Fasten your belts

Regulation in all walks of life is an eminently sensible thing. Take the Highway Code for instance. It is a set of rules designed to make the roads of Britain as safe as possible for the millions of pedestrians, cyclists and motorists that use them every day. Not only that, but were the people of Britain suddenly to decide that it wasn't necessary to adhere to the Highway Code, and ignore red lights, one-way systems and no-stop zones, the inevitable outcome would be chaos and gridlock.

The Code is not there just to tell drivers what they can't do, it also ensures that they can do a lot of things without putting their vehicle, or even their life, at risk. People accept the Highway
Code as part of the system and, bar the odd grumble about speed limits, they generally accept that without it, Britain's roads wouldn't work.

The Association of the British Pharmaceutical Industry (ABPI) Code of Practice operates in a similar way. Now nearly 50 years old, and revamped several times, the CoP, has become an intrinsic part of everyday medicines promotion. It also encompasses other areas, such as information made available to patients, public relations activity, and the provision of medical and educational goods and services. Quite simply, firms have to mould their activities around the parameters set by the CoP, or they risk a crash. An overly promotional leavepiece or a bout of excessive hospitality to members of the medical community could well constitute a breach of the CoP and mean a firm is fire-fighting for its reputation, particularly in the more punitive environment that the ABPI insists it has created.

Toughest code yet
Make no bones about it, the latest version of the CoP is the toughest yet. The ABPI is also keen to stress that it is the most transparent. There are clear guidelines on gifts and hospitality, advertising in journals, and promotional aids and samples. Yet, as with any Code, there is still a lot left open to interpretation and, as the latest Code of Practice Review has revealed, companies are have fallen foul of the CoP. Abbott Laboratories' well-publicised breach of Clause 2, in that its activities over a period in 2004 brought `discredit to, and reduction of confidence in the industry' is the most high-profile transgression in recent times, and saw the US company crossed off the ABPI's membership list for six months, with future readmission subject to audits.

ABPI spokesman, Matt Worrall, says that suspension from the ABPI is one of the most severe sanctions that derives from the CoP, acknowledging the level of seriousness with which a mis-demeanour is viewed: Although the Abbott case was under the old Code, one of the things that will be coming out of the new Code is that with the more serious cases comes the provision for putting adverts in the pharmaceutical and medical press, so naming and shaming is very much part of the new Code.

In an opinion article in Pharmaceutical Marketing (April 2006), Roy Lilley questioned whether the self-regulatory nature of the CoP was adequate and whether the sanctions meted out to Abbott were sufficient.

There is a case for financial fines to be imposed for serious breaches, although no one seems keen to suggest exactly how much these should be in relation to the offences. The ABPI's regulatory arm, the Prescription Medicines Code of Practice Authority (PMCPA) discussed the idea during the last 18-month review of the CoP, but came to the conclusion that putting information on breaches into the public domain is the most effective form of punishment. Claire Ashbridge-Thomlinson, head of healthcare public affairs at PR firm Fleishman-Hillard, is of the view that fines are not necessary because the adverse publicity following serious CoP breaches, not only in the UK but internationally via the internet, amount to significant sanctions in themselves.

Medical consultant, Dr Joan Barnard, has written a 'user-friendly' practical guide to the CoP, The Code in Practice, fully revised and expanded to accommodate the 2006 CoP (www.codeinpractice.co.uk). When questioned as to whether she feels a fiscal punishment would be more appropriate for serious breaches of the CoP, Dr Barnard argues that naming and shaming of company breaches, coupled with the consequent damage to reputation, is the ultimate weapon to keep firms on the right side of the law and is equally as effective as a financial penalty.

There was quite extensive coverage of Abbott's case in local newspapers, as well as the medical press, so it undoubtedly damaged their reputation locally and with health professionals, she says. If a doctor reads something negative about a company in a medical journal, what is his attitude going to be the next time a rep from that company tries to make an appointment? Even if the doctor agrees to a meeting, how will he treat the rep?

She adds that several pharma companies consider a good reputation to be strong commercial advantage: Anything that damages their reputation is likely to affect their bottom line, and you can't quantify that at all.

Ashbridge-Thomlinson thinks that the main adverse effects for companies that break the Code will be in terms of bad corporate publicity, a negative shareholder reaction and also any public reaction by competitors giving comment on the breach. She is less convinced that doctors will put a red mark against those firms that have received a rap over the knuckles.

Doctors are under an obligation to prescribe in the best interests of patients, so it would be difficult, not to say inappropriate, for them to refuse to prescribe a brand on the grounds that its marketer had breached the industry Code, she says.

Squeaky-clean
Despite the recent tightening of the CoP, few would say that it will lead to a new squeaky-clean environment of drug promotion. Dr Barnard believes that some cases are borne out of difference of opinion on interpretation, and that companies acting in good faith have later found out to their cost that their marketing has broken the rules. She says that if firms do breach the Code, they have to decide whether that breach occurred as a separate incident (ie, a rep making a mistake), or whether it betrays some deeper failing within their management and procedures.

The first step in reputation management is to assess to what extent the breach is an isolated event that could have been avoided, as opposed to something that is a natural consequence of the way the company manages itself, she says. She gives the example of the Merck KGaA rep, who, with the approval of a doctor, gained access to patients' medical records in order to assess possible changes in their treatment options, a flagrant breach of patient confidentiality.

Merck [KGaA] established that the rep was not acting on company orders, that it already had procedures in place to deal with this kind of behaviour and took disciplinary action against the employee, she continues.

Speak up for yourself
Of course, any company that finds itself fire-fighting after a Code breach is inevitably going to have to speak to the media. Pharma firms do not enjoy much of a reputation for being transparent and open at the best of times, so when they find journalists hammering on their doors demanding answers as to why they've committed CoP crimes, the natural urge is to withdraw into their shell and say as little as possible.

Ashbridge-Thomlinson says firms should be as open as possible in revealing the exact nature of the breach, how it came about and the measures they have taken to ensure that a repeat situation does not happen again. In addition to issuing a comprehensive press release where there are serious breaches, company spokespeople should be ready to provide detailed responses in answer to questions from the media, and a well-briefed senior executive should be offered for interview.

Of course, reacting well to a crisis is one thing, but making sure that a crisis never occurs is another entirely. While companies can never completely rule out the possibility of one of their employees taking the concept of creative licence a bit too far, there are steps they can take to minimise the threat of falling foul of the CoP. Getting buy-in at management level is not the challenge; it is achieving the required trickle down effect to the front line troops which remains the key to successful compliance. Many companies have their own corporate codes of practice which are even more stringent than the ABPI CoP.

Heather Simmonds, director of the PMCPA, says that there is an enormous amount of training going on within companies to ensure that sales reps are not only aware of the Code, but also of the consequences of breaching it.

Most sales representatives' contracts are such that if they breach the Code, there can be grounds for instant dismissal, she says. There's a lot of discussion about CoP issues and circulation of the Review to sales reps to show them relevant cases which can be used as examples - the reports serve an educational purpose as well, she notes.

To ensure that they are doing their job properly, teachers are subject to OFSTED inspections once in a while. Simmonds admits that the PMCPA hasn't considered doing similar OFSTED-style random visits in pharma but does not rule out the possibility of it happening under a revised CoP in the future.

Dr Barnard says that audits, the pharma equivalent of the OFSTED inspection, are applied by the PMCPA only if a company is found guilty of a serious breach, as with Abbott, and points out that they are prevalent in other areas of the pharma industry.

The Medicines and Healthcare products Regulatory Agency (MHRA) does audits for pharmacovigilance and there are also audits in relation to clinical studies, she explains. I think there's an argument that routine audit, in relation to promotional practices would improve the system.

Having recently hired PR firm SantÈ to help promote the CoP, the ABPI is clearly keen to raise awareness of the Code among health professionals. A recent ABPI survey of 400 doctors apparently found that only 52 per cent of them were aware of the CoP, and out of those who did know of it, a staggering 70 per cent did not know how to make a complaint. The ABPI has issued updated guidance notes for doctors, which summarises the purpose of the CoP, how complaints are dealt with and some of the principal areas covered by the Code, including gifts and hospitality, training for staff, how promotional material is approved, and relations with the media and the public. The effectiveness of such a campaign is still up for debate, and depends largely on whether doctors will have the time or the inclination to read the literature.

Dr Barnard argues that rather than taking the CoP to doctors, it is better to expound to them the principle that when they work together with the industry, there are mutually binding requirements: I think to approach this from a Code point of view is not addressing the doctors' needs - they want to know specific facts, like what is supposed to happen when they go to a conference or a meeting.

The future of self-regulation
Going forwards, the industry will continue to back self-regulation to the hilt and the recent overhaul to the CoP demonstrates that commitment. Simmonds says that one key advantage of self-regulation is that complainants are fully involved in the process, and another is that the CoP is more flexible and can be changed much more quickly than UK law.

She points to the fact that the MHRA is a ardent supporter of self-regulation and sees it as the first means of controlling advertising. To reinforce the relationship with the government authorities, the PMCPA has produced a memorandum of understanding which sets out the interaction between the self-regulatory system and the statutory system.

As a general principle, self-regulation works well in most industries and avoids excessive bureaucracy and rigidities, says Ashbridge-Thomlinson. Along with defence, the pharmaceutical industry is one of the most regulated private sector industries in the UK. The new CoP is not just an internal industry document - it has been agreed after extensive discussions with the MHRA, and should prove to be successful.

Time will tell whether it is, given that the ABPI's latest campaign could spark a significant rise in the number of doctors making complaints, not to mention the fact that Herceptin's tabloid tag of `wonder pill' is now being questioned by sections of the media. Pharma companies know only too well in this post-Vioxx world of increased media scrutiny and around-the-clock global reporting that one small slip-up can soon balloon into a major event.

The safety belt may have been tightened, but there could be a few bumps in the road to come yet.

The Author
Gareth Carpenter is assistant editor of Pharmaceutical Marketing