In February 2024, the Croatian Health Insurance Fund (CHIF) and the Ministry of Health launched public consultations on two draft regulations focused on the collection and monitoring of outcomes from medical treatments involving high-cost and off-list medications. The American Chamber of Commerce in Croatia (AmCham) supports the intent behind these regulations but has expressed several concerns and recommendations.

1) Support for Outcome Monitoring—With a Broader Perspective:

AmCham welcomes regulations aimed at systematically tracking treatment outcomes but emphasizes that the effectiveness of a medication should not be viewed in isolation. A patient’s full treatment journey—from early diagnosis to final outcome—must be considered.

2) Critical Gaps Identified in the Draft Regulations:

• Incomplete scope: Current drafts fail to include key factors like diagnosis timing, patient adherence, and interactions between treatments (e.g., surgery or radiotherapy).
• System limitations: Without proper infrastructure, new reporting obligations could strain hospitals, potentially compromising data accuracy.
• Lack of stakeholder involvement: The regulations overlook key players such as pharmaceutical companies, patient associations, and medical societies.

AmCham recommendations:

• Extend monitoring to the entire patient pathway, not just medication use.
• Establish centers of excellence and legal frameworks for multidisciplinary care.
• Introduce data quality control mechanisms with standardized parameters.
• Ensure transparency and stakeholder access to reports and appeals processes.
• Guarantee patient data protection and clearly define responsibilities for data analysis.

AmCham urges the Croatian authorities to revise the regulations to ensure they reflect the full complexity of medical treatments and involve all relevant stakeholders. International best practices show that close collaboration between healthcare systems and pharmaceutical companies leads to more reliable, objective, and actionable insights—benefiting patients and the healthcare system alike.