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Italian Sunshine Act for Smaller Pharma and MedTech Companies: What Changes When Your Reporting Volume Is Low?

by | Oct 30, 2026 | en

Table of content

Author


May Khan

Noemi Galbiati
Global Solutions Delivery Manager
Vector Health Compliance

Noemi is a Global Solutions Delivery Manager at Vector Health Compliance, where she supports client delivery across global transparency projects. Her work focuses on data accuracy, remediation, and country-specific reporting requirements, with a particular focus on Italy. She plays a key role in coordinating client needs with internal teams to ensure timely and compliant reporting outcomes.

 

Vector Health Compliance
Your Leading Partner in Global Sunshine Compliance

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For a smaller pharmaceutical or MedTech company, transparency reporting can appear deceptively simple. Fewer employees, fewer HCP engagements and fewer transactions may seem to suggest that preparing for the Italian Sunshine Act should require little more than a spreadsheet and someone to upload the final file.

That assumption can be costly.

Italy’s Law No. 62/2022 establishes transparency obligations for producer companies concerning certain financial relationships with persons operating in the healthcare sector and healthcare organisations (HCPs/HCOs), with the information ultimately communicated to the public Sanità trasparente register. The legislation does not create a separate, simplified reporting framework simply because a company is small or has a low transaction volume.

For smaller organisations, therefore, the challenge is often not the quantity of data. It is the ability to identify, organise, validate and govern the data they do have.

Fewer Transactions Do Not Mean Fewer Compliance Questions

A large pharmaceutical company may have dedicated transparency, compliance, finance, legal and IT teams. A smaller company may have one or two people covering several of those responsibilities at once. That difference matters.

Consider a company with only a modest number of Italian HCP engagements during a reporting period. Its transactions might still originate from several parts of the organisation: ravel and expenses, consulting arrangements, congress participation, sponsorships, grants, research arrangements and other business activities that may generate reportable transfers or relationships. The resulting information may therefore be distributed across different systems, teams or even external service providers.

The issue becomes less about extracting thousands of transactions and more about answering a fundamental question:

Have we identified every relevant source of data?

The framework established by Law No. 62/2022, together with the implementing measures for Sanità Trasparente, is designed around the communication and publication of information concerning financial transactions and relationships between producer companies and healthcare-sector stakeholders.

A smaller company therefore still needs a reliable process for determining what should be captured, where the information resides and whether the available data contains the attributes required for reporting.

The Spreadsheet Trap

Spreadsheets are not inherently a problem. For a smaller organisation with a limited number of transactions, they may be a practical part of the compliance process.

The problem arises when the spreadsheet becomes the system of record by default.

A manually maintained file can make it difficult to establish where each transaction originated, who changed a value, whether an HCP record has been updated, whether a payment has been duplicated, or whether the information has been reconciled against the company’s underlying financial records.

The risk becomes greater when different teams maintain separate files. Finance may have one version of a transaction, compliance another, and a commercial or clinical team a third.

The result can be a surprisingly complex reconciliation exercise—even when the total number of transactions is relatively small.

Start With a Transfer-of-Value Inventory

For smaller companies, one of the most effective preparation steps is to create a clear inventory of potential transfers of value and identify the systems or processes from which they originate.

This means asking practical questions:

  • Which teams interact with Italian HCPs and HCOs?
  • Which systems record payments or benefits?
  • Are consulting agreements captured separately from expenses?
  • Are congress and event-related transactions recorded elsewhere?
  • Are grants, sponsorships or research-related transactions managed by different functions?
  • Are any transactions processed manually?
  • Which data fields are captured consistently across these sources?
  • Who is responsible for reviewing the information before reporting?

Companies need to identify where their transfers of value originate and whether systems such as expense platforms, ERP systems and other source systems capture the details required for transparency reporting. 

For a smaller company, this inventory can be particularly valuable because it provides visibility without requiring a large compliance infrastructure.

Don’t Confuse a Small Data Set With a Simple Data Set

A company may have only a few hundred transactions and still face complicated data-quality questions.

An HCP could be recorded differently in two systems. An organisation could have multiple identifiers. A payment could be associated with the wrong entity. A transaction could be missing a required attribute. Or a manually entered value could differ from the underlying financial record. These issues do not necessarily disappear when transaction volumes are low.

In fact, smaller companies can be more exposed because they may lack automated reconciliation and validation processes. A practical workflow can map data against regulatory requirements, identify errors, route corrections for review and maintain client approval before the data progresses to reporting 

That principle is useful regardless of company size:every potentially reportable transaction needs to be reliable, not merely present. 

Build a Proportionate Control Framework

Smaller companies do not necessarily need the same technology stack or organisational structure as a multinational pharmaceutical or MedTech company. What they do need is a proportionate control framework.

At minimum, this should establish:

  1. Clear ownership
    Someone should be accountable for coordinating the reporting process, even when several functions contribute data.
  2. A defined data inventory
    The company should know which systems, teams and processes can generate reportable information.
  3. Data validation
    Records should be checked for completeness, consistency and obvious errors before submission.
  4. Approval controls
    Material corrections and final reporting data should be reviewed by an appropriate business owner.
  5. An audit trail
    The company should be able to explain where reported information came from and how discrepancies were resolved.

These controls can be implemented manually, through technology, or through a combination of both. The important point is that the process should be repeatable and defensible.

Outsourcing Can Address Capacity but not Accountability

For a smaller organisation, outsourcing some or all of the operational reporting work can be an attractive option, particularly when there is no dedicated transparency reporting team.

A managed reporting provider can consolidate data from multiple sources, perform mapping and validation, resolve data-quality issues and prepare the required reporting output. The source discussion describes precisely such a model, where the reporting stage follows earlier work around gap analysis, remediation, policy and team preparation. But outsourcing should not mean handing over responsibility without establishing controls.

The company should understand what information is being supplied, who validates corrections, who approves the final data and how the submission process is governed. A reporting provider can support the process; the organisation still needs sufficient oversight of its own reporting data.

The Advantage of Starting Small

For smaller pharma and MedTech companies, there is actually an opportunity hidden in the lower transaction volume.

A smaller data population can make it possible to establish good reporting discipline before the organisation’s Italian operations grow.

Instead of waiting until transaction volumes increase, companies can use the current preparation period to map their systems, establish ownership, standardise data capture and introduce validation controls. Once those processes are embedded, scaling them becomes considerably easier.

The goal should not be to build the largest possible transparency infrastructure.

It should be to build one that is accurate, proportionate, repeatable and capable of scaling.

Final Takeaway

The Italian Sunshine Act does not become simpler simply because a company is smaller. What changes is the way the compliance challenge needs to be approached.

For a smaller pharma or MedTech company, success may depend less on sophisticated infrastructure and more on disciplined data management: knowing where transfers of value originate, ensuring the right information is captured, assigning clear ownership, validating the data and maintaining an evidence trail.

When reporting volumes are low, there is a temptation to manage Sunshine reporting as an administrative exercise. A better approach is to treat it as a small but important data-governance process.

That approach can help smaller organisations avoid the most expensive mistake of all: discovering a data problem only after the reporting process has already begun.

Table of content

For a smaller pharmaceutical or MedTech company, transparency reporting can appear deceptively simple. Fewer employees, fewer HCP engagements and fewer transactions may seem to suggest that preparing for the Italian Sunshine Act should require little more than a spreadsheet and someone to upload the final file.

That assumption can be costly.

Italy’s Law No. 62/2022 establishes transparency obligations for producer companies concerning certain financial relationships with persons operating in the healthcare sector and healthcare organisations (HCPs/HCOs), with the information ultimately communicated to the public Sanità trasparente register. The legislation does not create a separate, simplified reporting framework simply because a company is small or has a low transaction volume.

For smaller organisations, therefore, the challenge is often not the quantity of data. It is the ability to identify, organise, validate and govern the data they do have.

Fewer Transactions Do Not Mean Fewer Compliance Questions

A large pharmaceutical company may have dedicated transparency, compliance, finance, legal and IT teams. A smaller company may have one or two people covering several of those responsibilities at once. That difference matters.

Consider a company with only a modest number of Italian HCP engagements during a reporting period. Its transactions might still originate from several parts of the organisation: ravel and expenses, consulting arrangements, congress participation, sponsorships, grants, research arrangements and other business activities that may generate reportable transfers or relationships. The resulting information may therefore be distributed across different systems, teams or even external service providers.

The issue becomes less about extracting thousands of transactions and more about answering a fundamental question:

Have we identified every relevant source of data?

The framework established by Law No. 62/2022, together with the implementing measures for Sanità Trasparente, is designed around the communication and publication of information concerning financial transactions and relationships between producer companies and healthcare-sector stakeholders.

A smaller company therefore still needs a reliable process for determining what should be captured, where the information resides and whether the available data contains the attributes required for reporting.

The Spreadsheet Trap

Spreadsheets are not inherently a problem. For a smaller organisation with a limited number of transactions, they may be a practical part of the compliance process.

The problem arises when the spreadsheet becomes the system of record by default.

A manually maintained file can make it difficult to establish where each transaction originated, who changed a value, whether an HCP record has been updated, whether a payment has been duplicated, or whether the information has been reconciled against the company’s underlying financial records.

The risk becomes greater when different teams maintain separate files. Finance may have one version of a transaction, compliance another, and a commercial or clinical team a third.

The result can be a surprisingly complex reconciliation exercise—even when the total number of transactions is relatively small.

Start With a Transfer-of-Value Inventory

For smaller companies, one of the most effective preparation steps is to create a clear inventory of potential transfers of value and identify the systems or processes from which they originate.

This means asking practical questions:

  • Which teams interact with Italian HCPs and HCOs?
  • Which systems record payments or benefits?
  • Are consulting agreements captured separately from expenses?
  • Are congress and event-related transactions recorded elsewhere?
  • Are grants, sponsorships or research-related transactions managed by different functions?
  • Are any transactions processed manually?
  • Which data fields are captured consistently across these sources?
  • Who is responsible for reviewing the information before reporting?

Companies need to identify where their transfers of value originate and whether systems such as expense platforms, ERP systems and other source systems capture the details required for transparency reporting. 

For a smaller company, this inventory can be particularly valuable because it provides visibility without requiring a large compliance infrastructure.

Don’t Confuse a Small Data Set With a Simple Data Set

A company may have only a few hundred transactions and still face complicated data-quality questions.

An HCP could be recorded differently in two systems. An organisation could have multiple identifiers. A payment could be associated with the wrong entity. A transaction could be missing a required attribute. Or a manually entered value could differ from the underlying financial record. These issues do not necessarily disappear when transaction volumes are low.

In fact, smaller companies can be more exposed because they may lack automated reconciliation and validation processes. A practical workflow can map data against regulatory requirements, identify errors, route corrections for review and maintain client approval before the data progresses to reporting 

That principle is useful regardless of company size:every potentially reportable transaction needs to be reliable, not merely present. 

Build a Proportionate Control Framework

Smaller companies do not necessarily need the same technology stack or organisational structure as a multinational pharmaceutical or MedTech company. What they do need is a proportionate control framework.

At minimum, this should establish:

  1. Clear ownership
    Someone should be accountable for coordinating the reporting process, even when several functions contribute data.
  2. A defined data inventory
    The company should know which systems, teams and processes can generate reportable information.
  3. Data validation
    Records should be checked for completeness, consistency and obvious errors before submission.
  4. Approval controls
    Material corrections and final reporting data should be reviewed by an appropriate business owner.
  5. An audit trail
    The company should be able to explain where reported information came from and how discrepancies were resolved.

These controls can be implemented manually, through technology, or through a combination of both. The important point is that the process should be repeatable and defensible.

Outsourcing Can Address Capacity but not Accountability

For a smaller organisation, outsourcing some or all of the operational reporting work can be an attractive option, particularly when there is no dedicated transparency reporting team.

A managed reporting provider can consolidate data from multiple sources, perform mapping and validation, resolve data-quality issues and prepare the required reporting output. The source discussion describes precisely such a model, where the reporting stage follows earlier work around gap analysis, remediation, policy and team preparation. But outsourcing should not mean handing over responsibility without establishing controls.

The company should understand what information is being supplied, who validates corrections, who approves the final data and how the submission process is governed. A reporting provider can support the process; the organisation still needs sufficient oversight of its own reporting data.

The Advantage of Starting Small

For smaller pharma and MedTech companies, there is actually an opportunity hidden in the lower transaction volume.

A smaller data population can make it possible to establish good reporting discipline before the organisation’s Italian operations grow.

Instead of waiting until transaction volumes increase, companies can use the current preparation period to map their systems, establish ownership, standardise data capture and introduce validation controls. Once those processes are embedded, scaling them becomes considerably easier.

The goal should not be to build the largest possible transparency infrastructure.

It should be to build one that is accurate, proportionate, repeatable and capable of scaling.

Final Takeaway

The Italian Sunshine Act does not become simpler simply because a company is smaller. What changes is the way the compliance challenge needs to be approached.

For a smaller pharma or MedTech company, success may depend less on sophisticated infrastructure and more on disciplined data management: knowing where transfers of value originate, ensuring the right information is captured, assigning clear ownership, validating the data and maintaining an evidence trail.

When reporting volumes are low, there is a temptation to manage Sunshine reporting as an administrative exercise. A better approach is to treat it as a small but important data-governance process.

That approach can help smaller organisations avoid the most expensive mistake of all: discovering a data problem only after the reporting process has already begun.

Author


May Khan

Noemi Galbiati
Global Solutions Delivery Manager
Vector Health Compliance

Noemi is a Global Solutions Delivery Manager at Vector Health Compliance, where she supports client delivery across global transparency projects. Her work focuses on data accuracy, remediation, and country-specific reporting requirements, with a particular focus on Italy. She plays a key role in coordinating client needs with internal teams to ensure timely and compliant reporting outcomes.

 

Vector Health Compliance
Your Leading Partner in Global Sunshine Compliance

Recent Blogs

Cerchi supporto per la compliance al Sunshine Act?

Scopri i nostri Partner consigliati — soluzioni legali, tecnologiche e operative selezionate per accompagnarti nella rendicontazione della trasparenza.

Hai domande pratiche?

Dai un’occhiata alla nostra sezione Domande Frequenti per risposte chiare su scadenze, obblighi e strategie.

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