In the past, the primary concerns for pharma marketers working with a widely distributed sales force were managing costs and reducing fulfillment times for their direct-to-physician (DTP) marketing campaigns. These are still major issues, but new regulations have introduced another wrinkle to the mix. With the passage of the Sunshine Act (i.e. Patient Protection and Affordable Care Act), pharmaceutical, biologic, medical device, and medical supply companies are now required to report any transfer of value to physicians of more than $10.
The boundaries of this regulation are still being determined, but the time to begin preparing is yesterday. The penalty for non-compliance starts at $10,000, and in certain cases, it can exceed $100,000. There is also the very real risk of having a damaged corporate reputation, strained business relationships and significant legal costs.
Abiding by the mandates of the Sunshine Act will be a challenge, but luckily, new fulfillment strategies for DTP marketing and sales support make it easier than ever to avoid violations while maximizing the effectiveness of printed collateral.
Here are three important factors to consider to effectively navigate the regulatory challenges created by the Sunshine Act.
The Ten Dollar Threshold
The objective of the Sunshine Act is to quantify the relationship between life sciences marketers and the healthcare professionals (HCPs) they do business with. Any transfer of value in the form of gifts, meals, speaking fees or professional development opportunities can be considered a gift. In some cases, printed marketing materials may also fall under this umbrella.
With even a modest DTP marketing campaign, the accumulated value of printed educational materials delivered to HCPs can quickly balloon past the $10 mark. If the total exceeds $100, the party being marketed to is required to report the amount themselves. When the cost of pharmaceutical marketing and literature is not tracked accurately, there is the very real risk of non-compliance.
Changing Customer Relationships
Healthcare professionals are just as concerned about the Sunshine Act as life science marketers are. To meet their own standards for compliance, many HCPs are eliminating lunches with sales reps, gifts and other perks that marketing departments once relied upon heavily. As the physician shortage continues to grow and challenge doctors with more patients and less time, access to HCPs has severely eroded for pharmaceutical and life sciences companies.
In the wake of this changing climate, marketing literature fulfillment has become more important than ever. When marketers cannot appeal to doctors, nurse practitioners, and physician's assistants directly, they are forced to rely on their printed collateral to do the talking. Meeting the requirements of the Sunshine Act will force life science marketers to reconsider the marketing strategies they have depended on for ages.
Relying on Marketing Collateral Management Solutions
Regulatory compliance is primarily a logistical challenge. Avoiding fines requires marketers to manage their distributed sales force, predict expenses, track spending levels, and report activities according to specific guidelines. The pioneering field of marketing collateral management makes this chore efficient and reliable.
Marketing collateral management (MCM) is a way to track and record marketing expenses across multiple channels and throughout a decentralized sales force. Using advanced technologies and time-honored techniques, MCM allows marketers to control costs, track expenditures, and enhance efficiency. In order to abide by the strict requirements of the Sunshine Act, this kind of systematized marketing approach is crucial.
The data collection provisions of the Sunshine Act have already gone into place. It would be a costly mistake not to begin preparing for them now. Using marketing collateral management solutions, life sciences marketers can meet their regulatory obligations and enhance the effectiveness of their entire direct-to-physician marketing strategy.
To learn more on how the Sunshine Act will affect your marketing and direct sales efforts, reference our free ebook, Streamlining Fulfillment, Simplifying Compliance, & Staying Competitive for the 21st Century Life Sciences Marketer.