European citizens have a right to access the clinical data on which marketing authorisations are based. Access to data helps to protect patients.

Right up until the end of 2010, the European Medicines Agency (EMA) was refusing to disclose documents containing clinical data that pharmaceutical companies had submitted in support of their marketing authorisation applications. This practice is inconsistent with the right of access to documents held by European Union institutions. A group of Danish researchers, and Prescrire (having requested documents from the EMA on a regular basis since the Agency's inception in 1995), both complained to the European Ombudsman, and these actions were successful. And so, in 2011, the EMA set about establishing a new transparency policy.

Judging by its responses to Prescrire's requests, the EMA became more transparent after this, yet secrecy and slow response times persisted in some areas and became more pronounced over the years. Particularly bothersome developments included the introduction of a queuing system; the release of documents in batches over a period of months; and a delay which allowed drug companies who opposed the disclosure of requested documents to bring legal proceedings.

The EMA's "proactive" disclosure policy was marked by similar failings. In 2016, the EMA began publishing large quantities of clinical data from marketing authorisation applications on its website. It was a remarkable advance, but marred by the fact that drug companies were given the opportunity to redact (i.e. to black out) large portions of these documents before their publication, including the possibility of redacting clinical data from clinical study reports.

The EMA's failings warrant an official enquiry, so that the causes can be analysed. European decision-makers can then take appropriate action: additional resources to enable the EMA to fulfil its transparency obligations; strict oversight and close monitoring of any redactions made to the documents it releases; and fair treatment of applicants who, like Prescrire, have no ties to industry.

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©Prescrire 1 May 2022

Source: "European Medicines Agency: transparency policy marred by too many failings" Prescrire International 2022; 31 (237): 131-139. Free.

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