[e-drug] India will not accept data exclusivity

E-DRUG: India will not accept data exclusivity
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INDIA SAYS 'NO' TO POLICY THAT WOULD BLOCK ACCESS TO AFFORDABLE MEDICINES
Focus shifts to remaining harmful provisions in EU-India trade deal

NEW DELHI/BRUSSELS, 22 June 2011
India formally announced at the UN High Level Meeting on HIV and AIDS that it will not accept data exclusivity, a provision harmful to access to affordable medicines, as part of a free trade agreement (FTA) currently being negotiated with the European Union (EU). Although this is an important victory for the global mobilisation against the potential negative impact of the FTA on access to medicines, further harmful measures remain on the negotiating table, the international
medical humanitarian organisation Medecins Sans Fronteres (MSF) said
today.

'MSF and other treatment providers depend on a sustainable flow of
affordable generics from India to treat people across the developing world.
Saying 'no' to data exclusivity will reach far beyond India's borders in
terms of ensuring access to affordable medicines in developing countries'
said Dr Tido von Schoen-Angerer, Executive Director of MSF's Campaign for
Access to Essential Medicines. 'This is a big victory, but we're not
letting up until we see all the potentially harmful policies off the
table'.

By delaying the registration of generic versions of a medicine by up to ten
years, data exclusivity would effectively have given a backdoor monopoly
status to companies, even for drugs that do not deserve a patent under
India's law. The clause, which was criticised by global health actors
including the Global Fund, WHO, UNAIDS, and UNITAID, threatened to further
limit price-busting generic competition in India, thanks to which the price
of HIV medicines has fallen by 99% over the last ten years.

The announcement by India at the AIDS Summit now means both the EU and
India have officially confirmed data exclusivity will not be part of the
FTA text. MSF is now calling on Europe to remove other harmful clauses from
the EU-India FTA negotiations.

'Europe is still pushing provisions on the enforcement of intellectual
property that are of great concern for procurers and suppliers of
medicines, like MSF, as they put us at risk of litigation,' said Michelle
Childs, Director of Policy/Advocacy of MSF's Access Campaign.

By allowing patent holders to target all persons involved in the
production, manufacture and delivery of medicines suspected of infringing
an intellectual property right, these provisions could draw in treatment
providers like MSF into legal proceedings. Enforcement provisions also
increase the risk of medicines being seized at Indian borders.

A second area of concern is the investment chapter of the FTA which
includes measures to protect the commercial interests of foreign companies
investing in India. Pharmaceutical companies would have the right to bypass
Indian courts and sue the Indian government in secret international
arbitration panels that do not balance public health against private
profit. This could lead to the Indian government facing long legal battles
over millions of dollars in damages if, for example, a drug company sees
its patent or trademarks (its 'investment') threatened by the actions of
the government - even if those actions are lawful means to protect public
health.

'At the recent AIDS Summit, governments - including European governments -
committed to reaching 15 million people with HIV treatment by 2015', said
Michelle Childs. 'Yet at the very same time, Europe is also pushing
policies that will limit options to ensure access to low-cost versions of
the newer drugs that people need to stay alive. This is unacceptable. The
EU must drop the remaining clauses that are harmful to public health.'

In 2010, MSF launched the HANDS OFF campaign to call on the EU to drop the
policies harmful to access to medicines being pushed as a part of the
EU-India free trade agreement. MSF sources more than 80% of the HIV
medicines it uses to treat more than 170,000 people living with HIV/AIDS
from manufacturers of generics in India.

In March 2011, around 4,000 people from across Asia living with HIV/AIDS
and other life-threatening diseases marched in the streets of New Delhi to
protest the impact the FTA could have on access to affordable medicines.

To read more about MSF's HANDS OFF campaign, visit www.msfaccess.org

Kind regards

Joanna

Joanna Keenan
Press Officer
Campaign for Access to Essential Medicines
Medecins Sans Frontieres
T: +41 22 849 87 45
M: +41 79 203 13 02
joanna.keenan[at]geneva.msf.org