title: Obstacles to transparency over pharmacovigilance data within the EMA.
abstract: In July and August 2014, the European Medicines Agency (EMA) organised two public consultations concerning European pharmacovigilance. These two consultations reveal a number of EMA proposals that are counterproductive to the objective of improving transparency over pharmacovigilance data. The EMA's proposals offer pharmaceutical companies an opportunity to participate in public hearings held by the European Pharmacovigilance Risk Assessment Committee (PRAC), in order to defend their drug. They also provide for the possibility of holding non-public hearings to discuss public data. There is a great risk that the drug industry might use these provisions to influence the debate. The strings attached to the access that the EMA proposes to grant researchers to data contained in the centralised European pharmacovigilance database would allow the EMA to censor the publication of their findings. The EMA seems to regard pharmacovigilance data as commercially confidential information. Responding to these consultations provided an opportunity to remind the EMA that data about adverse effects are a public good, in the common interest, and that it is unacceptable to keep this information confidential.
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence* / Q000592:standards; D004345:Drug Industry / Q000331:legislation & jurisprudence* / Q000592:standards; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005062:European Union; D006801:Humans; D060735:Pharmacovigilance; D018570:Risk Assessment / Q000331:legislation & jurisprudence