6.8
Tuberculosis
See Background Chapter 6.8
Tuberculosis (TB) is a major and growing threat to public health for Europe and the
world, with new epidemiological challenges. The EU25 now has a TB burden of more
than 50 000 new cases per year (see Figure 6.8.1). Of these, about 10% are infected with
bacteria that are already resistant to one or more of the existing medicines.1 Globally,
TB control is now threatened by an upsurge in patients who are co-infected with
HIV/TB, who are straining current TB treatment and control approaches to the limit.
Controlling TB with the existing tools is a cumbersome, expensive and sometimes
unsuccessful task. There are no cheap, rapid, reliable diagnostics for screening for
drug-resistant TB. Moreover, the current first-line TB diagnostic test picks up only 50%
of patients with active TB. To make matters worse, medicine therapies are resourceintensive and expensive, particularly in European settings, requiring six to eight
months of therapy. Therapies for resistant TB are even longer, up to two years, and
have high failure rates. All the current TB medicines were developed between 1940 and
1970, and there has since been a marked downturn in industry interest. There is no
reliable vaccine to prevent TB in adults.2
Although new tools and approaches are being developed in all areas – including basic
research, medicines, diagnostics and vaccines – progress is being delayed by lack of
targeted funding and support. The EU now provides less than 5% of global funding for
development of new TB tools. The U.S. Federal Government provides a high
throughput and an in vitro screening facility to stimulate research on TB. No such
service exists in Europe for any product of public health significance.
Figure 6.8.1: TB incidence in the expanded European Union
United Kingdom
Sweden
Spain
Slovenia
Slovakia
Portugal
Poland
Norway
Netherlands
Malta
Luxembourg
Lithuania
Latvia
Italy
Ireland
Hungary
Greece
Germany
France
Finland
Estonia
Denmark
Czech Republic
Belgium
Austria
0
10
20
30
40
50
60
TB Incidence per 100000
70
80
90
Source: European HFA Database 2003
The landscape of R&D for these new tools has also changed dramatically, with their
development now being driven by public-private partnerships (PPPs) and funded by
philanthropists. Only three major pharmaceutical companies remain active in TB
medicines discovery. Current EU funding for R&D of new TB tools does not always
reflect these new epidemiological and pharmaceutical realities. EU funding is
insufficient (around €7 million per year under the Fifth Framework Programme) and is
not well targeted at the PPPs, smaller industry and academic groups, which are now
the most active in TB research and development.3
The EU should support research on diagnostics, vaccines and pharmaceutical
translational research being undertaken by PPPs and by small and medium-sized
enterprises to address this serious public health problem. Every encouragement
should be given to the few large pharmaceutical companies still active in this field so
they can contribute new pharmaceutical products for the planned clinical trials of the
EDCTP.
1
Anti-TB drug resistance in the world. Report no. 2. Prevalence and trends. Geneva:
World Health Organization; 2000. Report No.: WHO/CDS/TB/2000.278.
2
O’Brien R, Nunn P. The need for new drugs against tuberculosis. Am J Respir Crit Care
Med 2001;163(5):1055-1058.
3
EC European research area fact sheet: EU-funded research in the fight against
tuberculosis. Available from:
http://europa.eu.int/comm/research/press/2003/pr2403en.html (accessed 3 March 2004).