GARDP mobilizes funding and provides strategic direction, advocacy and support to connect leadership from the public and private sectors, to develop antibiotic treatments and ensure they are available to every person who needs them. GARDP focuses on making drugs accessible for life-threatening and serious conditions, by supporting clinical development, partnering to remove access barriers, and generating post-approval evidence, for new treatments for serious bacterial infections, both in adults and children (including neonatal sepsis), and sexually transmitted infections (STIs). Still most patients are unable to participate in clinical trials, and variable delays in local availability of products between completion of phase 3 clinical trials and regulatory approval are expected. GARDP will consider facilitating access to treatments in response to unsolicited requests and in order to satisfy unmet medical needs, through consultation with local health authorities and in compliance with local regulations.

GARDP Managed Access Programmes (MAP) refer to a potential pathway for a patient with an immediately life-threatening or serious disease or condition (for which there is limited, or no, treatment options) to gain access to an investigational (unapproved) medical product, outside of a clinical trial and prior to local regulatory approval or commercial availability.

GARDP has engaged with Inceptua Group (a specialist provider of unlicensed medicines), to operationalise a MAP for a new treatment for uncomplicated urogenital gonorrhoea. The geographical scope of the MAP will be defined by the public health need and an implementation plan determined by existing research projects, availability of product for distribution and regulatory conditions.

Physicians who would like more information about the MAP should contact Inceptua by email at access@inceptua.com or by phone at +44 203 910 7600