[Ip-health] HEALTH-INDIA: Campaign to Stop Monopoly of Clinical Trial Data

[Joana Ramos]

http://www.ipsnews.net/news.asp?idnews=3D36541

HEALTH-INDIA:
Campaign to Stop Monopoly of Clinical Trial Data
Inter Press Service News Agency
Keya Acharya

BANGALORE, Feb 13 (IPS) - As public health groups await the outcome of
Swiss pharmaceutical giant Novartis AG=92s legal challenge to India=92s
patent law, a campaign is building up against a parallel move to obtain
'data exclusivity' on clinical trial data submitted to government for
marketing approval.

Under the drug regulatory process any drug, whether patented or not,
must pass safety, efficacy and quality tests for marketing from the Drug
Controller-General of India (DGCI). The DGCI thus requires the
manufacturer to submit data from three phases of clinical trials.

As per current law, the DGCI can rely on previous test data to approve
subsequent generic versions of the same drug. This allows generic drug
manufacturers to circumvent expensive repeats of clinical trials that
translate into cheap and quick drug availability in the market.

But in 2005, the powerful Pharmaceutical Research and Manufacturers of
America, (PhRMA) lobbied the United States Trade Representative to
impose data exclusivity on drug trial submissions, through the US Trade
Act=92s ( USTA) =91Special 301=92 clause.

The Special 310 clause identifies India and most other developing
countries as having inadequate intellectual property rights under the
World Trade Organisation (WTO)=92s trade-related intellectual property
rights (TRIPS) rules.

PhRMA is based in the U.S., but its membership includes the world's
major pharmaceutical companies, including such names as Pfizer,
Novartis, GSK, and Merck. Their bid for data protection, under clause
39.3 of TRIPS has found easy coincidence with the U.S.=92s interests in
India on nuclear deals, agricultural, trade, commerce, industry and
other agreements.

Many of these pharmaceutical majors are now also outsourcing clinical
trials to India through contract research organisations (CROs), ramping
up profits by taking advantage of lax laws and cheaper operational costs.

An UNCTAD document explains that article 39.3 in TRIPS does not prevent
a government authority from relying on test data from one company to
assess similar drugs from another company, making the U.S. demand a
=91TRIPS plus=92 stipulation.

If India amends its Drugs and Cosmetics Act, the DGCI will be barred
from relying on test data already in its possession for approving
generic medicines. The generic manufacturer, though not legally barred
from producing a drug, will nevertheless be forced to repeat
already-proved safety and efficacy trials, raising costs.

Public health groups assert that the implications of data exclusivity go
well beyond the obvious, protesting that this is yet another move by
MNCs to monopolise the drug market in India, to the detriment of public
health and the market for essential generic drugs.

Should Novartis, for instance, lose its legal bid to have India=92s patent
law amended, it may still be able to exert market monopoly for at least
5 years, if =91data exclusivity=92 becomes legal.

"We are very clear that 'data exclusivity' in its present proposed form
cannot be introduced into the Drugs and Cosmetics Act,=92=92 says Shankar
Rajkumar, Advocacy officer at the Lawyers=92 Collective in Bangalore.

Lawyers' Collective and the All India Drug Action Network together with
several national and international public-health organisations,
including Medecins Sans Frontieres (MSF), say it is unethical to repeat
clinical trials, thus driving up prices of generic drugs.

International charity Oxfam writes: "The U.S. government continues to
use bilateral and regional trade agreements outside the WTO to pressure
developing countries to implement TRIPS-plus standards. "

Several public health groups, including networks of HIV positive
patients have written in protest to Indian Prime Minister Manmohan
Singh. These groups, though invited to discuss their concerns by India=92s
Ministry of Chemicals and Fertilisers, say their suggestion to allowing
generic companies to pay royalty to the original drug company for use of
its data, was not heeded.

The ministry is due shortly to bring out a report for tabling in
Parliament, based on the outcome of several inter-ministerial meetings
on the issue pending since mid-2006.

''The basic point is that data protection has to be given -- but in what
form is being currently weighed,'' G.S. Sandhu, a high official at the
ministry told IPS. Sandhu said his ministry was aware of public concerns
on affordability and monopolistic trade practices.

India=92s 124,995 AIDS and 5.1 million HIV positive cases pay 497 US
dollars per year for first-line treatment, and approximately 3,532
dollars per year for second-line treatment. These costs will skyrocket
if data exclusivity pushes generic drugs out of the market.

The Indian Network of Positives have demanded that the government now
include these expensive second -line treatment drugs into its
free-distribution scheme, but questions arise on how the government will
afford this.

''It is not so much the affordability of second-line treatment, since
all treatment is anyway expensive; it is that we are still focusing on
first-line treatment to be fully established,=92=92 says Sujatha Rao,
director general of India=92s National Aids Control Organisation.

India is one of the world=92s largest providers of cheap, generic drugs.
MSF alone provides treatment to over 80,000 AIDS cases in 30 countries,
sourcing the bulk of its generic drugs from India that has helped bring
treatment costs down from 10,000 dollars annually per patient to 130
dollars.

--
Joana Ramos, MSW
Cancer Resources & Advocacy
7303 23rd Ave. NE
Seattle, WA  98115
206-229-2420
http://ramoslink.info/