In today's world, medical affairs (MA) are essential for communicating accurate scientific and medical information between pharmaceutical companies and industry leaders. But with growing responsibility come new challenges.
This article provides information on:
● What is a medical affair?
● Medical affairs landscape in the pharmaceutical industry
● Primary challenges of medical affairs
● Medical affairs redefining its relevance
What is a medical affair?
"Medical Affairs" broadly refers to a department of a pharmaceutical company or a medical device manufacturer that interacts with physicians and other healthcare providers who use the company's products or are involved in their research.
● The majority of MA departments handle medical communications with prescribers, grants for investigators' studies, and various other duties as well.
● The MA department is generally staffed with advanced degree-holders who can explain the science behind products and devices clearly.
● MA directors typically include Medical Science Liaisons (MSLs), who are MDs or Pharm Ds with advanced degrees in the medical sciences.
● Professionally, these degree holders can interact with physicians and healthcare providers.
● The responsibilities of MA personnel are varied but not limited to:
○ Manage key thought-leader relationships,
○ Present educational information,
○ Answer off-label questions from healthcare providers,
○ Publish trial data.
Medical affairs landscape in the pharmaceutical industry:
For a pharmaceutical organization, medical affairs involve communicating precise medical and scientific information. Among the information conveyed may be off-label usage information, publications, safety information, and independent medical education.
● In recent years, regulatory pressures have led pharmaceutical companies to move away from traditional sales representatives. A medical affairs department has emerged in their wake.
● MA also form a firewall between the commercial and R&D elements of drug development in Pharmaceutical industry.
● Companies require continually update their MA policies to ensure they are providing credible medical information.
Primary challenges of medical affairs
● As more therapies come to market, medical affairs companies are in a promising position to lead the transformation. But departments will also have to contend with regulatory challenges, including the rising cost of specialty treatments.
● Medical liaisons, or MSLs, are increasingly being used to foster scientific exchanges with healthcare providers, which calls for comprehensive policies and training of sales and marketing personnel.
● According to a Wall Street Journal report, life science companies employed almost 50 percent more MSLs over the last five years, based on data from major pharmaceutical (80% data) and biotechnology firms.
● Since MSLs are used more frequently, the compliance issues related to these practices also increase, since they must be evaluated for compliance with science communication regulations.
● According to "Medical Affairs Resources, Structures & Trends," primary research conducted by Best Practices, LLC's, another key challenge for medical affairs teams is overall budget.
Medical affairs redefining its relevance
As healthcare continues to evolve, experts believe it might be a good idea to reassess and redefine the vision for MA.
● The firstrecommendation is to enhance patient access to and best use of optimal medical treatment by demonstrating value to practitioners through the life cycle of each product.
● Second, MA teams can embrace patient-centric healthcare by engaging and partnering with a broader range of healthcare stakeholders to understand the needs and target areas for patients.
● And third, is to acquire and develop the talent to build a multi-faceted medical affairs organization that has the new set of competencies needed to navigate the future healthcare landscape globally.
Several other aspects of a medical affairs department's best practices are outlined in an additional 2020 publication, including:
● Enhance the independence of medical affairs
● Report organizational structure
● Establish adequate funding targets
● Establish a policy that governs the dissemination of off-label literature
● Establish grant review boards
● Honor compliance with federal and state marketing laws
● Establish and maintain an active compliance program
In advocating the patient-centric view, medical affairs must become as important as research and development. Medical affairs leaders should aim to improve patient care and outcomes as a central motivator.
References:
1. 2021. Impact of Medical Affairs on the Pharmaceutical Industry. [online] Available at: <https://pharmanewsintel.com/news/impact-of-medical-affairs-on-the-pharmaceutical-industry> [Accessed 13 January 2022].
2. Affairs, C., 2018. Compliance Challenges within Medical Affairs. [online] Policy & Medicine. Available at: <https://www.policymed.com/2014/06/compliance-challenges-within-medical-affairs.html> [Accessed 13 January 2022].
3. Mcguirewoods.com. 2012. [online] Available at: <https://www.mcguirewoods.com/news-resources/publications/health_care/focus-life-science-compliance-nov-2011.pdf> [Accessed 13 January 2022].
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