[Ip-health] News: AlJazeera- EU deal threatens HIV drug supplies

Terri Beswick Terri at haieurope.org
Fri Nov 5 02:06:09 PDT 2010


EU deal threatens HIV drug supplies  

 

How a trade deal being brokered between Europe and India could cut off
the developing world's supply of cheap medicines.

Andrew Wander Last Modified: 04 Nov 2010 13:56 GMT 

 

Aids patients in developing countries could lose access to medicines as
a result of the EU trade deal [GALLO/GETTY] 

 

Until recently, Loon Gangte thought the days of watching his friends die
of Aids because they couldn't get access to medicine were firmly in the
past.

 

In a decade and a half since being diagnosed with HIV, Gangte, a 43
year-old living in New Delhi, has seen his illness transform from a
death sentence into a manageable condition, thanks largely to the
availability of cheap medicines produced in India.

 

"When I was diagnosed in 1997 there was medicine, but I could not afford
it," he says. "Only rich people from the West could pay for it, so I had
no treatment. All I could do was eat healthily, sleep regularly and
hope."

 

But with no access to essential anti-retroviral treatment, his condition
deteriorated. "According to the books, I was in the final stage of HIV -
I had Aids," he explains. But as he prepared for the worst, he was given
a lifeline: Indian-made generic medicines became available at a fraction
of the price charged by Western drug companies.

 

"My life changed totally. I'd lost 99.9 per cent of my best friends to
Aids," he says. "Why did I live and they die? It's simple- I had access
to these drugs."

 

Gangte's story should have ended there, another human life prolonged by
the steady march of medical progress. Instead, seven years later, he
says he is coming to terms with a new threat to his health: an
international trade agreement being brokered between the European Union
and India that medical experts warn could leave millions of HIV
sufferers in developing world without the drugs they need to stay alive.

 

Dirty legal tricks

 

The charity Medicins sans Frontieres (MSF) says that hidden clauses in
the free trade agreeement (FTA) currently being negotiated between
Europe and India will prevent the manufacture and distribution of
crucial generic medicines produced in the country.

 

"There are dirty legal tricks being used," says Dr. Tido von
Schoenangerer, who runs the MSF campaign for essential medicines. "Any
person living with HIV in the developing world is facing a future
scenario in which the medicines they need will be under threat."

 

Meanwhile the World Health Organisation, the UN's public health body,
has echoed MSF's concerns, saying that if the trade deal does indeed
include clauses governing the production of cheap generic medicines, the
ramifications for the public health could be serious.  

 

The issue hinges on a so-called "data exclusivity" provision in the free
trade agreement, which campaigners say would effectively copyright
information gathered in the clinical trials that prove the effectiveness
and safety of medicines.

 

At present, generic manufacturers rely on the results of the original
clinical trials carried out by the drug developer to get their cheap
version registered. If this information were to become exclusive, Indian
companies would be left without the data they need to register their
drugs.

 

"It means companies will have to repeat the trials, which not only would
be very costly, but raises ethical issues because it is basically doing
research to find out something that is already known," says von
Schoenangerer.

 

Dr. Hans Hogerzeil, director of the essential medicines and
pharmaceutical policies department of the World Health Organisation
(WHO), agrees that data exclusivity could pose a real threat to access
to medicines. 

 

"If data exclusivity clauses are indeed included that go beyond the
patent period, then we have real public health and ethical concerns
about this," he says. "First, it would delay the market entry of
generics; and secondly if generic manufacturers are forced to repeat
clinical trials, it is ethically unjust to conduct such trials on
patients when the data are already available."

 

The European Union says that data exclusivity clauses are included in
the FTA, but insists they will not affect India's ability to produce
generic medicines. "Data exclusivity is an issue we are discussing with
India but taking fully into account India's specific needs and
interests," says John Clancy, the EU's Trade spokesman. 

 

Developing world's pharmacy

 

The debate over generic drugs goes to the heart of the way medicines are
produced and distributed around the world. India's pharmaceutical
industry makes most of its money producing cheap generic versions of
drugs patented by its Western counterparts, bypassing a system designed
to ensure drug developers are rewarded with a period of exclusive sales
rights for new medicines.

 

 

Loon Gangte says he fears losing access to crucial medicines as a result
of the trade deal 

 

The patent system is supposed to incentivise the production of new
treatments and ensure that research costs are recouped. But it also
creates a monopoly, allowing drug companies to charge whatever they see
fit for their products, which are often desperately needed by the sick.

 

As a result, prices for patented drugs are high, beyond the reach of the
world's poorest people. In market terms, high demand and limited supply
mean healthy profits for pharmaceutical companies. 

 

But Indian rivals eat away at this profit. Competition amongst drug
producers can prompt massive falls in the cost - HIV treatment, for
example, has come down from around $10,000 dollars a year in 2000 to
just $70 a year today.

 

India's unique laws governing medicine production have helped provide
affordable healthcare to its huge population, and exports of these drugs
have cemented the country's reputation as the "pharmacy of the
developing world".

 

"India is a well known supplier of generic medicine," say Hogerzeil.
"For example, at least half of the five million Aids patients in Africa
already on treatment rely on Indian generic medicines for their
treatment." 

 

In the first half of this decade, India came under intense pressure from
the World Trade Organisation (WTO) to issue patents on drugs. It agreed
to do so in 2005, but ensured certain loopholes remained open that would
allow the continued generic manufacture of medicines deemed essential by
authorities.  

 

But essential medicines are among the most profitable, and
pharmaceutical companies turned their lobbying from the WTO to
individual governments, pushing them to broker bilateral restrictions
with India on generic drug production.

 

One of these governments was the supra-national European Union, whose
powerful member states are home to many multi-national drug companies.
The EU has held meetings and other exchanges with a range of
stakeholders, including representatives of the pharmaceutical industry.
Campaigners fear that the EU is now effectively negotiating with India
on behalf of its pharmaceutical industry.  

 

Counterfeit confusion

 

Health experts have also become increasingly concerned about a separate
treaty being negotiated by rich countries aimed at tackling the
international counterfeiting trade. The anti-counterfeiting trade
agreement (ACTA) negotiations are reportedly nearing their end and could
have a big impact on generic drug production.

 

The treaty is supposed to block the production of fake medicines, but
activists say that counterfeit medicines are deliberately being
conflated with generic medicines to interfere with their production and
distribution.

 

"There's a real threat from the FTA and ACTA in the way counterfeit
medicines will be defined," says MSF's von Schoenangerer. "Everyone
agrees we need to fight against fake medicines, but counterfeiting rules
are being used to protect trade interests."

 

The Indian generic pharmaceutical industry is predicting a global health
crisis if restrictions are introduced as a result of the trade
agreements.

 

"Outside India, the cost of medicines will go up or they will not be
available at all," says DG Shah, secretary general of the Indian
Pharmaceutical Alliance. "In India, the effects of this drop in supply
will be felt- the cost of medicine will go up, because production scales
have, until now, been a factor in keeping process low."

 

Human rights issue

 

The European Commission has flatly denied that its negotiations will
have a negative impact on India's generic medicine industry. "We are not
trying to limit the capacity of key Indian generic producers to export
to other developing countries," Clancy, the bloc's trade spokesman,
says.

 

But World Health Organisation says until a draft of the agreement is
released, concerns over its contents will persist.

 

"The department of essential medicines of WHO has never been given a
copy of the draft of the free trade agreement, so we are reacting to
rumours, not to what we have seen," says Hogerzeil.

 

"That said, the rumours are persistent that there are certain provisions
that could possibly delay the production of generic medicines. That
would be a very serious threat to public health."

 

Hogerzeil says that access to essential medicine is a "human rights
issue" and insists that both the European Commission and the Indian
government should "fully consider the global public health interest when
finalising the new trade agreement."

 

Fighting for life

 

Meanwhile, as the final details of the FTA and ACTA are hammered out,
many of those who rely on essential medicines produced in India have no
idea that the supply of medicines that keep them alive could be under
threat.

 

Those who are aware, like Loon Gangte, are doing what they can to ensure
their voices are heard. "These negotiations are a threat to my life,"
says Gangte, who now campaigns on behalf of HIV patients in India.
Generic drugs have allowed him to turn his life around - his HIV virus
is now undetectable and he has even been able to have a child with his
HIV-negative wife.

 

But without his medicines, he knows his illness would quickly take hold
again. "My virus keeps working, 24 hours a day, 365 days a year. It
doesn't take a holiday," he says. "We are doing all that is possible to
stop this from happening. We are fighting for our lives."

 

http://english.aljazeera.net/indepth/2010/10/2010102920031160477.html




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