Plans to improve contact in order to get better advice on medical matters
The European Medicines Agency (EMA) plans to establish a network of European organisations representing doctors, nurses and pharmacists.
The Agency wants to increase the input of healthcare professional organisations in its decision making by regularly working with a variety of groups and has outlined a new framework on interactions with them.
It is hoped the new network will deepen existing relationships with healthcare professionals and allow the regulator to gain a better understanding of how medicines are being used in real clinical practice - including through off-label prescribing.
Other suggested benefits include seeing how avoidable medication errors could be prevented and supporting a continuous assessment of benefits and risks throughout the product lifecycle of medicines marketed in Europe.
The new framework is intended to operate at a regional rather than country level, meaning the EMA wants to make contact with European rather than national organisations.
Another of the network's aims is to help the wider healthcare professional community better understand the EMA's role.
“Experience has shown that healthcare professionals may have some unrealistic expectations about the Agency's activities, for instance in relation to guidelines or information on medicines,” the EMA said. “The Agency does not issue therapeutic guidelines, and it communicates on medicines but not on diseases as such.”
It also plans to use this network to access the best possible independent expertise on medical matters and contribute to more efficient and targeted communication to healthcare professionals.
The changes will see the EMA's Healthcare Professionals' Working Group (HCPWG), which has met since 2006, transformed into a working party with links to all scientific committees dealing with human medicines.
The EMA has worked with healthcare professionals since it began operating in 1995, but said recent analysis had found gaps in its interaction with organisations representing healthcare professionals.
“The creation of a network of European healthcare professionals' organisations … not only prepares the ground for building confidence and trust in the regulatory system, but also gives the opportunity to strengthen the existing network of European experts,” the EMA said.
Organisations will need to fulfil a range of criteria in order to be able to be involved in the Agency's activities, including being representative of healthcare professionals across the EU or European Economic Area (EEA); a specific interest in medicines; and transparency over sources of funding.
Details of the organisations involved will be added to a forthcoming public online registry, which will contain information on the EMA's other stakeholders such as patients' and consumers' organisations and industry associations.
The EMA will develop procedures for groups such as its scientific advisory committees to consult healthcare professionals' organisations in the first half of 2013 and the online registry is planned to be set up by the second half of 2013.