As MSLs take on greater roles in healthcare, standardization is crucial to fostering trust.
Pictured: A doctor listens as a representative speaks, using a tablet as a visual aid/iStock, Ridofranz
According to IQVIA, the global pharmaceutical market is expected to grow at an annual rate of 5.8% from 2023 to 2028, reaching a value of $1.478 trillion by 2028. Much of this growth will be fueled by specialty products as well as ones for rare diseases and orphan drugs. This has increased the need for pharmaceutical industry professionals called medical science liaisons (MSLs) to educate healthcare providers (HCPs).
According to an analysis conducted by my organization, the Accreditation Council for Medical Affairs (ACMA), there are currently more than 300,000 medical affairs professionals worldwide. The majority of these are MSLs.
MSLs and other medical affairs professionals play a crucial role in bridging the gap between scientific advancements and healthcare practice, ultimately impacting patient care. Traditionally, medical affairs and MSL roles focused on disseminating clinical information and serving as a bridge between pharmaceutical companies and healthcare practitioners. However, these roles have transcended their original scope to become instrumental in driving key strategic decisions, providing critical scientific input, and fostering collaborations with various stakeholders. For example, medical affairs professionals can facilitate physician studies on a drug, thus playing a key role in helping generate new data for a medicine, which can in turn give it expanded indications and usage.
This evolution underscores the need for professionals in these roles to possess a diverse skill set that combines scientific knowledge with business acumen. Indeed, it was not until the early 2000s that MSLs and medical affairs professionals were required to have advanced degrees such as an MD, PharmD, or PhD. Ensuring competence and expertise in these roles is crucial to safeguarding patient wellbeing and fostering trust among stakeholders such as physicians, pharmacists and other healthcare providers.
As a former senior pharmaceutical executive working the majority of the time in medical affairs, I have personally witnessed the need for industry practice standardization. In one instance, the company I worked for had a product that was used in combination with an existing product on the market, yet no safety data existed on the combination of the two drugs in patients. When I proposed that a study was needed on this potential interaction, I was met with resistance, mainly because there was not a clear understanding within the medical affairs division where I worked of how to properly design these studies, or of the importance of meeting physician needs.
In 2015, I founded the Accreditation Council for Medical Affairs to help MSL and other medical affairs professionals adapt to evolving practices. The goal of the ACMA is to set standards in the industry by advocating that practitioners become board-certified in medical affairs. The Board Certified Medical Affairs Specialist (BCMAS) was the first and is currently the only accredited medical affairs and MSL board certification in the industry. To be eligible for BCMAS, a candidate must either hold an advanced degree (MD, PhD or PharmD) or have relevant industry experience within medical affairs or the pharmaceutical industry.
Certification is needed because medical affairs has grown increasingly complex, with some pharmaceutical manufacturers having thousands of medical affairs/MSL professionals dispersed globally. Additionally, there is now an increased level of scrutiny on medical affairs due to its visibility in shaping thought leadership in medicine. Finally, greater factors at play, such as the increased focus on the social responsibility of pharmaceutical companies, have necessitated transparency in the industry, which is advanced by ensuring that medical affairs/MSL professionals are accountable to an independent accrediting body.
The establishment of board certification has far-reaching benefits, with the most prominent advantage being the enhancement of patient safety. Professionals who possess a thorough understanding of scientific developments can contribute to guiding more informed healthcare decisions, leading to improved patient outcomes. For example, MSLs play an important role in helping to inform clinical decisions around rare diseases since these conditions are so rare that many physicians rely on natural history data that pharmaceutical companies may provide or have collected.
Furthermore, trust is established to a higher degree when healthcare providers are aware that an MSL has met competency standards. Effective communication of complex scientific information becomes possible, fostering better collaboration and understanding. As a result, healthcare providers can make well-informed treatment choices that align with the latest advancements.
Additionally, implementing competency standards elevates the reputation of the pharmaceutical industry as a whole. It demonstrates a commitment to professionalism and excellence, which resonates positively with stakeholders, including healthcare professionals, patients and regulatory bodies. For instance, in 2021, the U.S. House’s Health Subcommittee invited ACMA to discuss the importance of professional standards for medical affairs and MSL professionals in the life sciences industry.
As we enter a new era of increased visibility for medical affairs, the medical affairs and MSL landscape within the pharmaceutical industry is undergoing transformative changes. Ensuring competence through board certification is a pivotal step toward shaping the future of these roles. There have been barriers to its widespread implementation, such as resistance from professionals who question the necessity for certification, and collaboration is key to fostering industry-wide acceptance of competency standards. Stakeholders including pharmaceutical companies, regulatory bodies, and professional associations must work together to establish unified criteria for certification to ensure consistency and reinforce the credibility of certification programs. As the industry continues to evolve, the role of board certification remains indispensable in driving excellence and innovation in medical affairs and MSL roles.
William Soliman is the founder and CEO of the Accreditation Council for Medical Affairs (ACMA).
