Building Best-in-Class Capabilities for Medical Affairs: Mapping the Regulatory Landscape, Functional and Future Trends

STUDY OVERVIEW

A strong Medical Affairs function is essential to meeting current challenges in clinical development, market education, and regulatory compliance. Over time – and the last few years especially – healthcare regulations have been tightened and closely monitored through the use of Corporate Integrity Agreements. With the Affordable Care Act and the Sunshine Act coming into full force, Medical Affairs will be strongly influenced as the industry endures even higher levels of scrutiny.

This Best Practices, LLC study explores how U.S. and global biopharmaceutical companies are navigating through healthcare reform and how the shape of their Medical Affairs organizations are similarly adapting. More specifically, the research examines how compliance is affecting the way Medical Affairs operates and how different Medical Affairs functional areas are changing in relative importance. In addition, the study highlights the key success factors and challenges noted by other Medical Affairs executives as well as budget trends these groups are experiencing.

The study includes four segments: a mature markets segment from 2012 and 2009, a pharma segment, medical device segment, and an emerging market segment.

KEY TOPICS

• Impact of Medical Affairs Functions on Company Success
• Key Success Factors for Medical Affairs
• Key Regulatory Issues Influencing Medical Affairs
• Recent and Anticipated Changes in Budget

• Directional trends in Medical Affairs budget levels
• Relative importance of seven different Medical Affairs functions
• Reasons cited for increased importance
• Reasons cited for decreased importance
• Top three success factors for developing and maintaining effective Medical Affairs group
• Top three challenges for developing and maintaining effective Medical Affairs group

• Health Outcomes Importance on the Rise: As the industry becomes more sophisticated and data-driven, Medical Affairs needs to rely increasingly on health outcomes as a driver for both the success of the function as well as the company and its products. Healthcare payers in the mature markets want more value for their money and, as a result, the industry must show that their treatments reduce the overall use of resources and let patients remain as healthy as possible, for as long as possible.
• Medical Affairs, especially Pharma, Budget Growing Moderately: Forty-five percent of respondents said budget increased from 2011 to 2012, but the benchmark class was more tempered in their expectations for 2013. In 2009, over one-third of the benchmark class was growing at a rate of greater than 10%. While 45% of pharma expect budget to grow in the next year, half of the device segment predicts budgets to stay the same next year. Some of medical device Medical Affairs groups are finding their budgets under pressure because of the 2.3% medical device tax set to start Jan. 1, 2013.
  

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