Pharmacy of the world under threat – Issues with Intellectual Property Rights

India is considered “Pharmacy of the world” due to its affordable generic drugs to middle and low income countries saving millions of life worldwide.

Why it is called Pharmacy of the world?

  • 50% of its $10 Billion annual generic medicine production is exported
  • Supplied highly effective triple combination antiretroviral therapy well below 1$ a day when Africa is ravaging with AIDs and the Best offer that MNCs can offer the drug is at $10,430 per patient
  • More than 80 percent of the medicines MSF uses to treat over 200,000 people living with HIV in its projects are Indian generics, and MSF sources essential medicines from India to treat other diseases, including tuberculosis and malaria
  • Among padeatric ARV and adult nucleoside and non-nucleoside reverse transcriptase inhibitor markets, India produced medicines accounted for 91% and 81% of 2008 global purchases ,respectively.
  • The Indian pharmaceutical industry accounts for 8 percent of global production and nearly 20 percent of the world’s generic supply

How India is able to afford low medicines?

  • India’s generic medicines experiment dates back to 1960 when India commenced generic medicines from basic stage through public sector drug manufacturers.
  • After the agreement across political spectrum is was decided that India needs to achieve self sufficiency in generic medicine production,Intellectual property system that we inherited from British is overhauled by the new Patent Act 1970.
    • Under this act,Food and pharmaceutical are identified as areas where exclusive patent rights are limited
    • the Patent Act of 1970 awarded patents on processes. This meant that if a company developed a new product like a new medicine or a device, it would not be the sole owner of the product, but rather of the process by which the product was manufactured. Others would be able to reverse engineer the product and come up with another process. This way, no single company or individual would be able to extort or hold the entire industry to ransom by demanding exorbitant prices. This automatically kept competition high and the prices low.
  • Govt also put Industrial policy measures and encouraged public sector drug manufacturers to collaborate with local private industry
  • Over the next few decades India nurtured the generic medicines industry that stand out to be pharmacy of the world

What is the problem now?

  • Indian patent laws are major obstacle for the European ans US multinational pharmaceutical companies since the next big market for them is India
  • US is mounting pressure on in India to enact strict patent laws there by helping their pharmaceutical MNC companies
  • TRIPS- Trade related Intellectual property rights
    • sought to constrict the freedom of nations to tailor their patent regime in their own needs and interest
    • It made product patent mandatory and make global patent filing process more interconnected and in essence forced all WTO signatories to accept the western model of TRIPS.
    • Developed nations to begin TRIPS by Jan 1,1995 ,developing nations by Jan 12005 and Least developed nations by 2015
  • Emergence of voluntary Licencing
    • Under this partner companies pays royalty to the innovator company of the medicine and they are permitted to make copy-cat version and sell the product in the local market
    • But these partner companies are not allowed to export these Indian made generic medicines to other countries

What happend when India Needs to implement TRIPS in 2005?

In 2005, when it was faced with the implementation of the WTO rules, India globally changed conceptions of policy approaches to managing ever-greening in the patent examination system on pharmaceuticals to continue with the production, registration and supply of generic medicines to millions of patients in India and other developing countries.

Evergreening– Extending the patent of the product after its patent period is expired , to continue one’s companies monopoly over it

Consequences if VL and strict IPR are implemented in India?

  • Medicine would become costly that most of the middle income and Low income countries could not offer, sometimes they will become as high as possible that becomes difficult to afford for the people in developed countries also
  • According to a technical analysis by MSF, over 49 million Hepatitis C patients live in middle income countries excluded under the VL’s anti-diversion programme

What could be done to prevent it?

  1. Once again the Indian govt should step and made policy changes to address the issus
  2. Indian govt should not succumb to the Developed countries pressure who are on behalf of MNCs pressurizing the Indian govt

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