In 2003, a study published in the journal Nature told of a vaccine candidate that showed promise against Ebola when tried on monkeys. With funding or financial incentives, and the interest those might have prompted from large pharmaceutical companies, the next step would have been the development of the vaccine for use in humans, Dr. Peter Hotez of the Sabin Vaccine Institute noted last week. Instead, ten years later the world was unprepared as the Ebola crisis in West Africa began, he added.
Dr. Hotez highlighted that potentially pivotal moment as a missed opportunity at the Global Health Technologies Coalition launch of its most recent policy report on advancing global health research and development.
By the time the U.S. government made a $100 million contribution and GlaxoSmithKline and Merck stepped up with clinical trials for a vaccine, the outbreak was nearly over and 11,000 people had died, Hotez noted.
“We need new actors,” Hotez said. “We can’t depend exclusively on big pharma. We need to look at small and mid-size pharmaceutical companies and private-development-partnerships, and we need ways to help these organizations,” he said.
The report recommends the creation of new incentives to encourage small companies and the rest of the private sector to develop global health technologies, including tax credits, advance market commitments, and prizes, with a goal of promoting new resources for global health research and development while sustaining U.S. investment in new technologies. The report also recommends monitoring the effectiveness of the U.S. Food and Drug Administrations’s Priority Review Voucher program, to encourage new investment in neglected disease R&D and promote affordability and access to lifesaving technologies.
Along with identifying and dedicating new resources, the report recommends, the U.S. should ensure FDA’s engagement in global health includes efforts to help low and middle income countries build and streamline regulatory processes that benefit from existing protocols. Authors suggest Congress should direct the agency to establish “a specific mechanism to offer a formal scientific opinion on medical products for their use outside of the United States.” Such a mechanism would allow the FDA to provide formal opinions on the safety, efficacy, and manufacturing quality of global health technologies, the report says.
Helping other nations build health skills, leadership and resources is particularly important for deterring antimicrobial resistance, Ambassador Jimmy Kolker of the Department of Health and Human Services said. India in particular needs assistance in preventing antibiotic resistance and strengthening stewardship, Kolker said.
“Drinking water from the Ganges is the same as taking a course of antibiotics because of the medical waste in there.” he said.
He estimates that more than 23 million lives have been unnecessarily lost to antibiotic resistance.
In addition to better coordination with international partners, the report also recommends improved alignment and transparency of global health research and development efforts across U.S. agencies, including through an across-agency, coordinated global health research and development strategy.
The Coalition’s release of the report, which took place against the backdrop of continuing impacts from the West Africa Ebola Crisis and increasing knowledge of the impacts of Zika virus as its spread continues, can be watched here.