The European Medicines Agency (EMA), earlier this week, released a draft policy update on access to the data from the EudraVigilance database, which seems to imply they want the right to censor scientific work that uses the data.
Managed by the EMA, EudraVigilance is the European database that holds all information on suspected side effects that have been reported for medicines authorised in Europe. It is one of the greatest resources for adverse drug reaction data, receiving over one million reports of suspected side effects a year, and used in the continuous safety monitoring of medicines in Europe.
Within medical evidence, the importance of analysing adverse drug reactions cannot be underestimated. New medicines see their way to the public through clinical trials, using a set group of patients and usually within a set time period. But patients outside of a clinical trial environment may have other diseases, or be on other medication, which could interact with a particular drug, or adverse effects may only occur after prolonged use. Therefore, even large-scale clinical trials can miss rare side effects and continuous adverse drug reaction analyses are of crucial importance.
The first access to data policy for EudraVigilence came into force in 2011, which included predefined levels of access to information for different stakeholder groups, such as public access to adverse drug reaction reports or access to all data for authorised personnel in the European Commission. The updates proposed in this week's draft are to bring this policy in line with changes introduced by the pharmacovigilance legislation.
Through the EudraVigilance data access policy researchers can request adverse drug reaction data for their own analysis, which has been extended in this draft update to include data from individual case safety reports. However, the researchers are required to agree on a set of the principles of use upon request of this data.
The Agency has the right to view any publication resulting from EudraVigilance data before submission (maximum period for initial Agency review will be six weeks) including a privacy check as regards possible re-identification of patients. Any issues raised by the Agency concerning incorrect analyses, unsupported inferences, misleading statements or the protection of personal data must be addressed to the satisfaction of the Agency before submission for publication.
Controls for protecting individual patient data are crucial in any research, but the control the EMA wants to maintain over what they feel are incorrect analyses, unsupported inferences or misleading statements is unjustified.
This draft policy update is now in a six-week public consultation period. Interested entities have until September 15 to send their comments to the EMA via the email address: evaccess@ema.europa.eu.
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