analysis

Updated: Aug 28, 2017 15:13 IST

India’s Patent Office has dealt a major setback to hopes for improved access to an affordable pneumococcal conjugate vaccine (PCV) by granting a patent to the US pharmaceutical corporation, Pfizer, for its PCV13 product, marketed as Prevnar 13. The monopoly granted to Pfizer allows it to control the PCV13 market in India until 2026 and blocks Indian manufacturers from supplying a competing lower-priced version of this vaccine.

Pneumonia causes more than a quarter of deaths in children under the age of five – nearly one million young lives lost per year – whilst India, which carries the world’s highest burden of pneumonia, accounts for nearly 20% of these global infant pneumonia deaths. The PCV, which safeguards against 13 types of pneumococcal bacteria, also lowers antimicrobial resistance (AMR) by significantly reducing common childhood infections and decreasing antibiotic use in infants and children.

Pfizer and GlaxoSmithKline (GSK) presently control a duopoly market for PCV, the world’s best-selling vaccine that has brought in a whopping $39 billion in sales in the last 8 years to the two pharmaceutical corporations. The high price tag and absence of competition has allowed these corporations to quickly capture over 50% of the private vaccine market in India.

Pfizer and GSK have both been building so-called patent thickets restricting development and competition in the area of PCV. One study identified 106 applications potentially relevant to the manufacturing of pneumococcal vaccines. GSK, which markets PCV10 (Synflorix), and Pfizer (previously Wyeth), have filed the most number of patents in India, China and Brazil, in an attempt to create barriers in the development of less-expensive versions of PCV.

Meanwhile, about one third of countries around the world ( about 60 countries), predominantly low-and middle-income countries where millions of children risk getting pneumonia, have not yet been able to introduce the PCV in their national immunisation systems due to the exorbitant prices the two corporations charge – despite a 2007 World Health Organization (WHO) recommendation.

Over 50 governments – among them Angola, Botswana, Jordan, India, Iraq, Philippines and others – have voiced their concerns regarding inflated vaccine prices at the WHO’s annual World Health Assembly in 2015.

In 2016, with the aim of enabling and accelerating production of more affordable versions of PCV, MSF challenged Pfizer’s unmerited patent claims on the vaccine in India after the European Patent Office revoked the same patent judging it to be non-inventive. The patent is also under dispute in South Korea and before the US Patent Trademark Appeal Board. The patent claim is a mere addition of serotypes to the already established 7-valent vaccine and does not involve a technical advancement; it is just a way to preserve Pfizer’s monopoly for many more years.

The decision granting Pfizer a monopoly on the PCV13 has cemented Pfizer’s ongoing monopoly on the PCV market and could prove to have a deadly impact on public health. Manoeuvring to figure out new routes to develop a non-infringing PCV vaccine could delay the availability of cheaper drugs from Indian companies who are the cornerstone of the developing country vaccine manufacturers (DCVM). In the absence of competition in the market, the price of the pneumonia vaccine will remain inflated and out of reach for many parents and developing governments. At the lowest global price of nearly $10 a child, which isn’t accessible to most countries, it is now 68 times more expensive to vaccinate a child than in 2001.

In India, Pfizer’s PCV had until recently been available solely in the private market with an out-of-pocket price tag of over Rs.10,000, reducing the impact of the vaccine as it fails to reach the most vulnerable children.

To enable a broader dissemination, the vaccine is now being introduced into India’s Universal Immunisation Program (UIP) with financial support from the Vaccine Alliance (GAVI). Despite Gavi funding, the roll-out remains limited to just three states: Himachal Pradesh, Bihar, and Uttar Pradesh due to the high price and limited availability of the vaccine. The cost of vaccinating a child with Pfizer’s PCV could more than double the Health Ministry’s expenditure on vaccines in India. At this juncture, a lower-priced PCV is critically important to increase vaccine coverage across the entire country in the coming years.

Leena Menghaney is the South-Asia head of the Access Campaign at Médecins Sans Frontières (Doctors Without Borders)

The views expressed are personal