For anyone that hasn’t read that McKinsey report (A vision for Medical Affairs in 2025, McKinsey & Company, 2019), or you are relatively new to medical affairs, the existential questioning that medical affairs self imposes may not be on your radar. However, in a nutshell, the report stated medical affairs would, by 2025, be the third key strategic pillar alongside research & development and commercial & access. As the natural owners of scientific data medical affairs were to step forward and “leave behind its former status as principally a support function and to forge a new role as a primary strategic pillar of the organization”.
As we near the end of 2022, and we cross the halfway mark, I’m assessing how we are doing. Will medical affairs deliver on this lofty goal? Have we finally started to make progress as a recognised, valuable, and discrete function within the pharmaceutical industry? Or are we stuck in a Groundhog Day scenario of endless copy approval and requests from sales and marketing for support on commercial projects?
From personal experience, some of the issues that medical affairs has historically faced include a disconnection from the larger business as a whole and a lack of clear and distinct purpose within the pharmaceutical industry. Medical affairs is a heterogeneous group, made up of scientists, clinicians, nurses and pharmacists to name a few. All have different backgrounds, training, and unique skillsets which makes the task harder than for other areas of the business.
One of the perennial questions that has arisen in the 10 years I have been in the industry is “What is the value of medical affairs?”. In fact, I encountered the question before I even secured my first role as a medical advisor in 2012! For my first few years in industry, I was so taken by its seemingly unanswerable nature, that when I lead a team of my own, I started asking them. This progressed to asking interviewees when hiring, even going as far as getting them to do a prepared presentation!
But what has been fascinating is the range and variety of responses. That same range has been observed when discussing with colleagues at professional meetings. The range covers everything from commercial optimisation, clinical research, sales and access, NHS and policy, patient engagement, data expertise, and innovation to name a handful. With such a range of responses, it does beg the question of whether we have found an answer.
To my mind, to answer the question of value, first we must define. Afterall, if you want to attribute value to gold, Bitcoin, or anything for that matter, you first need to define what it is. From this starting point you can state what it does or can do, i.e., the utility that it affords the recipient, and therein lies the value. The value is simply the collective agreement on how much of something a recipient is willing to part with to obtain the perceived utility. If we are going to define medical affairs, I believe we certainly need to include all the different stakeholders that make it up; medical advisers, scientific advisers, MSLs, etc. but also the stakeholders we engage with, namely sales, marketing, market access etc. Afterall, we work within the larger business so need to ask it what we ought to be doing.
So, what do we ask? We could start with “What is medical affairs and what do we do?” Or another approach is to state, what can (we) medical affairs, and medical affairs alone, do? In my ten years in the pharmaceutical industry every job description I have seen has the following listed as core responsibilities (the language may vary by different companies, but whether a junior medical advisor, MSL, or a medical director, all that changes is the emphasis and responsibility, not the scope):
- Data generation
- Data dissemination
- Governance and compliance
- Non-promotional activities
- KOL mapping and engagement
Data generation and more specifically the generation of real-world evidence was the crux of the McKinsey report. Every company I have worked at, these types of activities have been handled by R&D or epidemiology/market access. However, to my mind this is really a task that sits within R&D as they are the function that deals with data handing and management and need for statistical support and writing. Affiliate level medical affairs on its own would appear to be woefully unskilled and unprepared to deliver these projects, but I appreciate global medical affairs is skilled and does deliver. However, the bulk of medical affairs headcount lies in the affiliates, not in global roles.
What about data dissemination and communications? Yes, medical affairs certainly talk data, but if we are talking about getting messages across to clinicians then this isn’t a specific medical affairs task. Rather, it’s exactly what sales and marketing is all about, getting the right message to the right customer to promote the brand. So, while medical affairs certainly does communicate data, we are not a data communicator function per se; it is simply a tool we utilise.
Compliance and medical governance are certainly areas of the business that traditionally land on medical shoulders. However, in the UK this has become a quasi-legal activity and approval and “sign-off” are very UK specific activities built up because of the ABPI and self-regulation. It is no doubt an important task, but outside of the UK is not considered a core medical affairs activity and often resides with legal or regulatory affairs.
Non-promotional activities may include disease awareness, medical education, patient engagement and the like. Many non-promotional tasks within the pharmaceutical industry are perfectly acceptable to be done by commercial functions operating in a non-promotional capacity. After all, sales representatives can deliver MEGS (or now referred to as educational goods and donations) if separated from any promotional activities. Indeed, most disease awareness and medical education I have witnessed have often been successfully delivered by marketing. So, while this is a facet of medical affairs activities, it is not unique to medical affairs or a differentiating skillset.
So that leaves us with KOL mapping and engagement. This needs a bit more explanation behind it, as what I’m referring to is mapping and engagement with the right KOLs to gather insights (via active listening), engagement with KOLs at advisory boards to seek specific advice and appropriately discuss various topics with through scientific exchange – a mutual, peer-to-peer level engagement – on the science. This may include reactive product conversations. Now, this is where the law and regulation make things interesting. By law, company personnel operating in a commercial capacity are not permitted to discuss off-licence or pre-licence content, as that would constitute off-licence/pre-licence promotion which is illegal. However, since medical affairs is a non-promotional function, it is permitted to discuss these topics as long as in doing so they don’t promote the medicines about which they are discussing.
Therefore, for me this is the most likely area where medical has a distinct and clear remit and therefore value, namely in appropriate KOL engagement and scientific exchange upstream of a marketing authorisation. Ideally this would be around 2-3 years prior to marketing authorisation as this can then lead to a solid medical foundation to springboard a successful commercial launch. And it’s interesting to see that some pharmaceutical companies are embedding this model. Does it work and can the value be measured? Well, time will tell, but a good surrogate will be the success of their product launches.