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http://www.hindu.com/2007/06/04/stories/2007060401361300.htm
Date:04/06/2007 URL: http://www.thehindu.com/2007/06/04/stories/20070=
60401361300.htm
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National
An important win for domestic pharma industry
Sarah Hiddleston
``Committee concludes that there is no need to change laws that=
govern drug registration''
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a.. Need for transparent legal mechanisms
a.. Additions should be made to the Drugs and Cosmetics Act
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Chennai: In an important win for the domestic pharmaceutical industry=
, a government committee has concluded that there is no need to change the =
laws that govern drug registration in the country. It has recommended again=
st allowing pharmaceutical companies exclusive rights to clinical trial and=
other test data they submit when registering a new drug for sale in the co=
untry. Instead, it proposed that data be treated as a trade secret under co=
mmon law. However, it suggested that this might be reviewed after an unspec=
ified period of debate.
The Satwant Reddy Committee, an inter-departmental group, was constit=
uted in February 2004 to review the protection of undisclosed information i=
n the light of intellectual property rights set down by the World Trade Org=
anisation. It submitted its report to the Ministry of Chemicals and Fertili=
zers on May 31 =97 the day its chairman, Satwant Reddy, stepped down from o=
ffice.
It noted that the country was entitled to determine the appropriate m=
ethod of implementing WTO intellectual property rights recommendations but =
pointed out that there was a need for transparent legal mechanisms to prote=
ct undisclosed test data. As such, it recommended separate provisions for t=
hree different sectors. So while it advocated that test data for pharmaceut=
ical drugs be protected as a trade secret under common law, it has recommen=
ded giving three years of exclusive rights to test data for companies regis=
tering new agro chemicals and five years of exclusive rights to test data f=
or companies registering new traditional medicines. This would effectively =
give a company that first registers a new product sole access to the market=
for the duration of the right.
The domestic pharmaceutical industry will avoid the delays, costs, an=
d the ethical black hole of retesting a generic drug. This is because the d=
rugs regulator, which judges how safe and effective a drug is, will continu=
e to be able to refer to the clinical trial data of an original drug to app=
rove generic versions that are chemically the same (bio equivalent).
Multinational pharmaceutical companies, backed by the US and the EU, =
had lobbied for a five-year data protection term to recoup investments in c=
linical trials and encourage innovation. They claimed that Indian practice =
constituted ``unfair commercial use'' and contravened the internationally a=
greed guidelines laid down by the World Trade Organisation on intellectual =
property.
The domestic pharmaceutical industry and public interest groups had o=
pposed this. They argued that it was a means for foreign owned pharma compa=
nies to avoid competition and make extra profits on drugs with expiring pat=
ents or drugs that were not patented because they lacked innovation. They m=
aintained that WTO intellectual property rights, which award patents for in=
novation, were being deliberately confused with the separate process of reg=
istering drugs.
In committee reasoned, that "there was enough flexibility in the [WTO=
] TRIPS [trade related aspects of intellectual property rights] Agreement f=
or a country to determine the appropriate means of protecting test data.'' =
It cited paragraph 4 of the Doha declaration, which states that the WTO Agr=
eement should be "interpreted and implemented in a manner supportive of WTO=
members' right to protect public health and... promote access to medicines=
." It also recommended that in order to ensure confidentiality of data, add=
itions should be made to the Drugs and Cosmetics Act 1940 to specify third =
party liability for unauthorized use and make data protection enforceable t=
hrough courts.
However, the committee kept the door open for higher standards of dat=
a protection for a pharmaceutical innovator in the future. It suggested a f=
ive-year data exclusivity model for discussion with 14 safeguards to preven=
t excessive monopolies and enable the government to override data protectio=
n in the case of a public health emergency.
G.S. Sandhu, Joint Secretary, Department of Chemicals and Fertilizers=
, which authored the report, said that the future model for pharmaceuticals=
was not a recommendation but a base from which discussion should begin. He=
stressed the importance of as wide a debate as possible and said that crit=
ical upgrades were necessary in the infrastructure and technical skills of =
the drug regulator before higher standards of protection could be considere=
d.
=A9 Copyright 2000 - 2006 The Hindu
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