Argentina Fines Ferring: Privacy Wake-Up Call for Pharma

In a precedent-setting decision, Argentina’s Data Protection Authority (Agencia de Acceso a la Información Pública – AAIP) has fined LABORATORIOS FERRING S.A. a total of ARS 205,001 (approx. USD 2,400) for multiple violations of the country’s data protection law (Law No. 25.326). This marks the first known case in Latin America where a pharmaceutical company is held accountable for mishandling personal data—specifically in the context of patient engagement outside clinical trials. But the impact reaches far beyond the company itself.

This case is a wake-up call for the entire life sciences and research ecosystem.

The Facts: Consent, Access, and Data Sharing

The investigation began following a complaint from an individual who reported receiving unsolicited calls from a third party claiming to act on behalf of Ferring. The caller claimed the patient was enrolled in a support program and requested personal data. When the complainant asked for confirmation and requested access to their personal information—including any consent documentation—the request was ignored.

Ferring later argued that consent had been provided through the patient’s treating physician as far back as 2011 and cited a decade-long interaction with the individual, including the regular delivery of medication to their home. However, the company failed to produce any written or equivalent proof of informed, express, and freely given consent—required by law for processing sensitive health data.

Furthermore, the patient data had been shared with a third-party service provider responsible for follow-up and logistics. Ferring did not demonstrate compliance with legal safeguards required for such data transfers.

The AAIP found the company guilty of:

• Failing to respond in a timely and complete manner to a data subject access request (serious infraction)
• Processing sensitive health data without valid consent (serious infraction)
• Sharing personal data with a third party without meeting legal conditions (very serious infraction)

The authority concluded that mere “long-term engagement” with the patient could not replace the legal requirement for express and documented consent. The explanations provided were dismissed as speculative and insufficient. As a result, the AAIP imposed a monetary fine and instructed that the sanction be recorded in the National Register of Data Protection Offenders.

Why This Matters: A Turning Point for Pharma and Research

Although the fine amount is symbolic compared to the budgets of multinational pharmaceutical companies, the decision itself is groundbreaking. It demonstrates that data protection authorities in Latin America are becoming more assertive and prepared to sanction noncompliance—even against powerful global players.

For pharmaceutical and life sciences companies, this case serves as a critical reminder that:

• Patient support programs are subject to the same privacy obligations as clinical trials. Even if data processing does not happen within a formal research protocol, it must still respect individuals’ rights and consent requirements under applicable law.
• Express, informed, and documented consent is non-negotiable. Companies must be able to prove that consent was freely given, with full awareness of how personal data—including health data—will be used and shared.
• Third-party vendors must be properly governed. Any data shared with external partners must follow strict rules, including data processing agreements and clear responsibilities to ensure lawful handling.

The Broader Implications: Reputation, Trust, and Regulatory Ripples

While the monetary fine is modest, the reputational impact on the company is far greater. The AAIP’s resolution publicly exposes a breach of fundamental rights—an issue that erodes public trust in the pharmaceutical sector. When individuals lose confidence in how their data is handled, their willingness to participate in research or patient programs declines, which can ultimately undermine scientific progress and public health efforts.

Moreover, this ruling may trigger further scrutiny. Other national data protection authorities—both in Latin America and beyond—could initiate their own investigations ex officio, particularly if the same patient support program operates across multiple jurisdictions. In that context, compliance with stricter laws such as the EU General Data Protection Regulation (GDPR) becomes critical. Under the GDPR, unlawful data processing and transfers can result in fines of up to 20 million euros or 4% of global annual turnover—far more substantial than the Argentine penalty.

The Ferring case highlights that even localized enforcement actions can carry global consequences, especially when multinational companies operate patient-facing programs that cross borders. Regulatory cooperation is increasing, and no jurisdiction is immune from scrutiny.

A Broader Trend: Growing Enforcement and Patient Awareness

This case is not an isolated event. Across Latin America, data protection authorities are stepping up enforcement. Argentina, Brazil, Mexico, Uruguay, and Chile have all shown increasing regulatory maturity, and other countries are strengthening their privacy laws. With the region rapidly catching up to global standards, data protection is no longer an optional compliance checkbox—it is a business-critical function.

At the same time, patients are becoming more aware of their rights. The complainant in this case knew they had the right to access their data, request a copy of their consent, and question the legitimacy of data processing. As awareness continues to grow—fueled by news, education, and digital access—pharma companies will face more scrutiny not only from regulators, but from the very individuals whose data they process.

Final Thoughts: A Call to Action for the Sector

Life sciences organizations must proactively strengthen their privacy frameworks. This includes reviewing patient-facing programs, updating consent collection processes, auditing third-party arrangements, and ensuring rapid response mechanisms for data subject requests.

In the context of clinical trials, observational studies, real-world data initiatives, and support programs, companies must treat privacy as a core part of patient trust and scientific integrity. Failure to do so can now lead not only to reputational risk—but to real regulatory consequences.

This case against Ferring is not just about one company. It’s about a global shift that has reached Latin America—and it’s here to stay.

You can find the AAIP Resolution here: RS-2025-16101171-APN-AAIP (2).pdf

For now, it remains unclear whether Laboratorios Ferring has appealed the decision. Still, regardless of any legal steps that may follow, the significance of this case cannot be overstated. It marks a turning point for the pharmaceutical and research sectors in Latin America—one that calls for attention, dialogue, and decisive action.