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Global HCP Disclosure and the Sunshine Act Explained

Written by Andreea Susanu | 25 July 2025

 

HCP global and Sunshine Act compliance simplified

Healthcare compliance and anti-bribery regulations

Financial transparency in the healthcare industry is not only nice-to-have, it's a legal and ethical imperative.

You might be asking: "Does this apply to my company if we’re not based in the U.S.?"

Around the world, pharmaceutical, biotech, and medical device companies are required to disclose financial interactions with healthcare professionals (HCPs) and organisations (HCOs).

While local requirements vary, the growing emphasis on Global HCP Transparency reflects a wider shift toward ethical standards, public trust, and compliance.

One of the most well-known regulations, the US Sunshine Act, has inspired similar frameworks across Europe and beyond.

What is global HCP transparency?

Healthcare Professional (HCP) Transparency refers to the disclosure of financial relationships between healthcare companies and medical professionals or organisations.

These relationships must often be reported to public authorities or industry bodies to promote integrity and prevent conflicts of interest.

The rationale is clear: when a doctor receives payments from a drug manufacturer, the public deserves to know. Transparency builds trust, ensures accountability, and enables regulatory oversight.

What are some challenges people face with global HCP transparency?

Over the last decade, an increasing number of countries have adopted their own rules or voluntary codes to regulate these disclosures. However, companies do face several challenges:

  • Inconsistent local regulations
  • Different formats, deadlines, and thresholds
  • Complexity of tracking cross-border expenses
  • Manual, error-prone reporting systems

These factors make compliance resource-intensive, especially for multinational organisations with a wide geographic footprint.

What are examples of global HCP transparency frameworks?

Which companies fall under the Sunshine Act?

Here are some of the most prominent frameworks shaping global compliance:

A voluntary code requiring pharmaceutical companies to disclose payments or transfers of value (ToVs) made to HCPs and HCOs. Members must name recipients and specify the nature and value of each ToV.

One of the most stringent laws in Europe, requiring disclosure of any ToV above €10. Disclosures must be submitted to a central public platform and include detailed contractual information.

Governed by the Japan Pharmaceutical Manufacturers Association, this code promotes fair marketing and requires disclosure of payments to healthcare professionals.

Other examples of voluntary industry-led codes that encourage transparency and responsible interactions with HCPs.

Together, these frameworks highlight a global movement toward disclosure, and demonstrate just how complex the regulatory landscape can be.

The Sunshine Act: the foundation of modern HCP transparency

Which companies fall under the Sunshine Act?

The Sunshine Act, officially known as the Physician Payments Sunshine Act, was enacted in 2010 as part of the U.S. Affordable Care Act. It mandates that manufacturers of drugs, medical devices, and biological products report most payments or transfers of value made to physicians and teaching hospitals.

What needs to be reported?

These payments fall into three categories:

  • General payments – e.g., consulting fees, gifts, meals, travel
  • Research payments – linked to clinical trials or research agreements
  • Ownership or investment interests

What are the penalties for failing to report or misreporting?

Non-compliance can be costly. Penalties for knowingly failing to report range from $10,000 to $100,000 per payment, with an annual cap of $1 million.

The data is made publicly available through the Open Payments Program, aiming to shine a light on industry-provider relationships.

How the Sunshine Act fits into the global picture?

How does the Sunshine Act compare to laws in France, Belgium, or Germany?

The Sunshine Act has served as a blueprint for transparency legislation around the world. But with each country introducing its own flavour of regulation, multinational companies now face a complex compliance puzzle.

Some key contrasts:

  • Centralised vs. decentralised reporting: Some countries use national databases (e.g. France), others allow self-publishing (e.g. UK).
  • Mandatory vs. voluntary frameworks: Not all regulations carry legal weight, some are industry-led.
  • Disclosure thresholds and categories vary: What qualifies as a ToV in one country may not in another.

What does the Sunshine Act mean for global compliance teams?

  • Reconciling and standardising expense data across regions
  • Training employees on local rules
  • Ensuring timely, accurate disclosures without duplication

How do we set up a compliant process across multiple departments?

Best practices for compliance across jurisdictions

Staying ahead of transparency regulations requires a robust and scalable compliance strategy. Here’s what the most successful companies are doing:

1. Automate expense and payment tracking

If you need to know which systems you should use to track payments globally, you've come to the right place.

Manual tracking is slow, error-prone, and risky. Tools like Declaree and MXP by Mobilexpense let users log expenses on the go, attach receipts, and link them to HCP profiles with minimal effort.

2. Centralise HCP data

Using approved HCP databases (e.g. MediSpend, MedPro, IQVIA), employees can pull accurate details for each contact.

Mobilexpense supports both list-based and manual entry workflows.

3. Ensure structured, accurate reporting

With preconfigured templates, companies can generate disclosure reports aligned with local requirements. These reports are formatted for submission to authorities or associations.

4. Stay audit-ready

Automated systems create a digital audit trail, reducing fraud and simplifying investigations.

5. Train globally, report locally

Teams must understand how regulations vary. Embedding compliance into travel and expense workflows ensures that nothing is overlooked.

TLDR; Suggested compliance process (summary checklist)

  1. Create a policy: Define what’s reportable and who is responsible.
  2. Centralise data: Consolidate from CRM, finance, events, and third parties.
  3. Automate tracking: Use tools that tag and categorise spend per HCP.
  4. Clean data regularly: Standardise physician details (e.g. NPI, specialty).
  5. Run internal reviews: Monthly or quarterly checks.
  6. Submit on time: Meet CMS deadlines and respond to disputes quickly.
  7. Document everything: Keep thorough records in case of audit.

Conclusion: compliance as a competitive advantage

The world of HCP transparency is evolving rapidly, and compliance is no longer a burden. On the contrary, it’s an opportunity to build trust and demonstrate integrity.

Whether you're dealing with the Sunshine Act, or EFPIA’s Disclosure Code, the core challenge remains the same: managing complex, high-volume data in a consistent and auditable way.

Mobilexpense empowers healthcare companies to meet this challenge with ease. Our HCP transparency module helps you record, track, and report every relevant payment or transfer of value. All within a single, automated platform. Resulting in better compliance, less admin, fewer errors, and total peace of mind.

Ready to start? Download our free guide to HCP Sunshine Act Compliance in the pharma industry.