Master Alliance Provisions Guide (MAPGuideⓇ)
Creating Successful Stewardship and Access Plans
Stewardship and access plans can play an important role in achieving equitable access to medical product innovations. Global health funders often include requirements for such plans in their access policies and/or through contractual obligations in product development agreements. However, it can be difficult to understand the key building blocks of an effective stewardship and access plan, as these documents are often agreement annexes that are held confidentially between parties. Even template stewardship and access plans are not widely available.
One useful resource is the Stewardship and Access Plan Development Guide recently published by Wellcome Trust and a group of stakeholders. The Guide originates from a contractual requirement for all CARB-X funded product developers to create a Stewardship and Access Plan, or SAP, after they enter into pivotal human trials (generally phase III trials). The SAP will be published on CARB-X’s website following the product’s first regulatory approval. The full text of the SAP requirements included in all CARB-X sub-award agreements can be found in the GHIAA MAPGuide.
The SAP Development Guide is intended to serve as a resource for both product developers and the broader global health and scientific communities. It was developed by a cross-sector working group led by Wellcome Trust, with participation from other CARB-X funders, GARDP, and ATMF, as well as consultative input from BIO. All of the funders endorsing the Guide have agreed on the joint principles set out in the Guide. This approach helps to ease the compliance burden on awardees by avoiding duplicative and overlapping requirements.
An effective SAP should address the following areas:
- Product specifications – including product indication(s), target population and conditions of use
- Potential obstacles and constraints to stewardship and access – describing product specific considerations, for example availability and cost of raw materials, and manufacturing and scale-up challenges
- Ensuring timely receipt of marketing approvals – detailing factors such as the expected sequence of marketing applications, plans for additional clinical trials for specific indications or vulnerable population, and plans to use accelerated registration mechanisms
- Supporting global stewardship and access across territories – providing strategies to support these efforts in all territories, including those in which the product developer does not plan to market the product, such as pricing and marketing, education, surveillance and data sharing practices, out-licensing and technology transfer, and supply chain and manufacturing
- Project intellectual property rights – considering how to prevent intellectual property rights from creating barriers to access in all territories, including those in which the product developer does not intend to market the product, such as partnerships or licensing agreements with third parties
- Monitoring the effectiveness of stewardship & access activities – discussing methods for reporting on the implementation and progress of the activities outlined in the SAP, for example publishing an annual report, including reporting requirements in partner agreements, and establishing relationships with groups such as the Access to Medicines Foundation
The SAP Development Guide represents a significant step forward in supporting stewardship and access across the entire pipeline of antibacterial products, as well as providing a model that can be broadly applied to other products.
This blog post was written by Rose Garson, CARB-X, with input from GHIAA. Read more about CARB-X here. For additional information about the SAP Development Guide, visit CARB-X’s Stewardship and Access page.
CARB-X is sponsored by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by awards from Wellcome Trust, Germany’s Federal Ministry of Education and Research, the UK Global Antimicrobial Resistance Innovation Fund (GAMRIF) funded by the UK Government Department of Health and Social Care (DHSC) and the Bill & Melinda Gates Foundation. The content is solely the responsibility of the authors and does not necessarily represent the official views of CARB-X or any of its funders.