[Ip-health] News: PharmaTimes- India mulls compulsory licensing for cancer drugs

Terri - Louise Beswick Terri at haiweb.org
Tue Aug 31 09:06:56 PDT 2010

India mulls compulsory licensing for cancer drugs


World News | August 31, 2010


Lynne Taylor


India's government is asking for comment on proposals that it should
introduce compulsory licensing for medicines such as cancer drugs, which
are unaffordable for the vast majority of patients.


India has 2-2.5 million cancer patients and around 700,000 are
newly-diagnosed each year. A conservative annual estimate of the value
of medicines needed to treat them would be 50 billion rupees, yet Indian
sales of cancer drugs total only 1.5 billion rupees a year, says a
discussion paper published last week by the Department of Industrial
Policy and Promotion (DIPP). 


"The big gap indicates the near non-accessibility of the medicines to a
vast majority of the affected population mainly because of the high cost
of these medicines," it notes.


Compulsory licensing could also enable more of India's HIV/AIDS patients
to be treated, says the discussion paper, which notes that while no
compulsory licenses have been issued under India's patent regime, about
52 developing and less-developed countries have done so since the World
Trade Organisation (WTO)'s Doha Declaration. Wealthy nations have also
issued compulsory licenses, including the US, Canada, Italy and the UK,
where, it says: "compulsory licensing has been used by the National
Health Service (NHS) in the past. It imported drugs, patented in the UK
from countries where no pharmaceutical patent had been granted, on the
ground of 'Crown use.' Such provisions continue to exist in British


The DIPP discussion paper also considers the report of India's
Parliamentary Standing Committee on Health and Family Welfare, which was
published in early August and expressed a number of concerns. The first
of these is the high prices of newly-patented drugs which are not being
regulated by the National Pharmaceutical Pricing Authority (NPPA) and
the need to bring more drugs under its control.


Even for the 74 drugs which are regulated by the NPPA, drugmakers have
increasingly been adopting "unorthodox practices," under which they
substitute regulated drugs with "new ingredients in popular brands to
avoid regulation," says the Committee.


The Standing Committee is also worried about the "super profits being
generated by some drug companies who price their products significantly
above cost, and the need to explore possibilities of capping profit
margins for all medicines, including those not covered by the Drug Price
Control Order (DPCO).


Finally, the Committee notes its concern at the takeover of Indian
drugmakers by foreign firms, stressing the need to "generate policy
options to ensure that major Indian pharma companies remain in Indian


Of the four possible responses available to the Indian government for
dealing with these issues, only one - compulsory licensing - is
immediate, says the DIPP, and it is asking for comment on whether
changes are needed here, to be received by September 30.


It also puts forward three short-term policy options - on which the
discussion paper is not seeking comment. The first of these would be to
invoke the Competition Act 2002 to examine whether the price or
availability of a drug is a consequence of an anticompetitive agreement
or a "combination" which has an adverse effect on competition, or the
abuse of a dominant position by a company, and to therefore initiate
"suitable action."


The second short-term option is to review the policy on foreign
investment for pharmaceutical companies. "Presently, investment up to
100% in the pharmaceutical sector is on the automatic route," says DIPP,
which suggests that this could be "shifted to the government route so
that proposals for mergers and acquisitions in this important sector
could be scrutinised by the Foreign Investment Promotion Board (FIPB).
This could be a way of monitoring whether new technology is being
brought in by a foreign company while taking over an Indian company."


The third short-term option, the Department suggest, is to expand the
ambit of the NPPA and give it the power to regulate the prices of a
larger number of drugs than the present 74.


65% of the Indian population still lacks access to essential drugs, and
the need for affordable and high-quality medicines is critical for the
sustainable growth of the Indian economy, says the DIPP.



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