Working with the ABPI Code of Practice

Facilitators included:

Joan Barnard	Code In Practice
Christine Cameron	Cameron Medical Communications
Anne Fairey	Fairey Medical
Steven Gray	Steven Gray Consulting
Ian Hale	Code In Practice
Felix Jackson	medCrowd
Jane Marshall	Sanofi Aventis
Sharon McCulloch	Code In Practice
Andrea Ward	Allergan

GLOBAL VS UK ACTIVITY
Facilitated by Steven Gray, Steven Gray Consulting

In the era of global branding and international activities, there is a need to be cogniscent of Codes in countries other than the UK. The workshop explored the similarities between Codes within Europe and highlighted some of the variations.

Perhaps surprisingly, the ABPI Code is not the strictest Code in every area, however it is probably the most rigorously enforced! Every Code has its own quirks and simply applying the UK's standards will by no means guarantee compliance in every country.

Global campaigns should therefore be planned and structured so that they meet basic minimum standards and also allow flexibility in local application. This will provide greater opportunities to facilitate compliance without dropping to the lowest common denominator. It does mean relinquishing some control in global branding consistency but does not need to compromise the overall brand strategy.

Awareness of local differences is key in central planning; seeking the advice of the local signatories is critical in local delivery.

PRE-LICENCE ACTIVITY
Facilitated by Joan Barnard, Code In Practice

The Code, and legislation, prohibits the promotion of a medicine (or indication) before it is licensed. To be acceptable therefore, any activity during the pre-licence period must be non-promotional, but what does ‘non-promotional' mean?

There are a number of activities which can be considered to be ‘non-promotional' and can thus be undertaken pre-licence e.g.

• Clinical research
• Market research
• Public relations activity
• Provision of financial information
• Responding to requests for information
• Advisory Boards
• Information to budget holders
• Disease awareness
• Corporate advertising

However for all of these, there is the rather unhelpful caveat that this is only the case if they are ‘not promotional'. A key question to ask is ‘What is the purpose of this activity?' Bona fide activity in these areas is likely to be acceptable, ‘high-jacking' them for promotional purposes are not. How the activities are carried out, and by whom, is also very important.

Overall, there is much that can legitimately be done pre-licence, but there are many ways of getting it wrong. Any activity must be managed extremely carefully, with great attention to detail.

WORKING ON THE INTERNET – DO'S, DON'TS AND POSSIBILITIES
Facilitated by Felix Jackson, medCrowd

Attendance was high as the 2008 ABPI Code¹ has few clauses that specifically deal with pharmaceutical companies' activities on the Internet. We discussed many issues, the main ones highlighted below.

The Code states that “unless access to promotional material about prescription only medicines is limited to health professionals and appropriate administrative staff, a pharmaceutical company website or a company sponsored website must provide information for the public.”² Therefore, a login is now not essential if an appropriate website is provided for patients.

External links from a company (or company-sponsored) website to a third-party are possible. However, the company may be found responsible for this content. Therefore, links must be considered carefully and used sparingly.

Reference to the PMCPA Code Advice on blogs³ led to the conclusion that user-generated content is feasible, but only when moderated (ie checked before going ‘live'). Free-contributions are not possible as they cannot be controlled and they still remain the responsibility of the company.

Overall, the ABPI Code's lack of detail was appreciated for the freedom it gives, but more clarity on certain issues is important before companies will feel confident to engage in this complex and dynamic area.

¹ ABPI Code of Practice for the Pharmaceutical Industry.  2008 Ed
² Supplementary Information to Clause 24.1. ABPI Code of Practice for the Pharmaceutical Industry.  2008 Ed
³ PMCPA Code Advice on Blogs. www.pmcpa.org.uk. 15-Jul-7

WORKING WITH PATIENTS AND PATIENT ORGANISATIONS
Facilitated by Anne Fairey, Fairey Medical

The 2008 Code of Practice contains a new Clause, 23, dedicated to Relationships with Patient Organisations. This Workshop discussed the major impacts that this new Clause will have on day to day working practices and identified the following key areas that will need to be addressed:

• The purpose of any information supplied to a Patient Organisation must be made clear (S.I to Clause 23.2)
• A written agreement must be in place covering exactly what has been agreed by each party (Clause 23.3)
• Companies must make publicly available annually a list of Patient Organisations  supported either financially or by other significant activities (Clause 23.7)

The Workshop participants felt that all the above were easily achievable but that new processes may have to be implemented.
One issue that arose was that of sole funding, which a Company must not require, of a Patient Organisation but which may occur by default. It was concluded that as long as evidence existed that a) the Company had not specified sole funding and b) the Patient Organisation had sought additional sources of funding, this would be acceptable. 

The Workshop concluded that working with Patient Organisations remains an attractive and useful activity.

More information including a presentation, details of requirements for the written agreement and information on disclosure are available at the PMCPA website.

ADVISORY BOARDS
Facilitated by Anne Fairey, Fairey Medical

Advisory Boards appear to be a universal activity of all pharmaceutical companies and allied agencies. The 2008 Code of Practice contains a new Clause, 20, entitled The Use of Consultants. This Clause covers Advisory Boards, speaker meetings, and training activities and is applicable to individuals and groups of consultants.

This Workshop identified the following areas which might require a change of current practice:

• Identify (and therefore presumably document) a legitimate need for the services to be requested in advance of the activity i.e. not just because there is always an Advisory Board at a particular meeting!
• The compensation offered to the consultant/advisor for the service must be reasonable and reflect fair market value

The second point was the topic of much discussion including who decides what is fair market value and how do you know that you are competitive since hourly and daily rates for varying levels of advisor are not available in the public domain?

Nevertheless, the Workshop concluded that Advisory Board activity will continue and noted that, over time, Fair Market Values will become more transparent.

More information is available at the PMCPA website.

USE OF CONSULTANTS
Facilitated by Ian Hale, Code In Practice

During this workshop, Ian Hale provided delegates with a thorough overview of this new Clause, working with the group to ensure a thorough understanding of the detail of the Clause and the published supplementary information.

The workshop enabled delegates to identify and discuss key issues including:

• What does the new clause on consultants aim to achieve?
• What is a fair market value for consultancy services?
• What sort of review process should consultancy agreements undergo and do they need to be certified?
• Who keeps copies of consultancy contracts and for how long do they keep them?

Through a series of relevant questions, the group identified answers to the above issues plus a wide range of other related issues, which furthered their understanding of the need for this new Clause and how to ensure they, and the companies they work with or for conduct transparent, open and honest relationships with the consultants they engage with. 

Centrally stored contracts, detailed records of payments made to all consultants that a company works with, written agreements in advance of the commencement of services undertaken and a legitimate need for those services are all essential practice.

It was agreed that Clause 20 was a very good fit with lots of other areas within the Code, but that it might be one of the more challenging areas as it is new.

More information and a downloadable copy of the 2008 Code of Practice including Clause 20 is available at the PMCPA website.

MEETINGS AND HOSPITALITY
Facilitated by Sharon McCulloch, Code In Practice

The aim of the workshop was to ensure workshop delegates understood what Clause 19 Meetings and Hospitality actually aims to achieve.  The Code clearly states that Companies must only provide hospitality to members of the health professions and appropriate administrative staff in association with scientific meetings, congresses and other meetings and training.  However, Clause 19 has many specific details that companies must ensure they understand and work with, in order to ensure they are compliant with the Code. 

Key areas of discussion during this lively and informative workshop included:

• What does subsistence actually mean?
• Why does Clause 19 mention the GMC?
• Are there any circumstances where you could hold a meeting in a luxury hotel?
• What aspects of the Code should overseas affiliates be reminded about if they organise meetings attended by UK Health professionals?

Facilitator Sharon McCulloch took workshop delegates through various scenarios that they might need to consider when organising events attended by health professionals, to ensure that a thorough understanding of Clause 19 and its detailed supplementary information. 

The overall aim Clause 19 is of course to clarify what can and cannot be done and to ensure that education is the primary objective of any event and to avoid hospitality (location/hotel/etc) being the main focus.  The drive towards much more transparent and open relationships with health professionals was discussed with the point being made that HPs also have an obligation through their own GMC Code to ensure they do not ask Pharmaceutical companies to break the Code by making demands for inappropriate hospitality.

As with all aspects of the Code the group were advised that there is not substitute for reading the Code to ensure you have the most thorough understanding possible of the detail.