[Ip-health] Conceding data exclusivity will damage domestic drug industry - Dr. Joshi

[Mike Palmedo]

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Conceding data exclusivity will damage domestic drug industry=97Dr Joshi

The Organizer
July 4, 2006

Former Union Minister and senior BJP leader Dr Murli Manohar Joshi has
urged the Prime Minister Dr Manmohan Singh to look into the matter of
data protection urgently so that the Trade Related Aspects of
Intellectual Property Rights (TRIPS) measures are not pushed by the
ministries concerned for legislation.

In a letter to Prime Minister, dated June 16, Dr Joshi said during the
Uruguay Round of GATT negotiations the question of data protection or
data exclusivity was specially discussed. The demand of USA and other
developed countries for data exclusivity was rejected and only specific
provision was incorporated in section 7 of the TRIPS Agreement for
Protection of un-disclosed information.

He said the demand for data exclusivity has been raised at bilateral
level with our government by the MNCs and the US government. It is
understood that the concerned ministries have been deliberating on this
issue for the last 3 to 4 years and now they are at the verge of
conceding to the bilateral demand of data exclusivity instead of
implementing data protection as stipulated in the TRIPS Agreement.

=93The WTO agreement on TRIPS stipulates implementation of eight types of
Intellectual Property Rights (IPR). One of the IPR topics deals with the
=91Protection of Undisclosed Information=92. While we have enacted or
amended laws relating to other IPRs we have not legislated on protection
of Undisclosed Information. This topic of IPR is supposed to be covered
by suitable amendments to our Drugs and Cosmetics Act 1950. Providing of
data exclusivity has serious implications for the role of domestic
enterprises in the fields of pharmaceutical and agro-chemical products.
If data exclusivity is conceded domestic enterprises would be prevented
from taking marketing approval on the basis of the data submitted by the
first enterprise, who had generated the data and submitted the same for
taking marketing approval. Even if the domestic enterprise has been
granted compulsory licence to use the patented subject matter they would
be prevented from taking marketing approval during period the data
exclusivity is in operation. Thus, stipulation of TRIPS Agreement would
be rendered unimplementable and competitive environment, which could be
created would also be lost,=94 the letter said.

Dr Joshi pointed out that the World Health Organisation (WHO) had
thoroughly examined this issue in a document prepared by them. He said
the WHO, in conclusion, has recommended that the developing countries
would be well advised to keep the two systems of IPR and drug regulation
separate, and to reject any and all efforts to make connections between
them. He further said that the data exclusivity issue and its serious
implications were also brought to the notice of the Department Related
Parliamentary Standing Committee on Commerce in a meeting held recently.
=93In my opinion the views of the WHO deserve an indepth consideration. I
urge with you to kindly look into the matter urgently so that this kind
of TRIPS plus measures is not pushed by the ministries concerned for
legislation,=94 he added.