Breaking Barriers: The Role of Medical Affairs in Driving Health Equity

Health equity has emerged as a pivotal focus within the pharmaceutical industry, driven by the need to address disparities that hinder marginalized groups from achieving optimal health^1-5. Our recent Medical Affairs Leadership Council meeting brought together leaders from 12 biopharmaceutical companies to explore how Medical Affairs can play a key role in advancing health equity. The recent discussion, supplemented by a pre-meeting survey among council members and discussions with external health equity experts, underscored both progress and challenges while identifying actionable strategies to bridge care gaps. This piece summarizes the key takeaways from the meeting into critical themes, including challenges and strategies to advance health equity.

Understanding Health Equity in Medical Affairs

Health equity refers to ensuring fair and unbiased access to health resources, opportunities, and outcomes for all individuals, regardless of socioeconomic or demographic factors. However, achieving this goal remains challenging due to systemic barriers, data challenges, and varying stakeholder perceptions. As one expert rightly noted, “There is consensus around the idea of health equity, but no consensus on its practical implementation.”

Medical Affairs teams are uniquely positioned to address these challenges by integrating health equity into clinical research, stakeholder engagement, and strategic planning. By leveraging their cross-functional role, Medical Affairs can influence the development, commercialization, and accessibility of therapies to create equitable health outcomes.

What Are the Emerging Themes and Trends in Health Equity?

The pre-meeting survey and discussions highlighted several key themes shaping health equity efforts:

1. Diversity and Inclusion in Clinical Trials: Increasing representation of diverse populations in clinical trials remains a key health equity initiative. Despite progress, challenges persist in site selection, recruitment, and engagement. For example, participants noted that productive trial sites often lack diversity, which limits the inclusion of underrepresented groups. Internal survey results revealed that ~70% of leadership council members report increasing diversity in trials within their organization as a critical measure to close care gaps.
2. Access to Care and Affordable Medications: Ensuring equitable access to treatments and addressing cost barriers remain top priorities. Collaborative efforts between Medical Affairs and Market Access teams are crucial in understanding pricing, reimbursement, and access challenges. According to the survey, improving access to care and affordable medications ranked as the top two priorities for addressing health disparities.
3. Health Outcomes Research: Real-world evidence (RWE) studies are increasingly being used to evaluate health outcomes in diverse populations. These studies help to identify gaps in care and inform strategies to close them. Survey data highlighted ~85% of respondents are leveraging RWE studies within their organization to assess outcomes in underserved populations.
4. Cross-Functional Collaboration: Medical Affairs teams frequently collaborate with Commercial, R&D, and Regulatory colleagues to align on health equity objectives. Early engagement in clinical development and community outreach has proven critical.
5. Technological Innovations: Within the context of health equity, the use of artificial intelligence (AI) and data analytics is growing, enabling, among others, more precise identification of social determinants of health. Approximately ~60% of respondents reported utilizing technological advances, including AI and digital health, to enable solutions that may address health disparities.

What Challenges are Hindering Progress in Health Equity?

While the industry has made strides, significant challenges remain:

• Budgetary and Resource Constraints: Many organizations struggle with limited budgets and staffing to sustain health equity initiatives. Survey findings indicate budgetary restrictions (~85% respondents) and insufficient resources (~70% respondents) as a major barrier.
• Lack of Clear Metrics to Measure Impact on Health Equity: Collecting and analyzing data to measure progress in health equity is a persistent hurdle. Stakeholders emphasized the need for consistent metrics to evaluate and communicate impact.
• Difficulty in Reaching Underrepresented Populations: Medical Affairs teams face significant challenges in equitable outreach to underrepresented communities, including systemic barriers to access, mistrust in the healthcare system, inadequate clinical trial representation driven by pressures for rapid recruitment, and ineffective communication strategies.
• Insufficient Early Engagement: Medical Affairs teams often engage on health equity workstreams later in the drug development lifecycle, missing opportunities to shape inclusive strategies from the start.

What Strategies Can Drive Progress in Health Equity?

Council discussions yielded several actionable strategies, with illustrative examples of success:

• Enhancing Diversity in Clinical Trials: Increasing clinical trial diversity was noted as one of the most effective ways to advance health equity. Collaborating with patient advocacy groups (PAGs) and community organizations has proven successful in reaching underrepresented populations. For instance, a council member from a leading pharmaceutical company highlighted how partnerships with TOUCH— The Black Breast Cancer Alliance—significantly improved recruitment efforts, achieving greater representation of Black women in a pivotal U.S. breast cancer study. Another council member emphasized the value of having full-time employees and internal associates dedicated to diverse patient recruitment, instead of contracted organizations, which not only facilitated the enrollment of diverse populations but also ensured timely study initiation. A recent study⁶ further underscores the importance of capturing demographic data beyond race and ethnicity, including factors such as income, insurance status, disabilities, and employment, to gain a more comprehensive understanding of diversity in trial populations.
• Reaching Underrepresented Populations Through Customized Communication: Tailored educational materials and culturally sensitive outreach are key to improving engagement with underrepresented patient groups. Customizing communication to address specific cultural needs and barriers helps foster trust and promotes inclusion, enhancing access to healthcare services and clinical trials.
• Strengthening Partnerships with Patients and Health Equity Thought Leaders: Creating health equity boards that include representatives from indigenous populations, people with diverse socioeconomic backgrounds, and other underrepresented groups ensures their voices are heard and integrated into decision-making. In addition to partnering with PAGs, it is vital to engage regional health equity thought leaders in various communities. These experts can be influential at the local level, driving meaningful change and fostering community trust.
• Building Dedicated Health Equity Teams: Establishing Centers of Excellence (CoEs) for health equity can centralize efforts and drive accountability across organizations. While ~40% of respondents have health equity CoEs in their organization, these often exist outside Medical Affairs. Having dedicated health equity expertise within Medical Affairs teams is crucial to integrate equity-focused strategies into scientific and medical initiatives.
• Leveraging Technology: AI and data analytics are powerful tools to improve health equity. For example, it can help with identifying recruitment barriers, such as lack of awareness and access, and optimizing site selection to reach diverse populations. Organizations are also exploring how digital health tools, such as telemedicine and remote monitoring, can increase access to care. Insights from real-world evidence studies further inform strategies by pinpointing gaps in care for underserved populations and supporting targeted interventions to improve outcomes.
• Embedding Health Equity into Strategic Planning and Establishing Funding: Collaborating with a broad set of stakeholders including non- profits, government agencies, academic institutions, and other organizations, is critical to address health disparities at scale. Organizations are increasingly integrating health equity into their strategic planning, though council discussions and survey results suggest this trend is still gaining momentum. These efforts are not limited to innovative funding models but also include assigning dedicated budgets through traditional mechanisms.

The Path Forward

Discussions at the Medical Affairs Leadership Council meeting underscored the central role of Medical Affairs in advancing health equity. By fostering cross- functional collaboration, leveraging the latest technology, and continuing to advocate for solutions that address health disparities, Medical Affairs leaders are uniquely positioned to make meaningful strides in advancing health equity.

The future of health equity is poised to further evolve with technological advancements, policy reforms, and greater investments in the space. Governments and industry stakeholders are collaborating on incentives and frameworks, while AI integration can reduce biases and enable efficient data- driven decisions. Equality impact assessments are also becoming integral to organizational strategies.

As the conversation continues, Medical Affairs leaders must remain at the forefront, driving initiatives that ensure fair and just opportunities for health across all populations. Together, we can bridge the gap and create a more equitable healthcare future.

References:

1. Healthy People 2030 Framework. https://health.gov/healthypeople/about/healthy-people-2030-framework.
2. Healthy People 2030 Social Determinants of Health. https://health.gov/healthypeople/priority-areas/social-determinants-health.
3. Mackenbach, Johan P, José Rubio Valverde, Matthias Bopp, Henrik Brønnum-Hansen, Patrick Deboosere, Ramune Kalediene, Katalin Kovács, et al. 2019. ‘Determinants of Inequalities in Life Expectancy: An International Comparative Study of Eight Risk Factors’. The Lancet Public Health 4 (10): e529–37. https://doi.org/10.1016/S2468-2667(19)30147-1.
4. Montez, Jennifer Karas, and Anna Zajacova. 2014. ‘Why Is Life Expectancy Declining Among Low-Educated Women in the United States?’ American Journal of Public Health 104 (10): e5–7. https://doi.org/10.2105/AJPH.2014.302146.
5. 2024. ‘Improving Health Equity in Europe: Priorities for the 2024-2029 EU Policy Landscape’. https://eurohealthnet.eu/improving-health-equity-in-europe-priorities-for-the-2024-2029-policy-landscape/.
6. https://clinicalleader.com/doc/alexion-rethinks-diversity-metrics-and-why-race-alone-isn-t-enough-0001