Expert review: ABPI Code 2011 update – implementation and impact NOT to be underestimated!

Dr Rob Barden

Consulting pharmaceutical physician

January 2011 saw the introduction of the updated ABPI Code of Practice, with initial implementation being completed by the end of April. So what were...

The main changes centred largely around two main areas:

1. Cessation of branding items and the introduction of formal patient support programmes, including the provision of patient literature,

2. Increased transparency in terms of public disclosure of healthcare professionals and healthcare-related organisational activities sponsored by pharmaceutical companies.

1. Cessation of branding items and the introduction of formal patient support programmes

The cessation of branding items involved stopping ‘give-aways’ such as the ubiquitous distribution of product-branded note pads and pens, as well as mugs and so on to health professionals, as these could be seen as demeaning the status of the pharmaceutical industry, as well as possibly being an inducement to prescribe the respective medications.

“The cessation of branding items involved stopping ‘give-aways’"

The provision of notebooks and pens or pencils at ‘bona fide’ meetings, however, is now specifically permitted, so long as the overall package costs no more than £6 (or similar perceived value) per delegate (excluding value-added tax) and that only company names are permitted – i.e. no product branding.

Also, the provision of patient support items within formally approved patient support programmes was introduced. This is largely focused on providing items to patients that will benefit their care and includes product compliance items.

In this category it would appear to be appropriate to include the very useful new section on patient literature items, which covers the provision of product administration leaflets and information on the associated disease area. However, if the provision of patient literature is categorised in this way, then these items should only be provided within the following defined framework:

• They must be part of a formal patient support programme i.e. documented and certified – items should be described, stating how they will be used and how the patient is expected to benefit,

• They may bear the company name, but not a product name – unless the product name is an essential integral part of the item – for example, product-specific administration leaflet,

• They must be passed on to patients by a health professional,

• They may be given to administrative staff for passing on to a health professional,

• They may only be ordered/requested from a promotional stand – not be given out,

• They may be provided or delivered at a promotional call,

• If a product is mentioned (for example, in a product-specific administration leaflet) and the item will pass through a health professional en route to the patient, it is recommended that prescribing information should be provided in association with the item, for example loose, within pack or on tear-off pad.

There have been real challenges for companies in implementing this first main change of the 2011 code. Firstly, explaining to health professionals and associated staff about the cessation of note pads and pens, which have been the bedrock of practice-essential items!

Staff struggle to understand the reasons for them no longer being available – including resentment of any suggestion that prescribing could be bought by the provision of these items – and realise that these essential items will now have to be funded from the practice budget – often a considerable and unplanned impact!

"There have been real challenges for companies in implementing this first main change of the 2011 code."

Ironically, this has often been seen as reflecting badly on the ‘miserly’ pharmaceutical industry and has caused stand-offs between practice staff and company representatives (personal communications)!! Representatives have had to be briefed on managing conflict with irate practice staff.

The second implementation challenge required putting a system in place to accommodate the provision of patient support items. This involved providing the framework for a formal patient support programme (see above), the identification and certification of associated items, followed by briefing representatives on how to manage the provision of these items within the context of both promotional calls and meetings, and also in relation to promotional stands.

This has proved to be quite an undertaking in that it has involved a major operational change, not least ensuring and reassuring the representatives that they are working in a code-compliant manner, particularly as there seem to be a variety of interpretations on how correctly to manage the provision of patient support items.

2. Increased transparency in terms of public disclosure of activities sponsored by pharmaceutical companies

The second main area of change relates to the requirement for increased transparency in relation to the disclosure of pharmaceutical company sponsored activities by both the respective companies and also individual healthcare professionals and healthcare-related institutions, associations or organisations, including patient organisations.

The main objective of the disclosures is to increase the public trust by being more open in respect of publicly declaring certain specified activities that exist between pharmaceutical companies and healthcare professionals and healthcare-related organisations.

It will be the responsibility not only of the companies, but also individual healthcare professionals and healthcare-related organisations to make the requisite annual disclosures.

"Representatives have had to be briefed on managing conflict with irate practice staff!"

The following public disclosures will be mandatory for pharmaceutical companies on an annual basis.

1. Consultancy services

The total amount of fees paid, including details of any associated travel outside the UK and/or accommodation (anywhere) expenses incurred, to all healthcare professionals for permitted consultancy services (for example, presentations made at company-sponsored meetings, participation at a company advisory board, market research participation), also including the total number of consultants used.

2. Meetings sponsorship

The total amount paid, together with the total number of recipients and attendances, for sponsorship of healthcare professionals to attend educational meetings sponsored by third parties – mainly payment of registration fees to attend international academic conferences (often around £800), but also potentially support for travel (economy airfare) outside the UK and accommodation anywhere (not lavish) to attend these meetings.

3. Patient organisation support

A list of patient organisations to which a company provides financial support and/or significant indirect/non-financial support, together with the monetary value of the support, when it has a value to the organisation of at least £250 per project (excluding value-added tax).

4. Grants, donations and benefits in kind

Details of any grant, donation or benefit in kind provided under the provision of medical and educational goods and services (textbooks, for examples), including the financial amount or value of the support item and the name of the recipient organisation (cannot be an individual).

Certain increased disclosure requirements were effective from 1 May 2011 (patient organisation activities), whilst the majority will be effective from 2013, with market research from 2014. However, companies are likely to provide these disclosures ahead of the mandatory dates.

The disclosures will necessitate companies having systems in place which will enable the information to be aggregated and publicly disclosed. In most cases the disclosure will be made by placing the requisite information on the company website within three months of the end of the respective financial year following the activity.

"It will be the responsibility not only of the companies, but also individual healthcare professionals and healthcare-related organisations to make the requisite annual disclosures."

The disclosures will make publicly available the amount of finance that individual pharmaceutical companies – and ultimately the industry as a whole – invests annually in various activities involving healthcare professionals and healthcare-related organisations.

It will be interesting to review the financial amounts disclosed by companies in respect of supporting healthcare professionals and healthcare-related organisations, and also the extent of the collaborations – recent disclosures obtained from NHS hospitality registers by the Mail on Sunday (14 August 2011, available here) under freedom of information laws, already make for interesting reading.

With the current US-centred initiative by companies such as Pfizer to cease the provision of financial support for healthcare professionals' continuing professional development, it will be interesting to see how this initiative might evolve and indeed what consequences it might have on the future sustainability of international medical conferences – currently seen as essential conduits of global academic exchanges and clinical developments, not least in respect of the presentation and discussion of new pharmaceutical company therapeutic data.

Part 3 of the ‘Expert review’ series on doing business in the Nordics can be viewed here.

About the author:

This article was written by Dr Rob Barden, and was commissioned by PiR Interims.

Dr Rob Barden MB DRCOG is a consulting pharmaceutical physician. He can be contacted through PiR Interims – see details below.

PiR Interims is a leading provider of interim management solutions to international life science organisations. They identify and place some of the most highly regarded professional interims in the life science sector. PiR Interims works across a range of functions including: medical, clinical development, regulatory affairs, project management, commercial, market access, manufacturing, quality operations, supply chain, HR and finance.

Email: interims@pir-interims.com Phone: +44 (0) 844 880 4340

Website: www.pir-interims.com

What changes have you noted since the amendments to the ABPI code?