|The year 2014 was forever marked by the Ebola crisis in West Africa. With more than 10,000 people who died because of a lack of suitable treatments and vaccines, how can we, as clinicians, scientists, and drug developers, accept such a fatality when we know that the science that could have mitigated the impact of the disease outbreak exists?
A strikingly unprecedented year for global public health, 2014 saw many seemingly unrelated global health issues and hitherto divergent voices converge on one and the same conclusion: there is a pressing need to prioritize, anticipate, innovate, research, and develop appropriate health tools for neglected patients. But the global response, as we have seen from the hard-hitting health crises such as antimicrobial resistance, hepatitis C, Ebola, and many other neglected diseases, hinges on several pillars that have not always been seen in a consistent and coherent way.
Public leadership is beginning to seem geared for the challenge of ensuring research and development (R&D) meets the needs of populations and, importantly, no matter what the income classification of the country is. On the agendas of important political fora – including the World Health Assembly, G7, G20, African Union, BRICS, and United Nations Sustainable Development Goals – we might infer a growing consensus that public leadership is mandatory to define health priorities and establish a political environment that fosters innovation, including new incentives and financing mechanisms, but this remains to be proven. After a decade of high-level discussion and debate, with new experiments and initiatives for innovation for neglected diseases, might it be time to seriously table a new global fund and mechanism for R&D? We all recall the creation of the Global Fund against AIDS, tuberculosis and malaria, which resulted from, but also created the conditions for mobilization to tackle the ‘big three’. Today, a similar mechanism is needed, such as a global pooled fund, to complement the insufficient, albeit steadily increasing, financial flow of funding from public donors and philanthropists to support innovation for neglected patients, where market incentives are lacking.
In a way we have never seen before, these issues are now amplified through public opinion, mainstream media, and high-level political agendas and while the momentum is there, we need further action and decisions to create an irreversible trend.
Paving the way to an increasingly nimble and responsive organization
This process also builds directly upon the lessons learned after over a decade of experience, successes, and challenges of the organization. These lessons rendered several key foundations on which the organization is built: a patients’ needs-driven approach; the commitment to share knowledge and an access-oriented Intellectual Property (IP) policy; the fostering of innovative partnerships; and the diversification of funding sources to ensure scientific independence. It is clear that some important aspects of the organization will be reinforced as DNDi moves forward, including the role of the regional offices, engagement in patient access to treatments, and the strengthening of innovative partnerships with public and private actors.
Having built a robust portfolio with a mix of new chemical entities and improved treatments with existing drugs for the most neglected diseases over the past decade, DNDi has learned a great deal from experimental business models. These lessons, together with a recent analysis of the R&D landscape, will enable DNDi to consider new pathways towards a more nimble and responsive engagement in global health R&D.
A ‘dynamic portfolio’ approach’
With this new ‘dynamic portfolio’ approach, new disease areas such as hepatitis C and mycetoma are slated for uptake in the portfolio with different approaches, and initiatives such as antimicrobial resistance are being analysed for feasibility and eventual ‘incubation’ for further uptake elsewhere. The dynamic portfolio also implies completing projects when they have reached fruition. This is the case for the two malaria projects DNDi took on at its inception. In 2014, the transition of these projects to the Medicines for Malaria Venture (MMV) was prepared in a strategic move to consolidate the largest ever malaria portfolio at MMV, and thus concert efforts to make the best use of the WHO-recommended artemisinin-based combination treatments (ACTs) worldwide.
Innovative partnerships and new alliances
As DNDi gains experience, we endeavour to be constructive and honest in rendering the lessons learned from conducting R&D for neglected patients – from drug discovery to implementation – and this with models that we hope can provide insight into alternative R&D pathways, including for access. However, the work of DNDi would be able to provide a more effective response if it were part of a more appropriate R&D framework at global, regional, and national levels. As expressed in a recent publication by a group of global public health leaders, we call for a ‘Biomedical Research and Development Fund and Mechanism to Meet Pressing Global Health Needs’ in order to be part of a true and lasting change for millions of neglected patients.