EMA adopts new document access policy

Pharmaceutical Technology Europe

The European Medicines Agency (EMA) has adopted new policies on access to documents and the handling of conflicts of interest, which should make the processes in these two areas more efficient.

The European Medicines Agency (EMA) has adopted new policies on access to documents and the handling of conflicts of interest, which should make the processes in these two areas more efficient.

In particular, the new policy on access to documents takes into account recommendations made by the European Ombudsman, which earlier this year when the agency refused to grant public access to reports on adverse drug reactions. The new policy sets out how the EMA will proactively disclose such documents in the future. However, some documents or part of them may, however, have to be redacted prior to disclosure to protect confidential data, but the EMA believes the policy will “ensure the widest possible access to EMA documents”, according to a press statement.

Although the policy is still being finalized, it is expected to be published at the beginning of November.

With regards to the handling of conflicts of interest, the EMA’s new policy will help ensure that scientific committee members and experts participating in EMA activities, including meetings and inspections, have no interest in the pharma industry. The policy is due to be published next week.

“The new policy addresses experience with the handling of conflicts of interests gained since the establishment of the Agency in 1995 and the initial policy set up in 2004,” said the EMA. “It also answers demands for the Agency to strengthen its handling of conflicts of interests, whilst ensuring that the best scientific expertise is involved in the assessment process”.

The new policies were adopted at the EMA’s 68th meeting, where the EMA also delivered a mid-year report for 2010. According to the EMA, the majority of activities are on target, although the rate of submission for initial applications for new and generic medicines has been slow so far.

www.ema.europa.eu