A patient-centred approach to regulatory affairs

Marco Greco (3rd person starting from left), © TOPRA

EPF secretary General Nicola Bedlington and our Board Member Marco Greco attended the 11th TOPRA Annual Symposium on 13-15 October 2014. They discussed the theme 'Matching modern regulation with modern medicine – a patient-centred approach to regulatory affairs?'

The Symposium brings every year together regulatory professionals to discuss and understand today’s regulatory issues and debate future plans for regulation. In her keynote address, Nicola Bedlington challenged attendees to consider if the current regulatory system was delivering patient-centred approaches to get products on the market (patient involvement in ethics committees, medical devices, transparency of trial results, patient safety, etc.)

Patients are engaged and committed to working with partners in regulatory affairs to ensure equitable access to high quality patient-centred care – this is the name of the game” she said. “We are learning to work with regulatory environment but do you know how to work with us? How can we achieve maximum synergy whatever our entry points might be?”

Openness and transparency were also part of   the discussions. Our Board Member Marco Greco (pictured, 3rd person starting from left) explained how data disclosure supports patients: “The smooth processing of health data is fundamental for the good functioning of healthcare services, patients’ safety, and to advance research and improve public health.”

He also intervened into the pharmacovigilance session as he was appointed in 2013 as the alternate representative of patients to the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA). Through this role he is ensuring that the deliberations of the Committee take into account patients’ needs and he acts as an important liaison role with the patient community.

It is not only important to represent patients in such committee, it is symbolic. It means that patients' advocacy has now entered a new dimension. This is the recognition of many years of work of many persons, many volunteers. Our voice is not only listened, but listened in the right place”, he concluded.

Contact: Nicola Bedlington, EPF Secretary General, nicola.bedlington@eu-patient.eu.