[Ip-health] The Hindu: Extreme TB: No licence to heal

Thiru Balasubramaniam thiru at keionline.org
Sat Mar 3 21:52:11 PST 2018



Extreme TB: No licence to heal

Vidya Krishnan
NEW DELHI, MARCH 03, 2018 22:04 IST
UPDATED: MARCH 03, 2018 22:05 IST

Compulsory licence for 2 drugs may be needed, but Centre isn’t ready yet

Advanced patented medicines used to treat Drug Resistant Tuberculosis
(DR-TB) are available to only about 1,000 patients out of the tens of
thousands who need it, because the innovator-manufacturers are not ready to
licence Indian drug-makers who can sell them at affordable prices.

Bedaquiline and Delaminid, the new-generation drugs, are recommended by the
World Health Organisation (WHO) for DR-TB patients.

It is five years since Bedaquiline became available, but India has fewer
than 1,000 patients on it. Only 81 patients have access to Delaminid,
according to the Union Health Ministry.

“These numbers are terrifying. India does not seem to be mounting emergency
measures to deal with the airborne disease,” said Prof. Jennifer Furin of
Harvard Medical School, US, who has closely followed TB drug access in

Only donations

Nearly 1.3 lakh DR-TB patients need treatment but the Health Ministry has
only 10,000 doses of Bedaquiline and 400 doses of Delaminid, obtained as
‘donations’ from Janssen (US) and Otsuka Pharmaceuticals (Japan), the
respective manufacturers.

On September 19, 2017, a panel chaired by Dr. Soumya Swaminathan, then
Director-General of the Indian Council of Medical Research and currently
the Deputy Director-General of the World Health Organisation (WHO)
recommended, among other steps, that the Health Ministry consider issuing a
compulsory licence (CL) for the two TB drugs.

Dr. Swaminathan said recently that India should consider the CL option for
the two drugs, if the country runs out of options.

“We need better access to new TB drugs. We need to think of some feasible
strategies,” she said.

“One particular strategy would be to think about compulsory licensing.
Before we get to that point, we need to have a dialogue with the companies
about voluntary licensing. We have enough companies in India that can
manufacture and market these drugs and cost can be brought down and at the
same time, the innovator company will get their royalties. I would think
the VL option should be the one to be really explored. We should keep CLs
for when we run out of options,” she said.

A CL can be issued by the government, as provided for by the World Trade
Organization’s trade-related intellectual property regime, in case of
‘extreme urgency’ and ‘national emergency,’ without waiting for voluntary

The Union Health Ministry told The Hindu that it had requested Janssen and
Otsuka, to grant Voluntary Licenses (VL) to Indian manufacturers.

A VL would allow Indian companies to pay a royalty to the innovators and
manufacture generic, affordable versions. The Hindu found that both
companies turned down the Health Ministry’s request. While Janssen said it
will increase its donations, Otsuka did not respond to a query. Otsuka has
appointed Mylan India, subsidiary of US pharmaceutical company Mylan NV, as
a distributor (not manufacturer).

Sanjiv Navangul, managing director, Janssen India said, “since 2012 we’ve
donated approximately 1,000 courses of Bedaquiline in India through
compassionate use and controlled access programmes, and since April 2017,
we’ve supported the government’s move to expand treatment to 156 new sites
across the country by donating an additional 10,000 treatment courses of

A Janssen spokesperson said, Bedaquiline is manufactured in India and
exported. This has, however, upset domestic TB patients, who would have to
encounter rationing of medicines or face uncertainty after donations are
phased out in 2019. “Only 1,000 Indians have access to this medicine. What
do they plan to do after the donations run out? It is a violation of our
human rights to deny us treatment that exists,” said Ketholelie Angami, an

Active transmission

An estimated 1,300 Indians die due to TB everyday. India is home to the
largest number of TB patients, with 2.8 million suffering from the airborne
disease. Out of this, around 1,30,000 are the worst-affected as they have
become resistant to known medicines. Effective drugs are needed to prevent
spread of infection to families, co-workers and friends of patients.

The Health Ministry, however, has made little progress on Dr. Swaminathan’s
recommendations over the last six months. The compulsory licensing
committee has not met since 2014 and senior Ministry officials said they
would not consider the ‘CL route,’ due to pressure from the US government.
The Joint Secretary, Health Ministry, Sudhir Kumar, said the government was
unable to issue a compulsory licence because “no company has come forward
to apply for compulsory licence for the drugs before the competent

India exercised the CL option for the first time in 2012, and the Supreme
Court upheld the manufacturer, Natco’s move to make a generic version of
Bayer’s cancer drug Nexavar. The move cut the price of the drug by 97%,
from ₹2.8 lakh to ₹8,800.

Since then, the United States Trade Representative has demanded that India
protect patents of American pharmaceutical companies. D.G. Shah,
Secretary-General, Indian Pharmaceutical Alliance (IPA), a lobby group of
domestic drug makers said no generic company wanted to apply for a CL after
the “harassment” that Natco faced since it sought a CL.

The Health Ministry did not comment on why it was not invoking the
‘government-use’ CL option, for which an application from a domestic
company is not required.

In 2017, a teenage girl from Patna took the Centre to court over access to
the two TB medicines and won. The victory has not significantly increased
access to the medicines.

But with the option of compulsory licence ruled out, and the companies that
manufacture Bedaquiline and Delaminid refusing to issue VLs, the price at
which the drugs will be sold are to be decided in meetings between
officials of the TB programme and pharmaceutical companies.

Health Ministry sources said Bedaquiline is likely to be priced at $900 for
a six month course while Delaminid could cost each patient $1,700 for a six
month course. Patients with drug resistant TB typically need a course of 18
months of both drugs, which means a cost of about ₹5.1 lakh per patient.

Andrew Hill, Professor of Molecular and Clinical Pharmacology at the
University of Liverpool estimates that a generic version of Bedaquiline
could be sold at $54 - $96 and Delaminid at $24 - $54 for a six month
course if a generic company got a license.

Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org

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