Challenging the Current Compliance Paradigm

Jul 10, 2017

The compliance paradigm in pharma is flawed. My evidence, I confess, is largely anecdotal but as in medicine, a weight of anecdotal evidence does warrant further investigation and these are not simply my own observations. If you provide an opportunity to express frustration with “compliance”, you can hear the problems for yourself. In no particular order and without any claim to being exhaustive, here is a list of some of the things I heard from a mixed medical and commercial group to whom I gave the opportunity to vent.

Amongst other things, compliance was described as boring, inadequately explained, arbitrary and unmemorable, a legal exercise to apportion blame when things go wrong, and tribal.

From a business perspective, one could perhaps reasonably say “so what?” to most of this. So what if compliance is made boring? Lots of jobs are boring. So what if it appears arbitrary and a legal exercise? The company has to cover its responsibilities in law. So what if it is tribal? Medical and commercial functions have differing roles and objectives. In themselves perhaps these aren’t problems but they do reflect a compliance paradigm that has negative consequences for our business and society. It is a paradigm in which the central flaw is the belief that rules are the sole protection against immoral behavior and individuals cannot be trusted to reach good decisions.

Consider for a moment how commercial ideas are developed and progressed. An idea is created by a brand team (a sales aid, a meetings programme or a website) and it is flung with its details at a compliance sieve; what takes place is whatever gets out the other side. Too often that is very little or nothing. The compliance sieve is getting finer and finer as more and more mesh is added, not by regulators, but voluntarily by companies. This is in the mistaken belief that more rules make things clearer and less risky: doing nothing is compliant, surely the fewer things we can do—the more compliant we must be.

This “do-nothing default” may achieve compliance but it is ethically deficient; if a programme of education and communication in a neglected disease area is abandoned because of a small imagined risk, compliance is achieved, but no-one is helped and the ethical equation is in the negative. Worse perhaps is that doing nothing is more usually not even a conscious decision; it is simply a consequence of uncertainty about the what is allowed and fear of repercussions that leads to inertia and projects ending up in the long-grass that has grown around them.

The obsession with adding internal company compliance rules not only engenders inertia it also undermines the very thing that most protects the pharmaceutical industry; the ethical good sense of the people within it. Every time a new compliance SOP is issued, dictating the actions an individual MUST take in a particular arena of activity, it restricts further the need for that individual to decide for themselves. That may be the aim, but simultaneously it removes from the individual their accountability to do the right thing; they must comply with a course of action—not decide a course of action, they must learn a rule—not understand how to make a decision.

None of this is to say compliance regulation within companies is unnecessary; it is only to say it is not a panacea to address the ethical problems the industry gets itself into. We cannot write a rule for every scenario and we should stop trying to. Lay out basic expectations and critical process to get things done but let’s stop trying to dictate every action, or identify every possible wrong.

Just as internal company compliance regulation needs to change, so too does compliance education. We need the good people in pharma to think and we must empower them to do so. The pharmaceutical industry employs people with well above average intellect who in their day to day lives have formed views about some of the most complex moral issues humanity has faced from euthanasia to stem-cell research to capital punishment and beyond. These are people we should trust. Compliance education should utilise those natural ethical abilities, making the links between morality and compliance strong and intuitive such that being compliant is not seen as a company hurdle but a personal moral obligation.

In amongst all this there are some specific challenges upon which reflect some longstanding and fundamental compliance misunderstandings. For instance, much of what we can get wrong in pharma occurs when companies promote medicines badly yet we have seen in our training surveys that what people understand by the term “promotion” varies massively even within the same company. Detailed SOPs are written about the actions necessary to avoid off-label promotion without anyone stopping to consider what people understand by the term.

I am proud to work in the pharmaceutical industry and I know I try to do the right thing irrespective of the fact there are rules in place to discourage me from doing bad things. I believe the vast majority of those in pharma are the same and it is time our compliance paradigm recognized that, both in the rules we write and the education we provide. Across companies the emphasis of compliance rules and compliance education should be to recognize and empower ethical decision-making, to enable rather than discourage the work we do for patients and society.

Dr. Nick Broughton (@makarahealth) is a consultant and trainer in pharmaceutical ethics and compliance.









Changing the Current Compliance Paradigm

As a food and drug lawyer and life science compliance officer for the past 25 years, much of Dr. Broghton's expressed frustrations have merit. However, those frustrations do not address the challenge, but merely perpetuate the complaints with the current state of compliance. In large measure, the current compliance paradigm is the product of its environment where Government regulators push company's to write more rules to address perceived infractions. It also is the product that we have forgotten our history - compliance programs were never intended to prevent all infractions, but to be reasonable. Finally, because many in the industry do not fully value the nature of the work that compliance professionals do, it is hard to attract and retain the best talent. All of this can be remedied, but it starts with a conversation. We must talk amongst ourselves, with our stakeholders and with our regulators. Absent doing so, we are condemned to continue the current failed paradigm that Dr. Broughton sees. -- Dr. Seth Whitelaw

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