[Ip-health] Economic Times: Pharma firms will have to wait a while for data exclusivity norms

[Achal Prabhala]

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Pharma firms will have to wait a while for data exclusivity norms


GIREESH CHANDRA PRASAD

TIMES NEWS NETWORK[ WEDNESDAY, APRIL 18, 2007 01:59:00 AM]

NEW DELHI: Call it the Mashelkar effect! The Satwant Reddy committee, which=
 is examining whether MNCs should be allowed to guard their costly clinical=
 data from local rivals, is unlikely to take a call on the issue in the nea=
r future.

The decision has been taken considering the sensitive nature of the issue a=
nd the strong opposition NGOs and a section of the pharmaceutical industry =
recently put up against R A Mashelkar=92s report on patent laws, which appa=
rently favoured MNCs.

Mr Mashelkar, who resigned from the technical expert group following charge=
s of plagiarism, had said that not allowing patents on incremental innovati=
on would violate WTO agreements. While the Left parties want further tighte=
ning of the law, MNC pharma companies seek a more generous regime.

The law was designed in 2005 as a compromise between the two, with a commit=
ment from the government to get it reviewed by Dr Mashelkar.

Sources said that the data exclusivity panel may not submit its report by M=
ay, when Mrs Reddy is slated to retire as the chemicals and fertilisers sec=
retary. The government apparently does not want another controversy at this=
 point of time by granting data exclusivity =97 a demand from big pharma co=
mpanies =97 which would either delay the arrival of copycat versions of pat=
ented MNC drugs in the market or make them less price competitive.

Besides, the panel is yet to arrive at a consensus with the health ministry=
, which approves new drugs, on the issue.

It is understood that health minister A Ramadoss had opposed granting of da=
ta exclusivity at the April 10 group-of-ministers meeting on the new pharma=
ceutical policy. Mr Ramadoss pointed out that nothing beyond protection aga=
inst leakage or theft of data submitted to the government can be granted, s=
ources said.

Moreover, it is in the government=92s interest to reserve grant of data exc=
lusivity as a possible bargaining chip in the WTO negotiations later on.

It is interesting to note that the former chairman of the committee and Mrs=
 Reddy=92s predecessor in the ministry, Pratyush Sinha, too, had felt at th=
e end of his tenure that time was not ripe to take a view on the issue.
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