PHA-Exchange> Victory over Novartis

[Gopal Dabade]

A great success story,
From
Dr GOPAL DABADE,
57, Tejaswinagar,
DHARWAD 580 002.
INDIA
+91 (0)836-2461722
+91 (0)9448862270
drdabade at gmail.com


     *SECOND ARTICLE*

*Feb 10, 2006*
       *SECOND ARTICLE*

*Feb 10, 2006*

    *Patent remedy for India's health*
Friday February 10 2006 08:01 IST

*Priti Radhakrishnan*

Just how wealthy do you have to be to buy medicines in India? The UPA
government is about to decide. After the controversial Patent Amendment Act
was passed in March 2005, the government is now about to take critical
decisions impacting access to health. Its position will affirm or negate its
commitment to the promises of the Doha Declaration on Public Health, the
Common Minimum Programme and the health of ordinary Indians.

A few days ago, cancer patients won a stunning victory in Chennai. The
patent controller ruled against multinational conglomerate Novartis AG in
the Gleevec case, stating that Novartis had not shown any improvement over a
known compound. Controversy raged last year after Novartis was granted an
exclusive marketing right for the anti-cancer drug imatinib mesylate,
commonly known as Gleevec. This prevented other domestic companies from
making the drug and resulted in the price of Gleevec rising from Rs 10,000
per month (already out of reach for most Indians) to Rs 1.2 lakh per month.

Prices of other drugs are also expected to rise. One study estimates price
increases in one therapeutic class alone will be between 100-400 per cent.
The controller's ruling is significant as it sends a clear message to drug
companies that they can't obtain frivolous patents through chicanery:
patents will be granted only for real inventions. Last year, various
ministers stated that if medicine prices increase excessively in India due
to the patent regime, the government will intervene. In the case of Gleevec,
it was the unparalleled determination of the Cancer Patients Aid
Association, with the support of civil society and Indian drug companies,
that led to this adjudication. The government's only response was inaction.

It is time to demonstrate a commitment to health. The commerce and chemicals
ministries could begin by taking the inputs of the health ministry on issues
connected to pharmaceutical patents. The rebirth of the product patent
regime sounded the death knell for affordable generic medicines. Monopolies
on medicines, heretofore considered unacceptable for India, will now be the
norm as India complies with its WTO/TRIPS obligations in a manner that goes
beyond the call of duty. It is an open question as to which drugs will be
patentable, as the patent controller decides on issues of 'efficacy' and
'economic significance', standards that no country has employed. As a
result, without patent opposition from domestic patients and manufacturers,
there is scope for abuse and 'evergreening' to extend monopolies on
medicines.

Difficult decisions lie ahead. After the patent act passed, one of the open
issues was referred to a technical committee headed by Dr A.R. Mashelkar.
The committee will recommend whether the scope of patentability for drugs
will be limited to new chemical entities or expanded to include mere
modifications. Civil society groups have written to the PMO asserting that
the patent controller's grant of pharmaceutical patents will be ultra vires
(beyond his powers) and should be enjoined until the issue is decided. It
remains to be seen what action the PMO takes. The pressure is on.

The government, however, has some options. First, it can take decisive
action to check the scope of patentability and data protection. Health
groups are watching to see if the UPA is committed to protecting health as
promised. Thus far, there have been no mechanisms introduced to safeguard
the rights of patients. The defunct Drug Price Control Order can hardly be
used as a shield for the government to hide behind, even with a new
pharmaceutical policy on the anvil. Demonstrating commitment to open,
consultative processes on issues impacting access will be an important step
in the right direction.

Second, the UPA can ensure that flexibilities are utilised. In the event of
grant of a patent they can order immediately a licence under Section 92 for
public health crises such as HIV, TB or potentially the 'bird flu' pandemic.
Alternatively, they can override patents for "government use" purposes. The
health ministry must act swiftly to ensure licences are granted for drugs
desperately required in the next stage of India's HIV/AIDS epidemic.

The government would be wise to note that even these measures are merely
preliminary safeguards. It is hardly effective as a public health measure to
put a patient on TB medicines if she will thereafter succumb to another
disease such as diarrhoea. But for now, the question is, how seriously will
the government take its immediate commitment to public health?

*The writer is coordinator, the Affordable Medicines & Treatment Campaign*


--
Dr Gopal Dabade,
57, Tejaswinagar,
Dharwad 580 002
Tel 0836-2461722
Cell (0)9448862270
www.jagruti.org
-------------- next part --------------
An HTML attachment was scrubbed...
URL: <http://phm.phmovement.org/pipermail/phm-exchange-phmovement.org/attachments/20060210/287c7169/attachment-0001.html>