The ABPI Code of Practice: Negotiating the Present, Shaping the Future
Following the update to the ABPI Code of Practice in 2008, the 6th joint PM Society and PMCPA meeting was held in London with a view to providing greater understanding of Code changes and provide a forum for discussion on how as marketing practitioners we can work effectively within the Code in a fast changing environment.
Ivor Eisenstadt welcomed everyone to the meeting and extended a special thanks to Heather Simmonds from the PMPCA who had helped pull the meeting together and was taking a key role within the day's agenda. He then handed over the proceedings to Steven Gray, a recognised specialist in healthcare sales and marketing compliance, who chaired the meeting.
Under the overarching PM Society banner of 'Promoting Excellence in Pharmaceutical Marketing', Steven Gray set out the objectives and aims for the meeting very clearly:
- Opportunity to review lessons from Code cases
- Feedback on what is wanted/desired from the Code, moving forward
- Further understanding on how to work within the Code
He confirmed in everyone's minds not only the challenges posed by the ABPI Code but also its importance and significantly the global recognition it currently affords as the standard many other countries aspire to.
Recent Cases
Heather Simmonds, Director of the PMPCA and Chair of the Code of Practice Panel, began the day's meeting. She set the scene by explaining that there is a real drive worldwide for changes to the codes. In light of current UK issues affecting the governmental and financial markets Heather stressed the importance of self regulation, demonstrating effectiveness.
The Code has been operating successfully in the UK for 50 years. Whilst Heather admitted many marketers, at some point, may find the Code frustrating its aim is to set out clearly what can and cannot be achieved in the UK including UK law administered by the MHRA regulation. With thorough understanding and creativity a lot can and has been achieved within the Code. However as the review of current Code cases demonstrated, companies occasionally fall foul of the Code. The joint PM Society PMCPA meeting provides valuable forums for reviewing cases and intercompany learning.
Clause 7: was held up as the key clause of the Code and the main area of complaints. Clause 7 sets out the parameters for information, claims comparisons and substantiation Heather recommended that all marketers operating in the UK should make themselves very familiar with this clause.
Clause 9: High Standards, Format, Suitability and Causing Offence, Sponsorship. Heather highlighted this clause as particularly key to current issues. With different forms of sponsorship now available and sought, more than ever before there is a need for openness and complete transparency
Clause 18: Gifts, Inducements, Promotional Aids and the Provision of Medical and Education Goods and Services. Heather advised it is important that everyone within the industry is familiar with the content as it has been subject to revisions and additions.
Whilst there continue to be Code cases, in fact the numbers of complaints dropped in 2008 compared to 2007 companies continue to make voluntary admissions about possible breaches. This not only signifies greater understanding of the Code but also increasing transparency and accountability
The meeting was then divided into four key areas, which took the form of interactive workshops:
- Digital Communication
- Professional Medical Education
- Working with Patients and Patient Organisations
- New ABPI Guidance on Joint Working with the NHS etc.
Delegates had the opportunity to take part in two of the four workshops and then at the end of the day, representatives from all four groups were able to share top line outputs and key learnings from those sessions.
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Significantly in 2008 the Code clarified that promotional websites do not need to be password protected for healthcare professionals, as long as they are clearly labelled and there is separate section for the public. But there is still a huge sense of the 'unknown' about this area of the market. What can be done – what shouldn't be done? What is allowed – what isn't allowed?
We are all familiar with web design but we do need to be really careful about data protection and ensure that all activity sits within the Code and UK law. Likewise being familiar with the Disability Discrimination Act is important as this also applies to web design. It is also important to be aware that while dot.com websites are typically created by global teams, for the UK market the content needs to be UK Code compliant.
Felix and Kai stressed that the fundamental issue is that the pharmaceutical companies are responsible for everything they do directly and indirectly via sponsorship. If a chat room is sponsored the pharmaceutical company would be responsible for the content. As the purpose of a chat room is spontaneous discussion, it cannot be monitored, edited and policed before publication. As such it seems that this is an arm of digital communications that could not be easily employed by the pharmaceutical industry.
Fundamentally the sharing of information, 'user generated content' the very foundation of the World Wide Web is problematic for the pharmaceutical industry. Currently information changes on-line on a daily basis so a pharmaceutical company would need to continually check the information and links daily. Responsibility for this type of open information is not easy and as an industry we need to be seen to be providing validated, supported sources of information.
It was suggested that this is one area where perhaps the Code needs to change to allow the industry to use new channels of communication.
Whilst digital communications and these new forms of technology are exciting each company needs to take a step back and consider what the business really needs. Is involvement with Facebook really going to deliver any real value to patients, health professionals or the bottom line?
Digital is just one part of the communications mix and not a standalone activity. As always a balance of push and pull activity is required.
As an introduction they looked at all the areas of marketing and communications activity that as an industry we are involved in. What became clear is that whilst professional medical education has its own title and is referred to as a separate entity 'medical education' in a broader sense could be seen as a core element in a wide range of activity from press advertisements and feature articles through to formal CPD-approved educational programmes.
It was postulated that this broad diversity of activities might be the reason that the Code doesn't refer specifically to medical education. It can be challenging therefore to marketers as they need to understand the Code as a whole, and apply it appropriately to a particular activity.
Labelling something as 'educational' does not necessarily mean that it is non-promotional – similarly material which his promotional may also be educational. It is essential to address at the outset whether an activity is promotional or non-promotional, as this determines how it should be handled to ensure that it complies with the Code. But when does educational material become promotional and when is it truly independent and can be treated through the 'arms length arrangement'?
The delegates in this workshop were divided into four groups that then had to develop an educational scenario which would be either promotional or non-promotional. What became immediately clear is the different opinions people hold across the industry about what is educational or promotional.
The key learning is that a company will be considered wholly responsible for all content unless there is a clear arm's length arrangement – the Code doesn't recognise 'almost independent'. But 'hands off does not equate to hands free'. If a project is supported by a pharmaceutical company even though it may manage it at arm's length – it is still responsible. The company still needs to ensure the activity, and where appropriate, the content is Code compliant and that there is total transparency about the company's involvement. For CPD-approved activities the company needs to ensure compliance with the Code of the activity, but the independence of the content is additional subject to the requirements of CPD regulations.
Importantly, regardless of how a piece of material is produced - completely independently or not – as soon as the company uses this material, for its purposes eg at a promotional stand, or given out by representatives, it becomes 'promotional'. It must therefore comply fully with the Code and must have gone through the appropriate channels of approval.
Sponsorship of medical education is an important way for the pharmaceutical industry to work closely with key opinion leaders (KOLs) and demonstrate its commitment to a particular therapy area. But in order for this to work there needs to be thorough understanding of the Code and complete transparency.
Patient groups play an important role in providing information to patients and relevant members of the public, as well as campaigning on behalf of their members. It is important to remember that they are not bound by the ABPI Code, although they are bound by relevant legislation and some may be policed by the Charities Commission. However, pharmaceutical companies are bound by the Code when working with them, so in this situation the relationship, if not the patient group, is under the aegis of the Code.
For the industry, patient groups give a good insight into the views and needs of patients, and present good opportunities for disease awareness activities. Their passion to make their particular disease area a priority can be useful in bringing campaigns to life, and they have valuable local networks. In short, for the industry they are an independent, balanced and impartial source of information about patient needs.
So what can pharmaceutical companies bring to such relationships, beyond funding? They can help through other means, such as training and other resources. The view was expressed in the workshop that the industry should not be embarrassed that it funds patient groups: "Why should we not give back to a disease area that we make money from?" asked one participant.
The Code has specific requirements on pharmaceutical companies working with patient groups, and there is a clear need to manage the expectations of those groups, especially while the relationship is being built (it's not just about a one-off injection of funds). "You need to take your time and go gently to build the relationship," said Andrew Thomas.
Despite the valuable contribution the industry makes to patients groups, there is also a need to be vigilant that this is not perceived wrongly. The media can take a jaded view, with headlines such as 'Drug firms bankroll [charities'] attack on NHS' always a danger.
Lee gave us insight into the approaches and challenges faced by patient groups. All presenters agreed that above all, the independence of the patient group and the integrity of the relationship need to be protected, and there are a number of steps that both parties can take to do this. The first is to avoid sole sponsorship, and encourage a broader range of funding. [Post meeting note: The Code provides that a company cannot require that it be the sole sponsor of activities] Then, transparency at all stages of any industry-funded or partnership activity is a must. Robust agreements must be in place, with no disguised promotion – this needs to be an equal partnership of mutual respect. Above all, the activity needs to be in the best interests of patients, an important guiding principle.
The Code is quite clear about how such partnerships should be constructed, and its requirements are what many would regard to be good business practice.
However, there are also additional good practices which go beyond the Code, which were discussed in the workshop. Aiming for long-term relationships, holding regular meetings, and working with other partners – be they other pharmaceutical companies or non-pharmaceutical funders – are all advisable. The industry should support prevention campaigns, because these are in the patients' interests. But there can be no hidden agenda of promotion of prescription only medicines and no 'brand-creep'.
The overall message seems to be that in addition to the set-in-stone requirements of the Code, a useful yardstick is what Greg Page termed the 'Red Face Test': would you be embarrassed to have to explain what you are doing in the national press. If the answer is yes, then even if you are within the confines of the Code, you should be questioning whether what you are doing is appropriate. Of course, if your proposal is genuinely in the best interests of patients, you are very likely to pass this Red Face Test.
Joint working is defined by the Department of Health's guidance 'Best practice guidance on joint working between the NHS and the pharmaceutical industry' as 'Situations where, for the benefit of patients, one or more pharmaceutical companies and the NHS pool skills, experience and/or resources for the joint development and implementation of patient centred projects and share a commitment to successful delivery'.
In addition Heather advised that the ABPI guidance notes state that each party must make a significant contribution and the outcomes must be measured. Treatments must be in line with nationally accepted clinical guidance where such exists. Joint working between the pharmaceutical industry and the NHS must be conducted in an open and transparent manner.
One of the concerns about joint working often raised by companies is the impact of the Code particularly Clause 18. The PMCPA has also issued guidance which can be found on the PMCPA website. The guidance refers to each sub clause of Clause 18 as well as to the various ways of supplying medicines.
Heather stressed the importance of ensuring that the proposed activity meets the definition of joint working. Section 3 of the ABPI guidance includes a list of activities/practices that are not within the definition of joint working. The Code will be updated to reflect the ABPI and PMCPA guidance.
Post Workshops
Following the workshops there was an opportunity for delegates and presenters to share key outputs from each session and discuss the challenges and issues currently being faced. Following this there were five minute sessions from:
- Danny O'Connor, McCallan Group
- David Hunt, Creative Lynx
- Marc Southern, Fleishman Hillard
- Carwyn Jones, Doctors.net
Each presenter chose an area of their own interest and had five minutes to set out the current market situation and say what changes or reforms they would like from the Code. The presenters chose promotional items, advertising, social media and digital marketing.
The purpose of the sessions was to look at key marketing areas:
Questions raised:
- Will the UK follow the US example and ban promotional aids?
- Are we to accept the Royal College of Physicians (RCP) report, Innovating for Health : Patients, physicians, the pharmaceutical industry and the NHS which states all promotional aids are influential and if yes is this admitting that the Code has failed?
- Are educational grants to be phased out and if yes what will be the financial burden on the NHS?
- The industry already funds a lot of CPD events – if no longer allowed who will pick up this tab moving forward? This needs to be thought through really carefully.
- How can we encourage sharing of information within the Code?
- How can the pharmaceutical industry interact with internet browsers – is this the way we should go?
- How can online discussions be monitored?
- If the Code doesn't address on-line issues will companies be risk adverse and fail to embrace new digital technology?
- 92% of GPs use Google for clinical searches. How can the industry get more involved on line?
- How can we overcome fear of making a mistake – how can we work in closer collaboration with the ABPI?
- How can the Code appear be clearer about what we can do rather than what we can't do?
Back row: Ivor Eisenstadt, Kai Gait (GSK), Greg Page (Roche), Andrew Thomas (Pfizer) Eugene Pozniak (Siyemi)Front row: Stephen Gray, Felix Jackson (MedCrowd), Joan Barnard
Heather responded to these questions and issues. The Code actually provides a lot of this guidance already but the 'devil is in the detail' of any proposal. Any changes to the Code will be the subject of consultation. The RCP report will be carefully considered as will other comments and suggestions. As highlighted in the RCP report the PMCPA will continue to promote the Code to health professionals so they are more aware of the robust controls on pharmaceutical companies.
Provisional Timetable:
- Consultation during 2009
- New Code to come into effect in 2010
Held on: 24/03/2009