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Is there a difference?

The gap that exists between marketing aims and compliance is little more than a perception

Just how big is the gulf between the aims of pharma marketers and the need for compliance? Talk to many marketers and they will tell you that it is considerable. Talk to the medics who are often responsible for compliance within marketing functions and they will confirm that belief.

Everyone knows that the job of marketers is to sell products, while the role of the compliance function is to make sure that the way the product is sold falls within the Association of the British Pharmaceutical Industry (ABPI) Code of Practice.

By inference, this effectively means that compliance, and those responsible for it, are inhibitors to the pursuit of quality in marketing. Indeed, those responsible for compliance are often referred to as the sales prevention team.

However, there are some fundamental flaws with this mode of thinking. Firstly, it presumes that compliance is a bad thing. Secondly, it presumes that anything that is compliant is less effective than things that are not. Thirdly, and perhaps most concerning of all, it assumes that the value of compliance is (at best) misunderstood and possibly even held in contempt by some of those to whom we entrust our very future as an industry.

Good versus bad
Is compliance really such a bad thing? Is it really something that will damage our ability to sell products effectively? 'Compliance' is certainly not a word that resonates positively with everyone at present. However, there is always more than one way to look at a subject. For example, if we regard compliance as 'conformance with a set of requirements', it enables us to approach it from a different perspective - that of quality.

'Conformance with requirements' is a phrase coined by a famous American management guru called Philip Crosby. While Crosby is often quoted in marketing and MBA text books, he is actually an expert in the field of quality assurance. Crosby began developing his thinking around business strategy and long-term business success when he worked in a manufacturing environment.

We have all heard the phrase 'right first time'. Crosby conceived it. His fundamental belief was that the achievement of high-quality is absolutely necessary in order to ensure long-term market success and therefore the pursuit of quality must be built into every corporate strategy.

Crosby's expertise within manufacturing was driven by his beliefs on how to achieve consistent high-quality in production plants. At the time he reached prominence, the primary method of quality control was to inspect the finished product and to reject those items and batches that did not meet the required specifications.

However, Crosby preached the need to investigate the reasons for the failures and asked then that management take action to address them. It seems obvious now, but at the time (in the post-war mass-production era) this was radical thinking.

He helped drive the shift in emphasis from 'inspection' to 'prevention' in order to improve the quality of manufacturing outputs. But he didn"t stop there. He also promoted the idea that quality could be measured objectively and therefore that quality could be controlled. In order to do so, however, it was necessary to establish requirements (or objectives) for the quality level which was to be achieved - in short, it was necessary to achieve conformance with a set of targets.

In order to define those targets, it was necessary to identify who the customer was and what they wanted. So now we have a quality management guru talking about identifying customer needs.
Of course, Crosby's work was mainly based in manufacturing, so we could argue that it is not relevant to pharma marketing. However, Crosby's thinking can be applied to most industries and most companies - including pharma.

In one notable study, he compared a major manufacturing unit (a car factory) with a major service company (a bank). He concluded that around two-thirds of all staff employed in both industries actually provided support to the third who manned the front line, which in this instance was regarded as the main production line and the customer-facing bank clerks.Crosby also went much further, proposing that even those on the front line wereproviding a service to someone else; therefore just about every person in every industry could be regarded as being in a service function. (The only exception was professional blood donors, which he claimed should be regarded as a resource).

Crosby asserted that the same principles are true in all industries, therefore within your local marketing functions, if you have a set of requirements that you believe need to exist, you should be doing everything to satisfy those requirements. Of course, one of the sets of requirements is the Code of Practice.

Achieving quality outputs
In order to achieve high-quality outputs in manufacturing, pharma does everything it can: good quality materials and excipients; highly controlled processes; highly calibrated machinery and
rigorous inspection. Those in the marketing companies might grumble that a bit of a 'batch failure' causes uncertainty in the continuity of supply, but are also reassured that manufacturing compliance processes are protecting patient safety while identifying and stopping faulty products. My own belief is that there are obvious parallels here with the ABPI Code of Practice.

There are some people in the industry who question whether the existence of the ABPI Code is a good thing or not, but let"s put that particular debate to one side and revisit it another day. For the purposes of this article let's assume that managing directors at all the ABPI member companies signed up to the Code because they believe it is a set of standards that matter: a set of 'requirements' we should conform to. If that is the case, then perhaps we could consider applying Crosby's principles of quality management to marketing campaigns. Crosby's principles are very simple:

  • Identify your customer
  • Conform to their requirements
  • Prevention is better than inspection
  • Explain the cost of non-conformance in monetary terms.

If you were to apply these principles to pharmaceutical marketing, then first you would need to identify who your customers are and their requirements. Obviously, since that is what marketing is all about, you already comply with the first two principles.

Well actually, not quite. In this context we need to consider the requirements of all of our customers. The internal and the external. The prescribers, the shareholders and the consumers: not forgetting the wider stakeholders such as the government and the media. In one respect at least, the ABPI has already done the baseline work for us and published it as the Code of Practice. All you need to do is apply it and personalise it for your individual marketing campaigns.

But let's be honest, why bother? If the penalty for breaking the Code is so minor - a slap on the wrist, a bit of 'outing' in the media and a minor fine - what's the issue? To answer that point, we need to return to Crosby again and his fourth principle of quality - explaining the cost of 'non-conformance' in monetary terms.

Economic impact
What is the cost of having to redo a marketing campaign (because it has been found in breach)? Remember to include the cost of taking the salesforce off the road for a day to train them in the new campaign (and the cost of the meeting room itself). There is also the 'opportunity cost': the business not gained because the reps are off the road and the delay in the next campaign because this one has to be reworked. What about the loss of salesforce confidence in the campaign? Just what is the difference in value between a confident rep and an under-confident one?

Of course, the claim will have been seen by your customers for a while before your competitor forced you to withdraw it (although increasingly it is customers who are making complaints). However, only the marketers know whether the claim was out there long enough to justify the cost of its non-conformance.

Mind you, the non-compliant claim might not have reached the market. The sign-off process may have done its job and (with regard to Crosby's third principle) the earlier this happens in the process, the less costly it is for the company.

Remember that you also need to consider the impact non-conformance (with marketing regulations) has on your biggest stakeholders - the general public. It's all very well, for example, having strict regulations governing how you manufacture tablets and how you have to monitor safety, but if all the public read in the newspapers are stories about inappropriate hospitality being offered to prescribers then their perception of the industry remains relatively poor.

Then their belief in the industry and its products diminishes. This may go some way to explaining why, when product patents expire, your consumers do not object to being given a new brand (or even a totally unbranded medicine). Their acceptance of the generic alternative is despite the fact that they had (in some cases) literally trusted their lives to the original brand for many years. Would they accept the substitution of Tesco's cola instead of Coca-Cola with such subservience?

If we accept that Crosby's quality principles can apply to pharmaceutical marketing then 'conformance to requirements' takes on a new meaning. In which case, so does the need for 'compliance'. It means that the underlying principles of compliance become aligned with the fundamental principles of marketing.

So tell me again about the size of the gulf between the aims of marketers and those of the sales prevention teams?

Steven Gray is a chartered marketer and former compliance officer who specialises in providing compliance services to the pharmaceutical industry.

30th April 2007


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