Poverty-related and neglected diseases (PRNDs) carry high burdens of morbidity and mortality across the developing world. Some of the most common diseases within this category are malaria, HIV and tuberculosis. These diseases are endemic in impoverished and lower middle-income nations and cause considerable loss of life.
A large degree of the research into these conditions is undertaken by the public sector. The EU contributes a significant amount towards researching these conditions. Between 1999 and 2013 a total of €1.445 billion was allocated by the European Commission (EC) to PRND projects.
An EC-commissioned study by RAND Europe and Technopolis Group, Baird’s CMC and the Institut de Recherche en Sciences de la Santé (IRSS) has recently assessed the impact of EU funding and whether it has played a role in lessening the burden of these diseases within developing nations and LMICs. Hyderus is the largest shareholder in Baird’s CMC and a Hyderus team led interviewing in five countries for this research.
The EU’s Directorate-General for Research and Innovation commissioned the study with the goal of learning from previous investments to inform the future direction of research and funding. By doing so, the European Commission hopes to achieve more sustainable long term change in the global healthcare landscape.
The study encompasses a broad range of information, including the target projects of EU funding, the impact of these projects and public engagement. It used a mixed method analysis to assess the impacts of the funding.
Part of the research looked at the health research and innovation pathway. This covers the process from which initial scientific and medical research is transformed into medicinal products or devices. From there the new product must be made available to LMICs in order for the initial research to have any impact on disease prevalence.
The study notes that the majority of EU funding is focused on early stages of the research and innovation pathway. A significant time lag always exists between the conducting of biomedical research and any actual impact on patients.
This time delay is particularly pronounced in the creation of new medicines. From the discovery of medicinal compounds of interest or a gene implicated in a disease, it can take on average of twelve years for a medicine to be made commercially available. This concept — as well as the considerable cost involved — has been covered by Hyderus previously.
Human trials often last for years due to the need to assess side effects and efficacy of the potential medication. Following the release of the new medicine into the commercial market, the medicine still needs to be distributed among the target LMICs to show any measurable impact of the original research.
The study found significant challenges in observing any causal contributions and direct impacts on public health or the implementation of universal healthcare in LMICs, probably due to this time lag. However, due to the number of studies funded by the investment, considerable advancements in knowledge were recorded, with associated indirect improvements to health.
HIV/AIDS, tuberculosis and malaria: the primary targets of EU funding
The study found that, of the €1.445 billion invested over the 14-year period, a total of 930 PRND projects had benefited from the fund. Of these, 64 percent were focused on HIV/AIDS, tuberculosis (TB) and malaria.
These diseases are some of the most prevalent in the world today. The World Health Organization (WHO) estimated that there were 36.7 million people living with HIV at the end of 2016, with 1.8 million people becoming newly infected across the course of the year. HIV is most common in African nations, which often lack the financial resources to address the issue adequately without external aid.
In 2016, the WHO recorded 10.4 million cases of TB, with 1.7 million resultant deaths (including 0.4 million among people with HIV). Over 95 percent of TB deaths occur in LMICs. India currently has the highest number of cases of TB — it and just six other nations accounting for 64 percent of all cases.
Malaria, though causing fewer deaths than TB and HIV, has a far higher number of cases. There were an estimated 216 million cases of malaria in 2016, with the bulk of these cases occurring in poorer nations across Africa and Southeast Asia. Africa alone accounts for around ninety percent of malaria cases.
Investments such as that made by the EU are vital to the health of lower-income nations, few of which have a strong research infrastructure.
While the direct impacts of European investment are difficult to gauge, a number of research projects have contributed directly to either the treatment or diagnosis of these conditions.
GeneXpert for example is a molecular detection tool which analyses for hallmark DNA samples from the TB bacteria. The test was developed in part with funding from the EU. The test is widely used in India under the product name CB-NAAT. The test is incredibly fast, taking only 2 hours. This is a vast improvement on techniques such as sputum microscopy, which may take several weeks to produce a result. GeneXpert also has the advantage of detecting genetic mutations associated with resistance to the drug rifampicin.
EU funding has also contributed to the creation of Pyramax a fixed-dose combination of pyronaridine and artesunate for the treatment of malaria. The producers of this combination treatment have attempted to help the education of both policy makers within LMICs and those receiving treatment in its correct usage. The goal is to, promote adherence to the treatment to ensure effective outcomes.
Studies funded by the EU have also seen a great deal of success. The Kesho Bora study for example found a combination of three antiretroviral drugs which — when given to HIV positive mothers during childbirth and breastfeeding — greatly reduced the chances of passing HIV onto the newborn. The combination was found to reduce transmission rates from mother to child by 43 percent compared to previously used combinations.
Gaps in the system limiting impact?
EU funding has been successful in collaborations at the early stage of the healthcare and research pathway. Europrise — another EU funded project — has succeeded in bringing together a new network of HIV/AIDS researchers from 32 institutions across the fields of vaccines and microbicides. They developed the FluoroSpot assay (used to detect proteins of interest), which could be an efficient tool for vaccine trials in LMICs.
However, limitations arise later on in the pathway. While the development of new medications or diagnosis techniques are a quantifiable means of measuring the impact of an investment, it is far more difficult to gauge the impact of financed projects where there is no technological development.
Policy alteration is another means of measuring the outcomes of financed studies. An example of this is the EARNEST trial. The trial was developed as a way of assessing the best method of treating HIV patients who no longer respond to their initial combination of medicines. The trial included 1,277 people from five sub-Saharan African countries. The results of the study provided strong support for current WHO guidelines to switch antiretroviral therapy in a limited-resource setting when initial treatments are no longer controlling symptoms (in high-income countries, these switches usually only happen after complex and expensive blood tests have been carried out)
Surveys conducted by RAND of those performing studies benefiting from EU funding show a limited expectation of any immediate real world benefit to LMICs. A total of 43 percent of European and Developing Countries Clinical Trials Partnership (EDCTP) survey respondents and 22 percent of Framework Programme survey respondents indicated that their research project led to increased quality of care for PRND in LMICs. A further 22 percent and 27 percent, respectively, expected their project will do so in future.
Lower still was the expectation of survey respondents that their studies would improve access to treatments. Twenty-three percent of EDCTP survey respondents and eleven percent of FP survey respondents indicated that their research project may have improved access to treatment in poorer nations. A further 23 percent and 28 percent, respectively, expected their project to improve access in the future.
The surveys show researchers are more likely to believe their work has improved the quality of care than increased access to that care. This would indicate that those performing the research remain sceptical that the benefits of their work will reach most people in LMICs.
Both surveys indicate the need for a much longer term view when measuring the impact of the work performed. Many treatments and diagnostics tools will take many years to reach the market, following this it may be a considerable length of time before these products are made available at a low cost in poorer nations or provided free through aid programmes. As such, measuring the impacts of a study possibly decades in the future is all but impossible.
Numerous challenges exist which limit the ability to study the real world outcome of such investments. Funding was not allocated uniformly, and many projects were targeting far less media friendly conditions such as leishmaniasis or leprosy.
In many cases the impact of the studies are limited by the healthcare infrastructure of the target countries. Sub-Saharan Africa is a key example of this. While cases of diseases such as malaria may be falling due in part to focused aid efforts, healthcare facilities in many areas are unable to provide basic services. In many locations there is a complete lack of healthcare infrastructure.
Funding towards the creation of new medications or medical devices may not directly benefit a vast number of people from these LMICs. The GeneXpert TB diagnosis tool, for example, is being used in India and South Africa but is unlikely to be used in remote rural locations across the rest of Africa. This limitation directly impacts the outcomes and reduces the effect the initial investment has on TB prevalence.
There are however some programmes which the RAND study has deemed to have had a direct impact on the implementation of universal health care within LMICs. The COINFECT project, for example, brought together expertise from across malaria and helminth infections and sought to train doctors and nurses in endemic regions. This has a direct impact on local healthcare infrastructures, with local medical staff left better prepared to deal with infections.
Recommendations: Building bridges between high income and low income nations
There are numerous projects which have produced tangible results such as medications and diagnostic tools. Others may produce more indirect results such as policy guidance. In order to see more notable outcomes the study has several suggestions.
The first recommendation is supporting the linkage between R&D and universal healthcare. This would involve assessing how the initial research investments made by the EU could be implemented properly in real world situations.
Key to this are improvements to factors such as the healthcare workforce in target nations, as well as physical and digital healthcare infrastructure. Analysis of the financing of healthcare within target nations is also necessary, as without adequate funding, any new medical developments are unlikely to be brought to the target nation.
Focusing further down the health research and innovation pathway may produce more direct impact than continued investment in research and development. One example is investing in aid projects to ensure current medicines are made available as an alternative to researching new medicines that may not make it to the LMIC markets for many years.
An emphasis must also be placed on spreading awareness of the potential funding of PRND projects. This could be through creating an online portal to allow for greater internet exposure or greater use of social media.
Creation of online or in-person workshops that allow engagement between researchers and policymakers is also an option explored by the study. This could allow for the product of the research to more rapidly enhance the quality of healthcare systems in LMICs through direct involvement with policy makers in target nations.
Finally, more stringent analysis of the impacts of research funding and contributions should be carried out from the start. This recommendation ties in with the second, with the potential internet hub also displaying real time information regarding the status and processes of the research conducted. This may also stand to increase public engagement.
In summary, while EU funding has contributed notable positive outcomes to PRND healthcare, there may be more benefits to working more closely with those implementing these research outcomes within LMICs. By following through with the research and ensuring the products of EU funding reach the target nations, far greater strides towards universal health care as well as the elimination of poverty related diseases may be made.