The European Medicines Agency (EMEA) has announced plans to make information from EudraVigilance, its adverse drug reaction (ADR) database, available to health care professionals, patients and pharmaceutical companies.

EudraVigilance is the database of adverse reactions related to medicinal products authorized in the European Union (EU) and those which are subject to clinical trials. It is composed of: - EudraVigilance Gateway, the data-processing network for the exchange of adverse reaction data; - EudraVigilance Human, a database consisting of two modules, one for clinical trials and one for post-authorisations, to collect suspected adverse reactions related to human-use medicines; - EudraVigilance Medicinal Product Dictionary (EVMPD), to allow for standardisation of product information; and - EudraVigilance Data Warehouse and Analysis System (EVDAS), which supports the EU pharmacovigilance system with a main focus on data analysis.

Under the proposed EudraVigilance Access Policy, access to the database will be implemented at the level of EVDAS, taking into account “appropriate levels” of access to the various stakeholders and the need to protect personal data.

National and EU authorities, industry, health care professional and the public will all be able to access information relating to spontaneous reports of adverse reactions, but health professionals, the public, marketing authorisation (MA) holders and product sponsors will not be able to access data from interventional and non-interventional trials. “These adverse reaction data are reported in the context of defined protocols and are subject to an overall assessment, which summarises the results at the end of the study in a study report,” says the EMEA.

However, it has become evident, the Agency adds, that many smaller commercial and particularly non-commercial sponsors do not have the necessary technical tools to evaluate adverse reaction data related to interventional and non-interventional trials which they conduct in the European Economic Area (EEA). Therefore, it is proposed that for MA holders and sponsors, access to EudraVigilance data will be provided which is restricted to those individual cases related to such trials which they have transmitted electronically to the database.

The Agency is proposing that the Access Policy should be rolled out in a stepwise approach. The first step, granting access to the member states’ national competent authorities, was achieved through the roll-out of EVDAS in July 2007.

In a second phase, access will be granted to health care professionals and the general public, initially for centrally-authorised products, and then extended stepwise for all active substances and medicinal products.

In parallel, access will be provided to MA holders and sponsors of clinical trials in the EEA, initially for those which are currently registered, and then to all others.

“The protection of personal data and the provision of further information upon request are important elements that are to be addressed in the implementation of the access policy,” says the EMEA, which is calling for comments on its proposals by March 2, 2009.