BACKGROUND: While clinical trials remain the gold standard for drug approval, additional information is required on how specific drugs perform in a real-world setting. Observational studies providing Real World Evidence (RWE) help fill the knowledge gap between clinical trials and actual clinical practice and are increasingly demanded for submission by health authorities. By providing information on real-world environment, the analysis of retrospective data from medical records addresses the needs of key stakeholders before and after the drug approval. To harmonize legislation across European countries, the European regulatory framework is evolving (EU CRT N1 536/2014) and requires each local country legislation to follow. According to the European Medicines Agency (EMA) (statement Dec 2015) this new regulation should come into effect by October 2018 at the latest. In the interim, country specific legislation must be respected resulting in a high level of complexity for multi-country observational studies.
METHODOLOGY: Documentary Method – critical analysis of country specific legislations, government body requirements and recommendations. Results: In France, the Loi Jardé became effective in November 2016, but will require a new amendment for observational studies in order to conform with the forthcoming EU law. In Germany, studies involving the collection of retrospective medical records are mainly classified as ‘Anwendungsbeobachtungen (AWB)’, and require only the notification to central entities. Spain has a straightforward regulatory classification system for observational studies, but requires site-based Research Ethics Committee (REC) approvals. Even though the current legislation of the UK for observational studies is probably the most straightforward (e.g. service evaluation), the future evolution of regulations is highly uncertain due to BREXIT. CONCLUSIONS: Although EU harmonization of legal requirements for observational studies is supposed to take place in October 2018, we can expect many twists and turns until this is translated in real-world practice!
