Researchers are calling for a binding global health convention that requires all governments to share the costs of research and development (R&D), stating that such an international treaty would boost access for communities least able to pay for medical innovation – but who need it most.
“It’s clear that the present model of R&D financing and agenda-setting is flawed,” said Michelle Childs, director of policy and advocacy for a 13-year campaign run by international medical NGO Médecins Sans Frontières (MSF) to increase access to medicines for neglected communities.
But this and other efforts to correct a “fatal imbalance in R&D” are ad-hoc and inadequate, MSF conceded in a recent briefing because the areas affected by the “neglected” diseases of poverty offer pharmaceutical companies little commercial incentive to invest, yet have the highest disease burden.
The challenge has been to “de-link” profits from medical discoveries, so those patients least able to afford medical innovation can benefit. In 2010 a World Health Organization (WHO) commissioned expert working group (CEWG) set out to learn how it could create an R&D system where public interest, rather than profit, drives innovation.
A quixotic quest, but a necessary one, John-Arne Røttingen, the group’s chair, told IRIN. “When the idealistic solution is the only solution, we need to aim for that.”
In 2010 three diseases received most of the global funding for R&D. HIV/AIDS got US$1 billion (35 percent), tuberculosis (TB) was given $575 million (19 percent), and malaria $547 million (18 percent), according to the most recent Global Funding of Innovation for Neglected Diseases (G-FINDER) report from the independent group, Policy Cures.
Despite being the leading child-killer in developing countries, diarrhoeal diseases received less than 5 percent of global R&D funding ($18 million) in 2010.
Leprosy, Buruli ulcer, trachoma – an eye infection that can lead to irreversible blindness – and rheumatic fever are all among the “neglected” diseases of poverty that occur in overcrowded, remote and poor areas. They each received less than $10 million.
In 2010, eight of the top 12 governments that provided public funding for R&D into neglected disease (including HIV/AIDS, malaria and TB) cut their spending, according to the G-FINDER survey.
An exception was the UK government, which increased its allocation by $21 million in 2010, and in 2012 announced a five-fold increase in aid for neglected tropical diseases reaching $400 million by 2015.
The public sector donates most of the money for basic research on such diseases – about two-thirds in 2010. The pharmaceutical industry, valued at an estimated $880 billion in 2010 by G-FINDER, invests millions in following up promising leads and seeking regulatory approval through clinical trials, and then usually sells the product under patent to recoup R&D costs.
The problem arises when products like vaccines, or drugs designed with high-paying consumers in mind, land in places like Niger, Chad or the Democratic Republic of Congo, said Michel Queré, an MSF medical advisor to programmes operating in those countries.
“Keeping the cold-chain to conserve the vaccines at the right temperature when it is 45 degrees Celsius outside [113 degrees Fahrenheit] is a major challenge – in some rural areas, just maintaining the fridges in working order is hard to guarantee.”
Health experts working far from industry labs have long called for products that can hold up in the field, are easy to administer in places with few trained health workers, and treat diseases prevalent in poor countries.
Empty drug pipeline
But an MSF survey of drugs developed from 1975 to 2004 found that only 18 out of 1,556 were for such diseases.
“We have no model which would meet the need for new drugs in a sustainable way,” the head of pharmaceutical company Novartis told international media, while commenting on losses the company was absorbing for an anti-malarial drug. “You can’t expect for-profit organizations to do this in a large scale. If you want to establish a system where companies systematically invest in this kind of area, you need a different system.”
For example, no new TB drugs have come to market since the 1960s, even though a rising number of cases that are resistant to the recommended six-month minimum treatment of antibiotics are being discovered.
Anti-TB drug development in 2010 received 31 percent of the annual $740 million global plan target set by the international Stop TB partnership, headed by WHO.
In 2009 WHO identified antibiotic resistance as one of the three greatest threats to health. But even as the problem has grown in recent years, staff cuts and mergers have reduced the ability of pharmaceutical companies to respond to the threat, said Timothy Walsh, a professor of medical microbiology and antimicrobial resistance at Cardiff University in the UK, who is conducting bacteria research in Pakistan, Bangladesh and India.
“We are running out of antibiotics,” he said. “Increasing gram-negative [bacterial] resistance has caught people by surprise.” Companies often do not get their return on investment in possible new antibiotics, according to research cited in a November 2011 report published in the British medical journal, The Lancet Infectious Diseases, a further disincentive.
Most infections are treated in less than two weeks, but obesity may take years, or even a lifetime, of treatment, said Walsh. “Faced with that choice, a company would invest in treating obesity rather than life-threatening infections.”
Against this backdrop of heightened need, dwindling drugs, and ill-suited innovations, CEWG sought proposals in 2010 to remedy the failure of current R&D to address healthcare needs in developing countries.
After reviewing 15 methods of boosting health through R&D, the group concluded that prizes to stoke innovation may work. Advance market commitments, in which drug manufacturers produce vaccines for poor countries at reduced prices in exchange for guaranteed donor-funded orders over the long term, have had limited success.
An approving nod was given to the recently launched Medicines Patent Pool for HIV treatment. Patent holders agree to share their patents for HIV medicines with “pool” members. Generic manufacturers and other producers are then licensed, spurring the production of affordable medicines.
Also recommended is an international, legally binding health convention that requires all governments contribute .01 percent of GDP to R&D, which CEWG calculated would almost double current R&D spending on neglected diseases to $6 billion.
“Most of this should be spent and utilized to build capacity and conduct research within each country, but at least 20 percent should be channelled through an international funding mechanism. How this global pooled mechanism should be operated is too early to say,” said Røttingen.
The WHO Framework Convention on Tobacco Control and the Pandemic Influenza Preparedness Framework for sharing influenza viruses and access to vaccines are recent precedents.
An African Union summit in 2007 recommended that governments earmark 1 percent of their GDP for R&D. Of the 42 countries in sub-Saharan Africa, 14 submitted their R&D figures to the UN Educational, Scientific and Cultural Organization (UNESCO) 2010 Science Report. Only South Africa approached the goal at 0.9 percent.
“We hope that this trend will reverse,” said Solomon Nwaka, director of the Ethiopia-based African Network for Drugs and Diagnostics Innovation (ANDI), a recent pan-African initiative supported by the European Union and WHO to increase health research in Africa.
On 26 May, CEWG presented its recommendations to governments, whose representatives will draft a resolution to decide on the next steps.