What Italy Can Learn from the US, France, and Portugal Before Sanità Trasparente Goes Live

Practical lessons for companies preparing for the Italian Sunshine Act

When a new transparency regulation comes into force, the real problems don’t begin on submission day; they begin months (or even years) earlier, during preparation.

Italy is not the first country to adopt a centralized transparency system for publishing transfers of value. The United States, France, and Portugal have already been through this transformation, experiencing operational, technical, and relational challenges along the way.

The advantage for the Italian market? We can learn from their mistakes.

1. The Lesson from the United States: The Problems Aren’t Technical, They’re About Governance

The US Open Payments system showed a fundamental truth: The hardest part is not generating a file; it’s building a stable governance model.

US companies underestimated:

• fragmented data across ERP, CRM, agencies, Medical Affairs, and Finance
• the lack of a single identifier for healthcare professionals
• the need for year-round data quality controls
• the management of HCP disputes once the data became public

Companies that struggled the least were those that invested early in:

• HCP/HCO master data
• internal control frameworks, and
• clear ownership across Compliance, Finance, and IT

2. The Lesson from France: Grey Zones Are More Dangerous Than Technical Rules

France’s Loi Bertrand was characterised by legal ambiguities. Companies struggled for years to interpret:

• what constitutes an “agreement” versus a “benefit”
• how to classify travel, hospitality and hybrid events
• conflicts between EFPIA rules and strict French legal requirements
• how to communicate to HCPs what would be published

The most successful companies were those that:

• systematically documented all interpretive decisions
• built France-specific internal guidelines
• prepared clear and transparent materials for HCPs

3. The Lesson from Portugal: Small Details Create the Biggest Problems

Portugal demonstrated that: thresholds, exceptions, and micro-rules are often the main sources of error. Companies faced challenges with:

• the €60 threshold and aggregation rules
• handling scientific associations and patient organisations
• adapting global processes to the INFARMED portal
• onboarding device companies unfamiliar with EFPIA-style reporting

Many organisations underestimated the operational burden, especially mid-sized companies and those with lean compliance teams.

4. The Red Thread: The Recurring Mistakes Italy Can Avoid

Across all three countries, five patterns emerged:

1. The problem isn’t reporting; it’s data quality.
2. HCPs will react. Organisations must be ready for disputes.
3. Grey zones must be resolved BEFORE go-live.
4. EFPIA + national law = double complexity.
5. The first year is always the most scrutinised, and the most risky.

What Italian Companies Should Be Doing Now

Preparing for Sanità Trasparente is a practical consequence of the obligations introduced by Law 62/2022, the Ministerial Decree, and the Technical Specifications.

Below is what companies must begin doing now, with the explicit legal basis for each action.

1. Map All Spend Sources (Art. 3.1 – Direct and Indirect Advantages)

The Italian law requires disclosure of all direct and indirect transfers of value, regardless of how they are provided or through whom.

To comply, companies must identify every relevant data source:

• ERP / Finance
• CRM
• Medical Affairs and Events
• Travel & Expense systems
• Grants/Donations
• Third-party agencies and event organisers

Failing to map spend → missing ToVs → non-compliance.

2. Create a Single, Reconciled Dataset (Technical Specs – Single File Requirement)

The Ministry requires:

• one structured file per reporting entity
• complete, consistent, validated data
• no duplicates
• mandatory fields populated

This means:

• reconciling amounts and dates
• matching events to agreements
• validating financial and beneficiary details

If not done, the submission can be rejected by the portal.

3. Strengthen HCP/HCO Master Data (Decree – Beneficiary Identification Requirements)

The Italian system requires:

• tax code / VAT number
• professional classification
• registered address
• correct assignment of each ToV to each beneficiary

Without accurate master data, companies cannot meet the identification requirements. Errors lead to disputes, submission failures or misreporting.

4. Establish a Governance Model (Law 62/2022 – Manufacturer Liability)

The law holds the “manufacturing company” accountable for:

• accuracy
• completeness
• traceability
• management of corrections
• timely submission

This requires clear internal ownership:

• Who collects the data?
• Who validates it?
• Who approves the submission?
• Who manages disputes and corrections?

This must be defined in a cross-functional governance model.

5. Prepare HCP Notification Materials (Law + GDPR Transparency Requirements)

Italian law and GDPR require:

• clear notification to beneficiaries
• lawful basis for publication
• transparent communication
• procedures for disputes/corrections

Companies need:

• HCP communication letters
• disclosure clauses in contracts
• FAQs
• internal dispute-handling processes

Without these, companies risk GDPR violations and significant operational issues.

6. Document All Interpretive Decisions (GDPR Accountability + Decree Expectations)

The Italian Sunshine Act includes broad concepts such as:

• indirect advantages
• economic support
• benefits provided via intermediaries
• multi-beneficiary events
• verbal agreements

Regulators expect:

• internal documentation
• consistency across affiliates
• defensible reasoning for each classification

Documentation protects companies during audits, disputes and legal challenges.

Conclusion

Italy has a unique advantage: it can avoid the painful mistakes already made abroad. The experiences of the United States, France and Portugal clearly show where processes break, and how companies can prevent those pitfalls.

With structured preparation, Italian organisations can approach the first year of Sanità Trasparente with, fewer disputes, fewer data errors, stronger defensibility, and higher internal and external credibility

This is the moment to learn from the past and prepare intelligently for the future.

Ensure full compliance with the Italian Sunshine Act by scheduling a call with our experts.