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Is self-regulation of promotion in the UK pharmaceutical industry working?
Brad Abbey, industry observer,
The February 2002 review of the Prescription Medicines Code of Practice (PMCPA) activities gave us an unsurprising summary statistic that the number of complaints about the promotional activities of the pharma industry in 2001 did not drop compared to previous years.

Since the PMCPA's establishment in 1993, the number of complaints per year has ranged from 92 in the year it was formed to the vintage years of 1994 and 1997, where there were 145 for both. The current batch of 138 complaints is clearly indicative that some think the industry is not toeing the line. What is also clear is that many of the complaints are inter-company disputes (60 complaints), which exceeds the number of complaints coming from 'health professionals' (57). What is fascinating is that ten (7.2% of all complaints) were anonymous. The authority excuses this by suggesting that half of these were from health professionals who did not want to identify themselves, although it is difficult to give a good reason why any doctor who feels strongly enough to complain should not stand up and be identified.

The arms trade

To help understand what is going on, one can do no better to think about what the pharmaceutical industry does. It sells products to healthcare professionals who do not pay for them, and by and large they are administered to people who neither pay the market price for them, nor understand any of the processes by which the choices are made. In other words, the sales are made to the middleman, and the only other trade that is any way similar is the arms trade - think about it. If you were a patient, you would hope that your country's money was being spent in the best possible way, and you rely on your doctors to do that without any other influence than the clear judgements needed to arrive at that point. One would not be surprised, being faced with such an obvious road to hell, that the country would insist on regulating the process so that the taxpayers were not stiffed. Strangely enough, that is not the case, and there is a self-regulatory process - intended to curb the worst excesses of the marketers and salesmen - so that when the salesmen come to call, the prescribers should not be hoodwinked. The intention is to protect the profession from the excessive zeal of the industry and the patients from the consequences of this. All very laudable. However, the current state of the game is that for non-generic medicines, there is all to play for. The problem is whether he who dares wins.

All's fair in love and war

If a company has the only effective and safe treatment for disease X, there is no problem. You can politely tell the doctor the facts of the case, there is no need for anything but a presentation of the technical facts that outline the pro's and con's and that's it. The moment that another company comes up with the second treatment, if it differs in any way, war is declared, with the Code the rules of engagement. But all's fair in love and war, and if the rules can be re-interpreted or ignored, then popular opinion says that the chances of victory improve. Even in the regulated marketplace of ethical medicines, the name of the game is to succeed against the competition: emphasise product advantages and maximise the shortcomings of the opposition, look for scenarios where product A is better than product B, and make sure the doctors hear it - all within the Code's tricky framework. The glittering prize goes to the marketer who pushes the boundaries of regulations to the point where one micron more would be a breach.

But breaches of the Code occur all the time - the Code itself, which details only those complaints that get that far, confirms that. If the Code is supposed to protect the customers and patients against the worst excesses of the industry, is it really achieving that end, or is the Code of Practice Authority acting like the speed camera of the industry - just catching the offenders when the camera and film are operating, making it a risk-taker's environment? Arguably, the Code is a collection of random rules that is supposed to protect the vulnerable, but only succeeds in randomly persecuting companies, and does not improve the real ethical sales environment. One criticism that is frequently levelled against the way the Code operates is that is seems to defy natural justice. Once an intercompany complaint is made, it is not for the accuser to prove that an offence was committed, but more for the defending company to prove that no breach was committed. On the way, the Code of Practice Committee may chose to uncover other issues that neither accuser or accused had even thought of in the first place. Consider the case of the anonymous complaints, which are potentially one of the best ways to waste the time of a competitor company. The Committee says that it takes each and every one seriously, and investigates them. The accuser does not have to prove anything, and if wrong, nothing will happen to them.

Imagine if such a thing existed in criminal law in this country. If you did not like your neighbour, you could write an anonymous letter to the police saying he had murdered his wife. The police would arrest and charge him even if there was no evidence that he actually had a wife. He would have to prove that it did not happen. It sounds like the basis for anarchy. By the way, the police would also be entitled to look through his house to see if there was as much as an overdue library book, so they could make something stick. This sounds crazy, but this is potentially the way the Code could work.

The anonymous complaint system is arguably one of the worst features of the way the Code works. It is even acknowledged in the review of the Code that the five anonymous complaints that were alleged to have come from health professionals might not have. By now, creative product managers will be slavering. All they have to do to tie their competition in knots is to look in the medical directory for a suitable doctor's name, which they can keep secret, and accuse their main competitor from everything from failing to leave a notepad to the assassination of JFK.

It is also a disgruntled employee's dream come true - don't get mad, get even. It does not even matter if the accused company is exonerated; the amount of time, effort and money that is wasted in defending cases is huge. Most companies wishing to defend themselves will devote senior executive time to creating and presenting written and verbal defences. There will be many man/woman hours spent in meetings honing the response to perfection, all to satisfy an unknown accuser, who may actually be the enemy within. It seems probable for most companies that it would be more cost-effective to not defend minor breaches, and pay whatever administrative costs are levied by the Code. It works out far cheaper in the long run. Most breaches of the Code are pretty boring technicalities. They get lost among the many and are forgotten by the outside world. It is only the spectacular ones that are remembered.

Branded coffee mugs

A pertinent question is whether complaints from the medical profession are relevant and whether they really reflect bringing the industry into disrepute. The interaction between the industry and the Code makes the industry its own worse enemy. Given that the nature of salespeople is to sell, it is hardly surprising that they don't act like altruistic advisors. One of the most vulnerable areas for committing a breach is the offering of promotional items. The Code is understandably trying to prevent what is essentially bribery: you prescribe my product and I will give you the latest thing you never knew you wanted. The two main prophylactics are keeping the cost of items to 6 or below, and insisting that the donation is not conditional upon granting an interview or more. The industry sees the 6 not so much as a limitation, but more as a challenge. It is amazing what can be procured within this limit if your buying power is right, and that clearly gives those companies with big buying power the edge. What is the point of a promotional gift if there is no territory to be gained? Does anyone ever look at the brand name? Why should a representative have any interest in visiting a doctor's surgery to be told there is no chance of a discussion, but being asked to leave all the goodies - it just doesn't make sense. Think about the London GP who had his picture in the medical press for having the biggest collection of medically branded coffee mugs. I bet he didn't care what was printed on any of them.

My advice to the Committee would be to prohibit promotional gifts entirely. Quite frankly, there is nothing quite so disgusting as watching well paid doctors demeaning themselves for the chance of a peculiarly shaped pen - they should grow up and act like professionals. But it's all within the Code, so it must be OK.

One of the least satisfactory types of breach of the Code is where there has been a dispute between a health professional and a company about what was discussed between them. For the most part, because of the lack of objective independent evidence, they boil down to 'my word versus your word.' (For strange examples of this look at cases 1226 and 1227 in the Nov 2001 review.) Again, these cases exemplify the willingness of the Authority to allege breaches in the absence of evidence, placing the onus on the accused to prove their innocence.

The review is only the tip of the iceberg. As an observer of both doctors and the industry, I witness bizarre breaches of the Code precipitated by both sides. I know of representatives who have telephoned doctors to fake visits (presumably because they are pressurised to make the quota), doctors who demand to be taken for meals at expensive restaurants (which can be difficult to refuse if the doctor implies that he/she may cease prescribing your product), doctors who persistently bring their non-medical wives to professional meetings, and representatives who turn a blind eye to the practice.

Most breaches are never heard about and unfortunately the ones that do bring little credit to the Authority. What sense does it make that a road atlas is not relevant to the practice of medicine but a clock is? Sometimes the rules make as much sense as Mornington Crescent.

So, for aspiring product managers of the year, remember that when you receive that fax from the Code of Practice Authority, don't get mad, write an anonymous letter and get even.