EMA Adopts New Document-Access Policy

October 14, 2010
Stephanie Sutton
ePT--the Electronic Newsletter of Pharmaceutical Technology

The European Medicines Agency (EMA) has adopted new policies on access to documents and the handling of conflicts of interest

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 criticized EMA for its transparency when the agency refused to grant public access to reports on adverse drug reactions. The new policy defines how EMA will proactively disclose such documents in the future. Some documents or part of them may, however, have to be redacted prior to disclosure to protect confidential data, but 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 in early November.

With regard to the handling of conflicts of interest, EMA’s new policy will help ensure that scientific committee members and experts participating in EMA activities, including meetings and inspections, have no interests in the pharmaceutical 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 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 EMA also delivered a midyear report for 2010. According to EMA, the majority of activities are on target, although the rate of submission for initial applications for new and generic medicines has been slow thus far.