Medical affairs is a unique organization within a life sciences company that focuses on the communications between the company and medical professionals, healthcare providers, and patients.

Medical affairs’ primary role is to communicate scientific and clinical information to the medical community through various channels. These channels include:

• Standard response documents
• Approved presentations
• Educational collateral
• Medical publications
• Field interactions

Over the years, medical affairs departments have grown both in size and stature within the life sciences industry. In recent years they’ve risen above the commercial umbrella into a stand-alone function, and have gained more autonomy along the way.

A Brief History

Many of the roles that medical affairs departments are currently responsible for originated out of the commercial side of the business. As physicians desired additional clinical information about a drug, the need arose for a dedicated staff who would develop responses to these medical inquiries. The same dynamic already existed for other traditional medical affairs roles, such as developing medical publications or communicating with physicians in the field. Traditionally, commercial sub-teams handled these responsibilities, even though they were more oriented toward support and not directly tied to prescriptions and drug sales.

As time went on, and regulatory scrutiny increased surrounding the interactions between physicians and pharmaceutical companies, traditional medical affairs roles began to transform from commercial oversight into more autonomous groups and roles. The rationale behind these structural changes stemmed from the need to ensure that non‐promotional interactions remain uninfluenced by company sales and/or marketing. Additionally, the United States began passing landmark legislation to prohibit kickbacks paid by drug and device companies, which incentivized physicians to prescribe their products over a competitor's, regardless of the drug’s effects.

As regulations and compliance guidelines forced companies to separate medical sub-teams from the commercial organization, they also began to recognize the value that these teams provided to the medical community at large. Healthcare providers (HCPs) now had a distinct and direct connection to the scientific and clinical experts housed within drug and device companies. This connection provided HCPs with opportunities to develop new research, share outcomes data, and discuss medically related concepts with company personnel, without being forced into a sales conversation.

Separation of Medical Affairs from Commercial Operations

Nowadays, medical affairs is largely responsible for managing the company’s scientific and clinical data. Data impacts just about everything a pharmaceutical company does, from sales to marketing, to portfolio planning. At the end of the day, everything a drug company does impacts patient care. Medical insight, and an abundance of it, can only be beneficial to the company and patients alike.

As beneficial as medical affairs input can be, it’s limited by the level of communication encouraged between cross-functional teams within the organization. Compliance restrictions will incentivize companies to erect firewalls between medical affairs and commercial teams. The separation of these critical functions has increased medical affairs’ decision-making power, growth, and prominence in the industry. However, if organizational firewalls prohibit all communication between medical affairs and commercial groups, then the company as a whole will suffer. These two organizations will still support each other but must do so through the appropriate, and regulated, communication channels.

Fast-forward to 2022, and medical affairs is establishing the foundation upon which the road to commercial success is built. These roles were conceptualized to provide support to internal stakeholders— such as sales and marketing— either directly or through services provided to external stakeholders, such as healthcare practitioners.

A Note About Field Medical Personnel

As the medical affairs function began to take shape outside of commercial organization, a similar transition occurred in the field as a whole. Traditionally, sales representatives made calls to physicians’ offices to promote their products. While these conversations provided value to both the HCP and the company, the amount of in-depth scientific discussion was limited. Additionally, sales representatives in the pharmaceutical industry were traditionally not medically trained.

Physicians and other HCPs desired more in-depth scientific knowledge about the company’s products. In response to this need, they began to develop a new role within medical affairs departments – the medical science liaison (MSL). MSLs’ primary responsibility is to engage with physicians and HCPs through scientific and clinical discussions. These discussions often take place in medical offices. In addition to this responsibility, MSLs may also be called upon to deliver presentations at medical conferences, or at small medical meetings. MSLs will bring the valuable insights from these discussions back to their leaders, who use this field-based knowledge to shape not only their medical strategies. Medical teams also communicate these insights to marketing and commercial leaders so that they, too, can adapt their strategies.

Since the advent of the medical science liaison role, drug and device companies have sharply increased their MSL team sizes. The MSL role is now one of the most competitive and highly sought-after roles in the pharmaceutical industry.

The Medical Affairs Function Today

Medical affairs responsibilities will continue to evolve along with the regulatory landscape of the life sciences industry. Today, it’s common for medical affairs to support other key functions, such as regulatory affairs, sales, and marketing. However, regulatory agencies, formulary decision-makers, healthcare stakeholders, and public sentiment now demand a deeper level of scientific understanding and greater transparency. In this landscape, medical affairs emerges to actively anticipate and meet those evolving needs.

Medical affairs teams engage expert clinicians and researchers, share emerging science, and identify trends in clinical practice. Through their external interactions with healthcare providers, medical affairs professionals return insights to internal colleagues and actively contribute to medically valid brand plans, educational activities, communications, and market access strategies. As teams assume a more active role in engaging both internal and external stakeholders, the recognition of its value and contribution to company success will increase.

The Face of the Company

Due to the demand for medical communications, medical affairs is now a crucial function devoted to disseminating scientific information. This demand has allowed medical affairs to assume the “face of the company” toward the medical community. The growth of these teams has allowed more free-flowing communication to take place between healthcare providers and the life sciences companies.

Internal structural firewalls have allowed medical affairs teams to operate free from commercial influence. This freedom has given the medical affairs function unique, autonomous, decision-making power. Many teams have evolved to provide maximum value to corporate strategic development.

Learn how to become a medical affairs team leader