Administrative complexities for a European observational study despite directives harmonising requirements

Area of Science:

• Pharmacovigilance and Pharmacoepidemiology
• Health Services Research
• European Public Health Policy

Background:

• Pharmacoepidemiological studies are crucial for drug safety assessment in Europe.
• The 1995 Data Protection Directive (95/46/EC) aimed to standardize data access requirements.
• Multinational research necessitates navigating diverse regulatory landscapes.

Purpose of the Study:

• To evaluate the practicalities of data access for a multinational pharmacoepidemiological study in Europe.
• To assess compliance with and the practical implications of the Data Protection Directive (95/46/EC) for data access.

Main Methods:

• A multicentre, multinational, case-population observational study was conducted.
• The study retrospectively evaluated a 3-year period across European liver transplant centers in seven countries.
• Procedures for obtaining necessary data access authorisations were defined prior to data collection.

Main Results:

• Significant variation in data protection committee approval processes was observed across seven European countries.
• In some countries, multiple local committee approvals were required, even after national authority consent.
• The information requested and timeframes for approvals varied considerably, even within the same country.

Conclusions:

• The regulatory landscape for accessing data in European pharmacoepidemiological studies is complex and disharmonious.
• Current procedures create unnecessary time-consuming and costly burdens for researchers.
• Regulators must consider these complexities when planning future multinational research projects.