BMJ editorial: The production of generic drugs in India

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BMJ

2011;

342:d1694

doi: 10.1136/bmj.d1694

(Published

22 March 2011)

Cite this as:

BMJ 2011;

342:d1694

Editorial

The production of generic drugs in India

Love, director+ Author Affiliations

1Knowledge Ecology International, Washington, DC 20009, USA

james.love@...

A new trade agreement with the EU would hinder access to drugs in developing countries

Khalil Senosi/AP/PA

The European Union is negotiating

a trade agreement with India, the consequences of which will be serious

for billions of

people living in developing countries. Government officials in India are focused on economic growth and are keen to complete

a trade deal with the EU. In exchange for market access in other areas of the economy, the EU wants India, a country with

very low per capita incomes, to embrace tough new rules on ownership and enforcement of intellectual property for medical

inventions.

The negotiation is between two very different entities. The EU is now the world’s largest economy; its gross domestic product (GDP) was estimated at more than $16.4 trillion (£10.2 trillion; €11.8 trillion) in 2009—about 28% of the entire world’s

GDP⇑.

India has a large population—estimated at nearly 1.16 billion in 2009, or 17% of the world’s population. This is also about the same as the population of Europe plus all other countries in the Organisation for Economic Co-operation and Development combined.

India’s GDP was estimated at $1.3

trillion in 2009, about 8% of the size of the EU economy. On a per capita basis, Indian incomes were 3.5% of those in Europe. At the bottom

of the income distribution, the differences are even more stark. An estimated 317 million Indians live with incomes below the official poverty line—$12 a month for urban areas and $8 a month for rural areas.

In 1970, India eliminated patents on drug products.1

This move enabled India, a country with a relatively large domestic market, to develop a strong generic drug industry. In

1994 the World Trade Organization negotiated the controversial Agreement on Trade Related Aspects of Intellectual Property

Rights (TRIPS).2 3 4

India was required to extend patent protection to drugs and to implement other new obligations. In 2005 India implemented

the changes required by the World Trade Organization. In doing so, India limited patents in some areas, such as those on new

uses or new formulations of drugs unless they differ greatly in properties related to efficacy. As interpreted by

the Indian

courts, it is now more difficult for international companies to prevent the manufacture of generic drugs by making minor changes

to the formulation of products or finding new uses for them. These changes meant that Novartis could not obtain patent protection

of a new formulation of the cancer drug, imatinib, and Abbott could not stop the manufacture of generic heat stabilised versions

of the AIDS drugs, ritonavir and lopinavir. Taken together, the policies in place in India today provide important flexibility

in the law and make it possible to produce

more generic drugs.3 5 6

How do EU rules apply in Europe? Europe now grants up to 11 years of exclusive rights to rely on data from clinical trials

and other tests in the context of drug registration.7

During this period of exclusive rights, generic manufacturers cannot rely on the information used to first register the drug

and must repeat costly and time consuming clinical trials, making it difficult or impossible to register the generic version

of the drug. This regulatory monopoly operates outside and independently of the patent system. Trade officials

in Europe want

India to implement a similar regimen.8

If implemented in India, this intellectual property protection regimen would be more restrictive than patents. An absolute

monopoly right provides no safeguards against abuses, and nor does it allow any possibility for the state to order licensing

of the rights in the test data, as can be done for a patent. As noted, it is costly and time consuming to duplicate clinical

trials and doing so often violates ethical

standards relating to unnecessary repetition of scientific tests on humans.9 In the absence of regulatory pathways that permit manufacturers to rely

on existing evidence of safety and efficacy, no new

generic drug could be sold in India without the permission of the company that owned the rights to the data used to register

the brand name version of the drug. This limitation would dramatically shrink the global market for inexpensive generic drugs

during the first 11 years of a new drug. This is important for people living in India, especially the hundreds of

millions

who live on less than $2 a day, but it would also have an enormous impact on the entire developing world. Why? The manufacture

of generic drugs typically involves high fixed costs in the start-up phase and strong economies of scale. Few developing countries

have a large enough domestic market to attract and stimulate entry by suppliers of generic drugs. India does. Bangladesh,

Nicaragua, Kenya, South Africa, the Philippines, Thailand, and others do not.

If the EU can remove India as a legal market for early production of generic drugs it is likely that a big enough market will

not exist anywhere. Even if other developing countries can resist trade pressures to adopt restrictive rules on patents or

regulatory test data, they will not be able to turn to India to find affordable supplies of the drugs.

Trade officials in the EU promised—in the 2001 Doha Declaration on TRIPS and Public Health,10 and in the 2008 World Health Organization Global Strategy and Plan of Action on Public Health, Innovation and Intellectual

Property11—that

governments would implement intellectual property rules in such a way to “protect public health and, in particular, to promote access to medicines for all.†If the EU pushes for more extensive protection of patents than is required by the World Trade Organization, and for new exclusive rights in drug test data, it will make a mockery of these promises.

How important are the Indian generic drug manufacturers? From 2003 to 2008, in programmes supported by donor organisations

like the Global Fund, Indian generic drugs

accounted for more than 80% of the drugs used to treat AIDS, including 91% of paediatric

antiretroviral products, and 89% of the adult nucleoside and non-nucleoside reverse transcriptase inhibitor markets.12 India is also the most important source of generic drugs for cancer, heart disease, and other diseases and conditions.

The EU is currently negotiating the intellectual property chapter of its trade agreement with India in secrecy, despite the

high interest and its enormous importance for billions of people living in developing countries. It is regrettable

that an

agreement that will have such an important

effect on the human rights of billions of people is being negotiated in

secret,

and even more regrettable that the EU has asked India to sacrifice access to life saving drugs for market access in other

areas of the economy. Political and civic leaders from Europe and around the world must appeal to the EU to avoid outcomes

that make it even more difficult to manufacture and market inexpensive drugs in developing countries. This can begin by eliminating

demands that India adopt exclusive rights on drug test data, or lower its standards for granting patents on medical inventions.

Notes

Cite this as: BMJ 2011;342:d1694

Footnotes

Competing interests: The author has completed the Unified Competing Interest form at www.icmje.org/coi_disclosure.pdf

(available on request from the corresponding author) and declares: no support from any organisation for the submitted work;

no financial relationships with any organisations that might have an interest in the submitted work in the previous three

years; he is employed at Knowledge Ecology International, a non-profit consumer and human rights organisation that has been

active in debates on access to medicine; has been a paid consultant to the Global Fund for AIDS, TB, and Malaria, and the

UN Human Rights Council, and has also served in an unpaid capacity on several boards and committees of non-profit organisations

that focus on access to drugs and

policies on intellectual property rights.

Provenance and peer review: Commissioned; not externally peer reviewed.

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