Patent to Pfizer opens pandora’s box for pneumonia in India

By Ayushi Gupta

Multinational drug major Pfizer Inc has been granted a patent in India for its powerful and expensive vaccine Prevenar 13, which is used for protection against pneumonia. The decision by India’s patent office bars other companies from making generic versions (cheaper copies) of the vaccine and allows Pfizer to exclusively sell it in India.This development will put the treatment out of reach of thousands in poorer nations.

According to MSF (Doctors without Borders), pneumonia vaccines are one of the most expensive humanitarian products that they purchase across the developing world. At present, only two pneumococcal conjugate vaccines are imported into India: Pfizer’s Prevnar13 (PCV13) and GSK’s Synflorix (PCV10) which are very expensively priced at approximately Rs.3,800/dose and Rs.1,800/dose respectively in the private market.

In addition to the administering cost by the physician, a child needs at least three primary doses to get protection against pneumonia—taking the cost of the vaccine to Rs.11,400 and Rs.6,000-6,600, respectively, making it the costliest vaccine in the immunization schedule of a child. PCV had until recently been available solely in the private market with out-of-pocket price tags beyond the reach of not only vulnerable children and impoverished parents but also the Health Ministry.

Pfizer’s patent spells bad news for India

India has the world’s highest burden of pneumonia, accounting for nearly 20% of global pneumonia deaths in children under the age of five. As per a report released by International Vaccine Access Centre (IVAC), Johns Hopkins Bloomberg School of Public Health, nearly 3 lakh children died in 2016 due to lack of purchasing power by the vulnerable communities for the highly priced vaccine.

Understanding the need of the hour, the Indian government has introduced pneumonia vaccine into India’s Universal Immunization Program with support from the Global Alliance for Vaccine Immunization (Gavi), an international public-private partnership for improving access to vaccines. Yet high prices for the vaccine have forced the government to do limited rollouts of the PCV vaccine in just three states: Himachal Pradesh, Bihar, and Uttar Pradesh. A lower priced PCV vaccine is critically important to increase vaccine coverage across the entire country in the coming years and eliminate the disease from the country.

Pfizer’s Prevnar 13 an optimum solution?

Prevnar 13 protects children and adults from 13 types of pneumococcal bacteria. The granting of patent to Pfizer implies that it is the cheapest option available in India. In its justification for high prices, Pfizer spokesperson said, “Supported by extensive clinical research and real-world experience, each dose of PCV-13 requires 400 different raw materials, 580 manufacturing steps, 678 quality tests and two and a half years to produce.” The Indian institutes like Serum Institute and Panacea Biotech have developed affordable vaccines (Rs.400 for all 3 doses, per child) and can provide competition to Pfizer and GSK who currently dominate the market internationally and in India. This would lead to lowering of the vaccine prices and greater access to the masses. However, these companies can only start selling it if Pfizer is denied a patent.

In addition, the decision of the Indian patent office will hamper the country’s role of the ‘pharmacy of the developing world’ as the poor nations rely on India’s robust drugs industry to supply cheaper copies of medicines and vaccines. “It’s unfair and unacceptable that almost a million children die each year from pneumonia, even though a life-saving vaccine is available,” said MSF’s Prince Mathew.

There is smoke. Is fire nearby?

MSF (Doctors without Borders) says, “The method Pfizer is trying to patent is too obvious to deserve a patent under Indian law, and is just a way to guarantee an extended market monopoly for the corporation for many years to come.” The patent granted to Pfizer involves the method of conjugating (assembling) together distinct variations (serotypes) of the virus (streptococcus pneumonia) into a single carrier and is essential for PCV developers. The patent is a mere addition of serotypes to the already established 7 valent vaccine and lacks technical merit. Consequently, it ought to have been rejected. In 2014, Pfizer’s patent was revoked by the European Patent Office and is being legally challenged in South Korea and before the US Patent Trademark Appeal Board.

The case indicates a weakening of India’s strict patentability standards, which results in granting monopolies for minor and trivial improvements of existing medical products, as allowed in some other countries. Worldwide, pneumonia kills almost one million children every year. It is a child’s fundamental right to be protected from pneumonia and non-access to the available vaccine due to lack of monetary resources is a failure of the economies all over globe, who declare high growth numbers and make claims of development. The patent has been challenged by MSF and Panacea Biotech in India. Hopefully, a right decision by the Supreme Court could put the brake on the beginning of a humanitarian disaster.

Featured source image: Wikimedia Commons