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[e-drug] Al Jazeera: EU deal threatens HIV drug supplies

E-DRUG: Al Jazeera: EU deal threatens HIV drug supplies
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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  

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

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 Schoen Angerer. 
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.  
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.
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Alexandra Lee
Webmaster/Online Content Editor
Médecins Sans Frontières- Campaign for Access to Essential Medicines
+41 22 849 89 88 (Direct Line)
www.msfaccess.org
Follow us on http://twitter.com/MSF_access
Join us on http://www.facebook.com/MSFaccess


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