News and Opinions  –  2018

Six key points from ReAct on the provisional work plan for the Global AMR R&D Hub

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The Global AMR R&D Hub, an initiative established under the Germany Presidency of G20, and launched in conjuction with the World Health Assembly in Geneva earlier this year. The aim of the hub, according to their own vision, is “to promote high-level coordination among governments and upstream funders from different world regions, in order to better align national and international efforts in the fight against antimicrobial resistance (AMR).”

Photo: Unsplash.

In a public consultation, the hub sought feedback on their provisional annual workplan 2018-2021 through an on-line survey.

In short, the Provisional Work Plan (2018-2021) for the Global AMR R&D HUB proposes:

  1. The development of a dynamic dashboard.
  2. Operational activities and operational procedures for the Global AMR R&D HUB.
  3. The engagement of experts in ad-hoc Expert Advisory Groups to understand the range of R&D incentives and putative gaps in the incentive toolbox.

The survey fielded by the Global AMR R&D HUB did not allow for important points to be made in the online tool. To provide more useful feedback to the Global AMR R&D HUB, we would emphasize the following points:

1. In order for the Global AMR R&D HUB to be truly global it should continue to seek broader buy-in from all countries, particularly low- and middle income countries.

The usefulness of the dashboard will rely on how comprehensively it is able to capture information and what level of detail it is able to share publicly.

As this is a voluntary mechanism the HUB seems to rely on the goodwill and willingness of relevant actors to share and contribute information on antimicrobial resistance research and development (R&D) initiatives, funding and activities. Therefore, a clear strategy on how the HUB plans to access and promote reporting of relevant information to the dashboard, and how countries could be held accountable to provide real-time, accurate and reliable data should be developed and published. The WHO in particular already has experience in the area of mapping R&D activities through the Global R&D Observatory established in 2016.

It is important that new initiatives such as the HUB are complementary and work in close collaboration with existing similar initiatives such as the observatory to ensure synergies where possible and to avoid wasteful duplication of work. Moreover, it is crucial that the work of the HUB contributes positively to the further advancement and finalization of WHO’s Global Framework for Development & Stewardship which all governments mandated in the UNGA Political Declaration on AMR as well as aligning the already developed Tripartite’s Monitoring & Evaluation approach of the AMR GAP.

There should also be a clear buy-in and inclusion of civil society and non governmental organizations in this initiative.

2. The steering of the Global AMR R&D HUB should follow principles of inclusiveness, transparency and safeguards against conflicts of interests.

To be a trustworthy source of information for decision making, an initiative like the HUB, would need to be an inclusive organization based on a global mandate and perspective.

Buy-in and inclusiveness can be promoted by being steered by a group of countries with broad and inclusive representation from both high, middle and low-income countries. Especially if the HUB is planning on entering the discussion on the design of R&D incentives where discussions on pull incentives such as large market entry rewards, extended market exclusivity etc are reasons for concern.

Safeguards should be put in place to ensure that the whole initiative, including the dashboard and the ad-hoc Expert Advisory Group, is guided by global public health interests that reflect the needs of all countries, and that ensures that the initiative is not captured by economic vested interests of industry or individual countries.

The steering should also follow the principles for R&D laid out in the UNGA Declaration on AMR from 2016. Specifically, on “needs-driven, evidence-based and guided by the principles of affordability, effectiveness and efficiency and equity, and should be considered as a shared responsibility” and “the importance of delinking the cost of investment in research and development on antimicrobial resistance from the price and volume of sales so as to facilitate equitable and affordable access to new medicines, diagnostic tools, vaccines and other results to be gained through research and development”.

3. The HUB’s role in taking action and influencing decision-making, based on the information collected in the dashboard, would need to be clarified further.

For the information to have credibility and be of use for priority setting and decision-making it relies on being comprehensive, accurate and that it covers the full R&D and investment landscape.

Linked to the need of being comprehensive and accurate, it is unclear how the HUB will ensure data completeness, how data will be processed, and how missing data will be computed and acknowledged, as there will be unavoidable data gaps in the dashboard.

It is stated that the dashboard will help inform the monitoring of the Global Action Plan on AMR. This type of monitoring would certainly be beneficial, but such a mandate should in that case be covered and globally aligned with the Tripartite’s monitoring and evaluation framework. There should be a discussion on what potential actions that the HUB will be empowered to take based on the dashboard.

4. The value added from the Dynamic Dashboard must go beyond just focusing on the antibiotic R&D pipeline and should take on an end-to-end perspective and a One Health approach.

The goal of the HUB is to ”have a full picture of the AMR R&D landscape” when informing global decisions of investments needs.

Monitoring of global R&D efforts should lead to identifying the areas of greatest need, which in turn should inform investment decision making by funders. This requires going beyond the narrow focus on drug development and includes also capturing data on the R&D landscape and funding streams for the development of relevant diagnostics, prevention measures/technologies including vaccines and overlooked areas such as innovation in healthcare delivery systems, capacity building, improved clinical practices in human and animal health to name a few.

Given finite resources, a disproportionate focus on drug development might trade off against increased public investment that might otherwise have gone into complementary technologies, such as diagnostics, vaccines and other tools, that might reduce the need for antibiotic use in the first place.

5. The risk of inadvertently distorting the prioritization of investments must be considered when initially focusing solely on human health of the dashboard.

The planned approach of the HUB will initially focus on human health and only in later steps animals and environment. This, together with limiting the focus to new products, will risk to steer away from a needs assessments and priority setting that is comprehensive and follows a One Health approach.

Again, we reiterate the need for a better prioritization framework, and to consider the unanticipated effects a narrow-minded focus of one part of the R&D spectrum will have. Investments to address antimicrobial resistance should be distributed to where its impact on the global burden of disease is the greatest. There is also a need to emphasize the environmental aspects, and the need for R&D and investments in this sector.

6. The incentives debate must be broader and include a discussion on where the incentives should be targeted.

The HUB should make a clear analysis of what actors are actually involved in the field of antibiotic R&D and what new actors that would need to be involved throughout the R&D, production and delivery circle.

It is crucial that the government defined principles for AMR R&D from the UNGA Political Declaration are taken as the starting point for such an analysis; that close collaboration with the WHO’s Global Framework for Development & Stewardship is ensured to develop recommendations for targeted incentives that promotes open and collaborative approaches.

This also links with the need to take an end-to-end approach, where an intervention along the pharmaceutical value chain takes into account how it will affect the distal challenges of access and stewardship. A discussion on this topic should also ensure that investments and potential incentives are targeted towards where the greatest needs are.