R&D for neglected diseases reliant on just two donors, G-FINDER report warns

But other governments should be encouraged to “set the bar even higher” and make sure major diseases including tuberculosis are not left behind, health advocates warned.

The G-FINDER report, released on Wednesday, tracks investments in drugs, vaccines, diagnostics, microbicides, and vector control products and also basic research across 33 neglected diseases — a group of diseases that lead to approximately 6.4 million deaths per year and disproportionately affect people in developing countries. A smaller commercial market means the diseases typically struggle to attract sufficient research and development.

The 10th edition of the report, funded by the Bill & Melinda Gates Foundation, revealed that between 2015 and 2016, $3.2 billion was invested in neglected disease R&D — an increase of 3.4 percent on the previous year, and the first annual increase since 2012.

Discussing the results during a launch session hosted at the United Kingdom parliament on Wednesday, health experts and advocates welcomed the news, but warned that the report also pointed to significant funding gaps.

Those gaps highlighted specific diseases, such as TB, but also intervention areas, such as how much funding goes to ensure that new drugs and tools reach the patients who need them.

The report’s authors, Australia-based non-profit research group Policy Cures Research, also warned the sector was in danger of becoming overly reliant on United States government funding, which could be at risk in today’s increasingly inward-looking political climate; as well as on funding from the Gates Foundation.

“For the last 10 years, two-thirds of all funding has come from just two donors,” Nick Chapman, researcher at Policy Cures Research, said, adding that questions need to be asked about “what does that mean and how has that affected R&D in neglected diseases, and what can we expect over the next decade?”

The report comes during a busy week for global health, with the Universal Health Coverage Forum taking place in Tokyo, Japan. During the forum, the World Bank and World Health Organization revealed that half of the world’s population — 3.5 billion people — are still unable to access all the medical services they need, including vaccines.

Members of the G-20 Health and Development Partnership also met in the U.K. parliament on Tuesday to discuss how global health, and specific issues around R&D and antimicrobial resistance, will feature in upcoming G-20 discussions. The issue was elevated on the G-20 agenda under German leadership, but there are concerns this could fade under the Argentinian leadership that started in November. The issue does not appear on Argentina’s list of priorities, but a representative assured delegates on Tuesday that the country would continue progress made in Berlin around health system strengthening, universal health coverage, and tackling AMR.

The disease data

As in previous years monitored by the report, HIV/AIDS, malaria, and TB’s collectively received the lion’s share of the funding — more than 70 percent — with HIV/AIDS attracting the most. It also saw the biggest increase, benefiting from an extra $83 million, or 8 percent. However, funding for TB decreased by nearly 7 percent, a drop of $37 million compared to the previous year. That can mostly be explained by patterns in funding cycles, the report says, meaning that in reality investment remained flat.

However, Chapman said that overall the data shows the industry has been “pulling out” of R&D for TB — which leads to 1.1 million deaths annually, only slightly less than HIV — in recent years, and said it is important to think about how to “try and invigorate TB R&D funding.”

Funding for “second” and “third tier” neglected diseases — such as diarrhoeal diseases, helminth infections, dengue, leprosy and trachoma — remained unchanged.

Advocates at the launch session also raised concerns over the relative lack of funding for neglected tropical diseases.

U.S. setting the agenda

The U.S. was by far the biggest donor to R&D for neglected diseases, according to the report, contributing 73 percent of all public investment — $1.5 billion. This increased by 5.5 percent on the previous year, and equates to a sum 15 times greater than the next largest funder, the U.K.  This gap has been widening in recent years, Chapman said. Even when adjusted for gross national product, the U.S. is investing more than double the U.K.

Of this U.S. funding, 82 percent was spent on HIV/AIDS, TB and malaria, and most was spent on basic and early stage research as opposed to clinical or field development, or post regulation studies.

The report describes the U.S. as “the primary driver of changes in global funding for neglected disease R&D,” and warns about an over-reliance.

However, others at the launch event on Wednesday, including Jamie Bay Nishi, head of the Global Health Technologies Coalition, a group of 25 nonprofit organizations advocating for global health R&D, questioned this reading of the data, saying “we can’t really afford for the U.S. [funding] to go down.” Instead, she suggested that U.S. investment be seen as “setting the bar, rather than [as] over-reliance.” This is especially pertinent considering looming cuts under the Trump administration, including to the Fogarty Center, which was threatened with closure under the U.S. president’s draft budget. The Global Fund, which includes R&D work, is also due for replenishment in 2018.

Samia Saad, senior program officer for global health R&D policy and advocacy at the Gates Foundation, also said the strong and continued support for R&D from the U.S. should be “championed.”

“Everybody needs to stay the course,” she said, and keep up funding. While there is a “growing pipeline” of promising interventions that she expects “will come to fruition” in the next five years, “we still don’t have the tools we need” to combat neglected diseases, she said.

However, the U.S. government was not the only funder to up its commitments to neglected disease R&D in 2016. Philanthropic organizations, namely the Gates Foundation and the Wellcome Trust, also increased their investment, collectively providing $642 million. The private sector contributed $497 million, an upward trend that was driven by small pharmaceutical and biotech firms, mostly in India, according to the report.  

While these increases are encouraging, the plateau in investment from multinational pharmaceutical firms — which increased by less than 1 percent in both 2015 and 2016 — is worrying for the future growth of the sector. The report also warned against an over-reliance on funding from a single foundation.

“The world can ill afford to keep relying on the U.S. government and the Gates Foundation to provide two-thirds of all global funding for neglected disease R&D over the next 10 years, as they have done for the last decade,” it concludes.

Gaps in the funding

While Saad was positive about a “promising pipeline” of products for neglected diseases, she also said there was cause for concern that the majority of U.S. government funding “still sits with the National Institutes of Health,” meaning it is spent on research and early-stage development, rather than on the challenge of how to “get products over the hurdle” of regulatory and other barriers.

The G-FINDER data confirms that the majority of investments in R&D for neglected diseases was focused on the early development stage, with 70 percent of U.S. funding going to basic and early stage research, compared to just 14 percent for clinical or field development and post registration studies.

The point was taken up by Dr Sue Kinn, health research manager at the U.K.’s Department for International Development, who said “there needs to be a huge amount of research beyond just product research.” There is “no point in having masses of products” if there are not effective ways of delivering them to the people who need them and providing “effective care,” she said.

Dr Ashley Birkett from the international NGO PATH added that his organization has learned, from running major product development programs, or PDPs, over many years, the importance of taking a “beginning to end approach” and following the development from the early stage all the way through to delivery and scale up.

The ability to take such an approach could be compromised by falling levels of support for PDPs, Birkett warned. The G-FINDER study revealed that funding to PDPs decreased by $29 million, or 7 percent, to the lowest recorded levels in the history of the survey.

Birkett said he had noticed funders were starting to move away from the PDP model and were instead “building more internal capacity to do some of work historically done by PDPs,” in a “shift towards more short-term focused funding of projects.”  

“We really have learned there is a need to focus on early development all the way through to access, introduction and scale-up. Our concern is that as these grants become smaller and more focused it really impairs our ability to look overall,” he said.

Short-term funding is also “not conducive” to tackling many neglected diseases, such as malaria, Birkett said.

Post-approval costs and requirements

Advocates also pointed to the need for more data. Once licensed, new drugs and vaccines need to overcome additional data and other hurdles before they can be adopted and rolled out to users. However, there is currently little information about what these requirements are, leading to delays and also potentially high costs, according to David Reddy, head of the Medicines for Malaria Venture.

“This is an area which needs more thinking around what are the post-approval regulatory data requirements so they can be planned for early and ideally met during the drug development process,” he said, adding that it is vital to know “what is that costing us in terms of delays” and funds. Only then “we will understand the magnitude of the problem.”

PATH’s Birkett agreed and said the post-phase three costs are “running into the hundreds of millions of dollars,” but these are currently not being budgeted for within R&D cycles or captured by the G-FINDER report. Furthermore, when working on products for diseases such as malaria, for which there is no commercial market, these costs will fall to the public sector, he said.

Claire Wingfield, a product development policy officer at PATH also recommended that data around investments in strengthening regulatory systems and health system strengthening activities — all of which enable the vaccines, drugs, and diagnostic tools developed to reach consumers — should also be captured by the G-FINDER report.

“If the products can’t get through, it’s not going to be useful … How do we capture those types of investments, which are critical to strengthening the innovation landscape?” she said.

Source: Devex