EMA lack of transparency report

The EMA has come under attack for excessive secrecy, according to a new report.

Prescrire, the Paris-based non-profit publisher of independent drug reviews, has said that the agency “is backtracking on commitments to clinical data transparency” and that this is undermining the protection of patients.

Prescrire states that the EMA’s transparency policy is marred by failings and that secrecy has not only persisted, but has become more pronounced in some areas including:

• A queuing system which increases response times

• Slow provision of documents 

• Delays which allow drug companies to take legal action to tackle disagreements over the disclosure of their documents.

• Identification of applicants for data to pharmaceutical companies for information released by them

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The EMA faced criticism for its so-called excessive secrecy as far back as its establishment in 1995, however in the last decade, it was felt that progress was being made. Prescrire feels that that progress is now rowing back, however. One example of this is that companies have been given the opportunity to redact information from large quantities of clinical data published in 2016 – in some cases, up to 90%.

Prescrire states that the EMA has been particularly obstructive toward them, systematically refusing to disclose documents containing pharma company information, major documents relating to periodic safety update reports and even information requested relating to legal cases brought before the European Courts to prevent the EMA releasing documents relating to marketing authorizations. The EMA says that was to protect the commercial interests of the pharma companies that produced them – a reasoning determined as unfounded by the EU Ombudsman.

Prescrire feels that the lack of transparency shown by the EMA compromises the rights of European citizens to access data which could affect them, data which could ‘better protect patients’ and that an official enquiry is necessary to analyse the causes of the lack of transparency. It wants to see additional resources for the EMA so it has no excuses in meeting its transparency obligations. The report also states that it wants strict oversight of redactions made to released documents and fair consideration for applicants outside the pharma industry.

It feels that the EMA must show that its priority is keeping patients safe, rather than “pretending to be transparent while allowing pharmaceutical companies to hide clinical data.”