Brussels, 07/03/2016 (Agence Europe) - The European Union has a new system for optimising the development of priority medicines and facilitating patients' access. On Monday 7 March, the European Medicines Agency (EMA) launched its PRIME programme to provide scientific and regulatory support in the development of medicines where it is needed.
Vytenis Andriukaitis, EU commissioner for health and food safety, said “The launch of PRIME is a major step forward for patients and their families who have long been hoping for earlier access to safe treatments for their unmet medical needs…such as rare cancers, Alzheimer's disease and other dementias”.
The PRIME system supports manufacturers from the stage involving the conceptualisation of medicines up until the final authorisation phase by way of an accelerated assessment procedure. In practice, all companies will be able to request EMA support, with facilities for micro, small and medium-sized enterprises and researchers from academia, “who often lack experience regarding the regulatory framework”. They will be able to submit demands swiftly, without being obliged to compile nonclinical and tolerance data from clinical trials (proof of principle, rather than proof of concept). In all, the EMA will have 40 days to respond to an entity making a request. If the candidacy is accepted, the agency will appoint a rapporteur for innovative therapies. They will also organise a preparatory meeting with the rapporteur and group of multidisciplinary experts attached to it, in order to provide advice regarding the general development plan and regulatory strategy. It will then appoint a contact point at the EMA and provide scientific advice. Finally, it will confirm the potential for accelerated assessment procedure once the request has been introduced for marketing authorisation.
It is important not to confuse this programme with the EMA's “Adaptive Pathways” programme. The latter is a pilot project focusing on medical treatments for which traditional data collection has proved difficult and subsequently helps to promote the authorisation of prescriptions for medicines to a subgroup of patients for which there is no therapeutic treatment, before a more widescale authorisation is granted.
The European Social Insurance Platform (ESIP) said that whilst providing assurances that appropriate candidates are selected for PRIME, it is also necessary to ensure that public money is invested efficiently and appropriately, according to public health priorities and not those determined by companies. In response to the EMA headed consultation, ESIP drew attention to the possible repercussions from the programme on patient health and sustainable health systems. It has concerns that less robust marketing authorisation criteria could have a negative impact on the independence and impartiality of decision-making when authorising medicines. (Original version in French by Sophie Petitjean)