A workshop held on 6 September to hear the views of interested parties on the conflicts of interest (COI) policies of the European Medicines Agency (EMA) has left the agency with a slew of sometimes conflicting opinions as it ponders the next step.
The EMA was one of a number of EU bodies criticised last year by the European Court of Auditors for unsatisfactory management of COI issues – a matter of some concern given the EMA’s significant decision-making powers in an area of key importance to the health and safety of consumers. ‘If there are doubts or a loss of trust in our work we become more risk-averse and deny or postpone decisions and eventually public health is affected,’ said Professor Guido Rasi, Executive Director of the EMA.
A lot of credibility had been restored and lack of transparency was no longer an issue, ‘but we know there’s still room for improvement. What we still need is the right balance between having the best experts and having the right COI policies in place,’ he told the meeting.
For the most part, Professor Rasi’s audience accepted that the EMA faced a challenge in attracting the best available experts to its management board and scientific committees while ensuring that these same experts did not have vested interests in the products they were asked to pronounce on. But many were sceptical about the reach and effect of the present COI safeguards. Professor Wolf-Dieter Ludwig, who represents doctors’ organisations on the EMA’s management board and is a department head at the HELIOS Clinic in Berlin, said that there was ‘no question that collaboration between physician and industry is integral to medical research’ and had produced many benefits during the past decade.
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