To evaluate the full impact of Medical Affairs, there needs to be a complete appraisal of the value provided to all its stakeholders, both externally and internally. In most organizations, Medical Affairs represents the voice of the patient, providing a thorough understanding of the patient experience based on clinical insights, and through work conducted with patient advocacy groups (PAGs) [8]. This close relationship manifests into supporting pathways for early access of medicines and impactful patient support programs. Medical Affairs may not be the only function tasked with these insights, as some larger pharmaceutical companies may also employ a dedicated Patient Support function to gain a robust understanding of this key stakeholder.

Healthcare professionals are another critical stakeholder, and their perspectives are typically conveyed by the Medical Affairs group to other functions within the organization. The Medical Affairs function is often responsible for engaging with clinicians through the establishment of collaborative relationships during early KOL discussions and advisory boards, prior to the launch of new medications. The function builds constructive collaborative partnerships with clinicians providing value through the sharing of current data, establishment of advisory boards and medical education opportunities, clinical trial involvement and pipeline discussions that contribute to the ongoing development and optimal use of new therapies [8]. Although it is important to distinguish field Medical Affairs roles (i.e., MSLs) from commercial field roles (Sales), there is a distinct place for each function to provide the HCP a full offering of both scientific education (MSLs) and product promotion (Sales). With HCPs now opting for fewer promotional discussions, there is a transformation of the original sales position to become more of a product agnostic role in the form of a ‘disease management partner’ [9]. The scope of these new roles must be carefully considered to ensure they are compliant, and complementary to the MSL function so as to not create further confusion for HCPs. In some companies, these ‘hybrid’ roles are led by Medical Affairs, replacing both the sales representative and MSL roles.

Paradoxically, in a function that is a voice for the patient and HCP, Medical Affairs at times struggles to voice its value to internal stakeholders [8]. Although Medical Affairs can be succinctly perceived as ‘pre-launch champions and scientific experts’, the function has much more to offer, as highlighted in Fig. 2. With the patient as the central focus for the organization at large, Medical Affairs can serve to link patient experience and HCP insights into the quality use of medicines, driving overall stronger decision making for the organization on the optimal place of a particular intervention. The greater recognition of real-world evidence (RWE) for patients, HCPs and health technology assessment (HTA) bodies has dramatically prioritized the need for evidence generation. Real-world data generation coupled with medical information dissemination helps to shape practice by ensuring that high-quality scientific data is provided to HCPs to advance the full therapeutic area paradigm from screening to diagnosis, acute treatment and finally on-going management.

Multifaceted value of Medical Affairs to the local affiliate. H healthcare professional interactions; I institutions; P patient organizations

Upholding compliance and governance expectations are the responsibility of all functions within the organization. Medical Affairs, due to its unique position of engaging with HCPs and patients across the full product life cycle, assumes a broader scope of responsibility to ensure that quality practices are maintained, continuing the license to operate and supporting the corporate reputation of the affiliate [10].

Successful partnerships with external stakeholders are vital in policy shaping and the creation of a robust healthcare system. The position of Medical Affairs as the scientific external face of the organization provides opportunities for the establishment of innovative partnerships that contribute to the shaping of policy and therapeutic area environment. Medical Affairs is positioned at the center of the interactions between the patient, medicine, health technology and the healthcare ecosystem, bridging the gap between all of these stakeholders to foster improvement in patient outcomes [8]. Due to the need for broad collaboration across diverse stakeholders, the Medical Affairs function is a source of internal talent that can be developed to fulfill senior leadership roles within the medical function or broader enterprise leadership.

The value of Medical Affairs can also be examined through a stronger focus on key activities throughout the lifespan of an innovative molecule from bench to bedside (Fig. 3). Medical Affairs typically provide input on the basic science of the molecule, outline the patient journey with insights into screening, diagnosis and challenges associated with clinical management, provide epidemiology figures and predict the future competitive landscape when the intervention is launched, thus contributing to the business case. The increased level of collaboration between affiliate and regional teams early in the medication lifecycle (phase I/II) can lead to better identification of local high-quality clinical trial sites, broader input through KOL engagement in international advisory boards and pathways of access to provide patients with earlier access to medicine. Furthermore, the collaboration with regional or global functions supports RWE gap analysis to ensure that necessary local data is generated in a timely way to positively impact reimbursement discussions, or later in the growth phase of the medication for population subgroup analysis.

Key Medical Affairs activities across the lifespan of the medication. HCP healthcare professional; IIR investigator-initiated research; KOL key opinion leader; MSL medical science liaison; PSP patient support program; RWE real-world evidence

The engagement of Local KOL stakeholders is led by the MSLs, who seek to gain an in-depth understanding of the therapeutic landscape and respond to reactive requests for information on the introduction of a new medication. The primary function of the MSL is scientific exchange, fostering RWE generation, gathering insights and supporting clinical trials; hence, the deployment of this role is ideally at the pre-launch and launch phase of the medication [11]. Local advisory boards, particularly focusing on the local landscape, patient journey and required patient support, yield a significant advantage when developing specific tactics to support the launch of new medications.

There are many different functions that generate different types of evidence—clinical development, market research, business analytics. RWE generated by Medical Affairs focuses on data about the health of patients and the routine delivery of healthcare, collected using a variety of methods other than traditional clinical trials. This has been and will continue to be an opportunity to unlock further potential for the reimbursement, growth and mature phase of a medication. More data points, greater accessibility and real-time data in the context of constrained health spend may see a greater requirement of real-time data from HTAs [12]. Therefore, it is imperative to adequately invest in RWE to fund both the studies and supporting resources to manage these trials. The impact of RWE really harnesses the power of Medical Affairs, from initial HCP discussions conducted by MSLs, through to multi-stakeholder engagements, and more importantly via the delivery of data that can support reimbursement through epidemiology, disease burden and cost-effectiveness data. During the growth phase, these RWE studies can provide subpopulation information, real-world efficacy and safety across local sites and drug utilization information, including persistence and adherence data. As the medication enters the mature phase, these studies help to strengthen both the relevance of the medication and the value of Medical Affairs via long-term safety information, comparative real-world efficacy between treatments, treatment sequencing, effects of switching medication and the potential for new indications.

Understanding the value of Medical Affairs as a GM can sometimes be challenging, given the heterogenous nature of different roles (medical information, promotional review teams, MSL field teams and medical advisors) within Medical Affairs, and noting there has never been a universally recognized singular metric to showcase performance for this function. Typically, the Marketing and Sales functions highlight market share and sales, Market Access measures the reimbursement success rate, and likewise Regulatory Affairs can highlight the duration and approval status of a regulatory submission to demonstrate their value, however, there is no single quantifiable KPI that highlights the value of Medical Affairs [8]. Substantial progress has been made to track the output and impact of Medical Affairs through capturing the volume of MSL interactions coupled with KOL net promoter scores, scientific share of voice measurements, promotional pieces reviewed, number of internal strategic meetings held, number and impact of MSL insights.

The impact of Medical Affairs can also be highlighted by anchoring the function’s activity to the improvement in the patient journey. Beginning with the end in mind and linking the impact to improvement in the treatment paradigm (screening, diagnosis, acute and long-term treatment), coupled with improvement in the emotional experience for the patient can make the impact of activities much more evident and aligned with the enterprise objective of patient centricity. Highlighting Medical Affairs activity in this way makes the contribution of the function much more relevant for the GM or BUD and provides clear rationale for the funding of projects.

We conducted a short online survey involving nine GMs and nine BUDs across 13 different innovative pharmaceutical companies in Australia (August 2022–October 2022). The short anonymous survey examined the perceptions of local Medical Affairs teams in Australia, specifically focusing on the prioritization of Medical Affairs activities most valuable to the GM/BUD, current value and future desired competencies, which were quantitatively assessed. Other domains that were examined (through qualitative means) included attributes and behaviors expected from medical directors, background qualifications of Medical Affairs leaders and an overview of any challenges/frustrations. Interestingly, the Medical Affairs activities rated of greatest value were focused on HCP field interactions, educational events led by Medical Affairs, pipeline assessments and strategic discussions (Fig. 4). These areas highlight the more strategic and external facing role that Medical Affairs offer to the local affiliate. Compliance guidance and promotional review, although well regarded by BUDs, was not a priority for GMs (Fig. 4). Although these tasks are still essential activities for local affiliates performed by Medical Affairs that support corporate reputation, in some companies this focus is a shared responsibility with legal and compliance functions. Whilst these custodianship tasks remain a vital responsibility of the medical function, more mature companies have imparted a truly shared compliance responsibility throughout all functions that has allowed the Medical Affairs department to direct their thinking toward more strategic and innovative opportunities.

Medical Affairs activities GMs (9) and BUDs (9) value most. BUDs, GMs general managers, HCP healthcare professionals, HCO healthcare organizations

Insight generation is another core responsibility of the Medical Affairs function, yet from the 13 companies surveyed, this was not deemed to be impactful by the GMs (Fig. 4). This is perhaps due to the high scientific focus of Medical Affairs engagements that can sometimes detract from what is relevant to the commercial objectives of the organization. Furthermore, the presentation of insights may be done on an infrequent basis, thus highlighting information that may not be of great relevance. Although most MSLs are confident to understand and uncover insights, they may lack the confidence to proactively share these during internal meetings and to manifest this insight into something more tangible and actionable. The advent of big data and digital processing of information through AI yields a lot of promise for insights, with the opportunity for pattern recognition from local data superimposed with international company data and current trends, that can be succinctly composed to answer business-critical questions in real time [12]. The Medical Affairs function should not wait for technology to improve this competency, rather it should focus on cultivating internal insights validation, strategic awareness and presentation skills to deliver actionable outcomes based on insights. Enterprise leaders play a role in fostering this competency, setting expectations regarding the collection and presentation of insights through dialogue with Medical leadership, supporting training and system infrastructure and highlighting the impact of insights.