RSSeNEWS to be determined...

Early in 2008, RSS NEWS featured an article covering the publication of an open letter in the British Medical Journal calling for more statistical resource in the EU medicines licensing agencies. Publication of this open letter was led by PSI (Statisticians in the Pharmaceutical Industry), and was supported by approximately 40 eminent statistical signatories. Tim Holt, David Hand and Sheila Bird signed the letter on behalf of the RSS.

As a follow-up to the BMJ open letter, PSI and EFSPI (European Federation of Statisticians in the Pharmaceutical Industry) developed a joint position paper in February 2009 calling for more statistical resource in the EU medicines regulatory agencies. Using this position paper, PSI submitted the topic as an agenda item for discussion at an HMA (heads of medicines agencies) meeting. This discussion took place last July and PSI received feedback on the content of that discussion in the autumn.

The discussion was very positive – with the EMEA (European Medicines Evaluation Agency) executive director championing the position – and specific actions have been proposed. The relevant excerpt of the meeting minutes is as follows:

‘Statisticians in the EU regulatory network

Thomas Lönngren informed the HMA about the publication in the British Medical Journal and the position paper from statisticians' organisations related to the low number of statisticians employed by regulatory agencies. He pleaded with HMA to recruit more statisticians at NCAs and involve them in the assessment of applications.

The HMA acknowledged the plea from the EMEA. It was also agreed to ask the HMA MG and Task Force on the HMA Strategy Paper II to consider, not only how we are dealing with statistics, but with data and data quality in the HMA strategy paper.’

For clarification, the task force on the HMA Strategy Paper II is a new task force of the HMA which will be dedicated to strategic issues. Their Strategy Paper I looked at the future of the EU medicines regulatory network and was adopted in November 2007. It covered themes such as communication and information, scientific resources, scientific assessment process, pharmacovigilence, inspection, lab control and enforcement and IT information systems. This second strategy paper is due to be released for consultation in July, with the final version being adopted in November.

Clearly, the current state of play will not change overnight. However, we look forward to observing how this topic evolves in the HMA Strategy Paper II in due course.

Sara Hughes is with GSK and is vice chair of PSI