PHA-Exch> Press Release to defend Indian generics

[Gopal Dabade]

http://www.cbgnetwork.org/2793.html

Coalition against Bayer Dangers

*Press Release, January 27, 2009*

Health Action International Asia Pacific (HAIAP)

Peoples Health Movement - India

Coalition against Bayer Dangers (Germany)

*Health groups: Defend affordable drug treatment in India*

*Bayer sues Indian Government to retain monopoly rights / International
coalition demands protection of generic pharmaceuticals*

Health groups call on German drugmaker Bayer to cancel the suit against the
Indian government and domestic drug company Cipla in order to protect
affordable drug treatment. The organizations fear that the fate of generics
in India may hinge on this case and that thousands of Indians will die
without affordable pharmaceuticals.

Last year Bayer sued the Indian government in the Delhi High Court for
giving marketing approval to Cipla for Bayer's patented cancer drug
Sorafenib. At present, the Indian drug regulator DCGI can give a marketing
approval to a generic drug even if the medicine is patented in India. Public
health experts point out that marketing approval for a drug is not an
infringement of a patent, and the generic company can be challenged once it
launches the drug.

Amit Sen Gupta from the Indian Peoples Health Movement says: "The Bayer case
has implications for drug access, not just for patients in India, but for
poor people in large parts of the world. It would mean giving sanctity to
higher standards of patent protection than what is required even by the
TRIPS agreement. Bayer not only seeks to safeguard its own monopoly right,
the company also wants to set a precedent that other corporations can
benefit from. In essence it would mean that the entry of generic versions of
life saving drugs would be delayed."

Philipp Mimkes from the Coalition against Bayer Dangers, an international
network based in Germany, adds: "The interest of patients is at risk if
marketing approvals are linked with patents. Countries like India must have
the possibility to issue compulsory licenses to generic companies or to
impose price controls in order to make available affordable drugs. We demand
that Bayer quits this suit! Safeguarding public health must take precedence
over patents and monopoly profits of drug companies!"

The case seeks to link the patent status of a drug with the procedures
related to the drug's marketing approval. Across the globe, such linkage is
the exception rather than the rule. That is so because the body responsible
for granting patent applications is distinct from the one that grants
approval for marketing. To ask drug regulators to do the job of the Patent
office is incorrect because they don´t have the expertise to decide on
patent related issues.

The Indian law has a provision for post-grant opposition, i.e. the grant of
a patent can be challenged on several grounds after it is granted. A blanket
bar on granting marketing approval to drugs which have been granted patents
would mean that this provision becomes ineffective– the generic company
would not be able to make use of this provision immediately even if a patent
grant is overturned.

Moreover, both the TRIPS agreement and the Indian law allow medicines to be
legally registered even when the drug is under patent protection. It can be
allowed so that the generic version of the medicine can be made immediately
available as soon as the patent term of a medicine expires or as soon as a
compulsory license is issued to a generic company. It can also be allowed in
situations where the medicine is used for research purposes. This provision
is an important health safeguard because it allows generic manufacturers to
conduct tests on its generic version, so that it is ready for marketing as
soon as it is legally possible. In the case of life saving drugs, even a
delay of a few months in the introduction of cheaper generics can mean
hundreds or thousands of deaths among patients who would die, not because
there is no treatment, but because the treatment with a patented medicine is
too expensive.

If Bayer's plea is upheld, it would be in violation of the Indian Patent
Act. This would be extremely unfortunate, as it would mean overturning some
of the health safeguards that the Indian Parliament had put in place when
the Indian Act was amended in 2005 to make it TRIPS compliant. It may be
recalled that the Indian Parliament, while putting in place these safeguards
had taken into account the very large mobilisation of people – in India as
well as across the globe - demanding that India continue to function as a
source for affordable generic medicines.

See also The Times of India: "Fate of generics hinges on Bayer case"
http://timesofindia.indiatimes.com/Fate_of_generics_hinges_on_Bayer_case/rssarticleshow/3998349.cms


contact:

·         Dr K Balasubramaniam, HAI Asia – Pacific, Tel: +94 112 554353,
bala at haiap.org, www.haiap.org

·         Amit Sen Gupta, Peoples Health Movement India, ctddsf at bol.net.in,
http://phm-india.org

·         Philipp Mimkes, Coalition against Bayer Dangers,
CBGnetwork at aol.com, www.cbgnetwork.org


-- 
http://novartisboycott.org/petition

Dr Gopal Dabade,
57, Tejaswinagar,
Dharwad 580 002
Tel 0836-2461722
Cell (0)9448862270
www.jagruti.org
http://aidanindia.wordpress.com/
www.daf-k.cjb.net
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