A slowdown in federal government funding for the National Institutes of Health (NIH), as well as the volatile environment in Congress for annual budget appropriations, could over the longer term threaten US leadership in supporting global health research and development, a new report warns.

The annual policy report from the Washington-based Global Health Technologies Coalition (GHTC) urges Congress to develop a sustainable budget solution that will

protect funding for global health-product development, while also ensuring that the federal budget for fiscal year (FY) 2015 “demonstrates a renewed commitment to global health research”.

The Coalition welcomed the two-year bipartisan budget agreement signed by President Barack Obama in December 2013, which put on hold the Congressional stand-off over spending and taxes – including, notably, President Obama’s Affordable Care Act – that had shut down the federal government for 16 days last October.

The agreement revived appropriations for global health initiatives hit by automatic sequestration-related budget cuts in March 2013.

Sequestration impact

According to the GHTC report, Innovation for a changing world: The role of US leadership in global health R&D, budget reductions triggered by the sequestration process were having “a major impact” on global efforts to combat infectious diseases.

For example, clinical-trial sites involved in developing a new drug for tuberculosis (TB) were forced to close down, both in the US and abroad.

While the bipartisan budget accord has restored funding for a range of federal programmes targeting global health threats such as TB and AIDS, underfunding of “the world’s biggest sponsor of global health research and development” has put a question mark over future progress in these areas, the GHTC argues.

“The end of political gridlock in Washington put many global health programmes on firmer footing, with one notable exception: it continued to weaken the National Institutes of Health, which is the engine that drives innovation in the fight against infectious diseases,” commented the Coalition’s director, Kaitlin Christenson.

Shrinking budget

Specifically, the report explains, the NIH budget for FY 2014 was eventually set at US$1 billion more than post-sequester funding for 2013. However, the 2014 allocation was actually $950 million less than the NIH received for 2012.

In particular, the report adds, two NIH institutes “critical to sparking global health innovations”– the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Child Health and Human  Development – have less money, in actual dollars, for 2014 than they received in 2012.

Moreover, the Congressional Research Service found that, when adjusted for inflation, federal funding for the NIH overall has been declining steadily for years, with the agency’s real spending power down by 22% compared with 2003, the GHTC pointed out.

A previous report issued by the Coalition in 2012 estimated that the US government was involved in developing more than half (24/53%) of the 45 global health products introduced between 2000 and 2010, while US federal agencies were working with other stakeholders on 200 (55%) of the 365 global health products currently in the R&D pipeline.

FY 2015 appropriations

In this year’s policy report, the GHTC calls for a FY 2015 budget agreement that will provide strong support for global health programmes across the US government.

It recommends a US$464 million appropriation for the Center for Global Health and US$445 million for the National Center for Emerging and Zoonotic Infectious Diseases, both part of the Centers for Disease Control and Prevention (CDC).

The GHTC wants to see a US$4.7 billion budget in FY 2015 for the US Food and Drug Administration, which “plays an important role in ensuring the safety and efficacy of health products for neglected diseases.

The NIH should get US$32 billion while US$10.358 billion should go to global health programmes at the US Department of State and the US Agency for International Development (USAID), the Coalition believes.  

Long-term plan

From a broader perspective, Congress needs to develop a long-term plan for retaining and expanding US leadership in global health-product development, the report says.

This should include evaluating innovative financing mechanisms – such as advance market commitments, priority-review vouchers, prizes and small-business innovation awards, procurement pools, tax credits and patent  pools – that would “leverage US funding, create efficiencies, and catalyse investments from all sectors”.

Among the report’s other recommendations are that the US government should work with United Nations member states to ensure the health R&D demonstration projects to be considered for endorsement at the World Health Assembly in May are high impact, and that new funding is available to support their implementation.

Demonstration projects

The demonstration projects, which were selected by the World Health Organization Executive Board at its most recent meeting in January 2014, will address health challenges such as neglected diseases that disproportionately affect low- and middle-income countries.

The GHTC also wants Congress to make sure it passes the 21st Century Global Health Technology Act.

Introduced in April 2013, this bipartisan bill would bolster USAID’s product-development efforts, promote the alignment of global health R&D activities across the US government, and ensure the transparency and accountability of R&D activities – all without the need for new funding.