EUDRALEX, GDPR - Pharma companies and data security

In the European Union (EU), pharmaceutical companies are governed by a complex regulatory framework designed to protect patient privacy while ensuring that healthcare data is used appropriately for research, clinical trials, and patient care. One of the cornerstone regulations for pharmaceutical companies operating in the EU is EUDRALEX, the body of rules governing medicinal products in the EU. Chapter 9 of EUDRALEX, specifically, outlines how patient and clinical data should be handled, including transparency in sharing data with third parties.

With the increasing importance of data sharing for pharmaceutical research, compliance with EUDRALEX has become more critical than ever. Pharmaceutical companies are required to disclose with whom they share patient and clinical data, and failure to do so has led to fines and audits. This article explores the data types exchanged, typical recipients, the purposes behind the exchange, key responsible roles within companies, and the risk management importance of continuously monitoring these data flows.

The Role of EUDRALEX in Data Disclosure Requirements

EUDRALEX is a series of guidelines and legal frameworks that govern various aspects of pharmaceutical manufacturing, distribution, and research within the EU. Of particular importance for data handling are Directive 2001/83/EC and Regulation (EU) No 536/2014 on clinical trials, which emphasize the need for data transparency and patient protection.

EUDRALEX stipulates that pharmaceutical companies must maintain records of any patient or clinical data they share with third parties. This includes disclosing the recipients of the data, the purpose of the exchange, and the duration of data retention. Furthermore, companies are obligated to report any data sharing to relevant authorities, ensuring compliance with both GDPR (General Data Protection Regulation) and specific EUDRALEX provisions. These disclosures are typically submitted to national competent authorities or the European Medicines Agency (EMA).

Types of Data Exchanged and Typical Recipients

Pharmaceutical companies handle a wide array of patient and clinical data, including:

- Patient medical records used in clinical trials.

- Genomic data for precision medicine research.

- Adverse event reports during drug development.

- Efficacy and safety data required for regulatory submissions.

These data sets are often shared with a variety of recipients, including:

- Contract Research Organizations (CROs): Conduct clinical trials on behalf of pharmaceutical companies, often across borders, necessitating stringent data sharing protocols.

- Regulatory authorities like the EMA, which require access to trial results and adverse event reports.

- Academic institutions and research collaborators for scientific studies or drug development partnerships.

- Cloud service providers who offer data storage or computing resources, though the specific locations and security of these systems must be closely monitored to avoid GDPR violations.

For example, a pharmaceutical company conducting a multi-center clinical trial may need to share patient data with CROs and research institutions in different EU countries. Each recipient must comply with EUDRALEX requirements, and the pharma company must catalog these exchanges and disclose them as required.

Roles Responsible for Cataloging Data Transfers

Inside pharmaceutical companies, several key roles are responsible for ensuring compliance with EUDRALEX and GDPR:

- Data Protection Officer (DPO): Mandated under GDPR, the DPO ensures that all personal data, including patient and clinical information, is handled in compliance with privacy laws. The DPO is often the central figure ensuring that data sharing is properly cataloged and disclosed.

- Clinical Operations Managers: These professionals oversee the execution of clinical trials, including the transfer of patient data to third parties such as CROs and research institutions.

- Chief Compliance Officer (CCO): In many large pharmaceutical companies, the CCO ensures that all aspects of the business, including data handling and reporting, comply with EUDRALEX and GDPR regulations.

Reporting obligations typically fall under Article 82 of Regulation (EU) No 536/2014, which requires companies to ensure that data privacy is maintained throughout clinical trials, with clear records of data sharing to be reported to national authorities and the EMA.

Examples of Non-Compliance and Consequences

Failure to properly disclose data sharing has led to significant fines for some pharmaceutical companies. A high-profile example is Novartis, which was fined by authorities for improper handling of clinical trial data that was shared with third-party organizations without proper disclosure. Similarly, Sanofi faced audits after regulators discovered that data from European patients had been shared with overseas partners without the proper safeguards or disclosures.

In both cases, the companies faced not only financial penalties but also reputational damage, highlighting the critical nature of transparent data management practices.

The Need for Constant Monitoring and Data Flow Posture Correction

Given the complexity of the pharmaceutical industry’s data ecosystem, monitoring data flows is not optional—it is an essential part of risk management. Modern pharmaceutical operations involve numerous third parties, cross-border data exchanges, and vast amounts of sensitive information. These factors create significant risks if data sharing is not correctly disclosed and managed.

Constant monitoring of data flows helps pharmaceutical companies identify potential compliance gaps before they lead to regulatory action. Tools that automatically track and catalog data sharing can help ensure that every exchange is recorded and reported in real time, reducing the risk of non-compliance with EUDRALEX and GDPR.

For example, automated systems can flag when data is transferred to new recipients or when existing agreements with third parties expire, prompting immediate action to update disclosures or renew data-sharing agreements.

Conclusion: A Compliance Imperative

EUDRALEX, alongside GDPR, creates a stringent framework for pharmaceutical companies operating in the EU. As companies increasingly rely on third parties for clinical trials, research, and data storage, the need for constant oversight of data flows has never been greater. The consequences of failing to comply—fines, audits, and reputational damage—are significant, making data flow monitoring and posture correction a fundamental component of risk management.

Pharmaceutical companies must invest in technologies and processes that allow for real-time tracking of data exchanges, continuous compliance monitoring, and immediate reporting. This is not just a legal requirement but also a competitive advantage in today’s regulatory environment.

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