Compliance is often perceived as impeding interaction. Better go the extra mile of involving compliance early on.
Dealing with risks and side effects in a responsible way is everyday practice in the pharmaceutical industry. That said, the risk of violating compliance regulations pervades the industry to a much greater extent than most others. New projects involve a broad spectrum of guidelines and the common reaction in companies is that of a deer in the headlights: in an attempt to not put a foot wrong, not taking a step seems like a good idea.
When it comes to new fields of interaction, the practices needed to keep things flexible are often lacking. The question needs to be addressed: how can we explore these new fields without setting ourselves on a collision course with compliance regulations?
Setting the parameters for action
A Metaplan case study: The marketing department of a pharmaceutical company wanted to better understand therapeutic considerations in medical indications during interactions with doctors. The project was set up as a goal-oriented program with the aim of better aligning marketing department goals with what happens when a prescriber is in a decisionmaking situation. The issue with these kinds of discussions was twofold: first, it is possible doctors would bring in examples from their own practical experience with the medication in question. Second, they may discuss what happens if the approved dosage is exceeded. For doctors, both activities form part of their day-to-day work. For marketing departments, however, they are strictly out of bounds in terms of conforming to compliance guidelines. This led compliance officers to insist on putting a comprehensive conditional program in place that meticulously monitored every single interaction with doctors. Marketing continued to operate as it always had in these situations: new guidelines would cause a stop of action without attempt to negotiate room for maneuver.
This kind of defensive attitude was no longer satisfactory. Marketing set itself the task of figuring out with compliance officers how complying with regulations could go hand in hand with interactions that were viable from a marketing perspective. Marketing then took the unconventional step of suspending the ‘detailed monitoring’ undertaken by compliance management. At the same time, compliance management was brought in to help find a way to balance the constraints of the conditional program with achieving the objectives of the goal-oriented program. Only when compliance managers understood the interactions that took place, were they able to convert regulations into manageable decision premises.
Exploring possibilities together
The challenge for marketing was to be able to demonstrate unbiased ways interactions could comply with regulations without coming across as being a potential rule breaker. This was achieved through openly involving compliance management in the process and together conducting a meta-discourse on the issue of how marketing should operate. As a result, compliance officers could fully understand the rationale behind how marketing operated. In the end, they were able to make an informed decision on which compliance regulations were appropriate and which ones needed to be amended. For example, the conditional program for external bodies proved more flexible. Therefore, external agencies should carry out preliminary discussions with doctors. Moreover, conditional program regulations are also less restrictive for workshops, so experts from the company’s medical department were brought in for them. This led to the development of a conversation that was relevant to doctors, where practical rationales were explored. It furthermore meant participants acted in a way that conformed to regulations throughout the compliance process. Also, by applying strict regulations on a trial basis, the organization learned which level of compliance actually made sense. As a result, new possible courses of action with greater flexibility for all could be explored.
DR. SEBASTIAN BARNUTZ
is Partner at Metaplan and a keen advisor in strategic planning and the intra-organizational powerplay.
This article has been published in Metaplan’s new international Life Science magazine ‚connect‘.
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