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Health ministry can invoke provision of Patent Act to reduce cost of procurement of Prevnar 13 under UIP: says Dr Nair
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Laxmi Yadav, Mumbai
October 31 , 2017
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Even though the Indian patent office has granted Pfizer a patent for
Prevnar 13 pneumonia vaccine making it unaffordable for many, the Union
health ministry can invoke government use provision under section 100
and 101 of Patent Act to designate an Indian vaccine manufacturer to
manufacture the life saving vaccine exclusively for government use which
will be distributed through government channel, said noted patent
expert Dr Gopakumar G Nair.
The Prevnar 13 patent will expire in
2026. The grant of patent to Pfizer for Prevnar 13 was challenged by
Médecins Sans Frontières (MSF) in Delhi High Court. The NGO claimed that
the patent can directly affect access to life-saving medicines and
vaccines in India and across the developing world.
Prevnar 13 is
used for the prevention of pneumococcal pneumonia and invasive diseases
caused by 13 Streptococcis pneumoniae strains. It also reduces the
likelihood of antimicrobial resistance (AMR) by considerably decreasing
common childhood infections. Pneumococcal disease is the leading cause
of vaccine-preventable deaths in children under five years of age
globally and in India. India accounts for nearly 20% of global pneumonia
deaths in this age group.
The Union health ministry had
introduced pneumococcal conjugate vaccine (PCV) in the Universal
Immunization Programme (UIP) in May 2017. The pneumonia vaccine is being
supplied to UIP at discounted price under the Global Alliance for
Vaccines and Immunization (Gavi). India is supposed to begin
transitioning away from Gavi support from 2017 and is expected to begin
fully self-financing all its vaccine programmes by 2021.
Nair
said the government is receiving life saving vaccine through Gavi which
is quiet expensive, it must look for other options to ensure
availability of vaccine at affordable prices. It can allow an Indian
manufacturer to produce the vaccine exclusively for government
distribution and use by invoking government use provision under section
100 and 101 of Patent Act. It will bring down the cost of production and
procurement for the government, who only pays the cost of production to
designated Indian manufacturer for making it available to the
government for use under UIP.
The NGOs and people's
representatives must come forward and build pressure on the government
to invoke this provision under Patent Act to get the vaccine
manufactured by an Indian player exclusively for the government
sponsored immunization programme, he opined.
As per market sources, Prevenar 13 is priced at Rs.3,800
per dose in the private market. A child needs three doses. Thus it is
inaccessible for significant portion of the country's population. By
making the vaccine available under the UIP, government is ensuring
equitable access to those who need them the most, he said.
The
vaccine is being rolled out to around 21 lakh children in Himachal
Pradesh and parts of Bihar and Uttar Pradesh in the first phase of UIP.
This will be followed by introduction in Madhya Pradesh and Rajasthan
next year, and eventually be expanded to the country in a phased manner.
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TOPICS
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