Certain intellectual property (IP) proposals being negotiated as part of the free trade agreement between India and the European Free Trade Association (EFTA) could have serious implications for access to affordable generic medicines in India and other developing countries, civil society and patient groups say.
A leaked draft on February 13 suggests that the India-EFTA trade deal includes excessive intellectual property provisions that may require India to weaken pro-public health safeguards, according to the international medical humanitarian agency, Médecins Sans Frontières (MSF), and patient groups.
Health groups have stated that if the final text retains the currently included harmful IP proposals, access to cheaper generics for millions worldwide may be severely undermined. One of the key concerns is the proposal to introduce an additional IP barrier—data exclusivity (DE)—which could potentially delay the manufacturing of generic versions of new medicines, biologics, and preventive HIV therapy for a defined period, even when there is no patent on the medicine.
The proposed changes in India’s drug regulatory and patent laws, if finalized and accepted, could have a devastating impact on the future supply of potentially life-saving medicines from India, often referred to as the ‘pharmacy of the developing world.’
For instance, MSF heavily depends on India for its procurement of generic medicines, estimated at 95% for HIV, 90% for hepatitis C antivirals, 36% for tuberculosis (TB) treatments, and 30% for vaccines.
“Over the last two decades, the fact that India did not have data exclusivity in its law facilitated the affordable entry of new drugs for HIV, TB, and viral hepatitis, which MSF has been able to use to treat people in our care. Implementing data exclusivity now has the potential to jeopardize access to essential medicines in general, as well as to delay the approval of generic versions of newer medicines, such as pediatric formulations for new TB drugs for which patents have expired. In Jordan, for example, where data exclusivity was introduced as part of the US-Jordan FTA, a study found that of 103 medicines registered and launched between 2002 to 2006 that had no patent protection in Jordan, 79% had no competition from a generic equivalent because of data exclusivity,” said Leena Menghaney of MSF.
The provision goes beyond obligations under international trade rules enshrined in the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), a representative of MSF said, adding that the agency has appealed to the government to “reject the proposal.”
“India is already TRIPS-compliant, and should continue with this position,” a representative of the pharma industry told TOI.
“Let’s remember that prices of newer medicines drop by over 90% when there is generic competition from India. So, for the multinational pharmaceutical industry, data exclusivity will expand their monopolies and profiteering by blocking the availability of generics from India. India has been through this before with the EU-India trade agreement and other FTAs, where similarly harmful provisions undermining access to medicines were rejected and withdrawn,” Loon Gangte, founder of Delhi Network of Positive People, said.
A leaked draft on February 13 suggests that the India-EFTA trade deal includes excessive intellectual property provisions that may require India to weaken pro-public health safeguards, according to the international medical humanitarian agency, Médecins Sans Frontières (MSF), and patient groups.
Health groups have stated that if the final text retains the currently included harmful IP proposals, access to cheaper generics for millions worldwide may be severely undermined. One of the key concerns is the proposal to introduce an additional IP barrier—data exclusivity (DE)—which could potentially delay the manufacturing of generic versions of new medicines, biologics, and preventive HIV therapy for a defined period, even when there is no patent on the medicine.
The proposed changes in India’s drug regulatory and patent laws, if finalized and accepted, could have a devastating impact on the future supply of potentially life-saving medicines from India, often referred to as the ‘pharmacy of the developing world.’
For instance, MSF heavily depends on India for its procurement of generic medicines, estimated at 95% for HIV, 90% for hepatitis C antivirals, 36% for tuberculosis (TB) treatments, and 30% for vaccines.
“Over the last two decades, the fact that India did not have data exclusivity in its law facilitated the affordable entry of new drugs for HIV, TB, and viral hepatitis, which MSF has been able to use to treat people in our care. Implementing data exclusivity now has the potential to jeopardize access to essential medicines in general, as well as to delay the approval of generic versions of newer medicines, such as pediatric formulations for new TB drugs for which patents have expired. In Jordan, for example, where data exclusivity was introduced as part of the US-Jordan FTA, a study found that of 103 medicines registered and launched between 2002 to 2006 that had no patent protection in Jordan, 79% had no competition from a generic equivalent because of data exclusivity,” said Leena Menghaney of MSF.
The provision goes beyond obligations under international trade rules enshrined in the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), a representative of MSF said, adding that the agency has appealed to the government to “reject the proposal.”
“India is already TRIPS-compliant, and should continue with this position,” a representative of the pharma industry told TOI.
“Let’s remember that prices of newer medicines drop by over 90% when there is generic competition from India. So, for the multinational pharmaceutical industry, data exclusivity will expand their monopolies and profiteering by blocking the availability of generics from India. India has been through this before with the EU-India trade agreement and other FTAs, where similarly harmful provisions undermining access to medicines were rejected and withdrawn,” Loon Gangte, founder of Delhi Network of Positive People, said.