Engaging with healthcare professionals (HCPs) is an industry practice built on a need for the exchange of scientific and medical information. Industry fee-for-service arrangements with HCPs for consultancy and promotional services are very common and the risks associated with those engagements have been well documented.
Recently, I led a group discussion, “Reduce Risk and Maximize Compliance Across the HCP/HCO Engagement Process,” at CBI’s Managing HCP Interactions conference in Philadelphia, PA.
Here are some of the key takeaways:
While the United States continues to dominate the world’s pharmaceutical and medical device markets, the industry is also remaining highly competitive and lucrative globally. An increasing number of companies have presence in foreign countries and as a result, global relationships with key opinion leaders (KOLs) have also evolved to an increased number of arrangements. With local laws, regulations and industry codes for HCP engagements differing throughout the world, this ‘cross-border’ complexity creates challenges for commercial and compliance functions that oversee these activities. The risk is also increased for companies subject to the Foreign Corrupt Practices Act (FCPA) and other anti-corruption laws that prohibit bribery to foreign officials to assist in obtaining or retaining business. In many of these countries, HCPs are considered foreign officials under a system of universal healthcare.
Another significant business concern is the potential mismanagement of KOLs. As a marketing director from a medical device company recently shared with me, “Cross-border engagements complicate our management of the physician. We struggle with who ‘owns’ the relationship.”
Fortunately, technology can enable everyone in the organization to play a role in managing HCP engagements by providing real-time visibility and insight into the utilization of KOLs throughout the organization.
An important element of managing engagements with HCPs are policies and procedures outlining the company’s rules for engagement. These policies and procedures should be:
- Easy to read and understand
- Easily accessible
- Supplemented by documented training
- Reviewed and revised (as needed) on a regular basis
- Subject to change management controls
These rules act as preventative measures to manage the risks associated with HCP engagements, but they are only effective if properly implemented.
Tools as Resources
Manual processes create opportunities for error, inconsistency, lack of visibility and inefficiency.
During our group discussion, 100% of the audience who participated in our poll (n=33) stated that their organization has considered a technology solution to manage HCP engagements. MediSpend’s Engagement Manager (EM) integrates and automates global HCP engagement rules which empowers companies to proactively manage and monitor these activities. Some of the benefits include:
- Built in rules and controls to avoid error
- Automated processes that can be applied consistently throughout the organization
- An environment where everyone in the organization has visibility into the use and management of KOLs
- An efficient, streamlined process of reviewing and approving engagements
- A repository for document retention which helps prepare organizations for potential audits and investigations