DISCLAIMER: The views, statements, and opinions expressed in this White Paper are our own and do not represent those of our employers. The strategies and tactics described herein would be subject to multi-functional review and approval prior to implementation by an organization.
Executive Summary
Life sciences companies are pursuing more cost-effective tools— such as digital channels or virtual agents—to help respond to increasing product and medical inquiries. In an era when regulatory approvals for new products are rapidly increasing and customers are feeling overwhelmed by new medical information, they are increasingly seeking immediate answers to specific questions. As a result, the need for high-quality, relevant, timely medical information is skyrocketing and the Medical Information function (MI) is rapidly evolving—or trying to—in terms of how the external service operates and its role internally.
With the sudden emergence and acceleration of large language model capabilities in Generative Artificial Intelligence (AI) in 2023, many in the industry are looking ahead at what may be possible. However, regulations are not keeping up with demand in many territories. (1) (2)
Regarding improving MI’s external service, as Medical Communications teams have raced ahead in using digital channels, MI remains largely reactive and restricted by privacy regulations and compliance firewalls. MI leaders need to challenge regulations in overly restrictive regions such as Europe and Asia-Pacific (APAC), where, in some countries, healthcare professionals (HCPs) can barely access product labeling through digital channels. Progress is being made in regions such as the US and Europe, where organizations are collaborating to deliver customer-centric MI services.
Notably, the “hidden gem” that is MI, with its highly knowledgeable team members and vast wealth of patient and HCP customer data, is being increasingly recognized for the wealth of strategic input that could be mined by AI and leveraged throughout the value chain.
Pharmaceutical, biotech, and MedTech companies must provide non-promotional MI services to support HCPs and patients using their medicines or devices. MI activities involve the collection, handling, and dissemination of evidence-based, up-to-date, and scientifically balanced information on products, ensuring their safe and correct use. By doing so, the MI function plays a key role both internally and externally, adhering to strict regulations that mandate the provision of unbiased, scientifically accurate information upon request. MI professionals maintain auditable records of exchanges, ready for inspection at any time, making them invaluable in aiding informed decision-making by HCPs and patients. (1)
Externally, MI is one of the limited sources that can provide reliable, scientifically accurate, unbiased, and timely information on medicines or devices, making the role especially important in situations in which there is risk of acquiring inaccurate or outdated information from third-party sources, which can lead to overall risk.
Customer Insights from MI Offer Significant Value
In fulfilling its external function, MI collects rich insights into customer needs, which have the potential to be leveraged across the organization. Insights from MI, when combined with insights from Field Medical, Medical Communications, and Commercial, provide a holistic view of how a product is being received and may help inform product strategy. Moreover, in very early stages of the product lifecycle, prior to having an established field force in place, MI can be one of the few sources of reliable customer insights.
While Medical Science Liaisons (MSLs) primarily interact with key opinion leaders (KOLs) who specialize in certain areas and Commercial interacts with targeted KOLs, HCPs and payers, MI is able to represent concerns of grassroots HCPs, actively prescribing medications or using devices as part of their clinical practice; these include prescribers, pharmacists, and practitioner nurses as well as patients actively taking medications or using devices. MI also augments and supports Sales and Field Medical customer inquiries, resulting in a richer dataset. Importantly, MI inquiries are unprompted and reflect the immediate informational needs of those considering use of the products. This granular understanding of customers and patients enables MI teams to contribute significant value to stakeholders and the overall business. (5) (6)
Broader Context
MI fits under the Medical Affairs (MA) umbrella of life sciences organizations, working synergistically with various MA functions such as Medical Communications and Field Medical to ensure that the medical information needs of customers are being met for a company’s products. In parallel, MI also supports Commercial functions such as field Sales Representatives and Marketing Managers for product-related HCP inquiries that fall outside the approved labeling, as Commercial teams are not permitted to discuss information that is not consistent with approved local prescribing information.
MI teams are composed of highly educated, analytical, and scientific minds. Team members typically possess health sciences or graduate degrees and extensive product portfolio or pipeline knowledge, are highly versed in regulatory and compliance risks, and are masters of navigating complex medical literature. (1) As MI is a customer-facing role, the skill set includes agile communication styles when responding to both HCPs and patients.
Historic Lack of Trust of MI and Underutilization Despite Being of High Quality
Historically, MI services have been underutilized by customers due to a lack of trust in the function. As MI is a service provided by a Commercial company that manufactures or provides a product, customers may avoid using this resource because of their distrust in the company or in the pharmaceutical and medical device industries as a whole. However, according to a 2021 survey of 500 clinicians, published in The Journal for Nurse Practitioners and supported by phactMI and Indegene, 60 to 70% of clinicians who received industry medical information gave it a quality rating of 4 or 5 on a 5-point scale for trustworthiness, conciseness, completeness, clarity, and relevance, and the majority (72%) used it to enhance patient education. (3)
MI Channels are Hindered in a Digital World
As HCPs show a growing preference and expectation for digital communication channels, the absence of a regulatory framework for non-promotional MI services presents a significant challenge, hindering the ability of companies to fulfill these needs effectively. Concurrently, for patients, the internet is flooded with a vast array of unregulated, readily accessible information from various sources, which may vary widely in quality and reliability. (4)