India must not get into bed with Europe - millions of lives at stake

[Guest guest]

AFRICA: EU-India deal could threaten access to essential HIV drugs NAIROBI, 9

November 2010 (PlusNews) - As Indian and European officials meet in Brussels to

thrash out the details of a Free Trade Agreement (FTA), civil society activists

are concerned the deal could mean tighter intellectual property protections that

could reduce access to cheap Indian generic drugs.

" The European Union is pushing for data exclusivity, which means Indian generics

manufacturers would no longer be able to use existing studies to make identical

drugs, a practice recommended by WHO [uN World health Organization] – they

would

have to conduct their own clinical trials, which would be unethical and

redundant since we already have evidence that the drug works, but also, the data

exclusivity could last anywhere between five and 10 years, delaying poor

countries' access to these drugs for long periods, " Childs, director of

policy and advocacy for Médecins Sans Frontières' campaign for access to

essential medicines, told IRIN/PlusNews.

 

More than 80 percent of all donor-funded antiretroviral drugs used in developing

countries are Indian generics; the availability of cheap ARVs

has enabled more than five million people globally to access essential HIV

treatment. Until 2005, the country did not grant patents on medicines, but World

Trade Organization (WTO) rules now require India to grant patents. Indian law

only grants patents on drugs that show a therapeutic benefit over existing ones;

activists fear that trade agreements like the EU-India one could override these

public health concerns.

According to a 2010 study published in the Journal of the International AIDS

Society this year, " future scale-up using newly recommended ARVs will likely be

hampered until Indian generic producers can provide the dramatic price

reductions and improved formulations observed in the past " . The authors

recommend that rather than agreeing to inappropriate intellectual property

obligations through FTAs, India and its trade partners " should ensure that there

is sufficient policy space for Indian pharmaceutical manufacturers to continue

their central role in supplying developing countries with low-priced,

quality-assured generic medicines " .

Childs accused Europe of employing " dirty legal tricks " to circumvent India’s

public health protections and boost its own pharmaceutical

industry, which could have fatal consequences.

However, European officials deny that the FTA with India will interfere with the

capacity of India’s generics industry. The EU spokesman for trade,

Clancy,

told IRIN/PlusNews by email that the EU intended to follow the Trade Related

Aspects of International Property (TRIPS) laid out by the WTO, which include –

under the Doha Declaration - provisions for countries to override intellectual

property rights in the interests of public health.

For example, TRIPS gives countries the right, in specific situations such as

public health emergencies, to issue compulsory licences - an

authorization given by a government to a third party to produce a patented

invention without the permission of the patent-holder.

" Data exclusivity is an issue we are discussing with India but taking fully into

account India's specific needs and interests - such as India's legal system, its

policy developments, its developing country status and the role it plays in

producing generic medicines for the developing world, " Clancy said. " The

[European] Commission explicitly recognizes India's right to issue compulsory

licences for life-saving medicines. "

But Childs says on its own, data exclusivity is an example of TRIPS-plus, which

refers to tougher or more restrictive conditions than required by TRIPS.

" Europe is using the fact that few people understand the technicalities of TRIPS

and the implications of data exclusivity to appear virtuous by

claiming that they will abide by the Doha Declaration while at the same time

tying India into an agreement that could make generics more expensive and delay

their access to people in the developing world who need them, " she said.

Kamau, who has lived with HIV for more than a decade and heads the Kenya

Treatment Access Movement, says if India " got into bed " with Europe, it could

have catastrophic consequences for people living with HIV in Africa.

" This would be a marriage of convenience with a child called profit, but this

marriage would also result in death for many Africans, particularly those who

need newer, second-line drugs that may now take years to reach them, " he said.

" This would not only affect HIV – most of the drugs we take here are Indian

generics, so anything that harms that industry harms the health of millions in

Africa. "

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