The probe – detailed in a letter to European Medicines Agency (EMA) executive director Guido Rasi on Monday – will examine how the regulator manages its interactions with drug firms prior to their submission of marketing authorisation applications (MAA).
The EMA says such interactions – pre-submission activities – are vital to aiding the development of effective and safe medicines that benefit patients.
O' Reilly acknowledged the value of the meetings, but said she had launched the investigation because “such activities may pose some risks.”
She said the aim was to determine if “eventual decisions by EMA on the authorisation of medicines may be influenced by what has been discussed during the meetings with medicine developers prior to receiving their marketing authorisation application.
O’Reilly cautioned that “Even if EMA were to ensure that its subsequent assessments of applications for marketing authorisations are objective and complete, there is still a risk that pre-submission activities create, in the eyes of the public, at least some perception of bias.”
The Ombudsman called on the EMA to provide details of the pre-submission process and how it is managed.
She also asked for an overview of pre-submission activities between 2012 and 2016, including a list of the 10 medicine developers that met with the EMA most often.
A spokeswoman for the European Ombudsman said: "Ms O’Reilly’s focus is mainly on transparency. As she notes in her letter, such meetings may lead to a perception of bias among the public and steps should be taken to limit this risk.
"We have put a number of questions to EMA concerning these pre-submission meetings. These questions will be the basis for a planned meeting between EMA and Ombudsman case-handlers in September. The next steps will be considered in light of this meeting, therefore it is difficult for me to say when the Ombudsman’s final analysis will be ready."
After this article was published the EMA told us it welcomes the European Ombudsman’s interest in the Agency’s work and is happy to provide information for the inquiry.
An agency spokeswoman told us in an email that: "Interaction with companies during early stages of medicines’ development is essential for EMA to fulfil its mission to promote and protect public and animal health in Europe. Like the Ombudsman expressed in her letter, these activities help the development and availability of high-quality, effective and acceptably safe medicines, benefit patients and serve the public interest.
"The Agency is confident that its robust and rigorous processes and procedures ensure the independence of the assessment of marketing authorisation applications" she continued, adding "EMA will be working with the Ombudsman and her team to explain these processes and provide any clarifications that might be needed."
Drug industry response
Since this article was published the European Federation of Pharmaceutical Industries and Associations (EFPIA) has issued its response to the investigation pointing out, like the EMA, that the rules on pre-submission discussions are clear.
The full statement is here.