India veering towards TRIPS-plus provisions in EU trade talks?
This article was originally published in Scrip
India is believed to be veering towards a position that would allow the inclusion of a host of 'TRIPS-plus' provisions as part of the proposed EU-India free trade agreement (FTA), much to the concern of Indian generics firms and NGOs.
India's position, according to industry experts, could be part of a quid pro quo of sorts that would probably safeguard India's rights in the area of geographical indications (GI), while allowing the EU more favourable intellectual property rights (IPR) provisions in return. The EU hopes to finalise the FTA this year.
"We understand that, over-ruling objections of four ministries, the Prime Minister's Office has decided to concede EU demands for TRIPS-plus provisions in India's IPR regime. The main concerns relate to supplementary protection certificates, data exclusivity, patent linkage and dilution of standards of patentability," said Dilip Shah, secretary general of the Indian Pharmaceutical Alliance (IPA), which represents leading domestic firms.
This has very serious implications not only for the national pharmaceutical industry but also for public health and medicine security, Mr Shah added.
Industry experts also claim that the potential gains on GI rights appear miniscule in comparison to what was being "traded away" to the EU. GIs involve the use of a place of origin name to describe a particular product or biological asset.
India's commerce and health and family welfare ministries, in addition to the department of industrial policy and promotion (DIPP), are among those that are said to have voiced concern against such TRIPS-plus provisions over the recent past.
The DIPP had earlier strongly opposed suggestions on the need to tweak Indian patent legislation to include provisions such as data exclusivity. It had specifically referred to a World Health Organization briefing note on the subject in 2006, which apparently stated that such exclusivity will obstruct the speedy entry of generic drugs, delay competition and thus put back the price reduction of drugs.
"The downsides of data exclusivity include providing unnecessary protection to non-patented/off patented drugs as well as creating a barrier to the issue of compulsory licenses by Government," the DIPP said in one note last August.
The humanitarian body Médecins Sans Frontières (MSF), which had in December last year staged a protest outside the EU-India summit held at the European Commission HQ in Brussels, has also expressed concern over the potential inclusion of a data exclusivity provision, possibly up to 10 years, that will limit the sale of generic medicines.
"There is to date no indication that the EU will refrain from pursuing such measures in the negotiations," MSF said then (scripintelligence.com, 14 December 2010).
The IPA too has been a strong opponent of TRIPS-plus measures. The industry body had earlier argued that provisions for supplementary protection certificates in the proposed EU-India FTA are unsuited to India, given its current development status and its regulatory apparatus.
The alliance had claimed that the prime movers of patent term extensions for medicinal products are the US, Japan and Europe (although several countries in Europe are said to have reservations), which have "near-universal" healthcare systems funded by the state or health insurance schemes. This is in stark contrast to the situation in India, where most people have to pay out-of-pocket for their medicines.
"Delay in the availability of affordable generics by extending patent monopolies is not warranted by consideration of socio-economic welfare at the current stage of India's development, or that of many other developing countries that India supplies affordable medicines to," the IPA had said at the time.
Some experts also add that should India permit the inclusion of such TRIPS-plus provisions, it could find itself in a 'Catch-22' situation where its domestic patent laws and the FTA offer varied levels of IPR protection. "India will not like to renege on its FTA commitments, so this could be considered a backdoor attempt to seek a review of the domestic regulations as well," one expert claimed.