When an International HCP Meeting Becomes a Compliance Nightmare

For many life science companies, transparency reporting works fine within a home market. U.S.-based systems, for instance, have been handling Open Payments for over a decade. Expense management systems are integrated, identifiers like NPIs are mapped, and local reporting thresholds are well-understood. But cross-border activity exposes gaps that weren’t apparent in a single-country setup.

Identifiers and System Limitations

The first challenge? Different countries, different identifiers. The U.S. uses NPIs, France relies on RPPS numbers, Belgium has its own unique codes, and Italy, before its new Sunshine Law fully rolls out, still depends on industry-specific codes like EFPIA or Confindustria. Most systems aren’t built to handle these variations simultaneously.

Then there’s currency. Expenses captured in USD must be converted accurately for local reporting. In our Madrid example, an Italian HCP’s reimbursement must be translated to EUR for EFPIA reporting while still being tracked in USD internally. Miss a step, and numbers can appear wildly inflated or underreported, a red flag for auditors and regulators alike.

Regulatory Approvals and Pre-Event Hurdles

Even a one-day meeting can trigger multiple regulatory obligations:

France
If an HCP’s compensation exceeds €2,000, prior approval from the French Medical Council (CNOM) is required — two months in advance. Schedule an event without that approval, and you’re already behind.

Belgium
Belgium requires hospitality pre-approval for HCPs via a Mdeon visa application. Deadlines vary: 15 days for standard events, six working days for smaller or multi-national groups. Accommodation and meal caps are strict — overspend even slightly, and compliance is breached.

Italy
Although Italy’s new Sunshine Law isn’t fully enforced yet, companies still need to coordinate with local industry associations to report spend. Historical gaps, if not tracked properly, can become compliance headaches once reporting is mandatory.

The True Cost: Beyond Money

It’s easy to think of cross-border compliance costs purely in financial terms. But in reality, the burden extends to:

• Time and resources: Compliance officers suddenly become global event managers.
• Operational stress: Multiple systems and manual conversions increase the risk of errors.
• Audit risk: Misreporting identifiers, amounts, or approvals can trigger regulatory scrutiny.
• Strategic impact: Delays or mistakes can stall critical clinical activities or relationships with key HCPs.

Even a single, seemingly simple meeting can multiply costs exponentially when regulatory requirements across countries collide.

Managing the Complexity

Companies that successfully navigate these challenges often centralize cross-border compliance processes. Best practices include:

• Creating a global point of coordination for HCP data collection.
• Standardizing currency conversions and reporting thresholds.
• Monitoring pre-approval timelines in advance to avoid last-minute scrambling.
• Producing outputs tailored to each country’s specific reporting format, from EFPIA templates to CNOM and Mdeon filings.>

This isn’t just about technology — it’s about strategy, foresight, and choosing the right partners who understand cross-border reporting nuances.

Closing Thoughts

Cross-border events reveal the hidden costs that single-country compliance systems rarely account for. Identifiers, currencies, and pre-approvals may seem minor, but when multiplied across jurisdictions, they can derail even the simplest meeting.

The lesson is clear: global activities demand global systems. Local comfort zones won’t cut it anymore. Advanced planning, centralization, and expert guidance aren’t luxuries — they’re necessities for staying compliant while keeping operations running smoothly.