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Wednesday, December 11, 2013
- While ‘data exclusivity’ clauses will not feature in the India-European Union free trade agreement (FTA), the threat posed by the impending deal to the world’s supply of cheap generic drugs is far from over.
India’s commerce and industry minister Anand Sharma assured Michel Sidibe, chief of the United Nations joint programme on HIV and AIDS (UNAIDS) at a meeting this week that India would reject attempts by pharmaceutical giants to include data exclusivity clauses in the FTA.
“The government of India reaffirms its full commitment to ensure that quality generic medicines, including antiretroviral (ARV) drugs, are seamlessly available, and to make them available to all countries,” Sharma said.
Sidibe was told that India will resort to flexibilities allowed under World Trade Organisation (WTO)’s Trade Related Aspect of Intellectual Property (TRIPS) agreement to ensure that people living with HIV have access to life-saving medicines.
Data exclusivity clauses are designed to stop clinical test or trial data submitted to regulatory authorities to prove the safety and efficacy of a drug from being used by the manufacturers of “copy cat” generic drugs.
“No data exclusivity and no TRIPs Plus are the stated positions that India takes on all such occasions,” Sachin Chaturvedi, senior fellow at the Research and Information System (RIS) for the Developing Countries, a New Delhi-based autonomous, state-funded, think-tank set up to promote South-South cooperation, told IPS.
After his meeting with Sharma, Sidibe said in a statement that the BRICS countries – Brazil, Russia, India, China and South Africa – could “forge an alliance with other high-income countries to ensure that no single person in the world dies for inability to afford life-saving medicines or healthcare.”
Brazil, which has a growing generic drugs industry, has also not accepted data exclusivity in bilateral deals.
Chaturvedi said that in the present climate of FTAs it makes sense for the BRICS countries to collaborate and produce affordable drugs, especially against infectious diseases in the developing world.
India’s generics industry is a world leader producing more than 85 percent of the first-line antiretroviral (ARV) drugs used to treat people living with HIV, pushing down the cost of the least expensive first- generation treatment regimen to less than 86 dollars per patient per year.
“Millions of people will die if India cannot produce generic ARV drugs, and Africa will be the most affected,” the UNAIDS chief said.
“Data exclusivity would have blocked the production and sale of affordable generic medicines by giving big pharma a backdoor means to get a monopoly on drugs ineligible for a patent under Indian law,” Leena Menghaney, a lawyer with the non- government organisation Médecins Sans Frontieres (Doctors Without Borders) told IPS.
“We understand that the EU will no longer push for data exclusivity,” Menghaney said. “Over the last few months there has been an amazing global mobilisation against the harmful policies in the proposed EU-India trade deal,” she added.
The World Health Organisation, UNAIDS and the Global Fund to Fight AIDS, Tuberculosis and Malaria have also lent weight to those concerns.
However, Menghaney said, the EU continues to push several other policies in the Indo-EU FTA trade deal that will make it harder for affordable generic medicines to be produced and exported.
She pointed to “IP enforcement” provisions that would allow the seizure of legitimate generic drugs and incriminate those handling such medicines, including MSF.
Worries include “investment” provisions that would allow EU companies operating in India to sue the government if their profitability is threatened by legislation.
For example, enforcement of bigger pictorial warning on cigarette packets or banning a carcinogenic chemical could attract compensation claims worth millions of dollars.
“This could happen under investor-state arbitration proceedings on the grounds that such measures damage investments and profits,” Menghaney explained.
Menghaney said the MSF, together with the other groups that are fighting EU’s policies, will continue to oppose efforts to stop the flow of affordable generic medicines that MSF relies on to treat patients in more than 60 countries.
Menghaney believes that the best way forward is for the BRICS countries to pool their strengths and markets to beat the challenges thrown up by the Western intellectual property systems, which work by blocking access to medicines and research data.
Increasing numbers of people are taking to more efficacious and tolerable first-line treatment. Also, as patients develop drug resistance and require costly, patent-protected second and third-line ARVs, costs are bound to escalate several fold.
An estimated 15 million people are eligible for ARV treatment in low and middle-income countries, and about 6.6 million people have access to HIV treatment. India alone provides free ARV treatment to more than 420,000 people living with HIV.
Pharmaceutical companies argue that generation of test data is costly and that it is unfair to allow the manufacturers of generics to ride on data submitted for registration purposes.
On the other hand, it has been pointed out that that repeating scientific tests on human beings, purely for commercial reasons, violates ethical norms.
In 1970, India eliminated patents on drug products and used its large domestic market to develop a powerful generic drug industry that gave it the reputation of being a “pharmacy to the world”.
“But, in 2005, India implemented changes required by the WTO’s TRIPS agreement and it is only after that India began providing patent protection,” Chaturvedi said. “What is needed now is a firm developing countries position on drug access.”