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‘Public-private
sector coordination needed in TB diagnostics’
 Dr
Mark D Perkins, science officer with the Global Programme on
Tuberculosis in WHO and manager of Diagnostics for the UNDP/ World
Bank/ WHO special programme for Research and Training in Tropical
Diseases (TDR), talks to Vijaya K on WHO initiatives in tropical
disease management and the role of private sector in development
of TB diagnostics. Excerpts:
What
are your plans for India in TB diagnostics?
We are planning to set up a TB diagnostic evaluation centre in India
for which we are in talks with the TB Research Centre in Chennai.
The WHO and TDR have plans to set up a TB Specimen Bank which would
cater to the need for a well-characterised clinical material from
patients with TB symptoms to rapidly evaluate and control quality
diagnostics tests. India is a critical player in tropical diseases
because of its geography, population, history, economic conditions.
We do have some projects underway for which we are looking at funding
in India.
What
are the technical & economic features of development of TB diagnostics?
The production cost of diagnostics is much lower as compared to
vaccines. Simple diagnostics development require just few hundred
thousand dollars. Hence, a large number of companies get involved
in drug discovery and development of TB diagnostics. Unfortunately,
most of the companies are not making heavy investments in tool optimisation
of area research. More often they take reagents or ideas that are
developed in academic setting, which results in manufacturing of
mediocre diagnostics products. Diagnostics lack regulatory rules
because they are not regulated like drugs. There is no pathway to
ensure that good manufacturing practices are maintained in diagnostic
development. A protocol has to be drawn for diagnostics and regulatory
norms should be made complex.
Is
the market lucrative for TB diagnostics?
Out of total ten leading companies engaged in diagnostics, only
three are involved in TB diagnostics. They produce high-end and
expensive diagnostic tools that are seen for sale in big laboratories.
The companies that are involved in diagnostic tests will have the
biggest impact in developing countries where as TB is seen more
in the smaller countries. In fact many companies are trying to move
away from this because this is not a big market.
How
does WHO initiate public-private sector coordination in TB diagnostics
development?
There should be coordination between private and public sector in
the area of health distinguished from the area of business. Private
public partnerships will be receptive in helping address the health
needs when there is a market.
In
India the problem is not the size of the market but the chaos in
the market. In India despite public sector participation, TB is
handled largely by the private sector, which has only complicated
the situation. Private sector in India tends to use a broad variety
of methodologies of treatment that are ineffective and below standards.
The diagnostic methodologies as well may be quite chaotic. Presently
India needs to organise the market rather than expand the market.
WHO
is working on improving private sector care of patients. The Indian
Medical Association should be a key partner in public-private sector
coordination for education and sustained efforts. The Indian government
should involve in setting up partnerships with the industry. Biotech
companies, both small and medium, involved in diagnostic work are
looking at large markets for TB products. So their goal is to make
expensive products. The difficulty is in getting the companies to
invest enough funds to come up with less expensive actual products
of excellent tool development work. WHO is trying to lower industry
obstacles. We hope to have low cost diagnostics in the private and
the public market for TB diagnostics. Our goal is to see that the
population is not neglected for want of these diagnostics. Our aim
is to procure simple and sophisticated TB diagnostics.
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