Biomed Analysis: Public–private health R&D can't stall
The funding stream for partnerships between the pharmaceutical and public sectors cannot be allowed to dry up, says Priya Shetty.
Global health experts have always felt that they are fighting a losing battle to galvanise funding to fight diseases of the poor.
Big pharmaceutical companies are understandably reluctant to invest in products for which there is no profitable market. And governments and universities cannot afford to gamble millions on developing a drug that may not even get approved.
This impasse seemed to be coming to an end with the advent of product development partnerships (PDPs), which combine academic know-how with pharmaceutical money.
But this progress is now under threat with the news that funding for PDPs is starting to dry up.
The latest report of the G-FINDER project, a freely accessible database tracking global financing of research and development (R&D) into diseases of the poor, sponsored by the Bill & Melinda Gates Foundation, was launched today (16 February). It shows that funding is shifting from PDPs to basic research.
Overall, global funding for R&D into neglected diseases rose by nearly a quarter of a billion US dollars from 2008 to 2009, reaching US$3.2 billion. Yet in 2009, PDPs received US$530 million — US$50m less than they did in 2008, a drop of 8.6 per cent.
Several key PDPs were hit, including the International AIDS Vaccine Initiative (IAVI), the Sabin Vaccine Institute and the Medicines for Malaria Venture (MMV).
This downward trend comes at a critical time and could endanger the pipeline of drugs for neglected diseases. Many PDPs have products, such as the malaria vaccine RTS,S developed by the Malaria Vaccine Initiative, in late-stage clinical trials — the most crucial and expensive stage of drug development.
Over the past 15 years, PDPs have been the major driver of R&D into drugs and vaccines for neglected diseases — they were responsible for 75 per cent of R&D in 2004.
Javier Guzman, a co-author of the report and director of research at the nongovernmental organisation Policy Cures, says that in the past five years alone, "PDPs have delivered nine new drugs, diagnostics and vaccines for malaria, tuberculosis, meningitis and visceral leishmaniasis, and have developed the largest pipeline of neglected disease products ever assembled with over 140 projects now in development".
For instance, the Drugs for Neglected Diseases initiative (DNDi) was responsible for developing two malaria drug combinations that have been enormously useful in fighting the disease: ASAQ (composed of artesunate and amodiaquine) and ASMQ, which combines artesunate and mefloquine.
The organisation's development portfolio now includes urgently needed treatments for Chagas disease.
The reduced financial support for PDPs came alongside a 21 per cent rise in funds for basic research. According to the report, one reason for this shift seems to be a change in the sources of funding.
In 2009, financial support from most philanthropic organisations — including the Gates Foundation — dropped by 8.7 per cent (US$62.5 million), while funding from public institutions rose by 14 per cent ($258.5 million).
The increase in public funding came from organisations such as the US National Institutes of Health (NIH) and the UK Medical Research Council, which are more likely to support basic research. They are also less likely to invest in high-risk product development.
The report's authors are not suggesting that investment in basic research should be sacrificed in favour of product development.
Instead, they call for better methods to evaluate investment into R&D for global health, so that funders can make an accurate judgment about when to invest in basic research and when to fund translational research.
For instance, says the report, "more than half of sleeping sickness funding went to basic research, although this area would benefit markedly from the development of new, safe, oral drugs that are active against both stages of the disease".
There are plans to build on existing support for PDPs. Last May, IAVI, the pharmaceutical manufacturer Novartis and the George Institute for International Health in Sydney, Australia, outlined plans for a 'PDP-plus' fund to coordinate funding from governments and other donors — and to ensure that PDPs had sustainable financing in place.
Are efforts to extend support for PDPs justified? Last May, an expert working group of the WHO presented its analysis of different mechanisms to stimulate R&D for neglected diseases. In its top five, along with PDPs, were advance market commitments — which guarantee a market for products that pharmaceutical companies make — and an R&D prize fund as an incentive for research.
These alternatives are not without merit. But with the exception of the Global Alliance for Vaccines and Immunisation's (GAVI) pilot programme of advanced market commitments for a vaccine against pneumococcal disease, only PDPs have delivered on their promise so far.
If funding for PDPs flounders for too long, drugs and vaccines for neglected diseases could be put even further out of reach of the world's poor.
This article was updated 17 February 2011. A previous version of this article stated that the malaria vaccine RTS,S was developed by the PDP Medicines for Malaria Venture. This statement was incorrect.