Latest decision concludes no maladministration at EMA

The European Medicines Agency (EMA) welcomes the decision by the European OmbudsmanExternal link icon, Emily O’Reilly, that there was no maladministration in its handling of the declaration of interests of its Executive Director.

The OmbudsmanExternal link icon’s review followed a complaint by the Nordic Cochrane organisation and other individuals, who reported allegedly undeclared interests of EMA’s Executive Director Guido Rasi, relating to certain pharmaceutical patents for which he was named as co-inventor, and raised concerns over EMA’s handling of these.

Following a complaint from the same reporting sources, the Ombudsman had already concluded in October 2017 that there was no maladministration by the Agency in the handling of its safety review of human papillomavirus (HPV) vaccines.

After a thorough analysis of all relevant documents, the Ombudsman concluded that the Executive Director “did not fail to declare any relevant interests when he joined EMA” in 2011. “The applicable rules did not require the Executive Director to declare that he was one of the inventors named in the applications. This is reasonable since, being an inventor does not, in itself, give rise to any financial interests that could have affected his work at EMA,” explains the Ombudsman. Therefore she found that “there was no maladministration by EMA in its obligation to ensure that its Executive Director declared all of his relevant interests.”

For one other invention, independently detected by the Ombudsman, Prof Rasi had transferred his share of ownership rights to the pending European Patent application to the other co-inventors, free of charge, before obtainment of thecorresponding patentand long before joining EMA.

The Ombudsman found that the Executive Director had not financially benefitted from, or retained any other financial interests in, any of the patents or patent applications at stake.

All institutions benefit from the Ombudsman’s rigorous approach towards good administration practices. For public health authorities such as EMA it also helps strengthen the public’s trust in the regulatory system. EMA is fully committed to ensure that patients can rely on EMA’s robust handling of the declaration of interests of staff members and scientific experts.

The Agency also welcomes two suggestions made by the Ombudsman on its rules on declarations of interests by EMA staff in order to avoid, to the greatest extent possible, similar concerns from arising in the future. An impact assessment and a plan for implementation of these suggestions will be presented to the Agency’s Management Board in 2018.

Posted on the EMA website on 24 November 2017