[Commons-Law] Govt may not provide five-yr data protection to traditional medicines

[Prashant Iyengar]

http://www.business-standard.com/common/storypage_c.php?leftnm=10&autono=313109

Govt may not provide five-yr data protection to traditional medicines
Joe C Mathew / New Delhi February 09, 2008
The government may take back its earlier plan to provide five-year
data protection to traditional systems of medicine.

The change has been triggered by the Department of Ayurveda, Yoga,
Unani, Siddha and Homoeopathy (AYUSH) taking the view that such a
protection will lead to similar demands from the allopathic segment.

While the government has been supporting the move to introduce data
protection for traditional medicines, it has been reluctant to offer
similar protection to the pharmaceutical sector in general due to the
concerns of the domestic drug industry.

Domestic manufacturers say "data protection", which results in
"non-reliance" of data generated by the patent-holding company, will
increase the cost of drug production and delay the entry of generic
drugs into the domestic market.

Incidentally, it was the Department of AYUSH that initially proposed
such a protection to encourage generation of data for scientific
validation of traditional medicines.

The government's plans for data protection began after a high-level
inter-ministerial committee, set up by the Department of Chemicals and
Petrochemicals in 2004, favoured such protection for traditional
medicines and agro-chemicals.

Though the committee's mandate was to examine whether the current laws
of the country were adequate to meet the obligations for "data
protection" under the TRIPS Agreement of the WTO, the issue of
providing data protection for traditional or herbal products, as
distinct from other pharmaceuticals, came up before the committee
through a submission by the Department of AYUSH in September 2006.

After considering the Department of AYUSH's submission, the committee,
in its report submitted in May 2007, recommended that irrespective of
the nature or the period of data protection granted to pharmaceuticals
in general, a five-year data protection should be provided for
traditional medicines.

It also wanted the health ministry to make amendments to the Drugs and
Cosmetics Rules, 1945, to effect the change.

The chemicals ministry has now found that the Department of AYUSH has
sought a review of the decision as it may have led to demand for data
protection for pharmaceutical products in general.

"There are serious concerns relating to the ever-greening of patents
under the guise of data protection and the need for providing
affordable drugs to people," it had reasoned.

Data protection to pharmaceuticals has been one of the most debated
issues due to the strong reservations expressed by the domestic drug
industry against such a move.

On the other hand, multinational drug majors have been saying that
data protection is a prerequisite for foreign investments in drug
research in India.

While the committee recommended a five-year data protection for
traditional medicines, it refrained from making such a recommendation
for other pharmaceutical products.