Hilton and MPI Academy partner to bring several HMCC US focused and HMCC European focused courses to the planning community!
Planning healthcare and pharmaceutical meetings is complex work, where any number of crucial components could slip through the cracks. Planners and suppliers equally must balance multiple aspects: event design, navigating frequent changes in global compliance and regulations, and delivering ROI to their companies, attendees and destinations. All this begs the question: Are your healthcare meetings compliant?
Designed for medical meeting professionals and the partners they work with, MPI’s Healthcare Meeting Compliance Certificate offers a broad understanding of regulatory topics, laying competency groundwork upon which critical thinking skills are developed, through case studies, business simulation, discussion and active exercises.
This intensive, four-hour program provides healthcare meeting compliance stakeholders with the knowledge and experience they need to successfully navigate the increasingly complex pharmaceutical, biotech and medical device regulatory environment.
After completing the Healthcare Meeting Compliance Certificate, you'll be ready to become compliant in planning your next event.
Here’s a clear comparison of U.S. Open Payments (Sunshine Act) versus the EFPIA (European Federation of Pharmaceutical Industries and Associations) Code / European Disclosure Code, specifically as they relate to medical meetings and events:
1. Legal Basis
U.S. – Open Payments (Sunshine Act):
- Law:
Federally mandated under the Affordable Care Act (Section 6002).
- Regulator:
U.S. Centers for Medicare & Medicaid Services (CMS).
- Legal Obligation: Failure to report can lead to civil monetary penalties.
- Scope:
Applies to all U.S. “Covered Recipients” — physicians and teaching hospitals.
Europe – EFPIA Disclosure Code:
- Framework:
Industry self-regulation, not law.
- Regulator:
National pharmaceutical associations in each EFPIA member country.
- Legal Force: Voluntary via company membership (though widely adopted).
- Scope:
Covers HCPs and HCOs in Europe (defined by EFPIA), but the rules vary country by country.
2. What Must Be Disclosed
U.S.
- All “Transfers of Value” (ToVs) to physicians and teaching hospitals.
- Meals, travel, accommodation, registration fees, honoraria, consulting, grants, etc.
- Must identify the individual recipient and specify the exact value.
- Aggregate reports submitted to CMS and publicly posted on the Open Payments database.
Europe:
- Disclosure categories:
- Transfers to HCPs: fees for service, travel, accommodation, registration.
- Transfers to HCOs: sponsorships, donations, grants, event support.
- Individual disclosure is encouraged (and often required), but some countries allow aggregate reporting for data privacy reasons.
- Publication usually occurs on the company’s own website, not a government database.
3. Scope of Recipients
U.S.:
- Only U.S.-licensed physicians, designated healthcare professionals and U.S. teaching hospitals.
- Does not
cover other HCPs (e.g., nurses, pharmacists) or non-U.S. physicians.
Europe:
- Covers all HCPs and HCOs located in Europe, regardless of nationality.
- Definitions often include other clinical staff who may influence prescribing.
4. Impact on Meetings and Events
U.S.:
- Any meeting-related expense (e.g., congress registration, hotel, airfare, meals) provided to a covered U.S. physician must be reported individually.
- Group meals must be attributed per person.
- Applies equally to in-person, virtual, and hybrid events if value is transferred.
- Stringent tracking requirements — precise spend capture and CMS reporting format.
Europe:
- Disclosures often required for sponsorships of attendance (registration, travel, accommodation) and event support paid to HCOs or organizers.
- The EFPIA Code prohibits direct sponsorship of HCPs by third parties
(companies must contract directly with HCPs).
- Transparency obligations vary: e.g., the UK ABPI Code has specific thresholds and rules about hospitality limits.
- Some countries (like France’s Loi Bertrand) go further — legally requiring event reporting.
5. Transparency vs. Privacy
U.S.:
- Transparency outweighs privacy; all individual data are publicly searchable.
Europe:
- GDPR
applies — limits the sharing of personal data without consent.
- In some countries, HCP consent is required to disclose individual-level data; otherwise, data are aggregated.
- Varies widely by market (e.g., full disclosure in the UK, partial in Germany).
6. Timing and Reporting
Region |
Frequency |
Reporting Platform |
Public Access |
U.S. |
Annual (March submission, June publication) |
CMS Open |
|