The DRIVE-AB consortium has worked for the past three years to develop recommendations on how to change the innovation system to revitalize the antibiotic pipeline, while ensuring sustainable use and access. Today it published its final report.
ReAct Europe was part of the DRIVE-AB project for over two years, but withdrew from the project in May 2017 due to problems of conflict of interest of the industry actors involved in the project and their dominance in developing DRIVE-AB’s policy recommendations. ReAct Europe was concerned about the interim recommendations being presented as consensus proposals backed by all participants, covering up and not reflecting the deep disagreement on certain issues that persisted among several participants in the project.
Having read the final report, we commend the consortium for more clearly reflecting in the report that consensus is lacking on some of its core recommendations, such as partial delinkage. We are also in favor of the recommendation to increase investments going into push funding in the early stage research, but believe that such funding should also strategically transform the drug development ecosystem to become more open and collaborative.
ReAct would like to make the following comments on the report:
- The DRIVE-AB final report did not arrive at consensus on its core recommendation. We also note that only a subset of the people that were central to the deliberations throughout the project have ultimately put their name on the final report. We strongly agree with the dissenting participants in DRIVE-AB that “partial delinkage” (which relies on the sales of antibiotics as a revenue stream for the company on top of the Market Entry Reward) contradicts, and is in fact incompatible with global conservation and stewardship goals of new antibiotics. Given that this seems to be one of the main recommendations of the report, this disagreement should cause pause for thought with policy makers.
- The DRIVE-AB final report removes price – and thereby affordable access – from how it defines delinkage arrangements. In September 2016, governments adopted a definition for “delinkage” for the development of novel antibiotics during the UN General Assembly. This definition separates the costs of research and development (R&D) from both sales volume and price. DRIVE-AB, however, has made its own definition of delinkage, which focuses on “making innovation more attractive for the developer” and “encouraging antibiotic stewardship”. Despite the report acknowledging that lack of access to antibiotic continues to kill more people than resistance, the DRIVE-AB definition does not include the separation of R&D costs from the end price of the product, which is a key element to achieve affordable access.
- The DRIVE-AB final report shifted the vision statement to drop the goal of “global access”. We note that DRIVE-AB has actually changed its own original vision statement in the final report to no longer include the words “global access”. Instead the vision now reads: “Transforming the way policymakers stimulate innovation, responsible use and equitable availability of novel antibiotics to meet public health needs”. It should be crystal clear to policy makers that availability is not the same as access. A product can be registered and available in a country, but still not be accessible for patients due to e.g. high prices.
- The DRIVE-AB report adds to a disproportionate focus on Market Entry Rewards (MERs) in the AMR debate. The report is the last addition to long list of reports calling for MERs, but it needs to be made clear that while a new type of pull incentive may be one component of a much broader set of interventions needed to change the R&D model for antibiotics, it is not a panacea for the broader problem of antibiotic resistance. The disproportionate focus on MERs in the global debate is increasingly concerning and risks diverting urgently need broader investments for early stage R&D, for improvement of global access to antibiotics and preventive measures, for the full implementation of national action plans in low- and middle income countries, and for strengthening of surveillance systems to name but a few areas.
- The DRIVE-AB report acknowledges that conflict of interest exists in the consortium, but its recommendations propose moving significant public funding towards the industry and organizations of some of its leading co-authors. We recognize that there may be a limited pool of experts in the field of antibiotic resistance to draw from when creating projects like DRIVE-AB. However, there is a difference between recruiting input from key stakeholders versus having those stakeholders author recommendations that favor their own interests. The report’s recommendations for substantial investments of public funding are closely aligned with the institutional interests of some of the authors who signed up for these recommendations. Important lessons about the need for transparency and safeguards against conflict of interest should be learned by the global health community from the DRIVE-AB process.
Lack of representation from low- and middle income countries
The overall lack of representation from low- and middle income countries in DRIVE-AB has unfortunately led to the proposals being geared toward high-income country settings. This is unfortunate given that a key challenge in addressing the global threat of antibiotic resistance is how to address overuse, misuse and underuse of antibiotics in all countries – both in high as well as in low- and middle-income where health systems are often weak.
Helle Aagaard, Policy Advisor at ReAct Europe, says:
“Bacteria do not respect borders. Governments in the G20 and Europe need to realize that if solutions to contain antibiotic resistance are to make a difference, then low- and middle income countries must be part of developing them.”
“Importantly, we cannot continue to rely on actors such as the pharmaceutical industry with such strong financial self-interests to provide the solutions to these problems.”
Anna Zorzet, Head of ReAct Europe, adds:
“Ensuring affordable and sustainable access to new antibiotics without risking excess in all countries should be at the crux of the R&D financing discussions – not placed as an afterthought.”
“The World Health Organization’s Development and Stewardship Framework provides an appropriate platform to take these discussions forward with the necessary broader representation of countries”.