News and Opinions  –  2018

UNCTAD and WHO focus in on investments for development of new antibiotics

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During the World Investment Forum 2018, UNCTAD and WHO jointly organized an event on ‘Fostering investments in the development of new antibacterial treatments.

The event focused on promoting partnerships between funders and developers, where efforts and attention should be focused in the R&D process and how actors such as UNCTAD can bring relevant actors together to devise solutions to the current challenges in antibiotic discovery, research and development.

Matching developers with investors to improve pipeline

The event brought together drug developers, investors and funding mechanisms and representatives from civil society and governments. ReAct was invited to speak about the need to consider the challenges of ensuring affordable access and stewardship throughout the research and development (R&D) process and how investors should take part in ensuring this.

Classic R&D model doesn’t work

The classic R&D model doesn’t work for developing new antibiotics as evidenced by decades of innovation void in this field as well as the WHO pipeline analysis which shows a big gap and need for innovative antibacterials for the priority pathogens. New innovation models are needed alongside innovative and transforming investment models to address the specific challenges of developing antibiotics.

Governments adopted the basic principles for such new models in the UN General Assembly Political declaration on AMR: that all R&D should be needs-driven and guided by the principles of affordability, effectiveness, efficiency and equity, and the importance of delinking the cost of investment in R&D on AMR from the price and volume of sales. This should be the starting point for all discussions on AMR R&D financing, but these principles are often departed from in new initiatives by funders and companies, something that ReAct repeatedly has been pointing out since their adoption.

Other panel speakers engaged in antibiotic development:

  • the private investor University of Tokyo Edge Capital (UTEC)
  • funding mechanisms CARB-X and UK Global AMR Innovation Fund
  • the product development partnership GARDP
  • smaller biotech companies (Bioversys and Bugworks Research)
  • a large pharmaceutical company (Shionogi)

Discussions stuck on push and pull incentives

Central to the discussions was once again how to balance push and pull mechanisms – while this is of course a relevant discussion to have, there is a need to move beyond this discussion which has dominated the R&D discussion for the past years. Disappointingly, but perhaps unsurprisingly, the representative from the pharmaceutical company Shionogi focused primarily on pull incentives as a solution and the problem of low return of investments in developing antibiotics. The biotech representatives and the private investors were on the other hand more openminded and reflected more broadly on that antibiotic development as an emerging investment opportunity, that smaller actors can contribute to make advancements in antibiotic research, and emphasised the need for both push and pull incentives.

GARDP: Public health driven strategy needed

GARDP gave their perspectives of the importance of having a public health driven strategy, with priority setting to meet the needs, incorporating a sustainable access and stewardship approach, finding collaborative forms of R&D and how registration and how intellectual property will be managed.

Importance of scientific bottlenecks of developing novel antibiotics

The discussions also reflected on the importance of not ignoring the significant scientific bottlenecks of developing novel antibiotics, such as finding compounds that can enter the cell walls of Gram-negative bacteria and keeping them from being expelled by efflux-pumps. For these reasons, much efforts and research are needed to overcome these bottlenecks and financing should in the first instance be focused on the actors involved in this space.

UNCTAD – a new actor on the antibiotic scene

UNCTAD first got involved in the antibiotic R&D discussion in 2017 when it held its first closed-door roundtable on the issue in Geneva. It is the agency within UN that is handling the international investment regime with a large number of bilateral and regional investment treaties. As such they are an important actor for promoting and foster international investments, with a specific focus on countries with the greatest needs.

With the technical experience and function as a convener and catalysing actor in the investment space, UNTCTAD has a potential to be an actor also for fostering the discussions on investments to develop new antibiotics. It is important and encouraging that more UN agencies are getting involved in the issue of antibiotic resistance for contributing to finding solutions to the challenges met on different fronts.

We need to take a more sustainable approach to investment in antibiotic R&D

We need to find solutions to the most pressing challenges related to how to reconcile innovation with access and stewardship. If not reconciling these aspects that are truly interlinked for antibiotics, resistance to new antibiotics will soon arise and our investments will be futile. These solutions require taking a holistic approach, which includes assessing the capacity of the health system that is intended to manage the antibiotics in a sustainable manner.

A holistic approach requires to look downstream of R&D to address challenges in regulatory practices, manufacturing, producing enough quantities that can meet environmental standards, purchasing, marketing, devising models for controlled purchasing, distribution and use in particular in countries with weak health systems and infrastructure.

The Global Development & Stewardship Framework which is under development by WHO, FAO, OIE and UNEP is taking such as holistic approach, and is closely based on the principles of the UNGA political declaration. This Member State led process will be crucial and the most obvious place to address and map out responsibilities to govern and coordinate development of new antibiotics. This process however requires even stronger commitment and engagement by Member States to move forward on reaching an agreement of the need to prioritize R&D on novel antibiotics and on the approach to get there.