A comprehensive and sustainable approach to access
For GARDP, a comprehensive and sustainable approach to access necessarily comprises innovation, access, and stewardship of antibiotic treatments. It also implies that the stewardship of antibiotic treatments is framed within an access-oriented approach and not vice versa. Considering its broad geographical scope, country income contexts, varying product characteristics, target populations, and collaboration agreements, GARDP will develop targeted access approaches for every R&D project.
GARDP’s access approach will include a range of different activities. For example, registration will be prioritized for countries with highest burden or need. Beyond the regulatory route, a ‘public health’ pathway will also be taken, including studies essential for public health use. Data from all studies and programmes will be made accessible to inform solid evidence-based policies and drive timely guideline change. Specific focus will also be given to the way products are packaged and distributed, and pilot implementation programmes will be developed to ensure rapid patient access to treatments. Supporting, piloting, and seeking to effectively adapt incentive mechanisms that can facilitate the scaling up of treatments will be considered. The principle of delinking the costs of R&D from price of products and volume-based sales will be applied ensuring affordability as well as sustainable quality production.
This work will consider and factor in ongoing work on the WHO Global Development and Stewardship Framework.
For each of these aspects of sustainable access, GARDP envisages varying degrees of involvement, from promotion and support to direct financing and project management. In addition, GARDP will work with a range of different partners, including local civil society organizations, universities, international organizations and agencies, funding bodies, as well as the private sector.