[Ip-health] A bitter pill for pharma units

Shailly Gupta shailly.gupta at geneva.msf.org
Mon May 4 21:45:37 PDT 2015


A bitter pill for pharma units

A new IPR policy was to have been announced in early 2015 and the industry
is still optimistic that the govt will not alter the very regime that enabed
India's generic industry to grow.

The thriving Indian generic pharmaceutical industry has, over the past
decade, earned its stripes globally as a source of reliable and cheap
generic versions of exorbitantly priced medicines made by multi-national
pharmaceutical companies. However, India's pre-eminent position could take a
hit if the changes in the Indian patent regime sought by the U.S. Trade
Representative (USTR) are put in place.

Last week, in its annual report on IPR (intellectual property rights) laws
and patents and its partner countries, the USTR announced it was continuing
to keep India under 'priority watch' list even as it stopped short of
imposing an out-of-cycle review of India's IPR laws. The report said China
and India were the sources of the most counterfeit pharmaceuticals shipped
to the U.S.

The report praised the Government efforts to increase bilateral engagement
in IPR matters. But the industry was surprised with the Indian Prime
Minister's statement that India needed to align its patent laws with
international standards. There have also been fears raised on the
unpredictability of India's IPR regime.

"India should not buckle under any pressure as our patent laws are already
TRIPS-compliant," D. G. Shah, Secretary General, Indian Pharmaceutical
Alliance (IPA) said. On a possible fall in foreign direct investment (FDI)
in the sector if it did not comply, he said, "Multi-national pharma
companies have been divesting their interests here and world-wide, there is
no correlation between an IPR and FDI."

"Increased levels of intellectual property - over and above what
international rules mandate - will not bring in 'investments' but create
exclusive rights for profiteering and further serve to undermine what
remains of generic competition in India," a letter addressed to the PM and
Commerce Minister from Delhi Network of Positive People (DNPP) an outfit
that works with AIDS patients said.

The industry particularly wants the government not to introduce data
exclusivity, which bars Indian Food and Drug Administration (FDA) from
approving a competitor's product as long as exclusivity on the data lasts
even for off-patent medicines.

Granting data exclusivity does away with the recourse to pre-grant
oppositions and compulsory licensing. "Being a major producer of generic
drugs, it would also hinder bulk procurers like MSF and bring into question
the future of the public procurement programmes," Leena Mehenganey, India
Manager, Access Campaign, MSF (Doctors without borders), said. "Accepting it
would lead to monopolies on patented and non-patented products through a
regulatory process."

A new IPR policy was to have been announced in early 2015 and the industry
is still optimistic that the government will not alter the very regime that
enabled India's generic industry to grow.



Shailly Gupta

MSF Access Campaign

New Delhi


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