EMA admits error over Humira trial data redactions


Claims time pressure to release the documents

The European Medicines Agency (EMA) has admitted it was wrong to redact some clinical trials documentation requested about Crohn’s disease medicine Humira, manufactured by AbbVie.


his followed a legal settlement between EMA and the pharmaceutical company, where the Agency agreed to release only parts of its trial data on the medicine.

Following a European Ombudsman probe into the case, where the watchdog concluded it had concerns about the legality of EMA’s actions, the Agency has now released a reply, in which it accepted that it should have provided information on 17 questions.

'EMA accepts that the information redacted should not have been redacted. This has been overlooked in light of the massive amount of documents reviewed and the time pressure to release the documents,' the EMA said.

The Agency argued that this 'information was not redacted in subsequent access to documents requests…' However, in other replies to the European Ombudsman, the Agency has justified its redactions as legal and also contested some claims that it concealed information.

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Andreas Pott, EMA’s Deputy Executive Director, commented: 'EMA…rejected some of the redaction proposed but accepted some redactions of information closely related to the ongoing and confidential commercial development of the product Humira.' EMA's behaviour was in this way legal under regulation (EC) No 1049/2001. He added: 'As a technical agency of the EU, responsible for providing opinions on medicinal products, EMA is aware of the importance of transparency and openness and to ensure the right of EU citizens to a good administration.'