This meeting was organised by the European AIDS Treatment Group (EATG) within its advocacy and dissemination activities as community partner within the Europrise network.
The objective was to bring together researchers, community advocates, the European regulatory body (EMA), European institutions (EC), the payers (represented by NICE) and the pharmaceutical industry with a PrEP portfolio to discuss scientific, policy, regulatory and reimbursement issues related to PrEP in the context of a public meeting by the European Community Advisory Board (ECAB).
The meeting objectives were the following:
* To come to an understanding regarding missing scientific data to be generated
* To discuss different strategic approaches to PrEP (continuous PrEP, iPrEP, iPrEP/PEP combination)
* To discuss PrEP strategies in combination with other prevention approaches
* To discuss upcoming trial data and how to handle eventually positive results
* To initiate a dialogue with the European regulatory bodies regarding the requirements for assessing ARVs for use in PrEP as well as pharmacovigilance aspects (e.g. long term safety studies, resistance monitoring, renal monitoring)
* To initiate a dialogue with an established Health Technology Assessment body (NICE) regarding possible ARV reimbursement if used as PrEP
* To discuss Community concerns related to PrEP research with all stakeholders represented at the meeting
* To gain a general overview of the agenda of the industry as it relates to prevention research and PrEP in particular
The meeting agenda can be found below:
Agenda PrEP meeting, Sept 25 2010.pdf (159.30 kB)
The pdf files of the presentations can be downloaded here:
* Introductions and meeting objectives (David Haerry EATG/Europrise)