UAEM’s Re:Route – New Mapping Tool For Alternative Health R&D Models

Re:Route, a mapping tool that lays out the research and development (R&D) landscape of innovation and financing for medicines, has been launched by the Universities Allied for Essential Medicines (UAEM). It is a one-stop place for the alternative biomedical research and development landscape.

The student-driven project, funded by Open Society Foundations, is a qualitative review of the alternative R&D initiatives around the world, in time for the United Nations High Level Panel on Access to Medicines dialogue next month.

In the backdrop of high prices of drugs, widespread antimicrobial resistance, the continuing challenge around neglected diseases, the challenge of Ebola and now, Zika – this report assumes significance. Authors of the report say nearly 1 in 3 people around the world lack access to essential medicines under the existing system that links drug prices to the costs of R&D.

As a result, neglected diseases, which primarily affect the world’s poor, only receive 2 percent of the funds invested in R&D annually. The report calls for a “people-centred approach” to R&D for drugs.

Re:Route investigates existing and proposed alternative R&D initiatives which seek to address the failings of the current system. This tool has found as many as 81 different existing and proposed initiatives, which were “genuinely innovative at some level.” These were chosen from a pool of more than 130 initiatives.

The authors say: “We consider our role as being to provide a platform, the basic structure and information which will allow the alternative R&D community to develop, improve and elaborate on its activities and overall strategy.”

A statement from UAEM said, “The mapping reveals a lack of fundamental systemic change in biomedical R&D. While some initiatives have undoubtedly made important advances on specific diseases and systemic issues, others are simply promoting a ‘business as usual’ approach.”

The initiatives were selected based on, one, the stage of the biomedical R&D system they seek to address, and two, the key innovation and access principles that support them.

These initiatives had to meet inclusion criteria such as being driven by patient needs globally, and be based on certain innovative principles. The innovative principles that form the basis of the selected initiatives include providing a “pull” mechanism, or a “push” mechanism, an intellectual property pooling mechanism, allowing broad collaboration, and adopting open networks to R&D (open source, open data sharing and open innovation).

Typically push mechanisms include grants, and incentives such as tax breaks that frontload financing of R&D, as a result reduce the cost of investment. These are given irrespective of the results of the research.

Pull mechanisms, on the other hand, can include prizes and advance market commitments, provided certain milestones in research are met and if it results in a viable market. The pool principle aims to distribute risk and finance R&D, by pooling in funds, managed by a joint entity. Similarly, patent pooling counts on enabling access by aiming for cooperative licensing negotiations. Others include collaborative and open initiatives.

The selected initiatives have been divided into existing and proposed.

The 49 existing alternative R&D initiatives in the report are classified into: drug discovery and data-sharing platforms; drug discovery incentives that include prizes, tax subsidy/priority review incentives, innovation fund/platform and venture philanthropy for drug discovery and development; drug licensing such as patent pools; drug advancement including as public private partnerships; drug development including product development partnerships working on one or more diseases.

There are about 32 different ‘proposed’ initiatives that feature in the mapping tool, categorised similarly. In addition there are those that intend to address four or more innovative R&D mechanisms.

The result is a mix of push, pull, pool and open strategies that combine collaborative data-sharing, data-mining, and other technologies. In addition, from using debt and bond financing to accelerated patent reviews and exclusive marketing, to spur research into neglected diseases, a range of existing and proposed initiatives are listed.

“While this mapping covers a significant number of potential alternatives, it is evident that the need for fundamental change is as urgent as ever,” the authors say. The tool is intended to be a living document, to be constantly revised and updated with inputs, so long as initiatives meet the inclusion criteria.

UAEM believes that the next step will involve further analysis on the initiatives that will succeed in the future and achieve the goal of access. This, it says, “will require open collaboration to figure out the lessons learned from these different initiatives, what works and what does not, and why.”

Image Credits: UAEM