Preparing for the Italian Sunshine Act: Key Steps for Manufacturers

The Italian Sunshine Act continues to be a top priority among industry experts, maintaining its position as one of the hottest topics in the field. While the Ministry of Health (MOH) has not released any significant updates in the Report Review of the Consultation. The Telematic Register is still expected to go live by the end of 2023, and manufacturers should remain vigilant in their preparations to ensure they can collect the necessary data for the first semester by January 1, 2024.

Transparency reporting experts and industry leaders recommend several crucial steps to prepare for the forthcoming law:

• Revise Policies and Procedures: Manufacturers should revisit and adapt their policies and procedures to effectively capture and report the transfer of values in accordance with the Italian Sunshine Act.
• Enhance Training Programs: Training programs should be updated to align with the revised policies, ensuring that employees are well-prepared to comply with the new regulations.
• Communicate Commitment: It’s essential to convey your organization’s commitment to complying with the law, both internally and externally. This commitment should be reflected on your website and in your communications.
• Data Management Capabilities: Establish or enhance your organization’s ability to collect, organize, verify, audit, report, and track the Italian Sunshine Report efficiently.
• Assess Data Collection: Evaluate your existing data collection capabilities to identify any areas that require improvement or adjustment.
• Identify Gaps: Conduct a thorough review of your business processes, systems, and databases to pinpoint any gaps that may hinder compliance.
• Remediate and Re-test: Address the identified gaps and thoroughly test your systems and processes to ensure they are robust and compliant.
• Mock Italian Sunshine Report: As a final step, consider producing a mock Italian Sunshine Report for the year 2023 to simulate the reporting process and confirm that your systems are ready for the actual reporting. 

These proactive steps will help manufacturers navigate the complexities of the Italian Sunshine Act and ensure that they are fully prepared to meet the upcoming legislative requirements. Stay tuned for further updates and guidance as the law’s implementation progresses.