July 10, 2014 - London/Geneva - A new report by the All-party Parliamentary Group (APPG) suggests a slew of measures to address the failings of commercially driven Research & Development (R&D) to address Poverty-Related and Neglected Diseases.
The report recommends increasing UK’s funding for R&D in global health, to push for greater support for product development partnerships, reduce financial risk and encourage non-commercially driven R&D models that delink price and innovation.
The report also notes how the lack of commercial incentives has led to a critical shortage of antibiotics even as we are fast approaching the post-antibiotic era.
In total, an estimated 13.7 million people die every year from ‘poverty-related and neglected diseases’. In addition to HIV, TB, and malaria, other diseases are Buruli ulcer, Chagas, dengue, guinea-worm, leprosy, river blindness, sleeping sickness and nearly a dozen others.
The differences in access and availability in the context of varying health burdens between high income countries (HICs), low and middle income countries (LMICs), make investments in R&D more difficult.
To understand the dynamics, take the example of TB and HIV, the world’s two biggest killers mostly found in LMICs, but also in HICs. The report says that for TB, the HIC market is small. This means that although the city of London has higher rates of TB than other capitals in Western Europe, it spends £7m on TB drugs. It also says that the global market for MDR-TB, which is more expensive to treat is estimated at $300m a year. Compare this to about 100,000 people living with HIV in the UK. It is understood that half the people are unaware that they carry the virus, but the UK spends £820m every year to treat HIV and drugs for the lifetime of an average patient costing £360,000. Clearly HIV has a significant HIC market, unlike diseases such as TB.
While crediting pharmaceutical company Janssen, for bringing bedaquiline to the market - the first and only TB drug approved by FDA in many decades - the report says that there have been over 20 FDA approved compounds for HIV in the last two decades. It also says that while there are point-of-care tests available for HIV, there are no equivalents for TB.
The report calls for a closer examination of what it entails to incentivise drug development for neglected diseases, while recognizing that such an assessment is far from easy. There is a need for devising systems to reduce financial risk and cost for the commercial sector during drug development, it says.
While taking into account the roles of governments, the private sector and academic institutions for R&D for vaccines, drugs and diagnostics, it draws attention to the role of product development partnerships (PDPs).
Given that research expertise lies with pharmaceutical companies, partnerships nevertheless are an important way to bring together different approaches, to breakthrough the "traditional paradigm of medical innovation" to address specific diseases. It cites the examples of Aeras, TB Alliance and FIND vaccines, drugs, and diagnostics respectively. The report also suggests that the UK must "champion the role of PDPs in global health R&D" and make efforts to strengthen and accelerate product pipelines.
To bulk up UK’s role in R&D for global health, it makes a series of recommendations. The report calls for UK’s DFID to commit to spending at least 5% of its budget on R&D and to restore funding for global health to previous levels of one-third of total R&D funding.
It also called for greater in-cash contributions to the European and Developing Countries Clinical Trial Partnership (EDCTP) from participating countries. EDCTP - that was established in June 2003 to overcome challenges around R&D for global health - focuses on pooling funding and expertise, coordinating activity focusing on developing and evaluating new and improved medical interventions for HIV, TB and malaria. It also promotes a more integrated approach to research on neglected diseases, supporting clinical trials at later stages, building sustainable clinical research capacity in Africa.
It says that DFID should work with PDPs to encourage the inclusion of open-access provisions in partnership with large commercial entities. It recommends examining the implementation of open-access and/or socially responsible licensing (SRL) across UK’s publicly funded R&D for health.
Interestingly, the report also pushes for a WTO Agreement on the Provision of Public Goods. The authors believe that a World Trade Organisation Agreement on the Provision of Public Goods could enhance incentives for countries to invest in R&D for global health and facilitate new collaborations and coordination.
At a time when the biggest free trade deals are under negotiation, the report says that trade agreements must safeguard access. "The UK should make sure that TRIPS flexibilities are not undermined in Free Trade Agreements agreed through the EU. As a major international power the UK should encourage and support countries utilisation of TRIPS flexibilities through investment to develop the technical capacity to do so and by championing their rights to do so in global forums", it says.
The report calls for the UK to spearhead efforts towards a WHO Global R&D Convention. Such a treaty would create structures that would delink the R&D process from the sale of the final product and incentivise innovation based on global health need. To support this process, the UK should commission studies to examine the costs of a delinked R&D model.
Other recommendations include building a non-commercial model for antibiotic development, to build a Global Alliance for Poverty Related Neglected Diseases and to establish a WHO Global R&D Observatory that would act as a central repository of information on global health R&D priorities, funding and research activities.
It urges political parties to identify and champion non-commercially driven models for health products. It asks of the WHO and industry host countries to draw in unengaged companies to invest in neglected diseases without harming commercial interests.
One way of incentivising companies, it says is by targeting and rewarding those companies who engage in partnerships working for R&D for global health. The Treasury should adjust the existing tax credit system to incentivise cash donations and in-kind contributions to PDPs and other platforms.
The report urged for more transparency in R&D costs and to support the development of Quality Adjusted Life Years (QALY) calculations. "Existing financial markets fail to correlate revenues with the public health benefit of a medical commodity. Therefore whilst a clearer idea of R&D costs will support this, accurately measuring the true impact of a commodity could play a central component to future incentive mechanisms," it says.