Compliance: The Underdogs

Words by James Coker

Successfully co-creating services and products with patients has felt like drinking from the holy grail for the pharmaceutical industry in recent years. But ensuring this aspiration ultimately develops into something more concrete than a Monty Python film requires a new type of relationship to be built with a department that is not always viewed in the most favourable of lights: compliance.

“I think compliance is the elephant in the room; it’s the issue that has to be addressed for an organisation to feel comfortable in going out and working with patients”, comments Geraldine Murphy, Vice President, Cluster Europe North, Australia & New Zealand, LEO Pharma, during the eyeforpharma Patient Summit Europe.

It can be tempting to compare compliance officers to a pompous bank manager, taking delight in denying loan applications based on spurious technicalities. Hearing ‘compliance says no’, or words to that effect, is a major source of frustration when exciting new initiatives are stopped dead in their tracks.

Far from being deliberately obstinate, however, compliance personnel are driven by the desire to protect their company’s interests. Additionally, the consequences of making the wrong call can even have legal implications for individual compliance officers. “Very often, we find ourselves having to make decisions on very little information and worst case, there are no regulations, and so we have to think about the risk we are covering and then make a decision. And even with the best intentions, the decision can be a roadblock”, explains Manuela Bruegger, Compliance Officer, Novartis.

Have us as part of the discussion and not at the very end when we have to say no

To add to this picture, numerous new regulations affecting pharma companies at a global level, particularly when collaborating with patients, have come into force over recent years. “We all know that the regulatory environment is becoming increasingly tough”, notes Paul Simms, Chairman, eyeforpharma.

A regular scenario is one of great ideas being delayed or even failing to see the light of day due to tedious bureaucratic red tape. To overcome this frustrating situation, a fundamental rethink is required regarding the input compliance currently has, to become heavily involved from project conception; this is the polar opposite to being forced into making a binary yes or no decision based on information passed to them at the end of the process. “One of the biggest challenges for patient organisations is the bureaucracy and the never-ending list of details that we need to have”, acknowledges Bruegger.

Early clarification for all parties as to regulatory and legal requirements on a given project could make all the difference. “This is a call from me as a compliance officer to have us as part of the discussion and not at the very end when we have to say no; have us at the very beginning because we truly can make a difference. We can be there, we can help you find a solution”, says Bruegger.

It is time for compliance to step out of their silo and engage with internal and external colleagues in a much more overarching way than is currently the case, beginning from the initial discussions of an idea with patient organisations. It is incumbent on both compliance departments and other areas of pharma, be it R&D or marketing, to cross the floor of the house and enter a permanent state of coalition to make this happen.