In the pharmaceutical sector, talking about medicines inevitably means talking about information: clinical data, safety profiles, and conditions of use. The proper and transparent management of this information is essential to ensure safety and appropriate use of medicinal products. In this context, Medical Information (MI) represents a key function, often not visible externally but essential to ensure the accurate and reliable dissemination of information about medicines.
What is medical information
Medical Information is a strategic company function that interacts directly with stakeholders and is dedicated to managing unsolicited medical-scientific information requests from healthcare professionals (physicians, pharmacists, nurses), patients, caregivers, and regulatory authorities.
Its objective is to provide objective, accurate, balanced, and evidence-based responses, always up to date and consistent with approved product information. A distinctive feature of MI is its non-promotional nature: all content must be scientifically rigorous, well documented, and aligned with what has been approved by regulatory authorities.
The origin of this function
Medical Information has evolved alongside the European pharmaceutical regulatory framework, which has progressively placed greater emphasis on transparency and the proper communication of scientific information.
A key milestone is Directive 2001/83/EC, which introduced the community code relating to medicinal products and established the obligation for Marketing Authorisation Holders (MAHs) to ensure the availability of comprehensive information on the quality, safety, and efficacy of medicines through a dedicated scientific service.
This is complemented by Regulation (EC) No. 726/2004, which harmonized the procedures for the authorization and supervision of medicinal products at the European level, extending monitoring throughout the entire lifecycle of the drug.
Further momentum came from pharmacovigilance legislation (Regulation (EU) No. 1235/2010 and Directive 2010/84/EU), which strengthened safety surveillance requirements and placed greater emphasis on risk communication and transparency toward healthcare professionals and patients.
Taken together, these provisions have contributed to defining the role of Medical Information as an essential function to ensure the quality and reliability of information about medicinal products.
Today, MI represents a true link between pharmaceutical companies and the external environment. On one hand, it collects the information needs of those who prescribe or use medicines; on the other, it provides reliable and documented responses, contributing to improved clinical decision-making.
In a context where information is increasingly accessible but not always verified, MI also plays a key role in counteracting misinformation by offering validated and up-to-date content.
Daily activities
Medical Information activities are diverse and require multidisciplinary expertise, ranging from medicine and pharmacology to scientific communication.
At the core of this function is the management of information requests: each inquiry is analyzed, supported by scientific literature, and translated into a clear, tailored, and documented response.
In addition, MI develops standard responses and technical documentation, supports pharmacovigilance activities, and analyzes collected data to identify trends and emerging information needs.
An increasingly strategic role
In recent years, this function has gained increasing importance. Digitalization, the growing complexity of therapies, and the increasing centrality of the patient are transforming MI from a reactive service into a strategic and proactive function.
More and more, MI is not only responding to questions but also anticipating information needs, contributing to improved access to high-quality scientific content.
The value of MI is directly reflected in the quality of healthcare. Providing accurate, timely, and evidence-based information helps to:
• reduce the risk of medication errors
• improve patient adherence to treatments
• increase the safety of medicine use
At the same time, this function strengthens the credibility of pharmaceutical companies by demonstrating a clear commitment to transparency and the protection of public health.
Conclusion
Medical Information is much more than a support service: it is a function rooted in regulatory requirements and today represents a fundamental pillar in ensuring the correct and informed use of medicines.
In an environment where the management of scientific knowledge is becoming increasingly complex, its role continues to evolve, becoming an essential point of reference for the dissemination of reliable information, the support of healthcare professionals, and the improvement of patient outcomes.
References
- Directive 2001/83/EC
- Regulation (EC) No. 726/2004
- Directive 2010/84/EU
- Regulation (EU) No. 1235/2010
- Mohamed S, Dunnett S, Flores A, Loew E, Pienaar S; MILE (Medical Information Leaders in Europe). A principles framework for digital provision of medical information for healthcare professionals. Pharmaceut Med. 2023 Mar;37(2):103–109.