Beyond Compliance: The Real Role of Medical Affairs

The role of Medical Affairs within the biopharma industry has undergone significant evolution over the past two decades, but not all of it has been positive. 

Historically, Medical Affairs was positioned to guide the late-phase development of a new medicine, ensuring that the science behind it was accurately communicated, both internally and externally, guiding healthcare professionals and stakeholders with up-to-date, research-backed information. As such, Medical Affairs occupied a unique space between R&D, commercial teams, and external stakeholders like physicians, patient advocacy groups, and regulatory bodies. 

The core purpose of Medical Affairs today remains the same: to ensure that medicines are rigorously characterised in late phase clinical development and in the real-world, and that the scientific and medical evidence surrounding a therapy is clearly, ethically, and effectively communicated to those that need that information - ultimately in pursuit of improved patient outcomes.

However, in many cases on the ground, the core role of Medical Affairs has drifted, primarily due to its entanglement with compliance requirements. 

In response to increasing regulatory scrutiny and corporate compliance pressures, Medical Affairs has, all-too-often, become a policing arm within biopharma companies, spending far too much time and focus overseeing the activities of Commercial departments. 

So, at present, although Medical Affairs departments should play a central, value-adding role, they have increasingly been co-opted into compliance duties that detract from the original mission. This is not the reason that Medical Affairs was created, and threatens its position in the future. 

Whilst compliance is undeniably crucial (we do a fair amount here at LUCENT, and compliance is an entire module of the LUCENT Academy), this ever-expanding responsibility shift into a quasi-regulatory function has diluted the Medical Affairs department’s scientific, clinical and strategic contributions, effectively hindering its capacity to fulfil its true potential as a bridge between science and patient care, leading to lost opportunities for value creation within our industry.

In effect, the function that should be the scientific voice of the company has been relegated to a role focused on limiting risk rather than driving value – the appropriate implementation of new medicines into routine clinical practice.

This shift has also introduced a misalignment between the skills of Medical Affairs professionals—many of whom are trained scientists or clinicians—and the tasks they are now required to perform. Instead of focusing on areas like strategic planning, evidence generation, scientific communication, and real-world data analysis, they spend substantial time on compliance checking and approval. 

This misalignment not only undermines the morale and engagement of Medical Affairs teams, but also hampers the industry’s capacity to provide credible, science-backed information to stakeholders, reducing the overall positive impact on patient care.

In its ideal form, Medical Affairs should be leading efforts to generate and disseminate evidence, educate on disease states and therapeutic options, and partner with external stakeholders to identify unmet needs. It should be proactive, working with R&D to shape clinical development plans based on real-world insights, or collaborating with commercial teams to ensure that messaging is scientifically robust and supports patient health. When constrained and distracted by compliance duties, however, Medical Affairs cannot fully deliver on these responsibilities.

For every hour that your Medical Affairs team spends policing marketing materials, they’re not adding either scientific or commercial value to the organisation or the medicines they work on. 

The future of Medical Affairs lies in redefining and reclaiming its place as a value-adding function. This means a structural separation between compliance and Medical Affairs functions, freeing Medical Affairs experts to prioritise scientific rigour and innovation over cross-functional policing. 

By focusing on evidence generation, scientific communications, and engagement with the healthcare community, Medical Affairs can return to its core mission: facilitating scientific integrity and improving patient outcomes. This shift will not only lead to more impactful and higher-value Medical Affairs teams that create a more significant impact on patient health (which is ultimately the raison d'être of the biopharma industry), but could restore morale within Medical Affairs team, improve the reputation of the function and serve to attract new talent to the specialty.

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It’s time that we reassess the role of Medical Affairs. The LUCENT team works tirelessly to shift perceptions within biotech and pharma organisations across the world. We have demonstrated how (even relatively small) changes to workflows and time spent managing compliance can dramatically increase the output and commercial value of Medical Affairs teams. 

With Medical Affairs teams under increasing pressure to appease multiple stakeholders, and shifting goalposts making it more difficult than ever to deliver, is it time that we let them focus on what they do best?

If you’d like to generate more value from your Medical Affairs team than ever before, book a call with our world-class biopharma specialists today. 

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