Cough Up For TB! The Underfunding of Research for Tuberculosis and Other Neglected Diseases by the European Commission

Executive Summary
Neglected diseases, neglected patients

Médecins Sans Frontières (MSF) teams are faced every day with the lack of adequate or effective tools needed to treat, detect or prevent disease. This situation is particularly dramatic for those diseases that predominantly occur in poor countries. All too often, effective medicines, vaccines or easy-to-use tests simply do not exist.

A major reason for this is the insufficient research devoted to developing new health tools for neglected diseases.

Globally, tuberculosis (TB), malaria and neglected tropical diseases account together for 12% of the burden of disease. Every year, 1.7 million people die as a result of TB alone.i Between 1.1 and 2.7 million people, mostly children under five years of age, die as a consequence of malaria.ii Over a billion people are estimated to suffer from neglected tropical diseases, and even this number is considered by some experts as an underestimation.iii Yet, despite such a deadly toll, these neglected diseases are much less researched than many other less lethal diseases.

Let deeds match words
Although the catastrophe due to these diseases has been repeatedly recognised, and ambitious but realistic targets have been set - not least through the UN Millennium Development Goals, and more recently through the work of the World Health Organizationhosted Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (WHO IGWG) - the financial commitments lag far behind the political rhetoric, raising questions about the seriousness of the international community’s response to this crisis in health.

This report examines the contributions of the European Commission (EC) to the funding of research for TB, malaria and other neglected diseases. The EC must be an important player in funding medical research, particularly as the European Union accounts for 31% of the world’s GDP.iv Individual European member states equally have a responsibility to do far more than they are at present.  This is addressed in other reports.2 Following MSF’s analysis of the Federal Republic of Germany’s limited contribution to neglected disease research in April 2008, there are early indications that the German Bundestag will wake up to the challenges and increase its funding.

Content overview
This report is divided into six parts. In Part 1. Why this report? We provide the context and objectives of the report, including the underlying assumptions and methods. Part 2: How the money is spent: the funding mechanisms of the EC lays out the technical details of the funding structures of the EC in Framework Programme 7, to help give an understanding of budgetary allocations. In Part 3. How much is spent: the flow of resources we provide a detailed breakdown of funding to the diseases in this report, in the year 2007. In Part 4. ‘Fair share’: how much should the EC be paying? we use tuberculosis to illustrate the current shortfalls in funding for the diseases of the report, and to determine the amount that the EC should be paying.  Part 5. Conclusions presents our main findings. In Part 6. Recommendations, we hone in on the particular policies that, in our view, can be directly targeted for change, and give our recommendations for policy action.

The Results
Significant shortfalls
Our findings, focused on the year 2007, show that through its various instruments, the EC spent an estimated 35.8 million euros on research and development for TB, malaria and other neglected diseases together. Tuberculosis accounted for 18.7 million euros, and malaria 17.1 million euros - nothing was disbursed for neglected tropical diseases.

While to the layperson a 35.8 million euros sum might seem substantial, the amount is in fact deeply inadequate, almost negligible, in both absolute and comparative terms. Methods to determine the ‘fair share’ that should be paid by the European Commission show to what extent the EC is falling short of pulling its weight.

We have chosen to focus on tuberculosis in order to determine what the EC’s ‘fair share’ might be.  A recent (July 2008) estimate provided by the Treatment Action Group (TAG) in its Analysis of TB funding trends, puts the figure for TB research and development (R&D) needs at 1.45 billion euros (US$2 billion) every year.  According to the same source, only one fifth of this is actually being provided.

Given that the European Union accounts for approximately 31% the world GDP, the EU’s ‘fair share’ of contributions required to reach the global TB R&D funding needs would be 409 million euros. This assumes that private contributions, including the massive financing given by the Bill and Melinda Gates Foundation and other private actors, stays as it is today.

This figure includes both the share of the 27 EU member states and the Commission’s. Current funding trends show how the EC contributes roughly a quarter of the EU’s financing of TB R&D. If one assumes this ratio to remain constant, the share that is thus attributable to the European Commission is 101 million euros a year. Compared to this, the EC’s actual contribution for TB research of 18.7 million euros is a shortfall of more than 80%.

On a comparative basis - the European Union (EC + member states) currently spend only one third as much on TB research and development as the US public sector. Given that the European GDP is 21% higher than that of the USA,v there is no basis for this huge discrepancy.

It is all the more astounding given that Europe is on the frontline of the TB epidemic, with rapid and alarming spread of the epidemic in Central Asia, the Caucasus and Eastern Europe, and even within the European Union in the Baltic States.

Systemic problems
In the course of compiling the EC’s contribution to funding resources, this report also identified various structural deficiencies in the way money for research is disbursed by the EC. These include: no earmarking of funds for tuberculosis, malaria and other neglected diseases, a model that is unfavourable to the large product development partnerships that work in R&D for tuberculosis, malaria and other neglected diseases, and a more general lack of clarity over disbursements and timelines.

Failure to promote alternative financing mechanisms
Research and development funding requires a well considered mix of different funding mechanisms. The lack of adequate medical tools for tuberculosis, malaria and other neglected diseases obviously shows that relying on intellectual property rights to encourage the private sector to invest in medical innovation for these diseases is grossly ineffective. New mechanisms are therefore necessary, and should be designed as complements to the traditional “push” mechanisms, and as alternatives to the patent-based model.  Many of these new mechanisms have attracted considerable interest - such as the idea of a prize fund for a point-of-care tuberculosis diagnostic test. The European Commission, and the 27 Member States, have also committed to exploring these mechanisms by adopting the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property, at the World Health Organization in May 2008.
Yet to date, little interest or motivation has been shownby the EC in this regard.

Cough up for TB, malaria and other neglected diseases!
In sum, the European Commission and its Directorate General Research is falling far short of carrying its weight in terms of research and development for TB, malaria and other neglected diseases.  This is a matter to be addressed urgently by the Commission, Parliament and Council and by the member states. MSF urges that these institutions come together, not to shift responsibilities, but to acknowledge the shortcomings and to act, at latest by the mid-term review, to substantially increase the budgets for these diseases.