Europe – Market survey: Data Access to an electronic health care record database from the United Kingdom

The European Medicines Agency (“the Agency” or “EMA”) is a decentralised agency of the European Union (EU) based in the Zuidas area of Amsterdam. EMA is responsible for the centralised procedure for the authorisation of medicines resulting in a single evaluation and a single authorisation for the whole of the EU. EMA also coordinates various aspects of the regulation of all other medicines in the EU (nationally authorised medicines). The EMA’s recommendations on medicines are based on rigorous scientific standards and the available evidence. Appropriate risk management systems are adopted to ensure the safe and effective use of the medicine post-authorisation. Building knowledge throughout the lifetime of a medicinal product is therefore critical in fully characterising the safety and
effectiveness profile of a medicine and thus its benefit/risk balance while it is marketed.

Many of the questions raised on the safety and effectiveness profile of a medicine by the EMA and its advisory committees can be addressed through analyses of observational health data. Because the objective of these analyses is often to resolve a current and ongoing benefit risk concern, the time frame may be short and hence fast access to retrospective electronic health records is an advantage…