India must respect intellectual property rights, report says

BMJ 2013; 347 doi: (Published 18 July 2013) Cite this as: BMJ 2013;347:f4618
  1. Anne Gulland
  1. 1London

India must respect intellectual pharmaceutical property rights if it wants to develop new medicines, a report by a London university has urged.

An analysis of healthcare in India by University College London School of Pharmacy warned that failure to respect intellectual property rights risked “undermining the future development of new and more effective medicines for conditions such as cancers and dementia.”1

David Taylor, the report’s author, said that reducing the price of drugs for conditions such as cancer, which are only effective in high technology settings, would not help the majority of people in India, 400 million to 600 million of whom do not have access to essential medicines. Novartis recently lost a case in the Indian Supreme Court to patent its drug imatinib mesilate (marketed as Glivec).2

Taylor added, “Measures like imposing compulsory licences on such medicines are mainly likely to benefit well-off individuals. The mass of the population will gain from better day to day access to low cost but highly effective treatments that are already available as off-patent generics.”

The report said that the high profile Novartis battle had “served to conceal much more important public health questions about the supply of basic established treatments to the mass of the population.”

It added that Indian state level powers to grant supply licences for new medicines when they had been available for sale for four years “cut across nationally awarded patent rights,” and that the granting of compulsory licences on medicines such as sorafenib (Nexavar) on the grounds that they were not manufactured in India was “inappropriate.”

The report highlighted the 2001 Doha Declaration, which allowed countries to over-ride patent protection when national health emergencies necessitated access to high cost pharmaceutical products.

Taylor told a meeting to launch the report at the House of Lords, “One of the problems with the Doha agreement is that in effect it drove a coach and horses through patent law. You can now declare anything a health emergency.”

The report said that almost half a century after the Patents Act 1970 a “remodernised approach to intellectual property law” would give researchers better protection.

Taylor added, “We need fundamental reform of patent law to ensure a degree of security for innovators.”

The report highlighted India’s ambition to be the “pharmacy of the world.” The country is the world’s third largest producer of drugs in terms of volume, but very few new products are developed there and its large scale production of off-patent generics has not led to “medicine for all.”

The report added, “The existence of an often apparently dysfunctional private market for non-patented branded medicines, coupled with problems such as stock outs and corruption affecting the public sector pharmaceutical supply chain, has meant that standards of treatment are not as high as could otherwise have been attained.”

Roy Anderson, professor of infectious disease epidemiology at Imperial College, London, told the meeting of the paradox in India where drug manufacturer the Serum Institute of India produces more vaccine than any other country in the world, yet vaccine uptake rates in some provinces are as low as 40%. He said that India was rich in medical and engineering talent yet “somehow the country is unable to deliver the public health impact.”

He added, “Dengue fever is the world’s fastest growing global infection and we don’t have a vaccine. India would be the obvious place to develop a vaccine but this is not at the forefront of Indian medicine.”


Cite this as: BMJ 2013;347:f4618


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