The ABPI Code of Practice:

Working With Patient Groups

With the implementation of the new EFPIA Code on the industry's relationships with patient groups, this workshop was highly pertinent.

Christine Cameron, facilitator for the group, has extensive experience in working in the UK, Europe and USA in this field.  She began the session by providing an overview of the key elements of the EFPIA Code of Practice on relationships between the pharmaceutical industry and patient organisations including:

• No advertising of prescription only medicines (POMs) to the public, the very real need for written agreements to be in place between companies and patient organisations and the need for companies to have approval processes in place in this area.
• EFPIA also covers the use of patient organisation logos and materials, that the involvement of a company must not in any way influence content of patient organisation materials, any factual inaccuracies must be corrected and most importantly of all the need for a transparency.
• Christine clarified that no company can require that it be the sole funder of any patient organisation or any of its major programmes which could apply to events and hospitality.  The implementation of the EFPIA Code is via national associations.

Following on from the EFPIA Code, relevant elements of the ABPI Code of Practice – Clause 20 – Relations with the General Public and the Media were discussed.

Clause 20 – The Public
No advertising of POMs to the public, the need for information to be factual and presented in a balanced way, that information must not raise unrealistic and unfounded hopes for successful treatment of patients and that it must also not be misleading.

The Codes apply to all materials that are proactive communications with these target groups and include a wide array such as:

  -   Booklets on diseases
  -   Press releases
  -   Briefings
  -   Conferences
  -   Mailings to Patient Groups
  -   Disease awareness advertising

Companies need to make sure that it is good practice to provide comprehensive and up-to-date resources that are available through a variety of methods including of course websites, including SmPC; PIL; public assessment reports (UK or European); registration studies; material supplied for HTAs to NICE, SMC, AWMSG; and medicines guides.

Certification is also a necessity for any information that is provided under Clause 20.2 in advance (as specified in Clause 14.3); however this does not apply to medical information responses to third parties.

Clause 20 – Patient Advocacy Groups
Companies are able to work with patient groups, however company involvement must be made clear and any arrangements that are made must of course comply with the Code with a declaration of sponsorship of any activities being made.

Written agreements, formalising exactly what has been agreed between the two organisations including any funding must be produced in relation to every significant activity that is undertaken and the ongoing relationship between the organisations.  The agreement must also refer to the approval processes that are in place for each party.  The agreements must clearly outline the purpose of any materials and/or activities.

When it comes to providing information to individual members of the public in response to questions relating to personal medical matters, then these requests must be refused and referred to consult with their healthcare professional (HCP).  Medical information departments should also be dealing with these requests, rather than anyone else in the organisation.

Prior to the launch of a new medicine, a company must take reasonable steps to inform the medical and pharmaceutical professions of its availability prior to announcement to the general public.  In addition, a company's responsibility also extends to information issued by their PR agency too. 

Finally, certification of materials was discussed with the following two categories of materials being confirmed as requiring certification in advance:

1. Educational materials for the public or patients issued by companies, which relate to diseases or medicines – but not intended as promotional material, including those materials relating to working with patient groups
2. Non promotional material for patient of HCPs, relating to the provision of medical and educational goods and services, including relevant internal company instructions

In conclusion, the key points the group felt were essential in order to work effectively within the Code were:

Q+A
Some of the issues and questions that were discussed by the group were put to the Panel of experts who included:

 

They asked:

Q:    What defines a patient advocacy group?
A:    Individuals need to make a judgement call on whether an organisation is an official group or purely an individual who has set up a blog.  Both the ABPI Code and EFPIA Code have definitions.  Companies can respond to questions from individuals, as long as the responses are non-promotional.

Q:    What is an 'arms-length' agreement?
A:    Written agreements are needed in order to help pharmaceutical companies and patient groups set out what arrangements have been made, what corporate sponsorship entails etc.  Written agreements provide a summary of the support that has been offered, transparency and formalising the arrangements agreed.  Arm's length is when the pharmaceutical company has little or no influence over the outcome or use of a project.  Guidance is given on the PMCPA website.

Q:    What would be classed as reasonable support?
A:    It would depend on the project and the type of support.  Hospitality for example needs to be reasonable.  Companies must be transparent.  Ask yourself 'what are you hiding?' if you haven't included all the details.

Q:    Are companies allowed to work in a therapy area that they do not have a product licensed in?
A:    It would depend on the activity.  When working with health professionals it would be unacceptable to promote a medicine/indication which is not authorized.  There is a difference between promoting a medicine and undertaking a disease awareness campaign.  Establishing a presence is not necessarily a problem, it depends on the detailed arrangements.
 
The panel also reminded delegates that companies are responsible for the actions of any spokespeople they might use in campaigns, briefings etc.  You must be very clear on what can and cannot be said to these individuals, even within your organisations when, for example, HCPs are used to brief representatives.  Campaign materials must also be used carefully and be sensitive to the impression they might give to anyone who might read them. 

 

 

Creating Disease Awareness

Increasingly now there is a broader group of decision makers who need tailored information from the industry.  This workshop looked at how to ethically raise a disease profile instead of scare-mongering or disease-mongering plus third party authorship of articles and papers.

Workshop facilitator, Joan Barnard has many years experience in the pharmaceutical industry and as author and publisher of ‘The Code in Practice’ and a member of the ABPI Code of Practice Appeal Board for 4 years, is ideally placed to provide insightful and relevant advice on all aspects of how to work within the Code when considering a Disease Awareness Campaign (DAC).

The workshop began with a summary of the relevant elements of the Code that need to be considered, which mirrored key points made during the introduction by Heather Simmonds however with a particular focus on the Guidelines specifically written for DACs.  These guidelines were produced by the MHRA in 2003, however are still very relevant and were produced to spell out the basic dos and don’ts for companies, to ensure Pharma companies are quite clear on what is permitted and what is not.  DACs can be of great benefit to the public the main purpose of which is to increase awareness of a particular condition, not to drive patients into surgeries requesting a specific product or as a way of promoting products DTC advertising of POM medicines is of course illegal.

There are seven key points that should be applied to any campaign, in that it should be:

1. Accurate
2. Up-to-date
3. Substantiable
4. Comprehensive
5. Balanced and fair
6. Readable/accessible
7. Source identified

Their main objective is to encourage patients to take the appropriate steps to seek medical advice and make any relevant lifestyle changes necessary

Issues raised during the workshop that were of particular interest to the groups included:

• The need to ensure that, where relevant, the time course of the development of the disease must be made clear, in order not to scaremonger people into demanding treatments.
• Language must be clear and items carefully worded so that misinterpretation does not occur and people do not misunderstand technical and complicated medical terminology.
• When using spokespeople (including celebrities and opinion leaders), you must be careful to train them properly and ensure that they do not contravene the Code.  For example, if they are over zealous in their support of a particular product companies should be aware of this and actively discourage product promotion, they will need to show that such a briefing was given in the case of a complaint.
• DACs must not be conducted in a way which leads the public to request a specific product.  Such campaigns are difficult when there is only one product available for a particular condition.

Workshop delegates were then split into three groups and each was given a different fictional case study and asked to consider a DAC in relation to a number of scenarios representing different stages of the product life-cycle.  These were discussed in detail and a fictional campaign was proposed for each considering: 

-    What is the objective?
-    Who is the audience?
-    What is the content?
-    What materials/media should be used?
-    Who in the company is involved?

From the Workshop, the group concluded that the key reasons for undertaking a DAC are:



And importantly, the way to work most effectively within the Code is to always remember:

Pre-launch/Off Label Work

Bringing a new medicine to market is a vital phase for any pharmaceutical company and the time leading up to that launch is key.  This workshop looked at what can be reasonably done ahead of marketing authorization for both new products and line extensions.

Steve Mackenzie-Lawrie, Vice-Chairman of the PM Society, together with Chairman Sandy Royden led the discussions, began by highlighting that the topics covered in the workshop would focus upon pre-launch activities, line extensions and new indications.

Workshop in action
The group began by looking at relevant clauses of the ABPI Code.  The objectives were to try to understand the letter and the spirit of the Codes as opposed to (and what came up frequently during the afternoon) what is internal company policy or indeed urban myth.

The workshop provided an overview of what clauses in the Code were relevant to this area of marketing and looked at some of the examples of core pre-launch activities that might need to be considered, including:



Workshop delegates were asked to consider three scenarios:

 

• Recruitment and management of advisory boards
• Branding and the dissemination of data
• Meetings and exhibition stands

They discussed what issues they would face in order to work effectively within the Code and how they felt they could improve relationships with the PMCPA and much lively debate ensured.

What became apparent during the afternoon is that in order to work effectively, a complete and clear understanding of the UK and European Codes was essential.  However, many of the delegates during this and other sessions did not have this and subsequently confused elements of the Code with their own company rules and regulations.  Companies need to ensure that their employees are trained to have a better understanding of the Code as opposed to what is their own company policy or indeed urban myths about restrictions and rulings.

It was agreed that improvements on working with the PMCPA effectively would be made by engaging in dialogue with the organisation at the planning stage of any pre-launch activities. It was also felt that the PMCPA could reciprocate open dialogue and relationship building by providing companies with clearer definitive rulings where there were grey areas and elements that were thought to be confusing and open to misinterpretation. 

Q +A
Some of the issues and questions that were discussed by the group and put to the Panel of experts included:

Q:    If you have a medicine with an unlicensed indication, can you proactively send out a balanced report on it?
A:    If you write a non-promotional report of a scientific symposium and send it only to people who attended, then this would be fine, however if the report was more widely circulated it would be classed as promotion of an unlicensed indication in breach of Clause 3.

Q:    Is there a restriction on when you can host a symposium on an unlicensed indication prior to launch?
A:     If the meeting is a legitimate exchange of medical information organised by a learned society or perhaps a satellite symposium at such a meeting and the presentation is factual scientific and low key then this might be acceptable.  A different view might be taken if the meeting is organised as a company stand alone meeting.  The closer a company is to launching a medicine or a new indication the more likely it is that such activity will to be deemed to be promotional.

Q:    If a product that has a licence in the US and a recognised logo, what is the restriction if any, on use of this logo/branding in the UK?
A:    It all simply boils down whether it is promotion of an unlicensed medicine.  Remember content, context, purpose and appearance.  It would be possible, for example, to take an acceptable meeting and by using logos turn it into something promotional and unacceptable.

 

 Working With E-media

The industry is still learning what can be done with e-media and with an opening up of legislation in this area, the opportunities are broad.  The workshop discussed new approaches to communication looking at both passive and active initiatives.

Group facilitators, Tim Benjamin and Andrea Ward took the workshop delegates through the basics of the Code that apply to e-media and stressed that although the regulations seem to reflect the ‘old’ technologies, we need to apply ‘hard copy/print’ regulations to e-media – ie make the content accurate, balanced, up to date, not misleading and take care with wording such as ‘new’, ‘safe’ etc.  Also, inclusion where necessary of PI, AE warnings, and use of proprietary names all need follow exactly the same rulings and regulations that you would do if producing printed materials.

Pharmaceutical companies are responsible for all content on their web sites and as such discussion forums and blogs are difficult to run, sponsor or support.  Moderating the content of forums and blogs was discussed as one possible solution, however it was felt that this would be a considerable burden on medical approval teams, and result in a loss of the immediacy that discussion forums and blogs are actually all about.  However, banners and company promotion may be placed on third party sites, which run blogs and or discussion groups as long as there is no influence over the content of the page.

The online posting of factual errors about pharmaceuticals by members of the public was discussed.  The example of 'Dell hell' in which Dell received a lot of adverse comment online but failed to do anything about them until it snowballed into a marketing nightmare, was highlighted.  Stephen Doyle of Bio Products Laboratory commented that patients were way ahead of the industry and were recommending off label use of drugs.  He asked whether the industry should just 'sit there and do nothing’?  However, it was agreed that the industry should not post responses in such discussion groups.  But, if necessary a legal route should be sought although it was acknowledged that this would be too late to influence the debate in most instances.

Workshop in action

When sending e-mail, it was confirmed that prior agreement is necessary for healthcare professionals (HCPs) to receive promotional email communications.  Ivor Eisenstadt of MGP asked about third party websites sending emails to their audiences on behalf of the industry.  It was agreed that it is acceptable for these websites to have a general opt in clause, as long as the HCPs are clear that they have chosen to receive promotional emails.

However, bought-in e-mail address lists, which claimed to have the addressee’s permission to be contacted, were not supported.  Tim Benjamin advised the group 'not to touch them with a barge pole' as any emails to these lists would most likely be considered as spam and 'might alienate the audience and be potentially catastrophic'.  Andrea Ward suggested that any company considering using a bought-in list should check that the recipients have opted in correctly and then uses their own judgment as to whether to proceed and use the lists.

No fee or inducement should be offered to HCPs to carry out a promotional e-Detail.  The key is whether any incentive offered, such as points or educational modules could be perceived as an inducement.  Incentives to generate new members for promotional websites were also thought to be inappropriate.  Electronic promotional gifts such as memory sticks with pre-loaded presentations were considered to be acceptable providing they complied fully with the Code.  These may be requested subsequent to an e-Detail but not used as an incentive to carry out an e-Detail. 

Niamh MacMahon of the PMCPA commented that promotional web sites should ideally be restricted to HCPs, but that password protection was not 'absolutely required' by the Code.  It was also felt that a 'concerted effort' should be demonstrated to ensure that HCPs were genuine.  The level of verification required when HCPs register for a site was hotly debated; the general feeling was that a GMC number was the minimum requirement even though this goes beyond the current requirements of the Code.

 

Other issues discussed and guidance given such as:

1. Corporate websites need to be non-promotional and news worthy.
2. The same rules apply for mobile devices as for the Internet.  HCPs need to have agreed to receive promotional mobile communications before they can be sent.  Tim Benjamin added that even non-promotional communications can irritate the audience unless requested.
3. The usual rules were thought to apply to web casts and pod casts.  It was re-iterated that all participants must give their permission to be shown on the web.
4. Search engine optimisation strategy and the sponsorship of keywords on search engines were discussed .It was considered that the use of product names for either of these would be in breach of the Code.

In conclusion, the group felt that the industry were very cautious when approving electronic media plus it is often difficult to fully visualise electronic content due to navigation and context issues.  It was suggested that discussing a proposed structure of a site with the medical approval team before starting development in earnest, would lead to a more straightforward approval process.
The group agreed that a positive way of moving forward and working most effectively with the PMCPA would be to set up an ongoing working group to address areas of the Code related to e-media.  Niamh MacMahon of the PMCPA stated that they would consider being involved in such a group to help resolve any grey areas.  Ivor Eisenstadt of MGP and the PM Society agreed to look at the possibility of such a working group being run by the Society.

 

Promotion vs Education

Following recent rulings regarding activities such as advertorials and that some education initiatives are being classed as ‘disguised promotion’, the main objective for the workshop attempted to find the line between promotional and educational activities. 

Workshop facilitator Steve Gray has worked in the industry for many years and his consultancy specializes in healthcare sales and marketing compliance.  He began the workshop by splitting the group into two and asking the delegates to brainstorm and discuss various educational activities against a written brief.  Each group then reviewed each others list of activities and were asked to classify which they thought were educational and which - promotional - and why.  By undertaking this exercise, the point was made clear to delegates that in our industry it is possible for anyone to be a critic of what you are doing within your educational and promotional campaigns and that everyone brings their own perspective of whether an activity constitutes ‘promotion’.  In light of the source of complaints to the ABPI (from internal company employees, ex-employees, healthcare professionals, other companies etc); that is exactly what is occurring in the real world – as indicated by Heather Simmonds in her opening address.

Following a review of a number of case studies which highlighted what was found to be in breach and what wasn’t, elements of the Code that are particularly relevant were summarised:

PMCPA Guidance: Sponsorship (placement of declaration)
Clause 9.10 of the Code states that material relating to medicines and their uses, whether promotional in nature or not, which is sponsored by a pharmaceutical company must clearly indicate that it has been sponsored by that company.  The relevant supplementary information also requires that such declarations of sponsorship must be sufficiently prominent to ensure that readers of sponsored material are aware at the onset.

Promotional material and activities must not be disguised (Clause 10.1) and as such a declaration of sponsorship at the end of a two-page invitation is not acceptable – as it should be made clear from the outset and also the type and level of sponsorship must not be misleading.

The definition of education was also discussed.  If, for example, a meeting is advertised as ‘educational’ and it is not made clear that it is a company-sponsored event, the presence of any promotional material (eg on an exhibition stand) might be deemed disguised promotion.  Even if a company supplies information about a therapy area, which contains no specific product information, this could be regarded as ‘promotional’ in that sense it falls within the scope of the Code because it was supplied by a company with an interest in that area.
Delegates then discussed the area of sponsorship, including the sponsorship of materials and what constitutes an “arms length agreement” and what would be classed as promotional.  Advice was given regarding the importance of keeping clear and accurate audit trails about how sponsorship funding decisions had been taken, in order that these could be reviewed if there was a complaint or query.

It is worth remembering that a company might be deemed to be inextricably linked to the production of material if any or all of the following apply:

• Lack of an arms-length-agreement
• The initiation of a project by the company
• Selection of authors by the company
• Provision of material for the document
• Payment of the authors by the company
• Payment to a journal for inclusion
• Having the final say about whether the material is published

As with other workshops, it is important to have a thorough knowledge of the Code and to have read it carefully, to clear up any misunderstandings there might be with regards to production educational material vs promotional items.  

Helpful insight was also given on sponsorship of meetings:





Within the remit of the workshop, Steve Gray also covered the areas of partnership working, scientific exchange of information and guidance for scientific advisors.  In summing up, he concluded that we all roughly know where the line sits – it is not rocket science and we need to refer to the Code regularly if in any doubt whether we are crossing that line. 
In fact - a failure to recognize when a document is promotional is likely to be regarded as a failure to maintain high standards.

The key take home points for companies on how to work effectively within the Code are summarised as follows:

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Q+A to the Panel

Q:    Are medical books when distributed by sales representatives seen as promotional educational if unbiased information?
A:    If an item is distributed by a representative then it is likely to be regarded as a promotional aid and limited to £6 cost/perceived value as well as being relevant to the recipient’s work.

Q:    If a company is sponsoring a meeting by paying for the speaker and the speaker has a disclaimer on their slides is the company obliged to provide PI on the slides?
A:    Due to the limitations of space on slides, this is not possible, but make sure PI is readily available in all meeting materials

Q:    Are there rules around the safe disposal of materials after a meeting (e.g. agendas) – do they need shredding?
A:    The panel said that they shredded absolutely everything!