about what is and is not acceptable. It is fair to say that many representatives have felt increasingly challenged to understand the point at which “acceptable” stops and “notacceptable” starts.

For decades, pharmaceutical company meetings were synonymous with ‘wining and dining’, supplemented with a limited amount of education. Some customers came to expect a certain level of hospitality. (Okay, so that’s a bit strong, but you know what I mean.) Yet now, companies are going out of their way to avoid being associated with the merest suggestion of excessive hospitality.

There has to be a sensible limit to the restraint, however. One major company experimented for a year with a mandate that four-star venues were too extravagant. Credit to them for the attempt, but, like everyone else, they have now reached the conclusion that four-star seems to be the natural level for the industry. For the vast majority of meetings, there really should not be any problems at all. Yet it is astonishing how often the same questions arise. So let’s take things one issue at a time.

First things first

The first thing that most representatives focus on is selecting the venue, and that is why the majority of problems occur. The venue is not the first thing that should be considered. When it is, the representatives and signatories find themselves in hours of entangled arguments about the suitability of the venue and how much leeway exists and what the risks are – usually because someone has already assumed it is okay and put down a deposit…

The venue is the wrong place to start. Get things in the right order and the majority of problems seem to disappear.

The first thing to establish is the objective for the meeting.This might be to achieve improved access to a single KOL, or it might be to make local GPs aware that the hospital consultant prescribes your product.Whatever it is, be clear in your own mind about what you are trying to achieve. Once the objective is defined, the agenda should be the next thing to shape.

As part of the consideration for the agenda, you will, of course, include whether the budget supports a short two-hour evening meeting or potentially a two-day event that might necessitate overnight accommodation. The time of day and the length of the agenda will determine what facilities you need. For example, the objective might be simple straightforward promotion of your product’s merits, which can be achieved at a bulk-standard lunchtime meeting. You decide to share information about your product using some presentation material that the marketing team have given you. The time available is limited because the audience are only available during their lunch-break, so the length of education is likely to be quite short. Less than an hour’s education at lunchtime – well, that hardly justifies a threecourse meal, obviously. But it is okay to provide sandwiches or have a hot take-away delivered to the chosen venue (which is likely to be a GP practice or a hospital department’s meeting room).

The practice-based lunch meeting

Even for such a simple meeting as a bulk-standard lunchtime promotion, it is sensible to issue a formal agenda.Why? Two reasons. The first is because under the Code the reason your customers attend has to be, first and foremost, the quality of the agenda. How can you ever prove that was the case if an agenda does not exist? Secondly, it is a fundamental requirement of the Code that the audience know the extent of any pharmaceutical company’s involvement in an activity so that they can decide whether they want to attend or not. Again, if you have not provided an agenda, how can you prove that they knew which company was organising the event?

Okay, so for most lunchtime meetings it is a standing arrangement that the practice has a rep in on certain days to promote their product.Therefore the doctors know someone from the industry is coming to talk about something promotional. Oh yes, and they know that the rep will be bringing lunch. So that’s alright then. By the way, the nurses will be attending, and Dr Smith is never actually there because he makes his house calls first, but he is usually back in time to grab a sandwich before you clear up; and, of course, you need to bring enough for the receptionists too.

That’s all right isn’t it? Er, no, actually. It isn’t.

Firstly, as the representative, I want the doctors to know it is me who is coming to present to them. And I want them to know what the meeting is about. I want them to know whether the sandwiches were paid for out of the Organon/Implanon promotional budget or the BayerSchering/ Mirena one. I understand that Dr Smith has house calls and that on the day he might be running late and miss my Bonviva presentation. I am sure I can be sensible and accommodate him.

However, it is not okay for him to plan to miss the education and then expect to be fed. In fact, that would be a straight breach of the Code, because subsistence can only be provided in association with a meeting – why? Because the assumption is that, in attending, the audience miss their usual meal and therefore it is reasonable for you to provide one.

So if Dr Smith doesn’t attend the education, you are not allowed to feed him. Nor are you allowed to bring extra food for the receptionists. Does that seem harsh? Remember that representatives are not even allowed to give biscuits away to receptionists any more, as they do not count as valid ‘promotional aids’. It is ok to feed the receptionists if they attend the talk, but it is not acceptable to do so if they do not receive education.

Which takes us nicely to the next point. Is the agenda and material suitable for receptionists? Or, for that matter, nurses? Nurses are healthcare professionals in their own right, so there is not usually a problem. However, practice managers, social workers and receptionists are classed as ‘administrative staff ’ under the Code.This means they can only be invited if the content is appropriate to their role.A talk that focuses on the implications that a new diabetes product has for patient record-keeping or referral arrangements would be fine for receptionists. But one that focused on the finer points of an HbA1C comparison between two products would not be.

Basically, if receptionists attend a straight product promotion, you are effectively promoting to the public. Even if the GP is the one who invites them (or insists on them being there) you are the representative of the licenceholder and therefore you are accountable.

So far there is a considerable list of things to think about, even for a bulk-standard lunchtime meeting. And nothing that we have discussed is really all that new; the principles have always been in place, it is just that people are paying much more attention to them now. And these basic principles apply to all your meetings, whether it is something you organise, or something you sponsor.

The speaker meeting

So lets complicate things a little. What about if you don’t want to make a product presentation yourself, but you want to provide an external speaker? No problem. Obviously the big issue now, though, is the fact that you no longer have full control over the content of the talk. Actually, that’s not true – you might not think you have full control, but as far as the Code is concerned, it is your meeting and therefore you are fully accountable for everything about it – including the content of the speaker’s presentation. Now, in the real world, you and I know how difficult it is to control that content. For a start, speakers expect to be regarded as ‘expert’ in their field – that’s why you invited them to talk after all. So how dare a ‘mere representative’ (or compliance officer) have the nerve to ask to vet the content? But, under the Code, companies have an obligation to ensure that all the arrangements for meetings are examined for compliance with the Code. How on earth do you meet your compliance obligations without upsetting your speaker? And even if you could get access to the slides, do you have the expertise to assess them? Most pharma head offices would not have enough resource to cope if every representative sent in every set of slides from every speaker.

The arrangements for speaker meetings vary a little between pharma companies. Some issue pre-approved slide decks, which they expect speakers to use. Seems fair enough at face value; the company pays their honoraria so, for the purposes of that presentation, they are an employee of the company and will use the material provided for that purpose. Other companies will ask speakers to submit slides to head office several days before the meeting so that they can be formally assessed and approved.

The increasingly common approach is for companies to provide the speakers with guidance on how to remain within the Code.This usually takes the form of a ‘speaker briefing’ document, which speakers are sometimes asked to sign. A few companies have gone as far as insisting speakers sign a document that is very formal (almost legal in appearance) and several pages thick. However, most speaker briefing documents are one or two sides of A4 and simply clarify the need for balanced, non-disparaging content.

“Whether your event is held in a single evening, during the course of an entire day or over several days, the choice of venue will always have the potential to be a contentious debate between representative and signatory.However, if the planning for the meeting occurs in the correct order, the venue will select itself. It is only if you want to stretch the boundary that issues will arise here”

It is not uncommon for representatives to complain about the need to get such a briefing document signed by the speaker, owing to the difficulties it causes them. In some ways, this is a surprising complaint.

Representatives have to enquire about the speaker’s availability and there is always a need to brief speakers on the subject matter and arrangements, therefore some kind of communication between the representative and the speaker must occur. However, it appears to be increasingly common for representatives to make these arrangements by email. This is despite the fact that a fundamental principle of relationship development is the necessity of meeting customers face-to-face.

From a compliance perspective, representatives need not worry about using one of their precious three pro-active calls, either. A visit to agree arrangements for a meeting does not count as one of your three proactive promotional calls, unless you start to try and convince the speaker of the merits of your product – and if you have to do that, then you have probably chosen the wrong speaker! Of course, while you are with them, there is every possibility that the customer will ask for clarification about a product-related matter…

Another important compliance consideration is the need to ensure that the content of the talk is on-licence. There will definitely be times when you are tempted to arrange a talk so that prescribers can hear about the latest clinical trial results that have just been released for your product, but be in no doubt whatsoever that you should not do this. There are very strictly controlled circumstances within which unlicensed information can be provided to prescribers – but a meeting organised by the local sales representative is not one of them.

Selecting a venue

Of course, most speaker meetings occur outside NHS premises, in restaurants and hotels.There are three major considerations when choosing where to hold your meeting – privacy, proximity and perception.

Since it is illegal to promote prescription medicines to the general public, you need to ensure that the educational talk cannot be heard (or seen) by anyone other than the invited delegates. This will almost always mean a private room. And since the discussion during the meal is likely to be about medical matters (hopefully product-related) – then it is difficult to defend circumstances where the group leave the private room and go to the main public area for the meal.

It seems obvious to say, but the venue should be chosen for the suitability of its facilities and its proximity to the audience.This includes the availability of a private room and its accessibility to the invited delegates. For example, it would be difficult to defend the use of a restaurant in a small country village when the majority of attendees are based in the nearby town – the suspicion would be that the venue was chosen for its reputation rather than its appropriateness for the occasion. Equally, there is the need to consider the perception of the overall arrangements to the outside observer, so it may be best to avoid venues that advertise award winning chefs and numerous Michelin stars. Now don’t get me wrong, there will be occasions where it is acceptable to use such establishments. Sometimes a ‘high profile’ venue will be the most suitable because of the facilities it offers and the suitability of the location. But where you believe that to be the case, you should document the reasons why – and then discuss them with your signatory in advance. Historical acceptability is no longer a valid guide to current suitability.

Whether your event is held in a single evening, during the course of an entire day or over several days, the choice of venue will always have the potential to be a contentious debate between representative and signatory. However, if the planning for the meeting occurs in the correct order, the venue will select itself. It is only if you want to stretch the boundary that issues will arise here.

For example, let’s assume you work in the Manchester area.You are planning an event for 50 GPs from across your territory.You need to select a venue near the centre of your territory that has a large enough room, has suitable projection facilities and is easily accessible. It also needs to be able to cater for an evening meal for all 50 delegates.The meeting needs to take place in November and the speaker is only available on Tuesday evenings.The local business- style four-star venues (e.g. Hilton, Holiday Inn) are fully booked every Tuesday evening in November.Your remaining choices include some three-star hotels, which have difficult access and limited parking, or two five-star hotels, both of which would be regarded as ‘deluxe’ owing to their reputation and leisure facilities. However, Old Trafford and the City of Manchester football stadiums are both available and both have suitable conference facilities. Could you use either of these?

As far as the Code is concerned, yes you can.You have exhausted the other options for valid reasons and chosen your location according to the needs of the meeting. Obviously you need to confirm (and document) that no football matches are taking place and you cannot offer a tour of the pitch!), but in principle, it is okay to use a football stadium as a meeting location. Of course, the invitation must be suitably worded – “Join Sven for supper at City” is unlikely to be well received by the PMCPA!

Other venues are also of a high-enough profile to warrant some careful consideration.The Code does not ban stately homes or castles, for example, and the majority of these would only rate four-stars in the various quality schemes. However, the perception arising from the use of such venues is something that it is appropriate to consider.The first question to ask is ‘do you need to use such a high profile venue?’ If the local business hotel is available, then why are you deliberately choosing somewhere which carries a greater risk of a negative perception in the eyes of the public? ‘Angry from Tonbridge Wells’ is far more likely to complain about the hospitality provided by a pharmaceutical company at a castle or country club, than they are about an event held at the Hilton!

As far as venue selection is concerned, go for what you need, not what you think you can get away with. And work with your signatories, you may be surprised at what they will allow if the circumstances are correct. Signatories are not naive; they know you want to impress your customers. And the best way to do that is with a high-quality agenda and a complementary location; rather than a high-risk venue and complimentary hospitality.

Alan Jones brings you another example of NHS partnership working forged by two competing companies working together for the ultimate benefit of patients.

Mental health can be something of a Cinderella service – a clinical specialty to which some PCTs still do not give enough priority. But this was exactly the area of a patient-focused NHS partnership project between Bolton PCT and two pharmaceutical companies – AstraZeneca (AZ) and Janssen- Cilag (JC).The project very much put patients first and involved the construction of practice-based registers for patients with severe mental illness (SMI). It provides a good example of a true partnership.The rationale for the project relates to current NICE guidance in SMI and also a national requirement of the new GMS contract under the Quality and Outcomes Framework (QOF) to have such a register of patients with SMI.This is about ensuring that these patients have a full annual physical health check aimed at improving their overall quality of life. In so doing, practices would qualify for their QOF points and the PCT would meet one of its targets.A win all around then!

With many other priorities for the PCT, the implementation of standardised practice-based registers for patients with SMI in all 58 GP practices within the Bolton health economy was proving to be a challenge.To combat this, two pro-active healthcare development managers – Pamela San Juan from AZ and Gary Davis-Miller from JC – approached the PCT in 2004 to see if they could help out.The project results have recently been issued into the public domain.

Getting going

Initially Pam and Gary found engaging with the PCT challenging, as there was a fair degree of skepticism around the area of joint (partnership) working with pharmaceutical companies. However, the PCT Director of Clinical Governance attempted to defuse this by saying,“The project would not use drugs just because these companies are sponsoring them.The two would not be linked”. And so the project began. First, a Project Manager was appointed, funded by the two companies. It is doubtful that the whole project would have got going at all without this financial support.The Project Manager set about forming a wide-ranging steering group with key stakeholders from across the local health economy, including the PCT, Bolton, Salford and Trafford Mental Health Trust, Bolton Patients Council for Mental Health and the voluntary sector. As said, the project was all about developing registers, vis-à-vis schizophrenia, bipolar affective disorder and other psychoses.

Physical health checks

The new registers are designed to improve the physical health of SMI patients. Evidence is now strong that these patients have a higher level of physical illness than the rest of the population, including coronary heart disease, diabetes and respiratory disorders. Also, due to their mental health problems, they often don’t seek help for their physical health problems and can be neglected, with the likelihood, therefore, of a reduction in both their quality of life and life expectancy. An annual health check performed by practices would be able to diagnose these other illnesses at an earlier stage. In fact, in Bolton, many GP practices were under-recording how many patients had SMI.The project has thus brought more people into the registers and allowed the poor physical health of many patients with SMI to be recognised. Other key benefits of the annual health check have included the opportunity to:

• give lifestyle advice on diet, exercise, smoking and alcohol
• review prescribed medication
• undertake physical health checks such as BP, blood glucose monitoring and, in some cases, prolactin
• change patients, where appropriate, to newer antipsychotic medications as recommended by NICE.

To ensure the effectiveness of the annual health check, 60 Practice Nurses were given additional training, not only in the health check itself, but also in SMI and its treatment. Funding was also provided for equipment on hospital wards (for physical reviews) and for education of community psychiatric nurses (CPNs) to conduct physical reviews. CPNs generally have little knowledge of how to conduct physical health checks. PCT Pharmaceutical Advisers, whose knowledge of mental health is not high, were also made more aware. Another key part of the project was to encourage closer working relationships between community mental health teams and primary care.

A ‘true’ partnership

Throughout the project both AZ and JC were provided with monthly updates from the PCT and regular meetings were held. Apart from funding support, both Pam and Gary also utilised their skills and competencies of project/key account management, networking and facilitation.Together, they:

• provided an interface enabling health care professionals to network with other PCTs who had previously implemented SMI registers and to share ideas and outcomes
• provided expertise, guidance and direction for the education of the primary care nurses and the CPNs
• helped CPNs engage better with primary care
• networked with the Sainsbury Centre for Mental Health and the National Institute for Mental Health in England. Advice from both had been issued on the mental health part of the GP GMS QOF but again it had not been well implemented
• acted as mental health information brokers, sounding boards, etc.

Progress at times was slower than hoped and, as might have been expected, a number of implementation difficulties arose along the way. However, through commitment and endeavour from the NHS and the pharma partners the challenges were overcome.

The evaluation report on the implementation of practice-based registers for SMI, learning disabilities and epilepsy was presented to the PCT Board in September 2006, with the main focus on SMI. In the report, both companies are generously thanked for their support: “The project has proved to be a successful example of partnership working with pharmaceutical companies to benefit patient care".

Full implementation of SMI registers is now forecast and a whole series of useful recommendations has emerged from the project. Good Practice Guidelines to support the implementation of SMI and learning disability practice-based registers have also been produced. But the PCT has recognised that these registers are only the start of a process of developing more systematic ways of treating patients with SMI.

Benefits

In a world of full ‘transparency’, readers might be interested to learn from the companies themselves as to the benefits of this project for them. According to Pam and Gary:“This project has helped improve the physical health care of over 500 patients with severe and enduring mental illness and is likely to help increase the life expectancy of these patients.The project has also helped remove some of the stigma that surrounds schizophrenia and bipolar depression by bringing these patients more into mainstream services. And it has increased the awareness of some of the side effects associated with the use of antipsychotic therapy that can have an impact on the physical wellbeing of patients. It has also opened the door to further partnership work for other companies within this PCT and enabled us to engage in similar projects with Trafford and Salford PCTs.



“This project has further proved to be a spring board for other joint collaborations within the PCT and within the local Mental Health Trust. This project, as with many, has been a long time in passing and without our commitment, engagement and project management skills these patients would have been less likely to have been put on the registers and reviewed. In true partnership style, the outcomes have been positive for all those involved – the PCT, AstraZeneca, Janssen-Cilag, the wider Mental Health Trust and, most importantly, the patients.The project has also helped to raise company profiles with NHS Policy makers and demonstrate added value to the whole business of the NHS and pharma working collaboratively. Consequently relationships have been more transparent and credible and this is a template for future working in a rapidly evolving NHS environment. This has also improved intercompany collaboration, moving away from the traditional singular approach to working with NHS Providers.”

Both pharma companies adhered to the ABPI Code of Practice through their own internal compliance procedures and whilst some concerns were raised early on about the partnership (particularly over companies gaining market advantage from the project), these have proven to be unfounded. Indeed those that originally raised concerns appear to have completely changed their views on joint-working with the industry.The project has also been recognised by both companies, as well as the ABPI, as an excellent case study of partnership working between industry and a PCT. It has been used as an example of best working practice and was presented by both Pam and Gary to the North West ABPI Partnership group comprising of around 23 other Pharma companies, helping other pharma companies engage with PCTs in the North West.

Conclusions

This flagship project is an excellent example of joint working and thus deserves much wider dissemination and recognition.The project has not only helped and enabled Bolton PCT to implement key mental health policies and protocols, it has also allowed SMI patients to have a better quality of life. In addition, two competing companies have been able to combine in productive collaborative working with the result that both Janssen-Cilag and AZ are now partners of choice. Well done Pam and Gary!