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.