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Editor's Note
Public health vs private enterprise
 In
the midst of the global slowdown, with but a few 'green shoots' of recovery
struggling to break through, the Indian biotechnology fraternity will meet once
more at Bangalore Bio, arguably India's biggest biotech event. On the agenda
are discussions on partnering, changing growth models, intellectual property
and the like. But as our Cover Story in this issue points out, without appropriate
regulation in place, the industry may flounder down the wrong path.
Regulation can be a guidance but it can also stifle. It is no wonder then that
even the US is taking its time to formulate its policy on biologics. It is a
balancing act that administrations have to aim for. On one hand you have patients
and their right to affordable medicines. A course of biotech drugs can set back
a patient by up to $1000 a month, and since unlike chemical-based medicines,
there are no generic substitutes for biotech drugs, patients have no choice.
And on the other hand, you have an industry investing years of time and money
in projects, of which only a handful turn out to be hits.
The pathway for approval of generic biologics, or biogenerics/ biosimiliars,
is strewn with objections from innovator biotech companies. Even though they
face much less competition than innovator pharmaceutical companies, because
biologics are much more complex to make and therefore entry barriers are higher,
innovator biotech companies are demanding a 14 year exclusivity period. Whereas
advocates for biogenerics are pushing for five years of competition-free marketing,
as studies have proved that price erosion in biogenerics will be only 10-20
percent, and not the 70-80 percent observed for small molecules. Five years,
innovators say is too short to for them to reap the rewards on their research.
This short period will not incentivise them to invest in future research.
The fact that the World Health Organization upgraded its status of the influenza
A (H1N1) infection to an influenza pandemic, the first since 1968, only underlines
that fact that vaccines and other biologic preparations are going to take over
the prominent position occupied by pharmaceuticals today. All the more reason
for policy makers not to be swayed by powerful lobbies and push for affordable
public health with reasonable profits.
Viveka Roychowdhury
viveka.r@expressindia.com
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