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," Michelle 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, John 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.
James 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."
kr/mw
"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," Michelle 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.
 Data exclusivity could last anywhere between five and 10 years, delaying poor countries' access to these drugs for long periods |
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.
| Read more | |
 India rejects ARV patent applications, saving "countless lives" |
|
| Seizure of drug shipment threatens ARV access |
|
| Generic medicines walk the plank |
|
"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."
kr/mw
This article was produced by IRIN News while it was part of the United Nations Office for the Coordination of Humanitarian Affairs. Please send queries on copyright or liability to the UN. For more information: https://shop.un.org/rights-permissions
Share this article