Please login to the form below

Not currently logged in
Email:
Password:

The code in greater detail

Some areas of the ABPI CoP warrant further explanation to put an end to any confusion

The length of time since the last major review, together with criticisms of how the industry operates, changes to UK and European law and the need to implement the changes to the European Federation of Pharmaceutical Industries and Associationsí Code, led to the changes to the Association of the British Pharmaceutical Industryís (ABPI) Code of Practice for the pharma industry, which came into operation at the beginning of 2006. The Health Select Committee enquiry into the influence of the pharma industry on prescribers was also taken into consideration when the Code was revised. Although many of the requirements of the Code remain unchanged, there is no doubt that the revisions to it and its operation have had a major impact on the industry, particularly for those in marketing and sales.

There has been some apprehension about the new requirements over the past year, which is to be expected when any new rules are introduced. One of the aims of the 2006 Code is to engender more transparency, which should enhance the industryís reputation and improve the quality of relationships in the longer term. For marketers, where has the impact of these changes to the Code been most keenly felt and what advice can be offered in these areas? One of the biggest issues with a number of the changes has been the interpretation of them. It can be difficult to interpret accurately some of the clauses when there is little case law on the new requirements and when companiesí own codes are often even more restrictive than the ABPI Code. For these reasons, it is worth looking in more detail at some of the areas that have caused the most discussion.

Hospitality and meetings
A useful criterion in determining whether the arrangements for any meeting are acceptable (Clause 19) is to ask: Would I and my company be willing to have these arrangements known publicly? How the arrangements for a meeting are perceived, can be as important in determining its acceptability under the Code as the arrangements themselves.

Requirements around meetings are that:
ï It must be scientific/educational content that attracts delegates to a meeting
ï Lavish or deluxe venues must not be used and companies should avoid using venues renowned for their entertainment facilities
ï Meetings wholly or mainly of a social or sporting nature are unacceptable
ï Pharma firms can sponsor meetings, but their sponsorship must be disclosed in all papers relating to the meeting and any published proceedings
ï Payment may not be made to doctors or other prescribers, either directly or indirectly, for rental for rooms to be used for meetings.

The Prescription Medicines Code of Practice Authority (PMCPA) has received a number of queries about choice of venue over the past year and realises that when large numbers of delegates are to be invited to a meeting it may be impossible to hold it at a business-style hotel. A conference centre within a football stadium or the like may have to be used instead. However, firms organising, or sponsoring, meetings at such high-profile venues should be satisfied that no other venue is large enough to accommodate the meeting and that the overall impression given by the proposed arrangements would not be unacceptable in relation to the requirements of Clause 19.1.

Gratuitous use of sporting or leisure venues is unacceptable. It must be the programme that attracts delegates to a meeting, not the venue. Furthermore, firms must ensure that no sporting events take place at the venue immediately before, during or immediately after the meeting. Venues must not be used to knowingly take advantage of any entertainment/ sport that has been organised/subsidised by a third party. Companies must also ensure that any third party to whom they entrust any aspect of organisation of a meeting is fully conversant with the relevant requirements of the Code. Responsibility for compliance cannot be delegated to third parties.

Requirements around hospitality state that:
ï Hospitality can be provided only in association with scientific and promotional meetings, and congresses etcÖ
ï Subsistence must be strictly limited to the main purpose of the event and be secondary to it
ï Hospitality cannot be offered to spouses or other such people unless they qualify as a delegate in their own right
ï Companies can only provide economy air travel to delegates sponsored to attend meetings.

events held outside the UK, particularly those which have been organised by a part of the company other than that which operates in the UK. If the UK company is expected to invite British health professionals, then it must ensure that arrangements for these health professionals comply with the Code.

Promotional aids
The 2006 Code is more specific on the types of items that are and are not acceptable as promotional aids (Clause 18) and a full list can be found in the supplementary information to Clause 18.2 of the Code. For example, items which are for use in the car or home are unacceptable, such as table mats, coasters and clocks, whereas items that are relevant to health professionalsí work are acceptable, such as pens, stationary and clinical items. Importantly, no gift, benefit-in-kind or pecuniary advantage should be offered or given as an inducement to prescribe, supply, administer, recommend, buy or sell any medicine. Promotional aids must be inexpensive (no more than £6 plus VAT and of a similar perceived value to the recipient) and relevant to their profession or employment.

The Code, however, allows companies to provide medical and educational goods and services which will enhance patient care or benefit the NHS, and maintain patient care, provided they do not constitute an inducement to prescribe, supply, administer, recommend, buy or sell any medicine (Clause 18.4). There is no limit on the cost of these goods and services.

Medical and educational goods/services
Medical and educational goods and services (Clause 18.4) must not bear a product name, but can bear a company name, as the involvement of the pharmaceutical company must always be made clear. The ABPI Code therefore does not prohibit pharma companies from funding the publication of educational books for health professionals as long as they comply with the requirements of Clause 18.4. Therapy review programmes and nurse audit services, which aim to ensure a patient receives optimal treatment following a clinical assessment, are also permitted. However, it is not acceptable for a company to assist with a switch programme where all patients on medicine A are simply switched to medicine B without any clinical assessment. Companies can promote a switch from one product to another, but must not assist in carrying it out. Further guidance is given in the supplementary information to Clause 18.4.

Patient organisations
For the first time, the 2006 ABPI Code of Practice includes a clause covering relationships between pharmaceutical companies and patient organisations (Clause 20.3). Requirements for working with patient organisations were introduced in order to increase transparency and openness. Further guidance has been issued on the requirements around certification which is available to download from both the PMCPA and ABPI websites as is further advice on written agreements.

Impact of the Code
While it is difficult to quantify exactly what direct effect the revised Code has had on the reputation of the industry over the past year, awareness among health professionals is increasing: some 73 per cent of doctors are now aware of the Code, compared to just 52 per cent at the beginning of 2006. Greater awareness of robust self-regulation supported by the Medicines and Healthcare products Regulatory Agency (MHRA) can only have a positive impact on how the pharma industry is perceived and this increased knowledge should lead to fewer unreasonable requests for gifts and hospitality from health professionals. Both the industry and health professionals have a responsibility to act ethically under the ABPI Code and medical codes.

Raising awareness
Code Awareness Day 2007 will take place on May 15 and is an opportunity for industry to engage in positive dialogue with stakeholders about how well regulated the promotion of drugs is in the UK. It was a great success last year with more than 8,000 employees from 50 pharmaceutical companies across the UK uniting to talk to doctors and other health professionals about the Code, and we want to continue to build on this success. The increased publication of the outcomes of complaints, including advertising certain cases in the medical and industry press has also increased awareness of the ABPI Code and its operation. Relationships between the industry and all of its stakeholders should be ethical, professional and put the care of patients first at all times. We hope that the Code will help ensure this and, in time, pay a part in re-building the reputation of the industry as a whole.

It is important for the industry to remember that anyone can contact the PMCPA for informal advice on the Code if they are unsure of what to do in a particular situation, and the Authority will issue additional guidance where possible. This guidance can be found at the front of the quarterly Code of Practice Review and, from the end of April 2007, will also be available in the ëLatest Adviceí section of the re-launched PMCPA website at www.pmcpa.org.uk.

11th May 2007

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
dna Communications

Healthcare communications with unique thinking, insight and attitude...

Latest intelligence

Is the pharma business model ready for precision medicine?
Precision medicine promises to revolutionise patient outcomes and reduce costs for industry but is pharma ready for it? Blue Latitude Health co-founder Head of Strategy Fred Bassett explores the challenges...
ABPI2018
The NHS and ABPI at 70: inching closer to the triple win
The NHS and UK pharma’s ABPI both turn 70 this year. After years of transactional relationships, there’s a will to work more closely - but friction on prices and value...
What pharma marketers can learn from behavioural science
Pharma behavioural science and traditional emotional marketing create a powerful mix of techniques that have impact on real lives....

Infographics