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Threat to generic drugs

Shaikh Azizur Rahman, New DelhiApril 25, 2013

As a free trade agreement between the European Union and India reaches the final stages, activists are worried it could stifle India’s ability to supply affordable lifesaving drugs.

https://p.dw.com/p/18NK7
Image: AP

India has become known as the "pharmacy of the developing world" since it leads in the production of generic drugs that have been crucial for treating patients with HIV/AIDS, malaria, cancer and many other illnesses.

However, Indian manufacturers have often been accused by international pharmaceuticals giants of flouting intellectual property rights. Although the government introduced the Indian Patents Act in 2005 after coming under pressure to conform to World Trade Organization rules, the EU is still pushing for stronger patent protection.

AIDS activists and people living with HIV march against EU-India deal (AP Photo/Khalil Senosi)
Many HIV/AIDS patients across the world use Indian-made genericsImage: AP

'Data exclusivity'

Under a "data exclusivity" clause in the proposed FTA, generic drug manufacturers would not be able to use clinical research submitted by the original drug maker to seek a license to produce a generic version.

Anand Grover, Senior Advocate and Director of  the Lawyer's Collective which campaigns for affordable drugs and patients' rights thinks this would be extremely detrimental.

"It would virtually cut down the ability of Indian manufacturers to produce affordable generic medicines," he told DW. "And that would be a colossal mistake because millions of people across the world depend on India as the pharmacy of the developing world."    

"Such provisions will not only undermine our citizens' fundamental rights such as the rights to health and access to medicine, they also threaten to subvert the fundamental tenets of the constitution of India," he added.

Kajal Bhardwaj, a Delhi-based lawyer working on HIV, health and human rights issues, agreed: "The EU's demands aim to change this fine balance in Indian law. For instance, leaked texts show that the EU is demanding that patent holders have the power to ask Indian courts to freeze the bank accounts of generic companies and seize their property in patent disputes."

Indian man working in a pharmaceutical laboratory, 2005. (Foto: Arindam Mukherjee /Landov +++(c) dpa)
India has been nicknamed the pharmacy of the developing worldImage: picture-alliance/ dpa

"This will threaten the production of all medicines by generic companies who may be in those disputes," he told DW.

Bhardwaj added that humanitarian groups such as Doctors Without Borders had publicly expressed apprehension that the EU's demands would mean that treatment providers could also get dragged into patent disputes and be subject to court orders hampering their work.

'A death sentence'

Earlier this month, hundreds of people with HIV and cancer demonstrated against the EU-India FTA in Delhi, expressing their misgivings that it will deny them access to affordable generics.

"If the production of Indian generic drugs stops, patented ARVs might possibly be 100 to 150 times more expensive. This will jeopardize the lives of the HIV population in India," said Loon Gangte of the Delhi Network of Positive People.

He added that over 80 percent of the millions of people who have HIV in Asia and Africa take Indian generic anti-retroviral (ARV) drugs. "The cost of the medication has come down to 70 or 80 US dollars per person per year. In 2001, the cost of drugs from multinational companies was 10,000 US dollars."

"In the past 10 years, I haven't found it that difficult to pay for my Indian generic ARV medication," he said. "Now if the generic ARV becomes unavailable to me, I shall never be able to afford to buy the patented ARV drug from a multinational company. Then, I will stand before a death sentence."

India and the EU are due to sign the agreement within the coming weeks.