The Pharmaceutical Journal
Vol 276 No 7398 p499-500
29 April 2006

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2006: a tighter ABPI Code of Practice?

On 1 January a revised ABPI Code of Practice, which calls for changes to industry's marketing practices, came into operation. Lin-Nam Wang (on the staff of The Journal) reports

Last week, product information was not the only thing pharmacists and other health care professionals received from visiting drug company representatives. On Tuesday, as part of an awareness campaign called “code day”, representatives from 52 pharmaceutical companies briefed their “customers” on the 2006 Association of the British Pharmaceutical Industry (ABPI) Code of Practice for the Pharmaceutical Industry, which replaces the 2003 edition. The code governs the promotion of prescription medicines to health care professionals and administrative staff, such as receptionists in GP surgeries. All members of the ABPI (about 75 companies) must follow the code and about 60 non-members have also undertaken to abide by it.

Giles Harper, a sales manager for Lilly Psychiatry Group, took part in code day. One way of initiating a discussion about the new code was to ask customers if they noticed any changes in the way that Lilly now works with them, Mr Harper told The Journal. For example, customers might have noticed changes in the way in which meetings are now arranged and in the material Lilly produces, he explained. The code now requires all printed promotional materials to include prominent information about adverse event reporting mechanisms and abbreviated advertisements must recommend that prescribers consult the summary of product characteristics before prescribing. Moreover, there are key changes regarding the hospitality companies can provide.

Mr Harper said that prescribers know that the ABPI code exists but many do not know the detail and what it means. Most health care professionals he spoke to were positive about the code and the day generated some interesting discussions about openness, transparency and disclosure, he added.

Revisions

It took over a year for the new code to be produced. Work began in September 2004, starting with open stakeholder consultations. This was the first time that patient organisations were consulted on the code. Although drug companies have been working with patient organisations for a number of years, the 2006 code recognises this relationship and makes clear that any sponsorship must be declared.

The Journal spoke to Heather Simmonds, director of the Prescription Medicines Code of Practice Authority (PMCPA), who was a member of the code review working group, about the reasons behind the some of the revisions. “Since 1993, when we last had a major review, things have changed a lot,” she said, adding that patients expect more information and transparency than they did before. Some additions to the code have been common practice in industry for some time. For example, companies generally have a “responsible person” to ensure that code requirements are met, but this is now set out in the code. “Putting it in black and white in the code demonstrates that it is required,” Mrs Simmonds said.

Some revisions to the 2003 code have been made to incorporate new technologies and changes to health care practices. For example, companies may now use validated electronic signatures for certifying promotional materials before they are issued and restrictions on promotional communications now cover automated calling systems. The 2006 code also encompasses requirements set out in the European Code of Practice for the Promotion of Medicines.

While work on the 2006 code was in progress, two significant documents were published: the House of Commons Health Committee report into the influence of the pharmaceutical industry,¹ and the Government response to it.² Both levelled criticisms at the industry and, according to Mrs Simmonds, the code review working group took the recommendations in the documents into consideration.

The Health Committee report, published in March 2005, was the result of the first major select committee inquiry into the industry in almost 100 years. The committee looked at the influence of the industry on areas such as research and development as well as its marketing practices. The report described the industry’s promotional efforts as “relentless and pervasive” and stated that the evidence presented to the committee showed “the lengths to which the industry goes to ensure that promotional messages reach their targets”, which included not only prescribing groups but also the general public.

The Government response agreed that “intensive marketing which encourages in-appropriate prescribing of drugs must be curbed”. Neither document blamed a particular marketing activity but, instead, found fault with the volume of activities. As a reflection of this, Mrs Simmonds explained that the code now specifies that, for a particular medicine, no more than eight mailings of promotional material may be sent to a health professional each year. Similarly, advertising in journals must be limited to two pages per issue.

The code itself reveals the ABPI’s concern over the bad press that the industry has attracted and expressly states that one new direction — that particular care needs to be taken in terms of promotional materials released in the first six months following the launch of a medicine — is “to avoid criticism of the industry”. The timing of the provision of medicines information was highlighted in the two parliamentary documents. The charge was that, in the first few months after a drug is launched, it was common practice for companies to embark on a mission of “explosive marketing” (in order to establish market position for their product), encouraging wide early prescribing at a time when there is insufficient information about the use of a new drug in the community.

Promotional aids

The clauses in the ABPI code relating to gifts and inducements have been extensively revised. In some places, where the word “gift” was previously used, “promotional aid” has been substituted, emphasising the distinction between the two. Although the acceptable cost of a promotional aid remains the same (no more than £6), the definition of the type of items allowed has been updated.

In the 2003 code, objects that could be used in the home but which could also be used in the practice of health care were all right. However, the 2006 code now disapproves of all items for use in the home or car. The list of examples that are not permitted has been expanded and now includes: coasters, clocks (previously an example of an acceptable promotional aid), desk thermometers, fire extinguishers, rugs, thermos flasks, tea or coffee pots, lamps, travel adapters, toolboxes and umbrellas. The code implies that anything more than a coffee mug is not allowed.

In addition, the previously authorised practice of using competitions or quizzes and giving prizes to promote products is now deemed unacceptable. “The industry looked at itself long and hard and it was thought that some forms of promotion were not acceptable for the type of product,” Mrs Simmonds explained.

Medical and educational goods and services that enhance patient care or benefit the NHS can still be provided but the code clarifies between “switch programmes” and industry sponsored therapeutic reviews. A switch programme is where a patient’s medicine is replaced with another without proper clinical assessment (there have been reports of industry sponsored nurses carrying out such switches). Although straightforward switching was never allowed, according to Mrs Simmonds, the 2006 code clearly sets out the prohibition. Companies can legitimately promote a cost-effective switch to a prescriber, but they cannot provide a means of implementing that switch.

Meetings

The other section of the code that has been heavily revised is the one on meetings and hospitality. Prescribers are often invited to attend sponsored events, such as workshops and conferences, and the pharmaceutical industry funds over half of all postgraduate education and training for doctors. However, the provision of hospitality by drug companies has been widely criticised and is cited as one of the factors contributing to the inappropriate prescription of medicines. One phrase used in the Health Committee report is “hospitality masquerading as education” and complaints have included the promotion of a meetings about erectile dysfunction by the offering of a champagne reception and gourmet dinner (Bayer Healthcare), and the entertainment of of health care professionals at lap dancing establishments and race tracks (Abbott Laboratories).

Elaine Riordan, senior account manager at public relations company Santé Communications Ltd, spent six years working in marketing at Novartis. She told The Journal that the code revisions had “huge implications for meetings for medical education”, adding that “some meetings, which were previously seen as a ‘bit of a jolly’ now need to be justified”.

The ABPI code now directs that meetings must be held in “appropriate venues conducive to the main purpose of the event” and that “lavish or deluxe venues must not be used”. Companies should also avoid using venues that are renowned for their entertainment facilities. According to Mrs Simmonds, who also sits on the PMCPA code of practice panel, the appropriateness of a venue will be determined on a case by case basis. “[The working group] considered specifying five-star hotels but often, such places are where you have meetings because they have large break-out rooms,” she said.

Furthermore, there must be cogent logistical reasons for holding meetings outside the UK (eg, where most participants are from outside the UK) and where companies provide air travel for participants, this can only be economy class. Ms Riordan told The Journal that although the corporate guidance of some companies is stricter than the code, many sponsored participants will now have to travel by economy class when they previously would have gone business or first class.

The code also states that hospitality must be “secondary to the purpose of the meeting” and this is emphasised by the use of the word “subsistence” instead of “hospitality”.

Will the code be more effective?

Complaints under the code can be made to the PMCPA, a body established by the ABPI. Cases are heard by a panel of three and appeals are forwarded to an appeal board, which can report companies to the ABPI board. Under this procedure, the PMCPA can impose various levels of sanction, the most serious being suspension or expulsion from the ABPI. According to Richard Ley, ABPI head of media relations, if a company is suspended or expelled from the ABPI, it will no longer receive information from the association and it is not allowed to participate in its policy forming committees — effectively, it will be “out of the loop”. It is worth noting, however, that no company has been expelled from the ABPI for a code breach, although some have been suspended.

The code revisions were welcomed by the Medicines and Healthcare products Regulatory Agency, the body responsible for enforcing medicines advertising regulations. Jeremy Means, senior policy manager at the MHRA, described the revisions as “positive changes to enhance patient safety to ensure that the code remains robust and rigorous”. Ike Iheanacho, editor of Drug and Therapeutics Bulletin, however, presented another view: there is a problem with the 2006 code because “there is no real evidence that the sanctions are much tighter”. Dr Iheanacho described the sanctions as “weak” and said that if the ABPI was serious about dealing with breaches it would impose greater sanctions, such as heavy fines. It would also ensure that if a breach were found, appropriate action would be taken to inform people who had been misled by it.

Countering the issue, Mr Ley said: “In terms of fining, what is going to be an appropriate fine for multi-million pound companies?” He reasoned that a more severe penalty would be to make a breach widely known. Mr Ley said that along with the revisions to the code, some parts of the PMCPA constitution and procedure have also been revised. This includes a new provision that details of cases in which certain code rules are breached will be advertised in the medical and pharmaceutical press. “It was decided that the best deterrent for any company is naming and shaming. This is something deeply, deeply embarrassing for any company,” Mr Ley said. “Reputation and knowledge that you are doing your business ethically is important and trust is necessary for pharmacists,” he added.

Responsibilities

Giving evidence to the Health Committee, Sir Richard Sykes, a former chairman of GlaxoSmithKline, said: “Today the industry has got a very bad name.” It appears that industry is trying to change this, by embracing the revised code. For example, in addition to participating in code day, Lilly representatives received three days’ training: one day was set aside for online training to review the new code and two days to get to grips with all the changes to procedure required to reflect the code.

Since the new code was introduced at least two workshops have been run by the Pharmaceutical Marketing Society to explore the impact of the code on marketing practices. In a commercial environment, it could be argued that the code revisions might make sales more difficult, but Mr Harper commented: “I do not think it is a question of the job being made harder or easier. I think it is about doing what is ethical and right.” It is inevitable, however, that more creative marketing practices will appear.

Although the industry has been criticised for influencing prescribers, the Health Committee report acknowledged that the blame for inadequate or misinformed prescribing decisions also lies with prescribers who “do not keep abreast of medicines information and are sometimes too willing to accept hospitality from the industry and act uncritically on the information supplied by the drug companies”.

In 2003, with the changing roles of pharmacists in mind, the Royal Pharmaceutical Society published guidance for pharmacists on working with the pharmaceutical industry (www.rpsgb.org). Propriety is not just about what the pharmaceutical industry does or does not do, Mr Ley concluded. “Pharmacists, as new prescribers, must also abide by their code of ethics. It takes two to tango,” he said.

References

1. House of Commons Health Committee. The influence of the pharmaceutical industry (PDF 580K)
2. Government response to the Health Committee’s report on the influence of the pharmaceutical industry