Blog
Disclosure of financial relationships: what are the obligations?

Who is Affected?

Marketing Authorization Holders (MAHs)—i.e., pharmaceutical companies that have received approval to market medicinal products—must annually disclose financial transfers to:

• Healthcare Professionals (HCPs)– Individual practitioners such as doctors, pharmacists, and nurses.

• Healthcare Organizations (HCOs)– Institutions like hospitals, medical associations, or universities.

• Patient Associations (POs)– Groups advocating for patient rights and disease awareness.

What Must Be Reported?

MAHs are required to report various types of financial transfers, including:

Donations and Grants to patient organizations and HCOs.

• Example: A pharmaceutical company donates €50,000 to a cancer patient association for advocacy programs.

Sponsorships and Event Contributions for medical education.

• Example: A pharma company sponsors a cardiology congress attended by specialists.

Honoraria and Consultancy Fees for expert roles.

• Example: A professor of oncology receives a consultancy fee for advising on entry of a new drug to the market

R&D  Support for clinical trials.

• Example: Funding provided for a hospital’s participation in a phase III drug study.

Travel and Accommodation for scientific events.

• Example: A researcher’s flight and hotel costs are covered for a European neurology conference.

Why is This Important?

Non-compliance can result in sanctions, reputational damage, and loss of stakeholder trust. While transparency strengthens ethical business practices, challenges include the administrative burden of reporting and adapting to evolving regulations. Future developments may further harmonize EU disclosure frameworks and enhance digital reporting processes.

Need Guidance on Transparency Compliance?

Understanding and managing compliance with transparency laws can be complex. If you are an HCP, HCO, or industry professional seeking clarity on your obligations, reach out to your Responsible Information and Publicity (RIP).

He/she can guide you on:

• Ensuring accurate and timely reporting.

• Mitigating risks associated with non-compliance.

• Navigating industry-specific regulatory updates.