Binding R&D convention takes centre stage

currently unmet.
International humanitarian medical organisations are urging health ministers to seize the unique opportunity and give the green light to a proposal that has been years in the making. By passing a resolution at the WHA, governments can this week take the first step to making an R&D convention a reality.

“Medical innovation is not delivering for the needs of people in developing countries. Governments have the power, the responsibility and, from today, the opportunity to change this,” said Michelle Childs, director of Policy/Advocacy at MSF’s Access Campaign. “A clear and compelling case has been made for an R&D convention. WHO member states must get on with starting the process, and not look for excuses to delay.”
Today’s system for medical R&D is flawed, in that it is predominantly driven by commercial rewards rather than health priorities. This means that research is steered towards areas that are the most profitable, leaving fundamental medical needs — particularly those that disproportionately affect developing countries like tropical diseases or tuberculosis — unaddressed.

MSF field teams see the consequences of this every day, and struggle to deliver quality care when appropriate medical tools do not exist. When drugs, diagnostics and vaccines do exist, they are often unsuitable for use in countries where MSF works, as they have been designed for resource-rich countries.
In Zimbabwe, just as in many developing countries, health professionals are confronted on a daily basis with the lack of adapted medical tools to treat people living with HIV/Aids or TB/DRTB (drug-resistant tuberculosis).

“For example, in Zimbabwe, there still remains a challenge in the treatment of children living with HIV since the safety and appropriate dosing of some key antiretrovirals used in adults have not been yet established in children and appropriate formulations simply do not exist. It is also difficult to routinely offer viral load monitoring since there is still no simple, adapted and affordable tool available,” representatives of MSF in Zimbabwe said.

Challenges in Zimbabwe are also being experienced in the detection of people with TB since the most widely available diagnostic method, microscopy, detects less than half of the cases; therefore it’s a priority to develop a simple to use, affordable and accurate point of care diagnostic test for TB. Additionally, no new drugs to treat TB and DRTB have come to the market since the 1960s.

The problem of lack of medical products adapted to the specificities of developing countries is a direct consequence of today’s medical innovation system and has long been acknowledged. However, efforts to overcome this problem and ensure adequate R&D for developing country needs have so far been ad hoc and insufficient.

Unmet needs include: more effective treatments for drug-resistant tuberculosis; paediatric versions of HIV drugs; a test to determine whether a patient with Chagas disease has been cured; new antibiotics to treat life-threatening infections in the face of increasing resistance; and vaccines that do not need to be refrigerated or can be given without an injection.

“Our field teams know where the medical needs are, but that knowledge isn’t enough to address the gaps. We need to connect the research priorities with the money, to drive the money spent on medical research to where the needs are and to ensure that the fruits of innovation are affordable and accessible. This is where the R&D convention can bring about transformation,” said Dr. Tido von Schoen-Angerer, executive director of MSF’s Access Campaign.

In April, a report was released by the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG), a WHO-convened group of experts mandated to look at medical innovation.
They concluded that a binding convention “is needed to secure appropriate funding and coordination to promote R&D needed to address the diseases that disproportionately affect developing countries and which constitute a common global responsibility.”

A convention would bring significant advantages. It would create an evidence-based process to define priorities. Signatory countries would then be bound to invest towards addressing those priorities. Importantly, any research funded thanks to the convention would deliver accessible and affordable products; for example, by ensuring price and supply commitments, adopting flexible licensing policies for developers, and supporting open innovation that would make knowledge available to others.

Over the past 10 years, product development partnerships have been created to fill some of the innovation gaps and new funding from philanthropic foundations and governments has been forthcoming. But these efforts are piecemeal and vulnerable. 
“We need a more sustainable system, particularly now that donor funds are increasingly scarce.
“The convention would encourage a fair contribution from all, but also shape how the money is spent. It should ensure that the money goes further and achieves more by supporting alternative models to stimulate R&D that cost less and deliver medical tools that are accessible and affordable to those that need them,” said

Childs.

The WHO Framework Convention on Tobacco Control provides a precedent of an internationally binding agreement negotiated and adhered to under the auspices of WHO.

Mari Carmen Viñoles is the MSF Head of Mission in Zimbabwe

 

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